A dispenser

Field of the Invention

0001The present invention relates to a dispenser for dispensing a metered volume of a fluid product and is particularly, but not exclusively, concerned with a dispenser for dispensing a metered volume of a fluid medicament, for instance medicaments having liquid, gaseous, powder or topical (cream, paste etc.) formulations. The invention also has application in the area of consumer healthcare.

Background of the Invention

0002Fluid product dispensers having metering mechanisms are known in the art. As an example, in the medical field the use of metered dose inhalers (MDIs) is well established. In a MDI, the fluid product is contained under pressure in a canister having an open end closed off by a valve mechanism. The valve mechanism has a valve body which defines a fixed volume metering chamber through which a valve stem is sealingly slidable between filling and discharging positions. In the filling position, the valve stem places the metering chamber in fluid communication with the canister contents, but isolates the metering chamber from the external environment Conversely, when the valve stem is moved to the discharge position, the metering chamber is placed in fluid communication with the external environment, but isolated from the canister contents. In this way, a metered volume of fluid product is sequentially transferred to the metering chamber and then discharged to the external environment for inhalation by a patient.

0003<patcit id="pcit0001" dnum="DE10017438A"><text>DE-A-10017438</text></patcit> discloses various embodiments of a cream dispenser having a dispenser head mounted on a container unit so that the respective axes are oriented orthogonally. The container unit defines an internal chamber which contains the cream to be dispensed. A channel fluidly connects the container internal chamber to a pumping chamber defined in the dispensing head. In the dispensing head there is a plunger which is sealingly slidable along the dispensing head axis for reciprocation in the pumping chamber. An outlet valve is positioned at an outlet of the pumping chamber. In operation, the user pushes the plunger into the pumping chamber to pump any cream in the pumping chamber out of the dispenser through the outlet valve.

0004There is disclosed a dosing pump in <patcit id="pcit0002" dnum="WO02068317A"><text>WO-A-02/068317</text></patcit>, which is only state o the art pursuant to Article 54(3) EPC.

0005The present invention provides a dispenser for a fluid product having a novel dispensing mechanism.

Summary of the Invention

0006According to the present invention there is a provided an intranasal dispenser for dispensing a metered volume of a fluid product according to claim 1.

0007Preferred features of the invention are set forth in the subordinate claims appended hereto, as well as in the exemplary embodiment hereinafter to be described.

Brief Description of the Drawings

0008The FIGURES of drawings are schematic, partial cross-sectional views of a dispenser according to the present invention in which:- <ul id="ul0001" list-style="none"><li><figref idref="f0001">FIGURE 1</figref> shows the dispenser in a rest mode;</li><li><figref idref="f0002">FIGURE 2</figref> shows the dispenser in a filling mode of operation; and</li><li><figref idref="f0003 f0004 f0005">FIGURES 3 to 5</figref> show the dispenser in various stages of a dispensing mode of operation.</li></ul>

Description of the Exemplary Embodiment of the Invention

0009In the FIGURES a hand-held, hand-operable dispenser 1 according to the present invention is shown. The dispenser 1 is a medicament dispenser, here an intranasal delivery device.

0010The dispenser 1 has a housing 2 which houses a container member 3 comprising a tubular body 5 in which an end wall 7 is sealingly slidable. The inner surfaces of the tubular body 5 and end wall 7 define a storage chamber 9 in which the fluid product 10 to be dispensed, a medicament, is contained. The tubular body 5 has a port 11 at its end opposite to that which receives the sliding end wall 7.

0011The dispenser 1 further comprises a metering member 13 having a tubular body 15 and an end wall 17 which is sealingly slidable in the tubular body 15. As can be seen from <figref idref="f0002">FIGURE 2</figref>, for example, a metering chamber 19 is defined between the inner surfaces of the tubular body 15 and the end wall 17. As will be described in more detail hereinafter, the metering chamber 19 operates to provide a metered volume of the fluid product 10 for discharge from the dispenser 1.

0012In a side of the tubular body 15 of the metering member 13 there is provided a port 20 which registers with the port 11 of the container member 3 thereby placing the storage and metering chambers 9, 19 in fluid communication with one another whereby the fluid product 10 can be transferred from the storage chamber 9 to the metering chamber 19 for subsequent discharge from the dispenser 1.

