GB2253200A - Inhalation apparatus and fracturable capsule for use therewith - Google Patents

Inhalation apparatus and fracturable capsule for use therewith Download PDF

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Publication number
GB2253200A
GB2253200A GB9102252A GB9102252A GB2253200A GB 2253200 A GB2253200 A GB 2253200A GB 9102252 A GB9102252 A GB 9102252A GB 9102252 A GB9102252 A GB 9102252A GB 2253200 A GB2253200 A GB 2253200A
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GB
United Kingdom
Prior art keywords
capsule
medicament
inhalation device
fracturable
shell
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
GB9102252A
Other versions
GB9102252D0 (en
Inventor
Alan Keith Langford
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Norton Healthcare Ltd
Original Assignee
Norton Healthcare Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Norton Healthcare Ltd filed Critical Norton Healthcare Ltd
Priority to GB9102252A priority Critical patent/GB2253200A/en
Publication of GB9102252D0 publication Critical patent/GB9102252D0/en
Publication of GB2253200A publication Critical patent/GB2253200A/en
Withdrawn legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/0007—Pill breaking or crushing devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/003—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
    • A61M15/0031—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up by bursting or breaking the package, i.e. without cutting or piercing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/06—Solids
    • A61M2202/064—Powder

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  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Anesthesiology (AREA)
  • Pulmonology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Preparation (AREA)

Abstract

A capsule (2) containing an inhalant medicament is so formed as to be readily fracturable to release the medicament into the air stream of an inhaler device. Preferably the capsule has areas of reduced cross section, but may be merely formed from readily crushable or fracturable material. The inhaler comprises a body having a mesh grid (48) on which the capsule sits, and part of the body (34) is movable with respect to the capsule in order to apply pressure to it and fracture it, using grid (50). A further grid (52) between the capsule and a mouth piece ensures that only the medicament exits through the mouth piece into the patient's airways. <IMAGE>

