WO2009022139A1

WO2009022139A1 - Metered dose inhaler comprising a dose counter

Info

Publication number: WO2009022139A1
Application number: PCT/GB2008/002750
Authority: WO
Inventors: Richard John Warby; Paul Allsop; Colin Dickens; David Jonathan Glenton; Michael Cameron Bainton; Shane Alistair Day; Robert Perkins; Stuart George David Kelly
Original assignee: Consort Medical Plc
Priority date: 2007-08-13
Filing date: 2008-08-13
Publication date: 2009-02-19
Also published as: GB2451833A; GB0921982D0; GB0715781D0; GB2462570A

Abstract

A metered dose inhaler apparatus, for dispensing a metered dose of a medicinal formulation. The apparatus (200) comprises a housing (201, 202), for receiving a dispensing container (2') of medicinal formulation; a valve actuation means (206), for supplying an electrical actuation signal; and a valve actuator (204), operably-connectable to said dispensing container, for receiving the electrical actuation signal and providing actuation of said dispensing container. Wherein, the metered dose inhaler apparatus comprises dose counter means (207) operable in response to the electrical actuation signal to index the dose counter.

Description

METERED DOSE INHALER COMPRISING A DOSE COUNTER

This invention relates to improvements in or relating to dispensing apparatus, in particular, dispensing apparatus in the form of a metered dose inhaler apparatus. Further in particular, the invention relates to a metered dose inhaler apparatus including a dose counter.

As will be known from the art, a typical dispensing apparatus in the form of an inhaler utilises a manual operation of the apparatus to actuate a dispensing container to provide a metered dose of product. Prior art dispensing apparatus also include dose counters. As the apparatus is manually operable, the dose counter is also manually operable. Often manual operation of the dose counter is provided by a number of levers, cogs and/or number rings, which are indexed by physical interaction with movement of the dispensing container, a sleeve surrounding the dispensing container, or any other moving part of the apparatus. Further, prior art electro-mechanical dose counters use a mechanical linkage to a moving part of the dispensing apparatus. The accuracy of mechanical dose counters included in dispensing apparatus, for instance, can be affected by the actions of the user if the valve is only partially actuated. Manual operation of the dispensing apparatus for triggering or indexing the dose counter and actuation of the dispensing container can lead to an inaccurate dose count and inaccurate doses - i.e. non-metered doses - being dispensed. In particular, the operation of the valve can be interfered with by a user - at least by non-full-depression of the valve in use - which either results in the valve firing but the counter not counting (under counting) or the counter operating and the valve not firing (overcounting) . Accordingly, dispensing apparatus of the present invention are aimed at reducing those disadvantages associated with the prior art dispensing apparatus .

In an aspect of the present invention, there is provided a metered dose inhaler apparatus, for dispensing a metered dose of a medicinal formulation, the apparatus comprising : a housing, for receiving a dispensing container of medicinal formulation; a valve actuation means, for supplying an electrical actuation signal; and a valve actuator, operably-connectable to said dispensing container, for receiving the electrical actuation signal and providing actuation of said dispensing container; wherein, the metered dose inhaler apparatus comprises dose counter means operable in response to the electrical actuation signal to index the dose counter. Preferably, the apparatus is arranged to provide the actuation signal direct to the dose counter. The metered dose inhaler, preferably, comprises processor means, for receiving the actuation signal from the actuation means and relaying that signal to the valve actuator. The apparatus may be arranged to provide the actuation signal from the processor means to the dose counter.

The housing may be adapted to receive an aerosol dispensing container or a pressurised dispensing container. Preferably, the valve actuation means is a push-button or slide switch. Alternatively, the valve actuation means may be a breath-actuated device. The breath-actuated device may be electro-mechanical or electronic and may be a movable vane or diaphragm. Alternatively, the device may be a pressure, temperature or flow-rate sensor.

The valve actuator may be a motor, a solenoid or a piezo electric device. Preferably, the valve actuator is arranged to act on said dispensing container, for providing actuation thereof.

The electronic valve actuator may be arranged to act directly on said dispensing container, for providing actuation thereof. Further, the valve actuator may be arranged to act on a valve seal or valve seat of said dispensing container, for providing actuation thereof.

Preferably, the valve actuator is arranged to act directly on the valve seal or valve seat of said dispensing container, for providing actuation thereof. The dose counter may be electro-mechanical and comprise movable indicia. Or, the dose counter may be electrical, comprising electronic indicia. The dose counter may comprise numerical and/or colour indicia.

Preferably, the metered dose inhaler apparatus comprises a dispensing container.

The metered dose inhaler apparatus is reusable and capable of receiving successive dispensing containers.

The dose counter may be arranged to be reset upon receipt of the dispensing container by the housing. And, may be arranged to be reset upon receipt of a full-dispensing container .

Preferably, the processor means comprises memory means, for storing dose regime data, and is arranged to process the actuation signal and dose regime data for determining whether the actuation signal should be relayed to the actuation means. Further, the dose regime data may comprise minimum time period data or maximum dose data. The - A -

processor means may be arranged to provide an electrical lock-out, for preventing further actuation of the actuation means, upon determining that the dose regime has been complied with. Further, the electrical lock-out may prevent further actuation of the actuation means, upon determining that a minimum time period between doses has not passed. Additionally, the electrical lock-out may prevent further actuation of the actuation means, upon determining that a maximum dose has been reached.

In a further aspect of the present invention, there is provided a dispensing apparatus comprising: a housing, for receiving a dispensing container; an actuation means, for supplying an electrical actuation signal; and a valve actuator, for receiving the electrical actuation signal and providing actuation of the dispensing apparatus; wherein, the dispensing apparatus comprises dose counter means operable in response to the electrical actuation signal to index the dose counter.

Preferably, the apparatus is arranged to provide the actuation signal direct to the dose counter.

Preferably, the dispensing apparatus comprises processor means, for receiving the actuation signal from the actuation means and relaying that signal to the valve actuator. In particular, the dispensing apparatus may be arranged to provide the actuation signal from the processor means to the dose counter. Most preferably, the dispensing apparatus is a medicinal dispensing apparatus or a metered dose inhaler. Preferably, the dispensing apparatus is a hand-held device .

The housing may be for receiving an aerosol dispensing container or a pressurised dispensing container. The actuation means may be a push-button or slide-switch or may be a breath-actuated device, such as, an electro-mechanical or electronic device in the form of a movable vane or diaphragm, or a pressure or flow-rate sensor . The valve actuator is, preferably, a motor, a solenoid or a piezo electric device. Preferably, the valve actuator is arranged to act on a dispensing container, for providing actuation thereof or, alternatively, the valve actuator is arranged to act directly on a dispensing container, for providing actuation thereof. Further, the electronic valve actuator may be arranged to act on a valve seal or valve seat of a dispensing container, for providing actuation thereof. Further still, the electronic valve actuator may be arranged to act directly on a valve seal or valve seat of a dispensing container, for providing actuation thereof.

