IE873338L - Medicament- containing pack. - Google Patents

Description

a » o 6 o 2 This invention relates to a medicament - containing pack for use in a device by means of which the medicament can bs administered to or by patients isxhaling through the device. The medicament is in powder form. Devices 5 are now quite well known for administering medicaments contained in capsules to patients suffering from bronchial conditions such as, for example/ bronchial asthma. It is well known for medicament in powder or other finely divided form to bs supplied in capsules 10 which are loaded by a patient into such a device.

The medicament is then released from the capsule and inhaled by the patient, usually through the mouth, but sometimes through the nose.

The specifications of PCT Application Publication 15 Ho. W082/01470 and U.K. Patent Specification Ho. 13879S«, both describe devices for dispensing medicament in powder form from capsules. In each of these previously fiascribsd devices, the capsules are mounted on a srotetffible support member on whleh each capsule In 20 turn can be brought to a position in which it is opened to enable medicament to exit from the capsule to permit it to be inhaled by a patient inhaling through a mouthpiece of the device. Xn the device described in O.K. Specification Mo. 1387954, the capsules may fes mounted in 25 a so-called blister pack. 3 There are disadvantages in the use of capsules, which are made of gelatin, to contain medicaments. Gelatin is relatively unstable and is lacking in physical strength so that the capsules need to be protected by packaging, for 5 example in glass bottles. Environmental degradation of both the capsules and their contents may occur in a relatively short time.

An object of the present invention is to provide a more convenient way of administering medicament to such patients 10 than has been possible hitherto and which avoids the need to pack medicaments in capsules.

According to the present invention there is provided a pack comprising a circular carrier disc which has a plurality of pre-filled, hermetically sealed containers formed 15 integrally therewith and arranged in a circle, each container containing directly, as herein defined, a dose of medicament in the form of a powder, the medicament being suitable for inhalation, each container being puncturable to form a hole on each side thereof to allow, in use, air to flow 20 through the container to entrain the powder contained therein.

As ussd herein, the reference to each container containing directly a dose of Qedicameat in the form of a powder is to be understood as meaning that the powder is free to come into contact with the internal wall of the container, 25 i.e., the container does not serve merely as an enclosure to house some other container which in turn contains the powder.

The pack of the present invention is preferably a blister pack, that is to say a pack comprising a $ sheet, which may be laminated, of foil or plastics material which acts as a carrier and which is provided with a number of puncturable containers called "blisters", the pack incorporating a further sheet secured on the 5 first sheet to form a cover or lid. Such blister packs are in common us® with tablets of one kind or another, but we have discovered that they can also be used with medicaments in powder form.

Our Patent Specification No. , frcm which this application is divided, claims devices for administering medicaments using the packs described herein, which devices ere also described in this specification.

The present invention is suitable for administering a variety of medicaments such as, for example, salbutamol, 15 beclomethasone dipropionate and sodium cromoglycate.

In the accompanying schematic drawings: Figure 1 is an exploded perspective view of a device according to one embodiment of the invention of Patent Specification No. 56057 and shows also a pack according 30 to the present invention; Figure 2 is a detailed view of a plunger device of che same device; Figure 3 is en elevation of another embodiment oi the invention of Patent Specification No .5b051 and also shows a 25 pack according to the present invention; Figure 4 is an exploded view of the embodiment illustrated in Figure 3, and Figure 5 is a perspective view of yet another embodiment of the invention of Patent Specification No. 5 A mouthpiece outlet 5 projects outwardly froa the cylindrical wall oil the housing 1 and cosiisun .testes with 10 the interior of the chejaber 2. & perforated guard, not shown, is provided in the mouth piece to prevent any solid particles of an undesirably large size being inhaled by a patient inhaling through the mouthpiece.

A rim or shoulder 6 i-uns round the inside wall o?; 15 the chamber 2 to provide aa annular support on which a blister pack 7 may be located.

