STEPHEN B. RUDDY,RAJEEVJAIN,RAKESH PATEL,MICHAEL JOHN WILKINS,TUULA RYDE,EVAN E. GUSTOW
申请号：
IN3843/DELNP/2004
公开号：
IN254678B
申请日:
2004.12.03
申请国别(地区):
IN
年份:
2012
代理人:
摘要：
The present invention relates to a stable fenofibrate composition for oral administration comprising particles of fenofibrate having an effective average particle size of less than about 500 nm, and at least one surface stabilizer adsorbed on the surface of the fenofibrate particles, wherein: (i) the composition exhibits bioequivalence upon administration to a human subject in a fed state as compared to administration to a human subject in a fasted state where bioequivalency is established by: (a) a 90% Confidence Interval for AUC which is between 80% and 125%, and (b) a 90% Confidence Interval for Cmax, which is between 80% and 125% (ii) the composition redisperses in a biorelevant media (iii) the surface stabilizer is not PEG-derivatized vitamin E and (iv) the composition is phospholipid-free.
