NOVEL CO-PRECIPITATE OF AMORPHOUS ROSIGLITAZONE

摘要

A novel coprecipitate of amorphous rosiglitazone maleate with a pharmaceutically acceptable carrier, e.g. polyvinylpyrolidone, mannitol, lactose, methylcellulose, cyclodextrin or silicon dioxide, a process for the preparation of said novel co­precipitate and the use of said novel coprecipitate of amorphous rosiglitazone with a pharmaceutically acceptable carrier in the treatment and / or prophylaxis of diabetes mellitus, conditions associated with diabetes mellitus and certain complications thereof, are disclosed. A novel solid solution of rosiglitazone maleate with a pharmaceutically acceptable carrier, preferably with polyethyelene glycol PEG from 4000 to 40.000 of average mol. wt., a process for the preparation thereof and use are disclosed. A novel coprecipitate of amorphous rosiglitazone maleate with a pharmaceutically acceptable carrier and a novel solid solution of rosiglitazone maleate with a pharmaceutically acceptable inert carrier are stable and may be particularly suitable for bulk preparation, handling and formulation advantages.