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WO1994009743A1 - Capsule a event - Google Patents

Capsule a event Download PDF

Info

Publication number
WO1994009743A1
WO1994009743A1 PCT/GB1993/002268 GB9302268W WO9409743A1 WO 1994009743 A1 WO1994009743 A1 WO 1994009743A1 GB 9302268 W GB9302268 W GB 9302268W WO 9409743 A1 WO9409743 A1 WO 9409743A1
Authority
WO
WIPO (PCT)
Prior art keywords
neck portion
capsule
plug
vent channel
capsule according
Prior art date
Application number
PCT/GB1993/002268
Other languages
English (en)
Inventor
Abdul Rashid
Howard Norman Ernest Stevens
Massoud Bakhshaee
James Robertson Miller Kelso
Mark Hegarty
James Leonard Mackie
Original Assignee
R.P. Scherer Corporation
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 R.P. Scherer Corporation filed Critical R.P. Scherer Corporation
Priority to AU54259/94A priority Critical patent/AU5425994A/en
Publication of WO1994009743A1 publication Critical patent/WO1994009743A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • A61J3/071—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 into the form of telescopically engaged two-piece capsules

Definitions

  • the present invention relates to a controlled release vented capsule construction, which comprises a male member engaged within a neck portion of a female body; the capsule including a water swellable material which swells so as to disengage the female body upon exposure of the capsule to an aqueous medium.
  • the capsule is intended to contain a pharmaceutically active material.
  • This may, for example, be useful in the treatment of medical conditions where it is desirable to administer a pharmaceutically active material to the patient sometime through the night while the patient is asleep, so as to provide a desired level of the drug in the patient in accordance with his needs, for example during the night or when he awakes. It may also be useful to allow dosing of materials at a predetermined point as the capsule passes through the gastro-intestinal tract, for example in the colon.
  • Patent specification W092/13521 (Alza Corporation) describes fluid-imbibing dispensing devices for delayed delivery of an active agent, which include an expansion means which absorbs fluid from a surrounding environment.
  • the dispensing device comprises a housing having first and second wall sections telescopically engaged with each other, particularly a capsule having a hollow cap and a hollow body; either the cap or the body is in the form of a male section fitted inside the open end of the other female section.
  • the expansion means is contained within the device and expands as it absorbs fluid, forcing apart the two sections of the device.
  • the expansion means may be a swellable polymer or an osmotic formulation which swells as it absorbs fluid.
  • one of the wall sections adjacent to the expansion means is fluid-permeable. After the sections are disengaged, fluid enters the device and comes into contact with the active agent contained within the device, thereby dispensing the active agent into the fluid.
  • European patent specification 246804 also discloses a capsule body having a groove near its mouth for the purposes of preventing the capsule distorting from its cylindrical form, which may cause difficulty in fitting the cap onto the capsule body.
  • a preferred embodiment of the controlled release capsule with which the present invention is concerned requires rhat a male member (such as a hydrogel plug) be a close fit within the neck of the female capsule body so that the male member is firmly retained and does not detach prematurely.
  • the hydrogel plug prior to hydration is a fairly rigid material. For these reasons, it may be difficult to insert the tightly fitting hydrogel plug into the mouth of a conventional cylindrical capsule body using high speed machinery. In view of the tight-fitting nature of the plug, there may be a build up of pneumatic pressure within the female body as the plug is inserted, which may tend to impede insertion.
  • the present invention provides a controlled release capsule which comprises a male member engaged within a neck portion of a female body; the capsule including a water swellable material which swells so as to disengage the female body upon exposure of the capsule to an aqueous medium; the female body having an entrance, and the neck portion having a first end nearer said entrance and a second end farther from said entrance; and a vent channel extending from said first end of the neck portion at least martially along the neck portion so as to allow venting from the capsule body during insertion of the male member into the neck portion.
  • the female body and the neck portion thereof are of substantially cylindrical configuration according to conventional practice.
  • the vent channel may extend the whole way down the neck portion. In this case, the channel remains open after insertion of the plug, and this construction is largely limited to filling of the capsule with solid materials, such as granules or tablets. Where the capsule is to contain a liquid or a flowable material such as a powder, it is preferred that the vent channel should only extend part way down the neck so that when the plug is inserted fully, it seals with an area of the neck into which the vent channel does not extend.
  • vent channels are provided.
  • the vent channel may be of any suitable cross sectional configuration, such as semi-circular, triangular, square, etc.
  • the channel may extend parallel to the longitudinal axis of the capsule or at an angle thereto; or even in a helical arrangement.
  • the neck may be narrower or wider than the remainder of the body, or of the same width.
  • the vent channel extends outwardly from the line of the capsule body by, for example, 5 to 10% of the body width.
  • the vent channel may be 5 to 10% of the width of the neck portion.
  • the walls of the female body may be formed from a wide variety of materials. They may be of homogenous constructions or they may be laminated. Examples of materials suitable for use in the construction of the body include polyethylene, polypropylene, poly(methylmethacrylate) , polyvinyl chloride, polystyrene, polyurethanes, polytetrafluoroethylene, nylons, polyformaldehydes, polyesters, cellulose acetate and nitro cellulose.
  • a preferred construction uses an impermeable coating to cover the exterior of a body which has been formed from a water soluble material.