The blister pack 7 can conveniently be a foil laminate with a plurality of puncturable containers or "blisters" 6 arranged in a circle. The blisters 8 20 are filled with medicament in powder form, having a particle sise in the range of 0°5 ~ 10 microns* The raadicaaant may be with a ph&rsnaceutically acceptable carrier such as leietose or starch in powder form. ;The blister pack is of circular disc form, and 25 is removably fitted inside the chamber so that it is replaceable when the individual doses o.i medicament contained in the blisters have been discharged. ;6 ;The chamber 2 contains a central open cylindrical support column 9 upstanding from the bottom wall 3 of the chamber, ft clamp disc member 10 is removably fitted inside the chamber 2 and has on its underside a plurality 5 of locating pegs, not shown, which engage inside the support column. The clamp member 10 is rotatable inside the chamber. In use, the clamp member is placed on top of a blister pack 7 which has already been'loaded into the chamber and is located on the support shoulder 6. The 10 blister pack 7 is preferably a circular disc of foil laminate material with blisters or containers 8. ;The clamp mesber 10 has a plurality of apertures 11 which are arranged in a circle and so spaced from each other that each of them will receive one of the blisters 8 IS of the blister pack 7. A knob 12 is upstanding from the clamp member 10 and when the lid 4 is fitted on the housing 1 the knob 12 will project through an aperture 13 in the top of the lid 4. This knob can be turned by the patient to rotate the clamp member 10 and since 20 the blisters 8 of the blister pack 7 are located in the apertures 11 in the clamp plate 10 rotation of the clamp number will elso rotate the blister ;7 ;pack. A plurality of protuberances or pips 14 are piT&wided on tha top of tha elasip (aesabsr 10 aitti en gags in a recess 15, sVtgusrs 2, on ths vndaz'side of tha eav&g 4 to EiaJca surts that aha el asp plate is correctly aligned in S position. lis will b® asaa, the knob 13 Is fluted to provide opeaiaga between the knob cad tha hols 13 through which esis can aster the ehcsohes: 2 from tha outside. ;The cover •« also has en aperture IS in which a plunger 17 contained in a pluager housing 18 ci® be received. She 10 pXuagsr has an annular shoulder IS and a spring 20 can bails b«atveas tha shoulder 19 and the bottom of, the plunger housing IS to urge tha plunger into an upper or inoperative position. I'ha pltrngar may be provided with a kaifa edge 21 or other means to enable the blister to ba opened. IS When the plunger 17 is depressed against the action of the spring 20, the lower edge portion 21 of thus plunger will pass through an aperture 22 in the plunger housing to pass through a blister 8 located in register with the plunger. Such engages ®nt will open the blister, and pesuit the 20 ruslwas© of medics® esst therefrom. This action will so ojses the blister that whan a patient inhales air will pass through the blister, the medicament bsing entrained in the air Slow jsjad asiciag through tha asouthpieee S via a transfer cavity 23 inside the chamber in coiaraunication with the 25 Mouthpiece 5. By rotation of the knob 12 the cXemp ;8 ;member 10 end the blister pack 7 can be rotated to bring each blister in turn into location beneath the plunger. The various protuberances or pips 14 will in turn engage in the recess 15 to make sure that the blister pack is 5 correctly registered with the plunger. ;It is not essential that the plunger have a knife 21 to open the blister. If desired a needle can be used to perforate the blister or the plunger itay have a pointed end or even a blunt end or any other convenient opening means 10 may be used. ;The mouthpiece cover can have a locking member 24 which can bs engaged with the pluager when 'che device is not In use to prevent accidental acmetion of the plunger. ;In use, the patient needing a dose of medicairent may 15 hold the device with the mouthpiece in his mouth.. The patient then depresses the plunger to open the blister and give access to the medicament therefrom and inhales through the mouthpiece so that the medicament will be entrained in the air flo& and will enter the lungs of the patient. If 20 desired, the mouthpiece can be provided with air inlet apertures 25 to isipsrov<3 the air flow as the patient inhales. ;In modification not illustrated she underside of the blister pack can ba supported on another clamp plate instead of the support rim or shoulder 6. 25 The blister pack is conveniently arranged to provide a sufficient numbes of individual doses for a patient for ;9 ;use duxing a convenient period such as one day or more. The housing can be modified, by providing an additional chamber, not visible, at the bottom, this additional chamber being closed by e removable cover 26. This additional 5 chamber can be used to store raplaeomsnt blister packs. ;The mouthpiece may, if desired, be arranged so that a patient may use it to inhale through the nose. ;A modified device which dogs not use tha clamp member 10 is illustrated in Figures 3 and 4. The device of this 10 Modification comprises a housing 30 having a chamber 31 therein. A mouthpiece 32 projects* outwardly from the cylindric&l wall of the housing 30 la a generally radial direction and concnunicates with the interior of the chamber 31. A perforated guard 33 is provided at the entrance to '.5 the mouthpiece 32. A rim or shoulder 34 runs round the inside wall of the chamber 31 to provide an annular support for a support member 35 in the Sosm of a circular plate or disc. This support member is arranged to receive a blister pack 36. The blister pack 33 has a plurality of frangible 20 containers 37 arranged in a circular row. These containers are in th® form of "blisters" of a generally conical form as clearly shown in Figure 4 and cosssein a madic&ntent as described with reference to Figusr® 1„ The support member 35 has a plurality of holes 38 squffil In number to the number 25 of blisters 37 of. the blistas? pack 36. The conical portion of on© blister 37 is loc&t&d in each of, the holes 38 when the 1 0 device Is Loaded and in use. An external rot&table member 39 with a knurled edge 40 Is located in face contact with the bottom of the housing 30. A spindle or the like 41 with radial projections 42 extends centrally from the 5 support member 35 through a hole 43 in the bottom of the housing 30 and into an opening 44 of complementary shape in a spigot €5 of the member 39. The spigot 45 passes through the hole 43 and the spindle 41 and 42 engages in the opening 44 so that rotation of the member 39 will cause 10 similar rotation to the support member 35. A removable cover 46 fits on top of the housing 30. An opening 47 is provided in the cover 46 and engages £ projection 48 in the housing 30 so as correctly to locate the cover. The cover 46 carries a bracket 49 on which a lever or trigger 15 50 is pivotally mounted. A plunger 51 is located on the lever or trigger SO and extends through a hole 52 in the cover. A spring 53 is provided to b The hole 52 is so positioned thet aach hole 3.8 in the support member 35 will register with this hole as the support irember 35 is rotated.

