STABILIZED PHARMACEUTICAL COMPOSITION OF PRAMIPEXOLE AND METHOD OF PREPARATION THEREOF

摘要

Stabilized pharmaceutical compositions comprising pramipexole or pharmaceutically acceptable salts thereof and one or more dextrins and to methods of preparation of the same. The said stabilized composition is in form of tablets comprising pramipexole dihydrochloride, beta-cyclodextrin and one or more pharmaceutically acceptable excipients. A process for preparing the stabilized tablet composition, the process comprising dissolving pramipexole dihydrochloride along with polyvinyl pyrrolidone in suitable solvent; granulating blend of cyclodextrin and other excipients with above solution as granulating fluid; drying of above formed granules; lubricating granules with glidants and anti-adherents; compressing granules using suitable tablet equipment. A further process of preparing a stabilized tablet composition the process comprising preparing pramipexole dihydrochloride-beta-cyclodextrin inclusion complex; admixing prepared inclusion complex with other excipients; granulating using either dry granulation process or wet granulation process or direct compression; drying, sifting and lubricating, formed granules; compressing granules using suitable tablet equipment to form tablet. A method of packaging the stabilized pharmaceutical composition comprising including oxygen absorbers or inert gas in the packaging system comprising the composition