Dispensing device and storage device for dispensing a formulation
12 claims: 3 independent, 9 dependent
- 1Storage device (4) for a preferably medical powder formulation (2), in particular containing or consisting of a drug, for a dry powder inhaler, the storage device (4) comprising a carrier (5) with multiple storage members (6), each storage member (6) comprising a storage cavity (9) containing a dose of the formulation (2), and a nozzle (11) for dispensing the respective dose in a dispensing direction (12), wherein the nozzle (11) is formed by a duct (10) which forms a channel from the storage chamber (9) to an outlet of the storage member (6), wherein the duct (10) is formed integrally with the storage chamber (9), and characterized in that the dispensing direction (12) of the nozzles (11) is directed in a lengthwise direction of the carrier (5), wherein the carrier (5) is band-like and in particular flexible.
- 4Storage device according to any one of claims 1 or 3, characterized in that the carrier (5) comprises a base layer (7) and a preferably peelable cover layer (8), wherein the storage members (6) are inserted or held between these layers (7, 8) before and/or during dispensing and/or the storage members (6) or nozzles (11) are sealed by one common sealing or cover layer (8).
- 8Dry powder inhaler for dispensing a preferably medical powder formulation (2), in particular containing or consisting of a drug, as a spray (3), wherein the inhaler comprises a storage device (4) according to any one of the preceding claims.
- 9Inhaler according to claim 9 characterized in that the storage device (4) or carrier (5) is a blister strip wherein the nozzles (11) can be opened one after the other by peeling, pushing, cracking, cutting, folding or bending the blister strip.
- 10Inhaler according to any one of claims 8 or 9, characterized in that the inhaler comprises an opening, connecting and/or supply means (14), in particular a piercing element (15), such as a needle, for opening or piercing the storage members (6) individually and/or supplying pressurized gas to the respective storage member (6) to dispense the respective dose.
- 11Inhaler according to any one of claims 8 to 10, characterized in that the inhaler comprises means for providing pressurized gas, in particular air, for dispensing the formulation (2), preferably wherein the inhaler comprises a preferably manually operated air pump (13) as means for providing pressurized gas.
Independent claims9
87 paragraphs, as filed
0001The present invention relates to a storage device for a preferably medical formulation, in particular containing or consisting of a drug or mixture of drugs, according to the preamble of claim 1, and to a dry powder inhaler for dispensing a preferably medical formulation comprising said storage device. Drugs delivered through dispensing devices, in particular inhalers, are intented to optimally target specific sites in the pulmonary system. These sites include the nasal passages, the throat, and various locations within the lungs, such as the bronchi, bronchioles and alveolar regions. The ability to deliver drugs to a target area depends inter alia on the aerodynamic sizes of the particles or droplets. As currently believed to be understood, particles having an aerodynamic diameter of less than 2 µm are considered to be potentially optimal for deposition in the alveolar region of the lung. Particles that have an aerodynamic diameter of between 2 and approximately 5 µm may be more suitable for delivery to the bronchiole or bronchi regions. Particles with an aerodynamic size range greater than 6 µm, and more preferably 10 µm, are typically suitable for delivery to the laryngeal region, throat or nasal passages.
0002In most cases, it is desired to achieve a high inhalable fraction and a high delivery efficiency, i.e. the fraction of the initial dose of drug that reaches the desired region, in particular in the lung. This depends on various factors, in particular on the characteristics of the generated spray plume, such as propagation velocity of the plume, particle size and its distribution, fraction of small particles, fraction of gas or the like. In the present invention, the desired spray plume characteristics include preferably a small particle size, a high fraction of drug particles with a diameter of 6 µm or less, a low propagation velocity and/or a long duration of spray generation and possible inhalation.
0003The present invention relates to the dispensing of a preferably medical formulation. The term "formulation" relates in particular to powder, but may include or relate to liquid as well. Consequently, the fine "particles" may be either solid or liquid. The term "liquid" has to be understood preferably in a broad sense covering inter alia solutions, suspensions, suslutions, mixtures thereof or the like. More particularly, the present invention relates to the dispensing of formulations for inhalation, such as medical formulations containing or consisting of at least one drug.
0004In the following, the description will focus mainly on powder formulations. However, the same applies for liquid formulations.
0005In particular, the present invention is concerned with dry powder inhalers for the delivery of drugs to the lungs. Many dry powder inhalers are on the market or have been proposed. There are two main types, namely the passive ones and the active ones. In passive inhalers all the energy required for de-agglomerating the powder and transferring the powder to the lungs is provided by the breathing of a user, respectively the patient. In active inhalers there is an additional source of energy to help to de-agglomerate the powder.
0006Most powder inhalers are of the passive type where the powder is inhaled by the patient without the aid of an additional energy source. The problem with passive inhalers is that the inhalable fraction, or the proportion of powder that actually enters the lungs, is largely dependent on the breathing of the patient. The de-agglomeration of the powder and hence the inhalable fraction is a function of the flow rate of inhaled air through the device and, therefore, varies greatly from patient to patient.
