Optimization of the Formulation of Film Coating of Metformin Hydrochloride Sustained-release Pellets in Compound Glipizde Extended-release Capsules

OBJECTIVE: To optimize the formulation of metformin hydrochloride sustained-release pellets prepared using film coating technology. METHODS: Taking release rate in vitro as index, the formulation of the film-coat was prelimilarily selected using one facotr sreening method and optimzed using orthogonal test. The release rate of the prepared metformin hydrochloride sustained-release pellets was determined and compared with that metformin hydrochloride pellets. RESULTS: The optimized formulation was as follows: the film material of Eudragit NE 30D and Eudragit L 30D55 at a ratio of 10∶1 were added with 40% talcum powder and 0.25% sodium dodecyl sulfate. The release rate of the metformin hydrochloride sustained-release pellets was higher than that of metformin hydrochloride pellets. CONCLUSION: The metformin hydrochloride sustained-release pellets were up to the requirements of sustained release and characterized by 24h continuous drug release.