DISPENSING CONTAINERS AND KITS THEREFORE

The invention relates to improvements in valve assemblies for dispensing containers, to dispensing containers and to a kit of parts therefore.

Dispensing containers are used for dispensing a wide variety of products from mobile to viscose liquid products, powdered products and the like and typically employ a liquid propellant such as a hydro-carbon or fluoro-carbon having sufficiently high vapour pressure at normal working temperatures to propel the product from a container through a valve. These are commonly used for dispensing pharmaceutical medicaments.

Typically a dispensing container will comprise a canister and a valve assembly. The valve assembly comprises a ferrule. The canister defines a volume for storing a product which typically comprises one or more active ingredients and a volatile propellant. The canister is sealed by means of the valve assembly to form the dispensing container.

The valve assembly may comprise, for example, a continuous flow valve or a metering valve. The dispensing container is typically combined with an actuator housing to form a dispenser apparatus. The actuator housing holds the dispensing container and defines an outlet such as a nasal duct or mouthpiece for the metered dose of discharged product. An example of a valve assembly comprising a metering valve is shown in GB2375098 in which a metering valve of the capillary-retention type is illustrated. By 'capillary- retention ¹ is meant that the metering chamber of the valve is designed to remain charged with product between actuations by surface tension between the liquefied product and the valve components. An alternative type of valve is illustrated in GB2417479 in which the metering chamber of the valve does not remain charged with product between actuations. Rather, the valve is designed to allow rapid filling of the metering chamber when the apparatus is inverted immediately prior to actuation. Dispensing containers have hitherto typically been used to contain a large number of doses of product. Typically, up to 200 doses may be stored in a single container.

An industry standard dispensing container 1000 comprising a canister 100 and a valve assembly 10 is illustrated in Figures 1 to 3. The particular example in Figure 1 shows a valve assembly comprising a metering valve. Parts of the industry standard dispensing container 100 are also shown, to a larger scale, in Figure 2 and the valve assembly 10 is shown in cross-section in Figure 3.

The canister 100 comprises a body 101, a neck 102 of reduced diameter and a head 103 with an open mouth. The head 103 of the canister comprises an upper rim and a cylindrical, or at least largely cylindrical, portion. The outer diameter of the largely cylindrical portion is labelled OD in Figures 1 and 2. In the case of an industry standard canister the outer diameter of the cylindrical portion of the canister at its widest point is 20 mm.

A valve assembly of an industry standard dispensing container comprises a valve stem 11, a valve body 14, one or more seals 17, 18 and a ferrule 15. Prior to assembly of the valve with the canister, the internal diameter of the ferrule 15 (shown as ID in Figures 1 to 3) is designed to be fractionally larger than the external diameter of the cylindrical portion of the canister. Thus, the internal diameter of the industry standard ferrule 15 is approximately 20.2 mm. Consequently, the ferrule (Internal Diameter 20.2 mm) can be placed over the cylindrical portion of the canister (External Diameter 20 mm) and crimped into place to seal the canister.

A problem with the industry standard size of valve assembly is that it is inefficient at dispensing from canisters that only contain a small number of doses - for example 10 to 30 doses due to the ullage volume of the devices. In addition, the size of the valve assembly makes it unsuitable for use in more compact dispensing containers. EP2028132 describes one type of valve that has been designed to allow for more compact dispensing containers. However, the valve of EP2028132 requires the valve body and dynamic seals to be located outside the body of the canister and for the mouth of the canister to provide physical support to the inner dynamic seal. The valve design is therefore unsuitable for use with valve designs where it is desirable for the valve body to project through the neck of the canister into the body of the canister and for designs where the valve body must support an underside of the inner dynamic seal.

