FI81255C - Packaging for use in inhalation device - Google Patents

Description

1 81255

Packaging for use in an inhaler. - Preparation for inhalation administration.

The present invention relates to a package for a medicament according to the preamble of claim 1. The drug can be administered to patients by a special dosing device, i.e., when patients inhale through the device. The drugs may be in solid, finely divided form. Such devices are now commonly known for administering capsule-containing drugs to patients suffering from bronchial diseases such as asthma. It is generally known to have a powdered or other finely divided form of the drug in capsules which the patient places in a device sometimes referred to as "air-blowing". The drug is then released from the capsule and the patient inhales it, usually through the mouth, but sometimes through the nose.

PCT application WO82 / 01470 and GB patent 1387954 disclose devices for dispensing a drug from capsules in finely divided form. In each of these previously described devices, the capsules are mounted on a rotatable support member on which each capsule is in turn brought into a position where it is opened to remove the drug from the capsule for inhalation by the patient through the mouthpiece of the device. In the device according to GB patent publication 1387954, the capsules can be placed in a so-called blister pack.

There are several disadvantages to the use of gelatin capsules containing drugs. Gelatin is relatively unstable and lacks physical strength so that the capsules must be protected with a coating, for example in glass bottles. Environmental degradation of both the capsules and their contents can occur in a relatively short time.

It is an object of the present invention to provide a more convenient way of administering a medicament to patients who have hitherto been able to administer medicaments in the form of capsules. According to the present invention, the use of packaging medicine technology is made possible by placing the medicines in the packages according to claim 1. In other words, the packages of the invention are characterized in that each container directly contains a dose of drug in powder form suitable for inhalation, each container being pierceable to form a reciprocating hole for air to pass through the container to transport the powder therein. The definition of "directly containing a dose of drug" is to be understood herein as meaning that the powder can be in free contact with the inner wall of the container, i. the container does not merely act as a housing for another container, which in turn contains the powder. The package is preferably formed as a blister pack according to the characterizing part of claim 4. Such blister packs with various tablets are commonly used, but according to the invention it has been found that they can also be used for drugs in finely divided solid form.

For the administration of medicaments to patients, it is advantageous to use a dispensing device comprising a housing with chambers and an air inlet leading to this chamber, a receiving member inside the chamber adapted to receive a support plate provided with a plurality of containers arranged in a circle, piercing a container to open this; means for rotating the support plate in steps to align each container with the piercing member; and an outlet tube from the chamber through which the patient can inhale the drug, which drug will pass through the airflow provided by the patient's inhalation and through the outlet tube, and which device is characterized in that the receiving member is arranged to hold the container in place except

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3 81255 during said alignment, the drug being released from the opened container upon inhalation of the patient with the container in place, and that the receiving member comprises a rotatable plate provided with a plurality of through holes arranged in a circle and each hole adapted to receive a corresponding drug container. The discharge tube is suitably, but not essentially, a mouthpiece through which the patient can inhale.

The kit according to the invention is suitable for the administration of various drugs, such as salbutamol, beclomethasone dipropionate and disodium chromium glycate, by means of a dispensing device.

Some embodiments of the invention are shown in the accompanying schematic drawings, in which:

Figure 1 is an exploded perspective view of a device using a package according to the invention.

Figure 2 shows a detail of a pusher of the same device.

Figure 3 shows a side view of another embodiment of a device using a package according to the invention.

Figure 4 is an exploded view of the embodiment shown in Figure 3.

Figure 5 shows a perspective view of yet another embodiment of a device using a package according to the invention.

In the embodiment shown in Figures 1 and 2 of the drawings, the drug delivery device comprises a low cylindrical housing 1 of plastic material with a cylindrical chamber 2. This chamber is closed at one end 3 with a chamber bottom and a tightly fitted removable lid 4 at the other end of the chamber.

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The mouthpiece outlet pipe 5 protrudes from the cylindrical wall of the housing 1 and joins the interior of the chamber 2. A perforated stop (not shown) is fitted to the mouthpiece to prevent solid particles of any undesired size from passing through the mouthpiece as the patient inhales.

The rim or shoulder 6 runs around the inner limb of the chamber 2 to provide an annular support on which the blister pack 7 can be placed.

