Bubbling tablet, bubbling bath additive tablet, bubbling washing detergent tablet, bubbling tablet for oral administration, and process for producing these
Claim Score by NHIP
Abstract
A tablet body produced by compressing a mixture comprising granules of a main active ingredient, carbonate granules, and organic acid granules. Lubricant powders are attached on the surface of the tablet body, the lubricant powders being applied onto a punch and a die and transferred to the surface of the tablet body when a compressing step is executed using the punch and the die.

Term
Term ended
Projected expiry passed 17 January 2021, 5.7 years ago.
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24 claims: 18 independent, 6 dependent
- 1An effevescent tablet comprising a tablet body which is produced by compressing a mixture comprising granules of a main active ingredient, carbonate granules, and organic acid granules, wherein lubricant powders are attached on the surface of said tablet body, said lubricant powders being applied onto a punch and a die and transferred to the surface of said tablet body when a compressing step is executed using said punch and said die.
- 4The effevescent tablet as set forth in any one of claims 1-3, wherein said carbonate granules are those comprising at least one kind or a mixture of at least two kinds selected from the group consisting of sodium hydrogen carbonate, sodium carbonate, sodium sesquicarbonate, calcium carbonate, potassium carbonate, magnesium carbonate, calcium hydrogen carbonate, and potassium hydrogen carbonate.
- 11An effevescent tablet for oral administration, wherein each of said granules of a main active ingredient, said carbonate granules and said organic acid granules in said effevescent tablet, as set forth in any one of claims 1-5, are those granulated with a binder including a saccharide with high wettability for water, respectively.
- 12A production method of an effevescent tablet, comprising the steps of:preparing a mixture including granules of a main active ingredient, carbonate granules, and organic acid granules;applying lubricant powders onto a material contacting surface of each of a punch and a die, both being used for compressing said mixture to produce said tablet, and compressing said mixture with said punch and said die, on material contacting surfaces of which said lubricant powders are attached.
- 16The production method of an effevescent tablet as set forth in any one of claims 12-15, wherein said granules of a main active ingredient, said carbonate granules and said organic acid granules are blended such that the particle size distribution of their granule mixture presents a regular distribution with one peak.
- 17The production method of an effevescent tablet as set forth in any one of claims 12-16, wherein said carbonate granules are those comprising at least one kind or a mixture of at least two kinds selected from the group consisting of sodium hydrogen carbonate, sodium carbonate, sodium sesquicarbonate, calcium carbonate, potassium carbonate, magnesium carbonate, calcium hydrogen carbonate, and potassium hydrogen carbonate.
- 18
- 24A production method of an effevescent tablet for oral administration, wherein each of said granules of a main active ingredient, said carbonate granules and said organic acid granules used in the production method of an effevescent tablet as set forth in any one of claims 12-21 are granulated with a binder including a saccharide with high wettability for water, respectively.
Independent claims18
1,065 paragraphs in 16 sections, as filed
TECHNICAL FIELD
[0001] The present invention relates to an effevescent tablet, an effevescent tablet for a bath agent, an effevescent tablet for a washing detergent, an effevescent tablet for oral administration and production methods thereof. Specifically, the present invention relates to an effevescent tablet and an effevescent tablet for a bath agent which don't generate almost any oil film on an aqueous solution surface when the tablet is dissolved in water to be used, an effevescent tablet for a washing detergent which doesn't generate almost any oil film on an aqueous solution surface when the tablet is dissolved in water to be used and which is thrown in a washing machine as a detergent to wash clothes or the like, an effevescent tablet for oral administration which doesn't generate almost any oil film on an aqueous solution surface when the tablet is dissolved in water to be used and which dissolves rapidly, and production methods of these tablets.
BACKGROUND ART
[0002] An effevescent tablet for oral administration which is dissolved in water and taken as a solution such as a supplement of vitamin like vitamin C and iron, antacids, analgesics and cold remedies, and an effevescent tablet for a bath agent which is used in a bath tab have been already placed on the market.
[0003] Further, a powder or granular washing detergent including an fluorescent bleach, enzyme and so on which is used for washing clothes in a washing machine has been also placed on the market.
[0004] However, those effevescent tablets generate an oil film on an aqueous solution surface when they are dissolved in water.
[0005] Such an oil film is lubricants added in a molding material for preventing tabletting problems such as capping, laminating, sticking and binding when an effevescent tablet is produced by compressing with a punch and a die. Such an oil film doesn't have any problem for human health, however, there is a problem that a person taking a solution and who soaks in a bath tub with an oil film doesn't feel good.
[0006] The disintegration pattern and time varies depending on the conventional effevescent tablets for oral administration and it requires a certain time to obtain a solution after the tablet is put in water (namely, before the tablet is completely dissolved in water). Therefore, there is a request from a patient to develop an effevescent tablet which can rapidly dissolve in water.
[0007] Further, the powders or granules of washing detergent are contained in a case as a final product to be sold and a user takes them out of the case by means of a measuring scoop and put them in a washing machine.
[0008] However, there is a problem that powdered or granular washing detergent is apt to be spilled out of the scoop to be scattered around the washing machine or it may get the user's hand or fingers dirty when it is fed in a sink of the washing machine.
[0009] Furthermore, the washing detergent powders or granules contained in a case get easily wet during storage, a user loses a measuring scoop, or such a detergent is hardly taken along for a journey. Therefore, there is a desire from a user to develop a washing detergent which is superior in storage and usability.
DISCLOSURE OF THE INVENTION
[0010] The present invention has been proposed to solve the above-mentioned problems. The object of the present invention is to provide an effevescent tablet and an effevescent tablet for a bath agent which don't generate an oil film on a solution surface when it is dissolved in water, to provide a newly shaped washing soap which is superior in storage and usability, different from a conventional powdered or granular washing soap, to provide an effevescent tablet for oral administration which doesn't generate an oil film on a solution surface when it is dissolved in water, has uniform disintegration speed and pattern between tablets and further has a rapid dissolution speed against water comparing with conventional effevescent tablets for oral administration, and to provide a production method of such an effevescent tablet, an effevescent tablet for a bath agent, an effevescent tablet for a washing detergent and an effevescent tablet for oral administration.
[0011] According to the present invention, an effevescent tablet is comprised of a tablet body which is produced by compressing a mixture including granules of a main active ingredient, carbonate granules and organic acid granules, wherein lubricant powders are attached on an outer surface of the tablet body. The lubricant powders are applied on a punch and a die and transferred to the surface of the tablet body when a compressing step is executed using the punch and the die.
[0012] According to such an effevescent tablet, lubricants aren't contained in the mixture to be compressed with the die and the punch. Only a slight amount of lubricant powders applied on the die and the punch is transferred and lubricants aren't included in the effevescent tablet.
[0013] Therefore, when the tablet is dissolved in water for use, an oil film is hardly appeared on a solution surface.
[0014] Further, for producing effevescent tablets by compressing a molding material with a punch and a die in the conventional manner, lubricants are contained in a molding material in order to prevent tabletting problems such as sticking as mentioned above. Because the lubricants have a water repellency, if they are dispersed in an effevescent tablet, water has difficulty to be permeated in the tablet because of the water repellency when the effevescent tablet is put in water so that the dissolution speed of the tablet becomes slow.
[0015] On the other hand, according to the effevescent tablet of the present invention, the lubricants aren't contained in the mixture to be compressed with the punch and the die, the effevescent tablet is rapidly dissolved while producing carbon dioxide (CO<sub>2</sub>) because water is easily permeated in the tablet which is put in water.
[0016] Therefore, this effevescent tablet has a high dissolution speed against water comparing with a conventional effevescent tablet.
[0017] In order to achieve a function of an effevescent tablet, it is preferable that the sum of carbonate granules and organic acid granules other than granules of a main active ingredient is equal to or more than 10 weight %, or more preferably equal to or more than 30 weight % when the total weight of the tablet is 100 weight %.
[0018] According to the effevescent tablet of the present invention, the particle diameters of the granules of a main active ingredient, the carbonate granules and the organic acid granules are almost the same.
[0019] Such an effevescent tablet uses granules of a main active ingredient, carbonate granules and organic acid granules which have almost the same diameter.
[0020] When the composition of the granules of a main active ingredient, the carbonate granules and the organic acid granules at a fixed rate is mixed with a generally used mixer, each granule shows the same behavior against the external forces given by the mixer so that each granule can be uniformly mixed by itself without being distributed unevenly.
[0021] When thus obtained mixture is mixed with a generally used tabletting machine, each granule shows the same behavior against the external forces given by the tabletting machine so that each granule isn't distributed unevenly.
[0022] Therefore, the disintegration time, the disintegration pattern and the dissolution time of the tablet become uniform when the tablet is put in water for use because the granules of a main active ingredient, the carbonate granules and the organic acid granules are evenly dispersed in the effevescent tablet.
[0023] According to the effevescent tablet of the present invention, the granules of a main active ingredient, the carbonate granules and the organic acid granules are blended in such a manner that the particle size distribution of their mixture presents a regular distribution with one peak.
[0024] In the effevescent tablet, the composition rate of the granules of a main active ingredient, the carbonate granules and the organic acid granules is arranged in such a manner that the mixture has a regular particle size distribution having one peak.
[0025] As the composition in which the granules of a main active ingredient, the carbonate granules and the organic acid granules are blended at a fixed ratio is mixed with a general mixer, it shows the same behavior as the case when one kind of powder material having a regular distribution with one peak against the external force given by the mixer is mixed. Therefore, the composition is uniformly mixed by itself without being distributed unevenly per each granule.
[0026] As a result, the granules of a main active ingredient, the carbonate granules and the organic acid granules are uniformly dispersed in the effevescent tablet so that there is no difference between the disintegration time, the disintegration pattern and the dissolution time of the tablets when tablets are put in water.
[0027] According to the effevescent tablet of the present invention, the carbonate granules are those comprising at least one kind or a mixture of two kinds selected from the group consisting of sodium hydrogen carbonate, sodium carbonate, sodium sesquicarbonate, calcium carbonate, potassium carbonate, magnesium carbonate, calcium hydrogen carbonate, and potassium hydrogen carbonate.
[0028] Such components have been already established as safe components of carbon dioxide of an effevescent tablet and have been generally used. Therefore, the resulting tablet has no problem in view of safety.
[0029] According to the effevescent tablet of the present invention, the organic acid granules are those comprising at least one kind selected from the group consisting of citric acid, tartaric acid, fumaric acid, succinic acid, adipic acid, malic acid, and maleic acid.
[0030] The organic acid granules has safety which has been already established, are easily obtainable and can decompose carbonate to generate carbon dioxide (CO<sub>2</sub>) when they get in touch with water, therefore, the produced tablet has no problem in view of safety.
[0031] According to the effevescent tablet of the present invention, each one of the granules of a main active ingredient, the carbonate granules and the organic acid granules are those granulated with a water-soluble polymer as a binder, respectively.
[0032] The granules of a main active ingredient, the carbonate granules and the organic acid granules are granulated materials produced with water-soluble polymer as a binder. Therefore, if the effevescent tablet is put in water for use, a binder forming each granule is dissolved in water so that each granule is easily dissolved into a particle level.
[0033] As a result, when the effevescent tablet is put in water, the contacting area of the main active agent, the carbonate and the organic acid with water becomes large. Then a reaction takes place by the carbonate and the organic acid so that the tablet is rapidly dissolved in water while generating carbon dioxide.
[0034] According to the effevescent tablet of the present invention, each one of the granules of a main active ingredient, the carbonate granules and the organic acid granules are those granulated with a binder including a surfactant.
[0035] The granules of a main active ingredient, the carbonate granules and the organic acid granules are granulated using a binder including a surfactant.
[0036] As a result, the effevescent tablet is constructed in such a manner that between the particles comprising the granules of a main active ingredient, between the particles comprising the carbonate granules and between the particles comprising the organic acid granules are combined with the binder including a surfactant. Therefore, when the effevescent tablet is put in water for use, the binder bonding the particles comprising each granule easily gets wet because of a surfactant contained therein so that the granules of a main active ingredient, the carbonate granules and the organic acid granules are easily decomposed into a particle unit.
[0037] Because the effevescent tablet is constructed in a manner that the granule components are rapidly decomposed into a particle unit when they get in contact with water, the dissolution speed in water is increased comparing with a conventional effevescent tablet.
[0038] According to the effevescent tablet for a bath agent of the present invention, the granules of a main active ingredient of the effevescent tablet are sodium carbonate granules.
[0039] The sodium carbonate which has been already established as safety component, is easily obtainable and can generate carbon dioxide (CO<sub>2</sub>) getting in touch with water is used for the granules of a main active ingredient, therefore, such an effevescent tablet for a bath agent has no problem in view of safety.
[0040] Disintegrater, disintegration supplements, stabilizers, perfume agents, coloring agents and hot spring components are added in the effevescent tablet for a bath agent if necessary.
[0041] According to the effevescent tablet for a washing detergent of the present invention, the granules of a main active ingredient of the effevescent tablet include surfactant granules and fatty acid alkali salt granules.
[0042] The “fatty acid alkali salt” used herein is a soap component, for example sodium fatty acid.
[0043] The effevescent tablet for a washing detergent is shaped as a tablet, therefore, if one tablet has the amount to be used at one time for putting in the tub of the washing machine, one tablet is merely put in the tub for washing clothes. Unlike conventional powdered or granular washing detergents, it can save the trouble of measuring with a scoop each time of putting the detergents in the washing tub, therefore, such a tabletted detergent is facilitated to be used comparing with the conventional powdered or granular washing detergent.
[0044] Further because of the tabletted shape of the effevescent tablet for a washing detergent, there isn't problem such that powdered or granular detergent is scattered around the washing machine or a person's hands or fingers get dirty with the detergent when the detergent is put in the washing tub.
[0045] Disintegrater, disintegration supplements, stabilizers, perfume agents, coloring agents, enzyme and dispersing agent are added in the effevescent tablet for a bath agent if necessary.
[0046] It is preferable that the final product shape is a package of one effevescent tablet for a washing detergent in view of its storage.
[0047] According to the effevescent tablet for a washing detergent of the present invention, the effevescent tablet further includes anhydrous sodium sulphate.
[0048] Because anhydrous sodium sulphate with a hygroscopic property is included in the tablet, the tablet is prevented from naturally foaming by the moisture contained in air while the tablet is stored. Namely, such an effevescent tablet is superior in storage stability.
[0049] According to the effevescent tablet for oral administration of the present invention, the granules of a main active ingredient, the carbonate granules and the organic acid granules in the effevescent tablet are those granulated with a binder including a saccharide with high wettability for water, respectively.
[0050] The “saccharide with high wettability for water” means a saccharide which are superior in wettability for water and have a little viscosity increase when a fixed amount of saccharide is dissolved in a fixed amount of water.
[0051] More specifically the “saccharide with high wettability for water” means a saccharide which satisfies the kinetic viscosity of a sample solution with 1.0 g/100 ml concentration is equal to or less than 0.92 centistoke (cSt) or the solubility in water (25° C.) is equal to or less than 18 weight % when the viscosity is measured by the Ubbelohde viscosimeter according to the viscosity measuring method defined by the General Test Procedures of Japanese Pharmacopoeia, 13th edition.
[0052] In more detail, preferable samples of “saccharide with high wettability for water” include trehalose (0.891 cSt), mannitol (0.896 cSt), maltose (0.896 cSt), sorbitol (0.897 cSt), lactose (0.897 cSt), maltitol (0.904 cSt), xylitol (0.904 cSt), sucrose (0.912 cSt) and glucose (0.895 cSt).
[0053] The value shown after each component in parenthesis is the kinetic viscosity of the solution in which 0.5 g of each component is dissolved in 50 ml of water (25° C.).
[0054] The effevescent tablet for oral administration is produced by granulating each granules of a main active ingredient, carbonate granules and organic acid granules using a binder including the saccharide with high wettability for water.
[0055] As a result, the effevescent tablet for oral administration is constructed in such a manner that between the particles comprising the granules of a main active ingredient, between the particles comprising the carbonate granules and between the particles comprising the organic acid granules are combined with the binder including a saccharide with high wettability for water. Therefore, when the effevescent tablet for oral administration is put in water for dosing, the binder bonding the particles comprising each granule easily gets wet because of the saccharide with high wettability for water contained therein so that the granules of a main active ingredient, the carbonate granules and the organic acid granules are easily decomposed into a particle unit.
[0056] Because the effevescent tablet is constructed in a manner that the granule components are rapidly decomposed into a particle unit when they get in contact with water, the dissolution speed in water is increased comparing with a conventional effevescent tablet.
[0057] When the amount of medicament containing active ingredient in the tablet is quite slight, powders of the medicament containing active ingredient are added in powders of saccharide with high wettability for water to be mixed uniformly each other and the granulated powders of the mixture may be used as main particles.
[0058] According to the production method of the effevescent tablet of the present invention, the method is comprised of the steps of preparing a mixture including granules of a main active ingredient, carbonate granules and organic acid granules; applying lubricant powders onto a material contacting surface of each of a punch and a die both of which are used for compressing the mixture to produce the tablet; and compressing the mixture with the punch and the die on material contacting surfaces of which the lubricant powders are attached.
[0059] In the production method of the effevescent tablet, surfaces of a punch and die, which are used for producing a tablet by compressing the mixture, are applied by lubricant powders, and the effevescent tablet is produced by compressing the mixture with the punch and die on which the surfaces thereof are applied by the lubricant powder. It is not necessary to contain lubricant powder in mixture.
[0060] The effevescent tablet is produced in such a manner no lubricant powders are included in the mixture or almost no lubricant powders are included therein, an oil film hardly floats on the solution surface if the tablet is dissolved in water for use.
[0061] If lubricants are contained in the mixture (molding material), water has difficulty to be permeated in the tablet because of the water repellency of the lubricants when the effevescent tablet is put in water so that the dissolution, speed of the tablet becomes slow.
[0062] On the other hand, the effevescent tablet is produced according to the present invention wherein lubricant powders are applied on the material contacting surface of the punch and the die which are used for compressing a mixture to produce a tablet and the mixture is compressed with the lubricated punch and die. Therefore, even if lubricant powders aren't added in the mixture, the effevescent tablet can be produced without causing tabletting problems such as sticking and so on.
[0063] Hence, if such a production method of the effevescent tablet is used, the effevescent tablet without including lubricant powders therein or the effevescent tablet scarcely including lubricant powders can be produced. Therefore, according to the effevescent tablet produced by the production method of the present invention, water is rapidly permeated in the tablet so that the tablet is dissolved in water in a short time while generating carbon dioxide (CO<sub>2</sub>).
[0064] Comparing to the conventional effevescent tablet, the effevescent tablet obtained by the present production method has a higher dissolving speed in water.
[0065] In order to achieve a function of an effevescent tablet according to the present production method, it is preferable that the sum of carbonate granules and organic acid granules other than granules of a main active ingredient is equal to or more than 10 weight %, or more preferably equal to or more than 30 weight % when the total weight of the tablet is 100 weight %.
[0066] According to the production method of an effevescent tablet of the present invention, the step of applying lubricant powders onto a material contacting surface of each of a punch and a die which are used for compressing the mixture to produce the tablet is executed in a manner that lubricant powders mixed with and dispersed in a positive pulsating vibration air are sprayed onto the material contacting surface of each of the punch and the die which are used for compressing the mixture to produce the tablet.
[0067] In such a production method, the lubricant powders mixed with and dispersed in a positive pulsating vibration air is sprayed on the material contacting surfaces of the punch and the die. Therefore, a minimum amount of lubricant powders can be uniformly applied on the material contacting surfaces of the punch and the die by a function of the positive pulsating vibration air.
[0068] As a result of such a production method, an effevescent tablet can be continuously produced without causing tabletting problems such as sticking on the produced tablets and without causing grinding on the punch and the die during tabletting.
[0069] In other words, the production method can be preferably applied as a production method of an effevescent tablet which is industrially viable.
[0070] According to the production method of an effevescent tablet of the present invention, the step of applying lubricant powders onto a material contacting surface of each of a punch and a die, both being used for compressing the mixture to produce the tablet, comprises the steps of a first lubricant applying step in which lubricant powders are applied onto the material contacting surfaces of a lower punch and a die, and a second lubricant applying step in which lubricant powders are applied onto the material contacting surface of an upper punch. The lower punch, the upper punch and the die are used for compressing the mixture to produce a tablet. The first lubricant applying step is comprised of spraying lubricant powders mixed with and dispersed in a positive pulsating vibration air from a lubricant spray port for upper punch, which is provided in a lubricant application means, onto the material contacting surface of the lower punch, which is inserted in a predetermined position in the die; and further applying lubricant powders onto the material contacting surface of the die, in which the lubricant powders are those blown off from the material contacting surface of the lower punch by the positive pulsating vibration air among lubricant powders sprayed onto the material contacting surface of the lower punch. The second lubricant applying step is comprised of blowing lubricant powders into a direction of the material contacting surface of the upper punch from a slit-like lubricant spray port for upper punch provided in the lubricant application means, the lubricant powders being such lubricant powders as to be left as residual lubricant powders which have not been attached onto each of the material contacting surface of the lower punch and the die among those sprayed, while being mixed with and dispersed in the positive pulsating vibration air onto each of the material contacting surface of the lower punch and that of the die from a lubricant spray port for lower punch, which is provided in a lubricant application means; and moving the upper punch from an initial end of the slit-like lubricant spray port for upper punch to the terminal end thereof, thereby taking enough time and applying lubricant powders to the material contacting surface of the upper punch.
[0071] In such a production method of an effevescent tablet, lubricant powders mixed with and dispersed in a positive pulsating vibration air are sprayed from the lubricant powder spray port provided for the lubricant apply means on the material contacting surface (upper face) of the lower punch on which lubricant powders are apt to be easily accumulated by gravity, thereby extra lubricant powders on the material contacting surface (upper face) of the lower punch can be blown off by the positive pulsating vibration air.
[0072] Therefore, a minimum amount of lubricant powders can be uniformly applied on the material contacting surface (upper face) of the lower punch on which extra lubricant powders are easily applied by gravity.
[0073] The extra lubricant powders blown out of the material contacting surface (upper face) of the lower punch by a positive pulsating vibration air apply on the material contacting surface of the die. Then the extra lubricant powders on the material contacting surface of the die is fed to the slit-like lubricant powder spray port for upper punch provided for the lubricant apply means.
[0074] As the result, a minimum amount of lubricant powders can be uniformly applied on the material contacting surface (inner circumference) of the die.
[0075] Further according to the production method of an effevescent tablet, lubricant powders can be applied on the material contacting surface (lower face) of the upper punch on which lubricant powders are hardly applied by gravity in such a manner that lubricant powders are sprayed from the slit-like lubricant spray port for upper punch into the direction of the material contacting surface (lower face) of the upper punch of the lubricant apply means while the upper punch is moved from the initial end to the terminal end of the slit-like lubricant spray port for upper punch taking enough time.
[0076] Thereby, necessary amount of lubricant powders can be applied on the material contacting surface (lower face) of the upper punch on which lubricant powders are hardly applied by gravity.
[0077] In other words, according to this production method of an effevescent tablet, the application method of lubricant powders on the material contacting surface (upper face) of the lower punch and that on the material contacting surface (lower face) of the upper punch are differed, thereby necessary amount of lubricant powders can be uniformly applied on the material contacting surface (upper face) of the lower punch and the material contacting surface (lower face) of the upper punch and further necessary amount of lubricant powders can be also uniformly applied on the material contacting surface (inner circumference) of the die.
[0078] As a result of such a production method, an effevescent tablet can be continuously produced for a long time without causing tabletting problems such as sticking on the produced tablets and without causing grinding on the punch and the die during tabletting.
[0079] In other words, the production method can be preferably applied as a production method of an effevescent tablet which is industrially viable.
[0080] According to the production method of the effevescent tablet of the present invention, the diameters of the granules of a main active ingredient, the carbonate granules and the organic acid granules are almost the same.
[0081] The granules of a main active ingredient, the carbonate granules and the organic acid granules which have almost the same diameter are used in this production method.
[0082] Therefore, when the composition of the granules of a main active ingredient, the carbonate granules and the organic acid granules at a fixed ratio is mixed with a general mixer, each granule shows the same behavior against the external forces given by the mixer so that each granule can be uniformly mixed by itself without being distributed unevenly.
[0083] Further, when thus obtained mixture is mixed with a generally used tabletting machine, each granule shows the same behavior against the external forces given by the tabletting machine so that each granule isn't distributed unevenly.
[0084] Applying the production method, the effevescent tablet in which the granules of a main active ingredient, the carbonate granules and the organic acid granules are uniformly dispersed can be easily produced. Therefore, the required number of the effevescent tablet which has uniform disintegration time, disintegration pattern and dissolution time when the tablet is put in water for use can be easily produced depending on the user's needs.
[0085] According to the production method of an effevescent tablet of the present invention, the granules of a main active ingredient, the carbonate granules and the organic acid granules are blended in such a manner that the particle size distribution of their mixture presents a regular distribution with one peak.
[0086] In this production method, the blended ratio of the granules of a main active ingredient, the carbonate granules and the organic acid granules is designed such that the mixture has a regular particle size distribution with one peak after they are mixed.
[0087] As the composition in which the granules of a main active ingredient, the carbonate granules and the organic acid granules are blended at a fixed ratio is mixed with a general mixer, it shows the same behavior as the case when one kind of powder material having a regular distribution with one peak against the external force given by the mixer is mixed. Therefore, the composition is uniformly mixed by itself without being distributed unevenly per each granule.
[0088] Applying the production method, the effevescent tablet in which the granules of a main active ingredient, the carbonate granules and the organic acid granules are uniformly dispersed can be easily produced. Therefore, the required number of the effevescent tablet which has uniform disintegration time, disintegration pattern and dissolution time when the tablet is put in water for use can be easily produced depending on the user's needs.
[0089] According to the production method of an effevescent tablet of the present invention, the carbonate granules are those comprising at least one kind or a mixture of at least two kinds selected from the group consisting of sodium hydrogen carbonate, sodium carbonate, sodium sesquicarbonate, calcium carbonate, potassium carbonate, magnesium carbonate, calcium hydrogen carbonate, and potassium hydrogen carbonate.
[0090] In this production method, such components have safety which has been already established as carbon dioxide components of an effevescent tablet and are been generally used. Therefore, the effevescent tablet produced by this production method also has high reliability.
[0091] According to the production method of an effevescent tablet of the present invention, the organic acid granules are those comprising at least one kind selected from the group consisting of citric acid, tartaric acid, fumaric acid, succinic acid, adipic acid, maleic acid, and maleic acid.
[0092] In this production method, the organic acid granules has safety which has been already established, are easily obtainable and can decompose carbonate to generate carbon dioxide (CO<sub>2</sub>) when they get in touch with water, therefore, such granules has no problem in view of safety.
[0093] According to the production method of an effevescent tablet of the present invention, each one of the granules of a main active ingredient, the carbonate granules and the organic acid granules are those granulated with a water-soluble polymer as a binder.
[0094] In the production method, the granulated material is produced by granulating the granules of a main active ingredient, the carbonate granules and the organic acid granules using, water-soluble polymer as a binder. Therefore, if the effevescent tablet is put in water for use, the binder forming each granule is dissolved in water so that each granule is easily dissolved into a particle level.
[0095] As a result, in the production method, when the effevescent tablet is put in water, the contacting area of the active agent, the carbonate and the organic acid with water becomes large. Then a reaction takes place between the carbonate and the organic acid so that the tablet is rapidly dissolved in water while generating carbon dioxide (CO<sub>2</sub>).
[0096] According to the production method of an effevescent tablet of the present invention, each one of the granules of a main active ingredient, the granules of a main active ingredient, the carbonate granules and the organic acid granules are a granulated material produced by means of a binder including a surfactant.
[0097] In the production method, a granulated material produced by using a binder including a surfactant is used for each one of the granules of a main active ingredient, the carbonate granules and the organic acid granules are.
[0098] As a result, the effevescent tablet is constructed in such a manner that between the particles comprising the granules of a main active ingredient, between the particles comprising the carbonate granules and between the particles comprising the organic acid granules are combined with the binder including a surfactant. Therefore, when the effevescent tablet is put in water for use, the binder bonding the particles comprising each granule easily gets wet because of a surfactant contained therein so that the granules of a main active ingredient, the carbonate granules and the organic acid granules are easily decomposed into a particle unit.
[0099] Because the effevescent tablet produced by this production method is constructed in a manner that the granule components are rapidly decomposed into a particle unit when they get in contact with water, the dissolution speed in water is increased comparing with a conventional effevescent tablet.
[0100] According to the production method of an effevescent tablet for a bath agent of the present invention, the granules of a main active ingredient used in the production method of an effevescent tablet are sodium carbonate granules.
[0101] In the production method, the sodium carbonate which has been already established safe component, are easily obtainable and can generate carbon dioxide (CO<sub>2</sub>) when they get in touch with water is used for the granules of a main active ingredient, therefore, the effevescent tablet has no problem in view of safety.
[0102] Disintegrater, disintegration supplements, stabilizers, perfume agents, coloring agents and hot spring components are added in the effevescent tablet for a bath agent if necessary. In order to blend such adjuvants, they are added in the mixture.
[0103] According to the production method of an effevescent tablet for a washing detergent of the present invention, the granules of a main active ingredient used in the production method of an effevescent tablet include surfactant granules and fatty acid alkali salt granules.
[0104] In the production method, the effevescent tablet for a washing detergent is shaped as a tablet, therefore, if one tablet has the amount to be used at one time for putting in the tub of the washing machine, one tablet is merely put in the tub for washing clothes. Unlike a conventional powdered or granular washing detergent, it can save the trouble of measuring with a scoop each time of putting the detergent in the washing tub, therefore, such a tabletted detergent is facilitated to be used comparing with the conventional powdered or granular washing detergent.
[0105] Further in the production method, because of the tabletted shape of the effevescent tablet for a washing detergent, there isn't problem such that powdered or granular detergent is scattered around the washing machine or a person's hands or fingers get dirty with the detergent when the detergent is put in the washing tub.
[0106] Disintegrater, disintegration supplements, stabilizers, perfume agents, coloring agents and hot spring components are added in the effevescent tablet for a washing detergent produced by this method if necessary. In order to blend such adjuvants, they are added in the mixture.
[0107] It is preferable that the final product shape produced by this method is a package of one effevescent tablet for washing detergent in view of its storage.
[0108] According to the production method of an effevescent tablet for a washing detergent of the present invention, anhydrous sodium sulphate is further added in the mixture.
[0109] In the production method, because anhydrous sodium sulphate with a hygroscopic property is included in the tablet, the tablet is prevented from naturally foaming by the moisture contained in air while the tablet is stored. Namely, such an effevescent tablet is superior in storage stability.
[0110] According to the production method of an effevescent tablet for oral administration of the present invention, each of the granules of a main active ingredient, the carbonate granules and the organic acid granules used in the production methods of an effevescent tablet for oral administration is granulated with a binder including a saccharide with high wettability fort water, respectively.
[0111] The production method of the effevescent tablet for oral administration uses the granulated material of granules of a main active ingredient, carbonate granules and organic acid granules obtained by granulation using a binder including a saccharide with high wettability for water.
[0112] As a result, the effevescent tablet for oral administration produced by this method is constructed in such a manner that between the particles comprising the granules of a main active ingredient, between the particles comprising the carbonate granules and between the particles comprising the organic acid granules are combined with the binder including a saccharide with high wettability for water. Therefore, when the effevescent tablet for oral administration is put in water for use, the binder bonding the particles comprising each granule easily gets wet because of the saccharide with high wettability for water contained therein so that the granules of a main active ingredient, the carbonate granules and the organic acid granules are easily decomposed into a particle unit.
[0113] Because the effevescent tablet for oral administration obtained by this method is constructed in a manner that the granule components are rapidly decomposed into a particle unit when they get in contact with water, the dissolution speed in water is increased comparing with a conventional effevescent tablet.
[0114] When the amount of medicament containing active ingredient in the tablet is quite slight, powders of the medicament containing active ingredient are added in powders of a saccharide with high wettability for water to be mixed uniformly each other and the granulated powders of the mixture may be used as main particles.
BRIEF DESCRIPTION OF DRAWINGS
[0115]FIG. 1 is an explanatory view of an effevescent tablet of the present invention, FIG. 1<i>a </i>is an external perspective view diagrammatically showing an effevescent tablet of the present invention, FIG. 1<i>b </i>is a sectional view diagrammatically showing the effevescent tablet shown in FIG. 1<i>a. </i>
[0116]FIG. 2 is a diagrammatical explanatory view showing the effevescent tablet of the present invention in granular unit when the area shown with an imaginary line in FIG. 1<i>b </i>is enlarged.
[0117]FIG. 3 is a diagrammatical explanatory view showing other embodiment of the effevescent tablet of the present invention in granular unit.
[0118]FIG. 4 is a diagrammatical explanatory view showing other embodiment of the effevescent tablet of the present invention in granular unit.
[0119]FIG. 5 is a diagrammatical explanatory view showing still other embodiment of the effevescent tablet of the present invention in granular unit.
[0120]FIG. 6 is an explanatory view diagrammatically showing an effevescent tablet for a washing detergent of the present invention.
[0121]FIG. 7 is an explanatory view diagrammatically showing a production method of an effevescent tablet for a washing detergent of the present invention.
[0122]FIG. 8 is an explanatory view diagrammatically showing a production method of an effevescent tablet for a washing detergent of the present invention.
[0123]FIG. 9 shows other embodiment of an effevescent tablet for a washing detergent wherein granules of a main active ingredient, carbonate granules, organic acid granules and anhydrous sodium sulphate granules are uniformly dispersed.
[0124]FIG. 10 is an entire construction diagrammatically showing an external lubrication type tabletting machine which can continuously and stably apply a minimum amount of lubricant on each surface (lower face) of an upper punch, surface (inner circumference) of a die, and surface (lower face) of a lower punch.
[0125]FIG. 11 is an explanatory view exemplifying a positive pulsating vibration air.
[0126]FIG. 12 is an explanatory view diagrammatically showing a quantitative feeder.
[0127]FIG. 13 is an explanatory view showing a hopper for storing lubricants in more detail, FIG. 13<i>a </i>is a perspective view diagrammatically showing the hopper for storing lubricant and FIG. 13<i>b </i>is a plan view diagrammatically showing an essential part of the hopper shown in FIG. 13<i>a. </i>
[0128]FIG. 14 is a plan view diagrammatically showing an elastic membrane.
[0129]FIG. 15 is a perspective view when the elastic membrane is attached on an elastic membrane installation means, of the quantitative feeder.
[0130]FIG. 16 is an exploded perspective view diagrammatically showing the construction of the elastic membrane installation means shown in FIG. 15.
[0131]FIG. 17 is a sectional view diagrammatically showing the construction of the elastic membrane installation means shown in FIG. 15.
[0132]FIG. 18 is a plan view diagrammatically showing a position of a pulsating vibration air supply port provided for a dispersion chamber when the chamber is seen from top, FIG. 18<i>a </i>is an explanatory view showing a preferable position for providing the pulsating vibration air supply port against the dispersion chamber and FIG. 18<i>b </i>is an explanatory view showing an actual position for providing the pulsating vibration air supply port against the dispersion chamber.
[0133]FIG. 19 is an explanatory view diagrammatically showing a position of a pulsating vibration air supply port and its discharge port provided for a dispersion chamber when the chamber is seen from top, FIG. 19<i>a </i>is an explanatory view showing a preferable position for providing the pulsating vibration air supply port and its discharge port against the dispersion chamber and FIG. 19<i>b </i>is an explanatory view showing an actual position for providing the pulsating vibration air supply port and its discharge port against the dispersion chamber.
[0134]FIG. 20 is an explanatory view diagrammatically showing operations of a gas injection means and a material feed valve provided for a hopper for storing lubricants of a quantitative feeder.
[0135]FIG. 21 is a flow chart diagrammatically showing operation programs of a gas injection means and a material feed valve stored in a memory of a processing unit in advance.
[0136]FIG. 22 is an explanatory view diagrammatically showing operations of an elastic membrane and a bypass pipe when a positive pulsating vibration air is supplied in a dispersion chamber.
[0137]FIG. 23 is a diagrammatic plan view showing a rotary type tabletting machine used for an external lubrication type tabletting machine of the present invention.
[0138]FIG. 24 is a plan view diagrammatically showing an enlarged lubricant spray chamber (lubricant apply means) <b>91</b> shown in FIG. 23.
[0139]FIG. 25 is a diagrammatic sectional view of the lubricant spraying chamber along the line XXV-XXV in FIG. 24.
[0140]FIG. 26 is a diagrammatic constructional view enlarging around the lubricant suction means shown in FIG. 10.
[0141]FIG. 27 is a diagrammatic sectional view showing a construction of a pulsating vibration air generation means.
[0142]FIG. 28 is a diagrammatic sectional view showing other embodiment of a pulsating vibration air generation means.
[0143]FIG. 29 is an exploded perspective view diagrammatically showing other embodiment of a pulsating vibration air generation means.
[0144]FIG. 30 is a diagrammatic plan view showing other embodiment of an elastic membrane used for a quantitative feeder of an external lubrication type tabletting machine of the present invention.
BEST MODE FOR CARRYING OUT THE INVENTION
[0145] Now, preferable embodiments of the present invention will be detailed.
[0146] (Embodiment of the Invention 1)
[0147]FIG. 1 is an explanatory view of an effevescent tablet of the present invention, FIG. 1<i>a </i>is an external perspective view diagrammatically showing an effevescent tablet of the present invention, FIG. 1<i>b </i>is a sectional view diagrammatically showing the effevescent tablet shown in FIG. 1<i>a. </i>
[0148] An effevescent tablet <b>1</b> is produced by compressing and tabletting a mixture including at least granules of a main active ingredient, carbonate granules and organic acid granules.
[0149] Further corrigent powders, coloring agent powders, disintegrater powders, disintegrater supplement powders, stabilizer powders and other adjuvant powders may be included in the effevescent tablet <b>1</b>.
[0150] The granules of a main active ingredient are medicinal properties of the effevescent tablet <b>1</b> and several components are used depending on the purpose of the effevescent tablet <b>1</b>. The granules of a main active ingredient may include one kind of component or plural kinds of component.
[0151] The carbonate granules are for example sodium hydrogen carbonate, sodium carbonate, sodium sesquicarbonate, calcium carbonate, potassium carbonate, magnesium carbonate, calcium hydrogen carbonate, and potassium hydrogen carbonate. They may be used solely or more than two of them may be combined to be used.
[0152] The organic acid granules are citric acid, tartaric acid, fumaric acid, succinic acid, adipic acid, malic acid, and maleic acid and so on. They may be used solely or more than two of them may be combined to be used.
[0153] Such organic acid granules are a component which reacts with carbonate and generates carbon dioxide (CO<sub>2</sub>) when the effevescent tablet <b>1</b> is put in water for use and the granules are used as neutralizer.
[0154] The effevescent tablet <b>1</b> is characterized in that a slight amount of lubricant powders L is applied only on a surface St of the tablet and lubricant powders L aren't contained in the tablet.
[0155] The lubricant powders on the surface St of the effevescent tablet <b>1</b> are transferred after compression from the lubricant powders applied on the surface of the punch and the surface of the die. The lubricant powders are applied thereon in order to prevent grinding of the punch and the die and avoid tabletting problems such as capping, laminating, sticking and binding caused by the mixture (molding material) attached on the punch and the die when the mixture (molding material) substantially comprising granules of a main active ingredient, carbonate granules and organic acid granules are compressed with the punch and the die of a tabletting machine.
[0156] In order to prevent the mixture (molding material) from adhering on the punch and die of the tabletting machine, it is required to provide a powder layer of lubricants between the mixture (molding material) and the surface of the punch and die of the tabletting machine.
[0157] It is necessary to add a certain amount of lubricant powders in the mixture (molding material) in order to exist enough amount of lubricant powders between the mixture (molding material) and the surface of the punch and die of the tabletting machine.
[0158] On the other hand, if lubricant powders are applied on the surfaces of the punch and the die, adequate amount of lubricant powders can exist between the surfaces of the punch and the die and the surface of the mixture (molding material) with remarkably a little amount of lubricant powders comparing with the case when lubricant powders are added in the mixture (molding material).
[0159] Therefore, when the lubricant powders are applied on the surfaces of the punch and the die without adding them in the mixture (molding material) and the mixture (molding material) is compressed, the amount of lubricant used per one effevescent tablet <b>1</b> can be remarkably reduced comparing with the case when lubricant powders are added in the mixture (molding material).
[0160] Further, the lubricant powders of the produced effevescent tablet <b>1</b> are those transferred from the lubricant powders applied on the punch and die of the tabletting machine so that the amount of lubricant per one effevescent tablet <b>1</b> becomes significantly a little comparing with the case when lubricant powders are added in the mixture (molding material).
[0161] If a large amount of lubricant is contained in the effevescent tablet, the tablet itself has water repellency because of the water repellency of lubricants. Therefore, when the tablet is put in water for use, water is hardly permeated in the tablet so that disintegration time and the dissolution time of the effevescent tablet become long.
[0162] Contrary, the effevescent tablet <b>1</b> of the present invention has only a little amount of lubricants on the surface St thereof so that water is easily permeated in the tablet when the effevescent tablet <b>1</b> is put in water for use.
[0163] Accordingly, because water is easily permeated in the effevescent tablet <b>1</b> of the present invention, the tablet is immediately disintegrated and dissolved in water to be a water solution (solution) while generating carbon dioxide (CO<sub>2</sub>) when the tablet is put in water for use.
[0164] The effevescent tablet <b>1</b> has characteristics in the following constructions.
[0165]FIG. 2 is a diagrammatical explanatory view showing the effevescent tablet in granular unit when the area shown with an imaginary line in FIG. 1<i>b </i>is enlarged.
[0166] The mixture for the effevescent tablet <b>1</b> is substantially comprised of granules of a main active ingredient <b>2</b> . . . , carbonate granules <b>3</b> . . . and organic acid granules <b>4</b> . . . as mentioned above. It is characterize in that granules of a main active ingredient <b>2</b> . . . , carbonate granules <b>3</b> . . . and organic acid granules <b>4</b> . . . of which diameters are almost the same are used.