  • the coating may conveniently be formed by dipping the body in a solution of a material which forms a layer which is impermeable to water.
  • the body might be spray-coated.
  • a preferred ciass of capsule bodies are conventional hard gelatin or starch capsule bodies coated with a solution of polyvinyl chloride or a polyvinyl acetate copolymer or an ethyl cellulose solution.
  • the male member is a plug formed of said water swellable material, such that as the plug swells it disengages from the female body.
  • the plug is preferably formed of a water-swella le hydrogel, such as described in W090/09168.
  • the male member is a hollow member closed at one end, whose opposite open end engages within the neck of the female body.
  • a water swellable material is provided within the capsule which serves to disengage the female body after a predetermined time, l ⁇ y forcing the male member and the female body apart as the material swells in the presence of water.
  • the swellable material inside the capsule may be an osmagent or an osmopolyer. Such an arrangement is disclosed in W092/13521.
  • a portion of the wall of the capsule adjacent thereto is preferably semipermeable; that is to say it is permeable to the passage of water into the capsule but impermeable to release of other substances from within the capsule.
  • Figure 1 is a cross-sectional elevation of a first embodiment
  • Figure 2 is a view from above with the cap removed.
  • Figure 3 is a partial elevational cross-section of a second embodiment.
  • the capsule shown in Figures 1 and 2 comprises a male member in the form of a plug 2 formed of a hydrogel material, inserted in neck 4 of female body 6.
  • the capsule is closed with a cap 8.
  • the body 6 comprises a cylindrical main portion 10 and closed end 12.
  • the main body narrows to the neck portion 4 which is substantially cylindrical so as to receive the male plug 2 with a close tolerance.
  • the neck portion then flares out to a flared mouth portion 14 which has an entrance 15 of a diameter substantially the same as the diameter of the main body portion 10.
  • the neck portion has a first upper end 11 adjacent the flared mouth portion and the entrance, and a second lower end 13.
  • the cylindrical neck portion is provided with a vent channel 16 shown in dotted lines which extends from the flared mouth portion part way down the neck portion and allows the release of pneumatic pressure from within the capsule body during insertion of the plug.
  • the vent channel extends only part way down the neck portion, so that when the plug is fully inserted into the neck, it seals with the lower region of the neck where the vent channel is absent. Thus, venting will only occur until the lower end of the plug passes the lower end of the vent.
  • a vent channel 16 may be provided on both sides of the neck as required.
  • the male plug 2 is formed of a hydrogel material (such as disclosed in WO 90/09168) and is usually inserted so that the upper end of the plug is level with or below the upper end of the capsule body. Whether the plug is inserted proud of the neck portion, flush with the upper end of the neck portion, or is recessed below the upper end of the neck portion can affect the time taken to expell the plug. This time will be chosen according to the desired release time of the capsule contents.
  • the capsule is then sealed with the cap 8 which is provided with detentes 18 which clip under the rim of the flared mouth portion thereby locking the cap in place.
  • the cap is formed of a water soluble material, such as gelatin.
  • the capsule body is formed of a water insoluble material, which may be a water insoluble plastics material or may be gelatin coated with a water-impermeable coating.
  • the capsule body is formed in conventional manner by dipping a mould pin into a gelatin solution and allowing to dry.
  • the gelatin is coated with a water-impermeable coating (e.g. by dip-coating) , after the capsule body has been stripped from the mould pin and trimmed to size.
  • the water-impermeable coating may be applied by spray coating or vapour deposition.
  • the cap 8 is then temporarily fitted over the capsule body such that the detentes 18 do not lock over the rim of the flared mouth portion.
  • the pre-assembled empty capsule is then stored for later filling. During filling, the cap is removed from the capsule body, and a pharmaceutically active material is filled into the capsule body. The hydrogel plug is then fitted into the neck of the body. Finally, the cap is replaced over the end of the capsule body and pushed down so that the detentes 18 clip over the rim of the flared mouth portion, thereby locking the cap in place.
  • the preassembly step is not essential.
  • the caps and bodies may be stored separately and fed separately to the filling machine, particularly if precautions are taken to prevent the caps nesting together and the bodies nesting together during storage and feeding in the filling machine.
  • the aqueous environment in the gastro-intestinal tract quickly dissolves the water soluble cap. Water is then absorbed into the hydrogel plug 2, which swells and is expelled from the body after a predetermined time interval (for example 2 to 10 hours) . This allows the contents of the capsule to be released into the patient's system gastro-intestinal tract.
  • Figure 3 shows a second embodiment which is similar to the first embodiment, except as regards the shape of the flared mouth portion and the extent of the vent channel.
  • vent channel 17 extends through the full length of the cylindrical neck portion, so that even when the plug is fully inserted, a total seal is not achieved.
  • a construction may be easier to demould than the shorter channel shown in the previous embodiment.
  • the flared mouth portion 14 is belled outwardly, such that the region of the entrance region 15A to the body portion is substantially cylindrical and of a diameter substantially the same as that of the main portion 10. The facilitates location of the plug in the mouth of the body prior to being fully inserted.
  • the narrow neck region 4 can be replaced by a neck region which is wider than the main body portion 10; or by a neck region of substantially the same width as the main body portion 10.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Medicinal Preparation (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