The dispensing apparatus, preferably, comprises a dispensing container, in the form of an aerosol dispensing container or a pressurised dispensing container.

Preferably, the dose counter is electro-mechanical, comprising movable indicia. Alternatively, the dose counter is electronic, comprising electronic indicia. Further preferably, the dose counter comprises numerical and/or colour indicia.

The dispensing apparatus may be reusable and capable of receiving successive dispensing containers. Further, the dose counter may be arranged to be reset upon receipt of a dispensing container by the housing. Ideally, the dose counter is arranged to be reset upon receipt of a full-dispensing container.

According to an additional aspect, the present invention provides a dispensing apparatus comprising: a housing, for receiving a dispensing container; an actuation means, for supplying an electrical actuation signal; a valve actuator, for receiving the electrical actuation signal and providing actuation of the dispensing apparatus; and processor means for receiving the actuation signal from the actuation means and relaying that signal to the valve actuator; wherein the processor means comprises memory means, for storing dose regime data, and is arranged to process the actuation signal and dose regime data for determining whether the actuation signal should be relayed to the actuation means. Preferably, the dose regime data comprises minimum time period data or maximum dose data.

The processor means may be arranged to provide an electrical lock-out, for preventing further actuation of the actuation means, upon determining that the dose regime has been complied with. In particular, the electrical lock-out prevents further actuation of the actuation means upon determining that a minimum time period between doses has not passed. Additionally, the electrical lock-out prevents further actuation of the actuation means upon determining that a maximum dose has been reached. Most preferably, the dispensing apparatus comprises dose counter means operable in response to the electrical actuation signal to index the dose counter.

According to a yet further aspect of the present invention, there is provided a dispensing apparatus comprising: a housing, for receiving a dispensing container; a breath-actuation means, for supplying an electrical actuation signal; and a valve actuator, for receiving the electrical actuation signal and providing actuation of the dispensing apparatus .

Preferably, the dispensing apparatus comprises dose counter means operable in response to the electrical actuation signal to index the dose counter.

Advantageously, metered dose inhaler apparatus of the present invention utilise electrical actuation of the inhaler apparatus - and, therefore, the dispensing container - to produce a metered dose of product from the dispensing container. Further, the present inhaler apparatus advantageously utilise the signal to actuate the dispensing apparatus to index - either to increase or decrease - the dose counter.

The accuracy of mechanical dose counters, as mentioned above, can be affected by the actions of the user. However, by powering the valve to open and close, as opposed to manual operation, and by indexing the dose counter from the actuation signal, there is markedly-less opportunity for the actions of the user to interfere with operation of the inhaler apparatus. In an electrical powered system, a common electronic trigger/command would actuate the valve fully - preventing user intervention - and simultaneously increment the electronic dose counter - thus ensuring integrity of delivered medicament and counting of the number of doses delivered.

Additionally, inhaler apparatus of the present invention are particularly beneficial when the electrical power source and signal to actuate the valve is used to operate additional features of the inhaler such as the above-identified dose counter, a breath-activated actuation, and/or a dose regime system having a lock-out feature. Alternatively, the electronic trigger/command could be an electronically driven breath-actuated trigger employing a number of means, such as, temperature, pressure or acoustic sensing, or a movable vane or diaphragm. One operation triggering the firing of the valve and simultaneous counter indexing results in less error, and helps to prevent over-counting and under-counting.

The present invention also provides a metering valve, for use in an aerosol dispensing container, comprising: a metering chamber; an inlet valve, for sealing an inlet to the metering chamber, comprising an inlet valve seal and valve seat which are movable relative to each other; an outlet valve for sealing an outlet from the metering chamber; wherein the inlet valve seal and/or valve seat is/are movable by the actuator between a first position, in which the inlet valve to the metering chamber is open, and a second position, in which the inlet valve to the metering chamber is closed, to provide movement of the outlet valve between a first position, in which the outlet valve to the metering chamber is closed, and a second position, in which the outlet valve to the metering chamber is open.

The inlet valve seal and/or seat may be movable to exert a force on a fluid in the metering chamber and the outlet valve may be movable in response to the force exerted on the fluid in the metering chamber.

The inlet and outlet valves may be independently movable and may be located at respective ends of the metering chamber. Accordingly, they may be diametrical.

Preferably, the metering chamber is arranged to provide uniflow of a fluid through the metering chamber. In particular, the uniflow of fluid is from the inlet to the outlet of the metering chamber. Most preferably, the metering chamber is cylindrical. However, the metering chamber may be tapered towards the outlet valve, for providing an increased force thereon.

Preferably, the inlet valve seal is cylindrical. Preferably, the inlet valve seal or seat is reciprocally-movable or linearly-movable. The inlet valve seal or seat may be movable along an axis of the metering chamber or along an axis parallel with the uniflow of fluid. The outlet valve may comprise an outlet valve seal and valve seat, wherein the valve seal and valve seat are movable relative to each other. Preferably, the outlet valve seal or seat is deflectably-movable between first and second positions to provide opening and closing of the outlet valve. The outlet valve seal or seat may be pivotally movable between first and second positions. Additionally, the outlet valve seal and the outlet valve seat may be biased together, when in rest, and the outlet valve seal or seat may be movable against the biasing force from first to second positions. The biasing force may be provided by a spring arrangement, or similar. Most preferably, the outlet valve comprises a sprung-loaded armature. The actuator may comprise a piston arrangement for connecting with the inlet valve seal. Further, the actuator may be located inside a pressurised dispensing container, or outside a pressurised dispensing container.

A protrusion may be provided which extends beyond the inlet valve seal or seat and is movable with the inlet valve seal or seat. The protrusion may be part of the inlet valve seal or may be integral with the inlet valve seal. Preferably, the protrusion is engagable with the outlet valve seal or seat through the outlet of the metering chamber and a clearance may be provided between the protrusion and a surface of the outlet, to aid engagement. The protrusion may engage the outlet valve seat, in use, to prevent closure of the outlet valve. By way of an alternative, or in addition to pressure of fluid alone, the protrusion may provide opening of the outlet valve.