According to the present invention there is provided a dispensing container comprising a canister and a valve assembly; the canister comprising: a) a body defining a storage volume for a product to be dispensed; b) a neck of reduced diameter; and c) an open mouth for receiving the valve assembly; the valve assembly comprising: d) a cup-shaped valve body; e) a valve stem; f) one or more dynamic seals extending between the cup-shaped valve body and the valve stem; g) a static gasket seal for sealing between the cup- shaped valve body and the canister; h) a spring extending between the valve stem and the cup-shaped valve body; and i) a ferrule; wherein the cup-shaped valve body comprises: j) an outer part; and k) an inner part;

1) the outer part of the cup-shaped valve body defining a seat for the static gasket seal; m) the inner part of the cup-shaped valve body defining a seat for an inner end of the spring and wherein the inner part of the cup-shaped valve body extends through the neck of the canister into the body of the canister; wherein, on assembly, the ferrule holds the valve assembly in place to seal the open mouth of the canister; characterised in that: the outer part of the valve body has an outer diameter at its widest point of from 13.00 mm to 16.30 mm. An equivalent feature of the dispensing container of the present invention may be to state that an inner diameter of the ferrule is from 13.00 mm to 16.30 mm where it is desired that the outer diameter of the outer part of the valve body contacts the inner surface of the ferrule on assembly. However, this is not essential and there can be a small gap between the outer part of the valve body and the inner surface of the side wall of the ferrule.

In one example, the outer part of the valve body has an outer diameter at its widest point of 13.15 mm.

In one example, the inner diameter of the ferrule is 13.15 mm.

In another example, the outer part of the valve body has an outer diameter at its widest point of 16.15 mm. In another example, the inner diameter of the ferrule is 16.15 mm.

Advantageously, it has been found that by reducing the inner diameter of the ferrule/outer diameter of the outer part of the valve body to measure from 13.00 mm to 16.30 mm a more compact valve assembly is obtained. A valve assembly with these dimensions can be used to seal a canister where the outer diameter of the cylindrical portion of the head between the neck of reduced diameter and the open mouth is from 13 mm to 16 mm. In particular, smaller actuator housings can be used with a dispensing container comprising the valve assembly of the present invention, which is beneficial in providing patients with apparatus which are lighter, more portable and less obtrusive to use in public. It has also been found that the valve assembly of the present invention has a lower level of ullage (waste product that cannot be dispensed because of valve assembly component geometry) compared to 20 mm standard valves which leads to less wastage of active ingredient.

A further advantage that the applicant has found is that the volume of seal material, such as elastomeric material, required in the valve assembly, in particular in forming the static gasket seal, is reduced which leads to a beneficial reduction in the quantity of extractables that can be expected to be leached from the seals over the storage and useful lifetime of the dispensing container.

Further, the smaller outer diameter of the valve assembly also reduces the circumferential path length of the outer face of the gasket sealing the valve assembly to the canister. This helps to reduce the likelihood of any significant leakage between the sealing gasket and the inner face of the ferrule. In one example, the outer part of the valve body has an outer diameter at its widest point of 16.15 mm. In another example, the outer part of the valve body has an outer diameter at its widest point of 13.15 mm.

Preferably the inner part of the cup-shaped valve body comprises a cylindrical section having an outer diameter of from 6.0 mm to 7.0 mm, preferably 6.6 mm.

The dispensing container may comprise an outer seal and an inner seal and wherein the cup-shaped valve body supports an underside of at least the inner seal. The dispensing container may further comprise a valve member received within the cup-shaped valve body and defining, at least partially, the geometry of a metering chamber of the valve assembly.

Preferably the external diameter of the canister at its widest point between the neck of reduced diameter and the open mouth is from 13 mm to 16 mm.

In one example the external diameter of the canister at its widest point between the neck of reduced diameter and the open mouth is 13.00 mm. In another example, the external diameter of the canister at its widest point between the neck of reduced diameter and the open mouth is 16.00 mm. Preferably, the ratio of the outer diameter of the outer part of the valve body to the longitudinal length of the valve assembly as measured from a distal outer end of the valve stem to an inner end of the inner part of the valve body is less than or equal to 0.57.

The dispensing container may be a metered dose inhaler device .

