公开(公告)号：EP3106153A1

公开(公告)日：2016-12-21

申请号：EP16173124.5

申请日：2014-06-04

申请人： LTS LOHMANN Therapie-Systeme AG

发明人： HILLE, Thomas ,  SEIBERTZ, Frank ,  WAUER, Gabriel ,  WEINHEIMER, Shu-Lun

IPC分类号： A61K9/70 ,  A61K31/485 ,  A61P25/04

CPC分类号： A61K31/4748 ,  A61F13/0256 ,  A61K9/0014 ,  A61K9/7053 ,  A61K9/7069 ,  A61K31/485 ,  A61K47/12 ,  A61K47/32

摘要： The invention relates to transdermal therapeutic system for the transdermal administration of buprenorphine, comprising a buprenorphine-containing self-adhesive layer structure comprising
A) a buprenorphine-impermeable backing layer, and
B) a buprenorphine-containing pressure-sensitive adhesive layer on said buprenorphine-impermeable backing layer, the adhesive layer comprising
a) at least one polymer-based pressure-sensitive adhesive,
b) an analgesically effective amount of buprenorphine base or a pharmaceutically acceptable salt thereof,
c) soluble polyvinylpyrrolidone, and
d) a carboxylic acid selected from the group consisting of oleic acid, linoleic acid, linolenic acid, levulinic acid and mixtures thereof, in an amount sufficient so that said analgesically effective amount of buprenorphine is solubilized therein to form a mixture including said polyvinylpyrrolidone, and wherein the carboxylic acid-, buprenorphine- and polyvinylpyrrolidone-containing mixture forms dispersed deposits in the said pressure-sensitive adhesive, and
wherein said buprenorphine-containing pressure-sensitive adhesive layer is the skin contact layer.

摘要翻译： 本发明涉及用于经皮施用丁丙诺啡的透皮治疗系统，其包含含有丁丙诺啡的自粘层结构，其包含：A）丁丙诺啡不可渗透的背衬层，和B）在所述丁丙诺啡不透性层上的含丁丙诺啡的压敏粘合剂层， 所述粘合剂层包含a）至少一种基于聚合物的压敏粘合剂，b）止痛有效量的丁丙诺啡碱或其药学上可接受的盐，c）可溶性聚乙烯吡咯烷酮，和d）选自 所述组由油酸，亚油酸，亚麻酸，乙酰丙酸及其混合物组成，其量足以使所述止痛有效量的丁丙诺啡溶解于其中以形成包含所述聚乙烯吡咯烷酮的混合物，并且其中所述羧酸 - 丁丙诺啡 - 和含有聚乙烯吡咯烷酮的混合物形成分散的沉积物 并且其中所述含有丁丙诺啡的压敏粘合剂层是皮肤接触层。