AU759609B2 - Method for preventing the misuse of a transdermal therapeutic system - Google Patents
Method for preventing the misuse of a transdermal therapeutic system Download PDFInfo
- Publication number
- AU759609B2 AU759609B2 AU96265/98A AU9626598A AU759609B2 AU 759609 B2 AU759609 B2 AU 759609B2 AU 96265/98 A AU96265/98 A AU 96265/98A AU 9626598 A AU9626598 A AU 9626598A AU 759609 B2 AU759609 B2 AU 759609B2
- Authority
- AU
- Australia
- Prior art keywords
- tts
- active substance
- substance
- denaturant
- layer
- 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
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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
-
- 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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P23/00—Anaesthetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/04—Centrally acting analgesics, e.g. opioids
Landscapes
- Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Dermatology (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Anesthesiology (AREA)
- Neurosurgery (AREA)
- Pain & Pain Management (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Electrotherapy Devices (AREA)
- Electrolytic Production Of Non-Metals, Compounds, Apparatuses Therefor (AREA)
- Radiation-Therapy Devices (AREA)
- Saccharide Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
According to the invention, denaturing agents are added to a transdermal therapeutic system to prevent misuse in the form of unauthorised oral application.
Description
Process for the protection of a person against contamination as a result of improper, i.e. oral, application of toxic components of a transdermal therapeutic system, as well as transdermal therapeutic systems containing a denaturant The invention relates to a process for the protection of a person against contamination as a result of improper, i.e.
oral, application of toxic components of a transdermal therapeutic system (TTS), comprising at least one active substance-containing, especially pressure-sensitive adhesive layer and at least one further, active substanceimpermeable backing layer, as well as a TTS containing a denaturant.
A series of TTS present an acute danger of undesired side effects if administered orally by a person in order to extract a soluble active agent either from a new system or a used one. Infants, for example, have a tendency to stick anything interesting into their mouth and to at least suck or chew on it. This cannot be avoided especially if children happen to attain access to such systems by chance, especially systems without a release liner.
Such incidents have not yet been known to occur, but the pharmaceutical authorities increasingly fear that they might and have therefore, in various instances, demanded childproof packages. Such childproof packages have, in fact, been developed in various embodiments. However, they do not protect a child from putting a TTS in its mouth once the package has been opened or if the child somehow gets hold of a used patch. Especially in the case of TTS with active substances such as anesthetics, analgesics, tranquilizers or psychopharmacological agents, an oral Wse can lead to serious health impairments. On the other hand, addicts could be tempted to extract such active agents from transdermal therapeutic systems by means of sucking of chewing.
It is known that drinkable ethyl alcohol can be denatured and then put on the market as methylated spirit. A denaturing of pharmaceutical active agents, on the other hand, has not yet been published.
There is a need in the art to develop a process for the protection of a person against contamination as a result of improper, oral application of toxic components of a TTS in a way that makes an oral abuse of the kind mentioned above impossible, at the same time, however, avoiding a disadvantageous change in the system's therapeutic active agent and also ruling out an impairment of health in the case of improper, i.e. oral, application.
.o The process according to the invention proposes the addition of a denaturant which, as used herein, is a therapeutically oooo neutral, non-interacting substance which has a disgusting taste. Because this substance causes extremely unpleasant and unexpected experiences with respect to taste, a first oral contact with the TTS according to the invention or with Sone of its denatured layers is sufficient for achieving a spontaneous reaction with the effect of immediately spitting out the corresponding patch and thus for preventing children or drug addicts from an improper, i.e. oral, application of the active substance contained in the patch.
Thus, in accordance with the present invention there is provided transdermal therapeutic system (TTS), comprising P:\WPDOCS\CRMSPECA7464462.spedo- 17/2/03 2a at least one active substance-containing adhesive layer, and at least one further, active substance-impermeable backing layer, characterized in that the active substance-containing adhesive layer is denatured with a denaturant which has a disgusting taste.
In accordance with another aspect of the present invention there is provided process for the protection of a person against contamination as a result of improper oral application of a TTS comprising toxic components, which comprises denaturing at least the active substancecontaining adhesive layer of said TTS with a denaturant, said TTS comprising at least one active substance-containing adhesive layer and at least one further active substanceimpermeable backing layer.
One embodiment provides that a substance is used for the denaturation of a TTS which causes nausea and thus spoils .the temptation of oral application for the person concerned.
o *ooo* *oo Another embodiment of the process according to the invention provides that the substance is applied on top of the active substance-containing layer in a separate, extremely thin layer which does not prevent the permeation of the active substance.
This has the benefit that the experiencing of an extremely disgusting taste directly upon first contact of the TTS with the oral mucosa or the tongue will dissuade further oral contact before a contamination through the active substance-containing layer can occur.
As a further measure, the substance can additionally be applied to the backing layer in a separate, preferably very thin layer, thus safely achieving a further intensification of the effect of denaturation.
In this case, the separate substance layer is to be applied in a thickness of between 10 and 100 Mm, preferably between and 20 pm.