0007Dry powder inhalers are subdivided into single dose and multi-dose devices or inhalers. Multi-dose inhalers are further subdivided into pre-metered types where the doses are stored individually and into metering inhalers where each powder dose is metered in the device.
0008<patcit id="pcit0001" dnum="US2005158394A1"><text>US 2005/158394 A1</text></patcit> discloses different ways to store or obtain pre-metered doses in an inhaler. One disclosed embodiment comprises a pre-metered blister: Upon actuation, the blister strip is advanced by a gear mechanism. Therein a seal covering one blister is taken up by a first roller and an equal portion of a substrate base is taken up by a second roller, whereby a unit-dose of multiparticulates is dispensed.
0009<patcit id="pcit0002" dnum="WO0064779A"><text>WO 00/64779 A</text></patcit> discloses a carrier sheet having a first portion with a retainer for containment of product and a second portion foldable towards the retainer to form a cover therefor and a join between cover and retainer. In one embodiment the carrier comprises a second fold in the second portion to form a pull release tab which can be connected to a release mechanism incorporated within an inhalation device. Additionally, a carrier comprising a plurality of retainers is disclosed.
0010Multi dose pre-metered inhalers have the advantage that the single doses are metered under strict factory conditions and the powder can quite easily be isolated from the atmosphere. In many applications the active drug powder is mixed with a carrier such as lactose which tends to absorb humidity from the atmosphere which makes it stick together and difficult to de-agglomerate.
0011The present invention relates in particular to an active, gas (preferably air) powered, pre-metered multi-dose dispensing device for dispensing a formulation containing or consisting of a drug, such as a dry powder inhaler.
0012<patcit id="pcit0003" dnum="US4627432A"><text>US 4,627,432 A</text></patcit> discloses a device for administering medicaments to patients, namely an inhaler. The inhaler comprises a disk-like blister pack having a plurality of blister pockets arranged in a circle. Each blister pocket contains a dose of the powder. A plunger can open a blister pocket. When a blister is opened, the medicament can be withdrawn by a patient inhaling through a mouthpiece.
0013It is difficult to empty the respective blister pocket completely during a dispensing operation. Incomplete emptying results in decreased delivery efficiency. Some powder may be lost in the inhaler and not dispensed because the known solutions require relatively long paths for the powder until the powder reaches a nozzle and is actually dispensed. This might reduce the delivery efficiency further. In addition, de-agglomeration of the powder is difficult and the powder may block an outlet nozzle that is used for dispensing multiple doses one after the other.
0014<patcit id="pcit0004" dnum="EP1726324A1"><text>EP 1726324 A1</text></patcit> discloses a medicament container to be used with a housing which selectively controls airflow through the medicament container to entrain the medicament in receptacles within the medicament container. The medicament container comprises a bottom layer with the receptacles, a middle layer defining individual flow channels to each receptacle and an upper layer which is punctured to provide first and second openings to allow airflow to enter and exit.
0015<patcit id="pcit0005" dnum="EP1521609A2"><text>EP 1521609 A2</text></patcit> discloses an dry powder inhaler and an associated multi-dose dry powder package. The multi-dose dry powder package comprises piezoelectric polymer material defining walls of powder containing elongated channels. A metallic material is attached to selected portions of the piezoelectric polymer material in the vicinity of the channels. In operation, the channels can be selectively individually activated to vibrate upon exposure to an electrical input. The channels form a resonant chamber in which the powder is actively dispersed.
0016<patcit id="pcit0006" dnum="WO2006037636A2"><text>WO2006/037636 A2</text></patcit> discloses a dispensing device wherein pressurized gas is used for discharging powder. The device comprises a storage device with multiple storage chambers and associated ducts or nozzles, so that each dose of powder can be dispensed through a separate duct or nozzle. A bursting element for closing a storage chamber is disclosed, wherein the bursting element bursts when the pressure of the gas used for forcing the powder through the duct reaches or exceeds a peak value.
0017<patcit id="pcit0007" dnum="WO2007062721A1"><text>WO 2007/062721 A1</text></patcit> which forms the starting point of the present invention, discloses a dispensing device for dispensing a preferably medical formulation as a spray. The dispensing device is adapted to receive or comprises a storage device. The storage device comprises a carrier with multiple cavities. Each cavity comprises a moveable insert. Each insert comprises a storage chamber with a dose of the formulation, and a duct for dispensing the respective dose. The cavities are sealed. The sealings can be opened by pushing the respective insert through the associated sealing. Then, the respective dose is dispensed by pressurized air supplied to the insert.
0018Object of the present invention is to provide an improved dispensing device, and a storage device for dispensing a preferably medical formulation, in particular wherein a very simple design of the storage device and/or simple opening of the storage device can be achieved.