[0167] If the diameters of granules of a main active ingredient <b>2</b> . . . , carbonate granules <b>3</b> . . . and organic acid granules <b>4</b> . . . are almost the same and the component thereof is mixed with a mixer, they can be uniformly mixed in spontaneously by the external force given by the mixer.
[0168] In the resulting mixture (molding material) in which granules of a main active ingredient <b>2</b> . . . , carbonate granules <b>3</b> . . . and organic acid granules <b>4</b> . . . of which diameters are almost the same are uniformly mixed with the mixer, each particle shows the same behavior against the external force given by the tabletting machine. Therefore, demixing phenomenon of granules of a main active ingredient <b>2</b> . . . , carbonate granules <b>3</b> . . . and organic acid granules <b>4</b> . . . isn't shown in the mixture (molding material) during a tabletting procedure.
[0169] Thus granules of a main active ingredient <b>2</b> . . . , carbonate granules <b>3</b> . . . and organic acid granules <b>4</b> . . . are uniformly dispersed in the effevescent tablet <b>1</b>. As the result, the disintegration time, the disintegration pattern and the dissolution time between tablets aren't varied when a tablet is put in water for use.
[0170] In the above-mentioned effevescent tablet <b>1</b>, the granules of a main active ingredient <b>2</b> . . . are obtained by granulating main powders P<b>2</b> . . . by a binder <b>5</b> and the granules <b>2</b> . . . are granulated with water-soluble polymer as a binder <b>5</b>.
[0171] Further in the effevescent tablet <b>1</b>, the carbonate granules <b>3</b> . . . are obtained by granulating carbonate powders P<b>3</b> . . . using water-soluble polymer as a binder <b>5</b> and the organic acid granules <b>4</b> . . . are obtained by granulating organic acid powders P<b>4</b> . . . using water-soluble polymer as a binder <b>5</b>.
[0172] Water-soluble polymers are for example hydroxypropylcellulose, polyvinylpyrrolidone, hydroxypropylmethylcellulose, partially saponified polyvinyl alcohol, methylcellulose (HPMC), pullulane, polyvinyl alcohol (PVA), and hydroxypropylcellulose (HPC).
[0173] In the effevescent tablet <b>1</b> granules of a main active ingredient <b>2</b> . . . , carbonate granules <b>3</b> . . . and organic acid granules <b>4</b> . . . which are obtained by granulation with water-soluble polymer as a binder <b>5</b> are compressed to produce a tablet. When the tablet <b>1</b> is put in water for dosage, the binder <b>5</b> forming each particle <b>2</b> . . . , <b>3</b> . . . , <b>4</b> . . . is dissolved in water so that each particle <b>2</b> . . . , <b>3</b> . . . , <b>4</b> . . . is easily dissolved into a particle level (powder unit).
[0174] As the result, the contacting area of each main particles P<b>2</b> . . . , carbonate particles P<b>3</b> . . . and organic acid particles P<b>4</b> . . . with water becomes large, thereby a reaction of carbonate and organic acid is took place and the tablet is rapidly dissolved in water while producing carbon dioxide (CO<sub>2</sub>).
[0175] In FIG. 2 granules of a main active ingredient <b>2</b> . . . , carbonate granules <b>3</b> . . . and organic acid granules <b>4</b> . . . are granulated by means of water-soluble polymer as a binder <b>5</b>, however, the binder <b>5</b> isn't limited to a water-soluble polymer.
[0176]FIG. 3 is a diagrammatical explanatory view showing other embodiment of the effevescent tablet of the present invention in granular unit.
[0177] In FIG. 3 the same member as described in FIG. 2 has the same reference numeral and its explanation is omitted.
[0178] In the effevescent tablet <b>1</b>A each one of granules of a main active ingredient <b>2</b> . . . , carbonate granules <b>3</b> . . . and organic acid granules <b>4</b> . . . are granulated by means of a binder <b>7</b> in which a surfactant <b>6</b> is dispersed in water-soluble polymer <b>5</b>.
[0179] Surfactants <b>6</b> are for example anionic surfactants, cationic surfactants, nonionic surfactants, amphoteric surfactants, as well as high molecular surfactants such as Pluron or Poloxamer which aren't classified therein.
[0180] More concretely, preferable examples of anionic surfactants are sulfate S(R.O.SO<sub>3</sub>—.M+) such as sodium lauryl sulfate.
[0181] Preferable examples of nonionic surfactants are sorbitan esters (Sorbitane SterS), and polysorbate. One of preferable example of polysorbate is polysorbate 80.
[0182] Surfactants <b>6</b> . . . having a HLB (hydrophile-lipophile balance) greater than or equal to 10 and less than or equal to 40 are preferable.
[0183] The binder <b>7</b> in which a surfactant <b>6</b> . . . is dispersed in water-soluble polymer <b>5</b> is used for the effevescent tablet <b>1</b>A.
[0184] Therefore, when the effevescent tablet <b>1</b>A is put in water for use, the binder <b>7</b> easily gets wet by the surfactant <b>6</b> . . . included in the binder <b>7</b> and the water-soluble polymer <b>5</b> are dissolved in water so that each particle <b>2</b> . . . , <b>3</b> . . . , <b>4</b> . . . is easily decomposed into a particle level (powder unit).
[0185] As the result, the contacting area of the powders of granules of a main active ingredient P<b>2</b> . . . , the carbonate powders P<b>3</b> . . . and the organic acid powders P<b>4</b> . . . with water becomes large, thereby a reaction of carbonate and organic acid is took place and the tablet <b>1</b>A is rapidly dissolved in water while generating carbon dioxide (CO<sub>2</sub>).
[0186]FIG. 4 is a diagrammatical explanatory view showing other embodiment of the effevescent tablet of the present invention in granular unit.
[0187] In FIG. 4 the same member as described in FIG. 2 has the same reference numeral and its explanation is omitted.
[0188] In the effevescent tablet <b>1</b>B each one of the granules of a main active ingredient <b>2</b>, the carbonate granules <b>3</b> . . . and the organic acid granules <b>4</b> . . . are granulated by means of a binder <b>9</b> in which a saccharide with high wettability for water <b>8</b> . . . is dispersed in water-soluble polymer<b>5</b>.
[0189] The “saccharide with high wettability for water” is for example trehalose, mannitol, maltose, sorbitol, lactose, multitol, xylitol, sucrose, and glucose.
[0190] In the effevescent tablet <b>1</b>B each one of the granules of a main active ingredient <b>2</b>, the carbonate granules <b>3</b> . . . and the organic acid granules <b>4</b> . . . are granulated by means of the binder <b>9</b> including a saccharide with high wettability for water.
[0191] As a result, between the particles comprising the granules of a main active ingredient <b>2</b>, between the particles comprising the carbonate granules <b>3</b> . . . and between the particles comprising the organic acid granules <b>4</b> . . . are combined with the binder <b>9</b> including a saccharide with high wettability for water. Therefore, when the effevescent tablet <b>1</b>B is put in water for use, the binder <b>9</b> bonding the particles comprising each granule <b>2</b> . . . , <b>3</b> . . . , <b>4</b> . . . easily gets wet because of the saccharide with high wettability for water included in the binder <b>9</b>. Therefore, the granules of a main active ingredient <b>2</b>, the carbonate granules <b>3</b> . . . and the organic acid granules <b>4</b> . . . are easily decomposed into particle level.
[0192] Because the components of the granules <b>2</b> . . . , <b>3</b> . . . , <b>4</b> . . . are rapidly decomposed into a particle level when the effevescent tablet <b>1</b>B gets in touch with water, the dissolution speed in water is faster than that of the conventional effevescent tablets. Reaction of carbonate and organic acid is caused to generate carbon dioxide (CO<sub>2</sub>), thereby the effevescent tablet <b>1</b>B can be rapidly dissolved in water.
[0193]FIG. 5 is a diagrammatical explanatory view showing other embodiment of the effevescent tablet of the present invention in granular unit.
[0194] In FIG. 5 the same member as described in FIG. 2 has the same reference numeral and its explanation is omitted.
[0195] In the effevescent tablet <b>1</b>C each one of granules of a main active ingredient, carbonate granules and organic acid granules are granulated by means of a binder <b>10</b> including surfactants <b>6</b> . . . and saccharides with high wettability for water <b>8</b> . . . .
[0196] As a result, between the particles comprising the granules of a main active ingredient <b>2</b> . . . , between the particles comprising the carbonate granules <b>3</b> . . . and between the particles comprising the organic acid granules <b>4</b> . . . are combined with the binder <b>9</b> including surfactants <b>6</b> . . . and saccharides with high wettability for water <b>8</b> . . . . Therefore, when the effevescent tablet <b>1</b>C is put in water for use, the binder <b>9</b> bonding the particles comprising each granule <b>2</b> . . . , <b>3</b> . . . , <b>4</b> . . . easily gets wet because of the surfactants <b>6</b> . . . and the saccharide with high wettability for water <b>8</b> . . . included in the binder <b>9</b>. Therefore, the granules of a main active ingredient <b>2</b>, the carbonate granules <b>3</b> . . . and the organic acid granules <b>4</b> . . . are easily decomposed into a particle level.
[0197] Because the components of the granules <b>2</b> . . . , <b>3</b> . . . , <b>4</b> . . . are rapidly decomposed into a particle level when the effevescent tablet <b>1</b>C gets in touch with water, the dissolution speed in water is faster than that of the conventional effevescent tablets. Rreaction of carbonate and organic acid is took place to generate carbon dioxide (CO<sub>2</sub>), thereby the effevescent tablet can be rapidly dissolved in water.
[0198] Next an embodiment when the effevescent tablet <b>1</b>A is applied to washing detergents will be explained.
[0199]FIG. 6 is an explanatory view diagrammatically showing an effevescent tablet for a washing detergent of the present invention.
[0200] In the effevescent tablet <b>1</b>D each one of granules of a main active ingredient <b>2</b>A . . . , granules of a main active ingredient <b>2</b>B . . . , carbonate granules <b>3</b> . . . , organic acid granules <b>4</b> . . . and anhydrous sodium sulphate granules <b>11</b> is granulated by means of a binder <b>7</b> including surfactants <b>6</b> . . . .
[0201] Surfactant granules are used as the granules of a main active ingredient <b>2</b>A.
[0202] Samples of a surfactant are alkylbenzene sulfonate or sodium lauryl sulfate.
[0203] Granules of soap component (fatty acid sodium salt) are used as granules of a main active ingredient <b>2</b>B . . . .
[0204] Sodium hydrogen carbonate granules are used as carbonate granules <b>3</b> . . . .
[0205] Fumaric acid granules are for example used as organic acid granules <b>4</b> . . . .
[0206] Anhydrous sodium sulphate granules <b>11</b> is contained in the effevescent tablet for a washing detergent <b>1</b>D in order to, prevent the tablet <b>1</b>D from naturally foaming because of the moisture in air during storage.
[0207] A binder solution in which a water-soluble polymer <b>15</b> and surfactants <b>6</b> . . . are dissolved in water is used for granulating each one of granules of a main active ingredient <b>2</b>A . . . , granules of a main active ingredient <b>2</b>B . . . , carbonate granules <b>3</b>, organic acid granules <b>4</b> . . . and anhydrous sodium sulphate granules <b>11</b> are granulated.
[0208] Water-soluble polymer <b>5</b> dissolved in the binder solution aren't limited if they are generally used water-soluble polymer. For example, polyvinyl alcohol (PVA), and hydroxypropylcellulose (HPC), and hydroxypropylmethylcellulose (HPMC) are used. One of them may be used or more than two of them are combined to be used.
[0209] The amount of water-soluble polymer <b>5</b> dissolved in the binder solution is preferably equal to or more than 3 weight % and equal to or less than 10 weight % for the water of 100 weight %.
[0210] Further, the amount of water-soluble polymer <b>5</b> to be used is preferably equal to or more than 1 weight % and equal to or less than 3 weight % for the tablet of 100 weight %.
[0211] It is because that if more than 3 weight % of water-soluble polymer <b>5</b> is used for the tablet of 100 weight %, the binder <b>10</b> stably binds between the particles comprising the granules <b>2</b>A . . . , the granules <b>2</b>B . . . , the carbonate granules <b>3</b> . . . and the organic acid granules <b>4</b> . . . which are to be granulated so that it takes a long time for each granules to be disintegrated when the effevescent tablet for a washing detergent <b>1</b>D is put in water.
[0212] On the other hand, if less than 1 weight % of water-soluble polymer <b>5</b> is added in a 1tablet of 100 weight %, a mechanical strength binding between the particles comprising each granule <b>2</b>A . . . , granule <b>2</b>B . . . , carbonate granule <b>3</b> . . . and organic acid granule <b>4</b> . . . which are to be granulated so that the effevescent tablet for a washing detergent is easily cracked, thereby it is undesirable.
[0213] The amount of surfactants <b>6</b> . . . dissolved in the binder solution is decided by experiments considering the mechanical strength and wettability of the binder <b>10</b> against water.
[0214] Next, the production method of the effevescent tablet for washing detergent <b>1</b>D is explained with an sample.
[0215]FIG. 7 and FIG. 8 are an explanatory views diagrammatically showing a production method of the effevescent tablet for a washing detergent <b>1</b>D.
[0216] For producing the effevescent tablet for a washing detergent <b>1</b>D, as shown in FIG. 7 surfactant powders P<b>2</b>A comprising a material of granules of a main active ingredient <b>2</b>A . . . , soap component (fatty acid sodium salt) powders P<b>2</b>B comprising a material of granules of a main active ingredient <b>2</b>B . . . , carbonate powders P<b>3</b> comprising a material of carbonate granules <b>3</b> . . . , organic acid salt powders P<b>4</b> comprising a material of organic acid granules <b>4</b>, and sodium sulphate powders P<b>11</b> comprising a material of sodium sulphate granules <b>11</b> are prepared.
[0217] A binder solution is prepared as shown in FIG. 7<i>b </i>by dissolving water-soluble polymers and surfactants in water.
[0218] Each one of surfactant powders P<b>2</b>A, soap component (fatty acid sodium salt) powders P<b>2</b>B, carbonate powders P<b>3</b>, organic acid salt powders P<b>4</b>, anhydrous sodium sulphate powders P<b>11</b> are granulated into granules of a main active ingredient <b>2</b>A . . . , granules of a main active ingredient <b>2</b>B . . . , carbonate granules <b>3</b> . . . , organic acid salt granules <b>4</b> and sodium sulphate granules <b>11</b> by means of a fluid bed granulator <b>21</b> as shown in FIG. 7<i>c. </i>
[0219] More specifically, surfactant powders P<b>2</b><i>a </i>are contained in a granulation tank <b>22</b> of the granulator <b>21</b> for obtaining granules of a main active ingredient <b>2</b>A . . . and mixed with a heated air according to a normal method to become a fluid bed. The binder solution prepared in the process of FIG. 7<i>b </i>is sprayed on thus fluidized surfactant powders P<b>2</b>A from a spray means <b>23</b> provided at a predetermined position in the granulation tank <b>22</b>, thereby the powders P<b>2</b>A are dried to produce granules of a main active ingredient <b>2</b>A . . . .
[0220] Further, for obtaining granules of a main active ingredient <b>2</b>B . . . by granulation, soap component (fatty acid sodium salt) powders P<b>2</b> are contained in the granulation tank <b>22</b> of the granulator <b>21</b> and mixed with a heated air according to a normal method to become a fluid bed. The binder solution prepared in the process of FIG. 7<i>b </i>is sprayed on thus fluidized soap component (fatty acid sodium salt) powders P<b>2</b>B from the spray means <b>23</b> provided at a predetermined position in the granulation tank <b>22</b>, thereby the powders P<b>2</b>B are dried to produce granules of a main active ingredient <b>2</b>B . . . .
[0221] Furthermore, for obtaining carbonate granules <b>3</b> . . . by granulation, carbonate powders P<b>3</b> are contained in the granulation tank <b>22</b> of the granulator <b>21</b> and mixed with a heated air according to a normal method to become a fluid bed. The binder solution prepared in the process of FIG. 7<i>b </i>is sprayed on thus fluidized carbonate powders P<b>3</b> from the spray means <b>23</b> provided at a predetermined position in the granulation tank <b>22</b>, thereby the powders P<b>3</b> are dried to produce carbonate granules <b>3</b> . . . .
[0222] Still further, for obtaining organic acid salt granules <b>4</b> by granulation, organic acid salt powders P<b>4</b> are contained in the granulation tank <b>22</b> of the granulator <b>21</b> and mixed with a heated air according to a normal method to become a fluid bed. The binder solution prepared in the process of FIG. 7<i>b </i>is sprayed on thus fluidized organic acid salt powders P<b>4</b> from the spray means <b>23</b> provided at a predetermined position in the granulation tank <b>22</b>, thereby the powders P<b>4</b> are dried to produce organic acid salt granules <b>4</b>.
[0223] Furthermore, for obtaining anhydrous sodium sulphate granules <b>11</b> by granulation, anhydrous sodium sulphate powders P<b>11</b> are contained in the granulation tank <b>22</b> of the granulator <b>21</b> and mixed with a heated air according to a normal method to become a fluid bed. The binder solution prepared in the process of FIG. 7<i>b </i>is sprayed on thus fluidized sodium sulphate powders P<b>11</b> from the spray means <b>23</b> provided at a predetermined position in the granulation tank <b>22</b>, thereby the powders P<b>11</b> are dried to produce sodium sulphate granules <b>11</b>. (See FIG. 8<i>a</i>)
[0224] For obtaining the granules of a main active ingredient <b>2</b>A . . . , the granules of a main active ingredient <b>2</b>B . . . , the carbonate granules <b>3</b> . . . , the organic acid granules <b>4</b> . . . and the anhydrous sodium sulphate granules <b>11</b>, each particle size diameter thereof is designed to be almost the same during granulation.
[0225] Otherwise, the particle size diameters thereof are arranged to be almost the same by screening each granules of a main active ingredient <b>2</b>A . . . , granules of a main active ingredient <b>2</b>B . . . , carbonate granules <b>3</b> . . . , organic acid granules <b>4</b> . . . and anhydrous sodium sulphate granules <b>11</b> after granulation.
[0226] The reference numeral <b>22</b><i>a </i>in FIG. 7<i>c </i>shows a heated air supply port, <b>22</b><i>b </i>shows a discharge port for discharging the heated air supplied in the granulation tank <b>22</b> therefrom.
[0227] The member shown with the numeral <b>24</b> is a porous screen, <b>25</b> shows a binder solution storage tank for storing a binder solution, <b>26</b> shows a binder solution supply means for supplying the binder solution stored in the tank <b>25</b> to the spray means <b>23</b>, <b>27</b> is a dust collection filter, <b>28</b> is a filter vibration means for vibrating the dust collection filter <b>27</b> in order to make the powders, granulated material or granulating material attached thereon drop in the granulation tank <b>22</b>, and the numeral <b>29</b> shows an air source for supplying compressed air for spraying the binder solution from the spray means <b>23</b> and for supplying compressed air for driving the filter vibration means <b>28</b>.
[0228] Then, as shown in FIG. 8<i>b</i>, granules of a main active ingredient <b>2</b>A . . . , granules of a main active ingredient <b>2</b>B . . . , carbonate granules <b>3</b> . . . , organic acid granules <b>4</b> . . . and anhydrous sodium sulphate granules <b>11</b> are blended at a fixed ratio and mixed with a well-known mixer (not shown) according to a normal method.
[0229] In the blended material of granules of a main active ingredient <b>2</b>A . . . , granules of a main active ingredient <b>2</b>B . . . , carbonate granules <b>3</b> . . . , organic acid granules <b>4</b> . . . and anhydrous sodium sulphate granules <b>11</b>, each particle size diameter of granules of a main active ingredient <b>2</b>A . . . , granules of a main active ingredient <b>2</b>B . . . , carbonate granules <b>3</b> . . . , organic acid granules <b>4</b> . . . and anhydrous sodium sulphate granules <b>11</b> is almost the same. Therefore, when such a blended material is mixed with a general mixer, each granule shows the same behavior against the external force given the mixer, thereby each granule is uniformly mixed by itself without causing particle segregation.
[0230] Next, the uniformly mixed mixture M (molding material) obtained by the above-mentioned procedure is compressed with an upper punch <b>31</b>, a die <b>32</b> and a lower punch <b>33</b> of a rotary type tabletting machine to be tabletted and an effevescent tablet for a washing detergent <b>1</b>D is obtained.
[0231] Lubricants aren't added in the mixture M (molding material) and are sprayed on a surface S<b>31</b> (lower face, material contacting surface) of the upper punch <b>31</b>, a surface S<b>32</b> (inner circumference, more specifically a material contacting surface above an upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) of the die <b>32</b> and a surface S<b>33</b> (upper face, material contacting surface) of the lower punch <b>33</b>. Thereby a minimum amount of lubricant is applied on the surface S<b>31</b> (lower face, material contacting surface) of the upper punch <b>31</b>, the surface S<b>32</b> (inner circumference, more specifically a material contacting surface above an upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) of the die <b>32</b> and the surface S<b>33</b> (upper face, material contacting surface) of the lower punch <b>33</b>. The mixture (molding material) M without including lubricants is compressed with the upper punch <b>31</b> on which face S<b>31</b> (lower face, material contacting surface) lubricants are applied, the die <b>32</b> on which surface S<b>32</b> (inner circumference, more specifically a material contacting surface above an upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) lubricants are applied and the lower punch <b>33</b> on which surface S<b>33</b> (upper face, material contacting surface) lubricants are applied, thereby the effevescent tablet for a washing detergent <b>1</b>D is produced. (See FIG. 8<i>c </i>and FIG. 8<i>d</i>)
[0232] In the mixture M (molding material), the particle size diameter D<b>2</b>A of granules of a main active ingredient <b>2</b>A . . . , the particle size diameter D<b>2</b>B of granules of a main active ingredient <b>2</b>B . . . , the particle size diameter D<b>3</b> of carbonate granules <b>3</b> . . . , the particle size diameter D<b>4</b> of organic acid granules <b>4</b> . . . and the particle size diameter D<b>11</b> of anhydrous sodium sulphate granules <b>11</b> are almost the same. Therefore, each granule <b>2</b>A . . . , <b>2</b>B . . . , <b>3</b> . . . , <b>4</b> . . . , <b>11</b> . . . shows the same behavior against the external force given by the tabletting machine, thereby each granule is uniformly mixed.
[0233] In the effevescent tablet for a washing detergent <b>1</b>D, lubricants aren't contained in the mixture M (molding material) to be compressed with the punches <b>31</b>, <b>33</b> and the die <b>32</b> and only a slight amount of lubricant powders applied on the punches <b>31</b>, <b>33</b> and the die <b>32</b> is transferred to the surface St of the tablet ID, thereby the tablet <b>1</b>D doesn't hardly include lubricant.
[0234] Therefore, when the effevescent tablet for a washing detergent <b>1</b>D is put in water to be used, the tablet <b>1</b>D is rapidly permeated with water, thereby it is disintegrated and dissolved in a short time to produce washing detergents solution while generating carbon dioxide (CO<sub>2</sub>).
[0235] Granules of a main active ingredient <b>2</b>A . . . , granules of a main active ingredient <b>2</b>B . . . , carbonate granules <b>3</b> . . . , organic acid granules <b>4</b> . . . and anhydrous sodium sulphate granules <b>11</b> are uniformly dispersed in the effevescent tablet for a washing detergent <b>1</b>D so that there are no difference of disintegration time, the disintegration pattern and the dissolving time between tablets when the tablet is put in water.
[0236] Further according to the effevescent tablet for a washing detergent <b>1</b>D, each of the granules of a main active ingredient <b>2</b>A . . . , the granules of a main active ingredient <b>2</b>B . . . , the carbonate granules <b>3</b> . . . , the organic acid granules <b>4</b> . . . and the anhydrous sodium sulphate granules <b>11</b> are bound by the binder <b>7</b> in which a surfactant <b>6</b> is included in a water-soluble polymer <b>5</b>. Therefore, when the effevescent tablet for a washing detergent <b>1</b>D is put in water, the binder binding the particles comprising each granules <b>2</b>A . . . , <b>2</b>B . . . , <b>3</b> . . . , <b>4</b> . . . , <b>11</b> . . . easily get wet because of the surfactant in the binder so that the granules of a main active ingredient <b>2</b>A . . . , <b>2</b>B . . . , the carbonate granules <b>3</b> . . . and the organic acid granules <b>4</b> . . . are easily decomposed into a particle unit level.
[0237] As the result, the contacting area of the main active agent, carbonate and organic acid in the effevescent tablet for a washing detergent <b>1</b>D with water becomes large when the tablet <b>1</b>D is put in water, thereby the carbonate reacts with the organic acid to cause the tablet <b>1</b>D to be rapidly dissolved in water while generating carbon dioxide (CO<sub>2</sub>).
[0238] Further, comparing with conventional powdered or granular washing detergent, if one effevescent tablet for a washing detergent <b>1</b>D has the amount to be put in a washing tub of a washing machine at one time, only one tablet is required to be put in the washing tab for washing. Therefore, unlike conventional powdered or granular washing detergent, the tablet <b>1</b>D can save the trouble of measuring with a scoop and putting in the tub, thereby facilitating its usage.
[0239] Furthermore, because of the tabletted shape of the effevescent tablet for a washing detergent <b>1</b>D, there isn't a problem such that powdered or granular detergents are scattered around the washing machine or a person's hands or fingers get dirty with the detergents when the detergents are put in the washing tub.
[0240] Because anhydrous sodium sulphate granules <b>11</b> . . . with a hygroscopic property are included in the effevescent tablet for a washing detergent <b>1</b>D, it is prevented from naturally foaming by the moisture contained in air while the tablet is stored. Namely, such an effevescent tablet is superior in storage stability.
[0241] In this embodiment, the granules of a main active ingredient <b>2</b>A . . . and <b>2</b>B . . . , the carbonate granules <b>3</b> . . . , the organic acid granules <b>4</b> . . . and the anhydrous sodium sulphate granules . . . having almost the same particle diameter are used. However, the granules of a main active ingredient <b>2</b>A . . . and <b>2</b>B . . . , the carbonate granules <b>3</b> . . . , the organic acid granules <b>4</b> . . . and the anhydrous sodium sulphate granules <b>11</b> . . . may not have almost the same particle size diameter.
[0242]FIG. 9 shows other embodiment of an effevescent tablet for a washing detergent <b>1</b>D wherein granules of a main active ingredient <b>2</b>A . . . and <b>2</b>B . . . , carbonate granules <b>3</b> . . . , organic acid granules <b>4</b> . . . and anhydrous sodium sulphate granules <b>11</b> . . . are uniformly dispersed.
[0243] In FIG. 9 the granules of a main active ingredient <b>2</b>A . . . and <b>2</b>B . . . , the carbonate granules <b>3</b> . . . , the organic acid granules <b>4</b> . . . and the anhydrous sodium sulphate granules <b>11</b> . . . are composed in such a manner that the particle size distribution of the mixture has a regular distribution having one peak after mixing.
[0244] When the composed material of the granules of a main active ingredient <b>2</b>A . . . and <b>2</b>B . . . , the carbonate granules <b>3</b> . . . , the organic acid granules <b>4</b> . . . and the anhydrous sodium sulphate granules <b>11</b> . . . is mixed with a generally used mixer, it shows the same behavior against the external force given by the mixer when mixing proceeds as when one kind of powdered material having a regular particle size distribution with one peak is mixed. Therefore, the composed material can be uniformly mixed by itself without causing demixing phenomenon per each granule.
[0245] Such a method can produce an effevescent tablet for a washing detergent in which granules of a main active ingredient <b>2</b>A . . . and <b>2</b>B . . . , carbonate granules <b>3</b> . . . , organic acid granules <b>4</b> . . . and anhydrous sodium sulphate granules <b>11</b> . . . are uniformly dispersed.
[0246] Disintegraters, disintegration supplements, stabilizers, perfume agents, coloring agents, enzymes and dispersed agents are added in the effevescent tablet for a bath agent <b>1</b>D if necessary.
[0247] Further, considering its storage stability, the final product of the effevescent tablet for a washing detergent <b>1</b>D is preferably packaged in a press-through pack (PTP), a blister pack and a laminate pack per one tablet.
[0248] In this embodiment the effevescent tablet for a washing detergent <b>1</b>D includes anhydrous sodium sulphate granules <b>11</b> . . . , however, according to the effevescent tablet for a washing detergent of the present invention, anhydrous sodium sulphate granules <b>11</b> . . . aren't a indispensable material. The effevescent tablet for a washing detergent without including anhydrous sodium sulphate may be included in the present invention.
[0249] In the embodiment the granular anhydrous sodium sulphate is added in the effevescent tablet for a washing detergent <b>1</b>D, however, powdered anhydrous sodium sulphate may be mixed in the granules of a main active ingredient <b>2</b>A . . . and <b>2</b>B . . . , the carbonate granules <b>3</b> . . . and the organic acid granules <b>4</b> . . . .
[0250] The effevescent tablet of the present invention is preferably used as an effevescent tablet for a bath agent.
[0251] For producing an effevescent tablet for bath agent, sodium carbonate granules are used as granules of a main active ingredient <b>2</b>.
[0252] More specifically, sodium carbonate powders are granulated by means of a binder solution in which a water-soluble polymer is dissolved in water according to a fluid bed granulation method, thereby producing sodium carbonate granules.
[0253] Sodium hydrogen carbonate granules are for example used as carbonate granules <b>3</b>.
[0254] More specifically, sodium carbonate hydrogen powders are granulated by means of a binder solution in which water-soluble polymers are dissolved in water according to a fluid bed granulation method, thereby producing sodium carbonate hydrogen granules.
[0255] Fumaric acid granules are for example used as organic salt granules <b>4</b>.
[0256] More specifically, fumaric acid powders are granulated by means of a binder solution in which water-soluble polymers are dissolved in water according to a fluid bed granulation, method, thereby producing fumaric acid granules.
[0257] In this case, each particle size diameter of the granules of a main active ingredient <b>2</b>, the carbonate granules <b>3</b> and the organic acid granules <b>4</b> is arranged to be almost the same.
[0258] Or the granules of a main active ingredient <b>2</b>, the carbonate granules <b>3</b> and the organic acid granules <b>4</b> may be blended so as to have a regular particle size distribution with one peak after they are mixed, like the production method shown in FIG. 9.
[0259] Disintegraters, disintegration supplements, stabilizers, perfume agents, colorants and hot spring components are added in the effevescent tablet for bath agent <b>1</b>D if necessary.
[0260] Then the granules of a main active ingredient <b>2</b>, the carbonate granules <b>3</b> and the organic acid granules <b>4</b> after adding disintegraters, disintegration supplements, stabilizers, perfume agents, coloring agents and hot spring components if necessary are uniformly mixed to obtain a mixture M (molding material).
[0261] As shown in FIG. 8<i>c</i>, lubricants aren't contained in the mixture M (molding material) and are sprayed on the surface S<b>31</b> (lower face, material contacting surface) of the upper punch <b>31</b>, the surface S<b>32</b> (inner circumference, more specifically the material contacting surface above the upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) of the die <b>32</b> and the surface S<b>33</b> (upper face, material contacting surface) of the lower punch <b>33</b>. Thereby a minimum amount of lubricant is applied on the surface S<b>31</b> (lower face, material contacting surface) of the upper punch <b>31</b>, the surface S<b>32</b> (inner circumference, more specifically the, material contacting surface above the upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) of the die <b>32</b> and the surface S<b>33</b> (upper face, material contacting surface) of the lower punch <b>33</b>. The mixture (molding material) M without including lubricants is compressed with the upper punch <b>31</b> on which face S<b>31</b> (lower face, material contacting surface) lubricants are applied, the die <b>32</b> on which surface S<b>32</b> (inner circumference, more specifically the material contacting surface above the upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) lubricants are applied and the lower punch <b>33</b> on which surface S<b>33</b> (upper face, material contacting surface) lubricants are applied, thereby the effevescent tablet for a bath agent (see the effevescent tablet <b>1</b>A shown in FIG. 3) is produced.
[0262] According to thus produced effevescent tablet for a bath agent, lubricants aren't contained in the mixture to be compressed with punches (see the upper punch <b>31</b> and the lower punch <b>33</b> in FIG. 8<i>c</i>) and a die. Only a slight amount of lubricants is transferred on the surface of the tablet from the lubricant powders applied on the punches and the die (see the die <b>32</b> in FIG. 8<i>c</i>), therefore, lubricants aren't contained in the tablet.
[0263] Herewith, if thus obtained effevescent tablet for a bath agent is dissolved in a hot water in a bath tub, an oil film doesn't appear on the water surface.
[0264] Further, the granules of a main active ingredient <b>2</b>, the carbonate granules <b>3</b> and the organic acid granules <b>4</b> are uniformly dispersed in the effevescent tablet for a bath agent, therefore there are any variations of dissolving time in a hot water between the tablets. Namely, effevescent tablets for bath agent having the same quality can be supplied in a market.
[0265] The effevescent tablet <b>1</b>A shown in FIG. 3 may be produced as an effevescent tablet for a bath agent in the same manner mentioned above other than a binder solution in which water-soluble polymers and surfactants are dissolved in water is used for producing the granules of a main active ingredient <b>2</b>, the carbonate granules <b>3</b> and the organic acid granules <b>4</b>.
[0266] More specifically, the effevescent tablet for a bath agent like the effevescent tablet <b>1</b>A shown in FIG. 3 may be produced according to the following production method.
[0267] At first a granulated material in which a binder including a surfactant binds between the particles P<b>2</b> . . . comprising the granules of a main active ingredient <b>2</b> is produced as the granules of a main active ingredient <b>2</b>.
[0268] Further a granulated material in which a binder <b>7</b> including a surfactant <b>6</b> binds between the particles P<b>3</b> . . . comprising carbonate granules <b>3</b> is produced as carbonate granules <b>2</b>.
[0269] Furthermore a granulated material in which a binder <b>7</b> including a surfactant <b>6</b> binds between the particles P<b>4</b> . . . comprising organic acid granules <b>4</b> is produced as organic acid granules <b>4</b>.
[0270] The granulated material in which the particles P<b>2</b> . . . comprising granules of a main active ingredient <b>2</b> are bound by the binder including a surfactant, the granulated material in which the particles P<b>3</b> . . . comprising carbonate granules <b>3</b> are bound by the binder <b>7</b> including surfactants <b>6</b> and the granulated material in which the particles P<b>4</b> . . . comprising organic acid granules <b>4</b> are bound by the binder <b>7</b> including surfactants <b>6</b> are blended, wherein other adjuncts excluding lubricant powders are added if necessary, and are uniformly mixed to obtain the mixture (molding material).
[0271] Lubricants aren't added in thus obtained mixture (molding material) M as shown in FIG. 8<i>c. </i>
[0272] Lubricant powders are sprayed on the surface S<b>31</b> (lower face, material contacting surface) of the upper punch <b>31</b>, the surface S<b>32</b> (inner circumference, more specifically the material contacting surface above the upper face (material contacting surface) of the lower punch inserted into a fixed position in a die) of the die <b>32</b> and the surface S<b>33</b> (upper face, material contacting surface) of the lower punch <b>33</b>. Thereby a minimum amount of lubricants is applied on the surface S<b>31</b> (lower face, material contacting surface) of the upper punch <b>31</b>, the surface S<b>32</b> (inner circumference, more specifically the material contacting surface above the upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) of the die <b>32</b> and the surface S<b>33</b> (upper face, material contacting surface) of the lower punch <b>33</b>.
[0273] Then the mixture (molding material) M without including lubricants is compressed with the upper punch <b>31</b> on which face S<b>31</b> (lower face, material contacting surface) lubricants are applied, the die <b>32</b> on which surface S<b>32</b> (inner circumference, more specifically the material contacting surface above the upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) lubricants are applied and the lower punch <b>33</b> on which surface S<b>33</b> (upper face, material, contacting surface) lubricants are applied, thereby the effevescent tablet for a bath agent like the effevescent tablet <b>1</b>A shown in FIG. 3 is produced.
[0274] According to the effevescent tablet for a bath agent, because particles comprising each granule <b>2</b> . . . , <b>3</b> . . . , <b>4</b> . . . are bound by the binder <b>7</b> including a surfactant <b>6</b>, the binder <b>7</b> easily gets wet. Therefore, the tablet can achieve more rapid dissolving property when it is put in a hot water in the bath tub comparing with the effevescent tablet for a bath agent in which each granules <b>2</b> . . . , <b>3</b> . . . , <b>4</b> . . . isn't bound by the binder <b>5</b> without including surfactants <b>6</b>.
[0275] Further, the effevescent tablet of the present invention can be preferably used as an effevescent tablet for oral administration.
[0276] For producing an effevescent tablet for oral administration, medicinal property granules are used for granules of a main active ingredient <b>2</b>, for example vitamin granules such as vitamin C, antacid granules such as aldioxa, analgestic granules such as acetaminophen, non-narcotic antitussive granules like dextromethorphan hydrobromide, bronchodilator granules like dl-methylephedrine hydrochloride, antihistamic agent granules like chlorpheniraminemaleate, caffeine granules like anhydrous caffeine. More than two of them may be combined and used as granules of a main active ingredient <b>2</b>.
[0277] More specifically, medicinal property powders are granulated by means of a binder solution in which water-soluble polymers are dissolved in water according to a fluid bed granulation method, thereby obtaining granules of a main active ingredient <b>3</b>.
[0278] Sodium hydrogen carbonate granules are for example used as carbonate granules <b>3</b>.
[0279] More specifically, sodium hydrogen carbonate powders are granulated by means of a binder solution in which water-soluble polymers are dissolved in water according to a fluid bed granulation method, thereby obtaining sodium hydrogen carbonate granules.
[0280] Citric acid granules or tartaric acid granules are for example used as organic acid granules <b>4</b>.
[0281] More specifically, citric acid powders are granulated by means of a binder solution in which water-soluble polymers are dissolved in water according to a fluid bed granulation method, thereby obtaining citric acid granules.
[0282] In this case the particle diameters of the granules of a main active agnet <b>2</b>, the carbonate granules <b>3</b> and the organic acid granules <b>4</b> are arranged to be almost the same.
[0283] Or the granules of a main active ingredient <b>2</b>, the carbonate granules <b>3</b> and the organic acid granules <b>4</b> may be blended so as to have a regular particle size distribution with one peak after they are mixed, like the production method shown in FIG. 9.
[0284] Disintegrater, disintegration supplements, stabilizers, perfume agents, coloring agents and corrigent agents are added in the effevescent tablet for oral administration. <b>1</b>D if necessary.
[0285] Then the granules of a main active ingredient <b>2</b>, the carbonate granules <b>3</b> and the organic acid granules <b>4</b> after adding disintegraters, disintegration supplements, stabilizers, perfume agents, coloring agents and corrigents if necessary are uniformly mixed to obtain a mixture M (molding material).
[0286] As shown in FIG. 8<i>c</i>, lubricants aren't contained in the mixture M (molding material) and is sprayed on the surface S<b>31</b> (lower face, material contacting surface) of the upper punch <b>31</b>, the surface S<b>32</b> (inner circumference, more specifically the material contacting surface above the upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) of the die <b>32</b> and the surface S<b>33</b> (upper face, material contacting surface) of the lower punch <b>33</b>. Thereby a minimum amount of lubricants is applied on the surface S<b>31</b> (lower face, material contacting surface) of the upper punch <b>31</b>, the surface S<b>32</b> (inner circumference, more specifically a material contacting surface above the upper face. (material contacting surface) of the lower punch inserted into a fixed position in the die) of the die <b>32</b> and the surface S<b>33</b> (upper face, material contacting surface) of the lower punch <b>33</b>. The mixture (molding material) M without including lubricants is compressed with the upper punch <b>31</b> on which face S<b>31</b> (lower face, material contacting surface) lubricants are applied, the die <b>32</b> on which surface S<b>32</b> (inner circumference, more specifically the material contacting surface above the upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) lubricants are applied and the lower punch <b>33</b> on which surface S<b>33</b> (upper face, material contacting surface) lubricants are applied, thereby the effevescent tablet for oral administration (see the effevescent tablet <b>1</b> shown in FIG. 2) is produced.
[0287] According to thus produced effevescent tablet for oral administration, lubricants aren't contained in the mixture to be compressed with punches (see the upper punch <b>31</b> and the lower punch <b>33</b> in FIG. 8<i>c</i>) and the die (see the die <b>32</b> in FIG. 8<i>c</i>). Only a slight amount of lubricants is transferred on the surface of the tablet from the lubricant powders applied on the punches (see the upper punch <b>31</b> and the lower punch <b>33</b> in FIG. 8<i>c</i>) and the die (see the die <b>32</b> in FIG. 8<i>c</i>), therefore, the lubricants aren't contained in the tablet.
[0288] Herewith, if thus obtained effevescent tablet for oral administration is dissolved in water or a hot water for dosing, an oil film doesn't appear on the resulting solution surface.
[0289] Further, granules of a main active ingredient <b>2</b>, carbonate granules <b>3</b> and organic acid granules <b>4</b> are uniformly dispersed in the effevescent tablet for oral administration, therefore there are any variations of dissolving time in water or a hot water between the tablets. Namely, effevescent tablets for oral administration having the same quality can be supplied in a market.
[0290] The effevescent tablet <b>1</b>A shown in FIG. 3 may be produced as an effevescent tablet for oral administration in the same manner mentioned above other than a binder solution in which water-soluble polymers and surfactants are dissolved in water is used for producing granules of a main active ingredient <b>2</b>, carbonate granules <b>3</b> and organic acid granules <b>4</b>.
[0291] More specifically, the effevescent tablet for oral administration like the effevescent tablet <b>1</b>A shown in FIG. 3 may be produced according to the following production method.
[0292] At first a granulated material in which a binder including a surfactant binds between the particles P<b>2</b> . . . comprising granules of a main active ingredient <b>2</b> is produced as granules of a main active ingredient <b>2</b>.
[0293] Further a granulated material in which a binder <b>7</b> including a surfactant <b>6</b> binds between the particles P<b>3</b> . . . comprising carbonate granules <b>3</b> is produced as carbonate granules <b>2</b>.
[0294] Furthermore a granulated material in which a binder <b>7</b> including a surfactant <b>6</b> binds between the particles P<b>4</b> comprising organic acid granules <b>4</b> is produced as organic acid granules <b>4</b>.
[0295] The granulated material in which the particles P<b>2</b> . . . comprising granules of a main active ingredient <b>2</b> are bound by the binder including a surfactant, the granulated material in which the particles P<b>3</b> . . . comprising carbonate granules <b>3</b> are bound by the binder <b>7</b> including surfactants <b>6</b> and the granulated material in which the particles P<b>4</b> . . . comprising organic acid granules <b>4</b> are bound by the binder <b>7</b> including surfactants <b>6</b> are blended, wherein other adjuncts excluding lubricant powders are added if necessary, and are uniformly mixed to obtain the mixture (molding material).
[0296] Lubricant aren't added in thus obtained mixture (molding material) as shown in FIG. 8<i>c. </i>
[0297] Lubricant powders are sprayed on the surface S<b>31</b> (lower face, material contacting surface) of the upper punch <b>31</b>, the surface S<b>32</b> (inner circumference, more specifically the material contacting surface above the upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) of the die <b>32</b> and the surface S<b>33</b> (upper face, material contacting surface) of the lower punch <b>33</b>. Thereby a minimum amount of lubricant is applied on the surface S<b>31</b> (lower face, material contacting surface) of the upper punch <b>31</b>, the surface S<b>32</b> (inner circumference, more specifically the material contacting surface above the upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) of the die <b>32</b> and the surface S<b>33</b> (upper face, material contacting surface) of the lower punch <b>33</b>.
[0298] Then the mixture (molding material) M without including lubricants is compressed with the upper punch <b>31</b> on which face S<b>31</b> (lower face, material contacting surface) lubricants are applied, the die <b>32</b> on which surface S<b>32</b> (inner circumference, more specifically a material contacting surface above the upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) lubricants are applied and the lower punch <b>33</b> on which surface S<b>33</b> (upper face, material contacting surface) lubricants are applied, thereby the effevescent tablet for oral administration is produced.
[0299] According to the effevescent tablet for oral administration, because particles comprising each granule <b>2</b> . . . , <b>3</b> . . . , <b>4</b> . . . are bound by the binder <b>7</b> including a surfactant <b>6</b>, the binder <b>7</b> easily gets wet. Therefore, the tablet can achieve more rapid dissolving property when it is put in water or a hot water for use comparing with the effevescent tablet for a bath agent in which each granule <b>2</b> . . . , <b>3</b> . . . , <b>4</b> . . . is bound by the binder <b>5</b> without including surfactants <b>6</b>.
[0300] The effevescent tablet <b>1</b>B shown in FIG. 4 may be produced as an effevescent tablet for oral administration in the same manner mentioned above other than a binder solution in which water-soluble polymers and a surfactant are dissolved in water is used for producing granules of a main active ingredient <b>2</b>, the carbonate granules <b>3</b> and organic acid granules <b>4</b>.
[0301] More specifically, the effevescent tablet for oral administration like the effevescent tablet <b>1</b>B shown in FIG. 4 may be produced according to the following production method.
[0302] At first a granulated material in which a binder <b>9</b> including a saccharide with high wettability for water <b>8</b> binds between the particles P<b>2</b> . . . comprising the granules of a main active ingredient <b>2</b> is produced as granules of a main active ingredient <b>2</b>.
[0303] Further a granulated material in which a binder <b>9</b> including a saccharide with high wettability for water <b>8</b> binds between the particles P<b>3</b> . . . comprising carbonate granules <b>3</b> is produced as carbonate granules <b>3</b>.
[0304] Furthermore a granulated material in which a binder <b>9</b> including a saccharide with high wettability for water, <b>8</b> binds between the particles P<b>4</b> . . . comprising organic acid granules <b>4</b> is produced as organic acid granules <b>4</b>.
[0305] The granulated material in which the particles P<b>2</b> . . . comprising granules of a main active ingredient <b>2</b> are bound by the binder <b>9</b> including a saccharide with high wettability for water <b>8</b>, the granulated material in which the particles P<b>3</b> . . . comprising carbonate granules <b>3</b> are bound by the binder <b>9</b> including a saccharide with high wettability for water <b>8</b> and the granulated material in which the particles P<b>4</b> . . . comprising organic acid granules <b>4</b> are bound by the binder <b>9</b> including a saccharide with high wettability for water <b>8</b> are blended, wherein other adjuncts excluding lubricant powders are added if necessary, and are uniformly mixed to obtain the mixture (molding material).
[0306] Lubricants aren't added in thus obtained mixture (molding material).
[0307] As shown in FIG. 8<i>c </i>lubricant powders are sprayed on the surface S<b>31</b> (lower face, material contacting surface) of the upper punch <b>31</b>, the surface S<b>32</b> (inner circumference, more specifically the material contacting surface above the upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) of the die <b>32</b> and the surface S<b>33</b> (upper face, material contacting surface) of the lower punch <b>33</b>. Thereby a minimum amount of lubricant is applied on the surface S<b>31</b> (lower face, material contacting surface) of the upper punch <b>31</b>, the surface S<b>32</b> (inner circumference, more specifically the material contacting surface above the upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) of the die <b>32</b> and the surface S<b>33</b> (upper face, material contacting surface) of the lower punch <b>33</b>.
[0308] Then the mixture (molding material) M without including lubricants is compressed with the upper punch <b>31</b> on which face S<b>31</b> (lower face, material contacting surface) lubricants are applied, the die <b>32</b> on which surface S<b>32</b> (inner circumference, more specifically the material contacting surface above the upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) lubricants are applied and the lower punch <b>33</b> on which surface S<b>33</b> (upper face, material contacting surface) lubricants are applied, thereby the effevescent tablet for oral administration is produced.
[0309] According to the effevescent tablet for oral administration, because particles comprising each granule <b>2</b> . . . , <b>3</b> . . . , <b>4</b> . . . are bound by the binder <b>9</b> including a saccharide with high wettability for water <b>8</b>, the binder <b>9</b> easily gets wet. Therefore, the tablet can achieve more rapid dissolving property when it is put in water or a hot water for use comparing with the effevescent tablet for oral administration in which each granule <b>2</b> . . . , <b>3</b> . . . , <b>4</b> . . . isn't bound by the binder <b>5</b> without including a saccharide with high wettability for water <b>8</b>.
[0310] The rapid dissolution property of the effevescent tablet for oral administration is realized by the saccharide with high wettability for water <b>8</b> included in the binder <b>9</b>.
[0311] Thus, a surfactant isn't used for thus obtained effevescent tablet for administration, thereby having high safety comparing with the effevescent tablet for oral administration using surfactants.
[0312] The effevescent tablet <b>1</b>C shown in FIG. 5 may be produced as an effevescent tablet for oral administration in the same manner mentioned above other than a binder solution in which water-soluble high polymers and saccharides with high wettability for water and surfactants are dissolved in water is used for producing granules of a main active ingredient <b>2</b>, carbonate granules <b>3</b> and organic acid granules <b>4</b>.
[0313] More specifically, the effevescent tablet for oral administration like the effevescent tablet <b>1</b>C shown in FIG. 5 may be produced according to the following production method.
[0314] At first a granulated material in which a binder <b>10</b> including a surfactant <b>6</b> and a saccharide with high wettability for water <b>8</b> binds between the particles including granules of a main active ingredient P<b>2</b> . . . comprising granules of a main active ingredient <b>2</b> is produced as the granules of a main active ingredient <b>2</b>.
[0315] Further a granulated material in which a binder <b>10</b> including a surfactant <b>6</b> and a saccharide with high wettability for water <b>8</b> binds between the particles P<b>3</b> . . . comprising the carbonate granules <b>3</b> is produced as carbonate granules <b>3</b>.
[0316] Furthermore a granulated material in which a binder <b>10</b> including a surfactant <b>6</b> and a saccharide with high wettability for water <b>8</b> binds between the particles P<b>4</b> . . . comprising organic acid granules <b>4</b> is produced as organic acid granules <b>4</b>.
[0317] The granulated material in which the particles including granules of a main active ingredient P<b>2</b> . . . comprising granules of a main active ingredient <b>2</b> are bound by the binder <b>10</b> including a surfactant <b>6</b> and a saccharide with high wettability for water <b>8</b>, the granulated material in which the particles P<b>3</b> . . . comprising carbonate granules <b>3</b> are bound by the binder <b>10</b> including a surfactant <b>6</b> and a saccharide with high wettability for water <b>8</b> and the granulated material in which the particles P<b>4</b> . . . comprising organic acid granules <b>4</b> are bound by the binder <b>10</b> including a surfactant <b>6</b> and a saccharide with high wettability for water <b>8</b> are blended, wherein other adjuncts excluding lubricant powders are added if necessary, and are uniformly mixed to obtain the mixture (molding material).
[0318] Lubricants aren't added in thus obtained mixture M (molding material).
[0319] Then lubricant powders are sprayed on a surface S<b>31</b> (lower face, material contacting surface) of an upper punch <b>31</b>, a surface S<b>32</b> (inner circumference, more specifically a material contacting surface above an upper face (material contacting surface) of a lower punch inserted into a fixed position in a die) of the die <b>32</b> and a surface S<b>33</b> (upper face, material contacting surface) of the lower punch <b>33</b>. Thereby a minimum amount of lubricant is applied on the surface S<b>31</b> (lower face, material contacting surface) of the upper punch <b>31</b>, the surface S<b>32</b> (inner circumference, more specifically the material contacting surface above the upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) of the die <b>32</b> and the surface S<b>33</b> (upper face, material contacting surface) of the lower punch <b>33</b>.
[0320] Then the mixture (molding material) M without including lubricants is compressed with the upper punch <b>31</b> on which face S<b>31</b> (lower face, material contacting surface) lubricants are applied, the die <b>32</b> on which surface S<b>32</b> (inner circumference, more specifically the material contacting surface above the upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) lubricant are applied and the lower punch <b>33</b> on which surface S<b>33</b> (upper face, material contacting surface) lubricants are applied, thereby the effevescent tablet for oral administration is produced.
[0321] According to the effevescent tablet for oral administration, because particles comprising each granule <b>2</b> . . . , <b>3</b> . . . , <b>4</b> . . . are bound by the binder <b>10</b> including a surfactant <b>6</b> and a saccharide with high wettability for water <b>8</b>, the binder <b>10</b> easily gets wet. Therefore, the tablet can achieve more rapid dissolving property when it is put in water or a hot water for dosing comparing to the effevescent tablet for oral administration in which each granule <b>2</b> . . . , <b>3</b> . . . , <b>4</b> . . . isn't bound by the binder <b>5</b> without including a surfactant <b>6</b> and a saccharide with high wettability for water <b>8</b>.
[0322] The rapid dissolution property of the effevescent tablet for oral administration is realized by the a surfactant <b>6</b> and the saccharide with high wettability for water <b>8</b> included in the binder <b>10</b>.
[0323] Comparing to the effevescent tablet for oral administration which uses only a surfactant <b>6</b>, the amount of surfactant contained in thus obtained effevescent tablet for oral administration can be reduced, therefore high safety is achieved.
[0324] By the way, according to the effevescent tablet, the effevescent tablet for a bath agent, the effevescent tablet for a washing detergent and the effevescent tablet for oral administration as mentioned above, lubricant powders are sprayed on the surface S<b>31</b> (lower face, material contacting surface) of the upper punch <b>31</b>, the surface S<b>32</b> (inner circumference, more specifically the material contacting surface above the upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) of the die <b>32</b> and the surface S<b>33</b> (upper face, material contacting surface) of the lower punch <b>33</b>. Thereby a minimum amount of lubricant is applied on the surface S<b>31</b> (lower face, material contacting surface) of the upper punch <b>31</b>, the surface S<b>32</b> (inner circumference, more specifically the material contacting surface above the upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) of the die <b>32</b> and the surface S<b>33</b> (upper face, material contacting surface) of the lower punch <b>33</b>. Then the mixture (molding material) is compressed with the upper punch <b>31</b> on which face S<b>31</b> (lower face, material contacting surface) lubricants are applied, the die <b>32</b> on which surface S<b>32</b> (inner circumference, more specifically a material contacting surface above an upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) lubricants are applied and the lower punch <b>33</b> on which surface S<b>33</b> (upper face, material contacting surface) lubricants are applied, thereby producing the effevescent tablet.
[0325] Namely, the effevescent tablet, the effevescent tablet for a bath agent, the effevescent tablet for a washing detergent and the effevescent tablet for oral administration of the present invention can be accomplished by the technology wherein a minimum amount of lubricant is applied on the surface S<b>31</b> (lower face, material contacting surface) of the upper punch <b>31</b>, the surface S<b>32</b> (inner circumference, more specifically the material contacting surface above the upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) of the die <b>32</b> and the surface S<b>33</b> (upper face, material contacting surface) of the lower punch <b>33</b>.
[0326] The inventors of the present invention have completed the technology wherein a minimum amount of lubricant is applied on the surface S<b>31</b> (lower face, material contacting surface) of the upper punch <b>31</b>, the surface S<b>32</b> (inner circumference, more specifically the material contacting surface above the upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) of the die <b>32</b> and the surface S<b>33</b> (upper face, material contacting surface) of the lower punch <b>33</b>.
[0327] Here the inventors of the present invention disclose an apply means and an apply method of lubricants for applying a minimum amount of lubricant on the surface S<b>31</b> (lower face, material contacting surface) of the upper punch <b>31</b>, the surface S<b>32</b> (inner circumference, more specifically the material contacting surface above the upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) of the die <b>32</b> and the surface S<b>33</b> (upper face, material contacting surface) of the lower punch <b>33</b>.
[0328]FIG. 10 is an entire construction diagrammatically showing an external lubrication type tabletting machine which can continuously and stably apply a minimum amount of lubricant on each one of the surface S<b>31</b> (lower face, material contacting surface) of the upper punch <b>31</b>, the surface S<b>32</b> (inner circumference, more specifically the material contacting surface above the upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) of the die <b>32</b> and the surface S<b>33</b> (upper face, material contacting surface) of the lower punch <b>33</b>.
[0329] The external lubrication type tabletting machine S is comprised of a pulsating vibration air generator <b>41</b>, a quantitative feeder <b>51</b>, a rotary type tabletting machine <b>81</b>, a lubricant spray chamber (lubricant apply means) <b>91</b> provided at a fixed position of the rotary type tabletting machine <b>81</b>, a lubricant suction means <b>101</b> for removing extra lubricants sprayed from a lubricant spray chamber (lubricant apply means) <b>91</b>, an air source <b>111</b> such as a blower, and a processing unit <b>121</b> for controlling and supervising the entire external lubrication type tabletting machine S.
[0330] A conduit Tm connects between the air source <b>111</b> and the pulsating vibration air generator <b>41</b> of the external lubrication type tabletting machine S so that a compressed air generated by driving the air source <b>111</b> is supplied to the pulsating vibration air generator <b>41</b>.
[0331] Between the pulsating vibration air generator <b>41</b> and the quantitative feeder <b>51</b> is connected with a conduit T<b>1</b> so as to convert the compressed air fed through the conduit Tm into a positive pulsating vibration air and to supply into the conduit T<b>1</b>.
[0332]FIG. 11 is an explanatory view exemplifying a positive pulsating vibration air.
[0333] The “pulsating vibration air” means an air wave of which pressure varies.
[0334] The “positive” means that the pressure is higher than the pressure (atmospheric pressure) out of the external lubrication type tabletting machine S.
[0335] The positive pulsating vibration air supplied in the conduit T<b>1</b> may be a pulsating vibration air in which an amplitude peak is positive and an amplitude valley is atmospheric pressure as shown in FIG. 11<i>a </i>or may be a pulsating vibration air in which both an amplitude peak and valley are positive as shown in FIG. 11<i>b. </i>
[0336] The quantitative feeder <b>51</b> is connected to the lubricant spray chamber (lubricant apply means) <b>91</b> via a conduit T<b>2</b>.
[0337] When the positive pulsating vibration air is supplied in the quantitative feeder <b>51</b> via the conduit T<b>1</b>, lubricants (powder) are mixed with and dispersed in the pulsating vibration air. Thus obtained pulsating vibration air in which lubricant is mixed with and dispersed in is supplied in the conduit T<b>2</b>.
[0338] Then, the lubricants (powder) supplied with the positive pulsating vibration air are pneumatically transported in the conduit T<b>2</b> together with the pulsating vibration air to be fed in the lubricant spray chamber (lubricant apply means) <b>91</b>, and the lubricants are sequentially applied on the surface S<b>31</b> (lower face, material contacting surface) of the upper punch <b>31</b>, the surface S<b>32</b> (inner circumference, more specifically the material contacting surface above the upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) of the die <b>32</b> and the surface S<b>33</b> (upper face, material contacting surface) of the lower punch <b>33</b>, those punches <b>31</b>, <b>33</b> and die <b>32</b> being accommodated in the lubricant spray chamber (lubricant apply means) <b>91</b>.
[0339] The lubricant spray chamber (lubricant apply means) <b>91</b> and the lubricant suction means <b>101</b> are connected by a conduit T<b>3</b>.
[0340] When the lubricant suction means <b>101</b> is driven, the extra lubricants (powder) are suck to be removed via the conduit T<b>3</b>. The extra lubricants (powder) are those being applied on the surface S<b>31</b> (lower face, material contacting surface) of the upper punch <b>31</b>, the surface S<b>32</b> (inner circumference, more specifically a material contacting surface above the upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) of the die <b>32</b> and the surface S<b>33</b> (upper face, material contacting surface) of the lower punch <b>33</b>, while those punches <b>31</b>, <b>33</b> and die <b>32</b> being accommodated in the lubricant spray chamber (lubricant apply means) <b>91</b>.
[0341] Each member comprising the external lubrication type tabletting machine S will be more detailed hereinafter.
[0342]FIG. 12 is an explanatory view diagrammatically showing a quantitative feeder.
[0343] The quantitative feeder <b>51</b> is comprised of a lubricant storage hopper <b>52</b>, a tubular body <b>53</b> airtightly connected to a discharge port <b>52</b><i>a </i>of the lubricant storage hopper <b>52</b>, a material feed valve <b>54</b> provided so as to be able to open and close the material discharge port <b>52</b><i>a </i>of the lubricant storage hopper <b>52</b>, an elastic membrane Et provided so as to form a bottom of the tubular body <b>53</b> and a dispersion chamber <b>55</b> airtightly connected under the tubular body <b>53</b> via the elastic membrane Et.
[0344] In the lubricant storage hopper <b>52</b> gas injection means <b>56</b>, <b>56</b> are provided around the material discharge port <b>52</b><i>a. </i>
[0345]FIG. 13 is an explanatory view showing the lubricant storage hopper <b>52</b> in more detail, FIG. 13<i>a </i>is a perspective view diagrammatically showing the hopper <b>52</b> and FIG. 13<i>b </i>is a plan view diagrammatically showing an essential part of the lubricant storage hopper <b>52</b> shown in FIG. 13<i>a. </i>
[0346] The gas injection means <b>56</b>, <b>56</b> are provided in a substantially tangential direction against the inner circumference of the lubricant storage hopper <b>52</b>.
[0347] More specifically, each gas injection means <b>56</b>, <b>56</b> is positioned at an outer circumference above the material discharge port <b>52</b><i>a </i>in a cone area <b>52</b><i>d </i>of the lubricant storage hopper <b>52</b> so as to be in a substantially tangential direction against the material discharge port <b>52</b><i>a. </i>
[0348] In FIG. 12 and FIG. 13, two gas injection means <b>56</b> are provided, however, the number of the gas injection means <b>56</b> isn't limited to two. One or more than three gas injection means may be provided. Further, if more than two gas injection means <b>56</b> are provided, they are arranged in such a manner that gas is injected in the same rotational direction from each gas injection port <b>56</b><i>a </i>. . . of the gas injection means <b>56</b> . . . .
[0349] The member indicated by the reference numeral <b>52</b><i>c </i>in FIG. 12 is a cover detachably provided for the material feed port <b>52</b><i>b </i>of the lubricant storage hopper <b>52</b>.
[0350] In this embodiment, the cover <b>52</b><i>c </i>is airtightly attached to the material feed port <b>52</b><i>b </i>of the lubricant storage hopper <b>52</b>.
[0351] A conduit T<b>4</b> is connected to the lubricant storage hopper <b>52</b> so as to be communicated with atmosphere.
[0352] The lubricant storage hopper <b>52</b> and the conduit Tm are connected with a conduit T<b>5</b> and a switch valve v<b>2</b> and a pressure control valve vp<b>2</b> are provided in the midstream of the conduit T<b>5</b>.
[0353] The member indicated by the reference numeral. F<b>1</b> and provided in the midstream of the conduit T<b>5</b> is a filter for removing dust in the air supplied in the conduit T<b>5</b>. The filter F<b>1</b> may be provided if necessary.
[0354] Each gas injection means <b>56</b>, <b>56</b> and the conduit Tm are connected with a conduit T<b>6</b>. In FIG. 12 only the conduit T<b>6</b> connected to one of the gas injection means <b>56</b> is shown and other conduit T<b>6</b> is omitted.
[0355] A pressure control valve vp<b>3</b> is provided for the conduit T<b>6</b>.
[0356] The member indicated by the reference numeral F<b>2</b> provided in the midstream of the conduit T<b>6</b> is a filter for removing dust in the air supplied in the conduit T<b>6</b>, however, the filter F<b>2</b> is only provided if necessary.
[0357] In this embodiment the material feed valve <b>54</b> has a valve plug <b>54</b><i>b </i>and an open-close drive means (actuator) <b>54</b><i>a </i>for moving the valve plug <b>54</b><i>b </i>up and down.
[0358] Open and close of the material feed valve <b>54</b> is driven by air.
[0359] The material feed valve <b>54</b> and the conduit Tm are connected with a conduit T<b>7</b>.
[0360] The conduit T<b>7</b> is branched into two pipes T<b>7</b><i>a </i>and T<b>7</b><i>b </i>to be connected with the open-close drive means (actuator) <b>54</b><i>a </i>of the material feed valve <b>54</b>.
[0361] A switch valve v<b>3</b> is provided in the midstream of the conduit T<b>7</b>. When the branch pipe T<b>7</b><i>a </i>side of the control valve v<b>3</b> is opened and the branch pipe side T<b>7</b><i>b </i>side is closed, the valve plug <b>54</b><i>b </i>of the material feed valve <b>54</b> is moved down to open the material discharge port <b>52</b><i>a </i>of the lubricant storage hopper <b>52</b>. When the branch pipe T<b>7</b><i>b </i>side of the control valve v<b>3</b> is opened and the branch pipe side T<b>7</b><i>a </i>side is closed, the valve plug <b>54</b><i>b </i>of the material feed valve <b>54</b> is moved up to close the material discharge port <b>52</b><i>a </i>of the lubricant storage hopper <b>52</b>.
[0362] The member indicated by the reference numeral F<b>3</b> provided in the midstream of the branch pipe T<b>7</b><i>a </i>and T<b>7</b><i>b </i>is a filter for removing dust in the air supplied in the conduit T<b>7</b>, however, the filter F<b>3</b> is only provided if necessary.
[0363] Next the construction of the elastic membrane Et will be explained.
[0364]FIG. 14 is a plan view diagrammatically showing the elastic membrane Et.
[0365] The elastic membrane Et is made of an elastic material such as a synthetic rubber like a silicone rubber and has a penetrating aperture Eta at the center. In this embodiment, the aperture Eta of the elastic membrane Et is formed like a slit.
[0366] The elastic membrane Et is installed between the tubular body <b>53</b> and the dispersion chamber <b>55</b> by means of an elastic membrane installation means <b>51</b>.
[0367]FIG. 15 is a perspective view when the elastic membrane is attached on the elastic membrane installation means of the quantitative feeder <b>51</b>. FIG. 16 is an exploded view diagrammatically showing the construction of the elastic membrane installation means shown in FIG. 15. FIG. 17 is a sectional view diagrammatically showing the construction of the elastic membrane installation means shown in FIG. 15.
[0368] The elastic membrane installation means <b>61</b> has a pedestal <b>62</b>, a push-up member <b>63</b> and a presser member <b>64</b>.
[0369] The pedestal <b>62</b> has a hollow part h<b>1</b> and a ring-like platform S<b>1</b> for placing the push-up member <b>63</b> is provided at the periphery of the hollow part h<b>1</b>. Further, a V-groove Dv is provided for the pedestal <b>62</b> so as to surround the hollow part h<b>1</b> like a ring.
[0370] The push-up member <b>63</b> has a hollow part h<b>2</b>. In this embodiment, the push-up member <b>63</b> has a stepped part Q<b>1</b> at its lower part as shown in FIG. 17 in such a manner that the part Q<b>1</b> is positioned on the platform S<b>1</b> of the pedestal <b>62</b> when the push-up member <b>63</b> is placed on the pedestal <b>62</b>.
[0371] When the push-up member <b>63</b> is placed on the pedestal <b>62</b> in this embodiment, a lower extended part Q<b>2</b> formed so as to be extended downward from the step Q<b>1</b> of the push-up member <b>63</b> is designed to be incorporated in the hollow part h<b>1</b> of the pedestal <b>62</b>. Namely, the lower extended part Q<b>2</b> of the push-up member <b>63</b> is precisely processed in such a manner that its outer diameter D<b>2</b> is almost the same or a little smaller than the inside diameter D<b>1</b> of the hollow part h<b>1</b> of the pedestal <b>62</b>.
[0372] Furthermore in this embodiment, an inclined plane extending from top to bottom in a sectional view is provided at the periphery of an upper part Q<b>3</b> of the push-up member <b>63</b>.
[0373] The presser member <b>64</b> has a hollow part h<b>3</b>. A ring-like V-shaped projection Cv is provided for a surface S<b>4</b> of the presser member <b>64</b> facing the pedestal <b>62</b> so as to be incorporated in the V-groove Dv on the surface of the pedestal <b>62</b>.
[0374] The member indicated by a numeral <b>65</b> in FIG. 15 and FIG. 16 shows fastening means such as a bolt.
[0375] The hole shown as h<b>4</b> in FIG. 16 is a fixing hole of the fastening means <b>65</b> formed on the pedestal <b>62</b>, and the hole shown as h<b>6</b> is a fixing hole of the fastening means <b>65</b> formed on the presser member <b>64</b> respectively. The hole shown as h<b>5</b> in FIG. 16 is a fixing hole of the pedestal <b>62</b> for attaching the elastic membrane installation means <b>61</b> to a desired device by means of fixing means such as a bolt (not shown). The hole h<b>7</b> of the presser member <b>64</b> is for attaching the elastic membrane installation means <b>61</b> to a desired device by means of fixing means such as a bolt (not shown).
[0376] In this embodiment, the inside diameter D<b>4</b> of the hollow part h<b>3</b> of the presser member <b>64</b> is precisely processed so as to be the same as or a litter larger than the external diameter D<b>3</b> of the push-up member <b>63</b>.
[0377] Next, installation procedures of the elastic membrane Et on the elastic membrane installation means <b>61</b> will be explained hereinafter.
[0378] The push-up member <b>63</b> is placed on the surface of the pedestal <b>2</b> at first for installing the elastic membrane Et on the elastic membrane installation means <b>61</b>.
[0379] Then, the elastic membrane Et is placed on the push-up member <b>63</b>.
[0380] The presser member <b>64</b> is placed on the push-up member <b>63</b> so as to cover both the push-up member <b>63</b> and the elastic membrane Et in such a manner that each fixing hole h<b>4</b> . . . on the pedestal <b>62</b> is aligned with each fixing hole h<b>6</b> . . . on the presser member <b>64</b>.
[0381] Next, the presser member <b>4</b> is fastened to the pedestal <b>62</b> by screwing each fastening means such as a bolt <b>65</b> . . . into each fastening hole h<b>4</b> . . . and each corresponding fastening hole h<b>6</b> . . . .
[0382] Accordingly, the elastic membrane Et is placed on the push-up member <b>63</b> on the pedestal <b>62</b> of the elastic membrane installation means <b>61</b> and the presser member <b>64</b> is fastened to the pedestal <b>62</b> so that the elastic membrane Et is pushed upward to the presser member <b>64</b> by the push-up member <b>63</b>. As a result, the elastic membrane Et is extended from its inside to its periphery by being pushed upward into the presser member <b>64</b>.
[0383] At first, the elastic membrane Et extended by the push-up member <b>63</b> is gradually inserted between the V-groove Dv formed on the pedestal <b>62</b> and the V-shaped projection Cv formed on the surface of the presser member <b>64</b> facing the pedestal <b>62</b> via the space between the periphery Q<b>3</b> of the push-up member <b>63</b> and the surface (inner surface) forming the hollow part h<b>3</b> of the presser member <b>64</b>.
[0384] Furthermore, as the presser member <b>64</b> is fastened to the pedestal <b>62</b> by means of the fastening means such as a bolt <b>65</b> . . . , the elastic membrane Et comes to be held between the periphery Q<b>3</b> of the push-up member <b>63</b> and the inner surface of the hollow part h<b>3</b> of the presser member <b>64</b> while being pushed up into the presser member <b>64</b> by the push-up member <b>63</b>. When the elastic membrane Et is further pushed up into the presser member <b>64</b> by the push-up member <b>63</b>, the extended part of the elastic membrane Et from inside to outside is held between the V-groove Dv of the pedestal <b>62</b> and the V-shaped projection Cv on the surface of the presser member <b>64</b> facing the pedestal <b>62</b>.
[0385] In other words, according to the elastic membrane installation means <b>61</b>, the elastic membrane Et is placed on the push-up member <b>63</b> on the pedestal <b>62</b> and the presser member <b>64</b> is fastened to the pedestal <b>62</b>, then the elastic membrane Et is pushed up to the presser member <b>64</b> by the push-up member <b>63</b>, thereby the elastic membrane Et is kept being stretched from its inside to outside. Furthermore, the periphery of the elastic membrane Et extended by the push-up member <b>63</b> is held between the V-groove Dv of the pedestal <b>62</b> and the V-shaped projection Cv provided on the face opposing the pedestal <b>62</b> of the presser member <b>64</b>. As a result, the elastic membrane installation means <b>61</b> can keep the elastic membrane Et stretched only by a simple operation such that the elastic membrane Et is placed on the push-up member <b>63</b> on the pedestal <b>62</b> and the presser member <b>64</b> is fastened to the pedestal <b>62</b>.
[0386] In addition, the inclined plane Q<b>3</b> enlarging from top to bottom in its section is provided at the periphery of the push-up member <b>63</b> of the elastic membrane installation means <b>61</b>.
[0387] The inclined plane Q<b>3</b> is an important element of the elastic membrane installation means <b>61</b> and is detailed hereinafter.
[0388] The inclined plane Q<b>3</b> which is enlarged from top to bottom is provided for the periphery of the push-up member <b>63</b> of the elastic membrane installation means <b>61</b>. Therefore, the extended part of the elastic membrane Et from inside to, outside by being pushed up into the presser member <b>64</b> is easily moved between the V-groove Dv annularly formed on the pedestal <b>62</b> and the V-shaped projection Cv annularly formed on the surface of the presser member <b>64</b> facing the pedestal <b>62</b>.
[0389] More specifically, when the external diameter of the inclined plane Q<b>3</b> of the push-up member <b>63</b> is substantially smaller than the inner diameter D<b>4</b> of the hollow part h<b>3</b> of the presser member <b>64</b>, there is an adequate gap (space) between the inclined plane Q<b>3</b> of the push-up member <b>63</b> and the surface forming the hollow part h<b>3</b> of the presser member <b>64</b>, thereby the extended part of the elastic membrane Et from inside to outside by the push-up member <b>63</b> being easily guided to the V-groove Dv annularly provided on the surface of the pedestal <b>62</b> by the gap.
[0390] The inclined plane Q<b>3</b> of the periphery of the push-up member <b>63</b> is designed so as to be enlarged from top to bottom in a sectional view. Therefore, the extended part of the elastic membrane Et from inside to outside by the push-up member <b>63</b> is guided to the V-groove Dv annularly provided on the pedestal <b>62</b> along the surface of the inclined plane Q<b>3</b>.
[0391] Then the presser member <b>64</b> is fastened to the pedestal <b>62</b> by screwing each fastening means such as a bolt <b>65</b> . . . into each fixing hole h<b>4</b> . . . and each corresponding fixing hole h<b>6</b> . . . . Accordingly the external diameter of the inclined plane Q<b>3</b> of the push-up member <b>63</b> gets closer to the inner diameter D<b>4</b> of the hollow part h<b>3</b> of the presser member <b>64</b>. When the gap (space) between the inclined plane Q<b>3</b> of the push-up member <b>63</b> and the surface consisting the hollow part h<b>3</b> of the presser member <b>64</b> becomes about the thickness (wall thickness) of the elastic membrane Et, the elastic membrane Et comes to be held between the inclined plane Q<b>3</b> of the push-up member <b>63</b> and the surface consisting the hollow part h<b>3</b> of the presser member <b>64</b>.
[0392] According to the above-mentioned operations, the elastic membrane Et is placed on the push-up member <b>63</b> on the pedestal <b>62</b> of the elastic membrane installation means <b>61</b>, then the presser member <b>64</b> is fastened to the pedestal <b>62</b> by means of a simple operation of fixing means such as a bolt <b>65</b> . . . , thereby keeping the elastic membrane Et strained.
[0393] When the presser member <b>64</b> is fastened to the pedestal <b>62</b> by means of the fixing means such as a bolt <b>65</b> . . . , the distance between the inclined plane Q<b>3</b> of the periphery of the push-up member <b>63</b> and the inner circumference of the hollow part h<b>3</b> of the presser member <b>64</b> becomes small, and the elastic membrane Et is tightly held between the inclined plane Q<b>3</b> of the push-up member <b>63</b> and the inner circumference of the hollow part h<b>3</b> of the presser member <b>64</b>, preventing the elastic membrane Et from being slack.
[0394] Further if the elastic membrane Et is attached on the elastic membrane installation means <b>61</b>, it is doubly locked between the inclined plane Q<b>3</b> of the push-up member <b>63</b> and the surface consisting the hollow part h<b>3</b> of the presser member <b>64</b> and between the V-shaped projection Cv annularly provided on the surface of the presser member <b>64</b> facing the pedestal <b>62</b> and the V-groove Dv annularly provided on the pedestal <b>62</b>. Thereby, the elastic membrane Et doesn't get slack after the presser member <b>64</b> is fastened to the pedestal <b>62</b>.
[0395] According to the quantitative feeder <b>51</b>, the presser member <b>64</b> of the elastic membrane installation means <b>61</b> on which the elastic membrane Et is attached is airtightly installed at the lower part of the tubular pipe <b>53</b> and the pedestal <b>62</b> is airtightly provided on the top of the dispersion chamber <b>55</b>.
[0396] The quantitative feeder <b>51</b> has a bypass pipe Tv between the dispersion chamber <b>55</b> and tubular body <b>53</b> as shown in FIG. 12. The bypass pipe Tv is provided so as to rapidly get the pressure in the dispersion chamber <b>55</b> and that in the tubular body <b>53</b> balanced.
[0397] A level sensor <b>71</b> for detecting the amount of lubricants (powder) stored on the elastic membrane Et in a lower tubular body <b>53</b><i>b </i>is provided for the lower tubular part <b>53</b><i>b</i>. The level sensor <b>71</b> has a light emitting element <b>71</b><i>a </i>for generating light such as infrared rays and visible rays and a light receiving element <b>71</b><i>b </i>for receiving the light generated from the light emitting element <b>71</b><i>a</i>. The light emitting element <b>71</b><i>a </i>and the light receiving element <b>71</b><i>b </i>are provided to be opposed each other so as to interpose the lower tubular part <b>53</b><i>b. </i>
[0398] The amount of lubricants (powder) stored on the elastic membrane Et in the lower tube <b>53</b><i>b </i>can be detected at a position Hth (at height where the level sensor <b>71</b> is provided above the elastic membrane Et).
[0399] Namely, when the amount of lubricants (powder) stored on the elastic membrane Et in the lower tube <b>53</b><i>b </i>exceeds the position Hth (height where the level sensor <b>71</b> is provided above the elastic membrane Et), the light radiated from the light emitting element <b>71</b><i>a </i>is blocked off by the lubricants (powder) and isn't received by the light receiving element <b>71</b><i>b </i>(being off). Then it can be detected that the height H of the lubricant stored on the elastic membrane Et in the lower tube <b>53</b><i>b </i>exceeds the height Hth (H>Hth).
[0400] On the other hand, when the amount of lubricants (powder) stored on the elastic membrane Et in the lower tube <b>53</b><i>b </i>becomes lower than the position Hth (height where the level sensor is provided above the elastic membrane Et), the light emitted from the light emitting element <b>71</b><i>a </i>can be received by the light receiving element <b>71</b><i>b </i>(being on). Then it can be detected that the height H of the lubricants (powder) stored on the elastic membrane Et in the lower tube <b>53</b><i>b </i>is under the height Hth (H<Hth).
[0401] In this embodiment the material feed valve <b>54</b> moves up and down depending on the detected values of the level sensor <b>71</b> so as to open and close the discharge port <b>52</b><i>a </i>of the material storage hopper <b>52</b>. More specifically according to the quantitative feeder <b>51</b>, the light emitting element <b>71</b><i>a </i>of the level sensor <b>71</b> is turned on while the quantitative feeder <b>51</b> is driven. When the light from the light emitting element <b>71</b><i>a </i>doesn't come to be received in the light receiving element <b>71</b><i>b </i>(being off), the material feed valve <b>54</b> is moved up to close the discharge port <b>52</b><i>a </i>of the material storage hopper <b>52</b>. When the light from the light emitting element <b>71</b><i>a </i>is received by the light receiving element <b>71</b><i>b </i>(being on), the material feed valve <b>54</b> is moved down to open the discharge port <b>52</b><i>a </i>of the lubricant storage hopper <b>52</b> until the light isn't received by the light receiving element <b>71</b><i>b </i>(being off), thereby approximately the same quantity of lubricants (powder) is always stored on the elastic membrane Et in the lower tube <b>53</b><i>b </i>while the quantitative feeder <b>51</b> is driven.
[0402] The inner shape of the dispersion chamber <b>55</b> is designed to be approximately tubular so as to make a positive pulsating vibration air swirl therein. In this embodiment, such a dispersion chamber <b>55</b> of which inner shape is tubular is used, however, its shape isn't limited as long as a positive pulsating vibration air easily swirls therein. Therefore, the inner shape isn't limited to be approximately tubular.
[0403] The lower tube <b>53</b><i>b </i>of the cylindrical body <b>53</b> is made of clear resin, specifically a light permeable material such as glass, acrylate resin, polycarbonate resin, and so on.
[0404] Further, it is preferable that the lower tube <b>53</b><i>b </i>is made of polycarbonate and its inner circumferential wall is mirror finished.
[0405] It is because that if the lower tubular body <b>53</b><i>b </i>is made of polycarbonate and its inner circumferential wall is mirror finished, a powdered material is hardly adhered on the inner circumference of the tubular body <b>53</b><i>b </i>comparing with the case when other material is used, thereby obtaining high detection accuracy of the level sensor <b>71</b>.
[0406] The pulsating vibration air supply port <b>55</b><i>a </i>is provided at a lower part of the dispersion chamber <b>55</b> in approximately a tangential direction of the inside perimeter of the chamber <b>55</b>. The discharge port <b>55</b><i>b </i>is provided at an upper part of the dispersion chamber <b>55</b> in approximately a tangential direction of the inside perimeter of the chamber <b>55</b>. A conduit T<b>5</b> is connected to the pulsating vibration air supply port <b>55</b><i>a </i>and a conduit (for example see the conduit T<b>6</b> in FIG. 12) is connected to the pulsating vibration air discharge port <b>55</b><i>b. </i>
[0407] Again, explained in reference to FIG. 12, the pulsating vibration air supply port <b>55</b><i>a </i>is provided at a lower part of the dispersion chamber <b>55</b> in approximately a tangential direction of the inside perimeter of the dispersion chamber <b>55</b> and the discharge port <b>55</b><i>b </i>is provided at an upper part of the dispersion chamber <b>55</b> in approximately a tangential direction of the inside perimeter of the dispersion chamber <b>55</b>.
[0408] The pulsating vibration air supply port <b>55</b><i>a </i>of the dispersion chamber <b>55</b> and the pulsating vibration air generation means <b>41</b> are connected with a conduit T<b>1</b> in such a manner that when the pulsating vibration air generation means <b>41</b> is driven, a positive pulsating vibration air generated from the pulsating vibration air generation means <b>41</b> is supplied in the dispersion chamber <b>55</b> via the conduit T.
[0409] The discharge port <b>55</b><i>b </i>and the lubricant spray chamber (lubricant spray chamber (lubricant apply means) <b>91</b> shown in FIG. 10) are connected with a conduit (the conduit T<b>2</b> shown in FIG. 10).
[0410] Here the position of the pulsating vibration air supply port <b>55</b><i>a </i>provided for the dispersion chamber <b>55</b> is detailed referring to FIG. 18.
[0411]FIG. 18 is a plan view diagrammatically showing a position of the pulsating vibration air supply port <b>55</b><i>a </i>provided for the dispersion chamber <b>55</b> when the chamber <b>55</b> is seen from top, FIG. 18<i>a </i>is an explanatory view showing a preferable position for providing the pulsating vibration air supply port <b>55</b><i>a </i>against the dispersion chamber <b>55</b> and FIG. 18<i>b </i>is an explanatory view showing an actual position for providing the pulsating vibration air supply port <b>55</b><i>a </i>against the dispersion chamber <b>55</b>.
[0412] The curved arrows in FIG. 18<i>a </i>and FIG. 18<i>b </i>diagrammatically show the directions of the swirling positive pulsating vibration air generated in the dispersion chamber <b>55</b>.