Suitably, the blister pack may be a film laminate having a plurality of rupturable containers or "bubbles" 8 formed around the periphery. These bubbles 8 are filled with a particular type of drug having a particle size of 0.5 to 10 microns. The medicament may contain a pharmaceutically acceptable carrier such as lactose or starch in various forms. Alternatively, the drug may be in liquid form. The blister pack is in the shape of a round plate and is fitted with a removable insert inside the chamber so that it is replaceable after individual doses of the drug contained in the bubbles have been removed.

The chamber 2 comprises a central open cylindrical support column 9, which rises from the bottom wall 3 of the chamber. Inside the chamber 2, a fastening member 10 is removably arranged, the lower surface of which has a plurality of guide pins (not shown) connected inside the support column. The fastener member 10 is rotatable within the chamber. In use, the fastening member 10 is placed on a bubble package 7, which is already fitted in the chamber and placed on the support shoulder 6. The blister pack 7 is preferably a circular plate of film laminate material with bubbles or containers 8. The fastener member 10 has a plurality of openings 11 made on its circumference and spaced apart so that each of them receives one blister 8 of the blister pack 7. A knob rises from the fastener member 10 12, and when the lid 4 is fitted on the housing 1, this knob 12 will protrude above the opening of the lid 4. The patient can rotate this knob to rotate the fastener member 10, and since the bubbles 8 of the blister pack 7 are located in the openings 11 in the fastener member 10, the rotation of the fastener member will also rotate the blister pack. A plurality of protrusions or marks 14 are made on the fastener member 10 which, as shown in Figure 2, engage the recesses 15 in the lower surface of the cover 4 to ensure that the fastener member is properly aligned. As will be seen, the knob 12 is grooved to provide openings between the knob and the hole 13 through which air can enter the chamber 2 from outside.

The cover 4 also has an opening 16 into which a pusher 17 in the piston cylinder 18 can be fitted. This pusher has an annular shoulder 19 and a spring 20 can be located between the shoulder 19 and the piston cylinder 18 to force the pusher to a higher or inoperative position. The pusher may have a sharp edge 21 or other means for bursting the bubble. When the pusher 17 is pressed down against the action of the spring 20, the lower edge 21 of the pusher passes through the opening 22 in the piston cylinder to pass through a bubble 8 aligned with the pusher. Such contact will burst the bubble and allow the drug to be released from it. This movement will open the bubble so that when the patient inhales air passes through the bubble, the drug enters the air stream and out through the mouthpiece 5 through the transfer cavity 23 inside the chamber in contact with the mouthpiece 5. By turning the knob 12, the fastening member 10 and the blister pack 7 can be rotated to bring each bubble in turn to the position below the pusher. The various protrusions or marks 14 will in turn engage the recesses 15 to ensure that the blister pack is exactly aligned with the pusher.

It is not essential that the pusher has a blade 21 for bursting the bubble. If desired, a needle may be used to perforate the bubble, or the pusher may have a sharp end or even a rounded end, or any suitable piercing means may be used.

The mouthpiece cover may have a locking member 24 which may engage the pusher when the device is in use to prevent accidental operation of the pusher.

When used to obtain a dose, the patient may hold the mouthpiece in his mouth. The patient then presses down on the pusher to burst the bubble and receives the drug from it, and inhales it through the mouthpiece so that the drug enters the air stream and the patient's lungs. If desired, the mouthpiece may be provided with air inlets 25 to improve airflow as the patient inhales.

In an embodiment not shown, the underside of the blister pack may be supported on a second fastening plate instead of a support rim or shoulder 6.

Suitably the blister pack is arranged to provide a sufficient number of individual doses for use by the patient over a suitable period of one or more days. The housing can be modified by arranging in the bottom an additional chamber (not shown), which is closed by a removable lid 26. This additional chamber can be used for storing blister packs.

If desired, the mouthpiece can be positioned so that the patient can use it to inhale through the nose.