0019The above object is achieved by a storage device according to claim 1 . Preferred embodiments are subject of the subclaims.
0020According to a first aspect of the present invention, the dispensing direction of the ducts or nozzles of storage members located on a carrier is directed at least essentially in a lengthwise or indexing direction of the storage device or carrier. This allows in particular a very simple construction and/or opening.
0021According to a second aspect of the present invention, the storage device or carrier is a peelable blister strip, wherein the ducts or nozzles can be opened one after the other by peeling the blister strip. This allows a very simple construction and/or opening.
0022According to a third aspect of the present invention, the storage members are separate parts that are fixed on the carrier and cannot be moved relatively to the carrier. The storage members or its ducts or nozzles are closed by a preferably common sealing or cover layer. The storage members, ducts or nozzles can be opened one after the other by opening or peeling the sealing or cover layer. This allows a very simple construction and/or opening.
0023It has to be noted that each storage member preferably comprises an individual duct or nozzle for dispensing the respective dose. In particular, a spray is directly or only formed by or directly after the duct or nozzle. The duct or nozzle may dispense the generated spray in to a mouthpiece for inhalation by a user or patient. However, any further spray forming means is preferably not provided.
0024Further aspects, advantages and features of the present invention will be apparent from the claims and following detailed description of preferred embodiments. In the drawings show: <dl id="dl0001"><dt>Fig. 1</dt><dd>a schematic sectional view of a dispensing device with a storage device according to the present invention during dispensing;</dd><dt>Fig. 2</dt><dd>a top view of a part of the storage device with multiple storage members;</dd><dt>Fig. 3</dt><dd>a schematic sectional view of a part of the storage device with one storage member;</dd><dt>Fig. 4</dt><dd>a schematic sectional view of a part of the storage device according to an other embodiment;</dd><dt>Fig. 5</dt><dd>a schematic sectional view of a part of the storage device according to a further embodiment;</dd><dt>Fig. 6</dt><dd>a schematic sectional view of a part of the storage device according to still an other embodiment;</dd><dt>Fig. 7</dt><dd>a schematic sectional view of a part of the storage device shown in <figref idref="f0001">Fig. 1 to 3</figref> when pierced to discharge a formulation; and</dd><dt>Fig. 8</dt><dd>a sectional view perpendicular to <figref idref="f0003">Fig. 7</figref>.</dd></dl>
0025In the Fig., the same reference signs are used for same or similar components, wherein same or similar characteristics, features or advantages are or can be realized or achieved even if a repeated discussion is omitted. Further, the features and aspects of the different embodiments can be combined in any desired manner and/or used for other dispensing devices for dispensing in particular medical formulations for inhalation.
0026<figref idref="f0001">Fig. 1</figref> shows in a schematic sectional view - for illustration purposes not in scale - a dispensing device 1 according to the present invention. The dispensing device 1 is an active device, in particular gas powered. Here, the dispensing device 1 is a preferably oral or nasal inhaler, in particular a dry powder inhaler, for a user, respectively the patient (not shown).
0027The dispensing device 1 may be used for dispensing any formulation 2 as defined in the introductory part of the description. In particular, a medical formulation 2 or a formulation 2 for inhalation will be used. The formulation 2 preferably contains or consists of at least one drug. When the formulation 2 is dispensed, a spray 3 is generated as indicated in <figref idref="f0001">Fig. 1</figref>. The spray 3 includes fine particles (solid and/or liquid) of the formulation 2 and preferably has the desired spray plume characteristics.
0028The formulation 2 may be a powder or a liquid, in particular a solution, a suspension or any mixture thereof, i.e. a so-called suslution. Preferably, when different drugs are dispensed simultaneously, a suslution may be used. The principle of the suslution is based on that different drugs may be combined in one formulation simultaneously as a solution and as a suspension. In this respect, reference is made to <patcit id="pcit0008" dnum="EP1087750A1"><text>EP 1 087 750 A1</text></patcit>.
0029Preferably, the formulation 2 is a powder. The powder may be a pure drug or a mixture of at least two drugs. In addition, the powder may contain at least one other material, in particular a drug carrier such as lactose. In the following, the description focuses on powder as formulation 2. However, the description applies in a similar manner if a liquid formulation 2 is used. Preferably the mean diameter of the powder particles is about 2 to 7 µm, in particular 6 µm or less. This applies in particular if the powder does not contain any drug carrier such as lactose.
0030If the powder contains a drug carrier, such as lactose, and at least one drug, the powder 2 may have a particle size of 20 to 300 µm, in particular about 30 to 60 µm. However, the de-agglomeration, which will be described later in more detail, may result even in this case in a spray 3 with a smaller particle size, e.g. of about 10 to 50 µm, preferably of about 10 µm or less. In particular, the drug may be separated from the drug carrier during de-agglomeration so that primarily the drug will be inhaled due to its small particle size of about 2 to 6 µm and the larger drug carrier will be swallowed when using the dispensing device as an inhaler. Alternatively or additionally, breaking or opening of the drug carrier is possible during de-agglomeration.
