Patent ID: 6511681
Filing Date: 2003-01-28
Classification: A61K,A61P,C07D

Abstract:
A solid dosage form comprising a therapeutic amount of granular particle comprising:a) a solid solution of an amorphous, pharmaceutically active agent and a pharmaceutically acceptable hydrophobic vehicle, wherein said pharmaceutically active agent is normally crystalline and sparingly water-soluble at ambient pressure and temperature; b) a stabilizer comprising a polyethylene glycol, sugars, sorbitol, mannitol, polyvinylpyrrolidone, or one or more cellulose ethers; and c) a disintegrant comprising croscarmellose sodium, sodium starch glycolate, crospovidone, or a cross-linked polyacrylate; wherein said granular particle is made by a process which comprises the steps of: i) heating the hydrophobic vehicle to a temperature to form a molten hydrophobic vehicle and to a temperature at which said pharmaceutically active agent dissolves in the molten hydrophobic vehicle; ii) dissolving said pharmaceutically active agent in the molten hydrophobic vehicle to form a molten solution of said pharmaceutically active agent in said hydrophobic vehicle; then iii) adding a stabilizing amount of said stabilizer to said molten solution; and iv) granulating the molten mixture from step (iii) with a cooled disintegrant and optionally a binder to form said granular particle.