Description

APPARATUS FOR USE IN INHALATION This invention relates to a method and means for dispensing a medicament for use in inhalation.
It is known to provide an inhaler device for the administration of a drug used in the treatment of respiratory diseases, e.g. asthma, and it has been proposed to administer single dosage of drugs by providing "unit dose" capsules.
In our co-pending British Patent Application number 8914384.6 there is described a particular method of pre-piercing capsules of that type to readily facilitate access to the encapsulated medicament.
In accordance with the present invention there is provided a capsule for the containment of a medicament whereby the capsule is readily fracturable to allow egress of the medicament. There is further provided an inhalation device having means for fracturing a capsule contained therein.
In one aspect of the invention there is provided a medicament containing capsule comprising a shell formed with weakened portions whereby the shell is readily fracturable.
The shell may be made of a brittle material and the weakened portions may be in the form of areas of reduced cross section.
However, the capsule may not be formed with a shell, but may be aerated to provide microencapsulations which contain the medicament.
The capsules may be of any three-dimensional form, but are preferably spherical or substantially so.
However, they may be of cuboid, hexagonal or generally cylindrical form, the form being such that will lend itself to automatic filling, capping and manipulating during the manufacturing operations.
In another aspect of the invention there is provided an inhalation device for use with fracturable capsules, wherein there is provided a body which includes means for locating a fracturable capsule, an air inlet port and an air outlet port and means adapted to impart a force to the capsule in order to fracture the shell.
The air outlet port may comprise a mouth piece.
The means for exerting pressure on the capsule may be a part of the body of the device which is hinged to provide a pincer-like action, or it may be a manually operable plunger device, or by means capable of a twisting action.
The inhalation device may be provided with means whereby only medicament entrained air passes into and through the outlet port and the means may include a filter capable of preventing passage of parts of the fractured or fragmented shell.
The filter may be a mesh screen, and/or a spacer type device of the type described in our co-pending British Patent application number 8926543.3.
Various embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings in which: Figures 1 to 11 illustrate various "unit-dose" capsules according to one aspect of the invention, Figure 12 is a perspective view of an inhaler according to a second aspect of the invention, Figure 13 is a perspective view of an inhaler similar in some respect to that of Figure 12, Figure 14 is a section view of an alternative embodiment of an inhaler.
In Figure 1 is shown a medicament containing capsule having a shell 2 comprising a body part 4 and a cap part 6. In manufacture, a single dose of prescribed medicament powder is inserted into the base part after which the cap is assembled thereon. The cap may be held frictionally on the base e.g. by shrinkage, or by an adhesive material, or by a band 8 as illustrated in Figure 3. Alternatively the connection may be by means of the physical engagement of a projection on the cap with a groove in the base, or vice versa.
In some cases the base part 4, as seen in Figure 2 may; after being filled or part-filled with the medicament powder, be sealed by a cap or lid 10.
Other shapes of capsule are illustrated in Figures 4, 5 and 6 which show respectively substantially spherical, cuboid and hexagonal polyhedron forms, each having body portions 4 and caps 6.
In all the above cases the shell is made of a rigid but brittle material so that it can be readily crushed, fragmented or pulverized to release the medicament powder contained therein. The shell may be made of hard gelatine of the type used for oral drug preparations and specially formulated to have the required fracturing characteristics over a wide range of temperatures and humidities. With this in mind it may be treated before or after filling by dehydration or irradiation for example.
Alternatively the shell may be formed of moulded or compressed materials such as starch, lactose or other suitable pharmaceutically acceptable materials. These materials may include additives to facilitate capsule formation, during the manufacturing process of the capsules and may also contain substances to impart the desired fragmentation characteristics, either directly or after additional treatment such as heat or irradiation.
Figures 7, 8, 9 and 10 illustrate various ways in which the shell is moulded or compressed into shapes that effect ready fragmentation, and at the same time facilitate high speed automatic manipulation during the processing and filling operations.
Figures 7 and 8 illustrate a spherical capsule which is formed with fracture lines 10 of reduced cross section, which assist in ready fragmentation of the shell when subjected to pressure.
The capsules illustrated in Figures 9 and 10 have their shells formed with indentations 12 which facilitate ready fragmentation to release the medicament.
The capsule 100 illustrated in Figure 11 has a number of microencapsulations or hollow spherical "bubbles" 102 and medicament is caused to be encapsulated within those "bubbles" during the manufacturing process.
Referring nowtb Figure 12, an inhaler 20 is illustrated and has a body 22 formed with an air inlet port 24, and an air outlet port 26. The outlet port is formed in a mouth piece 28.