0031The diameters mentioned above and below may be understood as mass medium aerodynamic diameters and/or may apply to the particle size or a fraction of the particles of the spray 3.
0032The dispensing device 1 is adapted to receive or comprises a storage device 4 for storing preferably multiple and pre-metered doses of the formulation 2. The storage device 4 may be integrated into the dispensing device 1 or form part of the dispensing device 1. Alternatively, the storage device 4 may be a separate part that can be inserted or connected with the dispensing device 1 and optionally replaced.
0033The storage device 4 comprises a carrier 5 with storage members 6, as shown also in the top view of <figref idref="f0001">Fig. 2</figref> of a part of the storage device 4. In particular, the carrier 5 may comprise 20 to 120, preferably 30 to 60 storage members 6. Each storage member 6 contains preferably one pre-metered dose of the formulation 2. However, each storage member 6 may also contain more than one formulation 2, i.e. different formulations 2. Additionally or alternatively, different storage members 6 may contain different formulations 2. In the present invention, "different" means in particular that the formulations 2 differ in at least one of the composition, the drug, the dose or amount, the concentration, and consistence of the formulation 2, e.g. liquid or dry or powder.
0034The storage device 4 or carrier 5 is preferably a blister strip.
0035In the present embodiment, the carrier 5 comprises or consists of a base layer 7 and a sealing or cover layer 8, as shown in <figref idref="f0001">Fig. 3</figref> representing a schematic sectional, longitudinal view of a part of the storage device 4 with one storage member 6.
0036In the present embodiment, the storage members 6 are preferably formed or made as separate parts. In particular, the storage members 6 are mounted or fixed on the carrier 5 or inserted or held between the two layers 7 and 8 before and/or during dispensing.
0037Before use or opening, the storage members 6 are sealed by the base layer 7 and/or cover layer 8. In the present embodiment, the base layer 7 is indented and/or follows the contour of the preferably bulky storage members 6. The storage members 6 preferably end at least essentially flat in the main plane of the base layer 7. The cover layer 8 is preferably flat and forms a sealing or cover so that the storage members 6 are sealed from each other and/or hermetically against the atmosphere.
0038The base layer 7 may be formed by any suitable material, in particular plastic or the like, most preferably by any suitable composite material.
0039The cover layer 8 may be formed by any suitable material, in particular aluminum foil, a plastic/AC composite, a composite foil or any other material suitable for humidity protection and/or gas tight sealing.
0040However, other constructions are possible. In particular, the base layer 7 may be flat and the cover layer 8 may be indented/embossed, or vice versa. Alternatively, both layers 7 and 8 may be indented and/or non-flat.
0041Alternatively or additionally, the layers 7 and 8 and/or other parts of the carrier 5 may form the storage members 6.
0042The storage device 4, carrier 5 or blister strip is preferably longitudinal and/or band-like.
0043In particular, the storage members 6 are located one after the other in a row and spaced in lengthwise or longitudinal direction of the storage device 4, carrier 5 or blister strip.
0044Preferably, each storage member 6 is made of foil, plastics, ceramics and/or composite material, in particular of thermoplastics or thermoplastic elastomers and for sealings of elastomers or silicone.
0045Each storage member 6 may form a preferably block-like unit and/or may be rigid. Alternatively, the storage members 6 may be flexible. In particular, each storage member 6 may be a unitary unit or consists of multiple elements. Each storage member 6 may be a molded element, a cartridge, a blister, a capsule, a container or the like.
0046In the following, a preferred construction of one storage member 6 is explained. Preferably, all storage members 6 are identical. However, it is also possible that all or some storage members 6 are different. For example, two or more groups of different storage members 6 can be provided. It is possible that one group has a different dose or different formulation 2 than the other group. For example, the storage members 6 of the different groups could be arranged alternately one after the other so that a patient or user may use for example each morning a storage member 6 of one group and each evening a storage member 6 of the other group.
0047Each storage member 6 comprises a storage chamber 9 for the formulation 2.
0048Each storage member 6 further comprises a duct 10 or the like for discharging the formulation 2 during the dispensing operation. The formulation 2 is dispensed through the duct 10 during the dispensing operation, in particular for de-agglomerating the powder and/or forming the spray 3.
0049The duct 10 can comprise or form a nozzle 11 preferably at the outlet. Alternatively, the nozzle 11 or any other suitable nozzle arrangement could be used instead of or in any other combination with duct 10.
