Inhalation device

According to the present invention there is provided an inhalation device for dispensing medicament comprising a body (150), the body being shaped for receipt of a medicament carrier (286); and an actuator (10) having a mouthpiece (20), the actuator being reversibly movable between a dispensing position and a storage position; wherein the body includes an air channel (253), and the actuator includes an air hole (225) such that the air channel communicates with the air hole when the actuator is in the dispensing position and the air channel and air hole do not communicate when the actuator is in the storage position.

This application is filed pursuant to 35 USC 371 as a U.S. National Phase Application of International Patent Application Ser. No. PCT/EP01/09202 filed 9 Aug. 2001, which claims priority from GB 0021024.5 filed on 29 Aug. 2000 in the United Kingdom.

FIELD OF THE INVENTION

The present invention relates to an inhalation device for use in the administration of medicament to a patient.

BACKGROUND TO THE INVENTION

The use of inhalation devices in the administration of medicaments, for example in bronchodilation therapy, is well known. Such devices generally comprise a body or housing within which a medicament container is located. A mouthpiece (or nozzle) is typically provided which communicates with the medicament container to allow passage of medicament from the source to the mouthpiece and thence, to the patient. When the patient breathes to take in the medicament, typically air is allowed to circulate throughout the body of the device to create airflow.

However, there are certain devices where it is advantageous that the volume of the body of the device that is exposed to airflow (and therefore moisture) is reduced. Typically such devices have moisture sensitive components such as medicament (for example dry powder) or electronic or other moisture sensitive equipment.

The applicants have now found that this problem can be salved by employing a device wherein the mouthpiece and the body of the device are separated such that the airflow between these parts is minimized. A specially created air hole in the mouthpiece and air channel in the body allow air to circulate through a part of the body not containing moisture sensitive components. These air holes and air channels are only able to communicate when the device is in a dispensing position. Preferably these air holes and channels are blocked during storage to prevent the entry of contaminants.

SUMMARY OF THE INVENTION

According to one aspect of the present invention there is provided an inhalation device for dispensing medicament comprising a body, said body being shaped for receipt of a medicament carrier; and an actuator having a mouthpiece, said actuator being reversibly movable between a dispensing position and a storage position;

wherein said body includes an air channel, and said actuator includes an air hole such that said air channel communicates with said air hole when the actuator is in said dispensing position and the air channel and air hole do not communicate when the actuator is in said storage position.

The term ‘medicament carrier’ is used in a general sense to mean any carrier for a medicament product which product can itself be in any suitable form e.g. aerosol, dry powder, solution etc. Suitable carriers include aerosol containers, blister packs, capsules and reservoirs.

Preferably the actuator additionally comprises a collar portion for receipt of a medicament carrier.

Preferably the actuator additionally includes a wall to create a closed off cavity around the mouthpiece such that air flow is between the air hole and mouthpiece only.

Preferably the actuator additionally comprises a support for a medicament carrier and nozzle providing communication between the mouthpiece and a medicament carrier inserted in said support.

Preferably either the air channel or air hole is blocked when the actuator is in the storage position. More preferably both the air channel and air hole are blocked when the actuator is in the storage position.

Preferably, the air channel is in the form of a slot.

Preferably the body has a plurality of air channels. Preferably said plurality of air channels are arranged in a finger arrangement. Alternatively said plurality of air channels are arranged in a series of grooves.

Preferably the mouthpiece has a plurality of air holes. In one embodiment of the invention the air hole is a slot.

Preferably the mouthpiece is covered by the body in the storage position and protrudes from the body in the dispensing position.

Preferably the mouthpiece is rotatably movable between the storage position and the dispensing position. Alternatively the mouthpiece is pivotally movable between the storage position and the dispensing position.

Preferably the inhalation device additionally comprises a monitor for monitoring the breath of a patient.

According to one embodiment of the invention said monitor comprises one or more sensors for sensing the pressure profile associated with the breath cycle.

According to another embodiment of the invention said monitor comprises one or more sensors for sensing the airflow profile associated with the breath cycle.

According to another embodiment of the invention said monitor comprises one or more sensors for sensing the temperature profile associated with the breath cycle.

According to a further embodiment of the invention said monitor comprises one or more sensors for sensing the moisture profile associated with the breath cycle.

According to a further embodiment of the invention said monitor comprises one or more sensors for sensing the oxygen or carbon dioxide profile associated with the breath cycle.

Preferably said monitor sends an actuation signal to the actuator.

