WO2011073306A1

WO2011073306A1 - Inhaler device

Info

Publication number: WO2011073306A1
Application number: PCT/EP2010/069868
Authority: WO
Inventors: Stephen John Marshall; Christopher Ferris; Sandrine Cuney; Matthew Young; Jon G. Jamin; John Mcgarva; Grant Smetham; Stephen Edward Augustyn; Laura Kaye; Sean Reynolds; Steven Dudley; Iain Breakwell; John Palmer-Feldgate
Original assignee: Novartis AG
Current assignee: Novartis AG
Priority date: 2009-12-17
Filing date: 2010-12-16
Publication date: 2011-06-23
Anticipated expiration: 2012-06-17

Abstract

The invention relates to an inhaler (1) comprising a body (2) and a cartridge (4). The cartridge forms part of, or is releasably attachable to, the body to form the inhaler. The cartridge is suitable for containing a plurality of blister packs (24). The cartridge comprises a carousel (20) which has a centre portion (25) which includes a first axis (26) about which the carousel is rotatable. The carousel further comprises a plurality of blister storage portions (22) distributed about the first axis in which a blister pack can be stored. The carousel is arranged so that it can be rotated within the inhaler to sequentially bring blister storage portions into register with a withdrawing region (16) of the inhaler such that at least a portion of the blister pack within a blister storage portion in register with the withdrawing region can be withdrawn from the cartridge.

Description

Inhaler Device

The present invention relates to an inhaler device comprising a cartridge for containing blisters containing a product, particularly a powder, for example a powdered medicament. The present invention is particularly intended for use with individual blisters that contain an inhalable powder.

It is often desirable or convenient to use a dispensing device such as an inhaler to dispense blisters and/or medicament to a patient. The dispensing device may be adapted to dispense a product, for example a medicament dose, from blisters within which the medicament is stored. This is particularly the case for inhalers where the medicament is typically in a powdered form to be inhaled by a user. It is known to have an inhaler device into which blister packs having only a single blister cavity can be inserted, opened and the medicament inhaled therefrom. However, such single dose inhalers may not be convenient for all users since additional individual blisters must be carried with the inhaler.

Multiple dose inhalers are also known which use a blister strip or disc which includes a plurality of individual blister cavities, each of which contains a powdered medicament for inhalation. In such inhalers the blister strip or disc is moved so that blister cavities are sequentially moved to a dispensing position from which the medicament can be dispensed to a user, in this case during inhalation. The blister cavities are opened when in the dispensing position, or as they are moved to that position.

Some medicaments or inhalers may require blister cavities that are comparatively large and in such cases arranging such blister cavities in blister strips or discs can result in a device which is unacceptably large, inconveniently shaped or contain too few doses of medicament to be considered acceptable to patients.

According to the present invention there is provided an inhaler comprising a body and a cartridge, the cartridge forming part of, or being releasably attachable to, the body to form the inhaler, the cartridge being suitable for containing a plurality of blister packs, the cartridge comprising a carousel, the carousel having a centre portion which includes a first axis about which the carousel is rotatable, the carousel further comprising a plurality of blister storage portions distributed about the first axis in which a blister pack can be stored, the carousel being arranged so that it can be rotated within the inhaler to sequentially bring blister storage portions into register with a withdrawing region of the inhaler such that at least a portion of the blister pack within a blister storage portion in register with the withdrawing region can be withdrawn from the cartridge.

By providing an inhaler which includes a cartridge as an integral part, or as a removable, replaceable part a multidose inhaler can be supplied rather than a single dose, refillable inhaler and this can provide significant advantages for users as they do not need to carry anything except the multidose inhaler during a time, for example a short trip, during which they would expect to take several doses of medicament. If the cartridge is replaceable a longer trip could be undertaken with the inhaler and one or more additional cartridges. The arrangement of blister packs around an axis within the carousel is advantageous for packing blisters into the carousel so the inhaler can be fabricated at a size acceptable to users while containing an acceptable number of doses. This is particularly important where large blister cavities are required. An inhaler comprising a body and a cartridge is only operable to dispense a medicament when the cartridge is coupled to the body. The body is not does not form an inhaler on its own. It should be understood that the inhaler may comprise more parts than the body and cartridge, for example a removable cover.