The present invention may also provide a metering valve, for use in an aerosol dispensing container, comprising: a metering chamber; an inlet valve, for sealing an inlet to the metering chamber, comprising an inlet valve seal and seat; and an outlet valve, for sealing an outlet from the metering chamber, comprising an outlet valve seal and seat; the inlet valve seal and/or seat is/are movable between a first position, in which the inlet valve to the metering chamber is open, and a second position, in which the inlet valve to the metering chamber is closed, and the outlet valve seal and/or seat is/are movable between a first position, in which the outlet valve is closed, and a second position, in which the outlet valve is open, wherein the inlet valve seal and/or seat is/are movable by the actuator in a linear manner between first and second positions .

Preferably, the outlet valve seal and/or seat is/are movable in a linear manner between first and second positions. However, the inlet valve seal and/or seat, and the outlet valve seal and/or seat may be independently movable. Alternatively, the inlet valve seal and/or seat, and the outlet valve seal and/or seat may be movable together . Preferably, the inlet valve seal is reciprocally-movable and/or the outlet valve seal is reciprocally-movable .

Preferably, the inlet valve seal is movable along an axis of the metering chamber and/or the outlet valve seal is movable along an axis of the metering chamber.

Preferably, the inlet valve seal is movable along an axis parallel with the uniflow of fluid and/or the outlet valve seal is movable along an axis parallel with the uniflow of fluid. The inlet and outlet valves seals or seats may be movable, in use, in opposite directions to provide closure of the respective inlet and outlet or may be movable, in use, in the same direction between first and second positions . Most preferably, the metering chamber is cylindrical and the inlet and outlet of the metering chamber may be located at respective ends of the metering chamber. As such, the inlet and outlet may be located diametrically.

The metering chamber may be arranged to provide uniflow of a fluid through the metering chamber. The uniflow of fluid may be from the inlet to the outlet of the metering chamber .

The actuator may be located inside a pressurised dispensing container or outside a pressurised dispensing container. The inlet valve seal or seat may be located externally of the metering chamber. Further, the outlet valve seal or seat may be located externally of the metering chamber. The inlet actuator may comprise a heat-extendable portion to provide movement of the inlet valve seal or seat between first and second positions. Further, the outlet actuator may comprise a heat-extendable portion to provide movement of the outlet valve seal or seat between first and second positions. Preferably, the inlet or outlet actuator is a hot wire. Preferably, the hot wire is electrically heated. The outlet valve seal or seat may be tapered or wedge-shaped. Preferably, the inlet valve seal or seat is disc-like. A portion of the outlet actuator may extend through the inlet valve and/or a portion of the outlet actuator may extend through the metering chamber.

The present invention may also provide a metering valve, for use in an aerosol dispensing container, comprising : a metering chamber; an inlet valve, for sealing an inlet to the metering chamber, comprising an inlet valve seal and seat; and an outlet valve, for sealing an outlet from the metering chamber, comprising an outlet valve seal and seat; the inlet valve seal and/or seat is/are movable between a first position, in which the inlet valve to the metering chamber is open, and a second position, in which the inlet valve to the metering chamber is closed, and the outlet valve seal and/or seat is/are movable between a first position, in which the outlet valve is closed, and a second position, in which the outlet valve is open, wherein the inlet valve seal or seat is located internally of the metering chamber.

Further, a portion of the inlet actuator may be located in the metering chamber. Ideally, the outlet valve seal or seat is located internally of the metering chamber. Further, a portion of the outlet actuator is located in the metering chamber. The inlet actuator may comprise a solenoid to provide movement of the inlet valve seal or seat between first and second positions. The outlet actuator may comprise a solenoid to provide movement of the outlet valve seal or seat between first and second positions.

Preferably, the inlet solenoid comprises a magnetic shuttle which carries the inlet valve seal or seat. Additionally, the inlet solenoid may comprise a coil surrounding the magnetic shuttle, which may be located in a wall of the metering chamber. Preferably, the outlet solenoid comprises a magnetic shuttle which carries the outlet valve seal or seat. Additionally, the outlet solenoid may comprise a coil surrounding the magnetic shuttle, which may be located in a wall of the metering chamber. The inlet shuttle and the outlet shuttle may be operably-connected. The connection may provide a tensionable and compressible linkage. Preferably, the linkage is capable of controlling the distance of separation of the shuttles, and may be a spring. The term uniflow is used to mean a flow of fluid in one direction only. Therefore, a fluid which is expelled from a metering valve travelling in uniflow, travels in approximately one direction through the metering valve. Naturally, slight changes in direction will not substantially alter the main direction of the flow or nature of the flow of fluid, and the term encompasses small variations in direction.

The valve (valve assembly) may be for use in a pharmaceutical dispensing device, such as, for example, a pulmonary, nasal, or sub-lingual delivery device. A preferred use of the valve 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, antibodies, vaccines, bronchodilators, antihistamines, therapeutic proteins and peptides, antitussives, anginal preparations, antibiotics, anti-inflammatory 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, insulin, DNAse, adrenochrome, trypsin, epinephrine, ephedrine, narcotine, codeine, 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, ipratropium bromide and salbutamol, 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 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, such as the valve body, chamber body and valve stem may be formed, for example, from polyester, nylon, acetal or similar. Alternative materials for the rigid components of the valve include stainless steel, ceramics and glass. These rigid components can be termed as 'non-sealing components', although it will be understood that the inner seal, outer seal or gasket may form a seal when abutting the so-called non-sealing components.

One or more components of the metering valve may have a layer of one or more polymerised monomers bonded to at least a portion thereof. Preferably the one or more monomers are selected from the group of materials comprising perfluoro- cyclohexane, perfluoro-hexane, tetrafluoroethylene, trifluoroethylene, vinylidene fluoride, vinylfluoride, fluoroethylene, fluoropropylene, a siloxane, a silazane, and a parylene.

In order that the invention may be fully disclosed, embodiments will now be described, by way of example only, with reference to the accompanying drawings, in which:

Figure 1 is a cross-sectional view of a metering valve according to the present invention;

Figure 2 is a cross-sectional view of the metering valve of Figure 1 Figure 3 is cross-sectional view of an alternative arrangement of metering valve of Figure 1;

Figures 4A, 4B and 4C are cross-sectional views of a second embodiment of metering valve according to the present invention; Figures 5A, 5B and 5C are cross-sectional views of a third embodiment of metering valve according to the present invention;

Figure 6 is a cross-sectional view of a fourth embodiment of metering valve according to the present invention; and

Figure 7 is a partial front elevation of a metered dose inhaler apparatus according to the present invention. Figure 7 shows a metered dose inhaler apparatus according to the present invention, indicated in general by reference 200. The apparatus 200 is provided by an upper casing 201 and lower casing 202. A mouthpiece cap 203 is also provided.

The upper casing 201 is hollow and receives a pressurised dispensing container 2' in use. The upper casing 201 is transparent, although this is not a strict requirement. The upper casing 201 is provided with a valve actuator 204 which, when actuated by an electrical actuation signal, depresses the container 2' within the lower housing 202.