Preferably receipt of said actuation signal triggers release of medicament from a medicament carrier.

Preferably the collar portion additionally includes a microelectronic memory chip.

Preferably the body includes electrical contact pins. Preferably said electrical contact pins are connectable to a microelectronic system. Preferably said electronic contact pins are positioned such that they only contact the microelectronic memory chip when the actuator is in the dispensing position.

Preferably the body is additionally provided with a sensor to detect the initial movement of the actuator from the storage position.

Preferably the device is provided with a dose counter.

Preferably the device is provided with a display window.

Preferably the inhalation device additionally comprises a medicament carrier, receivable by the collar portion and the body.

Preferably the medicament carrier is insertable into the support to allow passage of medicament through the nozzle and into the mouthpiece.

Preferably the medicament carrier and actuator are reversibly loadable into the body when the actuator is positioned midway between the storage and dispensing positions.

Preferably the medicament carrier is an aerosol container.

Preferably said aerosol container comprises a suspension of a medicament in a propellant.

Preferably said propellant comprises liquefied HFA134a, HFA-227 or carbon dioxide.

Preferably the medicament is selected from the group consisting of albuterol, salmeterol, fluticasone propionate and beclomethasone dipropionate and salts or solvates thereof and any mixtures thereof.

Preferably the medicament comprises salmeterol xinafoate and salts or solvates thereof and any mixtures thereof. More preferably the medicament comprises fluticasone propionate and salts or solvates thereof and any mixtures thereof. More preferably the medicament comprises a combination of salmeterol xinafoate and fluticasone propionate and salts or solvates thereof and any mixtures thereof.

Preferably said body is shaped to be holdable in one hand and the mouthpiece is movable from its storage position to its dispensing position by a motion of the thumb on the same hand.

Preferably at least a portion of the mouthpiece is shaped for ease of grip by the user.

In one aspect of the present invention there is also provided the use of an inhalation device for dispensing medicament

According to one embodiment there is also provided a kit of parts comprising a body, the body being shaped for receipt of a medicament carrier and having an air channel therein; and an actuator having a mouthpiece, the actuator being reversibly movable between a dispensing position and a storage position, the actuator including an air hole; such that when assembled the air channel communicates with the air hole when the actuator is in the dispensing position and the air channel and the air hole do not communicate when the actuator is in the storage position.

The kit of parts may additionally comprise an aerosol container for containing medicament.

DETAILED DESCRIPTION OF THE DRAWINGS

FIG. 1shows an actuator10for use in an inhalation device comprising a collar portion5; mouthpiece20; stem block30; and a passage defining a nozzle40. The collar portion5is separated from the mouthpiece by solid base portion12. The stem block30provides a support for the dispensing end of a medicament container such as a valve stem of an aerosol container (not shown) and nozzle40allows for passage of the contents of the aerosol container into the mouthpiece for subsequent inhalation by the patient through the mouthpiece20. The solid base portion12prevents air from entering the collar10and subsequently the body of the device (not shown), therefore preventing moisture from containing any moisture sensitive apparatus located within the body. The mouthpiece20has air holes25(only one shown) located in the non-dispensing end22. The air holes25communicate with air channel located in the body (not shown) to provide an air path.

FIG. 2shows a portion of the body150. The body150has a hole151shaped to receive the collar of the actuator ofFIG. 1and a portion152shaped to fit with the mouthpiece of the actuator ofFIG. 1. The actuator (not shown) may be inserted into the body150so that the collar is located in hole151and the mouthpiece lies against the portion152when it is in the storage position. End cap154covers the dispensing end of the mouthpiece, protecting it from ingress of contaminants. The body portion152contains a number of air channels153which are arranged in a finger pattern and pass through the surface of the body150. The finger arrangement has been found to allow for a high level of air movement through the body150, however the air channels153may be arranged in other formations, for example in a series of lines or grooves, or in another suitable pattern.

FIG. 3ashows the actuator and body ofFIGS. 1 and 2in position with the mouthpiece220located in the storage position. The figure has been simplified to show only the actuator, a body250and aerosol container280. The aerosol container280is inserted in the stem support230, blocking airflow between the mouthpiece220and the collar portion205. The solid base portion212of the collar portion205prevents airflow between the mouthpiece220and the rest of the inhalation device. The mouthpiece220is covered by end cap254of the body250, preventing ingress of contaminants during storage. The air holes225(only one shown) in the mouthpiece220are blocked by the body250and the air channels253in the body250are blocked by the mouthpiece220. There is therefore no communication between the body and the mouthpiece during storage. Also shown is microelectronic memory chip260located next to the aerosol container280and electrical contact pins262located within the body250. In the storage position, the microelectronic memory chip260does not make electrical contact with the contact pins262.