The present invention also extends to a valve assembly for use in a dispensing container as described above. The present invention also provides a kit of parts for manufacturing a plurality of valve assemblies of a dispensing container comprising: i) a common type of valve stem; ii) a common type of valve member; iϋ) first and second types of cup-shaped valve body having differing outer diameters; iv) a common type of inner and outer dynamic seals extending between the cup-shaped valve body and the valve stem; v) first and second types of static gasket seal having differing outer diameters; vi) a common type of spring extending between the valve stem and the cup-shaped valve body; and i) first and second types of ferrule having differing outer diameters; wherein a valve assembly of a first type with a first outer diameter can be assembled from the common type of valve stem, the common type of valve member, the first type of cup-shaped valve body, the common type of inner and outer dynamic seals, the first type of static gasket seal, the common type of spring and the first type of ferrule; wherein a valve assembly of a second type with a second outer diameter can be assembled from the common type of valve stem, the common type of valve member, the second type of cup-shaped valve body, the common type of inner and outer dynamic seals, the second type of static gasket seal, the common type of spring and the second type of ferrule.

Advantageously, the kit of parts provides a more economical approach to manufacturing a range of sizes of dispensing containers since a single size and configuration of valve stem, valve member and inner and outer dynamic seals can be used in multiple sizes of valve assembly and dispensing container. Optionally, a single size and configuration of spring can be utilised in different sizes of valve assembly. The kit of parts of the present invention helps to reduce the number of components that require manufacture and storage during the production of dispensing containers, such as metered dose inhaler devices. In addition, utilising a common size of valve stem helps to increase the interoperability of the dispensing containers as other parts for attachment to the valve stem, such as actuators and spray caps, do not require resizing.

The first type of cup-shaped valve body may have an outer diameter at its widest point of approximately 20.2 mm. In other words, the valve assembly of the first type may be of the industry standard size.

The second type of cup-shaped valve body may have an outer diameter at its widest point of between 13 and 16.3 mm. In one example, the second type of cup-shaped valve body has an outer diameter at its widest point of approximately 16.15 mm. In a further aspect of the present invention there is provided a dispensing apparatus comprising an actuator housing for receiving the valve assembly and canister, wherein the actuator comprises an outlet for discharged product .

The smaller size of the valve assembly allows proportionally a greater volume for other components of the dispensing apparatus, such as counter mechanisms, breath- actuatable triggers, breath co-ordination mechanisms, etc. where the valve assembly is incorporated into an actuator housing of standard size.

The valve assembly particularly lends itself to use with canisters containing a relatively low number of metered doses. For example, 30, 15 or even 10 metered doses per apparatus.

The valve assembly may, for example, comprise a metering valve of the capillary-retention type or the fast- fill-fast-empty type as described, for example, in GB2375098 and GB2417479. The dispensing apparatus may include a dose counter mechanism of a mechanical, electronic or mechatronic form.

The dispensing apparatus may further incorporate ancillary features such as breath-actuable triggers and breath co-ordination systems as well known in the art. The valve assembly may be for use in a pharmaceutical dispensing device or apparatus, such as, for example, a pulmonary, nasal, or sub-lingual delivery device. A preferred use of the valve assembly is in a pharmaceutical metered dose aerosol inhaler device. The term pharmaceutical as used herein is intended to encompass any pharmaceutical, compound, composition, medicament, agent or product which can be delivered or administered to a human being or animal, for example pharmaceuticals, drugs, biological and medicinal products. Examples include antiallergics, analgesics, bronchodilators, antihistamines, therapeutic proteins and peptides, migraine treatments, antitussives, anginal preparations, antibiotics, antiinflammatory preparations, hormones, or sulfonamides, such as, for example, a vasoconstrictive amine, an enzyme, an alkaloid, or a steroid, including combinations of two or more thereof. In particular, examples include isoproterenol [alpha- (isopropylaminomethyl) protocatechuyl alcohol], phenylephrine, phenylpropanolamine, glucagon, adrenochrome, trypsin, epinephrine, ephedrine, narcotine, codeine, dihydroergotamine, atropine, heparin, morphine, dihydromorphinone, ergotamine, scopolamine, methapyrilene, cyanocobalamin, terbutaline, rimiterol, salbutamol, flunisolide, colchicine, pirbuterol, beclomethasone, orciprenaline, fentanyl, and diamorphine, streptomycin, penicillin, procaine penicillin, tetracycline, chlorotetracycline and hydroxytetracycline, adrenocorticotropic hormone and adrenocortical hormones, such as cortisone, hydrocortisone, hydrocortisone acetate and prednisolone, insulin, cromolyn sodium, and mometasone, including combinations of two or more thereof.

