WO2002000206A2 - Systeme de gelule inviolable - Google Patents

Systeme de gelule inviolable Download PDF

Info

Publication number
WO2002000206A2
WO2002000206A2 PCT/GB2001/002825 GB0102825W WO0200206A2 WO 2002000206 A2 WO2002000206 A2 WO 2002000206A2 GB 0102825 W GB0102825 W GB 0102825W WO 0200206 A2 WO0200206 A2 WO 0200206A2
Authority
WO
WIPO (PCT)
Prior art keywords
capsule
indicator
tamper
evident
solid
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.)
Ceased
Application number
PCT/GB2001/002825
Other languages
English (en)
Other versions
WO2002000206A3 (fr
Inventor
Victor Morrison Young
James Savage
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.)
MW Encap Ltd
Original Assignee
MW Encap 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 MW Encap Ltd filed Critical MW Encap Ltd
Priority to AU66166/01A priority Critical patent/AU6616601A/en
Publication of WO2002000206A2 publication Critical patent/WO2002000206A2/fr
Publication of WO2002000206A3 publication Critical patent/WO2002000206A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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

Definitions

  • This invention relates to a tamper-evident capsule system for the administration of at least one active principle in single or multiple therapy (ies) .
  • Incidents such as that in the United States of America where an individual adulterated capsules with cyanide resulting in the untimely death of several people, have resulted in agencies, such as the Federal Drug Administration, bringing out legislation requiring two-piece capsules to be banded as part of a tamper-evident system. As a consequence of this legislation, all prescription capsules in the United States of America are required to be tamper-evident and from the end of
  • a major disadvantage associated with a banded two-piece capsule is that it will only show tamper- evidence if it has been split or separated. Small holes, such as those which can be caused by a hypodermic needle, leave little or no trace of the integrity of the capsule having been breached.
  • an associated blister pack could be punctured without evidence of tampering.
  • a first aspect of the invention provides a tamper-evident capsule system comprising an inner capsule containing an active principle and encapsulated within an outer capsule at least partially filled with at least a tamper-evident indicator.
  • the inner capsule may be made of any suitable material, such as gelatin with or without a plasticiser, whilst the outer capsule is preferably made of hard gelatin or any other suitable material .
  • the indicator may be in any suitable form, as long as it is capable of being released from the outer capsule when the integrity thereof is breached.
  • a preferred indicator may be in the form of a liquid, more preferably of low viscosity, for example an oil, to provide tamper-evidence by visible means and/or smell.
  • any other suitable form of indicator may be employed, for example, a gas which, again, may provide tamper-evidence by visible means, such as colour, and/or smell.
  • the indicator may be selected to provide a secondary indication of tamper-evidence, for example, by smell, colour change, phase change or any combination thereof. Further, the indicator may be coloured or colourless, as long as detection of its leakage from the outer capsule when the integrity thereof is breached, is maximised.
  • Types of tamper-evident indicator other than those mentioned above may be used, for example, semi-solid, solid and/or gelatinous materials.
  • the outer capsule is preferably of two-part form and sealed by banding or any other suitable method, whilst the inner capsule containing the active principle may also be in two-piece form, again sealed by banding, with the active principle being particulate, liquid, semi-liquid, solid or semi-solid.
  • the outer capsule may also contain, in addition to the tamper-evident indicator, an, active principle or other material
  • the contents of the inner capsule may also include a colourant or other modifier, such as a pH indicator, capable of reacting with the indicator contained in the outer capsule when, say, the integrity of the inner capsule is breached.
  • a colourant or other modifier such as a pH indicator
  • the inner and outer capsules may be made from the same or different materials and one or both may be transparent. Where the outer capsule is transparent, changes to the indicator contained therein and/or the inner capsule would be more obvious than having the outer capsule opaque. Also, with a transparent outer capsule, the inner capsule could be readily identifiable by its colour markings and/or printing or any other identifying marks.
  • One or both of the inner and outer capsules may also be coated in known manner or uncoated, as required, and the system could comprise more than one inner capsule for, say, multi-therapy purposes.
  • Packaging such as a blister pack could be used in addition to the innovative system discussed above as the integrity of such packaging could also be breached by, for example, a hypodermic syringe, with the outer capsule providing evidence of tampering.
  • a second aspect of the invention provides a method of rendering tamper-evident at least one capsule containing an active principle, which method comprises encapsulating the capsule (s) within an outer capsule containing a tamper-evident indicator.
  • the preferred characteristics of the outer capsule and/or tamper-evident indicator may be the same or similar to the preferences described above in relation to the first aspect of the invention.
  • a tamper-evident capsule system indicated generally at 1, comprises an inner one-piece, soft gelatine capsule 2 containing an active principle 3.
  • the inner capsule 2 and its contents of active principle 3 are encapsulated within an outer two- piece, hard gelatine capsule 4 at least partially filled with a tamper-evident indicator 5 which is of any suitable material capable of being released from the outer capsule 4 when the integrity of the latter is breached, for instance, by being punctured by a hypodermic needle.
  • a tamper-evident indicator 5 which is of any suitable material capable of being released from the outer capsule 4 when the integrity of the latter is breached, for instance, by being punctured by a hypodermic needle.
  • the outer capsule 4 is banded at 6 in a conventional manner.
  • the inner capsule 2 is made of any suitable material, in this particular case, plasticised gelatin, whilst the outer capsule 4 is made of a hard material, for example, non-plasticised gelatin, as is conventional in the art.
  • a tamper-evident capsule system 1 which is capable of evidencing tampering, for- example, by attempting to adulterate the contents thereof by injection of a hazardous material into the system 1 by, for example, use of a hypodermic syringe . - 1 ⁇
  • the indicator 5 is a coloured liquid, such as a low viscosity oil.
  • a liquid active principle may be included with the indicator 5 in the outer capsule 4.
  • a further advantage of the present invention is that the outer capsule 4, and to a certain extent its contents 5, provides an additional layer of protection for the inner capsule 2 and its active contents 3.

