SUSTAINED-RELEASE PHARMACEUTICAL COMPOSITION CONTAINING PRAMIPEXOLE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF WITH IMPROVED STABILITY

摘要

Disclosed is a sustained-release pharmaceutical composition containing pramipexole or a pharmaceutically acceptable salt thereof and, more particularly, a pharmaceutical composition that uses a stabilizer for inhibiting production of related substances caused by additives and greatly enhances stability. The pharmaceutical composition shows an effectively controlled dissolution profile, realizing its usefulness in the manufacture of pramipexole-containing sustained-release preparations in various dosage forms easy for drug release control; includes a stabilizer to minimize impurity production of the drug-containing products during drug storage, remarkably improving chemical stability; and thereby eliminates a need for separate studies on the physical chemical structure analysis and/or on the toxicological effects of the corresponding impurities.