The body is in two parts, a base part 30, and, connected by a hinge 32 thereto at the end distal from the mouth piece is an upper part 34 The base part is formed with side walls 36 and an end wall 38. The upper part has side walls 40 and an end wall 42. When the hinged upper part 34 is closed on to the base part 30, the side walls 36, 40, the end walls 38, 42 and the mouth piece 28 together define a chamber 44 Within the chamber 44 and mounted between the side walls of the inhaler is a capsule crushing mechanism 46 comprising a grid 48 supported by the base part 30 and a further grid 50 supported between the walls 40 of the upper part 34.
A filter, in the form of a wire or plastics mesh screen 52 is provided within the mouth piece 28. The plastic screen may be moulded in one with the body of the inhaler.
In use the upper part 34 is opened about its hinge32 and the capsule 2 is placed on the grid 48.
When the hinged upper part 34 is closed onto the base part 30, the grid 50 applies pressure on the capsule, with a "nutcracker" effect to cause the shell of the capsule to fragment or disintegrate and release the medicament powder into the chamber 44. Inhalation by the patient through the mouthpiece 28 entrains the powder into the air stream and into the patient's airways.
The arrangement and design of the capsule shell is such that the fragmented parts of the shell are too large to pass through the filter 52.
In an alternative inhaler shown in Figure 13 the body 22A is in one piece and has an end wall 38A in which is formed an air inlet port 24A through which a capsule may be inserted to be seated on a grid 48A.
A plunger 53 is provided above the grid 48A and is normally urged upwardly by a spring 55 to project through its locating hole 54 in the upper surface of the body 22A, being suitably retained therein. A screen 52 and mouth piece 28 are provided in the same way as in the inhaler described with reference to Figure 12.
In operation a capsule 2 is inserted through the port 24A to rest on the grid 48A. Digital pressure on the plunger 53 against the action of the spring is effective to fragment the capsule and release medicament into the inhaler from where it is entrained in the air stream by inhalation by the patient.
In both the embodiments of Figures 12 and 13 the grids 48 and 48A may be formed with a shallow depression to locate the capsules.
The screen 52 may be replaced by, or used in conjunction with, other types of filter devices, e.g.
intermediate 'spacer" type of filters between the body of the inhaler and the mouth piece, wherein the fragmented shell portions are centrifuged by the air stream to be temporarily retained by the filter device or devices.
A centrifugal separator may be located between the crushing grid 48A and the mesh screen 52 preferably below the crushing grid 48A. In this manner air entering through port 24A will drive the centrifuge.
Other arrangements of capsule fragmenting devices within the inhaler may be provided without departing from the invention, for example, by imparting a twisting action to part or parts of the inhaler, or to the capsule itself.
As a further example, a blade or blades may be provided in place of the grids 48, 50 of Figure lt, the closure of the hinged body portion causing splitting of the shell by the blades.
Similarly the plunger 53 of Figure 13 may have its lower part formed as, or provided with, a blade or wedge shaped section to have a splitting effect on the shell.
Although the examples illustrated in Figures 12 and 13 require individual placement of each capsule, there may be included in the inhaler device means whereby capsules may be readily or automatically fed into position for fracturing, e.g. from a magazine device.
Such an arrangement is illustrated in Figure 14 where an inhaler 20A is provided with a grid 48R and a plunger 53A. A magazine chute 25 with a lid 27 is loaded with capsules 2 and attached to the plunger 53A is an extension 56 having a downwardly depending tongue 58 and an upwardly depending tongue 60. The tongues 58 and 60 are arranged to pass through slots formed in the walls of the magazine chute 25. A spring 55A surrounds the plunger 53A and urges the plunger upwardly.
In use, the magazine chute 25 is loaded with capsules 2 and depression of the plunger 53A against the action of the spring 55A first causes the tongue 60 to be lowered out of its retaining engagement with the lowermost capsule within the chute. That capsule then enters the body of the inhaler and the uppermost tongue 58 moves into retaining position in the path of the next adjacent capsule.
The plunger is then released to assume its position as seen in Figure 14, with the first capsule positioned axially below the plunger and retained by a lip 48C on the mesh 48B.
As the plunger is next depressed to crush the capsule positioned between it and the mesh 48B, the next following capsule in the magazine chute is released as just described, and the sequence is repeated.
When the crushing device of Figure 13 is used with respect to capsules of the type seen in Figure 11, the material between the "bubbles" is crushed by the plunger 53 to release the encapsulated medicament so that it may be inhaled through the mouth piece 28.
The plunger may be provided with a control system which enables it to be depressed by a predetermined amount each time, the amount of depression determining the dosage of the medicament. The amount of depression may be determined, for example, by rotation of a screw threaded plunger, rotated according to requirements or by aratchet and pawl mechanism so arranged to give a pre-determined length of stroke to the plunger.
The illustrative embodiments of the invention have been described with reference to capsules containing powdered medicament; however, it is to be understood that the capsules may, of course, contain liquid or gaseous medicaments.