The lower housing 202 includes a valve stem receiving block (not shown) for receiving the valve stem of the container 2'. The lower housing 202 is also provided with a mouthpiece 205 which is coverable by the cap 203. A button 206 (valve actuation means) is provided on the lower housing 202 to actuate the inhaler 1, through an electrical actuation signal. Additionally, a dose counter 207 is provided in the lower housing 202 for indicating each time the inhaler 1 is actuated. In accordance with the invention, the dose counter 207 is indexed by an electrical actuation signal from the button 206.

A metering valve for use in a metered dose inhaler apparatus 100 according to the present invention is shown in Figures 1 to 3, and is indicated, in general, by reference 1. The metering valve 1 is intended for use in a pressurised dispensing container 2 and is arranged to be located in a neck of the container 2. A sleeve 3 is provided to hold the metering valve 1 in the correct position in the neck of the container 2 to provide a pressurised dispensing container which is capable of providing metered doses. Additionally, the sleeve 3 includes a ferrule 3. In an alternative, the sleeve 3 is a ferrule 3. A nozzle 37 is also provided as part of the sleeve / ferrule 3, to guide a dispensed pressurised fluid to a target area. The nozzle 37 is connected to the sleeve / ferrule 3. The metering valve 1 is provided by a metering chamber 5, inlet valve 7, and outlet valve 8. An inlet 9 to the metering chamber and an outlet 10 from the metering chamber are also provided.

The metering chamber 5 is cylindrical and is provided as part of the sleeve or ferrule 3, which provides the metering chamber body 5, and defines a metering chamber volume 5C together with the inlet and outlet valves 7,8. The metering chamber body 5 is provided with the inlet 9 and outlet 10 located at respective ends of the cylinder. In particular, the inlet 9 and outlet 10 are at least partially- diametric . As shown in Figures 1 and 2, the metering chamber body 5 may be integral with the sleeve / ferrule 3. Preferably, the metering chamber body 5 is arranged to provide uniflow of a fluid through at least part of the metering chamber body 5. Additionally, the uniflow of fluid is, preferably, from the inlet 9 to the outlet 10 of the metering chamber volume 5C.

The inlet valve 7 includes a valve seal 7A and a valve seat 7B which are movable between a first position, in which the inlet 9 to the metering chamber volume 5C is open, and a second position, in which the inlet 9 to the metering chamber volume 5C is closed, to provide movement of the outlet valve seal 8 between a first position, in which the outlet 10 to the metering chamber volume 5C is closed, and a second position, in which the outlet 10 to the metering chamber volume 5C is open. Most preferably, the inlet valve 7 and the outlet valve 8 are independently movable.

The inlet valve seal 7A is reciprocally-movable from its first position to its second position. Figure 1 shows the inlet valve seal 7A in its first, open position, where the inlet 9 to the metering chamber volume 5C is open. By contrast, Figure 2 shows the inlet valve seal 7A in its second, closed position, in which the inlet 9 is closed - following insertion of the inlet valve seal 7A into the metering chamber body 5. It will be noted from the movement of the inlet valve seal 7A between first and second positions shown in Figures 1 and 2, that it is movable in a linear fashion, which linear movement is also along the axis of the metering chamber body 5. In addition, the inlet valve seal 7A is movable along an axis parallel with the uniflow of fluid. The inlet valve seal 7A is connected to a piston 6 which is actuated by a piezo linear actuator 11 or a solenoid actuator 11. The piston 6 is reciprocally movable to provide for movement of the inlet valve seal 7A between first and second positions. The inlet valve seal 7A comprises first and second sealing portions 4A,4B. The sealing portions 4A, 4B are contactable with an inner surface 12 of the metering chamber volume 5C - which surface includes the valve seat 7B - to provide a fluid-tight, but movable, seal therebetween. Sealing portion 4A is circular in profile and tapered providing a narrower diameter portion of the sealing portion 4A which initially contacts the surface 12 and/or the valve seat 7B. A wider diameter portion of the sealing portion 4A contacts the surface 12 when the inlet valve seal 7A is inserted further into the metering chamber body 5, to provide a more secure seal therebetween. The sealing portion 4B is separated from the sealing portion 4A by a trough 13, which is circular. The trough allows for deflection of the sealing portions 4A, 4B when the inlet valve seal 7A is inserted into, or removed from, the metering chamber body 5. The trough 13 aids movement of the inlet valve seal 7A into and out of the metering chamber volume 5C, whilst maintaining a good seal between the inlet valve seal 7A and the surface/valve seat

12, 7B. The sealing portion 4B is circular in profile and of regular diameter along its length.

The outlet valve 8 includes a valve seal 8A and a valve seat 8B which are deflectably-movable between first and second positions. Deflection is capable because the outlet valve seat 8B is pivotally mounted to a part of the valve chamber body 5 or the sleeve / ferrule 3. As shown in Figure 1, the outlet valve seat 8B is shown in its first, closed position. The outlet valve seat 8B is biased against the outlet 10 of the metering chamber volume 5C in its closed position. Following movement of the inlet valve 7, the outlet valve seat 8B is caused to move from its first position to its second, open position, shown in Figure 2. In order to move the outlet valve seat 8B, a force in excess of the biasing force must be applied. As shown in Figure 1 and 2, the outlet valve seat 8B is provided by a sprung-loaded armature arrangement 14 in which the armature 14 is connected at one end 15 to a portion of the metering chamber body 5 or the sleeve / ferrule 3. The other end 16 of the armature 14 provides the outlet valve seat 8B on an inner-facing surface thereof, which is contactable with the outlet 10. The outlet 10 includes the valve seal 8B which is connected and sealed around an inner surface of the outlet 10 and can contact directly the armature 14 and the valve seat 8B. The valve seal 8A is elastomeric and provides a fluid tight seal together with the armature 14 - which provides the outlet valve seat 8B.

In a preferred embodiment, the inlet valve 7 is movable to exert a force on a fluid in the metering chamber volume 5C, and the outlet valve 8 is movable in response to the force exerted on the fluid in the metering chamber volume 5C. Advantageously, the inlet valve 7 and the outlet valve 8 are independently movable. However, movement of the outlet valve 8 is a direct result of movement of the inlet valve 7. Typically, the inlet valve seal 7A acts as a piston in a hydraulic system and exerts a force on the fluid in the metering chamber volume 5C at the inlet 9 when the inlet valve seal 7A moves from its first to its second position. The fluid at the inlet 9 exerts a hydraulic force on fluid in the middle of the metering chamber volume 5C, which in turn exerts a hydraulic force on fluid at the outlet 10. The fluid at the outlet end of the metering chamber volume 5C exerts a hydraulic force on the outlet valve seat 8B, causing that seat 8B - and the armature 14 - to move from its first to its second position.