The cartridge is suitable for containing a plurality of blister packs and may be configured and adapted for this purpose. To withdraw a blister from the cartridge the blister may be moved away from the centre portion. The withdrawing action may comprise a pushing action from within the cartridge, a pulling action from outside the cartridge, a combination of these two actions or any other action suitable for causing at least a portion of the blister pack to be moved out of the cartridge. The blister pack may be of a known construction, numerous suitable constructions are described in the art. For example the blister pack may comprise a formed layer and a lid layer. In one embodiment the formed layer may be substantially flat except for at least one cavity formed therein and the lid layer being coupled to the formed layer to substantially enclose and seal the cavity so that a product, for example a medicament, could be stored therein. The plan area of the formed layer and the lid layer may be substantially identical so that the lid substantially exactly overlies the formed layer. The lid layer may be sealed, either directly or indirectly, to the formed layer in substantially all the areas of the formed layer that do not form cavities. The plan area of the formed layer and lid layer may be substantially rectangular or square. The blister pack may have length and width dimensions greater than 10mm or greater than 15mm and less than 25mm or less than 20mm. The cavity may be substantially circular in cross section and have a diameter of greater than 7mm or greater than 10mm and may have a diameter of less than 16mm, or less than 12mm and a height of greater than 4mm, or greater than 5mm and may have a height less than 8mm or less than 7mm. The blister pack may be arranged to have a seal land of at least 2mm, or at least 3mm around the, or each, blister cavity. In one embodiment of a blister pack, the blister pack comprises only one cavity. In an embodiment of a blister pack each cavity contains a unit portion of a powdered medicament.

In some embodiments the powder may be suitable for use as an inhaled therapy which may be for one or both of local delivery or systemic delivery to a user through inhalation. As used here, a unit portion is a predetermined amount of powdered medicament which may comprise a part or all of a therapeutic dose of said medicament.

The cartridge may be fabricated from any suitable material, but could be moulded from a plastics material. The inhaler may be arranged such that each blister storage portion is arranged such that a blister pack within the blister storage portion extends from within, or adjacent, the centre portion towards an outer peripheral edge of the carousel. A blister pack within the blister storage portion may extend substantially radially from adjacent the centre portion as this can result in an increased blister density. The blister storage portions may comprise blister slots. The blister slots being arranged to contact edges of the blister pack. The blister storage portions may comprise a clamp within or adjacent the centre portion which is adapted to releasably hold a blister in the blister storage portion until it is dispensed.

The cartridge may be integrally formed with the inhaler device and therefore non-removable from the dispensing device. Such an arrangement may, for example, provide a disposable inhaler device that can be disposed of when the carousel contains no further blister packs containing a useable product. Such an arrangement may be particularly suitable for a simple inhaler device.

The cartridge may be formed so that it is separable from the inhaler device. This would leave an inhaler having an empty cartridge receiving portion. The same cartridge or a replacement cartridge containing blister packs having the same or a different medicament product therein can be fitted into the cartridge receiving portion to enable a user to dispense the product contained therein. Providing an inhaler device with a removable and replaceable cartridge can be particularly advantageous for a dispensing device which is expensive to produce as being able to replace a used cartridge for a new cartridge can significantly extend the useful lifespan of the dispensing device and reduce the amount of waste material produced during use of the dispenser. Inserting a cartridge into a cartridge receiving portion of an inhaler may comprise opening a door in the inhaler body and inserting the cartridge into the inhaler body before closing the door so that the cartridge is substantially contained within the inhaler body. In another embodiment the inhaler body includes a recess into which the cartridge fits such that at least part of the cartridge is visible to a user in use. In a yet further embodiment the cartridge receiving portion comprises one or more edges, or sides, of the inhaler body to which the cartridge is coupled to form the inhaler.

In order to avoid wasting doses, the cartridge to be removed may have no unopened blisters remaining. The cartridge and/or dispenser may include a latch which substantially prevents removal of the cartridge when there are unopened blisters in the cartridge. In order to allow the device to be deliver medicament for the longest time possible without needing a new cartridge the cartridge fitted may contain only unopened blisters. The replacement cartridge may contain the same medicament and dose strength as the cartridge removed, or may contain a different medicament or a different dose strength within some or each blister.

The cartridge may be manually refillable, or may be arranged such that when removed from the device adding or removing blisters is substantially prohibited.