Claims (19)

1. A capsule for the containment of a medicament wherein the capsule is readily fracturable to allow egress of the medicament.
2. A capsule according to claim 1 wherein the capsule comprises a shell which is readily fracturable to allow egress of the medicament.
3. A capsule according to claim 2 wherein at least part of the shell is made of a brittle material.
4. A capsule according to claims 2 or 3 wherein the shell has weakened portions in the form of areas of reduced cross section.
5. A capsule according to claim 1 which is of threedimensional form and constructed from at least two parts, and that will lend itself to automatic filling, capping and manipulating during manufacturing operations.
6. A capsule according to claim 1 wherein the medicament is encapsulated within the structure of the capsule.
7. An inhalation device for use with fracturable capsules wherein there is provided a body which includes means for locating a fracturable capsule, an air inlet port and an air outlet port and means adapted to impart a force to the capsule in order to fracture the capsule.
8. An inhalation device according to claim 7 wherein the air outlet port comprises a mouth piece.
9. An inhalation device according to claim 7 wherein the means for exerting pressure on the capsule is part of the body of the device which is hinged to provide a pincer-like action.
10. An inhalation device according to claim.7 wherein the means for exerting pressure on the capsule is a manually operable plunger device.
11. An inhalation device according to claim 7 wherein the means for exerting pressure on the capsule operates by means of a twisting action.
12. An inhalation device according to claims 7 to 11 inclusive wherein means are provided for ensuring that only medicament entrained air passes into and through the outlet port.
13. An inhalation device according to claim 12 wherein said means include a filter capable of preventing passage of parts of the fractured or fragmented shell.
14. An inhalation device according to claim 12 wherein the means include a cyclone separation device.
15. An inhalation device according to claim 12 wherein the filter is a mesh screen.
16. An inhalation device according to any of the above claims 7 to 15 wherein there is included means whereby capsules may be readily fed into position for fracturing.
17. An inhalation device according to claim 16 wherein the capsules are automatically fed into position from a magazine device.
18. An inhalation device according to any of the claims 7 to 17 wherein means are provided to fracture a capsule of the type according to claim 6 partially and sequentially.
19. A method of inhalation of a medicament whereby a medicament-containing capsule having a readily fracturable structure is placed within an inhalation device, manual manipulation of the device is effected to fracture the structure and the medicament is inhaled by suction through an air outlet port.
GB9102252A 1991-02-01 1991-02-01 Inhalation apparatus and fracturable capsule for use therewith Withdrawn GB2253200A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
GB9102252A GB2253200A (en) 1991-02-01 1991-02-01 Inhalation apparatus and fracturable capsule for use therewith

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
GB9102252A GB2253200A (en) 1991-02-01 1991-02-01 Inhalation apparatus and fracturable capsule for use therewith

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GB9102252D0 GB9102252D0 (en) 1991-03-20
GB2253200A true GB2253200A (en) 1992-09-02

