Extended release pellet formulation containing pramipexole or a pharmaceutically acceptable salt thereof, method for manufacturing the same and use thereof

摘要

Disclosed is an extended release pellet formulation comprising an inert pellet core; a first layer that has an active ingredient layer comprising pramipexole; and a second layer comprising pH-dependant polymer and pH-independent polymer. The pH-dependant polymer makes up 10-85% by weight and the pH-independent makes up 15-75% by weight. The resulting pellet has a close to zero order in vitro release characteristic at acidic pH values up to a pH 6.8, an accelerated release above pH 6.8 and a more accelerated release above pH 7.3. Also disclosed is the method of manufacturing the extended release pellet and the use of the medical preparation for treating Parkinson's disease.