Composição de liberação pulsátil de sildenafil e processo para prepará-la

摘要

The present invention relates to a pulsed-release sildenafil pharmaceutical composition comprising an immediate release fraction containing from 5 to 100 mg of sildenafil and a controlled release fraction containing from 25 to 150 mg of sildenafil, wherein the controlled release fraction consists of particles containing (a) a superdisintegrant agent (b) a coating comprising at least one pH-dependent solubility polymer and at least one pH-independent solubility polymer and (c) optionally, other pharmaceutical excipients. The composition of the present invention exhibits a faster dissolution profile in alkaline media than in acid media, which allows for obtaining enhanced pulsed-release formulations.