Additionally, a protrusion 17 is provided which extends beyond the inlet valve seal 7A and is movable with the inlet valve seal 7A. In the example shown in Figures 1 and 2, the protrusion 17 is shown as connected to the inlet valve seal 7A. However, the protrusion 17 may be connected directly, or indirectly, to the piston 6, as long as it is movable with the piston 6. The protrusion 17 may be integral with the inlet valve seal 7A. In a first arrangement, the protrusion 17 may be sized to interact with the outlet valve seat 8B in order to prevent closure of the outlet valve 8 to maximise emptying of the metering chamber volume 5C. In this embodiment, the hydraulic pressure exerted on the outlet valve 8 is sufficient to operate it without any direct, or indirect, interaction of the protrusion 17 prior to opening of the outlet valve 8. However, from the ensuing pressure loss in the metering chamber volume 5C - following vaporisation of the fluid - the inlet valve seal 7A will shoot forwards to a position in which it interacts with the outlet valve seat 8B - which outlet valve 8 is already open. Therefore, operation of the outlet valve 8 is provided by hydraulic pressure alone. Advantageously, the outlet valve 8 will be held open to allow all of the fluid in the metering chamber volume 5C to be expelled. In a second arrangement, in addition or alternatively to the hydraulic force alone opening the outlet valve 8, the outlet valve seat 8B may be caused to move by the protrusion 17 interacting with it, either directly or indirectly. This can occur in a situation that it is desirable to actuate the outlet valve 8 using the protrusion in addition to hydraulic force or without hydraulic force. Again, advantageously, the outlet valve 8 will be held open to allow all of the fluid in the metering chamber volume to be expelled. In this arrangement, a dwell-time could be included to allow for the valve to remain open whilst the chamber is emptying, to allow for the chamber to completely empty. In either arrangement, the protrusion 17 is sized to engage the armature 14 of the outlet valve seat 8B through the outlet 10 of the metering chamber volume 5C when the inlet valve seal 7A is in its second position. A clearance 18 is provided between the protrusion 17 and the outlet 10 to provide a passageway for a fluid to exit the metering chamber volume 5C, through the outlet 10, as can be seen in Figure 2.

In use, a fluid flows into the metering chamber volume 5C through the inlet 9 until an equilibrium is reached between the container 2 and the metering chamber volume 5C. The first, open position of the inlet valve seal 7A is shown in Figure 1. The actuator 11 drives the inlet valve seal 7A and piston 6 towards the inlet 9 and seals the inlet 9 by contacting the valve seal 7A and the valve seat 7B together. A metered volume of fluid is now enclosed within the metering chamber volume 5C. Further movement of the inlet valve seal 7A provides a compressive-type force on the metered volume of fluid, which exerts a force on the outlet valve seat 8B. When the force exerted on the outlet valve seat 8B is sufficient, the outlet valve seat 8B is forced to move from the valve seal 8A, thus opening the outlet valve 8 and the outlet 10, as can be seen in Figure 2. The metered volume of fluid exits the metering chamber volume 5C through the outlet 10 and nozzle 37 owing to volatisation of the product within the metering chamber volume 5C, i.e. the fluid is expelled from the metering chamber volume 5C by the vapour pressure of the propellant, as the propellant comes in to contact with atmospheric pressure when the outlet 10 is opened. The loss of resistance in the metering chamber volume 5C - caused by the exiting of the metered volume of fluid - allows the inlet valve seal 7A to shoot forwards to the position shown in Figure 2. The protrusion then interacts with the armature 14 to keep the outlet open until all the metered volume of fluid has exited the metering chamber volume 5C.

Further preferably, the metering valve 1 comprises a dose counter for indicating each time the metering valve 1 is operated. The dose counter may be mechanical or electro-mechanical .

In an alternative, the inlet and/or outlet actuator 11 may be provided external of the container 2. This arrangement would provide a more simplified assembly and remove components from within the container 2, which is clearly beneficial. Figure 3 shows such an arrangement. In Figure 3 the actuator 11 is provided outside the container 2, at an opposed end of the container 2 to the metering valve 1. The piston 6 extends from the inlet valve seal 7A, through the container 2 and exits the container 2, through a seal 60, and corresponding aperture 61 in the container 2, where it connects with the actuator 11' on an outside of the container 2. Operation of this arrangement is otherwise the same as that described in relation to Figures 1 and 2.

A further metering valve for use in a metered dose inhaler apparatus according to the present invention is shown in Figures 4A, 4B and 4C. Common references have been utilised to identify those feature that are in common with the first embodiment. Accordingly, a metering valve 1 is shown in the neck of a container 2. The neck of the container 2 is closed by a sleeve 3 / ferrule 3. A nozzle 37 is also provided as part of the sleeve / ferrule 3, to guide a dispensed pressurised fluid to a target area.

The metering valve 1 is provided by a metering chamber 5, inlet valve 7, and outlet valve 8. An inlet 9 to the metering chamber 5 and an outlet 10 from the metering chamber 5 are also provided. The metering chamber 5 is cylindrical and is provided as part of the sleeve or ferrule 3, which provides the metering chamber body 5, and defines a metering chamber volume 5C together with the inlet and outlet valves 7,8. The metering chamber body 5 is provided with the inlet 9 and outlet 10 located at respective ends of the cylinder. In particular, the inlet 9 and outlet 10 are diametric. The metering chamber body 5 is connected to an elongate body 30 which houses actuators for the inlet and outlet valves 7,8. As shown in Figures 4A, 4B and 4C, the metering chamber body 5 may be integral with the sleeve / ferrule 3. Preferably, the metering chamber body 5 is arranged to provide uniflow of a fluid through the metering chamber body 5.

Additionally, the uniflow of fluid is, preferably, from the inlet 9 to the outlet 10 of the metering chamber volume 5C.

