ВАЛАЗЗА Стивен (US),УОГНЕР Роберт Франк (US),ВИППАГУНТА Судха (US)
申请号：
RU2011115712/15
公开号：
RU2011115712A
申请日:
2009.09.22
申请国别(地区):
RU
年份:
2012
代理人:
摘要：
1. A fixed dose pharmaceutical oral combination, including! a) a therapeutically effective amount of aliskiren or a pharmaceutically acceptable salt thereof, preferably a half-fumarate of said compound! b) a therapeutically effective amount of amlodipine or a pharmaceutically acceptable salt thereof, preferably a besylate of said compound! moreover, aliskiren is present in the form of a granulate in a mixture with at least one pharmaceutically acceptable additive! amlodipine is present in granular form in admixture with at least one pharmaceutically acceptable additive! a fixed dose pharmaceutical oral combination is characterized by an in vitro dissolution profile of component a) 60% or less after 10 minutes and 98% or less after 20 minutes, and a component dissolution profile b) 50% or more after 20 minutes and 70% or more after 30 min at pH 2.! 2. A fixed dose pharmaceutical oral combination, including! a) a therapeutically effective amount of aliskiren or a pharmaceutically acceptable salt thereof, preferably a half-fumarate of said compound! b) a therapeutically effective amount of amlodipine or a pharmaceutically acceptable salt thereof, preferably a besylate of said compound, wherein! - (1) aliskiren is present in the form of a granulate in a mixture with at least one pharmaceutically acceptable additive, optionally in the presence of a granulation liquid,! - (2) amlodipine is present in the form of a granulate in a mixture with at least one pharmaceutically acceptable additive,! - (3) the resulting corresponding aliskiren granules and amlodipine granules optionally in1. Фармацевтическая пероральная комбинация с фиксированной дозой, включающая ! а) терапевтически эффективное количество алискирена или его фармацевтически приемлемой соли, предпочтительно полуфумарата указанного соединения, ! б) терапевтически эффективное количество амлодипина или его фармацевтически приемлемой соли, предпочтительно безилата указанного соединения, ! причем алискирен присутств