[0413] The pulsating vibration air supply port <b>55</b><i>a </i>is preferably provided in a substantially tangential direction (a direction shown with a dashed line Lt in FIG. 18<i>a</i>) against the inside perimeter of the dispersion chamber <b>55</b> in order to generate a swirling positive pulsating vibration air in the dispersion chamber <b>55</b>.
[0414] However, the supply port <b>55</b><i>a </i>isn't always provided in a tangential direction against the inside perimeter of the chamber <b>55</b> as shown in FIG. 18<i>a</i>. It may be provided in an equivalent direction (namely, in a direction parallel to the tangential direction (a direction shown with a dashed line Lt in FIG. 18<i>b</i>) of the inner circumference of the dispersion chamber <b>55</b>, shown with a dashed line Lt in FIG. 18<i>b</i>) to the tangential direction (a direction shown with a dashed line Lt in FIG. 18<i>b</i>) as far as one dominant swirling flow is generated in the dispersion chamber <b>55</b>.
[0415] If the pulsating vibration air supply port <b>55</b><i>a </i>is provided in a direction into a center line of the dispersion chamber <b>55</b> as shown with an imaginary line Lc in FIG. 18<i>b</i>, two swirls, both of which don't seem a dominant flow, are generated when the inner shape of the dispersion chamber <b>55</b> is approximately cylindrical. Therefore, it isn't preferable to provide the supply port <b>55</b><i>a </i>in such a position considering generation of the swirling positive pulsating vibration air in the dispersion chamber <b>55</b>.
[0416] Next, the positional relation of the pulsating vibration air supply port <b>55</b><i>a </i>and the discharge port <b>55</b><i>b </i>in the dispersion chamber <b>55</b> is detailed referring to FIG. 19.
[0417]FIG. 19 is a plan view diagrammatically showing a position of the pulsating vibration air supply port <b>55</b><i>a </i>and its discharge port <b>55</b><i>b </i>provided for a dispersion chamber <b>55</b> when the chamber is seen from top, FIG. 19<i>a </i>is an explanatory view showing a preferable position for providing the pulsating vibration air supply port <b>55</b><i>a </i>and its discharge port <b>55</b><i>b </i>against the dispersion chamber <b>55</b> and FIG. 19<i>b </i>is an explanatory view showing an actual position for providing the pulsating vibration air supply port <b>55</b><i>a </i>and its discharge port <b>55</b><i>b </i>against the dispersion chamber <b>55</b>.
[0418] The curved arrows in FIG. 19<i>a </i>and FIG. 19<i>b </i>diagrammatically show directions of the swirling positive pulsating vibration air generated in the dispersion chamber <b>55</b>.
[0419] When the discharge port <b>55</b><i>b </i>is provided for the dispersion chamber <b>55</b> as shown in FIG. 19<i>a</i>, the position of the port <b>55</b><i>b </i>becomes opposite to the direction of the swirling pulsating vibration air (movement of the air flow) generated in the chamber <b>55</b>. In such a case, the discharge efficiency of the lubricants (powder) fluidized by being dispersed in air from the discharge port <b>55</b><i>b </i>can be set low.
[0420] Contrary if the discharge efficiency of the fluidized lubricant from the discharge port <b>55</b><i>b </i>is to be heightened, the port <b>55</b><i>b </i>is preferably provided in a forward direction of the swirling positive pulsating vibration air generated in the dispersion chamber <b>55</b> like the discharge port <b>55</b><i>b</i><b>1</b> or <b>55</b><i>b</i><b>2</b> illustrated in FIG. 19<i>b. </i>
[0421] The inner shape of the dispersion chamber <b>55</b> is designed to be approximately tubular so as to make a positive pulsating vibration air swirl therein. In this embodiment, such a dispersion chamber <b>55</b> is used, however, its inner shape isn't limited to be tubular as long as a positive pulsating vibration air easily swirls therein. Therefore, the inner shape isn't limited to be approximately tubular.
[0422] The member <b>72</b> in FIG. 12 is a pressure sensor for measuring the pressure in the lubricant storage hopper <b>52</b> and the member <b>73</b> is a pressure sensor for measuring the pressure in the tubular body <b>53</b>.
[0423] In the external lubrication type tabletting machine S, as shown in FIG. 10, the processing unit <b>121</b> and each member v<b>1</b>, v<b>2</b>, v<b>3</b>, v<b>5</b>, v<b>6</b>, v<b>7</b>, vp<b>1</b>, vp<b>2</b>, vp<b>3</b>, <b>41</b>, <b>71</b>, <b>72</b>, <b>73</b>, <b>102</b><i>i </i>and <b>111</b> are connected by signal lines so as to be able to drive, stop or control each member v<b>1</b>, v<b>2</b>, v<b>3</b>, v<b>5</b>, v<b>6</b>, v<b>7</b>, vp<b>1</b>, vp<b>2</b>, vp<b>3</b>, <b>41</b>, <b>71</b>, <b>72</b>, <b>73</b>, <b>102</b> and <b>111</b>.
[0424] Then operations of the quantitative feeder <b>51</b> is explained.
[0425]FIG. 20 is an explanatory view diagrammatically showing operations of the gas injection means <b>56</b>, <b>56</b> and the material feed valve <b>54</b> provided for the lubricant storage hopper <b>52</b> of the quantitative feeder <b>51</b>. FIG. 21 is a flow chart diagrammatically showing operation programs of the gas injection means <b>56</b>, <b>56</b> and the material feed valve <b>54</b> stored in a memory of the processing unit <b>121</b> in advance.
[0426] The open and close operations of the material feed valve <b>54</b> are executed as follows in the quantitative feeder <b>51</b>.
[0427] At an initial condition, the material feed valve <b>54</b> of the quantitative feeder <b>51</b> closes the material discharge port <b>52</b><i>a </i>of the lubricant storage hopper <b>52</b>.
[0428] An operator stores lubricant powders in the lubricant storage hopper <b>52</b> and attaches a cover <b>52</b><i>c </i>on the material feed port <b>52</b><i>b </i>(See FIG. 20<i>a</i>).
[0429] Next, an air source <b>111</b> is driven. Simultaneously the rotary cam <b>45</b> of the pulsating vibration air generation means <b>41</b> is rotated at a specified rotational speed so that a positive pulsating vibration air with a fixed flow amount, pressure and frequency and a desired wave shape is supplied in the conduit T<b>1</b>.
[0430] Each pressure control valve vp<b>1</b>, vp<b>2</b>, vp<b>3</b> and vp<b>4</b> is controlled.
[0431] At an initial condition, each switch valve v<b>1</b>, v<b>2</b> and v<b>3</b> is kept to be closed.
[0432] The level sensor <b>71</b> is actuated (see step <b>1</b>) and each pressure sensor <b>72</b>, <b>73</b> is also actuated (see step <b>2</b> and <b>3</b>).
[0433] The light emitted from the light emitting element <b>71</b><i>a </i>of the level sensor <b>71</b> is received in the light receiving element <b>71</b><i>b</i>. The signal indicating the light receiving element <b>71</b><i>b </i>has received the light emitted from the light emitting element <b>71</b><i>a </i>is sent to the processing unit <b>121</b>.
[0434] When the processing unit <b>121</b> receives the signal indicating the light receiving element <b>71</b><i>b </i>has received the light emitted from the light emitting element <b>71</b><i>a</i>, the processing unit <b>121</b> decides that the height H of the lubricant powders on the elastic membrane Et in the tubular body <b>54</b> is under a threshold Hth (see step <b>4</b>).
[0435] In this case the processing unit <b>121</b> opens the switch valve v<b>1</b> at a step <b>6</b> and keeps the pressure control valve vp<b>3</b> opened for a predetermined time. Thereby, gas is injected from the gas injection means <b>56</b>, <b>56</b> for a predetermined time so as to destroy the caked part even if such a part is generated in the lubricant powders stored in the lubricant storage hopper <b>52</b> (See FIG. 20<i>b</i>).
[0436] The pressure (Pr<b>52</b>) in the lubricant storage hopper <b>52</b> measured by the pressure sensor <b>72</b> and the pressure (Pr<b>53</b>) in the tubular body <b>53</b> measured by the pressure sensor <b>73</b> are sent to the processing unit <b>121</b>.
[0437] When the processing unit <b>121</b> receives a signal indicating gas has injected for a fixed time from the gas injection means <b>56</b>, <b>56</b> (signal showing the pressure control valve vp<b>3</b> is opened for a fixed time and closed thereafter), the pressure (Pr<b>52</b>) in the lubricant storage hopper <b>52</b> and the pressure (Pr<b>53</b>) in the tubular body <b>53</b> after gas is injected for a fixed time are compared (see step <b>7</b>).
[0438] When the processing unit <b>121</b> detects that the pressure (Pr<b>52</b>) in the lubricant storage hopper <b>52</b> is the same as the pressure (Pr<b>53</b>) in the tubular body <b>53</b> (pressure Pr<b>52</b>=pressure Pr<b>53</b>) in the step <b>7</b>, the unit <b>121</b> keeps the material feed valve <b>54</b> opened. Namely, in this embodiment, a processing unit (not shown) keeps the branch pipe T<b>7</b><i>a </i>side of the switch valve v<b>3</b> opened, and the branch pipe T<b>7</b><i>b </i>side closed.
[0439] Thereby, the material feed valve <b>54</b> is opened to discharge the lubricant powders stored in the lubricant storage hopper <b>52</b> into the tubular body <b>53</b> (see FIG. 20<i>c</i>).
[0440] Then, the processing unit <b>121</b> receives the signal indicating that the light receiving element <b>71</b><i>b </i>doesn't receive the light emitted from the light emitting element <b>71</b><i>a </i>of the level sensor <b>71</b>, the material feed valve <b>54</b> is closed. Namely in this embodiment, the processing unit <b>121</b> closes the branch pipe T<b>7</b><i>a </i>side of the switch valve v<b>3</b> and opens the branch pipe T<b>7</b><i>b </i>side (See step <b>10</b>).
[0441] Therefore, the material feed valve <b>54</b> is closed (See FIG. 20<i>a</i>).
[0442] The processing unit <b>121</b> detects that the pressure (Pr<b>52</b>) in the lubricant storage hopper <b>52</b> is higher than the pressure (Pr<b>53</b>) in the tubular body <b>53</b> (Pr<b>52</b>>Pr<b>53</b>) in the step <b>7</b>, the unit <b>121</b> keeps the switch valve v<b>1</b> opened until the pressure (Pr<b>52</b>) in the lubricant storage hopper <b>52</b> becomes equal to the pressure (Pr<b>53</b>) in the tubular body <b>53</b>. When the pressure (Pr<b>52</b>) in the lubricant storage hopper <b>52</b> becomes substantially equal to the pressure (Pr<b>53</b>) in the tubular body <b>53</b>, the switch valve v<b>1</b> is closed again (see step <b>7</b> and step <b>8</b>). Thereafter, the processing unit <b>121</b> detects that the pressure (Pr<b>52</b>) in the lubricant storage hopper <b>52</b> is the same as the pressure (Pr<b>53</b>) in the tubular body <b>53</b> (Pr<b>52</b>=Pr<b>53</b>) in the step <b>7</b>, the unit <b>121</b> keeps the material feed valve <b>54</b> opened. Namely, in this embodiment, a processing unit <b>121</b> keeps the branch pipe T<b>7</b><i>a </i>side of the switch valve v<b>3</b> opened, and the branch pipe T<b>7</b><i>b </i>side closed (see step <b>10</b>).
[0443] Then, the processing unit <b>121</b> receives the signal indicating that the light receiving element <b>71</b><i>b </i>doesn't receive the light emitted from the light emitting element <b>71</b><i>a </i>of the level sensor <b>71</b>, the material feed valve <b>54</b> is closed. Namely in this embodiment, the processing unit <b>121</b> closes the branch pipe T<b>7</b><i>a </i>side of the switch valve v<b>3</b> and opens the branch pipe T<b>7</b><i>b </i>side (see step <b>5</b>).
[0444] The processing unit <b>121</b> detects that the pressure (Pr<b>52</b>) in the lubricant storage hopper <b>52</b> is lower than the pressure (Pr<b>53</b>) in the tubular body <b>53</b> (Pr<b>52</b><Pr<b>53</b>) in the step <b>7</b>, the unit <b>121</b> keeps the switch valve v<b>2</b> opened until the pressure (Pr<b>52</b>) in the lubricant storage hopper <b>52</b> becomes equal to the pressure (Pr<b>53</b>) in the tubular body <b>53</b>. When the pressure (Pr<b>52</b>) in the lubricant storage hopper <b>52</b> becomes substantially equal to the pressure (Pr<b>53</b>) in the tubular body <b>53</b>, the switch valve v<b>2</b> is closed again (see step <b>7</b> and step <b>8</b>). Thereafter, the processing unit <b>121</b> detects that the pressure (Pr<b>52</b>) in the lubricant storage hopper <b>52</b> is the same as the pressure (Pr<b>53</b>) in the tubular body <b>53</b> (Pr<b>52</b>=Pr<b>53</b>) in the step <b>7</b>, the unit <b>121</b> keeps the material feed valve <b>54</b> opened. Namely, in this embodiment, a processing unit <b>121</b> keeps the branch pipe T<b>7</b><i>a </i>side of the switch valve v<b>3</b> opened, and the branch pipe T<b>7</b><i>b </i>side closed (see step <b>10</b>).
[0445] The processing unit <b>121</b> receives the signal indicating that the light receiving element <b>71</b><i>b </i>doesn't receive the light emitted from the light emitting element <b>71</b><i>a </i>of the level sensor <b>71</b>, the material feed valve <b>54</b> is closed. Namely in this embodiment, the processing unit <b>121</b> closes the branch pipe T<b>7</b><i>a </i>side of the switch valve v<b>3</b> and opens the branch pipe T<b>7</b><i>b </i>side (see step <b>5</b>).
[0446]FIG. 22 is an explanatory view diagrammatically showing operations of the elastic membrane Et and the bypass pipe Tv when a positive pulsating vibration air is supplied in the dispersion chamber <b>55</b>.
[0447] When the pulsating vibration air generation means <b>41</b> is driven, a positive pulsating vibration air with a desired flow amount, pressure, wavelength, wave shape is supplied in the conduit T<b>1</b>.
[0448] The positive pulsating vibration air supplied in the conduit T<b>1</b> is supplied from a pulsating vibration air supply port <b>55</b><i>aa </i>to the dispersion chamber <b>55</b>.
[0449] The positive pulsating vibration air supplied in the dispersion chamber <b>55</b> becomes a positive pulsating vibration air swirling upwardly like a convolution such as a tornado therein, then is discharged from the discharge port <b>55</b><i>b. </i>
[0450] The swirling positive pulsating vibration air generated in the dispersion chamber <b>55</b> doesn't lose its nature as a pulsating vibration air so that the elastic membrane Et vibrates according to the frequency, amplitude, and wave shape of the positive pulsating vibration air.
[0451] At a peak of the positive pulsating vibration air supplied to the dispersion chamber <b>55</b> and when the pressure Pr<b>55</b> in the dispersion chamber <b>55</b> becomes higher than the pressure Pr<b>53</b> in the tubular body <b>53</b> (pressure Pr<b>55</b>>pressure Pr<b>53</b>), the elastic membrane Et is elastically deformed so as to be curved upwardly as shown in FIG. 22<i>a. </i>
[0452] A penetrating aperture Eta becomes V-shaped with its upper end opened in a sectional view and a part of the lubricant powders stored on the elastic membrane Et in the tubular body <b>53</b> falls in the V-shaped aperture Eta.
[0453] An air communication passage between the tubular body <b>53</b> and the dispersion chamber <b>55</b> is formed with two systems in this quantitative feeder <b>51</b>: the penetrating aperture Eta of the elastic membrane Et and the bypass pipe Tv. Therefore, the air can pass between the tubular body <b>53</b> and the dispersion chamber <b>55</b> via an available system.
[0454] When the air flows from the dispersion chamber <b>55</b> to the tubular body <b>53</b> via the penetrating aperture Eta of the elastic membrane Et as shown in FIG. 22<i>a</i>, the air flow from the tubular body <b>53</b> to the dispersion chamber <b>55</b> is generated in the bypass pipe Tv. Accordingly the air can smoothly flow from the dispersion chamber <b>55</b> to the tubular body <b>53</b> via the aperture Eta of the elastic membrane Et.
[0455] Then as the positive pulsating vibration air supplied in the dispersion chamber <b>55</b> moves to its valley, the elastic membrane Et returns to its original position from an upwardly curved position by its resilience. At the same time the penetrating aperture Eta returns to its original shape from the V shape and the lubricant powders dropped in the opened aperture Eta are kept therein (see FIG. 22<i>b</i>).
[0456] As the air communication passage between the tubular body <b>53</b> and the dispersion chamber <b>55</b> of the quantitative feeder <b>51</b> is comprised of two lines: the penetrating aperture Eta of the elastic membrane Et and the bypass pipe Tv, the air can flow therebetween via an available line.
[0457] In other words, in case of the condition as shown in FIG. 22<i>b</i>, even if the penetrating hole Eta is closed, the air can flow from the tubular body <b>53</b> to the dispersion chamber <b>55</b> via the bypass pipe Tv, therefore, the pressures in the chamber <b>55</b> and in the tubular body <b>53</b> are quickly balanced.
[0458] Then when the positive pulsating vibration air supplied in the dispersion chamber <b>55</b> becomes its amplitude valley and the pressure in the dispersion chamber <b>55</b> is reduced, the elastic membrane Et is elastically deformed with its center curved downwardly. The penetrating aperture Eta becomes reverse V-shaped with its lower end opened in its section. Then the powders kept in the aperture Eta fall in the dispersion chamber <b>55</b> (see FIG. 22<i>c</i>).
[0459] As the air communication passage between the tubular body <b>53</b> and the dispersion chamber <b>55</b> of the quantitative feeder <b>51</b> is comprised of two lines: the penetrating aperture Eta of the elastic membrane Et and the bypass pipe Tv, therefore the air can flow therebetween via an available line.
[0460] In other words, the elastic membrane Et is curved downwardly and the volume of the tubular body <b>53</b> becomes larger, the air flows from the dispersion chamber <b>55</b> to the tubular body <b>53</b> via the bypass pipe Tv. Therefore, the air flow from the dispersion chamber <b>55</b> to the tubular body <b>53</b> via the penetrating aperture Eta isn't caused.
[0461] Accordingly, the lubricant powders can be smoothly discharged through the aperture Eta stably and quantitatively.
[0462] As the result of providing the bypass pipe Tv between the dispersion chamber <b>55</b> and the tubular body <b>53</b>, the time required for balancing the pressure in the tubular body <b>53</b> and the pressure in the dispersion chamber <b>55</b> when the positive pulsating vibration air is supplied to the dispersion chamber <b>55</b> of the quantitative feeder <b>51</b> becomes short so that the responsibility of the vertical vibration of the elastic membrane Et to the vibration of the positive pulsating vibration air becomes superior. As a result, the lubricant powders can be smoothly discharged via the penetrating aperture Eta.
[0463] According to the quantitative feeder <b>51</b>, the up and down vibrations wherein the center of the elastic membrane Et is operated as its antinode of the vibration and the periphery is operated as its node depend on the frequency, amplitude and wave shape of the positive pulsating vibration air supplied to the dispersion chamber <b>55</b>.
[0464] Therefore, as far as the positive pulsating vibration air supplied to the dispersion chamber <b>55</b> is constant, a fixed amount of lubricant powder is always accurately discharged to the dispersion chamber <b>55</b> via the penetrating aperture Eta of the elastic membrane Et. According to this quantitative feeder <b>51</b>, the lubricant powders can be stably supplied to the lubricant spray chamber (lubricant apply means) <b>91</b> at a fixed concentration.
[0465] The quantitative feeder <b>51</b> also has an advantage that if the frequency, amplitude and wave shape of the positive pulsating vibration air supplied to the dispersion chamber <b>55</b> are controlled, the amount of powder supplied to a desired place (instrument) can be easily changed.
[0466] Furthermore according to the quantitative feeder <b>51</b>, the positive pulsating vibration air becomes a swirl directing upward in the dispersion chamber <b>55</b>. Even if the aggregated particles with a large diameter are contained in the lubricant powders discharged to the dispersion chamber <b>55</b>, most of all can be pulverized and dispersed to be small particles by being caught in the positive pulsating vibration air swirling in the dispersion chamber <b>55</b>.
[0467] In addition, the positive pulsating vibration air in the dispersion chamber <b>55</b> becomes an upward swirling flow so that the dispersion chamber <b>55</b> has a size classification function like a cyclone.
[0468] Therefore, the lubricant powders with a predetermined particle size can be discharged to the conduit T<b>2</b> from the discharge port <b>55</b><i>b. </i>
[0469] Namely, the aggregated particles with a large diameter keep swirling in the lower part of the dispersion chamber <b>55</b> and are pulverized into a predetermined particle size by being caught in the positive pulsating vibration air swirling in the chamber <b>55</b>. Thereby, the aggregated material is controlled to be a predetermined particle size while being dispersed and is discharged to the conduit T<b>2</b> from the discharge port <b>55</b><i>b </i>so that large sized lubricant powders aren't sprayed in the lubricant spray chamber (lubricant apply means) <b>91</b>.
[0470] The lubricant powders supplied to the conduit T<b>2</b> connected to the discharge port <b>55</b><i>b </i>are pneumatically transported to the other end e<b>2</b> of the conduit T<b>2</b> by means of the positive pulsating vibration air.
[0471] Thereby, according to the quantitative feeder <b>51</b>, a deposit phenomenon and a pinhole phenomenon aren't caused in the conduit, which have been seen in transportation means wherein the powdered material supplied to the conduit is pneumatically transported by a steady pressure air with constant flow.
[0472] Therefore, according to the quantitative feeder <b>51</b>, the lubricant powders can be discharged from the other end e<b>2</b> of the conduit T<b>2</b> while keeping the concentration of the original powders discharged in the conduit T<b>2</b> from the discharge port <b>55</b><i>b </i>of the dispersion chamber <b>55</b>, thereby enabling an accurate control of the quantitativeness of the lubricant powders sprayed from the other end e<b>2</b> of the conduit T<b>2</b>.
[0473] Furthermore, according to the quantitative feeder <b>51</b>, substantially a fixed amount of lubricant powders is placed on the elastic membrane Et (at the height Hth where the level sensor <b>62</b> is provided above the membrane Et) while operating the quantitative feeder <b>51</b>. The amount of lubricant powders discharged from the penetrating aperture Eta of the elastic membrane Et doesn't vary depending on the change in the amount of lubricant powders placed on the elastic membrane Et. Accordingly, a fixed amount of lubricant powders can be stabley supplied to the lubricant spray chamber (lubricant apply means) <b>91</b>.
[0474] Still further according to the quantitative feeder <b>51</b>, even if the large size powders are discharged to the dispersion chamber <b>55</b>, such powders are pulverized into a predetermined particle size by being caught in the positive pulsating vibration air swirling in the chamber <b>55</b> to be discharged to the conduit T<b>2</b> from the discharge port <b>55</b><i>b</i>, so that the large size powders aren't deposited in the dispersion chamber <b>55</b>.
[0475] Therefore, if the quantitative feeder <b>51</b> is operated for a long time, the lubricant powders don't deposit in the dispersion chamber <b>55</b> so that the number of cleaning in the dispersion chamber <b>55</b> can be reduced.
[0476] When such a quantitative feeder <b>51</b> is attached to the external lubrication type tabletting machine S, the cleaning in the dispersion chamber <b>55</b> isn't almost required while executing a continuous tabletting. Therefore, there is an effect that an externally lubricated tablet (tablet without including lubricant powders) can be effectively produced using such a tabletting machine S.
[0477] In addition, according to this quantitative feeder <b>51</b>, the elastic membrane Et is stretched by means of the elastic membrane installation means <b>61</b> as shown in FIG. 15, FIG. 16 and FIG. 17. The quantitativeness of the feeder <b>51</b> isn't damaged because of a loosed elastic membrane Et.
[0478] While a positive pulsating vibration air is supplied in the dispersion chamber <b>55</b> of the quantitative feeder <b>51</b>, the lubricants (powder) are continuously discharged in the dispersion chamber <b>55</b> via the penetrating aperture Eta of the elastic membrane Et as mentioned above.
[0479] Next, the construction of the rotary type tabletting machine <b>81</b> will be explained.
[0480]FIG. 23 is a plan view diagrammatically showing the rotary type tabletting machine <b>81</b>.
[0481] A normal rotary type tabletting machine is used as the rotary tabletting machine <b>81</b>. The rotary type tabletting machine <b>81</b> has a turntable <b>34</b> rotatable for a rotary axis, plural upper punches (see the upper punches <b>31</b> . . . in FIG. 10) and plural lower punches (see the lower punches <b>33</b> . . . shown in FIG. 10).
[0482] Plural dies <b>32</b> . . . are provided for the turntable <b>34</b> and the, upper punch <b>31</b> . . . and its corresponding lower punch <b>33</b> . . . are provided for the dies <b>32</b> . . . . Those upper punches <b>31</b> . . . , corresponding lower punch <b>33</b> . . . and corresponding die <b>32</b> . . . are synchronously rotated.
[0483] Further, the upper punches <b>31</b> . . . are constructed so as to move up and down in a rotary axis direction at a predetermined position by means of a cam mechanism (not shown). The lower punches <b>31</b> . . . are also constructed so as to move up and down in a rotary axis direction at a predetermined position by means of a cam mechanism (see the cam mechanism <b>35</b> in FIG. 10).
[0484] The member shown as a reference numeral <b>36</b> in FIG. 10 and FIG. 23 indicates a feed shoe for charging a molding material in each die <b>32</b> . . . , <b>37</b> shows a scraping plate for making the molding material charged in the dies <b>32</b> . . . at a fixed amount, <b>38</b> shows a scraper for discharging the produced effevescent tablet t into a discharge chute <b>39</b>.
[0485] The position shown as R<b>1</b> in FIG. 23 is a lubricant spray position. According to this external lubrication type tabletting machine S, the lubricant spray chamber (lubricant apply means) <b>91</b> is provided at the lubricant spray point R<b>1</b>. More specifically, the lubricant spray chamber (lubricant apply means) <b>91</b> is fixedly provided on the turntable <b>34</b> in such a manner that the lubricants are applied on each surface of the dies <b>32</b> . . . , the upper punches <b>31</b> . . . and the lower punches <b>33</b> . . . which are sequentially accommodated in the lubricant spray chamber (lubricant apply means) <b>91</b> when the turntable <b>34</b>, the plural upper punches <b>31</b> . . . and the plural lower punches <b>33</b> . . . are rotated. The method of applying lubricants on each surface of the dies <b>32</b> . . . , the upper punches <b>31</b> . . . and the lower punches <b>33</b> . . . in the lubricant spray chamber (lubricant apply means) <b>91</b> will be detailed later.
[0486] The position shown as R<b>2</b> in FIG. 23 is a molding material charge position where the molding material m is charged in the cavity made by the die <b>32</b> and the lower punch <b>33</b> inserted to a predetermined position in the die <b>32</b> by the feed shoe <b>36</b>.
[0487] A position R<b>3</b> in FIG. 23 is a pre-tabletting point where a fixed amount of molding material which is filled in the cavity formed by the die <b>32</b> and the lower punch <b>33</b> and is scraped by the scraping plate <b>37</b> is preliminary tabletted by means of the upper punch <b>31</b> and the corresponding lower punch <b>33</b>.
[0488] A position R<b>4</b> in FIG. 23 is a main tabletting point where the pre-tabletted molding material is fully compressed by the upper punch <b>31</b> and the corresponding lower punch <b>33</b> so as to produce an effevescent tablet t.
[0489] A position R<b>5</b> in FIG. 23 is a tablet discharge point where the effevescent tablet t discharged outside when the upper face of the lower punch <b>33</b> is inserted into the upper end of the die <b>32</b> is discharged to the discharge chute <b>39</b> by means of the tablet discharge scraper <b>38</b>.
[0490] Next, the construction of the lubricant spray chamber (lubricant apply means) <b>91</b> will be detailed.
[0491]FIG. 24 is an enlarged plan view of the lubricant spray chamber (lubricant apply means) <b>91</b> shown in FIG. 23. FIG. 25 shows a diagrammatical section of the lubricant spray chamber (lubricant apply means) <b>91</b> along the line XXV-XXV in FIG. 24.
[0492] The lubricant spray chamber (lubricant apply means) <b>91</b> is fixedly provided at a predetermined position on the turntable <b>34</b> of the rotary type tabletting machine <b>81</b>.
[0493] A surface (bottom) S<b>91</b><i>a </i>of the lubricant spray chamber (lubricant apply means) <b>91</b> facing the turntable <b>34</b> is designed to get in touch with a surface S<b>34</b> of the turntable <b>34</b> and the turntable <b>34</b> rubs on the bottom S<b>91</b><i>a. </i>
[0494] The lubricant spray chamber (lubricant apply means) <b>91</b> has a lubricant introduction port <b>91</b><i>a </i>connecting the conduit T<b>2</b> to its outer surface S<b>91</b>.
[0495] The lubricant powders which have been supplied from the lubricant introduction port <b>91</b><i>a </i>and dispersed in a positive pulsating vibration air is fed to the surface (bottom) facing the turntable <b>34</b> of the lubricant spray chamber (lubricant apply means) <b>91</b> via a penetrating hole (lubricant powder spray port for lower punch) <b>91</b><i>h </i>which penetrates the lubricant spray chamber (lubricant apply means) <b>91</b>. Then the lubricant powders are sprayed on the surface (upper face, material contacting surface) S<b>33</b> of the lower punch <b>33</b> inserted in a predetermined portion in the die <b>34</b> of the turntable <b>34</b> from the discharge port <b>91</b><i>b </i>of the penetrating hole (lubricant powder spray port for lower punch) <b>91</b><i>h. </i>
[0496] Further in this embodiment, the lubricant powders dispersed in air is designed to be perpendicularly sprayed on the surface (upper face, material contacting surface) S<b>33</b> of the lower punch <b>33</b> from the penetrating hole (lubricant powder spray port for lower punch) <b>91</b><i>h </i>of the discharge port <b>91</b><i>b. </i>
[0497] A groove <b>92</b> is provided for the surface (bottom) S<b>91</b><i>a </i>facing the turntable <b>34</b> of the lubricant spray chamber (lubricant apply means) <b>91</b> from the discharge port <b>91</b><i>b </i>of the penetrating hole (lubricant powder spray port for lower punch) <b>91</b><i>h </i>into the reverse direction of the rotation of the turntable <b>34</b>.
[0498] The extra lubricant powders accumulated on the surface (upper face, material contacting surface) S<b>33</b> of the lower punch <b>33</b> are blown off by the air supplied together with the lubricant powders. A part of blown-out powders is designed to be applied on the surface S<b>32</b> (inner circumference, more specifically the material contacting surface above the upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) of the die <b>32</b>.
[0499] Further, the lubricant powders pass through a tubular portion formed by the groove <b>92</b> provided on the surface (bottom) of the lubricant spray chamber (lubricant apply means) <b>91</b> facing the turntable <b>34</b> and by the surface of the turntable <b>34</b> and are fed in reverse direction of the rotating direction of the turntable <b>34</b>.
[0500] The end of the groove <b>92</b> provided on the surface (bottom) facing the turntable <b>34</b> of the lubricant spray chamber (lubricant apply means) <b>91</b> is communicated with a hollow chamber <b>93</b> provided at the surface (bottom) side of the lubricant spray chamber (lubricant apply means) <b>91</b> facing the turntable <b>34</b>.
[0501] A slit <b>94</b> (slit-like lubricant powder spray port for upper punch) is formed above the hollow chamber <b>93</b> so as to penetrate the lubricant spray chamber (lubricant apply means) <b>91</b>.
[0502] At the outer surface of the lubricant spray chamber (lubricant apply means) <b>91</b>, an upper punch accommodation part <b>95</b> for sequentially accommodating the upper punches <b>31</b> . . . which rotates in synchronism with the turntable <b>34</b> along the slit <b>94</b> (slit-like lubricant powder spray port for upper punch) is formed along the rotary orbit of the upper punches <b>31</b> . . . .
[0503] The width W<b>95</b> of the upper punch accommodation part <b>95</b> is equal to or a little larger than the diameter of the upper punch <b>31</b>.
[0504] A suction head <b>96</b> is provided above the slit <b>94</b> (slit-like lubricant powder spray port for upper punch).
[0505] The numeral <b>91</b><i>a </i>in FIG. 25 is a connection port to be connected with the conduit T<b>2</b>.
[0506] The size of a suction port H of the suction head <b>96</b> is designed so as to cover the entire slit <b>94</b> (slit-like lubricant powder spray port for upper punch) and so as to be a similar shape to the slit <b>94</b> (slit-like lubricant powder spray port for upper punch).
[0507] As a result, when a suction means (the suction means <b>102</b> in FIG. 10) is driven, an upward air flow is uniformly and evenly generated from one end eS to the other end ee of the slit <b>94</b> (slit-like lubricant powder spray port for upper punch).
[0508] Therefore, lubricant powders can be applied taking enough time on the surface (lower face, material contacting surface) S<b>31</b> of the upper punch <b>31</b> on which lubricant powders have difficulty (because of gravity) to be applied while the upper punch <b>31</b> moves from the end eS to the other end ee of the slit <b>94</b> (slit-like lubricant powder spray port for upper punch) in the upper punch accommodation part <b>95</b>.
[0509] Further in this embodiment, at the downstream of the lubricant spray point of the lubricant spray chamber (lubricant apply means) <b>91</b> (at the upstream of the material charge point), a lubricant suction part <b>97</b> is provided for removing the lubricant powders L flown out on the turntable <b>34</b> or the lubricant powders L additionally attached on the surface (upper face, material contacting surface) S<b>33</b> of the lower punch <b>33</b> and on the circumferential wall S<b>43</b> of the die.
[0510] A suction means such as a blower (not shown) is connected to the lubricant suction part <b>97</b>. When the suction means (not shown) is driven, the lubricant powders flown out on the turntable <b>34</b> or the lubricant powders additionally attached on the surface (upper face, material contacting surface) S<b>33</b> of the lower punch <b>33</b>, on the surface (inner circumference, more specifically the material contacting surface above the upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) S<b>32</b> of the die <b>32</b> and on the surface (upper face, material contacting surface) S<b>33</b> of the lower punch <b>33</b> can be suck and removed from the suction port <b>97</b><i>a. </i>
[0511] The suction port <b>97</b><i>a </i>is formed like a slit (long shape) on the surface (bottom) facing the turntable <b>34</b> in such a manner that the longitudinal direction becomes a substantially central direction from the periphery of the turntable <b>34</b> and the suction port <b>97</b><i>a </i>bridges the die <b>32</b>.
[0512] The distance between the suction port <b>97</b><i>a </i>and the discharge port <b>91</b><i>b </i>is set to be a litter larger than the diameter D<b>32</b> of the die <b>32</b>.
[0513] Therefore, when the suction means such as a blower (not shown) connected to the lubricant suction part <b>97</b> is driven, the turntable <b>34</b> around the dies <b>32</b> can be always kept clean. As a result, the lubricant powders attached around the die <b>32</b> of the turntable <b>34</b> don't fall in the die <b>32</b> so that externally lubricated tablet which doesn't include any lubricant L in the tablet can be continuously tabletted.
[0514] Next, the construction of the lubricant suction means <b>101</b> will be detailed.
[0515]FIG. 26 is a constructional view diagrammatically enlarging around the lubricant suction means <b>101</b> shown in FIG. 10.
[0516] The lubricant suction means <b>101</b> has a suction means, <b>102</b> such as a blower and a conduit T<b>3</b> connected to a suction means <b>102</b>.
[0517] The conduit T<b>3</b> is connected to the suction head <b>96</b> of the lubricant spray chamber (lubricant apply means) <b>91</b>.
[0518] Further, the conduit T<b>3</b> is branched into two branch pipes T<b>3</b><i>a </i>and T<b>3</b><i>b</i>, integrated into one pipe T<b>3</b><i>c </i>again and connected to the suction means <b>102</b>.
[0519] A switch valve v<b>5</b> and a light permeable type powder concentration measuring means <b>103</b> are sequentially provided from the lubricant spray chamber (lubricant apply means) <b>91</b> into a direction of the suction means <b>102</b>.
[0520] The light permeable type powder concentration measuring means <b>103</b> has a measurement cell <b>104</b> and a light permeable type measuring means <b>105</b>.
[0521] The measurement cell <b>104</b> is made of quartz and connected in midstream of the branch pipe T<b>7</b><i>a. </i>
[0522] The light scattering type measuring means <b>105</b> is provided with a laser beam emitting system <b>105</b><i>a </i>for emitting laser beams and a scattering beam receiving system <b>105</b><i>b </i>for receiving the light scattered by an object and is designed to measure the flow rate, particle diameter, particle size distribution and concentration of the object according to the Mie theory. In this embodiment, the laser beam emitting system <b>105</b><i>a </i>and the scattering beam receiving system <b>105</b><i>b </i>are opposed so as to interpose the measurement cell <b>104</b> in such a manner that the flow rate, particle diameter, particle size distribution and concentration of the powdered material (lubricants (powder) in this embodiment) running in the branch pipe T<b>3</b><i>a </i>can be measured in the measurement cell <b>104</b>.
[0523] A switch valve v<b>6</b> is provided for the branch pipe T<b>3</b><i>b. </i>
[0524] Further, a switch valve v<b>7</b> is provided for the conduit T<b>7</b><i>c. </i>
[0525] For controlling the concentration of the lubricants (powder) in the lubricant spray chamber (lubricant apply means) <b>91</b> by means of the lubricant suction means <b>102</b>, the switch valves v<b>5</b> and v<b>7</b> are opened while the switch valve v<b>6</b> is closed, and then the suction means <b>102</b> is driven.
[0526] When the pulsating vibration air generation means <b>41</b> and the quantitative feeder <b>51</b> are driven, respectively, the lubricants (powder) mixed with and dispersed by a positive pulsating vibration air are supplied in the lubricant spray chamber (lubricant apply means) <b>91</b> together with the positive pulsating vibration air.
[0527] Then a part of the lubricants (powder) fed in the lubricant spray chamber (lubricant apply means) <b>91</b> is used for spraying on each surface (lower face, material contacting surface) S<b>31</b> of the upper punches <b>31</b>, each surface S<b>33</b> (upper face, material contacting surface) of the lower punch <b>33</b>, and each inner circumference S<b>32</b> of the dies <b>32</b> . . . . The extra lubricants are sucked to the suction means <b>102</b> from the suction head via the conduit T<b>3</b>, the branch pipe T<b>3</b><i>a </i>and the conduit T<b>3</b><i>c. </i>
[0528] This time the light permeable type measuring means <b>105</b> consisting of the light permeable type powder concentration measuring means <b>103</b> is driven to measure the flow rate, particle diameter, particle size distribution, and concentration of the lubricants (powder) running in the measurement cell <b>104</b>, namely in the branch pipe T<b>3</b><i>a. </i>
[0529] The concentration of the lubricants (powder) in the lubricant spray chamber (lubricant apply means) <b>91</b> is controlled by appropriately adjusting the drive amount of suction means <b>102</b> and the drive amount of pulsating vibration air generation means <b>71</b> depending on the measured value of the light permeable type measuring means <b>105</b>.
[0530] Under such operations, a problem is caused such that the lubricants (powder) are adhered in the inner circumference of the measurement cell <b>104</b> and the permeable type measuring means <b>105</b> can't accurately measure the flow rate and so on of the lubricants (powder) running in the branch pipe T<b>3</b><i>a </i>because of thus adhered lubricants (powder) in the measurement cell <b>104</b>. In such a case a compensation is required for removing the affection (noise) caused by the lubricants (powder) adhered in the measurement cell <b>104</b> from the measured value of the measuring means <b>105</b>. However, according to this suction means <b>102</b>, the switch valve v<b>5</b> is closed and the switch valve v<b>6</b> is opened while keeping the suction means <b>102</b> driven for measuring the affection (noise) by the lubricants (powder) attached in the measurement cell <b>104</b>. The lubricants (powder) sucked in the conduit T<b>3</b> from the suction head is further sucked in the suction means <b>102</b> through the branch pipe T<b>3</b><i>b </i>and the conduit T<b>3</b><i>c </i>so that the lubricants (powder) doesn't run in the branch pipe T<b>3</b><i>a. </i>
[0531] When the light permeable type measuring means <b>105</b> is driven at this time, the affection (noise) by the lubricants (powder) adhered in the measurement cell <b>104</b> can be measured.
[0532] The measured value of the affection (noise) by the lubricants (powder) adhered in the cell <b>104</b> is temporarily stored in a memory means of the processing unit <b>121</b>.
[0533] Thereafter, the switch valve v<b>5</b> is opened and the switch valve v<b>6</b> is closed while keeping the suction means <b>102</b> driven so as to run the lubricants (powder) through the branch pipe T<b>3</b><i>a</i>. Then the powder concentration measuring means <b>103</b> is driven to measure the flow rate and so on of the lubricants (powder) running in the branch pipe T<b>3</b><i>a</i>. The compensation value obtained by removing the affection (noise) of the lubricants (powder) adhered in the cell <b>104</b> from the measured value of the light permeable type measurement means <b>105</b> based on the compensation program and the measured value of the affection (noise) of the lubricants (powder) adhered in the cell <b>104</b> stored in the memory means of the processing unit <b>121</b> in advance. Then the concentration of the lubricants (powder) in the lubricant spray chamber (lubricant apply means) <b>91</b> is controlled by adjusting the driving amount of suction means <b>102</b> and that of pulsating vibration air generation means <b>21</b> based on the compensation value.
[0534] Next, a production method of an effevescent tablet by means of the external lubricating tabletting machine S according to the present invention will be diagrammatically explained.
[0535] At first, predetermined operation conditions are input in the processing unit <b>121</b>.
[0536] Lubricant powders are contained in the lubricant storage hopper <b>52</b>.