The cartridge may comprise a case within which the carousel is located, the case including a dispensing aperture aligned, in use, with the withdrawing region of a dispensing device within which the cartridge is located. The carousel may be arranged so that it can be rotated within the case to sequentially bring blister storage portions into register with the dispensing aperture such that a blister pack being withdrawn from the cartridge passes through the dispensing aperture. This is particularly useful when the cartridge is removable from the inhaler as the case can prevent unwanted access to blisters stored in the cartridge, for example it hinders access to the blisters by a child.

The case may substantially enclose the carousel and include an inner surface which may be substantially cylindrical extending along a cylinder axis. The outer surface of the case may be any suitable shape extending along a cylinder axis, for example substantially square or substantially cylindrical, and may be rotationally symmetrical or rotationally asymmetrical, for example including an asymmetric protrusion so as to assist alignment when the cartridge is inserted into the device. The case may include substantially planar end plates which extend substantially perpendicular to the cylinder axis. The carousel may also be substantially cylindrical as this enables the carousel to rotate about the cylinder axis within the case with the centre portion substantially surrounding the cylinder axis.

The blister holding portions within the cartridge may be contained within a storage area. The storage area may substantially surround the central portion, or may surround only a portion of the central portion. For example the storage area may surround more than 180° of the central portion, more than 240° or more than 300°. Additionally, or alternatively, the storage area may surround less than 350° of the central portion, less than 300°, less than 240° or less than 180°. The blister holding portions may be substantially evenly distributed about the centre portion within the storage area so that advancing the carousel requires a consistent amount of movement.

In one embodiment the cartridge has between 7 and 15 blister slots. It has been found that for some blister sizes this provides a good compromise between cartridge size and dose numbers, assuming a single dose per blister, by providing a cartridge that is suitable for use as a weekly cartridge for a single dose per day, a single cartridge for about half a month for a single dose per day or a weekly cartridge for two doses per day. Such quantities are particularly useful for a removable and replaceable cartridge. In some embodiments the cartridge may further include a carrier which is slidably arranged adjacent the dispensing aperture and arranged such that, when a blister holding portion is in register with the dispensing aperture the carrier can be moved such that it contacts the blister pack and causes at least a portion of the blister pack to move from the blister holding portion out of the cartridge. By including a carrier on the cartridge, rather than making it part of the rest of the device it can simplify the construction of the device as the alignment of carrier and carousel is easier. This is particularly useful for a removable cartridge where manufacturing tolerances can alter the final position of the cartridge within the device. In another embodiment the dispensing device includes a carrier which is slidably arranged adjacent the dispensing aperture and arranged such that, when a blister holding portion is in register with the dispensing aperture the carrier can be moved such that it contacts the blister pack and, when the carrier is moved, causes at least a portion of the blister pack to move from the blister holding portion out of the carrier.

In some embodiments the carrier can be moved such that a blister pack can be returned into the cartridge after a portion has been moved through the dispensing aperture. The blister may be returned to the same blister storage portion from which it was moved or a different blister storage portion. This means that disposal of individual blister packs is avoided as the empty blister packs can be retained within the cartridge. In some embodiments the carrier may contact a holding portion of the blister pack as this presents a low risk of substantially damaging the environmental protection provided by the cavity and lid layer. However the carrier could contact any part of the blister pack in order to move it. The carrier may contact the blister pack in a holding portion and this contact may be a touching contact, or a more positive engagement, for example a gripping contact or a slide fit contact. The carrier may remain in contact with the blister pack as the blister pack is moved out of the carrier, used and subsequently returned to the carousel, or the carrier may lose contact with the blister pack temporarily, for example, as the blister is opened or used and the inhaler may then return the blister pack to a position in which the carrier is in contact with the carrier so that the blister pack can be returned to the carousel. The carrier may engage a holding portion of the blister pack as the blister pack is rotated into register with the withdrawing region and lose contact only when the blister pack is rotated away from the withdrawing region. In another embodiment the carrier may engage a holding portion of a blister pack as the blister pack is rotated into register with the withdrawing region and lose contact only when the blister pack is rotated away from the withdrawing region or temporarily as the blister is opened or used in the inhaler.