The elongate body 30 is located on the axis of the metering valve 1 / container 2. A clearance 3OA is provided at the end of the body 30 which connects with the metering chamber body 5. The clearance 3OA provides access of a fluid to the region of the inlet 9 and allows for movement of the inlet valve 7 in that region. The body 30 houses an inlet actuator 31 and an outlet actuator 32. The inlet valve 7 comprises a valve seal 7A and a valve seat 7B. The outlet valve 8 comprise a valve seal 8A and a valve seat 8B. The inlet valve seat 7B and the outlet valve seal 8A are independently movable from first to second positions. Both valve parts 7B, 8A are linearly, reciprocally movable also. In a preferred embodiment, the inlet and outlet valve parts 7B, 8A are movable along an axis of the metering chamber, which may also be along an axis parallel with the uniflow of fluid. Both inlet and outlet valve parts 7B, 8A are located, substantially, externally of the metering chamber volume 5C and seal an outer surface of the metering chamber volume 5C. In particular, the inlet valve seat 7B is movable relative to the valve seal 7A and the inlet 9 between a first position, in which the inlet 9 to the metering chamber volume 5C is open - when the valve seal 7A and valve seat 7B are spaced apart - and a second position, in which the inlet 9 to the metering chamber volume 5C is closed - when the valve seal 7A and valve seat 7B are together. The outlet valve seal 8A is movable relative to the outlet 10 from the metering chamber volume 5C between a first position, in which the outlet 10 is closed - when the valve seal 8A and the valve seat 8B are together - and a second position, in which the outlet 10 is open - when the valve seal 8A and valve seat 8B are spaced apart. The relative movement of the inlet valve seat 7B and/or the outlet valve seal 8A is linear between first and second positions.

The inlet actuator 31 includes the inlet valve seat 7B and provides for movement thereof, upon actuation of the inlet actuator 31. The inlet actuator 31 is in the form of a 'hot wire' 31. The hot wire 31 is located within the body 30 and includes at least a portion that is heat-extendable to provide movement of the inlet valve seat 7B. Electrical wires 35 are attached to the hot wire 31 in order to provide heating thereof.

The inlet valve seat 7B is disc-like and seals against the valve seal 7A provided on an outer surface of the metering chamber body 5 at the inlet 9. The valve seal 7A provides an improved fluid-tight seal with the inlet valve seat 7B. The inlet valve seat 7B is provided with an aperture 33 through a seal 34, which allows part of the outlet actuator 32 to pass through the inlet valve seat 7B. The seal 34 provides a fluid-tight seal. Thus, a portion of the outlet actuator 32 is movable through the inlet valve seat 7B and through the metering chamber volume 5C, as can be seen in Figures 4A, 4B,4C.

The outlet actuator 32 includes the outlet valve seal 8A and provides for movement thereof, upon actuation of the outlet actuator 32. The outlet actuator 32 is in the form of a 'hot wire¹ 32. The hot wire 32 is located within the body 30 and includes at least a portion that is heat-extendable to provide movement of the outlet valve seal 8A. Electrical wires 35 are attached to the hot wire 32 in order to provide heating thereof.

The outlet valve seal 8A is wedge-shaped and seals against the valve seat 8B provided on an outer surface of the outlet 10 or in the region of an outer surface. The shape of the outlet valve seal 8A provides a good fluid-tight seal at the outlet 10 and also provides a reduced profile outlet valve seal 8 which a fluid exiting the metering chamber volume 5C will need to traverse.

Accordingly, it will be understood that the inlet and outlet valves 7,8 are movable, in use, in opposite directions to provide closure of the respective inlet 9 and outlet 10. Further, the inlet and outlet valves 7,8 are movable, in use, in the same direction between first and second positions to provide at first closure of the inlet 9 and subsequent opening of the outlet 10. In use, a fluid contained in the container 2 passes into the metering chamber volume 5C, through the clearance 3OA and the inlet 9. The inlet actuator 31 is energised by- electrical energy and expands pushing the inlet valve seal 7 towards valve seal 7A and the inlet 9 and closes the inlet 9. This first step is shown in Figure 4B where a first, open position of the inlet valve seal 7A¹ is shown by dotted lines and reference 7A¹ and the second, closed position of the inlet valve seal 7A is shown by reference 7A and non-dotted lines. A metered volume of fluid is now enclosed within the metering chamber volume 5C. Subsequently, the outlet actuator 32 is energised by electrical energy and pushes the outlet valve seal 8A away from the valve seat 8B and outlet 10 and opens the outlet 10, as shown in Figure 4C - as compared to Figure 4B. The metered volume of fluid in the metering chamber volume 5C exits the metering chamber volume 5C, through the outlet 10, past the wedge-shaped outlet valve seal 8A, and through the nozzle 37, by vaporisation .

Further preferably, the metering valve 1 comprises a dose counter for indicating each time the metering valve 1 is operated. The dose counter may be mechanical or electro- mechanical.

In an alternative, the inlet and/or outlet actuator may be provided external of the container 2. This arrangement would provide a more simplified assembly and remove components from within the container 2, which is clearly beneficial.

In a third aspect, the invention provides a metered dose inhaler apparatus including the metering valve exemplified in Figures 5A, 5B and 5C. Common references have been utilised to identify those feature that are in common with the first and/or second embodiment. Accordingly, a metering valve 1 is shown in the neck of a container 2. The neck of the container 2 is closed by a sleeve 3 / ferrule 3. In this embodiment, no nozzle is shown but one may be provided.

The metering valve 1 is provided by a metering chamber 5, inlet valve 7, and outlet valve 8. An inlet 9 to the metering chamber 5 and an outlet 10 from the metering chamber 5 are also provided.

The metering chamber 5 is cylindrical and is provided as part of the sleeve or ferrule 3, which provides the metering chamber body 5, and defines a metering chamber volume 5C together with the inlet and outlet valves 7,8. The metering chamber body 5 is provided with the inlet 9 and outlet 10 located at respective ends of the cylinder. In particular, the inlet 9 and outlet 10 are diametric. As shown in Figures 5A, 5B and 5C, the metering chamber body 5 may be integral with the sleeve / ferrule 3. Preferably, the metering chamber body 5 is arranged to provide uniflow of a fluid through the metering chamber body 5. Additionally, the uniflow of fluid is, preferably, from the inlet 9 to the outlet 10 of the metering chamber volume 5C. The metering chamber volume 5C houses at least part of an inlet actuator 41 and at least part of an outlet actuator 42, as can be seen in Figures 5A,5B,5C.

