VALAZZA, STEPHEN,WAGNER, ROBERT FRANK,VIPPAGUNTA, SUDHA
申请号：
MYPI 2011000931
公开号：
MY153610A
申请日:
2009.09.22
申请国别(地区):
MY
年份:
2015
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.
