发明名称 Fixed dose combination in form of a bilayered or monolayered tablet of aliskiren and amlodipine
摘要 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.
申请公布号 AU2009292908(A1) 申请公布日期 2010.03.25
申请号 AU20090292908 申请日期 2009.09.22
申请人 NOVARTIS AG 发明人 STEPHEN VALAZZA;ROBERT FRANK WAGNER;SUDHA VIPPAGUNTA
分类号 A61K9/20 主分类号 A61K9/20
代理机构 代理人
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