Capsule de libération régulée comprenant un bouchon mâle (2) constitué d'un hydrogel gonflant dans l'eau qui est introduit dans une partie (4) de goulot d'un corps femelle (6). La capsule est destinée à libérer une matière pharmaceutiquement active. Lorsque le bouchon d'hydrogel se trouve en contact avec un milieu aqueux tel que celui du tractus gastro-intestinal, il gonfle et se sépare du corps permettant ainsi à la matière active de sortir. Pour faciliter l'introduction du bouchon d'hydrogel, la partie de goulot du corps est pourvue d'au moins un canal (16) faisant office d'évent qui s'étend partiellement ou totalement sur la longueur de la partie de goulot. Les canaux faisant office d'évent réduisent la pression pneumatique qui s'exerce lorsqu'on introduit le bouchon.
PCT/GB1993/002268 1992-11-05 1993-11-04 Capsule a event WO1994009743A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU54259/94A AU5425994A (en) 1992-11-05 1993-11-04 Vented capsule

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB929223146A GB9223146D0 (en) 1992-11-05 1992-11-05 Vented capsule
GB9223146.3 1992-11-05

Publications (1)

Publication Number Publication Date
WO1994009743A1 true WO1994009743A1 (fr) 1994-05-11

Family

ID=10724554

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB1993/002268 WO1994009743A1 (fr) 1992-11-05 1993-11-04 Capsule a event

Country Status (3)

Country Link
AU (1) AU5425994A (fr)
GB (1) GB9223146D0 (fr)
WO (1) WO1994009743A1 (fr)

