公开(公告)号：US20070042045A1

公开(公告)日：2007-02-22

申请号：US10573019

申请日：2004-09-15

申请人： Rosario Lizio ,  Hans-Ulrich Petereit ,  Manfred Assmus ,  Herna Ravishankar

发明人： Rosario Lizio ,  Hans-Ulrich Petereit ,  Manfred Assmus ,  Herna Ravishankar

IPC分类号： A61K9/24

CPC分类号： A61K9/5078 ,  A61K9/5026

摘要： The invention relates to a multilayer pharmaceutical form for controlled active ingredient release, essentially comprising a) optionally a neutral core (nonpareilles), b) an inner controlling layer comprising a substance having a modulating effect, which is embedded in a matrix which influences the delivery of the modulatory substance and which comprises pharmaceutically usable polymers, waxes, resins and/or proteins, and where appropriate an active ingredient, c) an active ingredient layer comprising an active pharmaceutical ingredient and, where appropriate, a substance having a modulating effect, d) an outer controlling layer comprising at least 60% by weight of one or a mixture of a plurality of (meth)acrylate copolymers composed of 98 to 85 C1 to C4 alkyl esters of (meth)acrylic acid and 2 to 15% by weight of methacrylate monomers with a quaternary ammonium group in the alkyl radical, and, where appropriate, further water-insoluble pharmaceutically usable polymers, where the layers may additionally and in a manner known per se comprise pharmaceutically usual excipients.

摘要翻译： 本发明涉及用于受控活性成分释放的多层药物形式，其基本上包括a）任选的中性核心（非矫正剂），b）内部控制层，其包含具有调节作用的物质，其嵌入影响递送的基质中 的调节物质，并且其包含药学上可用的聚合物，蜡，树脂和/或蛋白质，并且在适当的情况下为活性成分，c）活性成分层，其包含活性药物成分和适当时具有调节作用的物质，d ）外部控制层，其包含至少60重量％的由98至85℃1至C 4的至少一种或多种（甲基）丙烯酸酯共聚物的混合物， （甲基）丙烯酸的烷基酯和2至15重量％的在烷基中具有季铵基团的甲基丙烯酸酯单体，以及在适当情况下进一步的水不溶性药学上可接受的聚 其中层可以另外地以本身已知的方式包含药学上通常的赋形剂。