An especially advantageous embodiment of the invention further provides for the use of a substance which causes an irritation such as a burning of the oral mucosa and the tongue. One such negative experience should suffice tolastingly dissuade a child or an addict from further attempts at oral contact with a TTS. A similar effect can also be achieved if a substance is used which causes an intensely bitter taste and especially aftertaste.
An effective embodiment of the process according to the invention provides for the use of gallic acid, quinine, tannin, angostura, (pure) caffeine, lobeline, tea tree oil, certain hyphomycete cultures, denatured or coagulated substances, turpentine or ammonia as amaroids or substances jN)~: with a disgusting taste for the denaturation of at least one layer of a TSS.
For the implementation of one embodiment of the process, the invention provides for the incorporation of the substances used for denaturation in a film layer with which the-active substance-containing layer and, depending on the case, also the backing layer are coated. An especially advantageous solution provides for the use of a film layer soluble in saliva.
The process is uncomplicated and effective and protects e children and/or addicts against improper, i.e. oral, application of toxic components of a transdermal therapeutic system. Thus, the process and the TTS according to the invention present an ideal means of achieving the object as mentioned above.
Throughout this specification and the claims which follow, unless the context requires otherwise, the word "comprise", or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated integer or group of integers or steps but not the exclusion of any other integer or group of integers or steps.
The reference to any prior art in this specification is not, and should not be taken as, an acknowledgement or any form of suggestion that the prior art forms part of the common general knowledge in Australia.
Claims (12)
1. Transdermal therapeutic system (TTS), comprising at least one active substance-containing adhesive layer, and at least one further active substance-impermeable backing layer, characterized in that the active substance-containing adhesive layer is denatured with a denaturant which has a disgusting taste.
2. TTS according to claim 1, characterized in that the denaturant is also incorporated in a film layer with which the active substance-containing adhesive layer and, optionally the backing layer are coated.
3. TTS according to claim 2, characterized in that the film layer is soluble in saliva.
4. TTS according to anyone of claims 1 to 3, characterized in that said denaturant causes nausea.
5. TTS according to claim 1, characterized in that said denaturant is applied on top of the active substance- containing adhesive layer in a separate, extremely thin layer which does not prevent the permeation of the active substance. e*
6. TTS according to claim 5, characterized in that said denaturant is applied to the backing layer in the form of an additional separate, extremely thin layer.
7. TTS according to claim 5 or claim 6, characterized in that the separate substance layer is applied in a P:AWPDOCS\CRN\SPECI\746462sptdo-17/2/3 6 thickness of between 10 and 100 Am and preferably between 5 and 20 Am.
8. TTS according to anyone of claims 1 to 7, characterized in that the substance which causes a disgusting taste is a substance which causes an irritation such as burning of the oral mucosa and the tongue.
9. TTS according to anyone of claims 1 to 8, characterized in that the substance which causes a disgusting taste is a substance which causes an intensely bitter taste and especially aftertaste.
TTS according to anyone of claims 1 to 9, characterized in that the denaturant comprises gallic acid, quinine, tannin, angoustura, (pure) caffeine, lobeline, tea tree oil, hyphomycete cultures, denatured or coagulated substances, turpentine or ammonia as amaroids or substances with a disgusting taste.
11. Process for the protection of a person against contamination as a result of improper oral application of a TTS comprising toxic components, which comprises denaturing at least the active substance-containing 25 adhesive layer of said TTS with a denaturant, said TTS comprising at least one active substance-containing adhesive layer and at least one further active substance-impermeable backing layer. 1. P:\WPDOCSxCR?4PECI\74642.,pd.-7/2/03 7
12. A TTS or processes comprising same, substantially as hereinbefore described. DATED this 17th day of January, 2003 LTS LOHMANN THERAPIE-SYSTEME AG By its Patent Attorneys DAVIES COLLISON CAVE 0* 0 S*0 9 9* 99 9 I. 0@ 0 09* 0 *3 S 00 @0 S. 09 0 9 0 *SS. 5* 0 SO 99 0 S. 9 9 0S 0
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE19743484A DE19743484C1 (en) | 1997-10-01 | 1997-10-01 | Transdermal patches containing substance with unpleasant taste |
| DE19743484 | 1997-10-01 | ||