The inlet valve 7 includes a valve seal 7A and a valve seat 7B. The outlet valve 8 includes a valve seal 8A and a valve seat 8B. Both valves 7,8 are independently movable from first to second positions. Both valve seals 7A, 8A are linearly, reciprocally movable also. In a preferred embodiment, the inlet and outlet valve seals 7A, 8A are movable along an axis of the metering chamber, which may also be along an axis parallel with the uniflow of fluid. Both inlet and outlet valve seals 7A, 8A are located, substantially, internally of the metering chamber volume 5C and seal against their respective valve seats 7B, 8B provided on an inner surface of the metering chamber volume 5C. In particular, the inlet valve seal 7A is movable relative to the inlet 9 (and valve seat 7B) between a first position, in which the inlet 9 to the metering chamber volume 5C is open - when the valve seal 7A and the valve seat 7B are spaced apart - and a second position, in which the inlet 9 to the metering chamber volume 5C is closed - and the valve seal 7A and the valve seat 7B are together. The outlet valve seal 8A is movable relative to the outlet 10 (and valve seat 8B) from the metering chamber volume 5C between a first position, in which the outlet 10 is closed - when the valve seal 8A and the valve seat 8B are together - and a second position, in which the outlet 10 is open - when the valve seal 8A and the valve seat 8B are spaced apart. The relative movement of the inlet valve seal 7A and/or the outlet valve seal 8A is linear between first and second positions . The inlet actuator 41 is a solenoid and comprises a magnetic shuttle 43 - which carries the inlet valve seal 7A

- and a coil 44, which surrounds the inlet shuttle 43. The inlet shuttle 43 is located within the metering chamber volume 5C . The inlet shuttle 43 is movable from a first, open position of the inlet 9 to a second, closed position of the inlet 9 by supplying electrical energy to the coil 44. The solenoid 41 acts in a usual manner and the coil 44 creates a magnetic field which drives the inlet shuttle 43 from its rest position to its actuated position. The inlet valve seal 7A is disc-like and seals against the valve seat 7B provided on an inner surface of the inlet 9 of the metering chamber volume 5C, and provides a fluid-tight seal. Electrical wires (not shown) provide electrical energy for powering the solenoid. The outlet actuator 42 is a solenoid and comprises a magnetic shuttle 45 - which carries the outlet valve seal 8A

- and a coil 46, which surrounds the outlet shuttle 45. The outlet shuttle 45 is located within the metering chamber volume 5C . The outlet shuttle 45 is movable from a first, closed position of the outlet 10 to a second, open position of the outlet 10 by supplying electrical energy to the coil 46. The solenoid 42 acts in a usual manner and the coil 46 creates a magnetic field which drives the inlet shuttle 45 from its rest position to its actuated position. The outlet valve seal 8A is tapered and seals against the valve seat 8B provided on an inner surface of the outlet 10 of the metering chamber volumes 5C, and provides a fluid-tight seal. Electrical wires (not shown) provide electrical energy for powering the solenoid. The shape of the outlet valve seal 8A (i.e. tapered valve seal 8A) provides a good fluid-tight seal at the outlet 10 and also provides little resistance to a fluid exiting the metering chamber volume 5C.

The inlet and outlet shuttles 43,45 are operably-connected by a linkage 47. The linkage 47 provides a tensionable and/or compressible link between the two shuttles 43,45, depending upon which shuttle 43,45 is moving and in which direction. In this embodiment, the linkage 47 is a spring 47, which is capable of controlling the distance of separation of the shuttles 43,45.

As shown in Figures 5A,5B,5C, the inlet and outlet shuttles 43,45 are located within the metering volume 5C. The coils 44,46 are located in a wall 5B of the metering chamber body 5 and can interact with their respective shuttles 43,45.

Accordingly, it will be understood that the inlet and outlet valve seals 7,8 are movable, in use, in opposite directions to provide closure of the respective inlet 9 and outlet 10. Further, the inlet and outlet valve seals 7,8 are movable, in use, in the same direction between first and second positions to provide at first closure of the inlet 9 and subsequent opening of the outlet 10.

In use, a fluid contained in the container 2 passes into the metering chamber volume 5C, through the inlet 9. The inlet actuator 41 is energised by electrical energy and the coil 44 drives the inlet shuttle 43 and the inlet valve seal 7 towards the inlet 9, away from the outlet 10, and closes the inlet 9. The result of this first step is shown in Figure 5B, where it can be seen - in contrast to Figure 5A - that the inlet 9 to the metering chamber volume 5C is closed. A metered volume of fluid is now enclosed within the metering chamber volume 5C. Subsequently, the outlet actuator 42 is energised by electrical energy and the coil 46 drives the outlet shuttle 45 away from the outlet 10, towards the inlet 9, the result of which can be seen in Figure 5C, where the outlet 10 is shown as open. The metered volume of fluid in the metering chamber volume 5C exits the metering chamber volume 5C by vaporisation. Further preferably, the metering valve 1 comprises a dose counter for indicating each time the metering valve 1 is operated. The dose counter may be mechanical or electromechanical .

In an alternative, the inlet and/or outlet actuator may be provided external of the container 2. This arrangement would provide a more simplified assembly and remove components from within the container 2, which is clearly beneficial .

Figure 6 shows a fourth embodiment of metering valve for use in the metered dose inhaler apparatus of the present invention. Common references have been utilised to identify those feature that are in common with the first, second and/or third embodiments. The metering valve is indicated, in general, by reference 100 and includes an inner seal 101, outer seal 102, valve stem 103, valve body 104 and ferrule 105. The metering valve 100 is located in an open end of a container 106 and retained in place by the ferrule 105. A metering chamber 107 is provided by the inner and outer seals 101,102 and the valve body 104. The valve stem 103 is slidale within the metering chamber 107 - and comprises a flange 103A - and provides a passageway 108 for fluid to enter the metering chamber 107 from the container 106. A further passageway 109 is provided to allow fluid to escape the metering chamber 107 to the atmosphere. Only one passageway 108,109 provides access to the metering chamber 107 at any one time. Figure 6 shows the metering valve 100 in a dispensing condition, in which the passageway 109 is within the metering chamber 107 - such that a fluid can pass from the metering chamber 107 to the atmosphere. These types of metering valves are well-know in the art. According to the present invention, the metering valve 100 is provided with a valve stem 103 which is connected to, or integral with, a piston 6. The piston 6 extends from the metering chamber 100, right through the container 106, through an aperture 110 and corresponding seal 111, located at a far end of the container 2 remote from the metering valve 100, and is connected to an actuator 11', located at the remote end of the container 2 on an outside thereof. The actuator 11' provides reciprocal movement of the piston, which provides opening and closing of the metering chamber 107 by altering the placement of the passageways 108,109 within the metering chamber 107. Advantageously, all valve embodiments of the invention are capable of operating as claimed in the claims. In particular, the valve embodiments comprise a housing, for receiving a dispensing container; an actuation means, for supplying an electrical actuation signal; and a valve actuator, for receiving the electrical actuation signal and providing actuation of the dispensing apparatus. The dispensing apparatus comprises dose counter means operable in response to the electrical actuation signal to index the dose counter.