0013The metering chamber 19 communicates with an outlet orifice 21 of a spray head 23, which is shaped and sized for insertion into a user's nostril. The tubular body 15 of the metering member 13 includes an extension 25 through which a narrow channel 27 extends to connect the outlet orifice 21 to the metering chamber 19. The channel 27 has a branched end 29 so as to form an annular outlet port 31 in the outlet orifice 21. The spray head 23 further includes a skirt member 33 mounted on the tubular body 15 about the extension 25 which acts_to focus the spray stream discharged through the annular outlet port 31.

0014The end wall 17 of the metering member 13 forums the head of a spring-loaded plunger member 35 of a hand-operable actuating mechanism of the dispenser 1. The plunger member 35 further has an arm 37 on which a spring 44 acts to bias the plunger member 35 to the rest or return position shown in <figref idref="f0001">FIGURE 1</figref>. The arm 37 is operatively connected to a trigger member 39 of the actuating mechanism, the trigger member 39 having a grip or button 40 for a user of the dispenser 1 to grip with a hand, or press with a finger or thumb, to operate the actuating mechanism. The trigger member 39 is mounted for sliding movement in the dispenser 1 in a direction transverse to the direction of sliding movement of the plunger member 35. In this connection, the dispenser 1 has guides 36 for guiding the sliding movement of the trigger member 39. Moreover, the trigger member 39 is spring-loaded with a spring 38 which biases the trigger member 39 to its extended position shown in <figref idref="f0001">FIGURE 1</figref>.

0015As will be understood from <figref idref="f0002">FIGURE 2</figref>, the trigger member 39 has a camming surface 41 which, when the trigger member 39 is moved inwardly (arrow A), acts on a cam follower 42 provided on the arm 37 of the plunger member 35 so as to displace the plunger member 35 rearwardly (arrow B) to a primed position, as shown. This is the filling mode of the dispenser 1 in the sense that rearward movement of the plunger member 35 causes a pressure difference between the metering chamber 19 and the storage chamber 9 which causes the end wall 7 of the container member 3 to be displaced inwardly (arrow C) thereby pushing fluid product 10 from the storage chamber 9 into the metering chamber 19 for filling thereof.

0016A non-return valve 43 is mounted at the outlet orifice 21 about the extension 25 of the tubular body 15 of the metering member 13. The non-return valve 43 is in the form of a sleeve member. The negative pressure created in the metering chamber 19 as the plunger member 35 is retracted from the rest position shown in <figref idref="f0001">FIGURE 1</figref> causes the valve 43 to be biased to a closed position in which it seals off the annular outlet port 31.

0017Referring to <figref idref="f0003 f0004 f0005">FIGURES 3 to 5</figref>, once the dispenser 1 has been primed, by inward movement of the trigger member 39 causing retraction of the plunger member 35 to the rearwardmost primed position and compression of the springs 38,44, the dispenser 1 can be actuated by releasing the inward force on the trigger member 39. This releases the loading on the spring 38 allowing it to drive the trigger member 39 outwardly (arrow D) whereupon the plunger member 35 is released from capture by the trigger member 39 and driven forwardly by the spring member 44 (arrow E). This is the discharge mode of the dispenser 1.

0018The initial stage or phase of the discharge mode is shown in <figref idref="f0003">FIGURE 3</figref>. In this initial stage, the forward movement of the plunger member 35 pushes surplus fluid product 10 received in the metering chamber 19 in the filling mode back into the storage chamber 9 through the communicating ports 11, 20. In this regard, the bleeding of the surplus fluid product is accommodated by outward sliding movement of the end wall 7 of the container member 3 (arrow F) responsive to the increase in pressure in the storage chamber 9 as the surplus fluid product is received therein.

0019As will be understood from <figref idref="f0004">FIGURE 4</figref>, as the plunger member 35 is slid forwardly it reaches an intermediate position at which the plunger head 17 closes off the port 20 thereby sealing the metering chamber 19 from the storage chamber 9. The end wall 7 of the container member 3 is adapted to move outwardly at a lower pressure than the valve 43 thereby ensuring that during movement of the plunger member 35 from its rearwardmost primed position to the intermediate position surplus fluid product is transferred back to the storage chamber 9, not discharged from the outlet orifice 21.

0020At the intermediate position in the discharge mode of the dispenser 1, shown in <figref idref="f0004">FIGURE 4</figref>, the metering chamber 19 defines a predetermined volume filled with the fluid product 10. This is the "metered volume" of fluid product to be dispensed by the dispenser 1.