Landscapes

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

Abstract

La présente invention concerne un système (1) de gélule inviolable qui comprend une gélule intérieure (2) contenant un principe actif (3), encapsulée dans une gélule extérieure (4) au moins partiellement remplie avec au moins un indicateur (5) d'inviolabilité. Cette invention concerne aussi un procédé correspondant permettant de rendre inviolable au moins une gélule (2) contenant au moins un principe actif (3) par encapsulation de cette gélule (2) dans une gélule (4) extérieure contenant un indicateur (5) d'inviolabilité.
PCT/GB2001/002825 2000-06-26 2001-06-26 Systeme de gelule inviolable Ceased WO2002000206A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU66166/01A AU6616601A (en) 2000-06-26 2001-06-26 Tamper-evident capsule system

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0015523A GB2363982A (en) 2000-06-26 2000-06-26 Tamper-proof capsules
GB0015523.4 2000-06-26

Publications (2)

Publication Number Publication Date
WO2002000206A2 true WO2002000206A2 (fr) 2002-01-03
WO2002000206A3 WO2002000206A3 (fr) 2002-04-11

Family

ID=9894335

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2001/002825 Ceased WO2002000206A2 (fr) 2000-06-26 2001-06-26 Systeme de gelule inviolable

Country Status (3)

Country Link
AU (1) AU6616601A (fr)
GB (1) GB2363982A (fr)
WO (1) WO2002000206A2 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004071217A1 (fr) * 2003-02-12 2004-08-26 Mw Encap Limited Capsule aromatisante pour aliments
US7132443B2 (en) 2001-06-27 2006-11-07 Smithklinebeecham Corporation Fluoropyrrolidines as dipeptidyl peptidase inhibitors
WO2006106344A3 (fr) * 2005-04-06 2006-12-28 Mw Encap Ltd Capsules a l'epreuve d'abus
US7682696B2 (en) 2004-09-13 2010-03-23 Sabic Innovative Plastics Ip B.V. Medical article and method of making and using the same
US20110171281A1 (en) * 2010-01-14 2011-07-14 Karl Wei Cao Soft capsule composition and method of use

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0017673D0 (en) * 2000-07-20 2000-09-06 Mw Encap Limited Delivery device

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1815902A (en) * 1927-07-16 1931-07-28 Nat Aniline & Chem Co Inc Device for administering medicaments
FR1454013A (fr) * 1965-08-18 1966-07-22 Pluripharm Mode de présentation de deux médicaments associés
US3702653A (en) * 1970-09-14 1972-11-14 Parke Davis & Co Package means
DE2729068A1 (de) * 1977-06-28 1979-01-11 Rainer Dr Med Liedtke Verfahren zur freisetzungssteuerung von arzneimitteln aus kapseln
FR2524311A1 (fr) * 1982-04-05 1983-10-07 Azalbert Gilles Gelule compartimentee aux fins d'ingestions simultanees a effets differes
US4434893A (en) * 1983-01-14 1984-03-06 Gordon Barlow Design Tamper evident packaging
US4883182A (en) * 1985-05-31 1989-11-28 Hughes Raymond J Tamper evident capsule and insert device
US5624681A (en) * 1995-04-26 1997-04-29 R. P. Scherer Corporation Tamper evident pharmaceutical dosage form
JP3667045B2 (ja) * 1997-09-10 2005-07-06 森下仁丹株式会社 口臭除去用多重ソフトカプセルおよびその製造法

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7132443B2 (en) 2001-06-27 2006-11-07 Smithklinebeecham Corporation Fluoropyrrolidines as dipeptidyl peptidase inhibitors
WO2004071217A1 (fr) * 2003-02-12 2004-08-26 Mw Encap Limited Capsule aromatisante pour aliments
US7682696B2 (en) 2004-09-13 2010-03-23 Sabic Innovative Plastics Ip B.V. Medical article and method of making and using the same
WO2006106344A3 (fr) * 2005-04-06 2006-12-28 Mw Encap Ltd Capsules a l'epreuve d'abus
US20110171281A1 (en) * 2010-01-14 2011-07-14 Karl Wei Cao Soft capsule composition and method of use

Also Published As

Publication number Publication date
GB2363982A (en) 2002-01-16
AU6616601A (en) 2002-01-08
GB0015523D0 (en) 2000-08-16
WO2002000206A3 (fr) 2002-04-11

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