The pharmaceutical may be used as either the free base or as one or more salts conventional in the art, such as, for example, acetate, benzenesulphonate, benzoate, bircarbonate, bitartrate, bromide, calcium edetate, camsylate, carbonate, chloride, citrate, dihydrochloride, edetate, edisylate, estolate, esylate, fumarate, fluceptate, gluconate, glutamate, glycollylarsanilate, hexylresorcinate, hydrobromide, hydrochloride, hydroxynaphthoate, iodide, isethionate, lactate, lactobionate, malate, maleate, mandelate, mesylate, methylbromide, methylnitrate, methylsulphate, mucate, napsylate, nitrate, pamoate, (embonate) , pantothenate, phosphate, diphosphate, polygalacturonate, salicylate, stearate, subacetate, succinate, sulphate, tannate, tartrate, and triethiodide, including combinations of two or more thereof. Cationic salts may also be used, for example the alkali metals, e.g. Na and K, and ammonium salts and salts of amines known in the art to be pharmaceutically acceptable, for example glycine, ethylene diamine, choline, diethanolamine, triethanolamine, octadecylamine, diethylamine, triethylamine, l-amino-2-propanol-amino-2- (hydroxymethyl) propane-1, 3-diol, and l-(3,4- dihydroxyphenyl) -2 isopropylaminoethanol . The pharmaceutical will typically be one which is suitable for inhalation and may be provided in any suitable form for this purpose, for example as a solution or powder suspension in a solvent or carrier liquid, for example ethanol, or isopropyl alcohol. Typical propellants are HFA134a, HFA227 and di-methyl ether.

The pharmaceutical may, for example, be one which is suitable for the treatment of asthma. Examples include salbutamol, beclomethasone, salmeterol, fluticasone, formoterol, terbutaline, sodium chromoglycate, budesonide and flunisolide, and physiologically acceptable salts (for example salbutamol sulphate, salmeterol xinafoate, fluticasone propionate, beclomethasone dipropionate, and terbutaline sulphate) , solvates and esters, including combinations of two or more thereof. Individual isomers such as, for example, R-salbutamol, may also be used. As will be appreciated, the pharmaceutical may comprise of one or more active ingredients, an example of which is flutiform, and may optionally be provided together with a suitable carrier, for example a liquid carrier. One or more surfactants may be included if desired.

The seals and gaskets of the valve assembly may be formed from any suitable material having acceptable performance characteristics. Preferred examples include nitrile, EPDM and other thermoplastic elastomers, butyl and neoprene .

Other rigid components of the valve assembly, such as the valve body, valve member and valve stem may be formed, for example, from polyester, nylon, acetal or similar. Alternative materials for the rigid components of the valve assembly include stainless steel, ceramics and glass. Embodiments of the present invention will now be described by way of example only, with reference to the accompanying drawings, in which:

Figure 1 is a cross-sectional schematic view of an industry standard dispensing container; Figure 2 is a cross-sectional view of part of an industry standard dispensing container. The Figure shows only a ferrule and part of a canister prior to the crimping of the ferrule to the canister;