FIG. 3bshows the device ofFIG. 3awith the mouthpiece located in the dispensing position. The aerosol container280is inserted in the stem support and will release medicament through the nozzle240into the mouthpiece220for inhalation by the patient. The solid base portion212of the collar portion205prevents air from entering the rest of the device when the patient breathes into the mouthpiece220. The air hole225in the mouthpiece220is aligned with the air channels253in the body250, allowing in-use circulation of air and creating airflow through the mouthpiece220. The microelectronic memory chip260located next to the aerosol container280and the electrical contact pins262in the body are aligned when the mouthpiece is in the dispensing position such that electrical contact is made.

FIG. 4shows a metered dose inhaler for the delivery of medicament for inhalation by a patient. The inhaler comprises a housing body350in which an aerosol container380is located. An actuator in the form of a mouthpiece320is provided to the aerosol container380.

The aerosol container380has a valve dispensing mechanism382in the form of a slide valve. Valve stem384connects with a stem support330which forms part of the actuator310. The support330is provided with an outlet passage340enabling dispensed dose to pass through to the mouthpiece outlet321. It will be appreciated that dispensing of the dose requires the aerosol container380to be depressed to actuate the slide valve dispensing mechanism382and dispense medicament into the outlet321from which it can be inhaled by a patient.

The actuator310has a tubular neck portion305for receipt of a collar336which itself engages the neck of the aerosol container380. The tubular portion305is shaped such that collar336and so-engaged aerosol container are sufficiently movable in a sliding fashion therein to enable actuation of the slide valve mechanism382. The aerosol container380, collar336and actuator310together from a discrete unit which is reversibly removable from the body350when the actuator310is in certain orientations. The drawing shows the actuator in the endpiece secured orientation in which retaining lip308makes snap-fit engagement with groom338provided in the tubular portion305of the actuator. A perpendicular opposing point (i.e. 90° rotation therefrom) on the tubular portion305has no similar groove portion, such that when the actuator310is rotated through 90° to the endpiece unsecured orientation the actuator310, collar336and aerosol container may be removed from the housing body350.

The mouthpiece320is separated from the tubular collar305by solid base portion312. The solid base portion312prevents air from entering the collar305and the interior of the device, therefore preventing moisture from contacting any moisture sensitive apparatus located therewithin. The mouthpiece320has air bolts325(only one shown) located in the non-dispensing end322. In the dispensing position, the air holes325communicate with air conduits353located in the body350to provide an air path. In the storage (i.e. ‘endpiece unsecured’) position, it will be appreciated that the air holes325do not communicate with the air conduits353.

The collar336is provided with an electronic memory chip360which is capable of receiving data inputs and providing data outputs. The memory chip360connects via contact362to electronic circuitry (not visible) and power supply in the form of two lithium batteries362aand363b. The electronic circuitry further connects to electronic control system370which is capable of communication with the memory chip360and with various sensors on device (for simplicity, not shown) and of providing visual output via display374to the patient.

It may be seen that the upper part of the aerosol container380is received by container seat355. The container seat355is slidably movable within the housing along track356formed within the housing350. The container seat355also comprises a spring actuator return357and actuator button376for use as a manual override. Plural lengths of shape memory alloy wire372a,372b(only two wires shown for simplicity) connect the container seat355to anchor positions359a,359bin the lower part of the housing. The wires372a,372bcomprise a nickel-titanium alloy which contracts in response to the heating effect of the flow of electrical current therethrough. It may thus, be appreciated that when electrical current is passed through the plural lengths of wire372a,372bthe container seat355will be drawn towards to the anchor positions359a,359bas the wires372a,372bcontract. Actuation of the valve dispensing mechanism382and dispensing of medicament dose will thereby result. The flow of electrical current is controlled by the control system370, which is itself responsive to inputs from various sensors (not shown) such as a sensor which senses the breath of a patient.

In the event of failure of electrical current flow it may be appreciated that the manual actuation button376may be manually pushed downwards to actuate the valve dispensing mechanism382. The actuation step also results in the closing of switch376which records that a dose has been fired.

FIGS. 5aand5bshow aerosol container480with a collar490attached. The collar490is fixed such that the stem485of the aerosol container480protrudes. The assembly of aerosol container480and collar490may be combined with an actuator similar to that shown inFIG. 1and a body similar to that shown inFIG. 2to make an assembly similar to that shown inFIGS. 3aand3b.