Cited By (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999004768A3 (fr) * 1997-07-25 1999-04-08 Alza Corp Appareil modulateur de debit pour systeme d'apport osmotique
US6508808B1 (en) 1999-12-21 2003-01-21 Alza Corporation Valve for osmotic devices
WO2004103849A1 (fr) * 2003-05-20 2004-12-02 Reckitt Benckiser (Uk) Limited Contenant soluble dans l'eau
US7163693B1 (en) 1999-07-30 2007-01-16 Smithkline Beecham Plc Multi-component pharmaceutical dosage form
US8293159B2 (en) 2007-10-15 2012-10-23 Capsugel Belgium Method and apparatus for manufacturing filled linkers
US9526763B2 (en) 2005-02-03 2016-12-27 Intarcia Therapeutics Inc. Solvent/polymer solutions as suspension vehicles
US9539200B2 (en) 2005-02-03 2017-01-10 Intarcia Therapeutics Inc. Two-piece, internal-channel osmotic delivery system flow modulator
US9572889B2 (en) 2008-02-13 2017-02-21 Intarcia Therapeutics, Inc. Devices, formulations, and methods for delivery of multiple beneficial agents
US9682127B2 (en) 2005-02-03 2017-06-20 Intarcia Therapeutics, Inc. Osmotic delivery device comprising an insulinotropic peptide and uses thereof
US9724293B2 (en) 2003-11-17 2017-08-08 Intarcia Therapeutics, Inc. Methods of manufacturing viscous liquid pharmaceutical formulations
US9889085B1 (en) 2014-09-30 2018-02-13 Intarcia Therapeutics, Inc. Therapeutic methods for the treatment of diabetes and related conditions for patients with high baseline HbA1c
USD835783S1 (en) 2016-06-02 2018-12-11 Intarcia Therapeutics, Inc. Implant placement guide
US10159714B2 (en) 2011-02-16 2018-12-25 Intarcia Therapeutics, Inc. Compositions, devices and methods of use thereof for the treatment of cancers
US10231923B2 (en) 2009-09-28 2019-03-19 Intarcia Therapeutics, Inc. Rapid establishment and/or termination of substantial steady-state drug delivery
USD860451S1 (en) 2016-06-02 2019-09-17 Intarcia Therapeutics, Inc. Implant removal tool
US10501517B2 (en) 2016-05-16 2019-12-10 Intarcia Therapeutics, Inc. Glucagon-receptor selective polypeptides and methods of use thereof
US10527170B2 (en) 2006-08-09 2020-01-07 Intarcia Therapeutics, Inc. Osmotic delivery systems and piston assemblies for use therein
US10835580B2 (en) 2017-01-03 2020-11-17 Intarcia Therapeutics, Inc. Methods comprising continuous administration of a GLP-1 receptor agonist and co-administration of a drug
US10925639B2 (en) 2015-06-03 2021-02-23 Intarcia Therapeutics, Inc. Implant placement and removal systems
USD933219S1 (en) 2018-07-13 2021-10-12 Intarcia Therapeutics, Inc. Implant removal tool and assembly
US11246913B2 (en) 2005-02-03 2022-02-15 Intarcia Therapeutics, Inc. Suspension formulation comprising an insulinotropic peptide

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2232236A1 (de) * 1972-06-30 1974-01-17 Parke Davis & Co Hartschalige steckkapseln
GB2148235A (en) * 1983-10-20 1985-05-30 Warner Lambert Co Die pressure moulded capsules
US4793493A (en) * 1986-09-18 1988-12-27 Makiej Jr Walter J Multidose capsules
WO1990009168A1 (fr) * 1989-02-16 1990-08-23 National Research Development Corporation Dispositif de distribution

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2232236A1 (de) * 1972-06-30 1974-01-17 Parke Davis & Co Hartschalige steckkapseln
GB2148235A (en) * 1983-10-20 1985-05-30 Warner Lambert Co Die pressure moulded capsules
US4793493A (en) * 1986-09-18 1988-12-27 Makiej Jr Walter J Multidose capsules
WO1990009168A1 (fr) * 1989-02-16 1990-08-23 National Research Development Corporation Dispositif de distribution