[0537] A mixture (molding material) which is a raw material of an effevescent tablet is stored in the feed shoe <b>36</b> of the rotary type tabletting machine <b>81</b>.
[0538] Then the rotary type tabletting machine <b>81</b> and the suction means <b>102</b> are driven.
[0539] Further a suction means (not shown) connected to the lubricant suction part <b>97</b> is driven if necessary.
[0540] Then an air source <b>111</b> is driven under the operational conditions input in the processing unit <b>121</b>.
[0541] At the same time, the rotary cam <b>45</b> of the pulsating vibration air generation means <b>41</b> is driven at a fixed rotational speed, thereby supplying a positive pulsating vibration air with a fixed flow amount, pressure, frequency and wave shape in the conduit T<b>1</b>.
[0542] Further, the level sensor <b>71</b> is actuated.
[0543] Actuating the level sensor <b>71</b>, the gas injection means <b>56</b> and <b>56</b> and the material feed valve <b>54</b> are operated like FIG. 20 and FIG. 21, thus a fixed amount of lubricant powders is stored on the elastic membrane Et.
[0544] The positive pulsating vibration air generated from the pulsating vibration air generation means <b>41</b> is supplied in the dispersion chamber <b>55</b>. Therefore, the elastic membrane Et is vibrated up and down to discharge the lubricant powders into the dispersion chamber <b>55</b> through the penetrating aperture Eta provided on the elastic membrane Et.
[0545] Thus discharged lubricant powders in the dispersion chamber <b>55</b> are mixed with and dispersed in the positive pulsating vibration air swirling in the dispersion chamber <b>55</b> and are discharged to the conduit T<b>2</b> from the discharge port <b>55</b><i>b. </i>
[0546] The lubricant powders mixed with and dispersed in the positive pulsating vibration air which have been discharged in the conduit T<b>2</b> are pneumatically transported in the conduit T<b>2</b> into the lubricant spray chamber <b>91</b> by means of the positive pulsating vibration air.
[0547] The lubricant powders fed in the lubricant spray chamber (lubricant apply means) <b>91</b> pass through the penetrating aperture (lubricant powder spray port for lower punch) <b>91</b><i>h </i>from the lubricant introduction port <b>91</b><i>a </i>together with the positive pulsating vibration air and sprayed on the surface (upper face, material contacting surface) S<b>33</b> of the lower punch <b>33</b> inserted in a predetermined position in the die <b>32</b> which has come to the lubricant spray point R<b>1</b> by the rotation of the turntable <b>34</b> from the discharge port <b>91</b><i>b. </i>
[0548] The extra lubricant powders accumulated on the surface (upper face, material contacting surface) S<b>33</b> of the lower punch <b>33</b> are blown off by the air fed together with the lubricant powders L and a part of blown powders is applied on the surface S<b>32</b> (inner circumference, more specifically the material contacting surface above the upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) of the die <b>32</b>.
[0549] Further the lubricant powders are fed through the tubular part formed by the groove <b>92</b> provided on the surface (bottom) of the lubricant spray chamber (lubricant apply means) <b>91</b> facing the turntable <b>34</b> and by the surface (bottom) of the turntable <b>34</b> into a reverse direction of rotation of the turntable <b>34</b> and are supplied in the hollow chamber <b>93</b>.
[0550] The lubricant powders fed in the hollow chamber <b>93</b> ride on an upward flow uniformly generated above the slit <b>94</b> (slit-like lubricant powder spray port for upper punch) and moves in the suction port H of the suction head <b>96</b> when the suction means <b>102</b> is driven.
[0551] Lubricant powders are applied on the lower face S<b>31</b> (material contacting surface) of the upper punch <b>31</b> passing in the upper punch accommodation part <b>95</b> while the upper punch <b>31</b> moves from the one end eS to the other end ee of the slit (slit-like lubricant powder spray port for upper punch).
[0552] Extra lubricant powders are removed from the suction head <b>96</b>.
[0553] Next when the die <b>32</b> fed in the downstream of the lubricant spray point RI by the rotation of the turntable <b>34</b> and the lower punch <b>33</b> fed in the downstream of the lubricant spray point in synchronism with the rotation of the turntable <b>34</b> pass under the suction port <b>97</b><i>a </i>of the lubricant suction part <b>97</b>, the extra lubricant powders attached around the die <b>32</b> on the turntable <b>34</b> and the extra lubricant powders attached on the surface S<b>32</b> (inner circumference, more specifically the material contacting surface above the upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) of the die <b>32</b> and the surface S<b>33</b> (upper face, material contacting surface) of the lower punch <b>33</b> are removed.
[0554] At the molding material charge point R<b>2</b>, a mixture (molding material) is charged in the die <b>32</b> in which lubricant powders are uniformly applied on the surface S<b>32</b> (inner circumference, more specifically the material contacting surface above the upper face (material contacting surface) of the lower punch inserted into a fixed position in the die) and the lower punch <b>33</b> on which surface S<b>33</b> lubricant powders are uniformly applied is inserted into a fixed position.
[0555] After extra mixture is removed by a scraping plate <b>37</b>, a mixture (molding material) is preliminary tabletted at the pre-tabletting point R<b>3</b> by means of the upper punch <b>31</b> of which surface S<b>31</b> (lower face, material contacting surface) lubricant powders are uniformly applied, the lower punch <b>33</b> of which surface S<b>33</b> (upper face, material contacting surface) lubricant powders are uniformly applied, and the die <b>32</b> on which surface S<b>32</b> (inner circumference) lubricant powders are uniformly applied. Then the mixture is compressed at a main tabletting point R<b>4</b> to be produced as an effevescent tablet t to be sequentially discharged into the discharge chute <b>39</b> at the tablet discharge point R<b>5</b>.
[0556] A part or all of the lubricant uniformly applied on the surfaces of the punches <b>31</b> and <b>33</b> and the surface of the die <b>32</b> is transferred on the surface of the effevescent tablet t.
[0557] Operators observe the effevescent tablets t . . . discharged in the discharge chute <b>39</b>.
[0558] If the effevescent tablets t . . . causing tabletting problems such as sticking, capping and laminating are included, the concentration of the lubricants (powder) in the lubricant spray chamber (lubricant apply means) <b>91</b> is increased by appropriately controlling the drive amount of the air source <b>111</b> and the driving amount of the suction means <b>102</b> in order to reduce the frequency of the tabletting problems such as sticking, capping and laminating on the produced effevescent tablets t . . . . Further, the elastic membrane Et may be replaced with a one with a larger penetrating aperture Eta.
[0559] Because the external lubrication type tabletting machine S has the above-mentioned superior effects, externally lubricated tablets which have been difficult to produce in a good industrial productivity in prior arts can be stably produced in large scale under a high industrial productivity.
[0560] Even if tabletting problems such as sticking, capping and laminating aren't caused, the composition of the effevescent tablets t . . . is analyzed. If the amount of lubricant in the tablet composition is formed to be increased comparing with a scheduled amount, the driving amounts of air source <b>111</b> and suction means <b>102</b> are appropriately controlled so as to control the concentration of the lubricants (powder) in the lubricant spray chamber (lubricant apply means) <b>91</b> in a steady condition. When the amount of lubricants (powder) applied on each surface of the upper punches <b>31</b> . . . , each surface of the lower punches <b>33</b> . . . , each surface of the dies <b>32</b> . . . is controlled to be a fixed amount, the amount of lubricants (powder) transferred on each surface of the effevescent tablet t . . . from each surface of the upper punches <b>31</b> . . . , each surface of the lower punches <b>33</b> . . . , each surface of the dies <b>32</b> . . . is reduced. Further, the elastic membrane Et may be replaced with the one having a smaller penetrating aperture Eta.
[0561] Next, the construction of the pulsating vibration air generation means <b>41</b> will be explained in detail.
[0562]FIG. 27 is a diagrammatic sectional view showing the construction of the pulsating vibration air generation means <b>41</b>.
[0563] The pulsating vibration air generation means <b>41</b> has a hollow chamber <b>42</b> with an air supply port <b>42</b><i>a </i>and an air discharge port <b>42</b><i>b</i>, a valve seat <b>43</b> provided in the chamber <b>42</b>, a valve plug <b>44</b> for opening and closing the valve seat <b>43</b>, and a rotary cam <b>45</b> for opening and closing the valve plug <b>44</b> for the valve seat <b>43</b>.
[0564] A conduit Tm is connected to the air supply port <b>42</b><i>a </i>and a conduit T<b>1</b> is connected to the air discharge port <b>42</b><i>b. </i>
[0565] The member <b>42</b><i>c </i>in FIG. 27 is a pressure control port provided for the hollow chamber <b>42</b> if required and a pressure control valve v<b>8</b> is provided for the pressure control port <b>42</b><i>c </i>so as to communicate with and block off the atmosphere.
[0566] The valve plug <b>44</b> has a shaft <b>44</b><i>a</i>, under which a rotary roller <b>46</b> is rotatably connected.
[0567] A shaft hole h<b>41</b> for containing the shaft <b>44</b><i>a </i>of the valve plug <b>44</b> airtightly and movably up and down is provided for a main body <b>41</b><i>a </i>of the pulsating vibration air generation means <b>41</b>.
[0568] The rotary cam <b>45</b> has an inside rotary cam <b>45</b><i>a </i>and an outside rotary cam <b>45</b><i>b. </i>
[0569] A predetermined concavo-convex pattern is formed on each one of the inside rotary cam <b>45</b><i>a </i>and the outside rotary cam <b>45</b><i>b </i>so as to have a space about the distance of the diameter of the rotary roller <b>46</b>.
[0570] The rotary cam <b>45</b> which has a concavo-convex pattern suitable for mixing and dispersing a lubricants (powder) depending on their physical property is used.
[0571] The rotary roller <b>46</b> is rotatably inserted between the inside rotary cam <b>45</b><i>a </i>and the outside rotary cam <b>45</b><i>b </i>of the rotary cam <b>45</b>.
[0572] A member shown as ax in FIG. 27 is a rotary axis of the rotary drive means such as a motor (rotary drive means <b>41</b>M in FIG. 1O) and the rotary cam <b>45</b> is detachably provided for the rotary axis ax.
[0573] Next, a method for supplying a positive pulsating vibration air to the conduit T<b>2</b> by means of the pulsating vibration air generation means <b>41</b> is explained.
[0574] At first, the rotary cam <b>45</b> with a concavo-convex pattern suitable for mixing and dispersing lubricants (powder) depending on their physical property is attached on the rotary axis ax of the rotary drive means <b>47</b>.
[0575] Then the air source <b>111</b> is driven to supply a compressed air to the conduit Tm.
[0576] When the flow rate control valve vp<b>4</b> is provided, the compressed air is supplied to the hollow chamber <b>42</b> from the air supply port <b>42</b><i>a </i>after being adjusted to a predetermined flow amount by the flow rate control valve vp<b>4</b>.
[0577] The air source <b>111</b> and the rotary drive means <b>47</b> are driven, so that the rotary cam <b>45</b> attached to the rotary axis ax of the rotary drive means <b>47</b> is rotated at a fixed rotational speed.
[0578] Accordingly, the rotary roller <b>46</b> is rotated between the inside rotary cam <b>45</b><i>a </i>and the outside rotary cam <b>45</b><i>b </i>of the rotary cam <b>45</b> which are rotated at a predetermined rotational speed in such a manner that the rotary roller <b>46</b> reproducibly moves up and down according to the concavo-convex pattern of the rotary cam <b>45</b>. As a result, the valve plug <b>44</b> opens and closes the valve seat <b>43</b> according to the concavo-convex pattern formed on the rotary cam <b>45</b>.
[0579] If a pressure-control port <b>42</b><i>c </i>and the pressure-regulating valve v<b>8</b> are provided for the hollow chamber <b>42</b>, the pressure of the positive pulsating vibration air supplied to the conduit Ti is regulated by appropriately controlling the pressure-regulating valve v<b>8</b> provided for the pressure control port <b>42</b><i>c. </i>
[0580] Thus a positive pulsating vibration air is thus fed to the conduit T<b>1</b>.
[0581] The wavelength of the positive pulsating vibration air fed in the conduit T<b>2</b> is properly controlled depending on the concavo-convex pattern of the rotary cam <b>45</b> and/or the rotational speed of the rotary cam <b>45</b>. The wave shape of the positive pulsating vibration is also adjusted by the concavo-convex pattern of the rotary cam <b>45</b>. The amplitude of the positive pulsating vibration air is controlled by adjusting the drive amount of the air source <b>111</b>, by adjusting the pressure-regulating valve vp<b>4</b> if they are provided or by adjusting the pressure-regulating valve v<b>8</b> of the pressure regulating port <b>42</b><i>c </i>if it is provided, or by combining and adjusting them.
[0582] The pulsating vibration air generation means used for the external lubrication type tabletting machine S isn't limited to the pulsating vibration air generation means <b>41</b> and other pulsating vibration air generation means can be used.
[0583]FIG. 28 is a diagrammatic sectional view showing other embodiment of a pulsating vibration air generation means.
[0584] The pulsating vibration air generation means <b>41</b>A has the same construction as the pulsating vibration air generation means <b>41</b> other than the following constructions. Corresponding members have the same reference numerals and their explanations are omitted here.
[0585] The pulsating vibration air generation means <b>41</b>A has a cylindrical body <b>132</b> and a rotary valve <b>133</b> attached to a rotary axis <b>132</b><i>a </i>consisting a center axis of the cylindrical body <b>132</b> so as to divide a hollow chamber <b>133</b> into substantially two parts. The rotary axis <b>132</b><i>a </i>is designed to be rotated at a fixed rotational speed by a rotary drive means such as a motor (not shown).
[0586] Conduits Tm and T<b>1</b> are connected to the external circumferential wall of the cylindrical body <b>132</b> with a fixed space.
[0587] A compressed air source <b>111</b> is driven to supply a fixed amount of compressed air to the conduit Tm for supplying a desired positive pulsating vibration air to the conduit T<b>1</b> by means of the pulsating vibration air generation means <b>41</b>A. If a flow rate control valve vp<b>4</b> is provided, the flow rate of the compressed air to be fed in the conduit Tm is controlled by adjusting the flow rate control valve vp<b>4</b>.
[0588] The rotary axis <b>132</b><i>a </i>is rotated at a fixed rotational speed by the rotary driving means such as an electric motor (not shown) so that the rotary valve <b>133</b> attached to the axis <b>132</b><i>a </i>is rotated at a fixed speed.
[0589] Then the compressed air generated from the air source <b>111</b> is fed to the conduit T<b>1</b> through the conduit Tm because the conduits Tm and T<b>1</b> are communicated when the rotary valve <b>133</b> is at a position shown with solid lines in the figure.
[0590] When the rotary valve <b>133</b> is positioned as shown in imaginary lines, the conduits Tm and T<b>1</b> are shut off by the rotary valve <b>133</b>.
[0591] In such a case the compressed air is fed from the conduit Tm to one space Sa in the cylindrical body <b>132</b> divided by the rotary valve <b>133</b> and the air is compressed in the space Sa.
[0592] On the other hand, the compressed air stored in another space Sb in the cylindrical body <b>132</b> formed by the rotary valve <b>133</b> is fed to the conduit T<b>1</b>.
[0593] Repeating such operations by the rotation of the rotary valve <b>133</b>, a positive pulsating vibration air is transmitted to the conduit T<b>5</b><i>b. </i>
[0594]FIG. 29 is an exploded perspective view diagrammatically showing other embodiment of a pulsating vibration air generation means.
[0595] The pulsating vibration air generation means <b>41</b>B has a cylindrical body <b>142</b> and a rotary valve <b>143</b> rotatably provided in the body <b>142</b>.
[0596] The cylindrical body <b>142</b> is constructed such that one end <b>142</b><i>e </i>is opened and the other end is closed by a cover <b>142</b><i>b </i>and a suction port <b>142</b><i>a </i>and a transmission port <b>142</b><i>b </i>are provided for its circumferential side wall.
[0597] A conduit Tm to be connected to the air source <b>111</b> is connected to the suction port <b>142</b><i>a </i>and a conduit T<b>1</b> to be connected to the quantitative feeder <b>51</b> is connected to the transmission port <b>142</b><i>b. </i>
[0598] The member shown as <b>142</b><i>c </i>in FIG. 29 is a bearing hole for pivotally providing the rotary valve <b>143</b>.
[0599] The rotary valve <b>143</b> is cylindrical with a hollow part h<b>15</b> and an opening h<b>16</b> is provided on its circumferential wall S<b>143</b>. One end <b>143</b><i>e </i>of the rotary valve <b>143</b> is opened and the other end is closed by the cover <b>143</b><i>b. </i>
[0600] A rotary axis <b>144</b> is extended in the rotary center of the rotary valve <b>143</b>. Rotary drive means such as an electric motor (not shown) is connected to the rotary axis <b>144</b> and the rotary valve <b>143</b> is rotated around the rotary axis <b>144</b> when the rotary drive means (not shown) is driven.
[0601] The outer diameter of the circumferential wall S<b>143</b> of the rotary valve <b>143</b> is almost the same as the inner diameter of the cylindrical body <b>142</b> in such a manner that the rotary valve <b>143</b> is contained in the cylindrical body <b>142</b> so that the circumferential wall S<b>143</b> of the rotary valve <b>143</b> rubs against the inner circumference of the body <b>142</b> when the rotary valve <b>143</b> is rotated.
[0602] The member shown as <b>143</b><i>c </i>in FIG. 29 is a rotary axis rotatably contained in the rotary bearing hole <b>142</b><i>c </i>provided for the cover <b>142</b><i>b </i>of the cylindrical body <b>142</b>.
[0603] The rotary valve <b>143</b> is rotatably provided in the cylindrical body <b>142</b> such that the rotary axis <b>143</b><i>c </i>is attached to the rotary bearing hole <b>142</b><i>c. </i>
[0604] When a desired positive pulsating vibration air is supplied to the conduit T<b>1</b> by means of the pulsating vibration air generation means <b>41</b>B, a compressed air is supplied to the conduit Tm by driving the air source <b>111</b>.
[0605] The rotary valve <b>143</b> is rotated at a fixed rotational speed by rotating the rotary axis <b>144</b> at a fixed rotational speed by the rotary drive means such as an electric motor (not shown).
[0606] When the opening h<b>16</b> of the rotary valve <b>143</b> is positioned at the transmission port <b>142</b><i>b</i>, the conduits Tm and T<b>1</b> are communicated so that a compressed air is fed to the conduit pipe T<b>1</b>.
[0607] When the circumferential wall S<b>143</b> of the rotary valve <b>143</b> is positioned at the transmission port <b>142</b><i>b</i>, the conduits Tm and T<b>1</b> are closed by the wall S<b>143</b> so that a compressed air isn't fed to the conduit T<b>1</b>.
[0608] Repeating such operations by the rotation of the rotary valve <b>143</b>, a positive pulsating vibration air is fed in the conduit T<b>1</b>.
[0609] Any one of the pulsating vibration air generation means <b>41</b> shown in FIG. 27, the pulsating vibration air generation means <b>41</b>A shown in FIG. 28, and the pulsating vibration air generation means <b>41</b>B shown in FIG. 29 may be used as the pulsating vibration air generation means for the external lubrication type tabletting machine S. However, considering the decrescence property of a positive pulsating vibration air, it is preferable to produce a positive pulsating vibration air with clear on and off conditions from the pulsating vibration air generation means. In order to generate such a clear positive pulsating vibration air, it is preferable to use the rotary cam type pulsating vibration air conversion means <b>41</b> in FIG. 27 rather than the rotary type pulsating vibration air conversion means <b>41</b>A and <b>41</b>B shown in FIG. 28 and FIG. 29.
[0610] In the above-mentioned embodiment, an elastic membrane Et having one penetrating aperture Eta is explained, however, the elastic membrane isn't limited to the elastic membrane Et having one penetrating aperture Eta. An elastic membrane with plural penetrating apertures Eta . . . as shown in FIG. 30 may be used.
[0611] The above-mentioned external lubrication type tabletting machine and the method for applying lubricant on each surface of the punches <b>31</b> and <b>33</b> and the die <b>32</b> are only preferable embodiments for producing an effevescent tablet of the present invention. Other machines or apply methods may be used as far as a minimum amount of lubricant powder can be applied on each surface of the punches <b>31</b> and <b>33</b> and the die <b>32</b>.
[0612] Now, the present invention will be explained based on specific experimental data.
EXPERIMENT EXAMPLE 1
[0613] Experiment example 1 shows one embodiment when an effevescent tablet for oral administration is produced according to the present invention.
[0614] This experiment example 1 corresponds to the effevescent tablet 1 shown in FIG. 2 and shows a production example of an effevescent tablet for oral administration wherein granules are produced using a water-soluble high polymer solution as a binder to be compressed.
[0615] Ascorbic acid granules were used as granules of a main active ingredient <b>2</b> . . . , sodium hydrogen carbonate granules were used as carbonate granules <b>3</b> . . . and citric acid granules were used as organic acid granules <b>4</b> . . . .
[0616] In this embodiment ascorbic acid powders (Japanese Pharmacopoeia) were granulated to produce ascorbic acid granules.
[0617] More specifically, ascorbic acid granules were granulated as follows.
[0618] A fixed amount of ascorbic acid powders (Japanese Pharmacopoeia) was contained in a granulation tank of a fluid bed granulation dryer (Glatt Co., Ltd., WSG-type 5). Heated dry air was supplied in the granulation tank so as to fluidize the ascorbic acid powders (Japanese Pharmacopoeia) stored in the granulation tank and a binder solution was sprayed from a spray means provided in the granulation tank, thereby producing ascorbic acid granules.
[0619] A solution (2 w/w % HPC-SL solution) in which a water-soluble high polymers (specifically hydroxypropylcellulose (HPC-SL)) were dissolved in water was used as a binder <b>5</b>.
[0620] Sodium hydrogen carbonate granules were granulated according to the following method.
[0621] A fixed amount of sodium hydrogen carbonate powders (Japanese Pharmacopoeia) was contained in a granulation tank of a fluid bed granulation dryer (Glatt Co., Ltd., WSG-type 5). Heated dry air was supplied in the granulation tank so as to fluidize the sodium hydrogen carbonate powders (Japanese Pharmacopoeia) stored in the granulation tank and a binder solution was sprayed from a spray means provided in the granulation tank, thereby producing sodium hydrogen carbonate granules.
[0622] A solution (2 w/w % HPC-SL solution) in which a water-soluble high polymers (specifically hydroxypropylcellulose (HPC-SL)) were dissolved in water was used as a binder <b>5</b>.
[0623] For producing sodium hydrogen carbonate granules, the temperature and amount of the heated air supplied in the granulation tank of a fluid bed granulation dryer (Glatt Co., Ltd., WSG-type 5) and the spray amount per hour of the binder solution sprayed from the spray means were controlled in such a manner that the particle size of the sodium hydrogen carbonate granules became the same as that of the ascorbic acid granules.
[0624] Citric acid granules were granulated according to the following method.
[0625] A fixed amount of citric acid powders (Japanese Pharmacopoeia) was contained in a granulation tank of a fluid bed granulation dryer. Heated dry air was supplied in the granulation tank so as to fluidize the citric acid powders, (Japanese Pharmacopoeia) stored in the granulation tank and a binder solution was sprayed from a spray means provided in the granulation tank, thereby producing citric acid granules.
[0626] A solution (2 w/w % HPC-SL solution) in which a water-soluble high polymer (specifically hydroxypropylcellulose (HPC-SL)) were dissolved in water was used as a binder <b>5</b>.
[0627] For producing citric acid granules, the temperature and amount of the heated air supplied in the granulation tank of a fluid bed granulation dryer (Glatt Co., Ltd., WSG-type 5) and the spray amount per hour of the binder solution sprayed from the spray means were controlled in such a manner that the particle size of the citric acid granules becomes the same as that of the ascorbic acid granules.
[0628] The particle size distribution of the ascorbic acid granules, the sodium hydrogen carbonate granules and the citric acid granules obtained by the above-mentioned procedure is shown in a table 1. <tables id="TABLE-US-00001" num="1"><table frame="none" colsep="0" rowsep="0"><tgroup align="left" colsep="0" rowsep="0" cols="4"><colspec colname="1" colwidth="63PT" align="center" /><colspec colname="2" colwidth="49PT" align="center" /><colspec colname="3" colwidth="63PT" align="center" /><colspec colname="4" colwidth="42PT" align="center" /><thead><row><entry namest="1" nameend="4" align="center">TABLE 1</entry></row><row><entry /></row><row><entry namest="1" nameend="4" align="center" rowsep="1" /></row><row><entry /><entry>ascorbic acid</entry><entry>sodium hydrogen</entry><entry>citric acid</entry></row><row><entry>particle size</entry><entry>granules</entry><entry>carbonate granules</entry><entry>granules</entry></row><row><entry namest="1" nameend="4" align="center" rowsep="1" /></row></thead><tbody valign="top"><row><entry>more than 710 μm</entry><entry> 0%</entry><entry> 0%</entry><entry> 0%</entry></row><row><entry>500˜710 μm</entry><entry> 2%</entry><entry> 0%</entry><entry> 1%</entry></row><row><entry>350˜500 μm</entry><entry>20%</entry><entry>18%</entry><entry>22%</entry></row><row><entry>250˜350 μm</entry><entry>45%</entry><entry>42%</entry><entry>47%</entry></row><row><entry>105˜250 μm</entry><entry>21%</entry><entry>23%</entry><entry>23%</entry></row><row><entry>less than 105 μm</entry><entry>12%</entry><entry>17%</entry><entry> 7%</entry></row><row><entry>total</entry><entry>100% </entry><entry>100% </entry><entry>100% </entry></row><row><entry namest="1" nameend="4" align="center" rowsep="1" /></row></tbody></tgroup></table></tables>
[0629] The ascorbic acid content of thus obtained ascorbic acid granules was 99.01 w/w %, the sodium hydrogen carbonate content of the sodium hydrogen carbonate granules was 99.01 w/w % and the citric acid content of the citric acid granules was 99.01 w/w %.
[0630] Thus prepared ascorbic acid granules, sodium hydrogen carbonate granules and citric acid granules were blended at a fixed rate (in this embodiment, the ascorbic acid, sodium carbonate and citric acid were blended in a weight ratio of 6:1:1).
[0631] Then the blended material of the ascorbic acid granules, the sodium carbonate granules and the citric acid granules was mixed with a well-known mixer.
[0632] As shown in the table 1, when ascorbic acid granules, sodium hydrogen carbonate granules and citric acid granules having almost the same particle size were used, it was found that each ascorbic acid granule, sodium carbonate granule and citric acid granule was uniformly mixed by themselves spontaneously by the external force given by the mixer.
[0633] Thus obtained mixture of the ascorbic acid granules, the sodium hydrogen carbonate granules and the citric acid granules was tabletted by means of the external lubrication type tabletting machine S shown in FIG. 10.
[0634] An upper punch <b>31</b>, a lower punch <b>33</b> and a die <b>32</b> with 11 mm diameter were used for a rotary type tabletting machine <b>81</b>.
[0635] An upper punch <b>31</b> and a lower punch <b>33</b> with flat molding surface were used.
[0636] The tabletting pressure was 1500 kg/punch and the weight per a tablet was controlled to be 405 mg±1 mg.
[0637] Magnesium stearate (Japanese Pharmacopoeia) was contained in a lubricant storage hopper <b>52</b> of a quantitative feeder <b>51</b> of the external lubrication type tabletting machine S.
[0638] A rotary cam <b>45</b> having a concavo-convex pattern suitable for dispersing magnesium stearate (Japanese Pharmacopoeia) in airwasattached for a rotary axis of a rotary drive means (rotary drive means <b>41</b>M in FIG. 10) of a pulsating vibration air generation means <b>41</b> of the external lubrication type tabletting machine S.
[0639] Then, the mixture of the ascorbic acid granules, the sodium hydrogen carbonate granules and citric acid granules was stored in a molding material storage hopper (not shown) connected to a feed shoe <b>36</b>.
[0640] Next, an air source <b>111</b> was driven at a fixed drive amount to rotate a rotary drive means (rotary drive means <b>41</b>M in FIG. 10) of the pulsating vibration air generation means <b>41</b>. The frequency of the positive pulsating vibration air generated from the pulsating vibration air generation means <b>41</b> wasn't completely defined, but it was selected from the range of 10 Hz to 40 Hz.
[0641] The supply amount of magnesium stearate (Japanese Pharmacopoeia) into a lubricant spray chamber (lubricant apply means) <b>91</b> was controlled by driving a light permeable type powder concentration measuring means <b>103</b>.
[0642] The supply amount of magnesium stearate (Japanese Pharmacopoeia) into the lubricant spray chamber (lubricant apply means) <b>91</b> isn't completely defined. However, the amount ia selected from the range of 200 mg/min. to 2000 mg/min. Handling of the supply amount of magnesium stearate (Japanese Pharmacopoeia) into the lubricant spray chamber (lubricant apply means) <b>91</b> has been considered to be difficult when a steady flow air is used.
[0643] Then, the rotary type tabletting machine <b>81</b> was driven and at the same time the mixture was supplied from the feed shoe <b>36</b>. The mixture was compressed to produce a tablet by means of the upper punches <b>31</b> . . . on which a fixed amount of magnesium stearate (Japanese Pharmacopoeia) was applied, the lower punches <b>33</b> . . . on which a fixed amount of magnesium stearate (Japanese Pharmacopoeia) was applied and the dies <b>32</b> . . . on which a fixed amount of magnesium stearate (Japanese Pharmacopoeia) was applied.
[0644] Analyzing thus obtained tablet, the drive amount of air source <b>111</b>, the drive amount of pulsating vibration air generation means <b>41</b> were appropriately controlled in such a manner that the applied amount of magnesium stearate per a tablet became 0.4 mg±0.1 mg. Then the effevescent tablet 1 was produced in earnest.
[0645] The preparation of thus produced tablet (effevescent tablet <b>1</b>) is shown in a table 2. <tables id="TABLE-US-00002" num="2"><table frame="none" colsep="0" rowsep="0"><tgroup align="left" colsep="0" rowsep="0" cols="3"><colspec colname="OFFSET" colwidth="14PT" align="left" /><colspec colname="1" colwidth="105PT" align="left" /><colspec colname="2" colwidth="98PT" align="center" /><thead><row><entry /><entry namest="OFFSET" nameend="2" align="center">TABLE 2</entry></row><row><entry /><entry /></row><row><entry /><entry namest="OFFSET" nameend="2" align="center" rowsep="1" /></row><row><entry /><entry>component</entry><entry>content</entry></row><row><entry /><entry namest="OFFSET" nameend="2" align="center" rowsep="1" /></row></thead><tbody valign="top"><row><entry /></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="4"><colspec colname="OFFSET" colwidth="14PT" align="left" /><colspec colname="1" colwidth="105PT" align="left" /><colspec colname="2" colwidth="42PT" align="right" /><colspec colname="3" colwidth="56PT" align="left" /><tbody valign="top"><row><entry /><entry>ascorbic acid</entry><entry>300.0</entry><entry>mg</entry></row><row><entry /><entry>sodium hydrogen carbonate</entry><entry>50.0</entry><entry>mg</entry></row><row><entry /><entry>citric acid</entry><entry>50.0</entry><entry>mg</entry></row><row><entry /><entry>hydroxypropylcellulose (HPC-SL)</entry><entry>4.0</entry><entry>mg</entry></row><row><entry /><entry>magnesium stearate</entry><entry>0.4</entry><entry>mg</entry></row><row><entry /><entry>Total</entry><entry>404</entry><entry>mg/tablet</entry></row><row><entry /><entry namest="OFFSET" nameend="3" align="center" rowsep="1" /></row></tbody></tgroup></table></tables>
COMPARISON EXAMPLE 1
[0646] A fixed amount of magnesium stearate (Japanese Pharmacopoeia) was added in the mixture of the ascorbic acid granules, the sodium hydrogen carbonate granules and the citric acid granules and thus blended material of the ascorbic acid granules, the sodium hydrogen carbonate granules, the citric acid granules and the magnesium stearate (Japanese Pharmacopoeia) was mixed with a well-known mixer.
[0647] The mixture including magnesium stearate (Japanese Pharmacopoeia) was compressed to produce a tablet without applying magnesium stearate (Japanese Pharmacopoeia) on each surface of the upper punches <b>31</b> . . . , the lower punches <b>33</b> . . . and the dies <b>32</b> . . . by means of the rotary type tabletting machine <b>81</b>.
[0648] 1.0 weight % of magnesium stearate (Japanese Pharmacopoeia) was required per a tablet in order to prevent the mixture including magnesium stearate (Japanese Pharmacopoeia) from adhering on the upper punches <b>31</b> . . . , the lower punches <b>33</b> . . . and the dies <b>32</b> . . . and to avoid tabletting problems such as sticking on the produced tablet.
[0649] Then a characteristic test of the tablet (effevescent tablet <b>1</b> of the present invention) obtained by the experiment example 1 and the tablet obtained by the comparison example 1 was executed.
[0650] Characteristic Test 1
[0651] One of the tablet (effevescent tablet <b>1</b> of the present invention) obtained by the experiment example 1 was put in 100 ml drinking water, after one minute, the substance floating on the surface of the drinking water and turbidity thereof were observed.
[0652] Similarly one of the tablet obtained by the comparison example 1 was put in 100 ml drinking water, after one minute, the substance floating on the surface of the drinking water and turbidity thereof were observed.
[0653] In the drinking water in which the tablet (effevescent tablet <b>1</b> of the present invention) obtained by the experiment example 1 was dissolved, no floating substance was observed on the water surface. However, in the drinking water in which the tablet obtained by the comparison example 1 was dissolved, a floating substance was observed on the water surface.
[0654] Further the drinking water in which the tablet (effevescent tablet <b>1</b> of the present invention) obtained by the experiment example 1 was dissolved was clear, on the other hand the drinking water in which the tablet obtained by the comparison example 1 was dissolved was cloudy.
[0655] Characteristic Test 2
[0656] The disintegration time of each tablet (effevescent tablet <b>1</b> of the present invention) obtained by the experiment example 1 and the tablet obtained by the comparison example 1 was observed according to the disintegration test described in the Japanese Pharmacopoeia (13th edition).
[0657] Six pieces of sample wherein one tablet (effevescent tablet <b>1</b> of the present invention) obtained by the experiment example 1 was put in a glass tube of a tester used for the disintegration test method described in the Japanese Pharmacopoeia (13th edition) were prepared. They were put in a fixed amount of test solution (water of 37±2° C.) filled in a beaker, the tester was moved up and down and the time till the tablet in the glass tube was completely dissolved was measured.
[0658] Also, six pieces of sample wherein one tablet obtained by the comparison example 1 was put in a glass tube of a tester used for the disintegration test method described in the Japanese Pharmacopoeia (13th edition) were prepared. They were put in a fixed amount of test solution (water of 37±2° C.) filled in a beaker, the tester was moved up and down and the time till the tablet in the glass tube was completely dissolved was measured.
[0659] The results are shown in a table 3. <tables id="TABLE-US-00003" num="3"><table frame="none" colsep="0" rowsep="0"><tgroup align="left" colsep="0" rowsep="0" cols="3"><colspec colname="OFFSET" colwidth="63PT" align="left" /><colspec colname="1" colwidth="84PT" align="left" /><colspec colname="2" colwidth="70PT" align="center" /><thead><row><entry /><entry namest="OFFSET" nameend="2" align="center">TABLE 3</entry></row><row><entry /><entry /></row><row><entry /><entry namest="OFFSET" nameend="2" align="center" rowsep="1" /></row><row><entry /><entry>sample</entry><entry>disintegration time</entry></row><row><entry /><entry namest="OFFSET" nameend="2" align="center" rowsep="1" /></row></thead><tbody valign="top"><row><entry /></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="4"><colspec colname="OFFSET" colwidth="14PT" align="left" /><colspec colname="1" colwidth="49PT" align="left" /><colspec colname="2" colwidth="84PT" align="left" /><colspec colname="3" colwidth="70PT" align="center" /><tbody valign="top"><row><entry /><entry>experiment</entry><entry>sample 1</entry><entry>25 sec.</entry></row><row><entry /><entry>example 1</entry><entry>sample 2</entry><entry>27 sec.</entry></row><row><entry /><entry /><entry>sample 3</entry><entry>27 sec.</entry></row><row><entry /><entry /><entry>sample 4</entry><entry>27 sec.</entry></row><row><entry /><entry /><entry>sample 5</entry><entry>29 sec.</entry></row><row><entry /><entry /><entry>sample 6</entry><entry>31 sec.</entry></row><row><entry /><entry /><entry>average disintegration time</entry><entry>28 sec.</entry></row><row><entry /><entry>comparison</entry><entry>sample 1</entry><entry>31 sec.</entry></row><row><entry /><entry>example 1</entry><entry>sample 2</entry><entry>37 sec.</entry></row><row><entry /><entry /><entry>sample 3</entry><entry>48 sec.</entry></row><row><entry /><entry /><entry>sample 4</entry><entry>70 sec.</entry></row><row><entry /><entry /><entry>sample 5</entry><entry>70 sec.</entry></row><row><entry /><entry /><entry>sample 6</entry><entry>91 sec.</entry></row><row><entry /><entry /><entry>average disintegration time</entry><entry>58 sec.</entry></row><row><entry /><entry namest="OFFSET" nameend="3" align="center" rowsep="1" /></row></tbody></tgroup></table></tables>
[0660] As seen from the result of the table 3, the tablet (effevescent tablet <b>1</b> of the present invention) obtained by the experiment example 1 has a higher disintegration speed comparing with that obtained by the comparison example 1.
[0661] Characteristic Test 3
[0662] The elution test of ascorbic acid for each tablet (effevescent tablet <b>1</b> of the present invention) obtained by the experiment example <b>1</b> and the tablet obtained by the comparison example 1 was executed according to the elution test method described in the Japanese Pharmacopoeia (13th edition).
[0663] Five pieces of sample wherein one tablet (effevescent tablet <b>1</b> of the present invention) obtained by the experiment example 1 was put in a basket used for the rotary basket method tester used for the elution test described in the Japanese Pharmacopoeia (13th edition) were prepared. Five pieces of a fixed amount of test solution (water of 37±0.5° C. in this embodiment) were prepared in the tester (content: 1000 ml) of the rotary basket method tester used for the elution test method of the Japanese Pharmacopoeia (13th edition). Then the basket containing one tablet (effevescent tablet <b>1</b> of the present invention) obtained by the experiment example 1 was contained in the tester (content: 1000 ml) containing a fixed amount of test solution (water of 37±0.5° C. in this embodiment). Then the tester was rotated at a predetermined revolution number and after 30 seconds, a fixed amount of elute was sampled from a position 10 mm apart from the container wall of the tester and the eluted amount of ascorbic acid contained in the elute ([eluted amount of ascorbic acid contained in the elute/the contained amount of ascorbic acid in a tablet obtained by the experiment example 1 (effevescent tablet <b>1</b> of the present invention)]×100%) was measured. Such test was executed for each one of five samples.
[0664] Further five pieces of sample wherein one tablet obtained by the comparison example 1 was put in a basket used for the rotary basket method tester used for the elution test described in the Japanese Pharmacopoeia (13th edition) were prepared. Five pieces of a fixed amount of test solution (water of 37±0.5° C. in this embodiment) were prepared in the tester (content: 1000 ml) of the rotary basket method tester used for the elution test method of the Japanese Pharmacopoeia (13th edition).
[0665] Then the basket containing one tablet obtained by the comparison example 1 was contained in the tester (content: 1000 ml) containing a fixed amount of test solution (water of 37±0.5° C. in this embodiment). Then the tester was rotated at a predetermined revolution number and after 30 minutes, a fixed amount of elute was sampled from a position 10 mm apart from the container wall of the tester and the eluted amount of ascorbic acid contained in the elute ([eluted amount of ascorbic acid contained in the elute/the contained amount of ascorbic acid in a tablet obtained by the experiment example 1 (effevescent tablet <b>1</b> of the present invention)]×100%) was measured. Such test was executed for each one of five samples.
[0666] The result is shown in table 4 <tables id="TABLE-US-00004" num="4"><table frame="none" colsep="0" rowsep="0"><tgroup align="left" colsep="0" rowsep="0" cols="3"><colspec colname="OFFSET" colwidth="77PT" align="left" /><colspec colname="1" colwidth="63PT" align="left" /><colspec colname="2" colwidth="77PT" align="center" /><thead><row><entry /><entry namest="OFFSET" nameend="2" align="center">TABLE 4</entry></row><row><entry /><entry /></row><row><entry /><entry namest="OFFSET" nameend="2" align="center" rowsep="1" /></row><row><entry /><entry>sample</entry><entry>elution rate</entry></row><row><entry /><entry namest="OFFSET" nameend="2" align="center" rowsep="1" /></row></thead><tbody valign="top"><row><entry /></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="4"><colspec colname="OFFSET" colwidth="21PT" align="left" /><colspec colname="1" colwidth="56PT" align="left" /><colspec colname="2" colwidth="63PT" align="left" /><colspec colname="3" colwidth="77PT" align="center" /><tbody valign="top"><row><entry /><entry>experiment</entry><entry>sample 1</entry><entry>91%</entry></row><row><entry /><entry>example 1</entry><entry>sample 2</entry><entry>95%</entry></row><row><entry /><entry /><entry>sample 3</entry><entry>95%</entry></row><row><entry /><entry /><entry>sample 4</entry><entry>98%</entry></row><row><entry /><entry /><entry>sample 5</entry><entry>100% </entry></row><row><entry /><entry /><entry>average elution rate</entry><entry>96%</entry></row><row><entry /><entry>comparison</entry><entry>sample 1</entry><entry>43%</entry></row><row><entry /><entry>example 1</entry><entry>sample 2</entry><entry>58%</entry></row><row><entry /><entry /><entry>sample 3</entry><entry>67%</entry></row><row><entry /><entry /><entry>sample 4</entry><entry>88%</entry></row><row><entry /><entry /><entry>sample 5</entry><entry>97%</entry></row><row><entry /><entry /><entry>average elution rate</entry><entry>71%</entry></row><row><entry /><entry namest="OFFSET" nameend="3" align="center" rowsep="1" /></row></tbody></tgroup></table></tables>
[0667] As seen from the result of the table 4, it was found that the elution characteristic of the tablet (effevescent tablet <b>1</b> of the present invention) obtained by the experiment example 1 was superior to the tablet obtained by the comparison example 1.