A modified device for using a package according to the invention without using the fastening member 1G is shown in Figures 3 and 4. The device according to this embodiment comprises a housing 30 with a chamber 31. The mouthpiece 32 protrudes substantially radially outwardly from the cylindrical wall of the housing 30 and joins the chamber 31. The inlet of the mouthpiece 32 is

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7 81255 fitted perforated protection device 33. A rim or shoulder 34 extends around the inner wall of the chamber 31 to provide an annular support for a circular plate or disc shaped support member 35. This support member is adapted to receive a blister pack 36. This blister pack 36 has a plurality of rupturable containers 37 arranged in a circular row. These containers are usually conical "bubbles", as clearly shown in Figure 4, and contain the drug as described in connection with Figure 1. The support member 35 has a plurality of holes 38, the number of which is the same as the number of bubbles 37 in the blister pack 36. The conical portion of each bubble 37 is placed in one of the holes 38 when the device is filled and ready for use. An external rotatable member 39 with a knurled edge 40 is positioned in frontal contact with the bottom of the housing 30. The mandrel 41 or the like with its radial protrusions 42 protrudes centrally from the support member 35 through a hole in the bottom of the housing 30 into a correspondingly shaped opening 44 in the centering pin 45 of the member 39. The centering pin 45 passes through the hole 43. a similar rotation of the support member 35. The removable cover 46 fits over the top of the housing 30. An opening 47 is made in the cover 46, and the cover engages a protrusion 48 in the housing 30 to precisely position the cover. The lid 46 supports a bracket 49 on which a lever or trigger 50 is pivotally mounted. A spring 53 is arranged between the trigger or lever 50 and the top of the cover 46 to force the trigger or lever upward.

The hole 52 is positioned so that each hole 38 in the support member 35 aligns with this hole when the support member 35 is rotated.

When one of the holes 38 is aligned with the hole 52, the trigger 50 β 81255 can be depressed so that its pusher 51, which may be needle-shaped, will pierce the bubble 37 located in this hole (i.e., will pierce the top and bottom of the bubble), thus allowing the powder to exit the bubble. Some powder falls into the trough-shaped compartment 54 inside the chamber 31. As the patient inhales, air passes through the perforated bubble, whereby the powder enters a stream of air which is drawn with the powder out of the compartment 54 through the protective device 33 and the mouthpiece 32. When not in use, the mouthpiece 32 can be closed in its lid or sheath 55 with a trough-like extension 56 which engages the support 49 to prevent the pusher 51 from being pushed down through the hole 37.

When the device is used and the patient inhales through the mouthpiece 32, it is of course essential that air can enter the chamber 31. Any suitable air inlets can be arranged. However, expediently, air may enter through the hole 52, the diameter of the pusher or needle 51 being smaller than the diameter of the hole 52 so as to act as an air inlet.

Figure 5 shows a modified device that can be conveniently used to administer two different drugs to a patient at different times. The treatment of certain patients does not require them to inhale two different drugs. In the device shown in Figure 5, the common housing 57 comprises two chambers similar to the chamber 2 of the embodiment shown in Figures 1 and 2 or the chamber 31 of the embodiment shown in Figures 3 and 4. The two chambers are closed by removable lids 58 and blister packs in the chamber can be rotated previously described by rotating the knurled wheels, knobs, or other members 59. The outlet mouthpieces 60 protrude outwardly from the common housing 57, with each outlet mouthpiece 60 leading the common housing inside to enclose its own chamber. The trigger mechanisms 61 are provided

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9 81255 to pierce the blisters of the blister packs comprising the chambers so that the patient can inhale their contents.

Claims (7)

1. Packaging for use in an inhalation device, the package comprising a round support plate (7.36) having a plurality of integrally formed pre-filled airtight containers (8.37) disposed on the periphery of a circle, characterized in that each container (8.37) contains a dose of drug in powder form which comes in direct or free contact with the inner wall of the container, which drug is suitable for inhalation, wherein the container (8.37) can be perforated so that a shark on each side is formed and in use the air flows through the container to transport it in this existing powder. Packaging according to claim 1, characterized in that the containers (<88,37) are preferably in the form of conical. 3. Packaging according to claim 1 or 2, characterized in that the support plate (7.36) is a membrane laminate material. Packaging according to any of the claims presented above, characterized in that the package is in the form of a bubble package comprising a first diaphragm having a plurality of blisters and a second diaphragm attached to the first diaphragm to form a lid, while said blisters and said second membranes define the receptacles (8.37) between them. Packaging according to any one of claims 1-4, characterized in that the particle size of the drug is substantially 0.5 - 10 microns. Packaging according to any of the claims presented above, characterized in that the medicament contains a rigid, pharmaceutically acceptable carrier. 13 81 255 7. A coating according to claim 4, characterized in that the carrier is lactose.