CAWELLO, Willi,LAPPERT, Aurelia,KASSNER, Kristina,WOLFF, Hans-Michael,MÜLLER, Walter,LEONHARD, Johannes Josef,EMGENBROICH, Marco
申请号:
EPEP2013/003515
公开号:
WO2014/079573A1
申请日:
2013.11.21
申请国别(地区):
EP
年份:
2014
代理人:
摘要:
The present invention relates to a transdermal therapeutic system, comprising (a) a backing layer, (b) a solvent -based self-adhesive matrix layer containing rotigotine as active ingredient, and (c) a release liner, wherein the self- adhesive matrix layer has a coating weight of about 75-400 g/m2 and comprises a reservoir layer containing about 9-25 wt.-% rotigotine based on the weight of the reservoir layer, a kit comprising two transdermal therapeutic systems of the present invention as well as a method for the preparation of the transdermal therapeutic system of the present invention. In addition, the present invention relates to a transdermal therapeutic system comprising rotigotine as active ingredient for use in the treatment of patients suffering from Parkinson's disease, Parkinson's plus syndrome, depression, fibromyalgia and the restless-legs syndrome and for use in the treatment or prevention of dopaminergic neuron loss or cognitive disorders by transdermal administration of rotigotine once or twice weekly, wherein the transdermal therapeutic system comprises a backing layer, a solvent -based rotigotine containing self-adhesive matrix layer as well as a release liner and is adapted to allow for the transdermal administration of therapeutically effective amounts of rotigotine for at least 3 days.La présente invention concerne un système thérapeutique transdermique, comprenant (a) une couche de support, (b) une couche de matrice autoadhésive à base de solvant, contenant de la rotigotine comme principe actif, et (c) un revêtement antiadhésif, la couche de matrice autoadhésive ayant un poids de revêtement d'environ 75-400 g/m2 et comprenant une couche de réservoir contenant environ 9-25 % en poids de rotigotine en fonction du poids de la couche de réservoir, un coffret comprenant deux systèmes thérapeutiques transdermiques de la présente invention ainsi qu'un procédé de préparation du système thérapeutique transdermique de la présente invention. De plus, la pr