The aerosol container and inhalation device of the invention is suitable for dispensing medicament, particularly for the treatment of respiratory disorders. Medicaments which may be administered in the aerosol formulations include any drug useful in inhalation therapy. Appropriate medicaments may thus be selected from, for example, analgesics, e.g., codeine, dihydromorphine, ergotamine, fentanyl or morphine; anginal preparations, e.g., diltiazem; antiallergics, e.g., cromoglycate (e.g. as the sodium salt), ketotifen or nedocromil (e.g. as the sodium salt); antiinfectives e.g., cephalosporins, penicillins, streptomycin, sulphonamides, tetracyclines and pentamidine; antihistamines, e.g., methapyrilene; anti-inflammatories, e.g., beclomethasone (e.g. as the dipropionate ester), fluticasone (e.g. as the propionate ester), flunisolide, budesonide, rofleponide, mometasone e.g. as the furoate ester), ciclesonide, triamcinolone (e.g. as the acetonide) or 6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxy-androsta-1,4-diene-17β-carbothioic acid S-(2-oxo-tetrahydro-furan-3-yl) ester; antitussives, e.g., noscapine; bronchodilators, e.g., albuterol (e.g. as free base or sulphate), salmeterol (e.g. as xinafoate), ephedrine, adrenaline, fenoterol (e.g. as hydrobromide), formoterol (e.g. as fumarate), isoprenaline, metaproterenol, phenylephrine, phenylpropanolamine, pirbuterol (eg as acetate), reproterol (e.g. as hydrochloride), rimiterol, terbutaline (e.g. as sulphate), isoetharine, tulobuterol or 4-hydroxy-7-[2-[[2-[[3-(2-phenylethoxy)propyl]sulfonyl]ethyl]amino]ethyl-2(3H)-benzothiazolone; adenosine 2a agonists, eg 2R,3R,4S,5R)-2-[6-Amino-2-(1S-hydroxymethyl-2-phenyl-ethylamino)-purin-9-yl]-5-(2-ethyl-2H-tetrazol-5-yl)-tetrahydro-furan-3,4-diol (e.g. as maleate); α4integrin inhibitors eg (2S)-3-[4-({[4-(aminocarbonyl)-1-piperidinyl]carbonyl}oxy)phenyl]-2-[((2S)-4-methyl-2-{[2-(2-methylphenoxy) acetyl]amino}pentanoyl)amino]propanoic acid (e.g. as free acid or potassium salt), diuretics, e.g., amiloride; anticholinergics, e.g., ipratropium (eg as bromide), tiotropium, atropine or oxitropium; hormones, e.g., cortisone, hydrocortisone or prednisolone; xanthines, e.g., aminophylline, choline theophyllinate, lysine theophyllinate or theophylline; therapeutic proteins and peptides, e.g., insulin or glucagon; vaccines, diagnostics, and gene therapies. It will be clear to a person skilled in the art that, where appropriate, the medicaments may be used in the form of salts, (e.g., as alkali metal or amine salts or as acid addition salts) or as esters (e.g., lower alkyl esters) or as solvates (e.g., hydrates) to optimise the activity and/or stability of the medicament.

Preferred medicaments are selected from albuterol, salmeterol, fluticasone propionate and beclomethasone dipropionate and salts or solvates thereof, e.g., the sulphate of albuterol and the xinafoate of salmeterol.

Medicaments can also be delivered in combinations. Preferred formulations containing combinations of active ingredients contain salbutamol (e.g., as the free base or the sulphate salt) or salmeterol (e.g., as the xinafoate salt) or formoterol (e.g. as the fumarate salt) in combination with an anti-inflammatory steroid such as a beclomethasone ester (e.g., the dipropionate) or a fluticasone ester (e.g., the propionate) or budesonide. A particularly preferred combination is a combination of fluticasone propionate and salmeterol, or a salt thereof (particularly the xinafoate salt). A further combination of particular interest is budesonide and formoterol (e.g. as the fumarate salt).

It will be understood that the present disclosure is for the purpose of illustration only and the invention extends to modifications, variations and improvements thereto.

The application of which this description and claims form part may be used as a basis for priority in respect of any subsequent application. The claims of such subsequent application may be directed to any feature or combination of features described therein. They may take the form of product, method or use claims and may include, by way of example and without limitation, one or more of the following claims: