GB2426202A

GB2426202A - Inhaler

Info

Publication number: GB2426202A
Application number: GB0510091A
Authority: GB
Inventors: Alfred John Bailey
Original assignee: Individual
Current assignee: Individual
Priority date: 2005-05-18
Filing date: 2005-05-18
Publication date: 2006-11-22
Also published as: GB0510091D0

Abstract

A delivery device 8 comprising a magazine 7 of individual receptacles which dispense a pre-measured amount of material, a delivery passage 12, a delivery orifice 13, an actuation mechanism 10 to move the receptacles to the dispensing position and subsequently to the disposal position and a disposal magazine 15 for used receptacles. Preferably multiple receptacles are stacked in a spring loaded 9 magazine chamber and may be automatically advanced as each receptacle is emptied. Multiple delivery magazines and disposal magazines may be provided. The magazines may contain different materials such as powder or medicaments which may be compressed by the mechanism. Each receptacle may be sealed for protection from the atmosphere by its neighbouring receptacle. The device may be an inhaler with a mouthpiece 13 and may include a counter. Used receptacles may alternatively be ejected individually.

Description

1 2426202

INHALER

This invention relates to a novel form of material delivery device. In particular the invention provides a novel form of medicament delivery and is suitable as an inhaler It is especially suited as a dry power inhaler.

Dry powder inhalers typically use blister packed individual medicaments in strip form or as a disc like magazine having a plurality of medicament carrying receptacles around its periphery. These devices are generally bulky and require complex mechanisms for indexing the strip or disc.

A limitation of this type of device is apparent during the manufacture of the blister packed medicaments.

Once a strip or disk is filled with medicament it is difficult to check the weight of the individual doses and reject or replace under or overweight doses. More often the complete strip or disc has to be rejected creating unnecessary waste in the production process.

Other dry powder inhalers use a bulk container of medicament instead of individual doses. These devices have mechanisms within the device to meter individual doses of medicament. Such devices suffer from inaccuracy of amount of medicament delivered, and do not provide a good barrier to moisture for the medicament. Typical medicaments used in the treatment of asthma suffer from agglomeration in the presence of excessive humidity. Hence shelf life is limited with such devices, and they are sensitive to ambient conditions such as humidity. It is preferable to have individually pre- metered and enclosed doses as described in this invention.

In order to improve patient compliance and/or to ensure the user carries sufficient doses, it is preferable that this type of device includes a visual dose counter. This need further complicates devices by the addition of dose counting mechanisms and dose remaining indicators.

A further limitation of the current devices is that they are only capable of delivering one type of medicament. Modifications to the devices to add a second strip, disc or bulk container to enable the delivery of two medicaments adds further complexity and increases the size of the device.

It is the aim of the present invention to address the problems discussed above.

Broadly the invention resides in the provision of a simple and compact inhaler using individual receptacles containing medicament that are arranged in a stack form, and is capable of delivering one or more medicaments with each usage. Furthermore, the invention provides a simple visual indication of remaining doses.

The invention is characterized in that it is a compact device comprising a mouthpiece through which the user inhales the medicament, a simple mechanism to prime the device with each successive dose, and a magazine of individual medicament carrying receptacles In the preferred embodiment, the device comprises of a magazine of discs or cup shaped medicament carrying receptacles. Each receptacle contains an appropriate amount of medicament.

A plurality of the medicament carrying receptacles is stacked within a tubular chamber which constrains them within the body of the device.

It would be well understood by those trained in the art that the medicament powder may be free flowing or beneficially somewhat precompacted within the receptacles.

The device is provided with a suitable indexing means such as a push button and spring mechanism which allows the receptacles to advance towards the inhalation section under the force exerted by the spring.

Depression of the push button allows a receptacle containing the medicament to advance into the inhalation section of the device. The measured quantity of the medicament can then be inhaled by the user through the mouthpiece Once the user has inhaled, the top cap of the device is twisted relative to the body by the user. The button is depressed a second time which ejects the now empty receptacle into a disposal magazine which contains a series of balls which act as spacers in the chamber. They allow the force generated by the spring to also be applied in the delivery chamber and ensures the pressure exerted by the spring to remain relatively constant as each receptacle is used.

The top section is then twisted back to its original position The inhaler is thus reset and ready for delivery of another medicament dose.

Furthermore, the arrangement for the magazine allows for more than one magazine within the device More than one receptacle e.g. a pair can be advanced into the inhalation section and thus the device may deliver combination therapies. Alternatively, by having a plurality of magazines the number of receptacles within the device can be increased which extend the time the device can be used before replacement or re-charging.

