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    • 5. 发明申请
    • PH-DEPENDENT CONTROLLED RELEASE PHARMACEUTICAL COMPOSITION FOR NON-OPIOIDS WITH RESISTANCE AGAINST THE INFLUENCE OF ETHANOL
    • 对依赖于乙醇的影响的非依赖性药物的PH依赖性控制释放药物组合物
    • US20110229562A1
    • 2011-09-22
    • US13120112
    • 2008-09-24
    • Hans BärThomas FürstGerhard RennerMichael Gottschalk
    • Hans BärThomas FürstGerhard RennerMichael Gottschalk
    • A61K9/48B29C43/02A61K9/00A61K9/36A61K9/14A61K31/138
    • A61K9/5078
    • The invention relates to a pH-dependent controlled release pharmaceutical composition, comprising at least one pharmaceutical active ingredient, with the exception of opioids, wherein the core is coated at least by one coating layer, controlling the release of the pharmaceutical composition, wherein the coating layer comprises a polymer mixture of i) 40-95% by weight, based on dry weight of the polymer mixture, of at least one water insoluble essentially neutral vinyl polymer or copolymer, and ii) 5-60% by weight, based on dry weight of the polymer mixture, of at least one anionic polymer or copolymer, which is insoluble in a buffered medium below pH 4.0 and soluble at least in the range from pH 7.0 to pH 8.0, characterized in that the coating layer further comprises 110 to 250% by weight of a non-porous inert lubricant, 1 to 35% by weight of at least one neutral cellulosic compound and 1 to 25% by weight of at least one emulsifier, each calculated on dry weight of the polymer mixture.
    • 本发明涉及pH依赖性控释药物组合物,其包含除阿片样物质以外的至少一种药物活性成分,其中核心至少涂覆一层涂层,以控制药物组合物的释放,其中涂层 至少一种不溶于水的基本上中性的乙烯基聚合物或共聚物,和ii)5-60重量%,基于干燥的聚合物混合物,i)40-95重量%,基于聚合物混合物的干重, 聚合物混合物的重量,至少一种阴离子聚合物或共聚物,其不溶于低于pH 4.0的缓冲介质中并且可溶于至少在7.0至8.0的范围内,其特征在于所述涂层还包含110至250 重量%的无孔惰性润滑剂,1至35重量%的至少一种中性纤维素化合物和1至25重量%的至少一种乳化剂,其各自以聚合物混合物的干重计算。