Cited By (38)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999004768A3 (fr) * 1997-07-25 1999-04-08 Alza Corp Appareil modulateur de debit pour systeme d'apport osmotique
US6524305B1 (en) 1997-07-25 2003-02-25 Alza Corporation Osmotic delivery system flow modulator apparatus and method
US6840931B2 (en) 1997-07-25 2005-01-11 Alza Corporation Osmotic delivery system flow modulator apparatus and method
US7407500B2 (en) 1997-07-25 2008-08-05 Alza Corporation Osmotic delivery system flow modulator apparatus and method
US7163693B1 (en) 1999-07-30 2007-01-16 Smithkline Beecham Plc Multi-component pharmaceutical dosage form
US7691407B2 (en) 1999-07-30 2010-04-06 Smithkline Beecham Plc Multi-component pharmaceutical dosage form
US6508808B1 (en) 1999-12-21 2003-01-21 Alza Corporation Valve for osmotic devices
US6682522B2 (en) 1999-12-21 2004-01-27 Alza Corporation Valve for osmotic devices
WO2004103849A1 (fr) * 2003-05-20 2004-12-02 Reckitt Benckiser (Uk) Limited Contenant soluble dans l'eau
US7543707B2 (en) 2003-05-20 2009-06-09 Reckitt Benckiser (Uk) Limited Water soluble container
US9724293B2 (en) 2003-11-17 2017-08-08 Intarcia Therapeutics, Inc. Methods of manufacturing viscous liquid pharmaceutical formulations
US9526763B2 (en) 2005-02-03 2016-12-27 Intarcia Therapeutics Inc. Solvent/polymer solutions as suspension vehicles
US9539200B2 (en) 2005-02-03 2017-01-10 Intarcia Therapeutics Inc. Two-piece, internal-channel osmotic delivery system flow modulator
US9682127B2 (en) 2005-02-03 2017-06-20 Intarcia Therapeutics, Inc. Osmotic delivery device comprising an insulinotropic peptide and uses thereof
US11246913B2 (en) 2005-02-03 2022-02-15 Intarcia Therapeutics, Inc. Suspension formulation comprising an insulinotropic peptide
US10363287B2 (en) 2005-02-03 2019-07-30 Intarcia Therapeutics, Inc. Method of manufacturing an osmotic delivery device
US10527170B2 (en) 2006-08-09 2020-01-07 Intarcia Therapeutics, Inc. Osmotic delivery systems and piston assemblies for use therein
US8293159B2 (en) 2007-10-15 2012-10-23 Capsugel Belgium Method and apparatus for manufacturing filled linkers
US9572889B2 (en) 2008-02-13 2017-02-21 Intarcia Therapeutics, Inc. Devices, formulations, and methods for delivery of multiple beneficial agents
US10441528B2 (en) 2008-02-13 2019-10-15 Intarcia Therapeutics, Inc. Devices, formulations, and methods for delivery of multiple beneficial agents
US12042557B2 (en) 2009-09-28 2024-07-23 I2O Therapeutics, Inc. Rapid establishment and/or termination of substantial steady-state drug delivery
US10869830B2 (en) 2009-09-28 2020-12-22 Intarcia Therapeutics, Inc. Rapid establishment and/or termination of substantial steady-state drug delivery
US10231923B2 (en) 2009-09-28 2019-03-19 Intarcia Therapeutics, Inc. Rapid establishment and/or termination of substantial steady-state drug delivery
US10159714B2 (en) 2011-02-16 2018-12-25 Intarcia Therapeutics, Inc. Compositions, devices and methods of use thereof for the treatment of cancers
US9889085B1 (en) 2014-09-30 2018-02-13 Intarcia Therapeutics, Inc. Therapeutic methods for the treatment of diabetes and related conditions for patients with high baseline HbA1c
US10583080B2 (en) 2014-09-30 2020-03-10 Intarcia Therapeutics, Inc. Therapeutic methods for the treatment of diabetes and related conditions for patients with high baseline HbA1c
US10925639B2 (en) 2015-06-03 2021-02-23 Intarcia Therapeutics, Inc. Implant placement and removal systems
US11214607B2 (en) 2016-05-16 2022-01-04 Intarcia Therapeutics Inc. Glucagon-receptor selective polypeptides and methods of use thereof
US11840559B2 (en) 2016-05-16 2023-12-12 I2O Therapeutics, Inc. Glucagon-receptor selective polypeptides and methods of use thereof
US10501517B2 (en) 2016-05-16 2019-12-10 Intarcia Therapeutics, Inc. Glucagon-receptor selective polypeptides and methods of use thereof
USD835783S1 (en) 2016-06-02 2018-12-11 Intarcia Therapeutics, Inc. Implant placement guide
USD912249S1 (en) 2016-06-02 2021-03-02 Intarcia Therapeutics, Inc. Implant removal tool
USD840030S1 (en) 2016-06-02 2019-02-05 Intarcia Therapeutics, Inc. Implant placement guide
USD962433S1 (en) 2016-06-02 2022-08-30 Intarcia Therapeutics, Inc. Implant placement guide
USD860451S1 (en) 2016-06-02 2019-09-17 Intarcia Therapeutics, Inc. Implant removal tool
US11654183B2 (en) 2017-01-03 2023-05-23 Intarcia Therapeutics, Inc. Methods comprising continuous administration of exenatide and co-administration of a drug
US10835580B2 (en) 2017-01-03 2020-11-17 Intarcia Therapeutics, Inc. Methods comprising continuous administration of a GLP-1 receptor agonist and co-administration of a drug
USD933219S1 (en) 2018-07-13 2021-10-12 Intarcia Therapeutics, Inc. Implant removal tool and assembly

Also Published As

Publication number Publication date
AU5425994A (en) 1994-05-24
GB9223146D0 (en) 1992-12-16

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