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1. 发明授权

US06576258B1 Pharmaceutical formulation with controlled release of active substances 失效
标题翻译：具有活性物质控制释放的药物制剂
公开(公告)号：US06576258B1
公开(公告)日：2003-06-10
申请号：US09462698
申请日：2000-01-12
申请人： Bojan Kofler , Ljubomira Barbara Rebi{haeck over (c)} , Judita {haeck over (S)}irca , Peter Venturini
发明人： Bojan Kofler , Ljubomira Barbara Rebi{haeck over (c)} , Judita {haeck over (S)}irca , Peter Venturini
IPC分类号： A61K916
CPC分类号： A61K9/1652 , A61K9/2095 , A61K9/5073
摘要： There is disclosed a method for stabilizing active substances that are unstable in acidic medium, unstable when stored for longer periods of time in the presence of water and at the same time sensitive to heating, by means of anhydrous granulation of active substances and dried pharmaceutically acceptable auxiliary substances for the preparation of pellet cores or granules. All pharmaceutically acceptable auxiliary substances employed are dried before use so that their weight loss at drying is less than 1.0% of the total weight of the pharmaceutically acceptable auxiliary substance, preferably less than 0.5%. Organic solvents used in process of anhydrous granulation should contain less than 0.2% of water. A novel pharmaceutical formulation with controlled release of active substances that are unstable in acidic medium, unstable when stored for longer periods of time in the presence of water and at the same time sensitive to heating, is disclosed as well.
摘要翻译：公开了一种稳定在酸性介质中不稳定的活性物质的方法，在水存在下储存更长时间并且对加热敏感的同时，通过活性物质的无水造粒和干燥的药学上可接受的方法不稳定用于制备颗粒芯或颗粒的辅助物质。使用的所有药学上可接受的辅助物质在使用前被干燥，使得它们在干燥时的重量损失小于药学上可接受的辅助物质总重量的1.0％，优选小于0.5％。在无水造粒过程中使用的有机溶剂应含有少于0.2％的水。还公开了一种在酸性介质中不稳定的活性物质的控制释放的新型药物制剂，在水存在下储存更长时间并且对加热敏感的同时存在时不稳定。

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