A transparent or translucent window in the side of the device body provides a simple and reliable indication of how many receptacles are remaining without the need for complex counting mechanisms. The receptacles may be marked with an appropriate numbering system or the window or device body may be calibrated with appropriate graduations and numbers.

Combination therapies can also be provided by this invention by having a plurality of compartments within the same receptacle. e.g. a pair of compartments.

Each compartment can contain different medicaments thus providing the combinational therapy It is desirable to limit the effects of moisture on the powder in such inhalers to prevent degradation of the medicament over time and to prevent changes in the powder characteristics (e g. agglomeration, flow ability) and its subsequent performance when inhaled.

To overcome this problem current devices use dry powder that is contained in a sealed device such as a blister or capsule.

The arrangement of the receptacles in this invention allows each receptacle to be sealed by the receptacle that is above it. The receptacles are kept in contact with each other by the magazine spring force.

In one embodiment the wall of the receptacle is sealed by contacting the base of the receptacle above it.

In an alternative embodiment, each receptacle is joined to the next receptacle by either welding or bonding to provide a frangible seal that is broken when the top cap is twisted relative to the body.

Thus, according to the invention the delivery device is characterised by a magazine of receptacles which dispense a pre-measured amount of material, a delivery passage, a delivery orifice, an actuation mechanism to move the receptacles to the dispensing position and subsequently to the disposal position, and a disposal magazine for the used receptacles.

A simplified embodiment of the device has a magazine of receptacles that are not transferred into the second, disposal chamber Instead the receptacles are ejected from the device and are disposed of separately by the user. This embodiment provides a device that is very compact, less complex and similar to a pen in shape and size.

The use of individual receptacles as a means of containing the dose provides advantages in the production process. Inspection of the individual doses is possible by weighing the receptacle before and after filling the medicament. The weight of the medicament is then obtained by subtracting the receptacle weight from the combined weight of receptacle and medicament.

Under or over weight doses can be rejected individually following inspection resulting in minimal waste during production The invention will now be illustrated by way of example only and with reference to the accompanying drawings, in which.

Figure 1 is a perspective view of a single receptacle.

Figure 2 is a perspective view of an alternative single receptacle.

Figure 3 is a perspective view of a compartmented single receptacle Figure 4 is a cross-sectional view of the device with a single magazine and disposal chamber Figure 5 is a cross-sectional view of the device with a single magazine and disposal chamber with the top cap rotated Figure 6 is a cross-sectional view of the device body Figure 7 is a cross- sectional view of the device body with a multiple magazine arrangement.

Figure 8 is perspective view of the device showing the remaining dose counter.

Figure 9 is a cross sectional view of the stack of receptacles showing the sealing arrangement Figure 10 is an alternative cross sectional view of the stack of receptacles showing an alternative sealing arrangement.

Figure 11 is an alternative cross sectional view of the stack of receptacles showing an alternative sealing arrangement.

Figure 12 is a view of an alternative embodiment of the device without the disposal magazine.

Figure 13 is a cross-sectional view of an alternative embodiment of the device without a disposal magazine.

Figure 14 is a cross-sectional view of an alternative embodiment of the device shown with the device head in its reject position.

With reference to Figurel. A single medicament dose unit is comprised of a receptacle (1) and the medicament (2) With reference to Figure 2. An alternative shaped of receptacle(3) can be accommodated in the device.

With reference to Figure 3. A combinational medicament receptacle is comprised of a compartmentecj receptacle (4) and separate medicaments(5) and (6).

With reference to Figure 4. A plurality of receptacles are stacked vertically to provide a magazine(7) within the device body(8). The stack of receptacles is loaded with a spring(9) from underneath to provide an upwards force.

When button(1O) is depressed and released a single receptacle is transferred upwards into the top cap(11) and presents the medican,ent to the inhalation chamber (12) prior to inhalation through the mouthpiece(1 3) Rotation or twisting of the top cap(11) around pivot (14) relative to the device body(8), transfers the receptacle from the magazine(7) to a position above the disposal magazine(15).

With reference to Figure 5. When button(10) is depressed and released again the receptacle is transferred downwards from the top cap into the disposal magazine(15).

The balls(16) act as spacers in the receiving magazine and controls the orientation of the receptacles to prevents them falling randomly into the disposal magazine(15) thereby allowing all of the receptacles to be transferred from the magazine into the disposal magazine.

