ORALLY ADMINISTERED MEDICAL COMPOSITION
    6.
    发明公开
    ORALLY ADMINISTERED MEDICAL COMPOSITION 审中-公开
    口腔维生素A医药ZUSAMMENSETZUNG

    公开(公告)号:EP2891493A1

    公开(公告)日:2015-07-08

    申请号:EP13832156.7

    申请日:2013-08-30

    摘要: In order to provide the medical field with a single formulation comprising a modified release portion containing mirabegron or a pharmaceutically acceptable salt thereof and an immediate release portion containing solifenacin or a pharmaceutically acceptable salt thereof, (1) a single formulation having dissolution rates of both drugs similar to those of the current single drug formulations is provided, and (2) a single formulation having maximum percentages of dissolution of both drugs of 90% or more, and having a bioavailability equivalent to those of the current single drug formulations. Further, in order to provide a single formulation, (3) a single formulation having good productivity whereby failures in tabletting are reduced, and having good storage stability whereby the coloration of the immediate release portion is suppressed is provided. The pharmaceutical composition for oral administration of the present invention contains (1) a modified release portion comprising mirabegron or a pharmaceutically acceptable salt thereof, and (2) an immediate release portion comprising solifenacin or a pharmaceutically acceptable salt thereof, and calcium stearate.

    摘要翻译: 为了向医疗领域提供包含含有明美树或其药学上可接受的盐的修饰释放部分和含有索非那新或其药学上可接受的盐的速释部分的单一制剂,(1)具有两种药物的溶出速率的单一制剂 提供了与目前的单一药物制剂相似的方法,和(2)具有90%或更多种药物的最大溶解百分比且具有与当前单一药物制剂相当的生物利用度的单一制剂。 此外,为了提供单一制剂,(3)具有良好生产率的单一制剂,其中压片失败减少,并且具有良好的储存稳定性,从而可以抑制速释部分的着色。 本发明的口服给药用药物组合物含有(1)包含明美树或其药学上可接受的盐的改性释放部分,和(2)包含索非那新或其药学上可接受的盐和硬脂酸钙的速释部分。