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    • 1. 发明授权
    • Galenical formulations of organic compounds
    • 有机化合物的Galenical制剂
    • US08613949B2
    • 2013-12-24
    • US13063955
    • 2009-09-22
    • Stephen ValazzaRobert F WagnerSudha Vippagunta
    • Stephen ValazzaRobert F WagnerSudha Vippagunta
    • A61K9/28A61K9/20
    • A61K9/28A61K9/2027A61K9/2054A61K9/2077A61K9/209
    • The present invention relates to a pharmaceutical oral fixed dose combination comprising a) a therapeutically effective amount of Aliskiren, or a pharmaceutically acceptable salt thereof, b) a therapeutically effective amount of Amlodipine, or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical oral fixed dose combination shows an in vitro dissolution of component (a) of 60% or less after 10 minutes and 98% or less after 20 minutes, and a dissolution profile of component (b) of 50% or more after 20 minutes, and 70% or more after 30 minutes at pH 2, said pharmaceutical oral fixed dose combination being bioequivalent, or close to reaching bioequivalence, to a free dose combination of Aliskiren and Amlodipine.
    • 本发明涉及药物口服固定剂量组合,其包含a)治疗有效量的阿利吉仑或其药学上可接受的盐,b)治疗有效量的氨氯地平或其药学上可接受的盐,其中药物口服固定剂量 10分钟后组分(a)的体外溶出度为60%以下,20分钟后为98%以下,20分钟后成分(b)的溶出曲线为50%以上,70%以上 在pH 2下30分钟后更多地,所述药物口服固定剂量组合与阿利吉仑和氨氯地平的游离剂量组合是生物等效的或接近达到生物等效性。