The balls(16) also allow the spring(9) force to be applied to the disposal magazine and to maintain a constant force on each receptacles regardless of how many receptacles have been used.

When not in use the device is left in this condition. When the patient next wants to use the device the top cap(1 1) is rotated back to its original position, the button is depressed so the next receptacle with medicament is advanced into position ready for inhalation.

The device is provided with a mechanism for transferring the receptacles under the force provided by the magazine spring. When button(10) is depressed it latches down a intermediate piece(17) in the mechanism which in turn holds the transferred receptacle in the disposal magazine(1 5) whilst the top cap(11) can be rotated back ready to receive the next receptacle containing medicament. Pushing the button(10) again allows the intermediate part to unlatch allowing the next receptacle to transfer upwards into the top cap(1 1) The push button principle of the mechanism is similar to that commonly used in retractable ballpoint pens (detail not shown) With reference to Figure 6 The body(8) of the device has a magazine(7)chamber and a disposal magazine(1 5) chamber.

This body cross section is oval in shape in this embodiment. Alternative embodiments may use a circular or polygon shaped body cross section. In this embodiment, the magazine(7) and disposal magazine(15) are diametrically opposed, and to use the device the top cap (11) is turned through 180 degrees. It would be understood by someone well versed in the art that there are numerous other geometries possible. The magazine (7) and disposal magazine (15) could be side by side and the top cap would turn by an angle substantially less than 180 degrees.

With reference to Figure 7 multiple magazines e.g two magazines and two disposal chambers allow the use of combinational therapies. In this embodiment when the button is depressed two receptacles are simultaneously advanced upwards to an inhalation chamber that is common to both receptacles.

Alternatively, by having a plurality of magazines the number of receptacles is increased within the device which extends the length of time the device can be used for.

In this embodiment the device top cap(11) is twistedso that the inhalation chamber (12) aligns with magazine(18). Following the use of each medicament, the top cap(11) it is then twisted to align with disposal magazine(1 9) The empty receptacle is then transferred from the top cap.

The sequence is repeated until the magazine(18) of receptacles is emptied and transferred into the disposal chamber(1 9) When magazine (18) is empty, the top cap(11) is twisted so that the inhalation chamber aligns with a second magazine(20) this is then be used with its corresponding disposal chamber(21) With reference to Figure 8 The device has a transparent window(22) in the body(8) to enable the user to see how many receptacles are left in the magazine(7) or alternatively how many have been used.

To indicate the number the receptacles may be marked with a number(not shown) or alternatively the window or body may have numbered graduations(23) that line up with the receptacles to indicate the remaining doses. The last receptacle can be brightly coloured to enhance visibility through the window (22).

With reference to Figure 9 The magazine spring urges the receptacles to contact each other so that wall surface (24) of the receptacle (25) contacts the base surface (26) of the receptacle above (27).

The receptacles may joined together by bonding or welding to produce a frangible seal between the receptacles that is broken when the top cap is twisted. An alternative embodiment relies on the base surface of the receptacle having a suitable sealing material (28) bonded or molded to it to improve the sealing arrangement.

With reference to Figure 10 The receptacles (29) have a peripheral sealing material (30) in a groove in the receptacle.

The seal provides separation of the medicaments in each of the receptacles by sealing against the body wall (31) The receptacle may have the sealing material bonded or molded to it. Alternatively the receptacle itself may be manufactured from a suitable material that will seal against the chamber wall.

With reference to figure 11 Male and female interlocking features may be added to the receptacles to enhance sealing between them whilst providing the ability to be broken apart when required. Interlocking male (44) and female (45) features extend around the mating surfaces between adjacent receptacles.

With reference to Figure 12 An alternative embodiment of the device without a disposal magazine provides a very compact slimline device in a pen format. In this format the device is operated by rotating the head (32) of the device. A window (33) in the body provides a visual indication of the doses remaining.

With reference to Figure 13 A single magazine allows a compact slimline embodiment of the device. The receptacles (35) are allowed to advance upwards by a head(32) that rotates around pivot(36) The head has a recess(37) for accepting the receptacle.

To advance the receptacle the head is rotated anticlockwise until the recess in the head is aligned with the magazine chamber. During the rotation a ramp(38) allows the receptacle to gradually advance in a controlled manner until the recess is aligned.

The advanced receptacle aligns with the inhalation chamber(39) which allows the medicament(40) to be inhaled by the user through the mouthpiece(41).

