CZ20001025A3 - A method of preventing abuse of a transdermal therapeutic system - Google Patents

Abstract

To prevent inappropriate oral administration, denaturing, neutral, non-interacting, unpleasant-tasting substances are added to the transdermal therapeutic system.

Description

Technical field

The present invention relates to a method of protecting an individual from contamination as a result of inadmissible oral administration of toxic components of a transdermal therapeutic system (TTS) comprising at least one active ingredient comprising a particularly adhesive-coated layer and at least one additional active ingredient impermeable backing layer. TTS with denaturing agent.

BACKGROUND OF THE INVENTION

There is an acute risk of adverse events when a series of TTSs occurs when individuals, either from new or used systems, orally administer an active agent that can be released therefrom. For example, young children have the ability to put everything interesting in their mouths, or at least suck or chew. In particular, this cannot be prevented when children can accidentally access such systems, especially without a release pad. Until now, such cases have not been reported, but more and more are worried about the official medicines offices, which for this reason also express differently the requirements for child-proof packaging. Indeed, such packages have been developed in different embodiments. However, it does not protect the baby from taking the TTS into the mouth when the pack is already open or when the used patch is somehow in the hands of the child. Especially in TTSs with active substances such as narcotic drugs, pain relieving medicines, tranquillizers or psychopharmaceuticals, oral abuse can lead to serious health damage. On the other hand, drug addicts may also succumb to the temptation to release such an active substance from the transdermal therapeutic systems by sucking or chewing.

It is already known that the alcohol to be drunk is denatured to be marketed as alcohol for burning. On the other hand, denaturation of the active substances in medicaments has not yet been established.

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SUMMARY OF THE INVENTION

It is an object of the present invention to provide a method of protecting an individual in the manner described in the preamble of claim 1 such that oral abuse of the above-described type is not possible, while avoiding adverse change in the therapeutically active agent in the system.

In order to solve the problem, it is proposed to admix the therapeutically neutral and non-interacting substance with an unpleasant taste. Since this substance produces the most unpleasant and unexpected taste sensations, the first oral contact with the TTS of the invention or one of its denatured layers for spontaneous reaction is enough to spit the patch out immediately, thus detaining children and drug addicts from unauthorized oral application.

The treatment takes into account the use of a substance which causes vomiting to induce vomiting and thereby makes the affected temptation for oral administration harmful.

The modification of the process according to the invention provides for the substance to be applied to a layer containing the active substance in a separate, extremely thin and non-blocking active substance permeation. This has the advantage that, even at the first touch of the oral mucosa or tongue with TTS, prior to contamination with its own, active substance-containing layer, the most unpleasant taste experience will impair further oral contact intake.

In this case, it can furthermore be provided for application that the substance is additionally applied to the backing layer in a separate, especially very thin layer. This further reliably intensifies the denaturing effect.

In doing so, care should be taken to apply a separate layer of fabric between 10 and 100 μηι, preferably between 5 and 20 μιη.

In a particularly preferred embodiment of the invention, provision is made for the use of a substance which causes irritation such as burning of the oral mucosa and tongue. One experience that is so experienced should be sufficient for the child or addict to be permanently assisted from further attempts to plow plow contact with TTS. Moreover, a similar effect can also be achieved when a substance is used which produces an intense bitter taste, and in particular a subsequent aftertaste.

An effective modification of the process according to the invention is that in order to denature or refuse the denaturing process. The bitterness of at least one layer of TTS is used as a bitter substance. unpleasant tasting substances such as gallic acid, quinine, tannin, angostura, caffeine (pure), lobelin, tea tree oil, certain fungal cultures, bitter or precipitated substances, turpentine or ammonia.

An embodiment of the process according to the invention consists in incorporating the substances for denaturation into a coating layer with which the active substance-containing layer and optionally also the backing layer are coated. In this connection, a particularly preferred solution is to use a coating which is soluble in the oral liquid.

The method is not complicated, is effective, and protects children and / or addicts from inadmissible administration of toxic components of the transdermal therapeutic system. Thus, the method and TTS of the present invention optimally solve the task set out in the introduction.

Claims (12)

? / 2m> PATENT REQUIREMENTS A method of protecting an individual from contamination as a result of inadmissible oral administration of toxic substances of the transdermal therapeutic system (TTS) comprising at least one active ingredient comprising a particularly adhesive-coated layer and at least one additional active ingredient impermeable backing layer, that a therapeutically neutral and non-interacting substance of unpleasant taste is added to the transdermal therapeutic system during manufacture. Method according to claim 1, characterized in that the unpleasant taste substance is added at least to the layer containing the active substance. Method according to claim 1 or 2, characterized in that, for denaturing the substances used, they are incorporated into a coating layer with which the active substance-containing layer and optionally also the backing layer are coated. Method according to claim 3, characterized in that a coating layer is used which dissolves in the oral liquid. Method according to one or more of claims 1 to 4, characterized in that a substance which induces vomiting is used. Method according to one or more of Claims 1 to 5, characterized in that the substance is applied to the active substance-containing layer in a separate and permeation-resistant layer. Method according to one or more of Claims 1 to 6, characterized in that the substance is subsequently applied to the backing layer in a separate, extremely thin layer. Method according to one or more of Claims 1 to 7, characterized in that a separate layer of the substance is applied at a thickness of between 10 and 100 µm and preferably between 5 and 20 µm. • · Method according to one or more of Claims 1 to 8, characterized in that a substance which causes irritation such as burning of the oral mucosa and tongue is used. Method according to one or more of Claims 1 to 9, characterized in that a substance which produces an intense bitter taste and, in particular, a subsequent aftertaste is used. Method according to one or more of Claims 1 to 10, characterized in that, for denaturing or respiratory deposition, the process is used. The bitterness of at least one layer of TTS is used as a bitter substance. unpleasant tasting substances such as gallic acid, quinine, tannin, angostura, caffeine (pure), lobelin, tea tree oil, fungal culture, bitter or precipitated substances, turpentine or ammonia. 12. TTS, characterized in that it contains at least one active substance comprising, in particular an adhesive-coated layer, as well as at least one further active substance impermeable backing layer comprising a denaturing substance.