HK1029919B - Method for preventing the misuse of a transdermal therapeutic system - Google Patents

Description

The invention relates to a method for protecting a person from contamination by inadmissible oral application of toxic ingredients of a transdermal therapeutic system (TTS) comprising at least one active substance-containing layer, especially one with adhesive, and at least one additional back layer impermeable to the active substance, and a TTS with a gelling agent.

In a number of TTSs, there is an acute risk of adverse effects when people take a soluble active substance orally, whether from new or used systems. For example, infants have the ability to put anything of interest in their mouths and at least suckle or chew on it. This cannot be prevented, especially if children can accidentally access such systems, especially without a release liner. The Commission has already made a number of recommendations to the Council on the use of the TPS in the preparation of the Community's food aid programmes, and the Council has also taken a number of initiatives to improve the quality of the food supplies. The Commission has also taken a number of initiatives to improve the quality of the food supplies.

It is already known that drinking ethyl alcohol can be fermented and marketed as spirits, but the fermentation of active substances in medicinal products has not yet been known.

The purpose of the invention is to design a procedure for the protection of a person of the type described in the general term of claim 1 in such a way as to prevent oral abuse of the type described above, while at the same time avoiding adverse changes in the therapeutic active substance in the system and also to exclude harm to health from unauthorized oral application.

To solve the problem, it is proposed to use the method of the invention to add a therapeutically neutral and non-interacting substance of unpleasant taste. Because this substance causes a highly unpleasant and unexpected taste, a spontaneous reaction to the TTS of the invention or one of its plated layers is sufficient on first oral contact to spit out the patch immediately and thus to prevent children or drug addicts from inadmissible oral application of the active substance contained in the patch.

One design provides for the use of a substance to induce vomiting in order to induce the patient to be tempted to take it orally.

The method of the invention is to apply the substance in a separate, extremely thin layer on the active layer which does not impede the permeation of the active substance. This has the advantage that the first contact with the oral mucosa or tongue with the TTS, before contamination with the actual active substance, gives a highly unpleasant taste.

The method of applying the material in a separate, preferably very thin layer to the back layer can be used further, thus ensuring a further intensification of the galvanizing effect.

It is intended that the separate layer of the material is applied in a thickness of 10 to 100 μm, preferably 5 to 20 μm.

A particularly favourable design of the invention further provides that a substance is used which causes irritation such as burning of the mucous membranes of the mouth and tongue. A negative experience once experienced in this respect should be sufficient to permanently prevent a child or addict from attempting further oral contact with a TTS. Moreover, a similar effect can also be achieved by using a substance which causes an intensely bitter taste and in particular aftertaste.

An efficient design of the process according to the invention provides that at least one layer of a TTS is used as a bitter agent or a foul-tasting substance such as bile acid, quinine, tannin, angostura, caffeine (pure), lobelin, tea tree oil, certain fungal cultures, yellow or yellow substances, turpentine or ammonia.

In one embodiment of the procedure, the materials used for the galvanizing process are incorporated into a coating layer which coats the active layer and, where appropriate, the back layer, and a particularly preferred solution is to use a coating layer which is soluble in the oral fluid.

The procedure is simple and effective and protects children and/or addicts from inappropriate oral application of toxic ingredients of a transdermal therapeutic system, thus providing the best solution to the initial task.

Claims (12)

1. Transdermal therapeutic system (TTS) comprising at least one active substance-containing layer, more particularly an active substance-containing layer which has been rendered pressure-sensitive adhesive, as well as at least one further backing layer impermeable to the active substance, characterized in that it contains a substance which is therapeutically neutral and does not interact with the active substance and which has a repugnant taste.
2. TTS according to claim 1, characterized in that the substance of repugnant taste is contained at least in the active substance-containing layer.
3. TTS according to claim 1 or 2, characterized in that the substances used for denaturing are incorporated in a coat layer with which the active substance-containing layer and, as the case may be, the cover layer are coated.
4. TTS according to claim 3, characterized in that the coating layer is soluble in the oral fluid.
5. TTS according to one or more of claims 1 to 4, characterized in that the said substance is a substance causing nausea.
6. TTS according to one or more of claims 1 to 5, characterized in that the said substance is applied to the active substance-containing layer in a separate, extremely thin layer not impairing the permeation of the active substance.
7. TTS according to one or more of claims 1 to 6, characterized in that the said substance is additionally applied to the backing layer, in a separate, extremely thin layer.
8. TTS according to one or more of claims 1 to 7, characterized in that the separate layer of the said substance is applied in a thickness of between 10 and 100 µm, and preferably in a thickness of between 5 and 20 µm.
9. TTS according to one or more of claims 1 to 8, characterized in that the substance of repugnant taste is a substance causing an irritation such as burning of the mucosae of the oral cavity and the tongue.
10. TTS according to one or more of claims 1 to 9, characterized in that the substance of repugnant taste is a substance causing an intensely bitter taste and, in particular, aftertaste.
11. TTS according to one or more of claims 1 to 10, characterized in that, for denaturation or producing a repugnant taste, at least one layer of the TTS contains gallic acid, quinine, tannin, angostura, caffeine (pure), lobeline, tea tree oil, mould cultures, denatured or coagulated substances, turpentine or ammonia as amaroids or, respectively, substances having a repugnant taste.
12. Use of a therapeutically neutral substance of repugnant taste for preparing a transdermal therapeutic system which is thereby protected against impermissible oral application, said system comprising at least one active substance-containing layer, more particularly an active substance-containing layer which has been rendered pressure-sensitive adhesive, as well as at least one further backing layer impermeable to the active substance, and with said substance not interacting with the active substance.