Self-emulsifying pharmaceutical compositions of rhein or diacerein

摘要

The invention relates to self emulsifying drug delivery system based compositions of rhein or diacerein, or salts or esters or prodrugs thereof which are bioequivalent to a 50 mg diacerein formulation marketed under the trade name Art 50®. The compositions exhibit no variability in fed and fasted state conditions. The compositions also result in significant reduction in side effects such as, soft stools effects as compared to Art 50®. The invention also relates to methods for preparing such compositions.

主权项

1. A pharmaceutical composition comprising about 10-90% w/w of diacerein, about 1-70% w/w of labrafil, about 10-90% w/w of polyoxyethylene glycerol esters of fatty acid, about 5-70% w/w/of PEG 40 hydrogenated castor oil, about 2-50% of methylcellulose, wherein the composition exhibits a dissolution profile such that at least 60% of diacerein is released within 120 minutes, wherein the release rate is measured in Apparatus 2 USP, Dissolution, paddle, 75 rpm) using 1000 ml of pH 5.7 Tampon phosphate buffer at 37° C.±0.5° C.