WO2002000206A2 - Tamper-evident capsule system - Google Patents

Tamper-evident capsule system Download PDF

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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
Application number
PCT/GB2001/002825
Other languages
French (fr)
Other versions
WO2002000206A3 (en
Inventor
Victor Morrison Young
James Savage
Original Assignee
Mw Encap Limited
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 Limited filed Critical Mw Encap Limited
Priority to AU66166/01A priority Critical patent/AU6616601A/en
Publication of WO2002000206A2 publication Critical patent/WO2002000206A2/en
Publication of WO2002000206A3 publication Critical patent/WO2002000206A3/en

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.

Abstract

A tamper-evident capsule system (1) comprising an inner capsule (2) containing an active principle (3) and encapsulated within an outer capsule (4) at least partially filled with at least a tamper-evident indicator (5). Also provided is a corresponding method of rendering tamper-evident at least one capsule (2) containing at least an active principle (3) by encapsulating the capsule(s) (2) within an outer capsule (4) containing a tamper-evident indicator (5).

Description

TAMPER-EVIDENT CAPSULE SYSTEM
DESCRIPTION This invention relates to a tamper-evident capsule system for the administration of at least one active principle in single or multiple therapy (ies) .
Tampering with pharmaceutical products or other active principles encapsulated in two-piece capsules, has become of increasing concern.
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
1999, it has been a requirement for all US OTC two- piece capsules to be banded for tamper-evidence.
Companies in Europe are now using similar means for the same purpose.
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.
With hard capsules made of, say, hard gelatin, containing particulate material, a puncture hole formed in that material by, say, a hypodermic syringe, is usually sufficiently small for the particulate material to be retained in the capsule. As a consequence, tamper-evidence is not apparent.
Similarly, an associated blister pack could be punctured without evidence of tampering.
Thus, it is an object of the present invention to provide a tamper-evident capsule system which overcomes the disadvantages associated with known capsules and capsule systems discussed above, to provide evidence of tampering, particularly in relation to the contamination or other adulteration of the active principle contained therein.
Accordingly, 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.
However, 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.
Also, 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.
Further, 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.
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.
In order that the various aspects of the invention may be more fully understood, a preferred embodiment in accordance therewith will now be described by way of example and with reference to the accompanying Figure which is a sectional view of a tamper-evident capsule system with an inner, soft gelatine capsule and an outer, hard gelatine capsule.
Referring now to the Figure, 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.
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.
Thus, by encapsulating the inner capsule 2 and its contents 3 in the form of an active principle, within the outer capsule 4 filled, at least partially, with at least a tamper-evident indicator 5, there is provided 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 ■
As discussed above, the indicator 5 is a coloured liquid, such as a low viscosity oil.
However, it may take any other suitable form and may provide evidence of tampering by visual means, by smell or by a combination thereof.
Also, and in a modification of the capsule system 1 described above with reference to the drawing, 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.

Claims

1. A tamper-evident capsule system (1) comprising an inner capsule (2) containing an active principle (3) and encapsulated within an outer capsule (4) at least partially filled with at least a tamper-evident indicator (5) .
2. A system (1) according to claim 1, wherein the inner capsule (2) is made of gelatin with or without a plasticiser.
3. A system (1) according to claim 1 or 2, wherein the outer capsule (4) is made of hard gelatin.
4. A system (1) according to claim 1, 2 or 3, wherein the indicator (5) is in the form of a liquid, preferably of low viscosity.
5. A system (1) according to claim 4, wherein the indicator (5) is an oil.
6. A system (1) according to claim 1, 2 or 3, wherein the indicator (5) is a gas.
7. A system (1) according to claim 1, 2 or 3, wherein the indicator (5) is a semi-solid, solid and/or gelatinous material.
8. A system (1) according to any preceding claim, wherein the indicator is arranged to provide tamper-evidence by visible means, such as colour, and/or smell.
9. A system (1) according to any preceding claim, wherein the indicator (5) is selected to provide a secondary indication of tamper-evidence, for example, by smell, colour change, phase change or any combination thereof.
10. A system (1) according to any preceding claim, wherein the indicator (5) is coloured or colourless .
11. A system (1) according to any preceding claim, wherein the outer capsule (4) is of two-part form, preferably sealed by banding (6).
12. A system (1) according to any preceding claim, wherein the active principle (3) is particulate, liquid, semi-liquid, solid or semi- solid.
13. A system (1) according to any preceding claim, wherein the outer capsule (4) also contains, in addition to the tamper-evident indicator (5) , an active principle or other material.
14. A system (1) according to any preceding claim, wherein the contents of the inner capsule (2) include a colourant or other modifier, such as a pH indicator, capable of reacting with the indicator (5) contained in the outer capsule (4) .
15. A system (1) according to any preceding claim, wherein the inner and outer capsules (2,4) are made of the same material.
16. A system (1) according to any of claims 1 to 14, wherein the inner and outer capsules (2,4) are made of different materials.
17. A system (1) according to any preceding claim, wherein one or both of the inner and outer capsules (2,4) is or are transparent.
18. A system (1) according to any preceding claim, wherein one or both of the inner and outer capsules (2,4) is or are coated.
19. A system (1) according to any preceding claim, comprising more than one inner capsule (2) .
20. A system (1) according to any preceding claim, including outer packaging, preferably in the form of a blister pack.
21. A method of rendering tamper-evident at least one capsule (2) containing an active principle (3) , which method comprises encapsulating the capsule (s) (2) within an outer capsule (4) containing a tamper-evident indicator (5) .
22. A method according to claim 21, wherein the inner capsule (2) is made of gelatin with or without a plasticiser.
23. A method according to claim 21 or 22, wherein the outer capsule (4) is made of hard gelatin.
24. A method according to claim 21, 22 or 23, wherein the indicator (5) is provided in the form of a liquid, preferably of low viscosity.
25. A method according to claim 24, wherein the indicator (5) is provided as an oil.
26. A method according to claim 21, 22 or 23, wherein the indicator (5) is provided as a gas.
27. A method according to claim 21, 22 or 23, wherein the indicator (5) is provided as a semi- solid, solid and/or gelatinous material.
28. A method according to any of claims 21 to 27, wherein the indicator (5) provides tamper- evidence means, such as colour, and/or smell.
29. A method according to any of claims 21 to 28, wherein the indicator (5) provides a secondary indication of tamper-evidence, for example, by smell, colour change, phase change or any combination thereof.
30. A method according to any of claims 21 to
29, wherein the indicator (5) is coloured or colourless .
31. A method according to any of claims 21 to
30, wherein the outer capsule (4) is provided in two-part form, preferably sealed by banding (6) .
32. A method according to any of claims 21 to 31, wherein the active principle (3) is provided as a particulate, liquid, semi-liquid, solid or semi- solid.
33. A method according to any of claims 21 to 32, wherein the outer capsule (4) also contains, in addition to the tamper-evident indicator (5) , an active principle or other material.
34. A method according to any of claims 21 to 33, wherein the contents of the inner capsule (2) are provided with a colourant or other modifier, such as a pH indicator, capable of reacting with the indicator contained in the outer capsule (4) .
35. A method according to any of claims 21 to 34, wherein the inner and outer capsules (2,4) are made of the same material.
36. A method according to any of claims 21 to 34, wherein the inner and outer capsules (2,4) are made of different materials.
37. A method according to any of claims 21 to 36, wherein one or both of the inner and outer capsules (2,4) is or are transparent.
38. A method according to any of claims 21 to 37, wherein one or both of the inner and outer capsules (2,4) is or are coated.
39. A method according to any of claims 21 to 38, comprising more than one inner capsule (2) .
40. A method according to any of claims 21 to 39, wherein tamper-evident rendered capsule (1) is included in outer packaging, preferably in the form of a blister pack.
PCT/GB2001/002825 2000-06-26 2001-06-26 Tamper-evident capsule system WO2002000206A2 (en)