0050Preferably, the duct 10 / nozzle 11 is formed integrally with the storage chamber 9 and/or by a base member of the storage member 6, in particular by a recess, grove or the like in the base member 11, and by an associated cover member of the storage member 6. In particular, the duct 10 forms a channel from the storage chamber 9 to an outlet of the storage member 6 for discharging the formulation 2 as spray 3 as shown in <figref idref="f0001">Fig. 1</figref>.
0051Preferably, the duct 10 / nozzle 11 dispenses the dose of formulation 2 of the respective storage member 6 in a dispensing direction as indicated by arrow 12 in <figref idref="f0001">Fig. 1</figref>.
0052Preferably, the dispensing direction 12, the duct 10 and/or the nozzles 11 are directed in a lengthwise or indexing direction of the storage device 4 / carrier 5 / blister strip. This allows a very simple and compact design of the dispensing device 1 and/or storage device 4.
0053Preferably, the storage members 6 / ducts 10 / nozzles 11 are opened one after the other - i.e. individually - by peeling or cracking or tearing the blister strip, in particular the cover layer 8 and/or base layer 7 or any part thereof, so that the respective doses of the formulation 2 can be dispensed one after the other.
0054Preferably, the formulation 2 is dispensed by gas pressure, in particular air pressure, generating a gas/air stream (active inhaler). However, it is also possible to dispense the formulations 2 by means of an air stream generated by breathing in of a user or patient (not passive inhaler).
0055In the present embodiment, the dispensing device 1 is active and uses pressurized gas to force the formulation 2 through the duct 10 / nozzle 11 to de-agglomerate the powder and/or to generate the spray 3. Preferably, the dispensing device 1 comprises a means for providing pressurized gas, in the present embodiment an air pump 13 which can preferably be actuated or operated manually. In particular, the air pump 13 comprises or is formed by a bellows. But, it could be also a piston-cylinder-arrangement. Instead of the air pump 13, the means for providing pressurized gas can be e.g. a capsule, container or the like containing pressurized or liquefied gas for powering the dispensing device 1, i.e. dispensing the formulation 2 as desired.
0056The air pump 13 may provide a gas pressure of less than 500 or 400 kPa, in particular about 50 to 200 kPa. This is preferably sufficient for operating the dispensing device 1. If liquefied gas or a container with pressurized gas is used, the gas pressures might range from 100 kPa to about 700 kPa. Then, the pressure may be reduced or throttled to the preferred pressure range before supplying the gas to the storage device 4, in particular the storage chamber 9 of the respective storage member 6.
0057Preferably, all pressure values mentioned in the present description are gauge pressures, i.e. pressure differences. All pressure values relate to the pressure in a gas storage such as a container with pressurized or liquefied gas or provided by air pump 13 or relate to the pressures acting in the storage chamber 9 and/or in the duct 10.
0058<figref idref="f0001">Fig. 1</figref> shows schematically that the dispensing device 1 comprises a mechanism 14 for connecting the storage members 6 individually to the gas supply, in particular to the air pump 13. The mechanism 14 comprises preferably a piercing element 15, such as a hollow needle, or any other suitable connecting element.
0059The connecting mechanism 14 is preferably designed such that it open 5 or pierces the storage chamber 9 of the storage members 6 that shall be emptied next. In particular, the piercing element 15 can penetrate the base layer 7 and/or cover layer 8 and the wall of the storage chamber 9 so that gas can be supplied into the storage chamber 9 to generate a gas stream which entrains the formulation 2 in the storage chamber 9 and dispenses the formulation 2 through the duct 10 / nozzle 11 and generates the spray 3 as schematically shown in <figref idref="f0001">Fig. 1</figref>.
0060Actuation and/or movement of the connecting mechanism 14 and/or piercing element 15 can be combined with the actuation of the means for pressurizing gas (air pump 13) or operated separately.
0061Preferably the storage chamber 9 forms a mixing chamber for mixing the gas with the powder. The chamber 9 is preferably designed such that the gas can generate swirls or eddies for better mixing the powder with the gas. Preferably, the chamber 9 is substantially circular in cross section, in particular cylindrical. However, other shapes are also possible.
0062Further, the chamber 9 is formed with no sharp edges, comers or the like, but has a smooth contour so that the gas can sweep all chamber surfaces to prevent powder accumulating on said surfaces and to ensure or allow complete discharge of the powder. In particular, the gas inlet formed by the piercing element 15 or any other supply element is located opposite and/or offset to the outlet, i.e. duct 10 and/or nozzle 11, with regard to the axial or outlet direction.
0063The duct 10 is preferably at least essentially tangentially connected to the storage chamber 9 in the embodiment. Preferably, the duct 10 is connected at one axial end of the preferably cylindrical chamber 9, and the gas inlet is inserted to the other axial end of the chamber 9. In particular, the gas inlet is connected tangentially to the storage chamber 10, such that swirls are generated in the chamber 9 with a swirl direction supporting discharge of the mixture of gas and formulation 2 through the duct 10 which connects preferably at least essentially tangentially to the rotational direction of the swirl.
