VIPPAGUNTA SUDHA,VALAZZA STEPHEN,WAGNER ROBERT FRANK
申请号：
TN2011000100
公开号：
TN2011000100A1
申请日:
2011.02.28
申请国别(地区):
TN
年份:
2012
代理人:
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.
