Transdermal therapeutic system containing the active...

A - Human Necessities – 61 – K

Patent

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Details

A61K 31/46 (2006.01) A61K 9/70 (2006.01) A61K 31/439 (2006.01) A61M 37/00 (2006.01)

Patent

CA 2300339

A transdermal therapeutic system containing the active sub-stance scopolamine base and comprising a flexible, active substance-impermeable backing layer, an active substance--containing reservoir layer, a control membrane, a pressure--sensitive adhesive layer for attaching the system onto the skin, as well as a protective film or sheet which is like-wise active substance-impermeable and is to be removed prior to application, is characterized in that - the reservoir layer as well as the pressure-sensitive adhesive layer are made up of a self-adhesive amino--resistant silicone polymer as base polymer, - the control membrane is made up of an ethylene-vinyl acetate copolymer, and that - part of the scopolamine base is present, at least in the reservoir layer, in crystalline form.

L'invention concerne un système thérapeutique transdermique, contenant le principe actif scopolamine base, comportant une couche dorsale souple imperméable au principe actif, une couche réservoir contenant le principe actif, une membrane de régulation, une couche adhésive servant à fixer le système sur la peau, ainsi qu'un film de protection, également imperméable au principe actif, à enlever avant l'application du système. Ce système thérapeutique se caractérise en ce que la couche réservoir et la couche adhésive sont constituées d'un polymère silicone, comme polymère de base, collant sous l'effet d'une pression et résistant aux amines, en ce que la membrane de régulation est constituée d'un copolymère éthylène-acétate de vinyle et en ce que la scopolamine base est présente, en partie, au moins dans la couche réservoir, sous forme cristalline.

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