0064During the dispensing operation, the spray 3 is preferably directly generated by the respective storage member 6 or its duct 10 / nozzle 11 and outputted into a mouthpiece 16 of the dispensing device 1 as shown in <figref idref="f0001">Fig. 1</figref> for inhalation by a patient or user (not shown).
0065The powder will be discharged - in particular forced through the duct 10 - preferably with a comparatively low gas pressure (preferably less than 300 kPa, in particular about 50 to 200 kPa). This low gas pressure which is preferably significantly lower than the gas pressures usually used in the prior dispensing devices enables a respectively low discharge velocity and, therefore, a low spray 3 with slow propagation velocity.
0066After dispensing one dose or for dispensing the next dose, the piercing element 15 will be withdrawn from the connected storage member 6. During this opposite movement or by a separate actuation or during the movement for connecting the next storage member 6 to the gas supply, the carrier 5 will be indexed one step further to the next storage member 6.
0067In the shown embodiment, the carrier 5, base layer 7 and/or cover layer 8 may be used to feed or index or move the storage device 4 from one storage member 6 to the next storage member 6.
0068In particular, the base layer 7 and/or cover layer 8 can be peeled or pulled, preferably in at least essentially opposite directions or in directions inclined to each other. The storage device 4 / carrier 5 and/or layers 7 or 8 may be guided by guide rollers 17 or any other suitable guiding elements and/or wound up/or folded by suitable mechanisms, in particular spooling devices 18 or the like.
0069Preferably, the pooling of the carrier 5 and/or of the base layer 7 and/or cover layer 8 is preferably the only drive to index the storage device 4 one step further or to the next storage member 6. However, other constructional solutions are possible as well.
0070The unused storage device 4 may be wound up in the dispensing device 1, e.g. together with the carrier 5, in particular base layer 7.
0071According to another (not shown) embodiment, the duct 10 can also be used as a reservoir (storage chamber 9) for the formulation 2. In this case, the separate storage chamber 9 is not required. Then, the duct 10 is designed to enable sufficient mixing of the gas with the formulation 2 and sufficient de-agglomeration of the powder formulation 2.
0072Preferably, the spray 3 has a mean velocity (taken 20 cm from the outlet 15 or mouthpiece 16) of less than 2 m/s, in particular less than 1 m/s. Preferably, the mean duration of the spray 3 is at least 0.2 or 0.3 s, in particular about 0.5 to 2 s.
0073In general, a secondary packaging may be used for packing and protecting the storage device 4 / carrier 5, in particular for storage purposes before storage membering the storage device 4 / carrier 5 into the dispensing device 1. Additionally the whole device 1 including storage device 4 / carrier 5 may be stored in a secondary water vapour proof packaging.
0074In general, the dispensing devise 1 may be breath activated, in particular wherein the formulation 2 is only released after the patient's or user's inhalation rate has reached a predetermined level, preferably by the use of a pressure sensitive means, such as a bursting element, membrane or valve, or any other mechanism.
0075In general, the storage member 6 will be preformed and/or formed separately before connected with or integrated into the carrier 5. Preferably, the storage members 6 are separately or individually sealed, in particular after filling and before integration into or connection with the carrier 5.
0076However, the storage member 6 can also be formed directly by the carrier 5. This is realized in the other embodiment shown in a schematic partial section of <figref idref="f0002">Fig. 4</figref>. Here, the storage members 6 are preferably formed by indenting and/or embossing the base layer 7 and/or cover layer 8.
0077It has to be noted that the storage members 6 could also be arranged on the carrier 5, if desired even without any (common) base layer 7 or cover layer 8.
0078In order to open the storage member 6, the base layer 7 and the cover layer 8 are preferably moved or guided or torn away from each other, in particular in opposite directions e.g. as shown in <figref idref="f0001">Fig. 1</figref> and <figref idref="f0002">4</figref>. However, the layers 7 and 8 could also be moved, guided and/or torn into the same direction as schematically shown in the further embodiment according to <figref idref="f0002">Fig. 5</figref>. Here, the duct 10 for discharging the formulation 2 may be opened by rupturing the base layer 7 or cover layer 8 and/or by bending, flexing or folding the carrier 5. In particular, this opening can also be achieved or supported by guiding the carrier 5 around a corner or roll with a very small radius such as one or two millimeters or less. The opening may also be supported or defined by a predetermined breaking point 19, preferably formed by weakening or perforating the material, in particular the layer 7 or 8, forming a chamfer indentation or notch or the like. This will result in a defined tracking or rupturing of the carrier 5, in particular of only one of the layers 7 and 8, at the desired point or portion.
0079<figref idref="f0002">Fig. 6</figref> shows in a partial sectional view of the opened carrier 5 that the breaking point 19 can also be used when the layers 7 and 8 are not moved in the same direction for opening the carrier 5 or the respective storage member 6 / duct 10.