With reference to Figure 14 To reset the device prior to use, the empty receptacle (42) is discharged by rotating the head(32) clockwise until the receptacle is clear of the body(43) The receptacle drops out of the head for disposal by the patient. The head(32) is then rotated back anticlockwise to advance the next receptacle

Claims

I A delivery device characterised by a magazine of individual receptacles which dispense a pre-measured amount of material, a delivery passage, a delivery orifice, an actuation mechanism to move the receptacles to the dispensing position and subsequently to the disposal position, and a disposal magazine for the used receptacles.

2 A delivery device characterised by a plurality of individual receptacles and a means to transfer each receptacle from a first holding position, to a second dispensing position, and following dispensing to a third disposal position, in which the second dispensing position is connected to a delivery passage which is connected to a delivery orifice.

3 A delivery device according to claim 1, in which the receptacle in the first holding position forms the top of a magazine, which is a stack of receptacles within a magazine chamber within the delivery device 4 A delivery device according to claim I or claim 2, in which the receptacle in the third disposal position forms the top of a disposal magazine, which is a stack of used receptacles within a disposal magazine chamber within the delivery device.

A delivery device according to claim 2, in which the action of transferring a receptacle from the first holding position to the second dispensing position causes all the receptacles in the magazine to move closer to the first holding position by the height of one receptacle.

6 A delivery device according to claim 3, in which the action of transferring a receptacle from the second dispensing position to the third disposal position causes all the receptacles in the disposal magazine to move further from the third disposal position by the height of one receptacle.

7 A delivery device according to claims 2 and 3, characterised by a connecting chamber between the magazine and the disposal magazine containing rolling elements and a spring, such that used receptacles fill the void generated when a receptacle is transferred and to generate an approximate constant force to the stack of receptacles.

8 A delivery device according to claim 1 to 7, characterized by a plurality of magazines 9 A delivery device according to claim 7, characterized by each magazine having a corresponding disposal magazine.

A delivery device according to claim 7, characterized by a pJurality of magazines containing different materials.

11 A delivery device according to claims 1, 2, 4, 6, 7 and 9, in which used receptacles are ejected for disposal by the user.

12 A delivery device according to claim 1-10 in which the receptacles have compartments containing one or more materials.

13 A delivery device according to claims 1-11 in which the material is a powder.

14 A delivery device according to claims 12 in which at least one of the powders is partially compressed during manufacture.

A delivery device according to claims 12 and 13, in which the action of the device compresses at least one of the materials.

16 A delivery device according to claims 1-14 in which material is a medicament. 7.

17 A delivery device according to claims 7- 15, in which a combination of pre-measured medicaments are isolated within the device and are administered at the same time.

18 A delivery device according to claims 1-16 characterised by the receptable having features that protect and isolate the material from the ambient atmosphere.

19 A receptacle according to claim 17, characterized by seals between successive receptacles.

A delivery device according to claim 17 and 16, characterised in that the receptacle has a seating element to aid sealing between the receptacles.

21 A delivery device according to claims 17-19, where sealing pressure between receptacles is maintained by means of a spring.

22 A receptacle according to claim 17-20, characterized by seals between the receptacles and the walls of the magazine chamber.

23 A delivery device according to claim 17-21 characterised in that the receptacle is moulded with suitable sealing features such as lips, rings or locking features.

24 A delivery device according to any of the preceding claims characterised in that the receptacles are joined together by bonding or welding means to produce a frangible seal between the receptacles.

A delivery device according to to any of the preceding claims, which has a window in the device body allowing visual indication of the magazine and hence the number of receptacles that are remaining for the user 26 A delivery device according to claim 24 in that the window or surrounding body of the device has graduations with or without numbers to indicate the number of receptacles remaining 27 A delivery device according to to any of the preceding claims characterised in that the receptacle is cup shaped.

28 A delivery device according to any of the preceding claims characterised in that the medicament delivery device is an inhaler 29 A delivery device according to Claim 27 characterised in that the inhaler is a dry powder inhaler.

A method for delivering pre-metered medicament and protecting it from the atmosphere during transport and use according to the preceeding claims.

31 A method for delivering pre-metered combinations of medicaments and protecting them from the atmosphere during transport and use according to claims 1-28.

32 A delivery device according to any of the proceding claims characterised in that the individual receptacles can be inspecte&by weighing or other means during the production process to allow the individual dose weights to be established 33 A delivery device substantially as described with reference to the accompanying drawings.