The cartridge may include a window, possibly formed in the case, and the carousel a dose indicia associated with each blister holding portion so that a dose indicia is in register with the window which a blister slot is in register with the dispensing aperture. This provides a simple dose counter which is associated with the cartridge. The dose indicia may be any suitable visible symbol or colour, for example the indicia may comprise one or more of numerals, letters, pictures, symbols, colours, patterns or any other suitable indicia or combinations thereof.

In some embodiments the portion of the blister pack moved from the cartridge may include substantially the entire cavity, or cavities, as this makes it easier for the inhaler to engage with the cavity, or cavities, to deliver the medicament. The blister cavity may be opened as the blister pack is withdrawn from the cartridge, but it may be more convenient to open the blister cavity after it has been withdrawn from the cartridge and just prior to the delivery of the medicament.

In some embodiments, the inhaler device may include a blister opening mechanism to open the blister and allow access to the medication within the blister so that the dispensing device dispenses medication to a user. In some embodiments the blister opening mechanism may include at least one piercer and / or cutter which is adapted to pierce, cut or tear at least one access hole in the blister to allow the medicament to be dispensed from within the blister. In some of these embodiments the at least one access hole may be created in the formed layer of the blister, may be formed in the lid layer, or access holes may be formed in both. The inhaler device may include an active deagglomeration mechanism which is adapted to cause a medicament within the blister to be dispensed from the blister and delivered to a user. The active dispensing mechanism may include a power source from which energy can be supplied to the medicament to cause deagglomeration. The dispensing mechanism may include an air path along which a user may inhale, the air path adapted to direct an airflow through the dispensing device such that it entrains medicament from a blister and transports that entrained medicament to a user. The entrained medicament may be delivered to the users lungs. In one embodiment each blister pack contains an inhalable dry powder medicament formulation.

The invention also provides a cartridge for use with an inhaler device as described above, the cartridge comprising a case and a carousel located within the case, the carousel having a centre portion which includes a first axis about which the carousel is rotatable, the carousel further comprising a plurality of blister storage portions distributed about the first axis in which a blister pack can be stored. The invention also provides an inhaler comprising a cartridge receiving portion which is adapted to receive a cartridge as described above.

A kit of parts may be supplied to a user, the kit of parts comprising an inhaler as described above and at least one, and preferable a plurality of, cartridges. The cartridges each containing a plurality of blister packs. At least some of the blister packs containing a medicament product.

The invention also provides a method of using an inhaler as described above to dispense a medicament from a blister pack which is stored within a cartridge as described above, the method comprising the steps of:

a. coupling the cartridge to the inhaler;

b. rotating the carousel until a blister storage portion containing a blister pack having medicament therein is in register withdrawing portion;

c. withdrawing at least a portion of the blister pack from the cartridge;

d. using the inhaler to access the medicament within said blister pack and thereby dispense the medicament from the blister pack so that the blister pack becomes a used blister pack. The various features and embodiments of the present invention, referred to in individual sections and/or embodiments above apply, as appropriate, to other sections and/or embodiments, mutatis mutandis. Consequently features specified in one section or in connection with one embodiment may be combined with features specified in other sections and/or embodiments, as appropriate.

It should be understood that throughout this specification and in the claims that follow, unless the context requires otherwise, the word "comprise", or variations such as "comprises" or "comprising", implies the inclusion of the stated integer or step, or group of integers or steps.

The invention will now be further described, by way of example only, with reference to the following drawings in which:

Figure 1 shows a schematic view of a dispensing device and associated cartridge;

Figure 2 shows a detailed view of a cartridge; Figure 3 shows a view of the cartridge with an endplate of the case removed;

Figure 4 shows a cross-section view of the cartridge and blisters of Figure 2;

Figure 5 shows a view of a carousel filled with blisters; and

Figure 6 shows a schematic view of a carousel with one blister removed and an associated blister opening mechanism.

Figure 1 shows a dispensing device 1 for dispensing a medicament, the dispensing device comprising a body 2 and a cartridge 4' that fits into a cartridge receiving portion 3 of the body 2. In this embodiment the cartridge 4' is shown as having a substantially square shape, but could be of any shape.

A more detailed view of the outside of a substantially cylindrical cartridge 4 is shown in Figure 2. The cartridge 4 comprises a case 6 which includes a substantially cylindrical circumferential wall 8 and substantially planar endplates 10, 12. One endplate 12 includes a window 14 through which, in use, dose indicia are visible.