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US5881719A (en) * 1995-06-30 1999-03-16 Asta Medica Aktiengesellschaft Inhaler for administering medicaments from blister packs
US6029661A (en) * 1991-08-26 2000-02-29 3M Innovative Properties Company Powder dispenser
FR2805165A1 (en) * 2000-02-23 2001-08-24 Medtronic Inc IMPLANTABLE DEVICE AND METHOD FOR ADMINISTERING A MICRO ENCAPSULE MEDICAMENT
US6418926B1 (en) * 1996-12-18 2002-07-16 Custom Focus Limited Medicament delivery and packaging
EP1238680A1 (en) * 2001-03-05 2002-09-11 Ivo Pera Inhaling device for dispersing powdered medicaments contained in a capsule through the respiratory tract
EP1245243A1 (en) * 2001-03-28 2002-10-02 Ivo Pera Pen-shaped inhaling device for dispersing powdered medicaments through the respiratory tract
WO2005089842A1 (en) * 2004-03-17 2005-09-29 Josef Eckert Inhalator, in particular a powder inhalator
US7249600B2 (en) 2001-12-14 2007-07-31 Technology Innovation Limited Medicament packaging and dispenser
US7305986B1 (en) * 1999-07-23 2007-12-11 Mannkind Corporation Unit dose capsules for use in a dry powder inhaler
US7464706B2 (en) 1999-07-23 2008-12-16 Mannkind Corporation Unit dose cartridge and dry powder inhaler
US7562769B2 (en) 2003-03-15 2009-07-21 Brintech International Limited Formulation and presentation of medicaments
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US7905228B2 (en) 2001-03-20 2011-03-15 Trudell Medical International Nebulizer apparatus and method
US8061352B2 (en) 1996-02-13 2011-11-22 Trudell Medical International Aerosol delivery apparatus and method
AU2006283113B2 (en) * 2005-08-25 2011-12-01 Oriel Therapeutics, Inc. Drug containment systems with sticks, related kits, dry powder inhalers and methods
US8074642B2 (en) 2002-05-21 2011-12-13 Trudell Medical International Visual indicator for an aerosol medication delivery apparatus and system
WO2012156692A1 (en) * 2011-05-13 2012-11-22 British American Tobacco (Investments) Limited Container
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US8459252B2 (en) 2002-05-02 2013-06-11 Pari Innovative Manufacturers, Inc. Aerosol medication inhalation system
US20130239964A1 (en) * 2010-11-29 2013-09-19 Sanofi-Aventis Deutschland Gmbh Medicated Module for an Inhaler
US9010323B2 (en) 2008-03-13 2015-04-21 Boehringer Ingelheim Pharma Gmbh & Co. Kg Inhaler and sieve for an inhaler
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US9192675B2 (en) 2008-06-13 2015-11-24 Mankind Corporation Dry powder inhaler and system for drug delivery
US9220687B2 (en) 2008-12-29 2015-12-29 Mannkind Corporation Substituted diketopiperazine analogs for use as drug delivery agents
US9233159B2 (en) 2011-10-24 2016-01-12 Mannkind Corporation Methods and compositions for treating pain
US9241903B2 (en) 2006-02-22 2016-01-26 Mannkind Corporation Method for improving the pharmaceutic properties of microparticles comprising diketopiperazine and an active agent
US9283193B2 (en) 2005-09-14 2016-03-15 Mannkind Corporation Method of drug formulation based on increasing the affinity of crystalline microparticle surfaces for active agents
US9346766B2 (en) 2004-08-20 2016-05-24 Mannkind Corporation Catalysis of diketopiperazine synthesis
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US9364436B2 (en) 2011-06-17 2016-06-14 Mannkind Corporation High capacity diketopiperazine microparticles and methods
US9630930B2 (en) 2009-06-12 2017-04-25 Mannkind Corporation Diketopiperazine microparticles with defined specific surface areas
US9662461B2 (en) 2008-06-13 2017-05-30 Mannkind Corporation Dry powder drug delivery system and methods
US9675674B2 (en) 2004-08-23 2017-06-13 Mannkind Corporation Diketopiperazine salts for drug delivery and related methods
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US9801925B2 (en) 1999-06-29 2017-10-31 Mannkind Corporation Potentiation of glucose elimination
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US9925144B2 (en) 2013-07-18 2018-03-27 Mannkind Corporation Heat-stable dry powder pharmaceutical compositions and methods
US9943571B2 (en) 2008-08-11 2018-04-17 Mannkind Corporation Use of ultrarapid acting insulin
US9983108B2 (en) 2009-03-11 2018-05-29 Mannkind Corporation Apparatus, system and method for measuring resistance of an inhaler
US10159644B2 (en) 2012-10-26 2018-12-25 Mannkind Corporation Inhalable vaccine compositions and methods
US10307464B2 (en) 2014-03-28 2019-06-04 Mannkind Corporation Use of ultrarapid acting insulin
US10342938B2 (en) 2008-06-13 2019-07-09 Mannkind Corporation Dry powder drug delivery system
US10421729B2 (en) 2013-03-15 2019-09-24 Mannkind Corporation Microcrystalline diketopiperazine compositions and methods
US10478572B2 (en) 2015-04-30 2019-11-19 Hovione Technology Ltd. Powder compartment for high dosage drug delivery
US10561806B2 (en) 2014-10-02 2020-02-18 Mannkind Corporation Mouthpiece cover for an inhaler
US10625034B2 (en) 2011-04-01 2020-04-21 Mannkind Corporation Blister package for pharmaceutical cartridges
US10786638B2 (en) 2016-07-08 2020-09-29 Trudell Medical International Nebulizer apparatus and method
US10850050B2 (en) 2016-05-19 2020-12-01 Trudell Medical International Smart valved holding chamber
US11446127B2 (en) 2013-08-05 2022-09-20 Mannkind Corporation Insufflation apparatus and methods
US11497867B2 (en) 2016-12-09 2022-11-15 Trudell Medical International Smart nebulizer
US11666801B2 (en) 2018-01-04 2023-06-06 Trudell Medical International Smart oscillating positive expiratory pressure device
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US11839716B2 (en) 2016-07-08 2023-12-12 Trudell Medical International Smart oscillating positive expiratory pressure device

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