By way of an alternative, the valve embodiments described can be used in dose regime systems . In particular, the valve embodiments comprise a housing, for receiving a dispensing container; an actuation means, for supplying an electrical actuation signal; a valve actuator, for receiving the electrical actuation signal and providing actuation of the dispensing apparatus; and processor means for receiving the actuation signal from the actuation means and relaying that signal to the valve actuator; wherein the processor means comprises memory means, for storing dose regime data, and is arranged to process the actuation signal and dose regime data for determining whether the actuation signal should be relayed to the actuation means. With the power source, processor and valve operating elements in place, the processor could be programmed to prevent multiple actuations over the prescribed number identified in the dose regime data. Accordingly, depression of the actuation button (means) prematurely or inhaling - in the case of a breath actuated design - would not actuate the valve nor the dose counter. A typical mode of operation would be inhalation by a user - operating an electro-mechanical or electronic sensor - the sensor sending a signal to the valve for opening the valve and operating the counter, subject to dose regime analysis.

Most preferably, a complete dispensing apparatus according to the present invention includes the dispensing container - with pressurised HFA formulation, a metering valve, a battery, a processor, a motor to drive the valve, an actuation button or breath-actuated element (electro-mechanical or electronic), and a housing/dust cap. Preferably, with the exception of the dispensing container and the valve, the dispensing apparatus is to be retained and reused. The dispensing container and, probably, the valve being disposable. A reset on the dose counter and/or dose regime system would, preferably, be provided.

In an alternative embodiment, the present invention - as indicated in the claims - may be utilised with valves without metering chambers. Such valves may utilise a form of timed opening and closing of the valve, in order to provide a metered dose of product from the dispensing container. In particular, the valves may be provided by a valve assembly, for use in an aerosol dispensing container, comprising : a valve seal movable relative to a valve seat to provide for opening and closing of the valve assembly; a valve actuator, which is able to interact with the valve seal or valve seat to open and close the valve assembly; and control means for controlling the valve actuator; the valve actuator being controllable by the control means, in use, to open the valve assembly to allow a fluid to pass through the valve assembly, and to subsequently close the valve assembly after a predetermined time-period to prevent fluid passing through the valve assembly, to thereby provide a metered dose of fluid, wherein the control means includes sensor means for measuring the temperature, pressure and/or flow rate of a fluid, in use, passing through the valve assembly, such that, the predetermined time-period is adaptable to compensate for changes in the temperature, pressure and/or flow rate of the fluid.

Claims

CLAIMS :

1.) A metered dose inhaler apparatus, for dispensing a metered dose of a medicinal formulation, the apparatus comprising: a housing, for receiving a dispensing container of medicinal formulation; a valve actuation means, for supplying an electrical actuation signal; and a valve actuator, operably-connectable to said dispensing container, for receiving the electrical actuation signal and providing actuation of said dispensing container; wherein, the metered dose inhaler apparatus comprises dose counter means operable in response to the electrical actuation signal to index the dose counter.

2.) A metered dose inhaler apparatus as claimed in claim 1, wherein the apparatus is arranged to provide the actuation signal direct to the dose counter.

3.) A metered dose inhaler apparatus as claimed in claim 1 or claim 2, comprising processor means, for receiving the actuation signal from the actuation means and relaying that signal to the valve actuator.

4.) A metered dose inhaler apparatus as claimed in claim 3, wherein the apparatus is arranged to provide the actuation signal from the processor means to the dose counter.

5.) A metered dose inhaler apparatus as claimed in any preceding claim, wherein the housing is adapted to receive an aerosol dispensing container or a pressurised dispensing container .

6.) A metered dose inhaler apparatus as claimed in any preceding claim, wherein the valve actuation means is a push-button or slide switch.

7.) A metered dose inhaler apparatus as claimed in any one of claims 1 to 5, wherein the valve actuation means is a breath-actuated device.

8.) A metered dose inhaler apparatus as claimed in claim 7, wherein the breath-actuated device is electro-mechanical or electronic.

9.) A metered dose inhaler apparatus as claimed in claim 8, wherein the device is a movable vane or diaphragm.

10.) A metered dose inhaler apparatus as claimed in claim 8, wherein the device is a pressure, temperature or flow-rate sensor .

11.) A metered dose inhaler apparatus as claimed in any preceding claim, wherein the valve actuator is a motor, a solenoid or a piezo electric device.

12.) A metered dose inhaler apparatus as claimed in any preceding claim, wherein the valve actuator is arranged to act on said dispensing container, for providing actuation thereof.

13.) A metered dose inhaler apparatus as claimed in claim 12, wherein the electronic valve actuator is arranged to act directly on said dispensing container, for providing actuation thereof.

14.) A metered dose inhaler apparatus as claimed in claim 12 or claim 13, wherein the valve actuator is arranged to act on a valve seal or valve seat of said dispensing container, for providing actuation thereof.

15.) A metered dose inhaler apparatus as claimed in claim 14, wherein the valve actuator is arranged to act directly on the valve seal or valve seat of said dispensing container, for providing actuation thereof.

16.) A metered dose inhaler apparatus as claimed in any preceding claim, wherein the dose counter is electromechanical, comprising movable indicia.

17. ) A metered dose inhaler apparatus as claimed in any one of claims 1 to 15, wherein the dose counter is electrical, comprising electronic indicia.

18.) A metered dose inhaler apparatus as claimed in any preceding claim, wherein the dose counter comprises numerical and/or colour indicia.

19.) A metered dose inhaler apparatus as claimed in any preceding claim, comprising a dispensing container.

20.) A metered dose inhaler apparatus as claimed in any- preceding claim, wherein the metered dose inhaler apparatus is reusable and capable of receiving successive dispensing containers .

21.) A metered dose inhaler apparatus as claimed in claim 20, wherein the dose counter is arranged to be reset upon receipt of the dispensing container by the housing.

22.) A metered dose inhaler apparatus as claimed in claim 21, wherein the dose counter is arranged to be reset upon receipt of a full-dispensing container.

23.) A metered dose inhaler apparatus as claimed in any one of claims 3 to 22, wherein the processor means comprises memory means, for storing dose regime data, and is arranged to process the actuation signal and dose regime data for determining whether the actuation signal should be relayed to the actuation means.

24.) A metered dose inhaler apparatus as claimed in claim 23, wherein the dose regime data comprises minimum time period data or maximum dose data.

25.) A metered dose inhaler apparatus as claimed in claim 23 or claim 24, wherein the processor means is arranged to provide an electrical lock-out, for preventing further actuation of the actuation means, upon determining that the dose regime has been complied with.

26.) A metered dose inhaler apparatus as claimed in claim 25, wherein the electrical lock-out prevents further actuation of the actuation means, upon determining that a minimum time period between doses has not passed.

27.) A metered dose inhaler apparatus as claimed in claim 25, wherein the electrical lock-out prevents further actuation of the actuation means, upon determining that a maximum dose has been reached.

28.) A metered dose inhaler apparatus substantially as herein described, with reference to the accompanying drawings and description.