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
GB0015523.4 2000-06-26
GB0015523A GB2363982A (en) 2000-06-26 2000-06-26 Tamper-proof capsules

Publications (2)

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

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2001/002825 WO2002000206A2 (en) 2000-06-26 2001-06-26 Tamper-evident capsule system

Country Status (3)

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

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004071217A1 (en) * 2003-02-12 2004-08-26 Mw Encap Limited Encapsulated flavouring for foods
WO2006106344A2 (en) * 2005-04-06 2006-10-12 Mw Encap Limited Abuse resistant capsules
US7132443B2 (en) 2001-06-27 2006-11-07 Smithklinebeecham Corporation Fluoropyrrolidines as dipeptidyl peptidase inhibitors
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

Citations (8)

* Cited by examiner, † Cited by third party
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US1815902A (en) * 1927-07-16 1931-07-28 Nat Aniline & Chem Co Inc Device for administering medicaments
FR1454013A (en) * 1965-08-18 1966-07-22 Pluripharm Presentation of two combined medicinal products
DE2729068A1 (en) * 1977-06-28 1979-01-11 Rainer Dr Med Liedtke Releasing incompatible pharmaceuticals from capsules - by including a second capsule inside the first
FR2524311A1 (en) * 1982-04-05 1983-10-07 Azalbert Gilles Multi:effect medical capsule with compartments contg. different medica - which are ingested simultaneously for programmed release to treat patient
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
WO1996033702A1 (en) * 1995-04-26 1996-10-31 R.P. Scherer Corporation Tamper evident pharmaceutical dosage form
WO1999012516A1 (en) * 1997-09-10 1999-03-18 Morishita Jintan Co., Ltd. Multilayered soft capsule for eliminating foul breath and process for producing the same

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3702653A (en) * 1970-09-14 1972-11-14 Parke Davis & Co Package means

Patent Citations (8)

* 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 (en) * 1965-08-18 1966-07-22 Pluripharm Presentation of two combined medicinal products
DE2729068A1 (en) * 1977-06-28 1979-01-11 Rainer Dr Med Liedtke Releasing incompatible pharmaceuticals from capsules - by including a second capsule inside the first
FR2524311A1 (en) * 1982-04-05 1983-10-07 Azalbert Gilles Multi:effect medical capsule with compartments contg. different medica - which are ingested simultaneously for programmed release to treat patient
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
WO1996033702A1 (en) * 1995-04-26 1996-10-31 R.P. Scherer Corporation Tamper evident pharmaceutical dosage form
WO1999012516A1 (en) * 1997-09-10 1999-03-18 Morishita Jintan Co., Ltd. Multilayered soft capsule for eliminating foul breath and process for producing the same

Cited By (6)

* 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 (en) * 2003-02-12 2004-08-26 Mw Encap Limited Encapsulated flavouring for foods
US7682696B2 (en) 2004-09-13 2010-03-23 Sabic Innovative Plastics Ip B.V. Medical article and method of making and using the same
WO2006106344A2 (en) * 2005-04-06 2006-10-12 Mw Encap Limited Abuse resistant capsules
WO2006106344A3 (en) * 2005-04-06 2006-12-28 Mw Encap Ltd Abuse resistant capsules
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
AU6616601A (en) 2002-01-08
GB2363982A (en) 2002-01-16
WO2002000206A3 (en) 2002-04-11
GB0015523D0 (en) 2000-08-16

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