When one o£ the holes' 38 is in register with the hole 52 the trigger 50 can be depressed so that its plunger 51, 25 which may be in the fossa of a needle, will pierce through the blister 37 located in that hole (i.e. pierce the top and l i the bottom of tha blister) thereby to permit powder to exit frcsn the blister. Some powder will fall into a traylike compartment 54 Inside the chamber 31. When the patient inhales, air passes through the pierced blister 5 so that powder will be entrained in the airflow and will, with powder from the compartment 54, be withdrawn through the guard 33 and the mouthpiece 32. When the device is not in use, the mouthpiece 32 c When the device is in use and the patient inhales through the mouthpiece 32 it is, of course, essential.for air to be able to enter the interior of the chamber 31. IS Any suitable air inlets can be provided. Conveniently, however, air can enter through the hole 52 the plunger or needle 51 being smaller in diameter than the diameter of the hole 52 so that it serves as an air inlet.

Figure 5 illustrates a modified device which can 20 conveniently be used to administer two different madictsisats to a patient at separate times. Treatment of certain patients does require that they inhale two different kinds of medicament. In tho device illustrated is Figure 5, a common housing 57 contains two chamber's 25 equivalent to the chamber 2 of the embodiment illustrated in Figure 1 and ?. or to the chamber 31 1 2 of the embodiment illustrated in Figures 3 and '3. These two chambers are enclosed by removable covers SO and blister packs contained in the chambers can be rotated in the manner previously described by rotation of knurled S wheels, knobs or oth.es unaabera 59. vaovithpiaces 60 project outwardly Ssem the common housing 57, each one of these outlets 60 leading into one o£ the chambers enclosed by the common housing. Trig§er mechanisms 61 are provided to enable the blisters of the blister packs lO contained in the chambers to be pierced so that the contents thereof can be inhaled by the patient.

Claims (10)

CLAIMS:

1. A pack comprising a circular carrier disc which has a plurality of pre-filled, hermetically sealed containers formed integrally therewith and arranged in a circle, each container containing directly, as herein defined, a dose of medicament in the form of a powder, the medicament being suitable for inhalation, each container being puncturable to form a hole on each side thereof to allow, in use, air to flow through the container to entrain the powder contained therein.

2. A pack as claimed in claim 1 wherein the containers are generally conical form.

3. A pack as claimed in either preceding claim wherein the carrier disc comprises a foil laminate material.

4. A pack as claimed in any preceding claim which is in the form of a blister pack and which comprises a first sheet in which are defined a plurality of blisters, and a secured sheet secured to the first sheet to form a lid, the said blisters and the said secured sheet defining the containers betsasn them.

5. A pack as cX&ieied in any preceding claim wherein the medicament comprises s&lbut&mol or beclomethasone dipropionate in powder form.

6. A pack as claimed In any one of claims 1 to 4 wherein the medicament comprises sodium cromoglycate In powder form.

7. A pack as claimed in claim S or 6 In which the particle size of the medicament Is substantially in the range 0.5 - 10 microns'.

8. A pack as claimed in any preceding claim in which the medicament includes a solid pharmaceutically acceptable carrier.

9. A pack as claimed in claim 8 in which the carrier is lactose.

10. A pack according to claim 1, substantially as hereinbefore described with particular reference to and as illustrated in Pigs. 1-4 of the accompanying drawings. Dated this the 8th day of December, 1987 F. R. KELLY & CO. BY: EXECUTIVE 27, Clyde Road, Ballsbridge, Dublin 4. AGENTS FOR THE APPLICANTS.