0080<figref idref="f0003">Fig. 7 and 8</figref> show schematic sectional views of a part of the carrier 5 with pierced storage member 6 according to a preferred embodiment. <figref idref="f0003">Fig. 7</figref> is a view from above or below. <figref idref="f0003">Fig. 8</figref> is a sectional view perpendicular to <figref idref="f0003">Fig. 7</figref>.
0081The piercing element 15 ends preferably radially offset in the storage chamber 9 as shown in <figref idref="f0003">Fig. 7</figref>, and/or axially offset in the storage chamber 9 relative to the duct 10 as shown in <figref idref="f0003">Fig. 8</figref>. Thus, a swirl 20 can be generated in the storage chamber 9 as schematically shown in <figref idref="f0003">Fig. 7</figref> which entranced the formulation 2 (not shown) contained in the storage chamber 9 when gas/air is guided into the storage chamber 9 via the piercing element 15.
0082However, other constructional solutions are possible to achieve a suitable supply of gas/air into the storage member 6, in particular its storage chamber 9.
0083It has to be noted that the storage member 6 or its duct 10 may end essentially at or before the pending of the carrier 5 or its layers 7, 8 or may extend beyond this point as schematically shown in <figref idref="f0003">Fig. 8</figref>, in particular by the dashed lines.
0084Further, it has to be noted that the layers 7 and 8 may also be bent - in <figref idref="f0003">Fig. 8</figref> in opposite directions - at different points, i.e. offset in lengthwise direction of the carrier 5 as indicated by the dashed part of the base layer 7. Alternatively or additionally, the layers 7 and 8 may also be bent or folded with different diameters.
0085In general, each storage member 6 can comprise an individual cover to facilitate filling and/or individual sealing of the respective storage member 6.
List of reference numbers:
0086<dl id="dl0002" compact="compact"><dt>1</dt><dd>dispensing device</dd><dt>2</dt><dd>formulation</dd><dt>3</dt><dd>spray</dd><dt>4</dt><dd>storage device</dd><dt>5</dt><dd>carrier</dd><dt>6</dt><dd>storage member</dd><dt>7</dt><dd>base layer</dd><dt>8</dt><dd>cover layer</dd><dt>9</dt><dd>storage chamber</dd><dt>10</dt><dd>duct</dd><dt>11</dt><dd>nozzle</dd><dt>12</dt><dd>dispensing direction</dd><dt>13</dt><dd>air pump</dd><dt>14</dt><dd>connecting mechanism</dd><dt>15</dt><dd>piercing element</dd><dt>16</dt><dd>mouthpiece</dd><dt>17</dt><dd>guide roller</dd><dt>18</dt><dd>spooling device</dd><dt>19</dt><dd>breaking point</dd><dt>20</dt><dd>swirl</dd></dl>
3 sheets
Sheet 1 Sheet 2 Sheet 3
Every citation, both ways
| Document | Relation | Office | Cited during |
|---|---|---|---|
| EP0845253A2 | Cites | European Patent Office (EPO) | Examiner |
| EP1521609A2 | Cites | European Patent Office (EPO) | Examiner |
| EP1726324A | Cites | European Patent Office (EPO) | – |
| EP1795221A | Cites | European Patent Office (EPO) | – |
| EP0845253A2 | Cites | European Patent Office (EPO) | – |
| EP1521609A2 | Cites | European Patent Office (EPO) | – |
| WO0064779A | Cites | World Intellectual Property Organization (WIPO) | – |
| WO2006037636A2 | Cites | World Intellectual Property Organization (WIPO) | – |
| US6123068A | Cites | United States of America | – |
| US2005158394A1 | Cites | United States of America | – |
9 members in 4 offices
Priority claims9
| Document | Office | Kind | Date |
|---|---|---|---|
| 08000010 | European Patent Office (EPO) | A | |
| 08000010 | European Patent Office (EPO) | – | |
| 2008011112 | European Patent Office (EPO) | W | |
| 08866097 | European Patent Office (EPO) | A | |
| WO2008EP11112 | – | – | – |
| EP20080000010 | – | – | – |
| EP20080866097 | – | – | – |
| 08000010 | – | – | – |
| 2008011112 | – | – | – |
Members9
| Document | Office | Kind | |
|---|---|---|---|
| EP2077132A1 | European Patent Office (EPO) | A1 | |
| WO2009083244A2 | World Intellectual Property Organization (WIPO) | A2 | |
| WO2009083244A3 | World Intellectual Property Organization (WIPO) | A3 | |
| EP2231237A2 | European Patent Office (EPO) | A2 | |
| JP2011508641A | Japan | A | |
| US2011277753A1 | United States of America | A1 | |
| JP5441919B2 | Japan | B2 | |
| EP2231237B1This record | European Patent Office (EPO) | B1 | |
| US10124129B2 | United States of America | B2 |
67 legal events, as 9 offices reported them to INPADOC
Over the term
Point at a mark for the eventEvents
