Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...
Patent
1998-06-23
1999-11-23
Kishore, Gollamudi S.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Web, sheet or filament bases; compositions of bandages; or...
424447, 424449, 514458, A61F 1302
Patent
active
059895853
DESCRIPTION:
BRIEF SUMMARY
FIELD OF INVENTION
The present invention relates to the transdermal administration of substances which are suited for substitution treatment of drug dependents and drug addicts, in particular to the structure of a transdermal therapeutic system (TTS) and a method for administration of such substances through intact skin. Concerning the suited substances, one could contemplate for example methadone, acetylmethadol, naltrexon, codeine or dihydrocodeine. In principle, the application of other strongly effective pain relievers is possible, for example morphine or buprenorphine. Methadone, mentioned as an example, is used in substitution therapy for opiate addicts, for example heroin addicts. One uses the L-enantiomorph as hydrochloride in the form of an aqueous solution, which is applied orally. The strongly analgesic effect of methadone is also used for drug dependent AIDS patients.
BACKGROUND OF INVENTION
Transdermal therapeutic systems for combating drug dependency and drug addiction are known, for example WO-A-9 219 226, WO-A-9 410 987, EP-B-0 113 562, EP-B-0 117 027 and EP-B-0 280 413.
The document WO-A-9 219 226 describes an application system containing lobeline for combating drug dependency. WO-A-9 410 987 relates to a combination of two application systems containing methadone. In EP-B-0 113 562, a container is suggested with which methadone can be applied through the skin. EP-B-0 117 027 describes a salve, a cream or a gel with an amount of methadone. Finally, a pharmaceutical composition is suggested in EP-B-0 280 413 for transdermal application of methadone with the aid of a permeation accelerator.
In principle, a transdermal administration of methadone and corresponding substances is preferable over an oral or parenteral application. It is apparent that a transdermal therapeutic system. (TTS) offers much greater security with respect to abusive use. For example, extraction of the drug from the TTS matrix without skilled knowledge is not possible. An abusive parenteral application by an addict to obtain satisfaction is much less of a danger than for example a solution administered orally.
A therapy using transdermal therapeutic systems can be carried out without direct supervision or without a doctor. A further advantage is the direct control of the dosage by means of the permeation surface. In withdrawal therapy, the necessary dosages can be adapted to the individual needs of the addict in simple manner. The known advantages of a transdermal application are also present, namely accommodates the first-pass effect, and better control of the blood values.
The document DE-A4 339 400 describes a drug plaster in the form of a laminate, which includes a carrier and a matrix of a single polymer and an amount of vitamin E or a vitamin E derivative as well as at least one active agent, which can be an analgesic agent. The flux J of the active agent through a membrane of defined thickness, for example through the skin, should follow the equation: coefficient K.times.agent concentration on the donor side of the membrane C.sub.o /membrane thickness h.
SUMMARY OF INVENTION
The agent flux J is thus proportional to the agent concentration C.sub.o. However, if one would replace an oral application, for example of methadone, by a transdermal application and if one will avoid low molecular alcohols as permeation promoters, then (even apart from the first-pass effect) such a high agent concentration would be necessary that DE5-A4 339 400 could not offer a solution.
The object of the present invention is solved with a transdermal therapeutic system (TTS) for the administration of methadone in the form of a racemate (D,L-methadone) or one of its enantiomers, acetylmethadol in the form of its racemate (D,L-Acetylmethadol) or one of its enantiomers, naltrexon, codeine, dihydrocodeine, morphine, buprenorphine and/or one of their pharmaceutically acceptable salts as the active agent. The system for the treatment of drug dependency or drug addiction is provided with agents, where on or over one side of the matrix is
REFERENCES:
patent: 5683711 (1997-11-01), Fischer et al.
Channavajjala Lakshmi
Hexal AG
Kishore Gollamudi S.
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