The cartridge 4 further includes a dispensing aperture 16 through the cylindrical wall 8 of the case and a carrier 18 which is arranged adjacent the dispensing aperture 16 and will be described in more detail below. Figure 3 shows a view of the cartridge 4 with the endplate 12 and cylindrical wall 8 not shown. The cartridge 4 includes a carousel 20 arranged within the case 6. The carousel 20 is substantially cylindrical in shape and includes a plurality of blister holding portions 22, in this case blister slots, which each contain a blister 24. The carousel 20 is rotatable within the case 6 about a centre portion 25 which surrounds a cylinder axis 26. Each blister slot 22 extends from a position adjacent the centre portion 25 substantially radially away from the cylinder axis 26 towards the cylindrical wall 8 (not shown in this figure). In this figure dose indicia, in this embodiment numbers 28 and a final warning indicia 30 can be seen marked, in this case by printing, on the carousel 20 so that an indicia associated with a blister slot 22 in register with the dispensing aperture 16 can be viewed through the window 14. Figure 4 shows a cross-section view of the cartridge and blisters of Figure 2. The blisters 24 comprise a formed layer 30 and a lid layer 32. The formed layer includes a cavity 34 and the blister comprising a handling portion 36 substantially surrounding the cavity 34. The lid layer 28 is sealed to the holding portion 26 to substantially enclose the cavity 34 such that a product therein, in this case a powdered medicament 35 (shown schematically as discs, but it should be understood that this product may be any product suitable to be stored in a blister) can be stored therein and released therefrom by Opening' the blister 24. The blister 24 can be Opened' by forming a flowpath from within the cavity 34 to outside the blister 24. The flowpath can be created by piercing, puncturing, tearing or otherwise removing at least a portion of the lid layer 32 or formed layer 30 from the cavity 34.

Figure 4 also shows the dispensing aperture 16 and an embodiment of the carrier 18 in more detail. The carrier 18 includes a rear portion 38 and a front portion 40 joined by side portions 44 (side portions can be more clearly seen in Figure 3). The rear portion 38, front portion 40 joined and side portions 44 define a blister gap 42. The rear portion 38 can be arranged within the centre portion 25 and the front portion adjacent the dispensing aperture 16. As the carousel 20 rotates within the case 6 the blisters 24 within the blister slots 22 pass through the blister gap 42. When a blister slot 22 is in register with the dispensing aperture 16 the carrier 18 can be moved radially away from the centre portion 25 such that the rear portion 38 contacts the handling portion 36 of the blister 24 and causes the blister 22 to slide through the dispensing aperture 16 such that the cavity is moved from the cartridge 4. After the blister 22 has been withdrawn by the carrier 18 and the blister either opened and used, or remaining unused, the carrier 18 can be moved radially towards the centre region 25 so that the front portion 40 contacts the handling portion 36 of the blister 24 and causes the blister 22 to slide back through the dispensing aperture 16 such that the blister 24 is moved back into the blister slot 22 within the cartridge 4. In a different embodiment, the carrier may engage an edge of the blister, for example an outermost edge of the blister. It should be noted that throughout the movement of the blister pack from within the cartridge to out of the cartridge and back into the cartridge, the carrier remains in contact with the blister pack.

Figures 5 and 6 show the carousel 20 and carrier 18 with a blister slot 22 and associated blister 24 in registration with the dispensing aperture 16, but not yet withdrawn and a blister 22 withdrawn from the carousel 20 respectively.

In Figure 6 it can be seen schematically that the blister 24 is not fully withdrawn from the blister slot 22. By leaving a portion of the handling portion 36 in the blister slot 22 when the cavity 34 is withdrawn from the cartridge 4 the return of the unopened or used blister to the cartridge is simplified.

