PHARMACEUTICAL COMPOSITION COMPRISING A SOLID DISPERSION OF TADALAFIL

摘要

The present invention relates to a pharmaceutical composition comprising a solid dispersion of tadalafil in at least two different types of polymers: a. At least one polymer soluble in aqueous medium up to pH 5.0; b. At least one polymer with pH dependent solubility soluble above pH 5.0; exhibiting a dissolution rate of at least about 85 wt% within 20 min when tested in 1000 ml of phosphate buffer (pH 6.8) + 0.35 wt% SDS in a USP apparatus II (peak vessels) at 50 rpm and a wet granulation process to prepare said composition.