The preparation of the sustained release metformin hydrochloride microcapsules by the Wurster fluidized bed.

The main objective of this study was to prepare sustained release metformin hydrochloride microcapsules by the Wurster fluidized bed and to obtain the optimized coating process and formulation. Fine microcapsules without agglomeration were obtained in a continuous coating process with the atomization air pressure of 0.2Mpa and an appropriate coating speed temperature. With other design variables of coating process fixed, the effects of different fluidizing air volume, coating temperature, coating speed, coating material, coating materials amount, plasticizer type and plasticizer amount on drug release were investigated respectively. Coating solution was achieved by dissolving EC45cps of 21 g, EC100cps of 7 g, DBS of 2.8 g and talcum powder of 8 g in ethanol to get a final volume of 500 ml. Particles of 150g along with 500mL coating solution would be fine. The results showed that with the air volume of 35 m3•h-1, coating temperature of 35o, coating speed of 6 mL•min-1 and proper amount of coating solution, fine microcapsules were obtained. The mean diameter of the microcapsules obtained eventually were 213 μm and the drug content were 23%, which was suitable for producing a suspension. Particle diameter distribution corresponded to the normal distribution and obviously prolonged drug-release was achieved.