COMPARISON EXAMPLE 2
[0668] Comparison example 2 shows one embodiment when an effevescent tablet for oral administration is produced according to a conventional method. Ascorbic acid granules were used as granules of a main active ingredient <b>2</b> . . . , sodium hydrogen carbonate granules were used as carbonate granules <b>3</b> . . . and citric acid granules were used as organic acid granules <b>4</b> . . . .
[0669] In this embodiment ascorbic acid powders (Japanese Pharmacopoeia) were granulated to produce ascorbic acid granules.
[0670] More specifically, ascorbic acid granules were granulated as follows.
[0671] A fixed amount of ascorbic acid powders (Japanese Pharmacopoeia) was contained in a granulation tank of a fluid bed granulation dryer (Glatt Co., Ltd., WSG-type 5). Heated dry air was supplied in the granulation tank so as to fluidize the ascorbic acid powders (Japanese Pharmacopoeia) stored in the granulation tank and a binder solution was sprayed from a spray means provided in the granulation tank, thereby producing ascorbic acid granules.
[0672] A solution (2 w/w % HPC-SL solution) in which a water-soluble high polymer (specifically hydroxypropylcellulose (HPC-SL)) was dissolved in water was used as a binder <b>5</b>.
[0673] Sodium hydrogen carbonate granules were granulated according to the following method.
[0674] A fixed amount of sodium hydrogen carbonate powders (Japanese Pharmacopoeia) was contained in a granulation tank of a fluid bed granulation dryer (Glatt Co., Ltd., WSG-type 5). Heated dry air was supplied in the granulation tank so as to fluidize the sodium hydrogen carbonate powders (Japanese Pharmacopoeia) stored in the granulation tank and a binder solution was sprayed from a spray means provided in the granulation tank, thereby producing sodium hydrogen carbonate granules.
[0675] A solution (2 w/w % HPC-SL solution) in which a water-soluble high polymer (specifically hydroxypropylcellulose (HPC-SL)) was dissolved in water was used as a binder <b>5</b>.
[0676] Citric acid granules were granulated according to the following method.
[0677] A fixed amount of citric acid powders (Japanese Pharmacopoeia) was contained in a granulation tank of a fluid bed granulation dryer. Heated dry air was supplied in the granulation tank so as to fluidize the citric acid powders (Japanese Pharmacopoeia) stored in the granulation tank and a binder solution was sprayed from a spray means provided in the granulation tank, thereby producing citric acid granules.
[0678] A solution (2 w/w % HPC-SL solution) in which a water-soluble high polymer (specifically hydroxypropylcellulose (HPC-SL)) was dissolved in water was used as a binder <b>5</b>.
[0679] The particle size distribution of the ascorbic acid granules, the sodium hydrogen carbonate granules and the citric acid granules obtained by the above-mentioned procedure is shown in a table 5. <tables id="TABLE-US-00005" num="5"><table frame="none" colsep="0" rowsep="0"><tgroup align="left" colsep="0" rowsep="0" cols="4"><colspec colname="1" colwidth="63PT" align="center" /><colspec colname="2" colwidth="49PT" align="center" /><colspec colname="3" colwidth="63PT" align="center" /><colspec colname="4" colwidth="42PT" align="center" /><thead><row><entry namest="1" nameend="4" align="center">TABLE 5</entry></row><row><entry /></row><row><entry namest="1" nameend="4" align="center" rowsep="1" /></row><row><entry /><entry>ascorbic acid</entry><entry>sodium hydrogen</entry><entry>citric acid</entry></row><row><entry>particle size</entry><entry>granules</entry><entry>carbonate granules</entry><entry>granules</entry></row><row><entry namest="1" nameend="4" align="center" rowsep="1" /></row></thead><tbody valign="top"><row><entry>more than 710 μm</entry><entry> 2%</entry><entry> 0%</entry><entry> 0%</entry></row><row><entry>500˜710 μm</entry><entry>24%</entry><entry> 0%</entry><entry> 7%</entry></row><row><entry>350˜500 μm</entry><entry>37%</entry><entry>15%</entry><entry>26%</entry></row><row><entry>250˜350 μm</entry><entry>28%</entry><entry>18%</entry><entry>23%</entry></row><row><entry>105˜250 μm</entry><entry> 7%</entry><entry>38%</entry><entry>21%</entry></row><row><entry>less than 105 μm</entry><entry> 2%</entry><entry>29%</entry><entry>23%</entry></row><row><entry>total</entry><entry>100% </entry><entry>100% </entry><entry>100% </entry></row><row><entry namest="1" nameend="4" align="center" rowsep="1" /></row></tbody></tgroup></table></tables>
[0680] Thus prepared ascorbic acid granules, sodium hydrogen carbonate granules and citric acid granules were blended at a fixed ratio (in this embodiment, the ascorbic acid, sodium hydrogen carbonate and citric acid were blended in weight ratio of 6:1:1). Then the blended material of the ascorbic acid granules, the sodium hydrogen carbonate granules and the citric acid granules was mixed with a well-known mixer.
[0681] As shown in the table 5, when the ascorbic acid granules, the sodium hydrogen carbonate granules and the citric acid granules having different particle sizes were used, it was found that ascorbic acid granules, sodium hydrogen carbonate granules and citric acid granules were not uniformly mixed.
[0682] A fixed amount of magnesium stearate (Japanese Pharmacopoeia) was added in the mixture of the ascorbic acid granules, the sodium hydrogen carbonate granules and the citric acid granules and the blended material of the ascorbic acid granules, the sodium hydrogen carbonate granules, the citric acid granules and magnesium stearate (Japanese Pharmacopoeia) was mixed with a well-known mixer. 1.0 weight % of magnesium stearate (Japanese Pharmacopoeia) was required per a tablet in order to prevent the mixture including magnesium stearate (Japanese Pharmacopoeia) from adhering on the upper punches <b>31</b> . . . , the lower punches <b>33</b> . . . and the dies <b>32</b> . . . and to avid tabletting problems such as sticking on the produced tablet.
[0683] Next the mixture including magnesium stearate (Japanese Pharmacopoeia) was compressed to produce a tablet without applying magnesium stearate (Japanese Pharmacopoeia) on each surface of the upper punches <b>31</b> . . . , the lower punches <b>33</b> . . . and the dies <b>32</b> . . . by means of the rotary type tabletting machine <b>81</b>.
[0684] Then a characteristic tests 1, 2 and 3 as mentioned in the experiment example 1 were executed for the tablet obtained by the comparison example 2.
Characteristic Test 1
[0685] One of the tablet (conventional type effevescent tablet) obtained by the comparison example 2 was put in 100 ml drinking water, after one minute, the substance floating on the surface of the drinking water and turbidity thereof were observed.
[0686] In the drinking water in which the tablet (conventional type effevescent tablet) obtained by the comparison example <b>2</b> was dissolved, a floating substance was observed on the water surface.
[0687] Further the drinking water in which the tablet (conventional type effevescent tablet) obtained by the comparison example 2 was dissolved was cloudy.
[0688] Characteristic Test 2
[0689] The disintegration time of the tablet (conventional type effevescent tablet) obtained by the comparison example 2 was measured according to the disintegration test described in the Japanese Pharmacopoeia (13th edition).
[0690] The results are shown in a table 6. <tables id="TABLE-US-00006" num="6"><table frame="none" colsep="0" rowsep="0"><tgroup align="left" colsep="0" rowsep="0" cols="3"><colspec colname="OFFSET" colwidth="63PT" align="left" /><colspec colname="1" colwidth="84PT" align="left" /><colspec colname="2" colwidth="70PT" align="center" /><thead><row><entry /><entry namest="OFFSET" nameend="2" align="center">TABLE 6</entry></row><row><entry /><entry /></row><row><entry /><entry namest="OFFSET" nameend="2" align="center" rowsep="1" /></row><row><entry /><entry>sample</entry><entry>disintegration time</entry></row><row><entry /><entry namest="OFFSET" nameend="2" align="center" rowsep="1" /></row></thead><tbody valign="top"><row><entry /></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="4"><colspec colname="OFFSET" colwidth="14PT" align="left" /><colspec colname="1" colwidth="49PT" align="left" /><colspec colname="2" colwidth="84PT" align="left" /><colspec colname="3" colwidth="70PT" align="center" /><tbody valign="top"><row><entry /><entry>comparison</entry><entry>sample 1</entry><entry>32 sec.</entry></row><row><entry /><entry>example 2</entry><entry>sample 2</entry><entry>37 sec.</entry></row><row><entry /><entry /><entry>sample 3</entry><entry>49 sec.</entry></row><row><entry /><entry /><entry>sample 4</entry><entry>68 sec.</entry></row><row><entry /><entry /><entry>sample 5</entry><entry>75 sec.</entry></row><row><entry /><entry /><entry>sample 6</entry><entry>89 sec.</entry></row><row><entry /><entry /><entry>average disintegration time</entry><entry>70 sec.</entry></row><row><entry /><entry namest="OFFSET" nameend="3" align="center" rowsep="1" /></row></tbody></tgroup></table></tables>
[0691] As seen from the result of the tables 3 and 6, the tablet (effevescent tablet <b>1</b> of the present invention) obtained by the experiment example 1 has a higher disintegration speed comparing with the tablet (conventional type effevescent tablet) obtained by the comparison example 2.
[0692] Further it was found that the disintegration time of the tablet obtained by the comparison example 1 was higher than that obtained by the comparison example 2 (conventional type effevescent tablet).
[0693] Characteristic Test 3
[0694] The elution test of the tablet (conventional type effevescent tablet) obtained by the comparison example 2 was executed according to the elution test described in the Japanese Pharmacopoeia (13th edition).
[0695] The result is shown in table 7 <tables id="TABLE-US-00007" num="7"><table frame="none" colsep="0" rowsep="0"><tgroup align="left" colsep="0" rowsep="0" cols="3"><colspec colname="OFFSET" colwidth="77PT" align="left" /><colspec colname="1" colwidth="63PT" align="left" /><colspec colname="2" colwidth="77PT" align="center" /><thead><row><entry /><entry namest="OFFSET" nameend="2" align="center">TABLE 7</entry></row><row><entry /><entry /></row><row><entry /><entry namest="OFFSET" nameend="2" align="center" rowsep="1" /></row><row><entry /><entry>sample</entry><entry>elution rate</entry></row><row><entry /><entry namest="OFFSET" nameend="2" align="center" rowsep="1" /></row></thead><tbody valign="top"><row><entry /></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="4"><colspec colname="OFFSET" colwidth="21PT" align="left" /><colspec colname="1" colwidth="56PT" align="left" /><colspec colname="2" colwidth="63PT" align="left" /><colspec colname="3" colwidth="77PT" align="center" /><tbody valign="top"><row><entry /><entry>comparison</entry><entry>sample 1</entry><entry>42%</entry></row><row><entry /><entry>example 2</entry><entry>sample 2</entry><entry>50%</entry></row><row><entry /><entry /><entry>sample 3</entry><entry>61%</entry></row><row><entry /><entry /><entry>sample 4</entry><entry>78%</entry></row><row><entry /><entry /><entry>sample 5</entry><entry>88%</entry></row><row><entry /><entry /><entry>average elution rate</entry><entry>64%</entry></row><row><entry /><entry namest="OFFSET" nameend="3" align="center" rowsep="1" /></row></tbody></tgroup></table></tables>
[0696] As seen from the result of the tables 4 and 7, it was found that the elution characteristic of the tablet (effevescent tablet <b>1</b> of the present invention) obtained by the experiment example 1 was superior to the tablet (conventional type effevescent tablet) obtained by the comparison example 2.
[0697] Further it was also found that the elution characteristic of the tablet obtained by the comparison example 1 was superior to the tablet (conventional type effevescent tablet) obtained by the comparison example 2.
EXPERIMENT EXAMPLE 2
[0698] Experiment example 2 shows other embodiment when an effevescent tablet for oral administration is produced according to the present invention.
[0699] This experiment example 2 corresponds to the effevescent tablet <b>1</b>A shown in FIG. 3 and shows a production example of an effevescent tablet for oral administration wherein granules are produced using a solution including a water-soluble high polymers and surfactant as a binder to be compressed.
[0700] Ascorbic acid granules were used as granules of a main active ingredient <b>2</b>, sodium hydrogen carbonate granules were used as carbonate granules <b>3</b> . . . and citric acid granules were used as organic acid granules <b>4</b> . . . .
[0701] In this embodiment ascorbic acid powders (Japanese Pharmacopoeia) were granulated to produce ascorbic acid granules.
[0702] More specifically, ascorbic acid granules were granulated as follows.
[0703] A fixed amount of ascorbic acid powders (Japanese Pharmacopoeia) was contained in a granulation tank of a fluid bed granulation dryer (Glatt Co., Ltd., WSG-type 5). Heated dry air was supplied in the granulation tank so as to fluidize the ascorbic acid powders (Japanese Pharmacopoeia) stored in the granulation tank and a binder solution including a surfactant was sprayed from a spray means provided in the granulation tank, thereby producing ascorbic acid granules.
[0704] A solution in which an appropriate amount of surfactant (more specifically polysorbate 80) was dissolved in 2 w/w % solution of a water-soluble high polymer (specifically hydroxypropylcellulose (HPC-SL)) was used as a binder <b>5</b>.
[0705] Sodium hydrogen carbonate granules were granulated according to the following method.
[0706] A fixed amount of sodium hydrogen carbonate powders (Japanese Pharmacopoeia) was contained in a granulation tank of a fluid bed granulation dryer (Glatt Co., Ltd., WSG-type 5). Heated dry air was supplied in the granulation tank so as to fluidize the sodium hydrogen carbonate powders (Japanese Pharmacopoeia) stored in the granulation tank and a binder solution including surfactants was sprayed from a spray means provided in the granulation tank, thereby producing sodium hydrogen carbonate granules.
[0707] A solution in which an appropriate amount of surfactants (more specifically polysorbate 80) was dissolved in 2 w/w % solution of a water-soluble high polymer (specifically hydroxypropylcellulose (HPC-SL)) was used as a binder <b>5</b>.
[0708] For granulating sodium carbonate granules, the temperature and amount of the heated air supplied in the granulation tank of a fluid bed granulation dryer (Glatt Co., Ltd., WSG-type 5) and a spray amount per hour of the binder solution sprayed from the spray means were controlled in such a manner that the particle size of the sodium hydrogen carbonate granules became the same as that of the ascorbic acid granule.
[0709] Citric acid granules were granulated according, to the following method.
[0710] A fixed amount of citric acid powders (Japanese Pharmacopoeia) was contained in a granulation tank of a fluid bed granulation dryer. Heated dry air was supplied in the granulation tank so as to fluidize the citric acid powders (Japanese Pharmacopoeia) stored in the granulation tank and a binder solution including a surfactant was sprayed from a spray means provided in the granulation tank, thereby producing citric acid granules.
[0711] A solution in which an appropriate amount of surfactant (more specifically polysorbate 80) was dissolved in 2 w/w % solution of a water-soluble high polymer (specifically hydroxypropylcellulose (HPC-SL)) was used as a binder <b>5</b>.
[0712] For granulating citric acid granules, the temperature and amount of the heated air supplied in the granulation tank of a fluid bed granulation dryer (Glatt Co., Ltd., WSG-type 5) and a spray amount per hour of the binder solution sprayed from the spray means were controlled in such a manner that the particle size of the citric acid granules becomes the same as that of the ascorbic acid granules.
[0713] The particle size distribution of the ascorbic acid granules, the sodium hydrogen carbonate granules and the citric acid granules obtained by the above-mentioned procedure is shown in a table 8. <tables id="TABLE-US-00008" num="8"><table frame="none" colsep="0" rowsep="0"><tgroup align="left" colsep="0" rowsep="0" cols="4"><colspec colname="1" colwidth="63PT" align="center" /><colspec colname="2" colwidth="49PT" align="center" /><colspec colname="3" colwidth="63PT" align="center" /><colspec colname="4" colwidth="42PT" align="center" /><thead><row><entry namest="1" nameend="4" align="center">TABLE 8</entry></row><row><entry /></row><row><entry namest="1" nameend="4" align="center" rowsep="1" /></row><row><entry /><entry>ascorbic acid</entry><entry>sodium hydrogen</entry><entry>citric acid</entry></row><row><entry>particle size</entry><entry>granules</entry><entry>carbonate granules</entry><entry>granules</entry></row><row><entry namest="1" nameend="4" align="center" rowsep="1" /></row></thead><tbody valign="top"><row><entry>more than 710 μm</entry><entry> 0%</entry><entry> 0%</entry><entry> 0%</entry></row><row><entry>500˜710 μm</entry><entry> 1%</entry><entry> 0%</entry><entry> 1%</entry></row><row><entry>350˜500 μm</entry><entry>20%</entry><entry>17%</entry><entry>21%</entry></row><row><entry>250˜350 μm</entry><entry>46%</entry><entry>44%</entry><entry>50%</entry></row><row><entry>105˜250 μm</entry><entry>22%</entry><entry>23%</entry><entry>21%</entry></row><row><entry>less than 105 μm</entry><entry>11%</entry><entry>16%</entry><entry> 7%</entry></row><row><entry>total</entry><entry>100% </entry><entry>100% </entry><entry>100% </entry></row><row><entry namest="1" nameend="4" align="center" rowsep="1" /></row></tbody></tgroup></table></tables>
[0714] The ascorbic acid content of thus obtained ascorbic acid granules was 98.91 w/w %, the sodium hydrogen carbonate content of the sodium hydrogen carbonate granules was 98.91 w/w % and the citric acid content of the citric acid granules was 98.91 w/w %.
[0715] Thus prepared ascorbic acid granules, sodium hydrogen carbonate granules and citric acid granules were blended at a fixed ratio (in this embodiment, ascorbic acid, sodium hydrogen carbonate and citric acid were blended in weight ratio of 6:1:1).
[0716] Then the blended material of the ascorbic acid granules, the sodium hydrogen carbonate granules and the citric acid granules was mixed with a well-known mixer.
[0717] As shown in the table 8, when the ascorbic acid granules, the sodium hydrogen carbonate granules and the citric acid granules having almost the same particle size were used, it was found that the ascorbic acid granules, the sodium hydrogen carbonate granules and the citric acid granules were uniformly mixed spontaneously by the external force given by the mixer.
[0718] Thus obtained mixture of the ascorbic acid granules, the sodium hydrogen carbonate granules and the citric acid granules was tabletted by means of the external lubrication type tabletting machine S shown in FIG. 10.
[0719] An upper punch <b>31</b>, a lower punch <b>33</b> and a die <b>32</b> with 11 mm diameter were used for the rotary type tabletting machine <b>81</b>.
[0720] An upper punch <b>31</b> and a lower punch <b>33</b> with flat molding surface were used.
[0721] The tabletting pressure was 1500 kg/punch and the weight per a tablet was controlled to be 405 mg±1 mg.
[0722] Magnesium stearate (Japanese Pharmacopoeia) was contained in the lubricant storage hopper <b>52</b> of the quantitative feeder <b>51</b> of the external lubrication type tabletting machine S.
[0723] A rotary cam <b>45</b> having a concavo-convex pattern suitable for dispersing magnesium stearate (Japanese Pharmacopoeia) in air was attached for a rotary axis of the rotary drive means (rotary drive means <b>41</b>M in FIG. 10) of the pulsating vibration air generation means <b>41</b> of the external lubrication type tabletting machine S.
[0724] Then, the mixture of ascorbic acid granules, sodium hydrogen carbonate granules and citric acid granules was stored in a molding material storage hopper (not shown) connected to the feed shoe <b>36</b>.
[0725] Next, the air source <b>111</b> was driven at a fixed drive amount to rotate the rotary drive means (rotary drive means <b>41</b>M in FIG. 10) of the pulsating vibration air generation means <b>41</b>. The frequency of the positive pulsating vibration air generated from the pulsating vibration air generation means <b>41</b> wasn't completely defined, but it was selected from the range of 10 Hz to 40 Hz.
[0726] The supply amount of magnesium stearate (Japanese Pharmacopoeia) into the lubricant spray chamber (lubricant apply means) <b>91</b> was controlled by driving the light permeable type powder concentration measuring means <b>103</b>.
[0727] Then, the rotary type tabletting machine <b>81</b> was driven and at the same time the mixture was supplied from the feed shoe <b>36</b>. The mixture was compressed to produce a tablet by means of the upper punches <b>31</b> . . . on which a fixed amount of magnesium stearate (Japanese Pharmacopoeia) was applied, the lower punches <b>33</b> . . . on which a fixed amount of magnesium stearate (Japanese Pharmacopoeia) was applied and the dies <b>32</b> . . . on which a fixed amount of magnesium stearate (Japanese Pharmacopoeia) was applied.
[0728] Analyzing thus obtained tablet, the drive amount of air source <b>111</b>, the drive amount of pulsating vibration air generation means <b>41</b> were appropriately controlled in such a manner that the applied amount of magnesium stearate (Japanese Pharmacopoeia) per a tablet became 0.4 mg±0.1 mg. Then the tablet (effevescent tablet <b>1</b>A) was produced in earnest.
[0729] The preparation of thus produced tablet (effevescent tablet <b>1</b>A) is shown in a table 9. <tables id="TABLE-US-00009" num="9"><table frame="none" colsep="0" rowsep="0"><tgroup align="left" colsep="0" rowsep="0" cols="3"><colspec colname="OFFSET" colwidth="14PT" align="left" /><colspec colname="1" colwidth="105PT" align="left" /><colspec colname="2" colwidth="98PT" align="center" /><thead><row><entry /><entry namest="OFFSET" nameend="2" align="center">TABLE 9</entry></row><row><entry /><entry /></row><row><entry /><entry namest="OFFSET" nameend="2" align="center" rowsep="1" /></row><row><entry /><entry>component</entry><entry>content</entry></row><row><entry /><entry namest="OFFSET" nameend="2" align="center" rowsep="1" /></row></thead><tbody valign="top"><row><entry /></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="4"><colspec colname="OFFSET" colwidth="14PT" align="left" /><colspec colname="1" colwidth="105PT" align="left" /><colspec colname="2" colwidth="42PT" align="right" /><colspec colname="3" colwidth="56PT" align="left" /><tbody valign="top"><row><entry /><entry>ascorbic acid</entry><entry>300.0</entry><entry>mg</entry></row><row><entry /><entry>sodium hydrogen carbonate</entry><entry>50.0</entry><entry>mg</entry></row><row><entry /><entry>citric acid</entry><entry>50.0</entry><entry>mg</entry></row><row><entry /><entry>hydroxypropylcellulose (HPC-SL)</entry><entry>4.0</entry><entry>mg</entry></row><row><entry /><entry>polysorbate 80</entry><entry>0.4</entry><entry>mg</entry></row><row><entry /><entry>magnesium stearate</entry><entry>0.4</entry><entry>mg</entry></row><row><entry /><entry>Total</entry><entry>405</entry><entry>mg/tablet</entry></row><row><entry /><entry namest="OFFSET" nameend="3" align="center" rowsep="1" /></row></tbody></tgroup></table></tables>
EXPERIMENT EXAMPLE 3
[0730] Experiment example 3 shows other embodiment when an effevescent tablet for oral administration is produced according to the present invention.
[0731] This experiment example 1 corresponds to the effevescent tablet <b>1</b>B shown in FIG. 4 and shows a production example of an effevescent tablet for oral administration wherein granules are produced using a solution in which a saccharide with high wettability for water is dissolved as a binder to be compressed.
[0732] Ascorbic acid granules were used as granules of a main active ingredient <b>2</b> . . . , sodium hydrogen carbonate granules were used as carbonate granules <b>3</b> . . . and citric acid granules were used as organic acid granules <b>4</b> . . . .
[0733] In this embodiment ascorbic acid powders (Japanese Pharmacopoeia) were granulated to produce ascorbic acid granules.
[0734] More specifically, ascorbic acid granules were produced as follows.
[0735] A fixed amount of ascorbic acid powders (Japanese Pharmacopoeia) was contained in a granulation tank of a fluid bed granulation dryer (Glatt Co., Ltd., WSG-type 5). Heated dry air was supplied in the granulation tank so as to fluidize the ascorbic acid powders (Japanese Pharmacopoeia) stored in the granulation tank and a binder solution containing a surfactant was sprayed from a spray means provided in the granulation tank, thereby producing ascorbic acid granules.
[0736] A solution in which a saccharide with high wettability for water was dissolved in water was used instead of a normal binder.
[0737] More specifically, mannitol (Japanese Pharmacopoeia) was used as a saccharide with high wettability for water in this embodiment.
[0738] Here 20 w/w % solution of mannitol (Japanese Pharmacopoeia) was used as a binder solution.
[0739] Sodium hydrogen carbonate granules were granulated according to the following method.
[0740] A fixed amount of sodium hydrogen carbonate powder (Japanese Pharmacopoeia) was contained in a granulation tank of a fluid bed granulation dryer (Glatt Co., Ltd., WSG-type 5). Heated dry air was supplied in the granulation tank so as to fluidize the sodium hydrogen carbonate powders (Japanese Pharmacopoeia) stored in the granulation tank and a binder solution including a surfactant was sprayed from a spray means provided in the granulation tank, thereby producing sodium carbonate granules.
[0741] A solution in which a saccharide with high wettability for water was dissolved in water was used instead of a normal binder.
[0742] More specifically, mannitol (Japanese Pharmacopoeia) was used as a saccharide with high wettability in this embodiment.
[0743] Here 20 w/w % solution of mannitol (Japanese Pharmacopoeia) was used as a binder solution.
[0744] For granulating hydrogen sodium carbonate granules, the temperature and amount of the heated air supplied in the granulation tank of a fluid bed granulation dryer (Glatt Co., Ltd., WSG-type 5) and a spray amount per hour of the binder solution sprayed from the spray means were controlled in such a manner that the particle size of the sodium hydrogen carbonate granules to be granulated became the same as that of the ascorbic acid granule.
[0745] Citric acid granules were granulated according to the following method.
[0746] A fixed amount of citric acid powders (Japanese Pharmacopoeia) was contained in a granulation tank of a fluid bed granulation dryer. Heated dry air was supplied in the granulation tank so as to fluidize the citric acid powders (Japanese Pharmacopoeia) stored in the granulation tank and a binder solution including a surfactant was sprayed from a spray means provided in the granulation tank, thereby producing citric acid granules.
[0747] A solution in which a saccharide with high wettability for water was dissolved in water was used instead of a normal binder.
[0748] More specifically, mannitol (Japanese Pharmacopoeia) was used as a saccharide with high wettability in this embodiment.
[0749] Here 20 w/w % solution of mannitol (Japanese Pharmacopoeia) was used as a binder solution.
[0750] For granulating citric acid granules, the temperature and amount of the heated air supplied in the granulation tank of a fluid bed granulation dryer (Glatt Co., Ltd., WSG-type 5) and a spray amount per hour of the binder solution sprayed from the spray means were controlled in such a manner that the particle size of the citric acid granules to be granulated becomes the same as that of the ascorbic acid granule.
[0751] The particle size distribution of the ascorbic acid granules, the sodium hydrogen carbonate granules and citric acid granules obtained by the above-mentioned procedure is shown in a table 10. <tables id="TABLE-US-00010" num="10"><table frame="none" colsep="0" rowsep="0"><tgroup align="left" colsep="0" rowsep="0" cols="4"><colspec colname="1" colwidth="63PT" align="center" /><colspec colname="2" colwidth="49PT" align="center" /><colspec colname="3" colwidth="63PT" align="center" /><colspec colname="4" colwidth="42PT" align="center" /><thead><row><entry namest="1" nameend="4" align="center">TABLE 10</entry></row><row><entry /></row><row><entry namest="1" nameend="4" align="center" rowsep="1" /></row><row><entry /><entry>ascorbic acid</entry><entry>sodium carbonate</entry><entry>citric acid</entry></row><row><entry>particle size</entry><entry>granules</entry><entry>granules</entry><entry>granules</entry></row><row><entry namest="1" nameend="4" align="center" rowsep="1" /></row></thead><tbody valign="top"><row><entry>more than 710 μm</entry><entry> 0%</entry><entry> 0%</entry><entry> 0%</entry></row><row><entry>500˜710 μm</entry><entry> 1%</entry><entry> 0%</entry><entry> 1%</entry></row><row><entry>350˜500 μm</entry><entry>18%</entry><entry>15%</entry><entry>20%</entry></row><row><entry>250˜350 μm</entry><entry>48%</entry><entry>46%</entry><entry>51%</entry></row><row><entry>105˜250 μm</entry><entry>22%</entry><entry>23%</entry><entry>21%</entry></row><row><entry>less than 105 μm</entry><entry>11%</entry><entry>16%</entry><entry> 7%</entry></row><row><entry>total</entry><entry>100% </entry><entry>100% </entry><entry>100% </entry></row><row><entry namest="1" nameend="4" align="center" rowsep="1" /></row></tbody></tgroup></table></tables>
[0752] From such an experiment, it was found that if a solution in which saccharides were dissolved was used as a binder, the granulated material (granules) with substantially same average particle size and substantially same particle size distribution could be produced even if components were different by controlling granulation conditions such as the temperature and supply amount of the heated air supplied in the granulation tank and spray amount of binder solution per time sprayed from the spray means.
[0753] The ascorbic acid content of thus obtained ascorbic acid granules was 90.91 w/w %, the sodium hydrogen carbonate content of the sodium hydrogen carbonate granules was 90.91 w/w % and the citric acid content of the citric acid granules was 90.91 w/w %.
[0754] Thus prepared ascorbic acid granules, sodium carbonate granules and citric acid granules were blended at a fixed ratio (in this embodiment, the ascorbic acid, sodium carbonate and citric acid were blended in weight ratio of 6:1:1).
[0755] Then the blended material of the ascorbic acid granules, the sodium hydrogen carbonate granules and the citric acid granules was mixed with a well-known mixer.
[0756] As shown in the table 10, when the ascorbic acid granules, the sodium hydrogen carbonate granules and the citric acid granules having almost the same particle size were used, it was found that ascorbic acid granules, sodium carbonate granules and citric acid granules were uniformly mixed spontaneously by the external force given by the mixer.
[0757] Thus obtained mixture of the ascorbic acid granules, the sodium hydrogen carbonate granules and the citric acid granules was tabletted by means of the external lubrication type tabletting machine S shown in FIG. 10.
[0758] An upper punch <b>31</b>, a lower punch <b>33</b> and a die <b>32</b> with 11 mm diameter were used for the rotary type tabletting machine <b>81</b>.
[0759] An upper punch <b>31</b> and a lower punch <b>33</b> with flat molding surface were used.
[0760] The tabletting pressure was 1500 kg/punch and the weight per a tablet was controlled to be 440 mg±1 mg.
[0761] Magnesium stearate (Japanese Pharmacopoeia) was contained in the lubricant storage hopper <b>52</b> of the quantitative feeder <b>51</b> of the external lubrication type tabletting machine S.
[0762] A rotary cam <b>45</b> having a concavo-convex pattern suitable for dispersing magnesium stearate (Japanese Pharmacopoeia) in air was attached for a rotary axis of the rotary drive means (rotary drive means <b>41</b>M in FIG. 10) of the pulsating vibration air generation means <b>41</b> of the external lubrication type tabletting machine S.
[0763] Then, the mixture of the ascorbic acid granules, the sodium hydrogen carbonate granules and the citric acid granules was stored in a molding material storage hopper (not shown) connected to the feed shoe <b>36</b>.
[0764] Next, the air source <b>111</b> was driven at a fixed drive amount to rotate the rotary drive means (rotary drive means <b>41</b>M in FIG. 10) of the pulsating vibration air generation means <b>41</b>. The frequency of the positive pulsating vibration air generated from the pulsating vibration air generation means <b>41</b> wasn't completely defined, but it was selected from the range pf 10 Hz to 40 Hz.
[0765] The supply amount of the magnesium stearate (Japanese Pharmacopoeia) into the lubricant spray chamber (lubricant apply means) <b>91</b> was controlled by driving the light permeable type powder concentration measuring means <b>103</b>.
[0766] Then, the rotary type tabletting machine <b>81</b> was driven and at the same time the mixture was supplied from the feed shoe <b>36</b>. The mixture was compressed to produce a tablet by means of the upper punches <b>31</b> . . . on which a fixed amount of magnesium stearate (Japanese Pharmacopoeia) was applied, the lower punches <b>33</b> . . . on which a fixed amount of magnesium stearate (Japanese Pharmacopoeia) was applied and the dies <b>32</b> . . . on which a fixed amount of magnesium stearate (Japanese Pharmacopoeia) was applied.
[0767] Analyzing thus obtained tablet, the drive amount of air source <b>111</b>, the drive amount of pulsating vibration air generation means <b>41</b> were appropriately controlled in such a manner that the applied amount of magnesium stearate per a tablet became 0.4 mg±0.1 mg. Then the tablet (effevescent tablet <b>1</b>B) was produced in earnest.
[0768] The preparation of thus produced tablet (effevescent tablet <b>1</b>B) is shown in a table 11. <tables id="TABLE-US-00011" num="11"><table frame="none" colsep="0" rowsep="0"><tgroup align="left" colsep="0" rowsep="0" cols="3"><colspec colname="OFFSET" colwidth="21PT" align="left" /><colspec colname="1" colwidth="84PT" align="left" /><colspec colname="2" colwidth="112PT" align="center" /><thead><row><entry /><entry namest="OFFSET" nameend="2" align="center">TABLE 11</entry></row><row><entry /><entry /></row><row><entry /><entry namest="OFFSET" nameend="2" align="center" rowsep="1" /></row><row><entry /><entry>component</entry><entry>content</entry></row><row><entry /><entry namest="OFFSET" nameend="2" align="center" rowsep="1" /></row></thead><tbody valign="top"><row><entry /></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="4"><colspec colname="OFFSET" colwidth="21PT" align="left" /><colspec colname="1" colwidth="84PT" align="left" /><colspec colname="2" colwidth="49PT" align="right" /><colspec colname="3" colwidth="63PT" align="left" /><tbody valign="top"><row><entry /><entry>ascorbic acid</entry><entry>300.0</entry><entry>mg</entry></row><row><entry /><entry>sodium hydrogen carbonate</entry><entry>50.0</entry><entry>mg</entry></row><row><entry /><entry>citric acid</entry><entry>50.0</entry><entry>mg</entry></row><row><entry /><entry>mannitol</entry><entry>41</entry><entry>mg</entry></row><row><entry /><entry>manesium stearate</entry><entry>0.4</entry><entry>mg</entry></row><row><entry /><entry>Total</entry><entry>441</entry><entry>mg/tablet</entry></row><row><entry /><entry namest="OFFSET" nameend="3" align="center" rowsep="1" /></row></tbody></tgroup></table></tables>
EXPERIMENT EXAMPLE 4
[0769] Experiment example 4 shows other embodiment when an effevescent tablet for oral administration is produced according to the present invention.
[0770] This experiment example 4 corresponds to the effevescent tablet <b>1</b>C shown in FIG. 5 and shows a production example of an effevescent tablet for oral administration wherein granules were produced using a solution in which a water-soluble high polymer and a saccharide with high wettability for water were dissolved as a binder to be compressed.
[0771] Ascorbic acid granules were used as granules of a main active ingredient <b>2</b> . . . , sodium hydrogen carbonate granules were used as carbonate granules <b>3</b> . . . and citric acid granules were used as organic acid granules <b>4</b> . . . .
[0772] In this embodiment ascorbic acid powder (Japanese Pharmacopoeia) were granulated to produce ascorbic acid granules.
[0773] More specifically, ascorbic acid granules were granulated as follows.
[0774] A fixed amount of ascorbic acid powders (Japanese Pharmacopoeia) was contained in a granulation tank of a fluid bed granulation dryer (Glatt Co., Ltd., WSG-type 5). Heated dry air was supplied in the granulation tank so as to fluidize the ascorbic acid powders (Japanese Pharmacopoeia) stored in the granulation tank and a binder solution was sprayed from a spray means provided in the granulation tank, thereby producing ascorbic acid granules.
[0775] A solution in which a water-soluble high polymer and a saccharide with high wettability for water were dissolved in water was used as a binder solution.
[0776] More specifically, hydroxypropylcellulose (HPC-SL) was used as a water-soluble high polymer and 2 w/w % solution of hydroxypropylcellulose (HPC-SL) were produced.
[0777] Further, a saccharide with high wettability was added in the 2 w/w % solution of hydroxypropylcellulose (HPC-SL).
[0778] In this embodiment, mannitol (Japanese Pharmacopoeia) was used as a saccharide with high wettability for water.
[0779] Here a binder solution in which mannitol (Japanese Pharmacopoeia) was controlled to be 20 w/w % solution against the entire amount of 2 w/w % solution of hydroxypropylcellulose (HPC-SL) was used.
[0780] Sodium hydrogen carbonate granules were granulated according to the following method.
[0781] A fixed amount of sodium hydrogen carbonate powders (Japanese Pharmacopoeia) was contained in a granulation tank of a fluid bed granulation dryer (Glatt Co., Ltd., WSG-type 5). Heated dry air was supplied in the granulation tank so as to fluidize the sodium hydrogen carbonate powders (Japanese Pharmacopoeia) stored in the granulation tank and a binder solution was sprayed from a spray means provided in the granulation tank, thereby producing sodium hydrogen carbonate granules.
[0782] A solution in which a water-soluble high polymer and a saccharide with high wettability for water were dissolved in water was used as a binder solution.
[0783] More specifically, hydroxypropylcellulose (HPC-SL) was used as a water-soluble high polymer and 2 w/w % solution of hydroxypropylcellulose (HPC-SL) was produced.
[0784] Further, a saccharide with high wettability was added in the 2 w/w % solution of hydroxypropylcellulose (HPC-SL).
[0785] In this embodiment, mannitol (Japanese Pharmacopoeia) was used as a saccharide with high wettability for water.
[0786] Here a binder solution in which mannitol (Japanese Pharmacopoeia) was controlled to be 20 w/w % solution against the entire amount of 2 w/w % solution of hydroxypropylcellulose (HPC-SL) was used.
[0787] For granulating sodium hydrogen carbonate granules, the temperature and amount of the heated air supplied in the granulation tank of a fluid bed granulation dryer (Glatt Co., Ltd., WSG-type 5) and a spray amount per hour of the binder solution sprayed from the spray means were controlled in such a manner that the particle size of the sodium hydrogen carbonate granules to be granulated became the same as that of the ascorbic acid granules.
[0788] Citric acid granules were granulated according to the following method.
[0789] A fixed amount of citric acid powders (Japanese Pharmacopoeia) was contained in a granulation tank of a fluid bed granulation dryer. Heated dry air was supplied in the granulation tank so as to fluidize the citric acid powders (Japanese Pharmacopoeia) stored in the granulation tank -and a binder solution was sprayed from a spray means provided in the granulation tank, thereby producing citric acid granules.
[0790] A solution in which a water-soluble high polymer and a saccharide with high wettability for water were dissolved in water was used as a binder solution.
[0791] More specifically, hydroxypropylcellulose (HPC-SL) was used as a water-soluble high polymer and 2 w/w % solution of hydroxypropylcellulose (HPC-SL) were produced.
[0792] Further, a saccharide with high wettability was added in the 2 w/w % solution of hydroxypropylcellulose (HPC-SL).
[0793] In this embodiment, mannitol (Japanese Pharmacopoeia) was used as a saccharide with high wettability for water.
[0794] Here a binder solution in which mannitol (Japanese Pharmacopoeia) was controlled to be 20 w/w % solution against the entire amount of 2 w/w % solution of hydroxypropylcellulose (HPC-SL) was used.
[0795] For granulating citric acid granules, the temperature and amount of the heated air supplied in the granulation tank of a fluid bed granulation dryer (Glatt Co., Ltd., WSG-type 5), and a spray amount per hour of the binder solution sprayed from the spray means were controlled in such a manner that the particle size of the citric acid granules to be granulated becomes the same as that of the ascorbic acid granules.
[0796] The particle size distribution of the ascorbic acid granules, the sodium hydrogen carbonate granules and the citric acid granules obtained by the above-mentioned procedure is shown in a table 12. <tables id="TABLE-US-00012" num="12"><table frame="none" colsep="0" rowsep="0"><tgroup align="left" colsep="0" rowsep="0" cols="4"><colspec colname="1" colwidth="63PT" align="center" /><colspec colname="2" colwidth="49PT" align="center" /><colspec colname="3" colwidth="63PT" align="center" /><colspec colname="4" colwidth="42PT" align="center" /><thead><row><entry namest="1" nameend="4" align="center">TABLE 12</entry></row><row><entry /></row><row><entry namest="1" nameend="4" align="center" rowsep="1" /></row><row><entry /><entry>ascorbic acid</entry><entry>sodium carbonate</entry><entry>citric acid</entry></row><row><entry>particle size</entry><entry>granules</entry><entry>granules</entry><entry>granules</entry></row><row><entry namest="1" nameend="4" align="center" rowsep="1" /></row></thead><tbody valign="top"><row><entry>more than 710 μm</entry><entry> 0%</entry><entry> 0%</entry><entry> 0%</entry></row><row><entry>500˜710 μm</entry><entry> 0%</entry><entry> 0%</entry><entry> 1%</entry></row><row><entry>350˜500 μm</entry><entry>18%</entry><entry>14%</entry><entry>20%</entry></row><row><entry>250˜350 μm</entry><entry>49%</entry><entry>47%</entry><entry>52%</entry></row><row><entry>105˜250 μm</entry><entry>22%</entry><entry>23%</entry><entry>20%</entry></row><row><entry>less than 105 μm</entry><entry>11%</entry><entry>16%</entry><entry> 7%</entry></row><row><entry>total</entry><entry>100% </entry><entry>100% </entry><entry>100% </entry></row><row><entry namest="1" nameend="4" align="center" rowsep="1" /></row></tbody></tgroup></table></tables>
[0797] The ascorbic acid content of thus obtained ascorbic acid granules was 90.09 w/w %, the sodium hydrogen carbonate content of the sodium hydrogen carbonate granules was 90.09 w/w % and the citric acid content of the citric acid granules was 90.09 w/w %.
