Method for producing osmosis-controlled tablets avoiding the use of chlorinated hydrocarbons
申请人:EGIS GYOGYSZERGYAR RT.
公开号:EP0662321A1
公开(公告)日:1995-07-12
A subject-matter of the invention is a diffusion-osmotic controlled drug-release one-layer or two-layer pharmaceutical tablet core (10) containing one or more therapeutically active principle(s) and a hydrophilic polymer and being coated with a polymeric film-coat (11), in case of a two-layer tablet core containing the active principle(s) and hydrophilic polymer in the first layer (14) thereof and hydrophilic polymer in the second layer (15) thereof, and the tablet core (10) further having at least one bore (13; 16) on the film-coat (11) in contact with the tablet core (10) [in case of one-layer tablet core] or on the part of the film-coat (11) in contact with the first tablet core layer (14) containing the active principle(s) [in case of two-layer tablet core], characterized in that the hydrophilic polymer is hydroxypropyl-methylcellulose and the coating material of the film-coat (11) contains an ammonium methacrylate copolymer or a mixture of such.
Furthermore according to the invention there is provided for a process for preparing these tablet cores.
本发明的一个主题是一种扩散-渗透控制药物释放的单层或双层药用片芯 (10),含有一种或多种治疗活性成分和亲水性聚合物,并涂有聚合物薄膜衣 (11),如果是双层片芯,则在其第一层 (14) 中含有活性成分和亲水性聚合物,在其第二层 (15) 中含有亲水性聚合物,片芯 (10) 进一步具有至少一个孔 (13. 16),在薄膜衣 (11) 上与片芯 (10) [如果是单层片芯] 接触的部分或在薄膜衣 (11) 上与第一片芯层 (15) 接触的部分;在与片芯 (10) 接触的薄膜涂层 (11) 上 [如果是单层片芯] 或在与含有活性成分的第一片芯层 (14) 接触的薄膜涂层 (11) 部分上 [如果是双层片芯],至少有一个孔 (13; 16),其特征在于亲水性聚合物是羟丙基甲基纤维素,薄膜涂层 (11) 的涂层材料含有甲基丙烯酸酯铵共聚物或其混合物。
此外,根据本发明,还提供了制备这些片芯的工艺。