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    • 12. 发明申请
    • CONTROLLED-RELEASE PHARMACEUTICAL COMPOSITION INCLUDING TAMSULOSIN OR THE PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, AND ORAL PREPARATION INCLUDING SAME
    • 控制释放的药物组合物,包括TAMSULOSIN或其药学上可接受的盐,以及包括其中的口服制剂
    • WO2011139044A3
    • 2012-03-01
    • PCT/KR2011003098
    • 2011-04-27
    • SAMYANG CORPCHUNG HO-JINPARK SANG-YEOBPAI CHAUL-MIN
    • CHUNG HO-JINPARK SANG-YEOBPAI CHAUL-MIN
    • A61K9/52A61K9/54A61K31/18A61K47/38
    • A61K31/18A61K9/5073A61K9/5078A61K9/5084
    • The present invention relates to a controlled-release pharmaceutical composition including tamsulosin or the pharmaceutically acceptable salts thereof as an active ingredient, and to an oral preparation including same, and more particularly, to a pharmaceutical composition comprising a core that includes tamsulosin or the pharmaceutically acceptable salts thereof, a controlled-release polymer coating layer formed on the core, and a plurality of microspheres including an enteric polymer outer layer formed on the controlled-release polymer coating layer, wherein the controlled-release polymer coating layer has a first and second group of microspheres, the average thicknesses of which are different; and to an oral preparation including same. The controlled-release pharmaceutical composition according to the present invention may increase the therapeutic effects for patients when orally administered, as the degree of release of the active ingredient according to pH changes in the digestive tract and the control of the release pattern of the active ingredient in the small intestine are facilitated, the effective plasma concentration of the active ingredient may be maintained for a certain period of time, and the bitter taste may be suppressed for a certain period of time even though the composition is exposed to the oral cavity.
    • 本发明涉及包含坦索罗辛或其药学上可接受的盐作为活性成分的控释药物组合物及其包含其的口服制剂,更具体地说涉及包含核心的药物组合物,所述核心包括坦索罗辛或药学上可接受的 其盐,形成在芯上的控释聚合物涂层和多个微球,其包含形成在控释聚合物涂层上的肠溶聚合物外层,其中控释聚合物涂层具有第一和第二组 的微球,其平均厚度不同; 以及包含其的口服制剂。 根据本发明的控释药物组合物可以增加口服给药时对于患者的治疗效果,作为活性成分根据消化道pH变化释放的程度和活性成分的释放模式的控制 在小肠方便的情况下,活性成分的有效血浆浓度可以保持一定时间,即使组合物暴露于口腔也可以将苦味抑制一定时间。