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Levetiracetam formulations of controlled release and Methods for their production

机译:左乙拉西坦控释制剂及其生产方法

摘要

Disclosed are Pharmaceutical compositions in the form of Tablets containing Active Ingredients such as levetiracetam Component and a water-soluble Polymer which mainly includes not water-soluble Polymers that comprise between 60% and 100% of the component of the core Polymer Compressed Component Polymer, preferably in the tablet Core.The pharmaceutical compositions may also include a Coating slow release that includes both water-soluble and non water-soluble Polymers.Claim 1: a Pharmaceutical composition in the form of Tablet comprises a Tablet Core which in turn comprises an active ingredient and a water-soluble Polymer Component comprising a water-soluble Polymer not comprising between about 1% and 50% by weight of Dec Ho Tablet Core,Where the water insoluble Polymer comprises between about 60% and 100% of the component of Polymer. Claim 2: the pharmaceutical composition according to claim 3, wherein the slow release Coating comprises a mixture of at least one Water insoluble Polymer and at least one water soluble Polymer.Claim 5: the pharmaceutical composition according to claim 1, wherein Said water-soluble Active Ingredient includes ievetiracetam.Claim 8: the pharmaceutical composition according to claim 1, wherein said not water-soluble Polymer is selected from the group consisting of Ethyl Cellulose, Cellulose acetate, butilcelulosa, Cellulose acetate butyrate, Copolymer of ethylene - vinyl acetate, polividonaceta To polivinilbutirato polymethyl methacrylate Polyvinyl Acetate,,,,Ammonia methacrylate Copolymer, and mixtures thereof. Claim 9: the pharmaceutical composition according to claim 8, wherein the water insoluble Polymer is selected from the group consisting of Ethyl Cellulose, polymethacrylates, Ammonia methacrylate Copolymer, and mixtures thereof.Claim 13: the pharmaceutical composition according to claim 4, wherein Said Coating slow release includes from about 1% and 20% by weight of said Pharmaceutical composition.Claim 16: the pharmaceutical composition according to claim 4, wherein the polymer is not Soluble in said Coating slow release is selected from the group consisting of Ethyl Cellulose, Cellulose acetate, butilcelulosa, Cellulose acetate butyrate, COPOLYMER Ethylene - vinyl acetate, Polyvinyl Acetate, polyvinyl - polividonacetato, butyrate, polymethacrylate,Ammonia methacrylate Copolymer, and mixtures thereof. Claim 17: the pharmaceutical composition according to claim 16, wherein the polymer is not Soluble in said Coating slow release comprising ethylcellulose.Claim 18: the pharmaceutical composition according to claim 4, wherein Said water-soluble Polymer in said slow release Coating is selected from the group consisting of methylcellulose, hydroxypropyl Cellulose, hydroxypropyl Methyl Cellulose, polyvinylpyrrolidone, Polyvinyl alcohol, Polyethylene glycol, and their mixtures.Claim: the pharmaceutical composition according to claim 18, wherein Said water-soluble Polymer in said Coating slow release comprises hydroxypropyl methylcellulose.
机译:公开了包含活性成分例如左乙拉西坦组分和水溶性聚合物的片剂形式的药物组合物,其主要包括不溶于水溶性聚合物,所述聚合物占核心聚合物压缩组分聚合物的60%至100%。药物组合物还可包含包衣的缓释剂,其包含水溶性和非水溶性聚合物。权利要求1:片剂形式的药物组合物包含片剂核心,片剂核心又包含活性成分以及水溶性聚合物组分,其包含不包含按重量计约1%至50%的Dec Ho片剂核的水溶性聚合物,其中所述不溶于水的聚合物占聚合物组分的约60%至100%。权利要求2:根据权利要求3的药物组合物,其中所述缓释包衣包含至少一种水不溶性聚合物和至少一种水溶性聚合物的混合物。5.根据权利要求1所述的药物组合物,其中所述水溶性权利要求8:根据权利要求1所述的药物组合物,其中所述非水溶性聚合物选自乙基纤维素,乙酸纤维素,丁纤维素,乙酸丁酸纤维素,乙烯-乙酸乙烯酯的共聚物,聚维酮乙酸酯。聚乙酸乙烯酯,聚甲基丙烯酸氨,甲基丙烯酸氨共聚物和它们的混合物。权利要求9:根据权利要求8的药物组合物,其中所述水不溶性聚合物选自乙基纤维素,聚甲基丙烯酸酯,甲基丙烯酸氨共聚物及其混合物。13,根据权利要求4所述的药物组合物,其中所述包衣16.根据权利要求4所述的药物组合物,其中,所述聚合物在所述包衣中不溶。缓释选自乙基纤维素,纤维素。乙酸,丁酸纤维素,乙酸丁酸纤维素酯,共聚物POLOYMER乙烯-乙酸乙烯酯,乙酸乙烯酯,聚乙烯基-聚对乙酰乙酸乙烯酯,丁酸酯,聚甲基丙烯酸酯,甲基丙烯酸氨共聚物及其混合物。 17.根据权利要求16所述的药物组合物,其中所述聚合物在所述包含乙基纤维素的包衣缓释中不溶。18.根据权利要求4所述的药物组合物,其中在所述缓释包衣中的所述水溶性聚合物选自19.根据权利要求18所述的药物组合物,其中在所述包衣缓释中的所述水溶性聚合物包含羟丙基甲基纤维素。

著录项

  • 公开/公告号AR081929A1

    专利类型

  • 公开/公告日2012-10-31

    原文格式PDF

  • 申请/专利权人 MYLAN INC.;

    申请/专利号AR2011P102067

  • 发明设计人

    申请日2011-06-14

  • 分类号A61K31/4015;A61K9/20;A61K9/22;A61K9/28;A61K47/38;A61P25/08;

  • 国家 AR

  • 入库时间 2022-08-21 17:25:37

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