CA2709624A1 — Immediate release dosage form of bosentan and process of manufacturing such

USPTO Abstract

The present invention provides an immediate release oral pharmaceutical dosage form comprising a high dose of a poorly water soluble active ingredient, and processes for manufacturing same, wherein the in vitro dissolution rate of the dosage form provides at least 90% dissolution of the active ingredient within 30 minutes as measured by USP Paddle Method at 50 rpm at 900 ml of dissolution buffer with 1% SDS at 37°C. In particular, the immediate release oral pharmaceutical dosage forms of the present invention comprise bosentan, or pharmaceutically acceptable salts thereof, as the active ingredient.