[0798] Thus prepared ascorbic acid granules, sodium hydrogen carbonate granules and citric acid granules were blended at a fixed ratio (in this embodiment, ascorbic acid, sodium hydrogen carbonate and citric acid were blended in weight ratio of 6:1:1).
[0799] Then the blended material of the ascorbic acid granules, the sodium hydrogen carbonate granules and the citric acid granules was mixed with a well-known mixer.
[0800] As shown in the table 12, when the ascorbic acid granules, the sodium hydrogen carbonate granules and citric acid granules having almost the same particle size were used, it was found that ascorbic acid granules, sodium carbonate granules and citric acid granules were uniformly mixed spontaneously by the external force given by the mixer.
[0801] Thus obtained mixture of the ascorbic acid granules, the sodium hydrogen carbonate granules and the citric acid granules was tabletted by means of the external lubrication type tabletting machine S shown in FIG. 10.
[0802] An upper punch <b>31</b>, a lower punch <b>33</b> and a die <b>32</b> with 11 mm diameter were used for the rotary type tabletting machine <b>81</b>.
[0803] An upper punch <b>31</b> and a lower punch <b>33</b> with a flat molding surface were used.
[0804] The tabletting pressure was 1500 kg/punch and the weight per a tablet was controlled to be 445 mg±1 mg.
[0805] Magnesium stearate (Japanese Pharmacopoeia) was contained in the lubricant storage hopper <b>52</b> of the quantitative feeder <b>51</b> of the external lubrication type tabletting machine S.
[0806] A rotary cam <b>45</b> having a concavo-convex pattern suitable for dispersing magnesium stearate (Japanese Pharmacopoeia) in air was attached for a rotary axis of the rotary drive means (rotary drive means <b>41</b>M in FIG. 10) of the pulsating vibration air generation means <b>41</b> of the external lubrication type tabletting machine S.
[0807] Then, the mixture of the ascorbic acid granules, the sodium hydrogen carbonate granules and the citric acid granules was stored in a molding material storage hopper (not shown) connected to the feed shoe <b>36</b>.
[0808] Next, the air source <b>111</b> was driven at a fixed drive amount to rotate the rotary drive means (rotary drive means <b>41</b>M in FIG. 10) of the pulsating vibration air generation means <b>41</b>. The frequency of the positive pulsating vibration air generated from the pulsating vibration air generation means <b>41</b> wasn't completely defined, but it was selected from the range of 10 Hz to 40 Hz.
[0809] The supply amount of the magnesium stearate (Japanese Pharmacopoeia) into the lubricant spray chamber (lubricant apply means) <b>91</b> was controlled by driving the light permeable type powder concentration measuring means <b>103</b>.
[0810] Then, the rotary type tabletting machine <b>81</b> was driven and at the same time the mixture was supplied from the feed shoe <b>36</b>. The mixture was compressed to produce a tablet by means of the upper punches <b>31</b> . . . on which a fixed amount of magnesium stearate (Japanese Pharmacopoeia) was applied, the lower punches <b>33</b> . . . on which a fixed amount of magnesium stearate (Japanese Pharmacopoeia) was applied and the dies <b>32</b> . . . on which a fixed amount of magnesium stearate (Japanese Pharmacopoeia) was applied.
[0811] Analyzing thus obtained tablet, the drive amount of air source <b>111</b>, the drive amount of pulsating vibration air generation means <b>41</b> were appropriately controlled in such a, manner that the applied amount of magnesium stearate (Japanese Pharmacopoeia) per a tablet became 0.4 mg±0.1 mg. Then the tablet (effevescent tablet <b>1</b>C) was produced in earnest.
[0812] The preparation of thus produced tablet (effevescent tablet <b>1</b>C) is shown in a table 13. <tables id="TABLE-US-00013" num="13"><table frame="none" colsep="0" rowsep="0"><tgroup align="left" colsep="0" rowsep="0" cols="3"><colspec colname="OFFSET" colwidth="14PT" align="left" /><colspec colname="1" colwidth="105PT" align="left" /><colspec colname="2" colwidth="98PT" align="center" /><thead><row><entry /><entry namest="OFFSET" nameend="2" align="center">TABLE 13</entry></row><row><entry /><entry /></row><row><entry /><entry namest="OFFSET" nameend="2" align="center" rowsep="1" /></row><row><entry /><entry>component</entry><entry>content</entry></row><row><entry /><entry namest="OFFSET" nameend="2" align="center" rowsep="1" /></row></thead><tbody valign="top"><row><entry /></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="4"><colspec colname="OFFSET" colwidth="14PT" align="left" /><colspec colname="1" colwidth="105PT" align="left" /><colspec colname="2" colwidth="42PT" align="right" /><colspec colname="3" colwidth="56PT" align="left" /><tbody valign="top"><row><entry /><entry>ascorbic acid</entry><entry>300.0</entry><entry>mg</entry></row><row><entry /><entry>sodium hydrogen carbonate</entry><entry>50.0</entry><entry>mg</entry></row><row><entry /><entry>citric acid</entry><entry>50.0</entry><entry>mg</entry></row><row><entry /><entry>mannitol</entry><entry>40.0</entry><entry>mg</entry></row><row><entry /><entry>hydroxypropylcellulose (HPC-SL)</entry><entry>4.0</entry><entry>mg</entry></row><row><entry /><entry>manesium stearate</entry><entry>0.4</entry><entry>mg</entry></row><row><entry /><entry>Total</entry><entry>444</entry><entry>mg/tablet</entry></row><row><entry /><entry namest="OFFSET" nameend="3" align="center" rowsep="1" /></row></tbody></tgroup></table></tables>
EXPERIMENT EXAMPLE 5
[0813] Experiment example 5 shows other embodiment when an effevescent tablet for oral administration is produced according to the present invention.
[0814] This experiment example 5 corresponds to the effevescent tablet <b>1</b>D shown in FIG. 6 and shows a production example of an effevescent tablet for oral administration wherein granules were produced using a solution in which a water-soluble high polymer, a saccharide with high wettability for water and surfactants were dissolved as a binder to be compressed.
[0815] Ascorbic acid granules were used as granules of a main active ingredient <b>2</b> . . . , sodium hydrogen carbonate granules were used as carbonate granules <b>3</b> . . . and citric acid granules were used as organic acid granules <b>4</b> . . . .
[0816] In this embodiment ascorbic acid powders (Japanese Pharmacopoeia) were granulated to produce ascorbic acid granules.
[0817] More specifically, ascorbic acid granules were granulated as follows.
[0818] A fixed amount of ascorbic acid powder (Japanese Pharmacopoeia) was contained in a granulation tank of a fluid bed granulation dryer (Glatt Co., Ltd., WSG-type 5). Heated dry air was supplied in the granulation tank so as to fluidize the ascorbic acid powders (Japanese Pharmacopoeia) stored in the granulation tank and a binder solution was sprayed from a spray means provided in the granulation tank, thereby producing ascorbic acid granules.
[0819] A solution in which a water-soluble high polymer, a saccharide with high wettability for water and a surfactant were dissolved in water was used as a binder solution.
[0820] More specifically, hydroxypropylcellulose (HPC-SL) was used as a water-soluble high polymer and 2 w/w % solution of hydroxypropylcellulose (HPC-SL) was produced.
[0821] Further, a saccharide with high wettability was added in the 2 w/w % solution of hydroxypropylcellulose (HPC-SL).
[0822] In this embodiment, mannitol (Japanese Pharmacopoeia) was used as a saccharide with high wettability for water.
[0823] Here a binder solution in which mannitol (Japanese Pharmacopoeia) was controlled to be 20 w/w % solution against the entire amount of 2 w/w % solution of hydroxypropylcellulose (HPC-SL) was used.
[0824] Further a surfactant was added in thus obtained solution containing hydroxypropylcellulose (HPC-SL) and mannitol.
[0825] In this embodiment polysorbate 80 was used as a surfactant.
[0826] Here a binder solution in which mannitol (Japanese Pharmacopoeia) was controlled to be 0.3 w/w % solution against the entire amount of solution containing hydroxypropylcellulose (HPC-SL) and mannitol was used.
[0827] Sodium hydrogen carbonate granules were granulated according to the following method.
[0828] A fixed amount of sodium carbonate powder (Japanese Pharmacopoeia) was contained in a granulation tank of a fluid bed granulation dryer (Glatt Co., Ltd., WSG-type 5). Heated dry air was supplied in the granulation tank so as to fluidize the sodium hydrogen carbonate powders (Japanese Pharmacopoeia) stored in the granulation tank and a binder solution was sprayed from a spray means provided in the granulation tank, thereby producing sodium hydrogen carbonate granules.
[0829] A solution in which a water-soluble high polymer and a saccharide with high wettability for water were dissolved in water was used as a binder solution.
[0830] A solution in which a water-soluble high polymer, a saccharide with high wettability for water and a surfactant were dissolved in water was used as a binder solution.
[0831] More specifically, hydroxypropylcellulose (HPC-SL) was used as a water-soluble high polymer and 2 w/w % solution of hydroxypropylcellulose (HPC-SL) was produced.
[0832] Further, a saccharide with high wettability was added in the 2 w/w % solution of hydroxypropylcellulose (HPC-SL).
[0833] In this embodiment, mannitol (Japanese Pharmacopoeia) was used as a saccharide with high wettability for water.
[0834] Here mannitol (Japanese Pharmacopoeia) was controlled to be 20 w/w % solution against the entire amount of 2 w/w % solution of hydroxypropylcellulose (HPC-SL).
[0835] Further surfactant was added in thus obtained solution containing hydroxypropylcellulose (HPC-SL) and mannitol.
[0836] In this embodiment polysorbate 80 was used as a surfactant.
[0837] Here a binder solution in which mannitol (Japanese Pharmacopoeia) was controlled to be 0.3 w/w % solution against the entire amount of solution containing hydroxypropylcellulose (HPC-SL) and mannitol (Japanese Pharmacopoeia) was used.
[0838] For granulating sodium hydrogen carbonate granules, the temperature and amount of the heated air supplied in the granulation tank of a fluid bed granulation dryer (Glatt Co., Ltd., WSG-type 5) and a spray amount per hour of the binder solution sprayed from the spray means were controlled in such a manner that the particle size of the sodium hydrogen carbonate granules to be granulated became the same as that of the ascorbic acid granule.
[0839] Citric acid granules were granulated according to the following method.
[0840] A fixed amount of citric acid powders (Japanese Pharmacopoeia) was contained in a granulation tank of a fluid bed granulation dryer. Heated dry air was supplied in the granulation tank so as to fluidize the citric acid powders (Japanese Pharmacopoeia) stored in the granulation tank and a binder solution was sprayed from a spray means provided in the granulation tank, thereby producing citric acid granules.
[0841] A solution in which a water-soluble high polymer and a saccharide with high wettability for water were dissolved in water was used as a binder solution.
[0842] A solution in which a water-soluble high polymer, a saccharide with high wettability for water and a surfactant were dissolved in water was used as a binder solution.
[0843] More specifically, hydroxypropylcellulose (HPC-SL) was used as a water-soluble high polymer and 2 w/w % solution of hydroxypropylcellulose (HPC-SL) was produced.
[0844] Further, a saccharide with high wettability was added in the 2 w/w % solution of hydroxypropylcellulose (HPC-SL).
[0845] In this embodiment, mannitol (Japanese Pharmacopoeia) was used as a saccharide with high wettability for water.
[0846] Here a binder solution in which mannitol (Japanese Pharmacopoeia) was controlled to be 20 w/w % solution against the entire amount of 2 w/w % solution of hydroxypropylcellulose (HPC-SL) was used.
[0847] Further a surfactant was added in thus obtained solution containing hydroxypropylcellulose (HPC-SL) and mannitol.
[0848] In this embodiment polysorbate 80 was used as a surfactant.
[0849] Here a binder solution in which mannitol (Japanese Pharmacopoeia) was controlled to be 0.3 w/w % solution against the entire amount of solution containing hydroxypropylcellulose (HPC-SL) and mannitol was used.
[0850] For granulating citric acid granules, the temperature and amount of the heated air supplied in the granulation tank of a fluid bed granulation dryer (Glatt Co., Ltd., WSG-type 5) and a spray amount per hour of the binder solution sprayed from the spray means were controlled in such a manner that the particle size of the citric acid granules becomes the same as that of the ascorbic acid granule.
[0851] The particle size distribution of the ascorbic acid granules, the sodium hydrogen carbonate granules and the citric acid granules obtained by the above-mentioned procedure is shown in a table 14. <tables id="TABLE-US-00014" num="14"><table frame="none" colsep="0" rowsep="0"><tgroup align="left" colsep="0" rowsep="0" cols="4"><colspec colname="1" colwidth="63PT" align="center" /><colspec colname="2" colwidth="49PT" align="center" /><colspec colname="3" colwidth="63PT" align="center" /><colspec colname="4" colwidth="42PT" align="center" /><thead><row><entry namest="1" nameend="4" align="center">TABLE 14</entry></row><row><entry /></row><row><entry namest="1" nameend="4" align="center" rowsep="1" /></row><row><entry /><entry>ascorbic acid</entry><entry>sodium carbonate</entry><entry>citric acid</entry></row><row><entry>particle size</entry><entry>granules</entry><entry>granules</entry><entry>granules</entry></row><row><entry namest="1" nameend="4" align="center" rowsep="1" /></row></thead><tbody valign="top"><row><entry>more than 710 μm</entry><entry> 0%</entry><entry> 0%</entry><entry> 0%</entry></row><row><entry>500˜710 μm</entry><entry> 0%</entry><entry> 0%</entry><entry> 0%</entry></row><row><entry>350˜500 μm</entry><entry>18%</entry><entry>14%</entry><entry>20%</entry></row><row><entry>250˜350 μm</entry><entry>50%</entry><entry>50%</entry><entry>53%</entry></row><row><entry>105˜250 μm</entry><entry>22%</entry><entry>23%</entry><entry>20%</entry></row><row><entry>less than 105 μm</entry><entry>10%</entry><entry>13%</entry><entry> 7%</entry></row><row><entry>total</entry><entry>100% </entry><entry>100% </entry><entry>100% </entry></row><row><entry namest="1" nameend="4" align="center" rowsep="1" /></row></tbody></tgroup></table></tables>
[0852] The ascorbic acid content of thus obtained ascorbic acid granules was 90.01 w/w %, the sodium hydrogen carbonate content of the sodium hydrogen carbonate granules was 90.01 w/w % and the citric acid content of the citric acid granules was 90.01 w/w %.
[0853] Thus prepared ascorbic acid granules, sodium hydrogen carbonate granules and citric acid granules were blended at a fixed ratio (in this embodiment, ascorbic acid, sodium carbonate and citric acid were blended in weight ratio of 6:1:1).
[0854] Then the blended material of the ascorbic acid granules, the sodium hydrogen carbonate granules and the citric acid granules was mixed with a well-known mixer.
[0855] As shown in the table 14, when the ascorbic acid granules, the sodium hydrogen carbonate granules and the citric acid granules having almost the same particle size were used, it was found that ascorbic acid granules, sodium carbonate granules and citric acid granules were uniformly mixed spontaneously by the external force given by the mixer.
[0856] Thus obtained mixture of ascorbic acid granules, the sodium hydrogen carbonate granules and the citric acid granules was tabletted by means of the external lubrication type tabletting machine S shown in FIG. 10.
[0857] An upper punch <b>31</b>, a lower punch <b>33</b> and a die <b>32</b> with 11 mm diameter were used for the rotary type tabletting machine <b>81</b>.
[0858] An upper punch <b>31</b> and a lower punch <b>33</b> with a flat molding surface were used.
[0859] The tabletting pressure was 1500 kg/punch and the weight per a tablet was controlled to be 445 mg±1 mg.
[0860] Magnesium stearate (Japanese Pharmacopoeia) was contained in the lubricant storage hopper <b>52</b> of the quantitative feeder <b>51</b> of the external lubrication type tabletting machine S.
[0861] A rotary cam <b>45</b> having a concavo-convex pattern suitable for dispersing magnesium stearate (Japanese Pharmacopoeia) in air was attached for a rotary axis of the rotary drive means (rotary drive means <b>41</b>M in FIG. 10) of the pulsating vibration air generation means <b>41</b> of the external lubrication type tabletting machine S.
[0862] Then, the mixture of the ascorbic acid granules, the sodium carbonate granules and the citric acid granules was stored in a molding material storage hopper (not shown) connected to the feed shoe <b>36</b>.
[0863] Next, the air source <b>111</b> was driven at a fixed drive amount to rotate the rotary drive means (rotary drive means <b>41</b>M in FIG. 10) of the pulsating vibration air generation means <b>41</b>. The frequency of the positive pulsating vibration air generated from the pulsating vibration air generation means <b>41</b> wasn't completely defined, but it was selected from the range of 10 Hz to 40 Hz.
[0864] The supply amount of magnesium stearate (Japanese Pharmacopoeia) into the lubricant spray chamber (lubricant apply means) <b>91</b> was controlled by driving the light permeable type powder concentration measuring means <b>103</b>.
[0865] Then, the rotary type tabletting machine <b>81</b> was driven and at the same time the mixture was supplied from the feed shoe <b>36</b>. The mixture was compressed to produce a tablet by means of the upper punches <b>31</b> . . . on which a fixed amount of magnesium stearate (Japanese Pharmacopoeia) was applied, the lower punches <b>33</b> . . . on which a fixed amount of magnesium stearate (Japanese Pharmacopoeia) was applied and the dies <b>32</b> . . . on which a fixed amount of magnesium stearate (Japanese Pharmacopoeia) was applied.
[0866] Analyzing thus obtained tablet, the drive amount of air source <b>111</b>, the drive amount of pulsating vibration air generation means <b>41</b> were appropriately controlled in such a manner that the applied amount of magnesium stearate per a tablet became 0.4 mg±0.1 mg. Then the tablet (effevescent tablet <b>1</b>D) was produced in earnest.
[0867] The preparation of thus produced tablet (effevescent tablet ID) is shown in a table 15. <tables id="TABLE-US-00015" num="15"><table frame="none" colsep="0" rowsep="0"><tgroup align="left" colsep="0" rowsep="0" cols="3"><colspec colname="OFFSET" colwidth="14PT" align="left" /><colspec colname="1" colwidth="105PT" align="left" /><colspec colname="2" colwidth="98PT" align="center" /><thead><row><entry /><entry namest="OFFSET" nameend="2" align="center">TABLE 15 </entry></row><row><entry /><entry /></row><row><entry /><entry namest="OFFSET" nameend="2" align="center" rowsep="1" /></row><row><entry /><entry>component</entry><entry>content</entry></row><row><entry /><entry namest="OFFSET" nameend="2" align="center" rowsep="1" /></row></thead><tbody valign="top"><row><entry /></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="4"><colspec colname="OFFSET" colwidth="14PT" align="left" /><colspec colname="1" colwidth="105PT" align="left" /><colspec colname="2" colwidth="42PT" align="right" /><colspec colname="3" colwidth="56PT" align="left" /><tbody valign="top"><row><entry /><entry>ascorbic acid</entry><entry>300.0</entry><entry>mg</entry></row><row><entry /><entry>sodium hydrogen carbonate</entry><entry>50.0</entry><entry>mg</entry></row><row><entry /><entry>citric acid</entry><entry>50.0</entry><entry>mg</entry></row><row><entry /><entry>mannitol</entry><entry>40.0</entry><entry>mg</entry></row><row><entry /><entry>hydroxypropylcellulose (HPC-SL)</entry><entry>4.0</entry><entry>mg</entry></row><row><entry /><entry>polysorbate 80</entry><entry>0.4</entry><entry>mg</entry></row><row><entry /><entry>manesium stearate</entry><entry>0.4</entry><entry>mg</entry></row><row><entry /><entry>Total</entry><entry>444</entry><entry>mg/tablet</entry></row><row><entry /><entry namest="OFFSET" nameend="3" align="center" rowsep="1" /></row></tbody></tgroup></table></tables>
[0868] Then characteristic tests 1, 2 and 3 as mentioned in the experiment example 1 were executed for the tablet obtained by the experiment examples 2, 3, 4 and 5.
[0869] Characteristic Test 1
[0870] In a drinking water in which a tablet (effevescent tablet <b>1</b>A, <b>1</b>B, <b>1</b>C and <b>1</b>D of the present invention) obtained by each experiment example 2, 3, 4 and 5 was dissolved, the substance floating on the surface of the drinking water wasn't observed.
[0871] The drinking water in which a tablet (effevescent tablet <b>1</b>A, <b>1</b>B, <b>1</b>C and <b>1</b>D of the present invention) obtained by each experiment example 2, 3, 4 and 5 was dissolved was clear.
[0872] Characteristic Test 2
[0873] The results of the characteristic test 2 are shown in a table 16. <tables id="TABLE-US-00016" num="16"><table frame="none" colsep="0" rowsep="0"><tgroup align="left" colsep="0" rowsep="0" cols="3"><colspec colname="OFFSET" colwidth="63PT" align="left" /><colspec colname="1" colwidth="84PT" align="left" /><colspec colname="2" colwidth="70PT" align="center" /><thead><row><entry /><entry namest="OFFSET" nameend="2" align="center">TABLE 16</entry></row><row><entry /><entry /></row><row><entry /><entry namest="OFFSET" nameend="2" align="center" rowsep="1" /></row><row><entry /><entry>sample</entry><entry>disintegration time</entry></row><row><entry /><entry namest="OFFSET" nameend="2" align="center" rowsep="1" /></row></thead><tbody valign="top"><row><entry /></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="4"><colspec colname="OFFSET" colwidth="14PT" align="left" /><colspec colname="1" colwidth="49PT" align="left" /><colspec colname="2" colwidth="84PT" align="left" /><colspec colname="3" colwidth="70PT" align="center" /><tbody valign="top"><row><entry /><entry>experiment</entry><entry>sample 1</entry><entry>15 sec.</entry></row><row><entry /><entry>example 2</entry><entry>sample 2</entry><entry>15 sec.</entry></row><row><entry /><entry /><entry>sample 3</entry><entry>17 sec.</entry></row><row><entry /><entry /><entry>sample 4</entry><entry>19 sec.</entry></row><row><entry /><entry /><entry>sample 5</entry><entry>22 sec.</entry></row><row><entry /><entry /><entry>sample 6</entry><entry>24 sec.</entry></row><row><entry /><entry /><entry>average disintegration time</entry><entry>19 sec.</entry></row><row><entry /><entry>experiment</entry><entry>sample 1</entry><entry>19 sec.</entry></row><row><entry /><entry>example 3</entry><entry>sample 2</entry><entry>20 sec.</entry></row><row><entry /><entry /><entry>sample 3</entry><entry>22 sec.</entry></row><row><entry /><entry /><entry>sample 4</entry><entry>25 sec.</entry></row><row><entry /><entry /><entry>sample 5</entry><entry>27 sec.</entry></row><row><entry /><entry /><entry>sample 6</entry><entry>29 sec.</entry></row><row><entry /><entry /><entry>average disintegration time</entry><entry>24 sec.</entry></row><row><entry /><entry>experiment</entry><entry>sample 1</entry><entry>17 sec.</entry></row><row><entry /><entry>example 4</entry><entry>sample 2</entry><entry>17 sec.</entry></row><row><entry /><entry /><entry>sample 3</entry><entry>20 sec.</entry></row><row><entry /><entry /><entry>sample 4</entry><entry>23 sec.</entry></row><row><entry /><entry /><entry>sample 5</entry><entry>27 sec.</entry></row><row><entry /><entry /><entry>sample 6</entry><entry>30 sec.</entry></row><row><entry /><entry /><entry>average disintegration time</entry><entry>22 sec.</entry></row><row><entry /><entry>experiment</entry><entry>sample 1</entry><entry>16 sec.</entry></row><row><entry /><entry>example 5</entry><entry>sample 2</entry><entry>17 sec.</entry></row><row><entry /><entry /><entry>sample 3</entry><entry>19 sec.</entry></row><row><entry /><entry /><entry>sample 4</entry><entry>22 sec.</entry></row><row><entry /><entry /><entry>sample 5</entry><entry>22 sec.</entry></row><row><entry /><entry /><entry>sample 6</entry><entry>22 sec.</entry></row><row><entry /><entry /><entry>average disintegration time</entry><entry>20 sec.</entry></row><row><entry /><entry namest="OFFSET" nameend="3" align="center" rowsep="1" /></row></tbody></tgroup></table></tables>
[0874] As seen from the result of the table 16, the tablet (effevescent tablet <b>1</b>A, <b>1</b>B, <b>1</b>C and <b>1</b>D of the present invention) obtained by each experiment example 2, 3, 4 and 5 had a higher disintegration speed comparing with that obtained by the experiment example 1.
[0875] Characteristic Test 3
[0876] The results of the characteristic test 3 are shown in table 17. <tables id="TABLE-US-00017" num="17"><table frame="none" colsep="0" rowsep="0"><tgroup align="left" colsep="0" rowsep="0" cols="3"><colspec colname="OFFSET" colwidth="77PT" align="left" /><colspec colname="1" colwidth="63PT" align="left" /><colspec colname="2" colwidth="77PT" align="center" /><thead><row><entry /><entry namest="OFFSET" nameend="2" align="center">TABLE 17</entry></row><row><entry /><entry /></row><row><entry /><entry namest="OFFSET" nameend="2" align="center" rowsep="1" /></row><row><entry /><entry>sample</entry><entry>elution rate</entry></row><row><entry /><entry namest="OFFSET" nameend="2" align="center" rowsep="1" /></row></thead><tbody valign="top"><row><entry /></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="4"><colspec colname="OFFSET" colwidth="21PT" align="left" /><colspec colname="1" colwidth="56PT" align="left" /><colspec colname="2" colwidth="63PT" align="left" /><colspec colname="3" colwidth="77PT" align="center" /><tbody valign="top"><row><entry /><entry>experiment</entry><entry>sample 1</entry><entry>93%</entry></row><row><entry /><entry>example 2</entry><entry>sample 2</entry><entry>95%</entry></row><row><entry /><entry /><entry>sample 3</entry><entry>96%</entry></row><row><entry /><entry /><entry>sample 4</entry><entry>96%</entry></row><row><entry /><entry /><entry>sample 5</entry><entry>98%</entry></row><row><entry /><entry /><entry>average elution rate</entry><entry>96%</entry></row><row><entry /><entry>experiment</entry><entry>sample 1</entry><entry>95%</entry></row><row><entry /><entry>example 3</entry><entry>sample 2</entry><entry>95%</entry></row><row><entry /><entry /><entry>sample 3</entry><entry>96%</entry></row><row><entry /><entry /><entry>sample 4</entry><entry>97%</entry></row><row><entry /><entry /><entry>sample 5</entry><entry>99%</entry></row><row><entry /><entry /><entry>average elution rate</entry><entry>96%</entry></row><row><entry /><entry>experiment</entry><entry>sample 1</entry><entry>94%</entry></row><row><entry /><entry>example 4</entry><entry>sample 2</entry><entry>95%</entry></row><row><entry /><entry /><entry>sample 3</entry><entry>95%</entry></row><row><entry /><entry /><entry>sample 4</entry><entry>97%</entry></row><row><entry /><entry /><entry>sample 5</entry><entry>99%</entry></row><row><entry /><entry /><entry>average elution rate</entry><entry>96%</entry></row><row><entry /><entry>experiment</entry><entry>sample 1</entry><entry>94%</entry></row><row><entry /><entry>example 5</entry><entry>sample 2</entry><entry>96%</entry></row><row><entry /><entry /><entry>sample 3</entry><entry>97%</entry></row><row><entry /><entry /><entry>sample 4</entry><entry>97%</entry></row><row><entry /><entry /><entry>sample 5</entry><entry>98%</entry></row><row><entry /><entry /><entry>average elution rate</entry><entry>96%</entry></row><row><entry /><entry namest="OFFSET" nameend="3" align="center" rowsep="1" /></row></tbody></tgroup></table></tables>
[0877] As seen from the results of the table 17, it was found that the elution characteristic of the tablet (effevescent tablet <b>1</b>A, <b>1</b>B, <b>1</b>C and <b>1</b>D of the present invention) obtained by each experiment example 2, 3, 4 and 5 was the same as that of the tablet obtained by the experiment example 1.
EXPERIMENT EXAMPLE 6
[0878] Experiment example 6 shows one embodiment when an effevescent tablet for a washing detergent is produced according to the present invention.
[0879] This experiment example 6 shows an example wherein the effevescent tablet <b>1</b>D shown in FIG. 6 is applied to an effevescent tablet for a washing detergent.
[0880] A mixed granules of sodium silicate aluminate and sodium lauryl sulfate (called a mixed granule of sodium silicate aluminate—sodium lauryl sulfate hereinafter) was used as principal (surfactant) agent granules <b>2</b>A . . . .
[0881] Sodium fatty acid granules (in this embodiment a mixed granules of sodium caprylate, sodium laulrate, sodium myristate, sodium palmitate, sodium stearate, sodium oleate, sodium linoleate) were used for granules of a main active ingredient (fatty acid alkali salt) <b>2</b>B . . . .
[0882] Sodium hydrogen carbonate granules were used as carbonate granules <b>3</b> . . . .
[0883] Fumaric acid granules were used as organic acid granules <b>4</b> . . . .
[0884] Anhydrous sodium sulphate granules were used as anhydrous sodium sulphate.
[0885] In this example, a mixed granule of sodium silicate aluminate—sodium lauryl sulfate was obtained by uniformly mixing sodium silicate aluminate powders (Japanese Pharmacopoeia) and sodium lauryl sulfate powders (Japanese Pharmacopoeia) which were blended at a fixed ratio and by granulating the mixed powders of sodium silicate aluminate—sodium lauryl sulfate.
[0886] More specifically, the mixed granules of sodium silicate aluminate—sodium lauryl sulfate were granulated as follows.
[0887] At first a fixed amount of sodium silicate aluminate powders (Japanese Pharmacopoeia) and a fixed amount of sodium lauryl sulfate powders (Japanese Pharmacopoeia) were blended (in this example sodium silicate aluminate powders (Japanese Pharmacopoeia) and sodium lauryl sulfate powders were blended at a weight ratio of 4:1).
[0888] Then thus blended mixture of sodium silicate aluminate powders (Japanese Pharmacopoeia) and sodium lauryl sulfate powders (Japanese Pharmacopoeia) was mixed with a well known mixer, thereby obtaining mixed powders of sodium silicate aluminate powders and sodium lauryl sulfate powders.
[0889] A fixed amount of mixed powders of sodium silicate aluminate powders—sodium lauryl sulfate powders was contained in a granulation tank of a fluid bed granulation dryer (Glatt Co., Ltd., WSG-type 5). Heated dry air was supplied in the granulation tank so as to fluidize the mixed powders of sodium silicate aluminate powders—sodium lauryl sulfate powders stored in the granulation tank and a binder solution was sprayed from a spray means provided in the granulation tank, thereby producing a mixed granules of sodium silicate aluminate—sodium lauryl sulfate.
[0890] A solution in which a water-soluble high polymer and a surfactant were dissolved in water was used as a binder solution.
[0891] More specifically, polyvinyl alcohol (Japanese Pharmacopoeia) was used as water-soluble high polymers and a solution containing 3 w/w % of polyvinyl alcohol was prepared.
[0892] Surfactant was added in the solution with 3 w/w % polyvinyl alcohol.
[0893] Polyethylene glycol (in this example, macrogol 6000 (Japanese Pharmacopoeia)) was used as a surfactant.
[0894] A binder solution in which polyethylene glycol (in this example, macrogol 6000 (Japanese Pharmacopoeia)) was controlled to be 0.3 w/w % solution for the entire amount of 3 w/w % polyvinyl alcohol solution was used.
[0895] Sodium fatty acid granules were obtained by granulating sodium fatty acid powders (in this example a mixed powder of sodium caprylate, sodium laulrate, sodium myristate, sodium palmitate, sodium stearate, sodium oleate, sodium linoleate).
[0896] More specifically, sodium fatty acid granules were granulated as follows.
[0897] At first, a fixed amount of sodium fatty acid powders (in this example a mixed powder of sodium caprylate, sodium laulrate, sodium myristate, sodium palmitate, sodium stearate, sodium oleate, sodium linoleate) (commercial reagent) was contained in a granulation tank of a fluid bed granulation dryer (Glatt Co., Ltd., WSG-type 5). Heated dry air was supplied in the granulation tank so as to fluidize the sodium fatty acid powders stored in the granulation tank and a binder solution was sprayed from a spray means provided in the granulation tank, thereby producing sodium fatty acid granules.
[0898] A solution in which water-soluble high polymer and a surfactant were dissolved in water was used as a binder solution.
[0899] More specifically, polyvinyl alcohol (Japanese Pharmacopoeia) was use as water-soluble high polymer and a solution containing 3 w/w % of polyvinyl alcohol was prepared.
[0900] A surfactant was added in the solution with 3 w/w % polyvinyl alcohol.
[0901] Polyethylene glycol (in this example, macrogol 6000 (Japanese Pharmacopoeia)) was used as a surfactant.
[0902] A binder solution in which polyethylene glycol (in this example, macrogol 6000 (Japanese Pharmacopoeia)) was controlled to be 0.3 w/w % solution for the entire amount of 3 w/w % polyvinyl alcohol solution was used.
[0903] For granulating sodium fatty acid granules, the temperature and amount of the heated air supplied in the granulation tank of a fluid bed granulation dryer (Glatt Co., Ltd., WSG-type 5) and a spray amount per hour of the binder solution sprayed from the spray means were controlled in such a manner that the particle size of the sodium fatty acid granules became the same as that of the mixed granules of sodium silicate aluminate—sodium lauryl sulfate.
[0904] Sodium hydrogen carbonate granules were obtained by granulating sodium carbonate powders.
[0905] Sodium hydrogen carbonate granules were granulated according to the following method.
[0906] A fixed amount of sodium hydrogen carbonate powders (Japanese Pharmacopoeia) was contained in a granulation tank of a fluid bed granulation dryer (Glatt Co., Ltd., WSG-type 5). Heated dry air was supplied in the granulation tank so as to fluidize the sodium hydrogen carbonate powders (Japanese Pharmacopoeia) stored in the granulation tank and a binder solution was sprayed from a spray means provided in the granulation tank, thereby producing sodium carbonate granules.
[0907] A solution in which water-soluble high polymer and a surfactant were dissolved in water was used as a binder solution.
[0908] More specifically, polyvinyl alcohol (Japanese Pharmacopoeia) was used as water-soluble high polymer and a solution containing 3 w/w % of polyvinyl alcohol was prepared.
[0909] A surfactant was added in the solution with 3 w/w % polyvinyl alcohol.
[0910] Polyethylene glycol (in this example, macrogol 6000 (Japanese Pharmacopoeia)) was used as a surfactant.
[0911] A binder solution in which polyethylene glycol (in this example, macrogol 6000 (Japanese Pharmacopoeia)) was controlled to be 0.3 w/w % solution for the entire amount of 3 w/w % polyvinyl alcohol solution was used.
[0912] For granulating sodium hydrogen carbonate granules, the temperature and amount of the heated air supplied in the granulation tank of a fluid bed granulation dryer (Glatt Co., Ltd., WSG-type 5) and a spray amount per hour of the binder solution sprayed from the spray means were controlled in such a manner that the particle size of the sodium hydrogen carbonate granules became the same as that of the mixed granule of sodium silicate aluminate—sodium lauryl sulfate.
[0913] Fumaric acid granules were obtained by granulating fumaric acid powders.
[0914] Fumaric acid granules were produced according to the following method.
[0915] A fixed amount of fumaric acid powder (commercial item) was contained in a granulation tank of a fluid bed granulation dryer. Heated dry air was supplied in the granulation tank so as to fluidize the fumaric acid powders stored in the granulation tank and a binder solution was sprayed from a spray means provided in the granulation tank, thereby producing fumaric acid granules.
[0916] A solution in which a water-soluble high polymer and a surfactant were dissolved in water was used as a binder solution.
[0917] More specifically, polyvinyl alcohol (Japanese Pharmacopoeia) was used as water-soluble high polymer and a solution containing 3 w/w % of polyvinyl alcohol was prepared.
[0918] A surfactant was added in the solution with 3 w/w % polyvinyl alcohol.
[0919] Polyethylene glycol (in this example, macrogol 6000 Japanese Pharmacopoeia)) was used as a surfactant.
[0920] A binder solution in which polyethylene glycol (in this example, macrogol 6000 (Japanese Pharmacopoeia)) was controlled to be 0.3 w/w % solution for the entire amount of 3 w/w % polyvinyl alcohol solution was used.
[0921] For granulating fumaric acid granules, the temperature and amount of the heated air supplied in the granulation tank of a fluid bed granulation dryer (Glatt Co., Ltd., WSG-type 5) and a spray amount per hour of the binder solution sprayed from the spray means were controlled in such a manner that the particle size of the fumaric acid granules became the same as that of the mixed granule of sodium silicate aluminate—sodium lauryl sulfate.
[0922] Anhydrous sodium sulphate granules were obtained by granulating anhydrous sodium sulphate powders.
[0923] Anhydrous sodium sulphate granules were produced according to the following method.
[0924] A fixed amount of anhydrous sodium sulphate powder (this example used one which is listed on Japanese Standard of Food Additives) was contained in a granulation tank of a fluid bed granulation dryer. Heated dry air was supplied in the granulation tank so as to fluidize the anhydrous sodium sulphate powders stored in the granulation tank and a binder solution was sprayed from a spray means provided in the granulation tank, thereby producing anhydrous sodium sulphate granules.
[0925] A solution in which water-soluble high polymer and a surfactant were dissolved in water was used as a binder solution.
[0926] More specifically, polyvinyl alcohol (Japanese Pharmacopoeia) was used as water-soluble high polymer and a solution containing 3 w/w % of polyvinyl alcohol was prepared.
[0927] A surfactant was added in the solution with 3 w/w % polyvinyl alcohol.
[0928] Polyethylene glycol (in this example, macrogol 6000 (Japanese Pharmacopoeia)) was used a surfactant.
[0929] A binder solution in which polyethylene glycol (in this example, macrogol 6000 (Japanese Pharmacopoeia)) was controlled to be 0.3 w/w % solution for the entire amount of 3 w/w % polyvinyl alcohol solution was used.
[0930] For granulating anhydrous sodium sulphate granules, the temperature and amount of the heated air supplied in the granulation tank of a fluid bed granulation dryer (Glatt Co., Ltd., WSG-type 5) and a spray amount per hour of the binder solution sprayed from the spray means were controlled in such a manner that the particle size of the anhydrous sodium sulphate granules became the same as that of the mixed granules of sodium silicate aluminate—sodium lauryl sulfate.
[0931] The particle size distribution of thus obtained sodium silicate aluminate granules, sodium lauryl sulfate granules, sodium fatty acid granules, (in this example a mixed granule of sodium caprylate, sodium laulrate, sodium myristate, sodium palmitate, sodium stearate, sodium oleate, sodium linoleate), sodium hydrogen carbonate granules, fumaric acid granules and anhydrous sodium sulphate granules is shown in table 18. <tables id="TABLE-US-00018" num="18"><table frame="none" colsep="0" rowsep="0" pgwide="1"><tgroup align="left" colsep="0" rowsep="0" cols="7"><colspec colname="1" colwidth="56PT" align="center" /><colspec colname="2" colwidth="56PT" align="center" /><colspec colname="3" colwidth="49PT" align="center" /><colspec colname="4" colwidth="42PT" align="center" /><colspec colname="5" colwidth="56PT" align="center" /><colspec colname="6" colwidth="42PT" align="center" /><colspec colname="7" colwidth="63PT" align="center" /><thead><row><entry namest="1" nameend="7" align="center">TABLE 18</entry></row><row><entry /></row><row><entry namest="1" nameend="7" align="center" rowsep="1" /></row><row><entry /><entry>sodium silicate</entry><entry>sodium lauryl</entry><entry>sodium fatty</entry><entry>sodium hydrogen</entry><entry>fumaric acid</entry><entry>sodium sulphate</entry></row><row><entry>particle size</entry><entry>aluminate granule</entry><entry>sulfate granule</entry><entry>acid granule</entry><entry>carbonate granule</entry><entry>granule</entry><entry>anhydrous granule</entry></row><row><entry namest="1" nameend="7" align="center" rowsep="1" /></row></thead><tbody valign="top"><row><entry>more than 110 μm</entry><entry> 0%</entry><entry> 0%</entry><entry> 0%</entry><entry> 0%</entry><entry> 0%</entry><entry> 0%</entry></row><row><entry>500˜710 μm</entry><entry> 0%</entry><entry> 0%</entry><entry> 0%</entry><entry> 1%</entry><entry> 0%</entry><entry> 1%</entry></row><row><entry>350˜500 μm</entry><entry>16%</entry><entry>12%</entry><entry>14%</entry><entry>19%</entry><entry>12%</entry><entry>19%</entry></row><row><entry>250˜350 μm</entry><entry>51%</entry><entry>49%</entry><entry>48%</entry><entry>53%</entry><entry>48%</entry><entry>53%</entry></row><row><entry>105˜250 μm</entry><entry>22%</entry><entry>23%</entry><entry>22%</entry><entry>20%</entry><entry>22%</entry><entry>21%</entry></row><row><entry>less than 105 μm</entry><entry>11%</entry><entry>16%</entry><entry>16%</entry><entry> 7%</entry><entry>17%</entry><entry> 6%</entry></row><row><entry>total</entry><entry>100% </entry><entry>100% </entry><entry>100% </entry><entry>100% </entry><entry>100% </entry><entry>100% </entry></row><row><entry namest="1" nameend="7" align="center" rowsep="1" /></row></tbody></tgroup></table></tables>
[0932] In the mixed granules of sodium silicate aluminate granule—sodium lauryl sulfate granule, the content of sodium silicate aluminate was 78.96 w/w % and the content of sodium lauryl sulfate was 19.74 w/w %.