0021As shown in <figref idref="f0005">FIGURE 5</figref>, onward forward movement of the plunger member 35 forces open the valve 43 and causes discharge of the metered volume of the fluid product from the annular outlet port 31 of the outlet orifice 21. The narrow dimensions of the channel 27 and annular outlet port 31 cause the discharged fluid product to be in the form of a spray stream if liquid is being dispensed.

0022Once the spring member 44 has returned the plunger member 35 to its forwardmost rest position, the pressure pulse which caused the valve 43 to open subsides whereby an inherent bias in the material of the valve 43 biases it back to its closed position over the annular outlet port 31.

0023As shown in <figref idref="f0001">FIGURES 1</figref> and <figref idref="f0005">5</figref>, the plunger head 17 has a front face 51 which sealingly closes the channel 27 to the outlet orifice 21 when the plunger member 35 is in the rest position. Moreover, in this embodiment, the front face 51 is of complementary shape to the front section 53 of the metering chamber 19 in which the channel 27 opens. In other words, the front face 51 sealingly engages the front section 53.

0024As will be seen from <figref idref="f0004">FIGURE 4</figref>, the plunger head 17 has a thickness t which is such that it maintains the port 20 in a closed state as it moves from the intermediate position to the forwardmost position. In this manner, fluid product 10 in the storage chamber 9 is unable to be transferred behind the plunger member 35, nor is fluid product 10 able to drain back from the metering chamber 19 to the storage chamber 9.

0025It will therefore be understood that a sealed system is achieved since the storage chamber 9 is sealed from the external environment about the dispenser 1.

0026After the metered volume has been dispensed, the dispenser 1 is left in the rest mode shown in <figref idref="f0001">FIGURE 1</figref> until such time as another metered volume is required to be dosed.

0027To refill the metering chamber 19, the trigger member 39 is re-engaged with the plunger member 35 so as to cam the plunger member 35 rearwardly. After the plunger member 35 has passed the intermediate position on its rearward travel, the port 20 is opened whereby the fluid product 10 can be transferred from the storage chamber 9 to the metering chamber 19 in the manner previously described preparatory to dispensing a further metered volume of the fluid product. After each actuation cycle, the volume of the storage chamber 9 decreases commensurate with the diminution of the volume of fluid product, i.e. by the metered volume. This is because during the initial phase of a discharge mode, the end wall 7 of the container member 3 is pushed back to a position closer to the port 11 than that at the start of the filling mode.

0028The dispenser 1 provides for high accuracy dosing from a sealed system which protects the fluid product 10 from contamination from the external environment. For instance, the non-return valve 43 prevents air ingress. Moreover, the storage chamber 9 is isolated from the outlet orifice 21 during the rest, filling and discharge modes, initially by the valve 43, then latterly by the plunger head 17. Accordingly, the fluid product 10 can be preservative-free, of particular benefit when the fluid product is a medicament.

0029The dispenser 1 further dispenses without the need for a dip tube, and gives no drain back.

0030Administration of the medicament by the dispenser of the invention may be indicated for the treatment of mild, moderate or severe acute or chronic symptoms or for prophylactic treatment.

