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Galenical formulations of organic compounds
专利权人:
Robert F Wagner;Sudha Vippagunta;Stephen Valazza
发明人:
Stephen Valazza,Robert F Wagner,Sudha Vippagunta
申请号:
US13063955
公开号:
US08613949B2
申请日:
2009.09.22
申请国别(地区):
US
年份:
2013
代理人:
摘要:
The present invention relates to a pharmaceutical oral fixed dose combination comprisinga) 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.
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