| PCT/EP1998/005955 WO1999016428A1 (en) | 1997-10-01 | 1998-09-18 | Method for preventing the misuse of a transdermal therapeutic system |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| AU9626598A AU9626598A (en) | 1999-04-23 |
| AU759609B2 true AU759609B2 (en) | 2003-04-17 |
Family
ID=7844345
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU96265/98A Ceased AU759609B2 (en) | 1997-10-01 | 1998-09-18 | Method for preventing the misuse of a transdermal therapeutic system |
Country Status (23)
| Country | Link |
|---|---|
| EP (1) | EP1019032B1 (en) |
| JP (2) | JP4755338B2 (en) |
| KR (1) | KR100552102B1 (en) |
| AT (1) | ATE228356T1 (en) |
| AU (1) | AU759609B2 (en) |
| CA (1) | CA2305432C (en) |
| DE (2) | DE19743484C1 (en) |
| DK (1) | DK1019032T3 (en) |
| ES (1) | ES2188021T3 (en) |
| HK (1) | HK1029919A1 (en) |
| HU (1) | HU226644B1 (en) |
| ID (1) | ID24333A (en) |
| IL (1) | IL134479A (en) |
| MY (1) | MY116425A (en) |
| NO (2) | NO319163B1 (en) |
| NZ (1) | NZ503643A (en) |
| PL (1) | PL193066B1 (en) |
| PT (1) | PT1019032E (en) |
| SK (1) | SK3332000A3 (en) |
| TR (1) | TR200000461T2 (en) |
| TW (1) | TW431894B (en) |
| WO (1) | WO1999016428A1 (en) |
| ZA (1) | ZA988904B (en) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE19743484C1 (en) * | 1997-10-01 | 1999-01-28 | Lohmann Therapie Syst Lts | Transdermal patches containing substance with unpleasant taste |
| GB0026137D0 (en) * | 2000-10-25 | 2000-12-13 | Euro Celtique Sa | Transdermal dosage form |
| US7867511B2 (en) * | 2004-01-23 | 2011-01-11 | Travanti Pharma Inc. | Abuse potential reduction in abusable substance dosage form |
| DE102004019916A1 (en) * | 2004-04-21 | 2005-11-17 | Grünenthal GmbH | Anti-abuse drug-containing patch |
| CN112823191A (en) * | 2018-10-17 | 2021-05-18 | 日荣新化株式会社 | Adhesive sheet and method for producing same |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1989007959A1 (en) * | 1988-02-23 | 1989-09-08 | John Mark Tucker | Occlusive body for administering a physiologically active substance |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5236714A (en) * | 1988-11-01 | 1993-08-17 | Alza Corporation | Abusable substance dosage form having reduced abuse potential |
| US5149538A (en) * | 1991-06-14 | 1992-09-22 | Warner-Lambert Company | Misuse-resistive transdermal opioid dosage form |
| DE4342174C1 (en) * | 1993-12-10 | 1995-05-11 | Lohmann Therapie Syst Lts | Transdermal therapeutic system and a method for producing a transdermal therapeutic system for the combined transdermal application of physostigmine and scopolamine for the prophylaxis and pretreatment of poisoning by highly toxic organophosphorus neurotoxins, in particular Soman and its use |
| DE19743484C1 (en) * | 1997-10-01 | 1999-01-28 | Lohmann Therapie Syst Lts | Transdermal patches containing substance with unpleasant taste |
-
1997
- 1997-10-01 DE DE19743484A patent/DE19743484C1/en not_active Expired - Fee Related
-
1998
- 1998-09-18 JP JP2000513566A patent/JP4755338B2/en not_active Expired - Lifetime
- 1998-09-18 TR TR2000/00461T patent/TR200000461T2/en unknown
- 1998-09-18 IL IL13447998A patent/IL134479A/en not_active IP Right Cessation
- 1998-09-18 PL PL339736A patent/PL193066B1/en not_active IP Right Cessation
- 1998-09-18 DK DK98950053T patent/DK1019032T3/en active
- 1998-09-18 AU AU96265/98A patent/AU759609B2/en not_active Ceased
- 1998-09-18 EP EP98950053A patent/EP1019032B1/en not_active Expired - Lifetime
- 1998-09-18 WO PCT/EP1998/005955 patent/WO1999016428A1/en active IP Right Grant
- 1998-09-18 SK SK333-2000A patent/SK3332000A3/en unknown
- 1998-09-18 PT PT98950053T patent/PT1019032E/en unknown
- 1998-09-18 AT AT98950053T patent/ATE228356T1/en active
- 1998-09-18 NZ NZ503643A patent/NZ503643A/en not_active IP Right Cessation
- 1998-09-18 HU HU0003476A patent/HU226644B1/en not_active IP Right Cessation
- 1998-09-18 CA CA002305432A patent/CA2305432C/en not_active Expired - Lifetime
- 1998-09-18 ES ES98950053T patent/ES2188021T3/en not_active Expired - Lifetime
- 1998-09-18 DE DE59806468T patent/DE59806468D1/en not_active Expired - Lifetime
- 1998-09-18 ID IDW20000399A patent/ID24333A/en unknown
- 1998-09-18 KR KR1020007003579A patent/KR100552102B1/en not_active IP Right Cessation
- 1998-09-25 TW TW087115939A patent/TW431894B/en not_active IP Right Cessation
- 1998-09-29 MY MYPI98004449A patent/MY116425A/en unknown
- 1998-09-30 ZA ZA988904A patent/ZA988904B/en unknown
-
2000
- 2000-03-22 NO NO20001492A patent/NO319163B1/en not_active IP Right Cessation
- 2000-03-31 NO NO20001691A patent/NO20001691D0/en not_active Application Discontinuation
-
2001
- 2001-01-15 HK HK01100389A patent/HK1029919A1/en not_active IP Right Cessation
-
2008
- 2008-08-20 JP JP2008212077A patent/JP2009035561A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1989007959A1 (en) * | 1988-02-23 | 1989-09-08 | John Mark Tucker | Occlusive body for administering a physiologically active substance |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FGA | Letters patent sealed or granted (standard patent) |