0031Appropriate medicaments may thus be selected from, for example, analgesics, e.g., codeine, dihydromorphine, ergotamine, fentanyl or morphine; anginal preparations, e.g., diltiazem; antiallergics, e.g., cromoglycate (e.g. as the sodium salt), ketotifen or nedocromil (e.g. as the sodium salt); antiinfectives e.g., cephalosporins, penicillins, streptomycin, sulphonamides, tetracyclines and pentamidine; antihistamines, e.g., methapyrilene; anti- inflammatories, e.g., beclomethasone (e.g. as the dipropionate ester), fluticasone (e.g. as the propionate ester), flunisolide, budesonide, rofleponide, mometasone (e.g. as the furoate ester), ciclesonide, triamcinolone (e.g. as the acetonide), 6α, 9α-difluoro 11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxy-androsta-1,4-diene-17β-carbothioic acid S-(2-oxo-tetrahydro-furan4-yl) ester of 6α, 9α-Difluoro-17α-[(2-furanylcarbonyl)oxy]-11β-hydroxy-16α-methyl-3-oxo-androsta-1,4-diene-17β-carbothioic acid S-fluoromethyl ester; antitussives, e.g., noscapine; bronchodilators, e.g., albuterol (e.g. as free base or sulphate), salmeterol (e.g. as xinafoate), ephedrine, adrenaline, fenoterol (e.g. as hydrobromide), formoterol (e.g. as fumarate), isoprenaline, metaproterenol, phenylephrine, phenylpropanolamine, pirbuterol (e.g. as acetate), reproterol (e.g. as hydrochloride), rimiterol, terbutaline (e.g. as sulphate), isoetharine, tulobuterol or 4-hydroxy-7-[2-[[2-[[3-(2-phenylethoxy)propyl]sulfonyl]ethyl]amino]ethyl-2(3H)-benzothiazolone; PDE4 inhibitors e.g. cilomilast or roflumilast; leukotriene antagonists e.g. montelukast, pranlukast and zafirlukast; [adenosine 2a agonists, e.g. 2R,3R,4S,5R)-2-[6-Amino-2-(1S-hydroxymethyl-2-phenyl-ethylamino)-purin-9-yl]-5-(2-ethyl-2H-tetrazol-5-yl)-tetrahydro-furan-3,4-diol (e.g. as maleate)]; [α4 integrin inhibitors e.g. (2S)-3-[4-({[4-(aminocarbonyl)-1-piperidinyl]carbonyl}oxy)phenyl]-2-[((2S)-4-methyl-2-{[2-(2-methylphenoxy) acetyl]amino}pentanoyl)amino] propanoic acid (e.g. as free acid or potassium salt)], diuretics, e.g., amiloride; anticholinergics, e.g., ipratropium (e.g. as bromide), tiotropium, atropine or oxitropium; hormones, e.g., cortisone, hydrocortisone or prednisolone; xanthines, e.g., aminophylline, choline theophyllinate, lysine theophyllinate or theophylline; therapeutic proteins and peptides, e.g., insulin or glucagons. It will be clear to a person skilled in the art that, where appropriate, the medicaments may be used in the form of salts, (e.g., as alkali metal or amine salts or as acid addition salts) or as esters (e.g., lower alkyl esters) or as solvates (e.g., hydrates) to optimise the activity and/or stability of the medicament and/or to minimise the solubility of the medicament in the propellant.

0032Preferably, the medicament is an anti-inflammatory compound for the treatment of inflammatory disorders or diseases such as rhinitis.

0033The medicament may be a glucocorticoid compound, which has anti-inflammatory properties. One suitable glucocorticoid compound has the chemical name: 6α, 9α-Difluoro-17α-(1-oxopropoxy)-11β-hydroxy-16α-methyl-3-oxo androsta-1,4-diene-17β-carbothioic acid S-fluoromethyl ester (fluticasone propionate). Another suitable glucocorticoid compound has the chemical name: 6α, 9α-difluoro-17α-[(2-furanylcarbonyl)oxy]-11β-hydroxy-16α-methyl-3-oxo-androsta-1,4-diene-17β-carbothioic acid S-fluoromethyl ester. A further suitable glucocorticoid compound has the chemical name: 6α,9α-Difluoro-11β-hydroxy 16α-methyl-17α-[(4-methyl-1,3-thiazole-5-carbonyl)oxy]-3-oxo-androsta-1,4-diene-17β-carbothioic acid S-fluoromethyl ester.

0034Other suitable anti-inflammatory compounds include NSAIDs e.g. PDE4 inhibitors, leukotriene antagonists, iNOS inhibitors, tryptase and elastase inhibitors, beta-2 integrin antagonists and adenosine 2a agonists.

0035The medicament is formulated as any suitable fluid formulation, particularly a solution (e.g. aqueous) formulation or a suspension formulation, optionally containing other pharmaceutically acceptable additive components. The formulation may contain a preservative, although the sealed system of the dispenser may negate the need for this.

0036The medicament formulation may incorporate two or more medicaments.

0037The dispenser herein is suitable for dispensing fluid medicament formulations for the treatment of inflammatory and/or allergic conditions of the nasal passages such as rhinitis e.g. seasonal and perennial rhinitis.

0038A suitable dosing regime would be for the patient to inhale slowly through the nose subsequent to the nasal cavity being cleared. During inhalation the formulation would be applied to one nostril while the other is manually compressed. This procedure would then be repeated for the other nostril. Typically, one or two inhalations per nostril would be administered by the above procedure up to three times each day, ideally once daily. Each dose, for example, may deliver 5µg, 50µg, 100µg, 200µg or 250µg of active medicament. The precise dosage is either known or readily ascertainable by those skilled in the art.

0039It will be understood by the skilled reader in the art that the present invention is not limited to the embodiment herein described with reference to the FIGURES of drawings, but may be varied to adopt other guises within the scope of the appended claims. As an example, the dispenser of the invention need not be hand-held, nor hand-operable.