Figure 3 is a cross-sectional view of a prior art valve assembly suitable for incorporation in the dispensing container of claim 1, with dimensions shown in millimetres; Figure 4 is a cross-sectional view of a valve assembly of the present invention, with dimensions shown in millimetres; and Figure 5 is a cross-sectional view of another valve assembly of the present invention, with dimensions shown in millimetres . As shown in Figure 4, a metering valve assembly 10 according to one embodiment of the present invention includes a valve stem 11 which protrudes from and is axially slidable within a valve member 12, the valve member 12 and the valve stem 11 defining therebetween an annular metering chamber 13. The valve assembly 10 further comprises a ferrule 15. The valve member 12 is located within a valve body 14. The valve body 14 provides structural support for the valve assembly 10 and comprises an outer end 14a nearest the dispensing end of the valve assembly that has an outwardly directed flange of relatively large outer diameter and an inner end 14b furthest from the dispensing end of the valve assembly of a cylindrical form with a relatively small outer diameter.

The valve member 12 (whose presence is optional) , sometimes referred to as a 'chamber body ¹ , forms the outer circumferential face of the metering chamber 13. The valve member 12 may comprise one or more radially-inwardly extending projections 32 at an inner end- thereof.

The ferrule 15 is provided for holding, on assembly of a dispensing container, the metering valve assembly 10 in position with respect to a canister 100. The ferrule 15 retains the metering valve assembly 10 by means of crimping of the ferrule 15 to the top of the canister 100 in a manner well known in the art. The ferrule 15 has an aperture 28 through which one end 19 of the valve stem 11 protrudes. Sealing between the valve body 14 and canister is provided by a static annular gasket 16 located against the outer end 14a of the valve body 14. A dispensing container comprises the metering valve assembly 10 and the canister 100.

A pair of dynamic seals 17, 18 of an elastomeric material extend radially between the valve stem 11 and the valve member 12 and/or valve body 14. An "outer" seal 17 is radially compressed between the valve member 12, valve stem 11 and ferrule 15 so as to provide positive sealing contact to prevent leakage of the contents of the metering chamber 13 between the valve stem 11 through the aperture 28. The compression is achieved by using a seal which provides an interference fit on the valve stem 11 and/or by the crimping of the ferrule 15 onto the canister 30 during assembly to form a dispensing container. An "inner" seal 18 is located between valve member 12 and valve body 14 and the valve stem 11 to seal an "inner" end of the metering chamber 13 from the dispensing container contents.

The end 19 of the valve stem 11 is the discharging end of the valve stem 11 and protrudes from the ferrule 15. The end 19 is a hollow tube, which is closed off by a first flange 20 which is located within the metering chamber 13. The hollow end 19 of the valve stem 11 includes a discharge port 21 extending radially through the side wall of valve stem 11. The valve stem 11 further has an intermediate section 22, extending between the first flange 20 and a second flange 26. The intermediate section 22 is also hollow between the flanges 20, 26 and defines a central passage. It also has a radial transfer port 23 and a radial inlet port 24 which are interconnected through the central passage. The second flange 26 separates the intermediate section 22 of the valve stem 11 and an inner end 27 of the valve stem 11. Preferably the valve stem 11 is formed from two separate parts - one part comprising the end 19 and first flange 20 and one part comprising the intermediate section 22, second flange 26 and inner end 27.

A spring 25 extends between the second flange 26 and a shoulder defined by the inner end 14b of the valve body 14 to bias the valve stem 11 into a non-dispensing position as shown in Figure 4 in which the first flange 20 is held in sealing contact with the outer seal 17. The second flange 26 is located outside the metering chamber 13, but within the valve body 14. On assembly as part of a dispensing container, the metering chamber 13 is thus sealed from the atmosphere by the outer seal 17, and from the canister 30 to which the valve assembly 10 is attached by the inner seal 18. In the non-dispensing position, radial transfer port 23 and radial inlet port 24, together with the central passage in the intermediate section 22 of the valve member 11 connect the metering chamber 13 with the valve body 14. Inlet ports 55, 56 connect the valve body 14 with the dispensing container so that in this non-dispensing condition, the metering chamber 13 will be charged with product to be dispensed. The valve body 14 is also provided with a vapour vent hole 58. The valve assembly 10 and canister 100 together form the dispensing ^' container.

