약제학적 조성물 및 이의 제조방법
    1.
    发明公开
    약제학적 조성물 및 이의 제조방법 审中-实审
    药物组合物及其制备方法

    公开(公告)号:KR1020130109425A

    公开(公告)日:2013-10-08

    申请号:KR1020120031154

    申请日:2012-03-27

    CPC classification number: A61K31/506 A61K9/2009 A61K9/485

    Abstract: PURPOSE: A pharmaceutical composition is provided to reduce electrostatic characteristics and adsorption with safety and to improve elution rate and bioavailability. CONSTITUTION: A pharmaceutical composition contains 20-1000 mg of 4-methyl-N-[3-(4-methylimidazole-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyrazine-2-yl-pyrimidine-2-ylamino)-benzamide hydrochloride as an active ingredient and a pharmaceutically acceptable excipient. The pharmaceutical composition is manufactured in the form of a granule, a powder, a tablet, a capsule, or a suspension. A method for manufacturing the pharmaceutical composition comprises the steps of wet/dry-granulating the active ingredient using a solvent or aqueous/oil cosolvent of a surfactant and/or an organic solvent as a solubilizing agent. [Reference numerals] (AA) Dissolution rate (%); (BB) Example 2; (CC) Example 3; (DD) Example 4; (EE) Comparative example 1; (FF) Comparative example 2; (GG) Comparative example 3; (HH) Comparative example 4

    Abstract translation: 目的:提供一种药物组合物,以安全降低静电特性和吸附,并提高洗脱速率和生物利用度。 组成:药物组合物含有20-1000mg的4-甲基-N- [3-(4-甲基咪唑-1-基)-5-三氟甲基 - 苯基] -3-(4-吡嗪-2-基 - 嘧啶-2-基) 吡啶-2-基氨基) - 苯甲酰胺盐酸盐作为活性成分和药学上可接受的赋形剂。 药物组合物以颗粒,粉末,片剂,胶囊或悬浮液的形式制造。 制备药物组合物的方法包括使用表面活性剂和/或有机溶剂的溶剂或水/油共溶剂作为增溶剂湿/干造粒活性成分的步骤。 (AA)溶解速度(%) (BB)实施例2; (CC)实施例3; (DD)实施例4 (EE)比较例1; (FF)比较例2; (GG)比较例3; (HH)比较例4

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