| Event | Code | Office | |
|---|---|---|---|
| Annual fee paid to national office [announced via postgrant information from national office to epo]GrantedPGFP | PGFP | EP | |
| Annual fee paid to national office [announced via postgrant information from national office to epo]GrantedPGFP | PGFP | EP | |
| Annual fee paid to national office [announced via postgrant information from national office to epo]GrantedPGFP | PGFP | EP | |
| Annual fee paid to national office [announced via postgrant information from national office to epo]GrantedPGFP | PGFP | EP | |
| Annual fee paid to national office [announced via postgrant information from national office to epo]GrantedPGFP | PGFP | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Fee paymentPLFP | PLFP | FR | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| No opposition filedOpposition26N | 26N | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| No opposition filed within time limitOppositionORIGINAL CODE: 0009261PLBE | PLBE | EP | |
| Information on the status of an ep patent application or granted ep patentGrantedSTATUS: NO OPPOSITION FILED WITHIN TIME LIMITSTAA | STAA | EP | |
| Patent lapsedLapsedMM4A | MM4A | IE | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| No opposition filed against granted patent, or epo opposition proceedings concluded without decisionGrantedR097 | R097 | DE | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Patent ceasedCeasedPL | PL | CH | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Deletion acc. to par. 5 (withdrawal of the translation of the ep patent)MK05 | MK05 | AT | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Patent invalid in the netherlands as no translation has been filedMP | MP | NL | |
| Invalidated european patentMG4D | MG4D | LT | |
| Lapsed in a contracting state [announced via postgrant information from national office to epo]LapsedPG25 | PG25 | EP | |
| Dpma publication of mentioned ep patent grantGrantedR096 | R096 | DE | |
| Reference to at number (ep patent validated in austria)REF | REF | AT | |
| European patents granted designating irelandGrantedFG4D | FG4D | IE | |
| European patent takes effect as a national patent in ch/liEP | EP | CH | |
| Fee paymentPLFP | PLFP | FR | |
| Designated contracting statesAK | AK | EP | |
| European patent grantedGrantedFG4D | FG4D | GB | |
| (expected) grantORIGINAL CODE: 0009210GRAA | GRAA | EP | |
| Grant fee paidORIGINAL CODE: EPIDOSNIGR3GRAS | GRAS | EP | |
| Intention to grant announcedINTG | INTG | EP | |
| Despatch of communication of intention to grant a patentORIGINAL CODE: EPIDOSNIGR1GRAP | GRAP | EP | |
| Information provided on ipc code assigned before grantRIC1 | RIC1 | EP | |
| Information provided on ipc code assigned before grantRIC1 | RIC1 | EP | |
| Amendment of ipc main classPREVIOUS MAIN CLASS: A61M0015000000R079 | R079 | DE | |
| First examination report despatched17Q | 17Q | EP | |
| Request for extension of the european patent (deleted)DAX | DAX | EP | |
| Request for examination filed17P | 17P | EP | |
| Designated contracting statesAK | AK | EP | |
| Request for extension of the european patentAX | AX | EP | |
| Public reference made under article 153(3) epc to a published international application that has entered the european phaseORIGINAL CODE: 0009012PUAI | PUAI | EP |
Numbers
- Publication
- 2231237
- Publication, DOCDB
- 2231237
- Publication, EPODOC
- EP2231237
- Application
- 8866097
- Application, DOCDB
- 08866097
- Application, EPODOC
- EP20080866097
Titles3
- German
- Abgabevorrichtung und Aufbewahrungsvorrichtung zur Abgabe einer Formulierung
- English
- DISPENSING DEVICE AND STORAGE DEVICE FOR DISPENSING A FORMULATION
- French
- Dispositif distributeur et dispositif de stockage pour la distribution d'une formulation
Classification
- CPC, 9
- A61M15/0045
- A61M11/001
- A61M15/0031
- A61M15/0043
- A61M15/0051
- A61M15/0061
- A61M2202/064
- A61M2205/07
- A61M2205/071
- IPC, 2
- A61M11 00
- A61M15 00
Designated states34
- Contracting states, 34
- Austria
- Belgium
- Bulgaria
- Switzerland
- Cyprus
- Czechia
- Germany
- Denmark
- Estonia
- Spain
- Finland
- France
- United Kingdom
- Greece
- Croatia
- Hungary
- Ireland
- Iceland
- Italy
- Liechtenstein
- Lithuania
- Luxembourg
- Latvia
- Monaco
and 10 moreShow fewer
- Malta
- Netherlands (Kingdom of the)
- Norway
- Poland
- Portugal
- Romania
- Sweden
- Slovenia
- Slovakia
- Türkiye