In use, the dispensing container is inverted such that the valve stem 11 is lowermost, as shown in Figure 3, such that the liquified propellant in the dispensing container collects at the end of the dispensing container adjacent the metering valve assembly 10 so as to cover inlet ports 55, 56. Depression of the valve stem 11 relative to the valve member 12 causes the stem to move inwardly. Alignment of the valve stem 11 and the valve member 12 is maintained by the axial ribs 31 guiding movement of the flange 20 and the projections 31 guiding movement of the intermediate section 22. The radial inlet port 24 is closed off as it passes through the inner seal 18 thereby isolating the metering chamber 13 from the contents of the valve body 14 and pressurised dispensing container. Upon further movement of the valve stem 11 in the same direction to a dispensing position, the discharge port 21 passes through the outer seal 17 into communication with the metering chamber 13. In this dispensing position, the product in the metering chamber 13 is free to be discharged to the atmosphere via the discharge port 21 and the cavity in the hollow end 19 of the valve stem 11.

When the valve stem 11 is released, the biasing of the spring 25 causes the valve stem 11 to return to its original position. Vapour vent hole 58 accommodates escape of any gas trapped within valve body 14. As a result, product in the pressurised dispensing container passes through inlet ports 55, 56 into valve body 14 and in turn from valve body 14 into the metering chamber 13 via the radial transfer port 23 and inlet port 24 to re-charge the chamber 13 in readiness for further dispensing operations.

According to the present invention, the inner diameter, ID, of the metering valve assembly 10 of Figure 4 is 16.15 mm. The inner diameter ID is measured as the widest internal diameter of the ferrule 15 as shown in Figure 4 or the outer diameter of the outer part 14a of the valve body 14 at its widest point.

These dimensions relate to the inner diameter of the ferrule prior to crimping onto a canister. When crimped the ID diameter may reduce by up to 0.2 mm.

Compared to a standard valve assembly as shown in Figure 3 having an inner diameter of 20 mm, the annular gasket 16, ferrule 15 and valve body 14 are altered to reduce their respective sizes. However, advantageously, the valve stem 11, valve member 12, outer and inner seals 17, 18 and spring 25 from a standard 20 mm metering valve such as that shown in Figure 3 (or described in GB2375098) can be utilised without modification. This allows a kit of parts to be produced to allow for efficient manufacture of valve assemblies and dispensing containers of a range of sizes. In particular, only a single type of one or more of the valve stem, valve member, outer and inner seals and spring need be made and stored, this reduces the costs and storage requirements of production.

Figure 5 shows a further valve assembly 10 of the present invention. Like components to the valve assembly of Figure 4 have been referenced with like numerals.

The inner diameter, ID, of the metering valve assembly 10 of Figure 5 is 13.15 mm. The inner diameter ID is measured as the widest internal diameter of the ferrule 15 as shown in Figure 5 or the outer diameter of the outer part 14a of the valve body 14 at its widest point.

Compared to a standard valve assembly as shown in Figure 3 having an inner diameter of 20 mm, the annular gasket 16, ferrule 15, valve member 12, inner seal 18, outer seal 17 and valve body 14 are altered to reduce their respective sizes. However, advantageously, the valve stem 11 and spring 25 from a standard 20 mm metering valve such as that shown in Figure 3 (or described in GB2375098) can be utilised without modification. (Optionally, a modified spring 25 may be used if desired) . A comparison of the components of the valve assemblies shown in Figures 3 to 5 is given below:

Table 1

A further advantage of the valves assemblies is that the outer diameter of the cylindrical section of the inner end 14b of the valve body 14 is the same at 6.6 mm. This means that the size, shape and location of the inlet ports 55, 56 and vapour hole 58 can be substantially constant between valve assemblies of different sizes. This helps to produce consistent performance of the valve assemblies, in particular consistent inflow characteristics of the product when charging the metering chamber 13 from the canister.

While the specific embodiments described above in detail relate to the use of a metering valve in the valve assembly, the skilled person will appreciate that the invention is equally applicable to other kinds of valves such as, for example, continuous flow valves.