[0933] The content of sodium fatty acid in the obtained sodium fatty acid granules was 98.92 w/w %.
[0934] The content of sodium hydrogen carbonate in the obtained sodium hydrogen carbonate granules was 98.92 w/w %.
[0935] The content of fumaric acid in the obtained fumaric acid granules was 98.92 w/w %.
[0936] The content of anhydrous sodium sulphate in the obtained anhydrous sodium sulphate granules was 98.92 w/w %.
[0937] Thus prepared mixed granule of sodium silicate aluminate granules—sodium lauryl sulfate granules, sodium fatty acid granules, sodium hydrogen carbonate granules, fumaric acid granules and anhydrous sodium sulphate granules were blended (in this example sodium silicate aluminate granules, sodium lauryl sulfate granules, sodium fatty acid granules, sodium hydrogen carbonate granules, fumaric acid granules and anhydrous sodium sulphate granules were blended so as to be 4:1:2:2:2:2 at weight ratio.)
[0938] Then the blended material was mixed with a well-known mixer.
[0939] As shown in the table 18, when mixed granules of sodium silicate aluminate granules—sodium lauryl sulfate granules, sodium fatty acid granules, sodium hydrogen carbonate granules, fumaric acid granules and anhydrous sodium sulphate granules having almost the same particle size were used, it was found that mixed granules of sodium silicate aluminate granules—sodium lauryl sulfate granules, sodium fatty acid granules, sodium hydrogen carbonate granules, fumaric acid granules and anhydrous sodium sulphate granules were uniformly mixed spontaneously by the external force given by the mixer.
[0940] Thus obtained mixture of mixed granules of sodium silicate aluminate granules—sodium lauryl sulfate granules, sodium fatty acid granules, sodium hydrogen carbonate granules, fumaric acid granules and anhydrous sodium sulphate granules was tabletted by means of the external lubrication type tabletting machine S shown in FIG. 10.
[0941] An upper punch <b>31</b>, a lower punch <b>33</b> and a die <b>32</b> with 14 mm diameter were used for the rotary type tabletting machine <b>81</b>.
[0942] An upper punch <b>31</b> and a lower punch <b>33</b> with a flat molding surface were used.
[0943] The tabletting pressure was 2500 kg/punch and the weight per a tablet was controlled to be 658 mg±1 mg.
[0944] Sucrose esters of fatty acid (commercial item) was contained in the lubricant storage hopper <b>52</b> of the quantitative feeder <b>51</b> of the external lubrication type tabletting machine S.
[0945] A rotary cam <b>45</b> having a concavo-convex pattern suitable for dispersing sucrose esters of fatty acid (commercial item) in air was attached for a rotary axis of the rotary drive means (rotary drive means <b>41</b>M in FIG. 10) of the pulsating vibration air generation means <b>41</b> of the external lubrication type tabletting machine S.
[0946] Then, the mixture of sodium silicate aluminate granules, sodium lauryl sulfate granules, sodium fatty acid granules, sodium hydrogen carbonate granules, fumaric acid granules and anhydrous sodium sulphate granules was stored in a molding material storage hopper (not shown) connected to the feed shoe <b>36</b>.
[0947] Next, the air source <b>111</b> was driven at a fixed drive amount to rotate the rotary drive means (rotary drive means <b>41</b>M in FIG. 10) of the pulsating vibration air generation means <b>41</b>. The frequency of the positive pulsating vibration air generated from the pulsating vibration air generation means <b>41</b> wasn't completely defined, but it was selected from the range of 10 Hz to 40 Hz.
[0948] The supply amount of sucrose esters of fatty acid (commercial item) into the lubricant spray chamber (lubricant apply means) <b>91</b> was controlled by driving the light permeable type powder concentration measuring means <b>103</b>.
[0949] The supply amount of sucrose esters of fatty acid (commercial item) into the lubricant spray chamber (lubricant apply means) <b>91</b> wasn't completely defined. However, the amount was selected from the range of 200 mg/min. to 2000 mg/min.
[0950] Handling of the supply amount of sucrose esters of fatty acid (commercial item) into the lubricant spray chamber (lubricant apply means) <b>91</b> has been considered to be difficult when a steady flow air was used.
[0951] Then, the rotary type tabletting machine <b>81</b> was driven and at the same time the mixture was supplied from the feed shoe <b>36</b>. The mixture was compressed to produce a tablet by means of the upper punches <b>31</b> . . . on which a fixed amount of sucrose esters of fatty acid (Japanese Pharmacopoeia) was applied, the lower punches <b>33</b> . . . on which a fixed amount of sucrose esters of fatty acid (commercial item) was applied and the dies <b>32</b> . . . on which a fixed amount of sucrose esters of fatty acid (commercial item) was applied.
[0952] Analyzing thus obtained tablet, the drive amount of air source <b>111</b>, the drive amount of pulsating vibration air generation means <b>41</b> were appropriately controlled in such a manner that the applied amount of sucrose esters of fatty acid (commercial item) per a tablet became 0.7 mg±0.1 mg. Then the tablet (effevescent tablet ID) was produced in earnest.
[0953] The preparation of thus produced tablet (effevescent tablet ID) is shown in a table 19. <tables id="TABLE-US-00019" num="19"><table frame="none" colsep="0" rowsep="0"><tgroup align="left" colsep="0" rowsep="0" cols="3"><colspec colname="OFFSET" colwidth="21PT" align="left" /><colspec colname="1" colwidth="84PT" align="left" /><colspec colname="2" colwidth="112PT" align="center" /><thead><row><entry /><entry namest="OFFSET" nameend="2" align="center">TABLE 19</entry></row><row><entry /><entry /></row><row><entry /><entry namest="OFFSET" nameend="2" align="center" rowsep="1" /></row><row><entry /><entry>component</entry><entry>content</entry></row><row><entry /><entry namest="OFFSET" nameend="2" align="center" rowsep="1" /></row></thead><tbody valign="top"><row><entry /></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="4"><colspec colname="OFFSET" colwidth="21PT" align="left" /><colspec colname="1" colwidth="84PT" align="left" /><colspec colname="2" colwidth="49PT" align="right" /><colspec colname="3" colwidth="63PT" align="left" /><tbody valign="top"><row><entry /><entry>sodium silicate aluminate</entry><entry>200.0</entry><entry>mg</entry></row><row><entry /><entry>sodium lauryl sulfate</entry><entry>50.0</entry><entry>mg</entry></row><row><entry /><entry>sodium fatty acid</entry><entry>100.0</entry><entry>mg</entry></row><row><entry /><entry>sodium hydrogen carbonate</entry><entry>100.0</entry><entry>mg</entry></row><row><entry /><entry>fumaric acid</entry><entry>100.0</entry><entry>mg</entry></row><row><entry /><entry>anhydrous sodium sulphate</entry><entry>100.0</entry><entry>mg</entry></row><row><entry /><entry>polyvinyl alcohol</entry><entry>7.0</entry><entry>mg</entry></row><row><entry /><entry>macrogol 6000</entry><entry>0.7</entry><entry>mg</entry></row><row><entry /><entry>sucrose esters of fatty acid</entry><entry>0.7</entry><entry>mg</entry></row><row><entry /><entry>Total</entry><entry>658</entry><entry>mg/tablet</entry></row><row><entry /><entry namest="OFFSET" nameend="3" align="center" rowsep="1" /></row></tbody></tgroup></table></tables>
[0954] When water (8 litter) was put in a washing tab of a washing machine for house-use and thus produced tablet (effevescent tablet <b>1</b>D) was put therein, the tablet was rapidly foamed and dissolved to produce a washing water.
[0955] A test wherein the tablet (effevescent tablet <b>1</b>D) was stored under a room temperature in atmosphere for six months was executed. After six months the tablet wasn't observed to be dissolved by the moisture contained in atmosphere (sample=20 tablets).
[0956] From the above-mentioned results, it was found that the tablet (effevescent tablet for a washing detergent) has practicability like powdered or granular washing detergent. Further, because the tablet was a solid agent, a problem such that washing detergents was spilled out of the scoop to be scattered around the washing machine or it gets the user's hands or fingers dirty when it was fed in the tab of the washing machine has been solved.
[0957] For producing a practical effevescent tablet for a washing detergent, bleaching agents, protein splitting enzyme, perfumes or PH control agents may be added if necessary.
[0958] In this example, the effevescent tablet for a washing detergent including anhydrous sodium sulphate was shown. Anhydrous sodium sulphate was added as drying agents in order to prevent the effevescent tablet for washing detergent from foaming and disintegrating when the tablet sucks moisture in air during storage. It isn't necessarily added in the effevescent tablet for washing detergent.
[0959] In this example the mixed granules of sodium silicate aluminate granule and sodium lauryl sulfate granules were used. However, sodium silicate aluminate granules, sodium lauryl sulfate granules, sodium fatty acid granules, sodium hydrogen carbonate granules, fumaric acid granules and anhydrous sodium sulphate granules may be produced respectively and they may be mixed to be compressed with the upper punches <b>31</b> . . . on which a fixed amount of sucrose esters of fatty acid (Japanese Pharmacopoeia) was applied, the lower punches <b>33</b> . . . on which a fixed amount of sucrose esters of fatty acid (commercial item) was applied and the dies <b>32</b> . . . on which a fixed amount of sucrose esters of fatty acid (commercial item) was applied by means of the external lubrication type tabletting machine S.
EXPERIMENT EXAMPLE 7
[0960] Experiment example 7 shows one embodiment when an effevescent tablet for a bath agent was produced according to the present invention.
[0961] Sodium carbonate granules were used as granules of a main active ingredient (a surfactant) <b>2</b> . . . .
[0962] Sodium hydrogen carbonate granules were used as carbonate granules <b>3</b> . . . .
[0963] Fumaric acid granules were used as organic acid granules <b>4</b>.
[0964] Sodium carbonate powders (Japanese Pharmacopoeia) were granulated to produce sodium carbonate granules.
[0965] More specifically, sodium carbonate granules were produced as follows.
[0966] A fixed amount of sodium carbonate powders (commercial item) was contained in a granulation tank of a fluid bed granulation dryer. Heated dry air was supplied in the granulation tank so as to fluidize the sodium carbonate powders stored in the granulation tank and a binder solution was sprayed from a spray means provided in the granulation tank, thereby producing sodium carbonate granules.
[0967] Methylcellulose (Japanese Pharmacopoeia) was used as water-soluble high polymer and 3 w/w % methylcellulose solution was prepared and used as a binder solution.
[0968] Sodium hydrogen carbonate powders (Japanese Pharmacopoeia) were used to produce sodium hydrogen carbonate granules.
[0969] Sodium hydrogen carbonate granules were produced according to the following method.
[0970] A fixed amount of sodium hydrogen carbonate powders (commercial item) was contained in a granulation tank of a fluid bed granulation dryer. Heated dry air was supplied in the granulation tank so as to fluidize the sodium hydrogen carbonate powders stored in the granulation tank and a binder solution was sprayed from a spray means provided in the granulation tank, thereby producing sodium hydrogen carbonate granules.
[0971] A solution in which water-soluble high polymer was dissolved in water was used as a binder solution.
[0972] For granulating sodium hydrogen carbonate granules, the temperature and amount of the heated air supplied in the granulation tank of a fluid bed granulation dryer (Glatt Co., Ltd., WSG-type 5) and a spray amount per hour of the binder solution sprayed from the spray means were controlled in such a manner that the particle size of the sodium hydrogen carbonate granules became the same as that of sodium carbonate granules.
[0973] Fumaric acid granules were obtained by granulating fumaric acid powders (Japanese Pharmacopoeia).
[0974] Fumaric acid granules were produced according to the following method.
[0975] A fixed amount of fumaric acid powder (commercial item) was contained in a granulation tank of a well-known fluid bed granulation dryer. Heated dry air was supplied in the granulation tank so as to fluidize the fumaric acid powders stored in the granulation tank and a binder solution was sprayed from a spray means provided in the granulation tank, thereby producing fumaric acid granules.
[0976] A solution in which water-soluble high polymers were dissolved in water was used as a binder solution.
[0977] For granulating fumaric acid granules, the temperature and amount of the heated air supplied in the granulation tank of a fluid bed granulation dryer (Glatt Co., Ltd., WSG-type 5) and a spray amount per hour of the binder solution sprayed from the spray means were controlled in such a manner that the particle size of the fumaric acid granules became the same as that of sodium carbonate granule.
[0978] The particle size distribution of thus obtained sodium carbonate granules, sodium hydrogen carbonate granules and fumaric acid granules is shown in table 20. <tables id="TABLE-US-00020" num="20"><table frame="none" colsep="0" rowsep="0"><tgroup align="left" colsep="0" rowsep="0" cols="4"><colspec colname="1" colwidth="56PT" align="center" /><colspec colname="2" colwidth="56PT" align="center" /><colspec colname="3" colwidth="63PT" align="center" /><colspec colname="4" colwidth="42PT" align="center" /><thead><row><entry namest="1" nameend="4" align="center">TABLE 20</entry></row><row><entry /></row><row><entry namest="1" nameend="4" align="center" rowsep="1" /></row><row><entry /><entry>sodium carbonate</entry><entry>sodium hydrogen</entry><entry>fumaric acid</entry></row><row><entry>particle size</entry><entry>granules</entry><entry>carbonate granules</entry><entry>granules</entry></row><row><entry namest="1" nameend="4" align="center" rowsep="1" /></row></thead><tbody valign="top"><row><entry>more than 710 μm</entry><entry> 0%</entry><entry> 0%</entry><entry> 0%</entry></row><row><entry>500˜710 μm</entry><entry> 0%</entry><entry> 0%</entry><entry> 0%</entry></row><row><entry>350˜500 μm</entry><entry>18%</entry><entry>14%</entry><entry>20%</entry></row><row><entry>250˜350 μm</entry><entry>52%</entry><entry>51%</entry><entry>55%</entry></row><row><entry>105˜250 μm</entry><entry>20%</entry><entry>22%</entry><entry>20%</entry></row><row><entry>less than 105 μm</entry><entry>10%</entry><entry>13%</entry><entry> 5%</entry></row><row><entry>total</entry><entry>100% </entry><entry>100% </entry><entry>100% </entry></row><row><entry namest="1" nameend="4" align="center" rowsep="1" /></row></tbody></tgroup></table></tables>
[0979] In the mixed granule of sodium carbonate, the content of sodium carbonate was 99.01 w/w %. The content of sodium hydrogen carbonate in the obtained sodium hydrogen carbonate granules was 99.01 w/w %. The content of fumaric acid in the obtained fumaric acid granules was 99.01 w/w %.
[0980] Thus prepared sodium carbonate granules, sodium hydrogen carbonate granules and fumaric acid granules were blended (in this example sodium carbonate, sodium hydrogen carbonate and fumaric acid were blended so as to be 3:1:1 at weight ratio.)
[0981] Then the blended material was mixed with a well-known mixer.
[0982] As shown in the table 20, when sodium carbonate granules, sodium hydrogen carbonate granules and fumaric acid granules having almost the same particle size were used, it was found that those granules were uniformly mixed spontaneously by the external force given by the mixer.
[0983] Thus obtained mixture of sodium carbonate granules, sodium hydrogen carbonate granules and fumaric acid granules was tabletted by means of the external lubrication type tabletting machine S shown in FIG. 10.
[0984] An upper punch <b>31</b>, a lower punch <b>33</b> and a die <b>32</b> with 500 mm diameter were used for the rotary type tabletting machine <b>81</b>.
[0985] An upper punch <b>31</b> and a lower punch <b>33</b> with a flat molding surface were used.
[0986] The tabletting pressure was 5000 kg/punch and the weight per a tablet was controlled to be 51 g±0.1 g.
[0987] Sucrose esters of fatty acid (commercial item) was contained in the lubricant storage hopper <b>52</b> of the quantitative feeder <b>51</b> of the external lubrication type tabletting machine S.
[0988] A rotary cam <b>45</b> having a concavo-convex pattern suitable for dispersing sucrose esters of fatty acid in air was attached for a rotary axis of the rotary drive means (rotary drive means <b>41</b>M in FIG. 10) of the pulsating vibration air generation means <b>41</b> of the external lubrication type tabletting machine S.
[0989] Then, the mixture of the sodium carbonate granule, sodium hydrogen carbonate granules and fumaric acid granules and was stored in a molding material storage hopper (not shown) connected to the feed shoe <b>36</b>.
[0990] Next, the air source <b>111</b> was driven at a fixed drive amount to rotate the rotary drive means (rotary drive means <b>41</b>M) of the pulsating vibration air generation means <b>41</b>. The frequency of the positive pulsating vibration air generated from the pulsating vibration air generation means <b>41</b> wasn't completely defined, but it was selected from the range of 10 Hz to 40 Hz.
[0991] The supply amount of sucrose esters of fatty acid into the lubricant spray chamber (lubricant apply means) <b>91</b> was controlled by driving the light permeable type powder concentration measuring means <b>103</b>.
[0992] The supply amount of sucrose esters of fatty acid into the lubricant spray chamber (lubricant apply means) <b>91</b> isn't completely defined. However, the amount was selected from the range of 200 mg/min. to 2000 mg/min.
[0993] Then, the rotary type tabletting machine <b>81</b> was driven and at the same time the mixture was supplied from the feed shoe <b>36</b>. The mixture was compressed to produce a tablet by means of the upper punches <b>31</b> . . . on which a fixed amount of sucrose esters of fatty acid was applied, the lower punches <b>33</b> . . . on which a fixed amount of sucrose esters of fatty acid was applied and the dies <b>32</b> . . . on which a fixed amount of sucrose esters of fatty acid was applied.
[0994] Analyzing thus obtained tablet, the drive amount of air source <b>111</b>, the drive amount of pulsating vibration air generation means <b>41</b> were appropriately controlled in such a manner that the applied amount of sucrose esters of fatty acid per a tablet became 0.05±0.01 g. Then the tablet (effevescent tablet <b>1</b>D) was produced in earnest.
[0995] The preparation of thus produced tablet (effevescent tablet <b>1</b>D) is shown in a table 21. <tables id="TABLE-US-00021" num="21"><table frame="none" colsep="0" rowsep="0"><tgroup align="left" colsep="0" rowsep="0" cols="3"><colspec colname="OFFSET" colwidth="21PT" align="left" /><colspec colname="1" colwidth="84PT" align="left" /><colspec colname="2" colwidth="112PT" align="center" /><thead><row><entry /><entry namest="OFFSET" nameend="2" align="center">TABLE 21</entry></row><row><entry /><entry /></row><row><entry /><entry namest="OFFSET" nameend="2" align="center" rowsep="1" /></row><row><entry /><entry>component</entry><entry>content</entry></row><row><entry /><entry namest="OFFSET" nameend="2" align="center" rowsep="1" /></row></thead><tbody valign="top"><row><entry /></row></tbody></tgroup><tgroup align="left" colsep="0" rowsep="0" cols="4"><colspec colname="OFFSET" colwidth="21PT" align="left" /><colspec colname="1" colwidth="84PT" align="left" /><colspec colname="2" colwidth="49PT" align="right" /><colspec colname="3" colwidth="63PT" align="left" /><tbody valign="top"><row><entry /><entry>sodium carbonate</entry><entry>30.0</entry><entry>g</entry></row><row><entry /><entry>sodium hydrogen carbonate</entry><entry>10.0</entry><entry>g</entry></row><row><entry /><entry>fumaric acid</entry><entry>10.0</entry><entry>g</entry></row><row><entry /><entry>methylcellulose</entry><entry>0.5</entry><entry>g</entry></row><row><entry /><entry>sucrose esters of fatty acid</entry><entry>0.05</entry><entry>g</entry></row><row><entry /><entry>Total</entry><entry>51</entry><entry>g/tablet</entry></row><row><entry /><entry namest="OFFSET" nameend="3" align="center" rowsep="1" /></row></tbody></tgroup></table></tables>
COMPARISON EXAMPLE 3
[0996] A fixed amount of sucrose esters of fatty acid powders (commercial item) was added in the mixture of sodium carbonate granules, sodium hydrogen carbonate granules and fumaric acid granules and the blended material of sodium carbonate granules, sodium hydrogen carbonate granules, fumaric acid granules and sucrose esters of fatty acid powders (commercial item) was mixed with a well-known mixer.
[0997] The mixture including sucrose esters of fatty acid powders was compressed to produce a tablet without applying sucrose esters of fatty acid powders on each surface of the upper punches <b>31</b> . . . , the lower punches <b>33</b> . . . and the dies <b>32</b> . . . by means of the rotary type tabletting machine <b>81</b>.
[0998] 5.0 weight % of sucrose esters of fatty acid powders was required per a tablet in order to prevent the mixture including sucrose esters of fatty acid powders from adhering on the upper punches <b>31</b> . . . , the lower punches <b>33</b> . . . and the dies <b>32</b> . . . and to avoid tabletting problems such as sticking on the produced tablet.
[0999] Each of the tablet (effevescent tablet for a bath agent) obtained in the experiment example 7 and the tablet (effevescent tablet for a bath agent) obtained in the comparison example 3 was put in a bath tab containing 150 litters of hot water and the conditions of each water were observed visually after 10 minutes.
[1000] The hot water in which the tablet (effevescent tablet for a bath agent) obtained in the experiment example 7 was put was clear and didn't show an oil film on the surface. However, the hot water in which the tablet (effevescent tablet for a bath agent) obtained in the comparison example 3 was put was cloudy and showed an oil film on the surface.
[1001] From the above-mentioned results, it was found that the tablet (effevescent tablet for a bath agent) of the present invention didn't show an oil film on the surface.
[1002] For producing a practical effevescent tablet for a bath agent, disintegrater, disintegration supplements, stabilizers, perfumes or hot spring components may be added in necessary.
INDUSTRIAL APPLICABILITY
[1003] According to the effevescent tablet of the present invention, lubricants aren't contained in the mixture to be compressed with the die and the punch. Only a slight amount of lubricant powders applied on the die and the punch is transferred so as not to include lubricants in a tablet.
[1004] Therefore, when the tablet is dissolved in water for use, an oil film is hardly appeared on a solution surface.
[1005] On the other hand, according to the effevescent tablet of the present invention, lubricants aren't contained in the mixture to be compressed with the punch and the die, the effevescent tablet is rapidly dissolved while generating carbon dioxide (CO<sub>2</sub>) because water is easily permeated in the tablet in water.
[1006] According to the effevescent tablet of the present invention, the granules of a main active ingredient, the carbonate granules and the organic acid granules having almost the same diameter are used.
[1007] When the composition of the granules of a main active ingredient, the carbonate granules and the organic acid granules at a fixed ratio is mixed with a general mixer, the granules show the same behavior against the external force given by the mixer respectively so that they can be uniformly mixed spontaneously without being distributed unevenly.
[1008] When thus obtained mixture is mixed with a general tabletting machine, the granules show the same behavior against the external forces given by the tabletting machine respectively so that they aren't distributed unevenly.
[1009] Therefore, the disintegration time, the disintegration pattern and the dissolution time of tablets become uniform when a tablet is put in water for use because the granules of a main active ingredient, the carbonate granules and the organic acid granules are evenly dispersed in the effevescent tablet.
[1010] According to the effevescent tablet of the present invention, the granules of a main active ingredient, the composition rate of the granules of a main active ingredient, the carbonate granules and the organic acid granules are arranged in such a manner that the mixture presents a regular particle size distribution having one peak.
[1011] As the composition in which the granules of a main active ingredient, the carbonate granules and the organic acid granules are blended in a fixed ratio is mixed with a generally used mixer, it shows the same behavior as the case when one kind of powder material presenting a regular distribution with one peak against the external force given by the mixer. Therefore, the composition is uniformly mixed spontaneously without being distributed unevenly per each granule.
[1012] As a result, the granules of a main active ingredient, the carbonate granules and the organic acid granules are uniformly dispersed in the effevescent tablet so that there is no difference between the disintegration time, the disintegration pattern and the dissolution time of the tablets when tablets are put in water.
[1013] According to the effevescent tablet of the present invention, carbon dioxide component used in the tablet has been already established as a safe material and generally used. Therefore, such tablet has no problem in view of safety.
[1014] According to the effevescent tablet of the present invention, the organic acid which has been already established as a safe material, is easily obtainable and can decompose carbonate to generate carbon dioxide (CO<sub>2</sub>) getting in touch with water is used, therefore, the resulting effevescent tablet has no problem in view of safety.
[1015] According to the effevescent tablet of the present invention, each one of the granules of a main active ingredient, the carbonate granules and the organic acid granules are a granulated material produced with water-soluble polymer as a binder. Therefore, if the effevescent tablet is put in water for use, a binder forming each granule is dissolved in water so that each granule is easily dissolved into a particle level.
[1016] As a result, when the effevescent tablet is put in water, the contacting area of the active agent, the carbonate and the organic acid with water becomes large. Then a reaction is caused by the carbonate and the organic acid to be rapidly dissolved in water while generating carbon dioxide (CO<sub>2</sub>).
[1017] According to the effevescent tablet of the present invention, each one of the granules of a main active ingredient, the carbonate granules and the organic acid granules are granulated using a binder including a surfactant.
[1018] As a result, the effevescent tablet is constructed in such a manner that between the particles comprising the granules of a main active ingredient, between the particles comprising the carbonate granules and between the particles comprising the organic acid granules are combined with the binder including a surfactant. Therefore, when the effevescent tablet is put in water for use, the binder bonding the particles comprising each granule easily gets wet because of the surfactant contained therein so that the granules of a main active ingredient, the carbonate granules and the organic acid granules are easily decomposed into a particle unit.
[1019] Because the effevescent tablet is constructed in a manner that the granule components are rapidly decomposed into a particle unit when they get in contact with water, the dissolution speed in water is increased comparing with a conventional effevescent tablet.
[1020] According to the effevescent tablet for a bath agent of the present invention, sodium carbonate which has been already established as a safe material, are easily obtainable and can decompose carbonate to generate carbon dioxide (CO<sub>2</sub>) when they get in touch with water is used for the granules of a main active ingredient, therefore, the resulting effevescent tablet has no problem in view of safety.
[1021] According to the effevescent tablet for a washing detergent of the present invention, it is shaped as a tablet, therefore, if one tablet has the amount to be used at one time for putting in the tub of the washing machine, one tablet is merely put in the tub for washing clothes. Unlike conventional powdered or granular washing detergents, it can save the trouble of measuring with a scoop each time of putting the detergent in the washing tub, therefore, such a tabletted detergent is facilitated to be used comparing with the conventional powdered or granular washing detergent.
[1022] Further because of the tabletted shape of the effevescent tablet for a washing detergent, there isn't problem such that powdered or granular detergents are scattered around the washing machine or a person's hands or fingers get dirty with the detergent when the detergents are put in the washing tub.
[1023] According to the effevescent tablet for a washing detergent of the present invention, because anhydrous sodium sulphate with a hygroscopic property is included in the tablet, it is prevented from naturally foaming by the moisture contained in air while the tablet is stored. Namely, such an effevescent tablet is superior in storage stability.
[1024] According to the effevescent tablet for oral administration of the present invention, the granules of a main active ingredient including active agent, the carbonate granules and the organic acid granules are a granulated material produced by means of a binder including a saccharide with high wettability for water.
[1025] As a result, the effevescent tablet for oral administration is constructed in such a manner that between the particles comprising the granules of a main active ingredient, between the particles comprising the carbonate granules and between the particles comprising the organic acid granules are combined with the binder including a saccharide with high wettability for water. Therefore, when the effevescent tablet for administration is put in water for dosing, the binder bonding the particles comprising each granule easily gets wet because of the saccharide with high wettability for water contained therein so that the granules of a main active ingredient, the carbonate granules and the organic acid granules are easily decomposed into a particle unit.
[1026] Because the effevescent tablet is constructed in a manner that the granule components are rapidly decomposed into a particle unit when they get in contact with water, the dissolution speed in water is increased comparing with a conventional effevescent tablet.
[1027] According to the production method of the effevescent tablet of the present invention, lubricant powders are applied on each material contacting surface of a punch and a die which are used for compressing the mixture to produce a tablet and the mixture is compressed with the punch and the die on which material contacting surfaces are lubricated. Therefore no lubricant is required to be contained in the mixture.
[1028] The effevescent tablet is produced in such a manner no lubricant powders are included in the mixture or almost no lubricant powders are included therein, an oil film hardly floats on the solution surface if the tablet is dissolved in water for dosing.
[1029] If lubricants are contained in the mixture (molding material), water has difficulty to be permeated in the, tablet because of the water repellency of the lubricants when the effevescent tablet is put in water so that the dissolution speed of the tablet becomes slow. On the other hand, the effevescent tablet is produced according to the present invention wherein lubricant powders are applied on the material contacting surface of the punch and the die which are used for compressing a mixture to produce a tablet and the mixture is compressed with the lubricated punch and die. Therefore, even if lubricant powders aren't added in the mixture, the effevescent tablet can be produced without causing tabletting problems such as sticking and so on.
[1030] Hence, if such a production method of the effevescent tablet is used, the effevescent tablet without including lubricant powders therein or the effevescent tablet scarcely including lubricant powders can be produced. Therefore, according to the resulting effevescent tablet, water is rapidly permeated in the tablet so that the tablet is dissolved in water in a short time while generating carbon dioxide (CO<sub>2</sub>).
[1031] Comparing with the conventional effevescent tablet, the effevescent tablet obtained by the present production method has higher dissolving speed in water.
[1032] According to the production method of an effevescent tablet according to the present invention, the lubricant powders mixed with and dispersed in a positive pulsating vibration air is sprayed on the material contacting surfaces of the punch and the die. Therefore, a minimum amount of lubricant powders can be uniformly applied on the material contacting surfaces of the punch and the die by a function of the positive pulsating vibration air.
[1033] As a result of such a production method, an effevescent tablet can be continuously produced without causing tabletting problems such as sticking on the produced tablets and without causing grinding on the punch and the die during tabletting.
[1034] In other words, the production method can be preferably applied as a production method of an effevescent tablet which is industrially viable.
[1035] According to the production method of an effevescent tablet of the present invention, lubricant powders mixed with and dispersed in a positive pulsating vibration air are sprayed from the lubricant powder spray port for lower punch provided for the lubricant apply means on the material contacting surface (upper face) of the lower punch on which lubricant powders are apt to be easily accumulated by gravity, thereby extra lubricant powders on the material contacting surface (upper face) of the lower punch can be blown off by the positive pulsating vibration air.
[1036] Therefore, a minimum amount of lubricant powders can be uniformly applied on the material contacting surface (upper face) of the lower punch on which extra lubricant powders are easily applied by gravity.
[1037] The extra lubricant powders blown out of the material contacting surface (upper face) of the lower punch by the positive pulsating vibration air apply on the material contacting surface of the die. Then the extra lubricant powders on the material contacting surface of the die is fed to the slit-like lubricant powder spray port for upper punch provided for the lubricant apply means.
[1038] As the result, a minimum amount of lubricant powders can be uniformly applied on the material contacting surface (inner circumference) of the die.
[1039] Further according to the production method of an effevescent tablet, lubricant powders can be applied on the material contacting surface (lower face) of the upper punch on which lubricant powders are hardly applied by gravity taking enough time in such a manner that lubricant powders are sprayed from the slit-like lubricant spray port for upper punch into the direction of the material contacting surface (lower face) of the upper punch while the upper punch is moved from the initial end to the terminal end of the slit-like lubricant spray port for upper punch.
[1040] Thereby, necessary amount of lubricant powders can be applied on the material contacting surface (lower face) of the upper punch on which lubricant powders are hardly applied by gravity.
[1041] In other words, according to this production method of an effevescent tablet, the application method of lubricant powders on the material contacting surface (upper face) of the lower punch and that on the material contacting surface (lower face) of the upper punch are differed considering the gravity, thereby necessary amount of lubricant powders can be uniformly applied on the material contacting surface (upper face) of the lower punch and the material contacting surface (lower face) of the upper punch and necessary amount of lubricant powders can be also uniformly applied on the material contacting surface (inner circumference) of the die.
[1042] As a result of such a production method, an effevescent tablet can be continuously produced for a long time without causing tabletting problems such as sticking on the produced tablets and without causing grinding on the punch and the die during tabletting.
[1043] In other words, the production method can be preferably applied as an industrially viable production method of an effevescent tablet.
[1044] According to the production method of the effevescent tablet of the present invention, the granules of a main active ingredient, the carbonate granules and the organic acid granules which have almost the same diameter are used.
[1045] Therefore, when the composition of the granules of a main active ingredient, the carbonate granules and the organic acid granules at a fixed ratio is mixed with a general mixer, each granules show the same behavior against the external force given by the mixer so that each granule can be uniformly mixed spontaneously without being distributed unevenly.
[1046] Further, when thus obtained mixture is mixed with a general tabletting machine, each granule shows the same behavior against the external force given by the tabletting machine so that each granule isn't distributed unevenly.
[1047] Applying this production method, the effevescent tablet in which the granules of a main active ingredient, the carbonate granules and the organic acid granules are uniformly dispersed can be easily produced. Therefore, the required number of the effevescent tablet which has uniform disintegration time, disintegration pattern and dissolution time when the tablet is put in water for dosing can be easily produced depending on the user's needs.
[1048] According to the production method of an effevescent tablet of the present invention, the blended ratio of the granules of a main active ingredient, the carbonate granules and the organic acid granules is designed such that the mixture presents a regular particle size distribution with one peak after they are mixed.
[1049] As the composition in which the granules of a main active ingredient, the carbonate granules and the organic acid granules are blended in a fixed ratio is mixed with a general mixer, it shows the same behavior against the external force given by the mixer as the case when one kind of powder material presenting a regular distribution with one peak is mixed. Therefore, the composition is uniformly mixed spontaneously without being distributed unevenly per each granule.
[1050] Applying this production method, the effevescent tablet in which the granules of a main active ingredient, the carbonate granules and the organic acid granules are uniformly dispersed can be easily produced. Therefore, the required number of the effevescent tablet which has uniform disintegration time, disintegration pattern and dissolution time when the tablet is put in water for use can be easily produced depending on the user's needs.
[1051] According to the production method of an effevescent tablet of the present invention, components of which safety has been already established as carbon dioxide components of an effevescent tablet, which have been generally used and which has no problem in view of safety are used. Therefore, the effevescent tablet produced by this production method also has high reliability.
[1052] According to the production method of an effevescent tablet of the present invention, the organic acid granules have safety which has been already established, are easily obtainable and can decompose carbonate to generate carbon dioxide (CO<sub>2</sub>) when they get in touch with water, therefore, the resulting effevescent tablets using such components have no problem in view of safety.
[1053] According to the production method of an effevescent tablet of the present invention, the granulated material is produced by granulating the granules of a main active ingredient, the carbonate granules and the organic acid granules using water-soluble high polymer as a binder. Therefore, if the effevescent tablet is put in water for use, a binder forming each granule is easily dissolved in water so that each granule is rapidly dissolved into a particle level.
[1054] As a result, in the production method, when the effevescent tablet is put in water, the contacting area of the main active agent, the carbonate and the organic acid with water becomes large. Then a reaction is caused by the carbonate and the organic acid to be rapidly dissolved in water while generating carbon dioxide (CO<sub>2</sub>).
[1055] According to the production method of an effevescent tablet of the present invention, each one of the carbonate granules and the organic acid granules are granulated materials produced with a binder including a surfactant.
[1056] As a result, the effevescent tablet is constructed in such a manner that between the particles comprising the granules of a main active ingredient, between the particles comprising the carbonate granules and between the particles comprising the organic acid granules are combined with the binder including surfactant. Therefore, when the effevescent tablet is put in water for use, the binder bonding the particles comprising each granule easily gets wet because of the surfactant contained therein so that the granules of a main active ingredient, the carbonate granules and the organic acid granules are easily decomposed into a particle unit.
[1057] Because the effevescent tablet produced by this production method is constructed in a manner that the granule components are rapidly decomposed into a particle unit when they get in contact with water, the dissolution speed in water is increased comparing with a conventional effevescent tablet.
[1058] According to the production method of an effevescent tablet for a bath agent of the present invention, sodium carbonate which has been already established as safe component, are easily obtainable and can decompose carbonate to generate carbon dioxide (CO<sub>2</sub>) when they get in touch with water is used for the granules of a main active ingredient, therefore, the resulting effevescent tablet has no problem in view of safety.
[1059] According to the production method of an effevescent tablet for washing detergent of the present invention, the effevescent tablet for a washing detergent is shaped as a tablet, therefore, if one tablet has the amount to be used at one time for putting in the tub of the washing machine, one tablet is merely put in the tub for washing clothes. Unlike conventional powdered or granular washing detergents, it can save the trouble of measuring with a scoop each time of putting the detergents in the washing tub, therefore, such a tabletted detergent is facilitated to be used comparing with the conventional powdered or granular washing detergent.
[1060] Further in the production method, because of the tabletted shape of the effevescent tablet for a washing detergents, there isn't problem such that powdered or granular detergents are scattered around the washing machine or a person's hands or fingers get dirty with the detergents when the detergent are put in the washing tub.
[1061] According to the production method of an effevescent tablet for washing detergent of the present invention, because anhydrous sodium sulphate with a hygroscopic property is included in the tablet, it is prevented from naturally foaming by the moisture contained in air while the tablet is stored. Namely, such an effevescent tablet is superior in storage stability.
[1062] According to the production method of an effevescent tablet for oral administration of the present invention, the granulated material obtained by granulating granules of a main active ingredient, carbonate granules and organic acid granules using a binder including saccharide with high wettability for water are used.
[1063] As a result, the effevescent tablet for oral administration produced by this method is constructed in such a manner that between the particles comprising the granules of a main active ingredient, between the particles comprising the carbonate granules and between the particles comprising the organic acid granules are combined with the binder including a saccharide with high wettability for water. Therefore, when the effevescent tablet for oral administration is put in water for use, the binder bonding the particles comprising each granule easily gets wet because of the saccharide with high wettability for water contained therein so that the granules of a main active ingredient, the carbonate granules and the organic acid granules are easily decomposed into a particle unit.
[1064] Because the effevescent tablet for oral administration obtained by this method is constructed in a manner that the granule components are rapidly decomposed into a particle unit when they get in contact with water, the dissolution speed in water is increased comparing with a conventional effevescent tablet.
Contents16
28 sheets
Sheet 1 Sheet 2 Sheet 3 Sheet 4 Sheet 5 Sheet 6 Sheet 7 Sheet 8 Sheet 9 Sheet 10 Sheet 11 Sheet 12 Sheet 13 Sheet 14 Sheet 15 Sheet 16 Sheet 17 Sheet 18 Sheet 19 Sheet 20 Sheet 21 Sheet 22 Sheet 23 Sheet 24 Sheet 25 Sheet 26 Sheet 27 Sheet 28
Every citation, both ways
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| US10065866B2 | Cited by | United States of America | Applicant |
| US2009291038A1 | Cited by | United States of America | Pre-grant |
| US10807876B2 | Cited by | United States of America | Applicant |
| US2008313800A1 | Cited by | United States of America | Pre-grant |
| US2019099348A1 | Cited by | United States of America | Search report |
| US2015182426A1 | Cited by | United States of America | Pre-grant |
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| US2006014386A1 | Cited by | United States of America | Pre-grant |
| US2012190608A1 | Cited by | United States of America | Pre-grant |
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| US2999293A | Cites | United States of America | Pre-grant |
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| US4707309A | Cites | United States of America | Pre-grant |
| US4783331A | Cites | United States of America | Pre-grant |
| US5017122A | Cites | United States of America | Pre-grant |
| US5064656A | Cites | United States of America | Pre-grant |
| US5254355A | Cites | United States of America | Pre-grant |
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12 members in 9 offices
Priority claims6
| Document | Office | Kind | Date |
|---|---|---|---|
| 2000008349 | Japan | A | |
| 0100246 | Japan | W | |
| 20008349 | – | – | – |
| JP20000008349 | – | – | – |
| PCTJP0100246 | – | – | – |
| WO2001JP00246 | – | – | – |
Members12
| Document | Office | Kind | |
|---|---|---|---|
| CA2397490A1 | Canada | A1 | |
| WO0152820A1 | World Intellectual Property Organization (WIPO) | A1 | |
| AU2703801A | Australia | A | |
| KR20020068081A | Republic of Korea | A | |
| EP1260220A1 | European Patent Office (EPO) | A1 | |
| US2003194434A1 | United States of America | A1 | |
| EP1260220A4 | European Patent Office (EPO) | A4 | |
| EP1260220B1 | European Patent Office (EPO) | B1 | |
| AT450593T | Austria | T | |
| ATE450593T1 | Austria | T1 | |
| DE60140657D1 | Germany | D1 | |
| ES2336539T3 | Spain | T3 |
4 legal events, as the office reported them to INPADOC
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|---|---|---|
| AssignmentAS | AS | |
| Information on status: application discontinuationABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTIONSTCB | STCB | |
| AssignmentAS | AS | |
| AssignmentAS | AS |
Numbers
- Publication, DOCDB
- 2003194434
- Publication, EPODOC
- US2003194434
- Application
- 10181346
- Application, DOCDB
- 18134602
- Application, EPODOC
- US20020181346
Titles
- English
- Bubbling tablet, bubbling bath additive tablet, bubbling washing detergent tablet, bubbling tablet for oral administration, and process for producing these
Classification
- CPC, 12
- A61K8/02
- A61K9/0007
- A61K8/0216
- A61K2800/222
- A61Q11/00
- A61Q19/10
- B30B15/0011
- C11D3/0052
- C11D3/10
- C11D3/1233
- C11D3/2075
- C11D17/0073
- IPC, 13
- A61K8 02
- A61K9 46
- A61K47 02
- A61K47 12
- A61Q11 00
- A61Q19 10
- B30B11 00
- B30B11 08
- C11D3 00
- C11D3 10
- C11D3 12
- C11D3 20
- C11D17 00
- USPC, 2
- 424466000
- 264109000