Figure 6 also shows a schematic view of a blister opening mechanism 50. The blister opening mechanism 50 includes two piercing members 52 and 54 which are forced into the blister, in this embodiment they are forced through a gap in the carrier and through the lid of the 32 of the blister 24, to create respectively an inlet into and an outlet from the blister cavity 34. This allows a user to inhale through a mouthpiece 56 to create an airflow 58 through the blister 24 to extract the medicament 35 from the blister and deliver it to the lungs of a user. For one embodiment which includes a removable cartridge, in use a cartridge 4 containing blisters 24 is inserted into the body 2 of an inhaler 1 . A user operates the inhaler such that the carousel 20 rotates until a blister slot 22 containing a blister 24 having medicament therein is in register with the dispensing aperture 16. The carrier 18 is then operated to withdraw at least a portion of the blister 24 from the cartridge 4 through the dispensing aperture 16. The portion of the blister 24 withdrawn from the cartridge 4 includes the cavity 34, but at least a portion of the handling portion 36 remains within the blister slot. The device is then operated to open the blister 24 using the blister opening mechanism 50 and dispense the medicament therefrom such that the blister 24 becomes a used blister.

The carrier can then be operated to return the used blister, or the unopened blister 24, if it was not opened, back into the blister slot 22.

It should be understood that the invention has been described above by way of example only and that modifications in detail can be made without departing from the scope of the claims.

Claims

1 . An inhaler comprising a body and a cartridge, the cartridge forming part of, or being releasably attachable to, the body to form the inhaler, the cartridge being suitable for containing a plurality of blister packs, the cartridge comprising a carousel, the carousel having a centre portion which includes a first axis about which the carousel is rotatable, the carousel further comprising a plurality of blister storage portions distributed about the first axis in which a blister pack can be stored, the carousel being arranged so that it can be rotated within the inhaler to sequentially bring blister storage portions into register with a withdrawing region of the inhaler such that at least a portion of the blister pack within a blister storage portion in register with the withdrawing region can be withdrawn from the cartridge.

2. An inhaler as claimed in claim 1 , in which each blister storage portion is arranged such that a blister pack within the storage portion extends from within, or adjacent, the centre portion towards an edge of the carousel.

3. An inhaler as claimed in claim 2, in which each blister storage portion is arranged such that a blister pack stored within the blister storage portion extends substantially radially from adjacent the centre portion.

4. An inhaler as claimed in any preceding claim, in which the blister storage portions are substantially evenly distributed about the centre portion within a storage area of the cartridge.

5. An inhaler as claimed in any preceding claim, in which there are between 7 and 15 blister storage portions.

6. An inhaler as claimed in any preceding claim, in which the cartridge further includes a carrier, the carrier being slidably arranged adjacent the withdrawing portion such that, when a blister storage portion is in register with the withdrawing region the carrier can be moved such that it contacts a blister pack stored therein and causes at least a portion of the blister pack to move out of the carousel.

7. An inhaler as claimed in claim 6, in which the carrier is arranged such that it can be moved such that a blister pack it has moved out of the carousel is returned into the blister slot.

8. An inhaler as claimed in any preceding claim, in which the cartridge comprises a case within which the carousel is located, the case including a dispensing aperture aligned with the withdrawing region and the carousel being arranged so that it can be rotated within the case to sequentially bring blister storage portions into register with the dispensing aperture such that a blister pack being withdrawn from the cartridge passes through the dispensing aperture.

9. An inhaler as claimed in any preceding claim, in which the dispensing device further includes a window and the carousel includes a dose indicia associated with each blister storage portion, a dose indicia being in register with the window which a blister storage portion is in register with the dispensing aperture.

10. An inhaler as claimed in any preceding claim, in which the dispensing device is an inhaler and the carousel includes a plurality of blister packs, each blister pack containing an inhalable dry powder medicament formulation.

1 1 . An inhaler as claimed in any preceding claim, in which the cartridge is reversibly removable from the inhaler.

12. A cartridge for use with an inhaler as claimed in any preceding claim, the cartridge comprising a case and a carousel located within the case, the carousel having a centre portion which includes a first axis about which the carousel is rotatable, the carousel further comprising a plurality of blister storage portions distributed about the first axis in which a blister pack can be stored.

13. A method of using an inhaler as claimed in claim 1 1 to dispense a medicament from a blister pack which is stored within a reversibly removable cartridge, the cartridge being as claimed in claim 12, the method comprising the steps of:

a. inserting the cartridge into the inhaler;

c. withdrawing at least a portion of the blister pack from the cartridge;

d. using the device to access the medicament within said blister pack and thereby dispense the medicament from the blister pack so that the blister pack becomes a used blister pack.

14. A method as claimed in claim 13, in which the method further includes the step of returning the used blister pack into a blister storage portion.