Preparation of Indomethacin Sustained-release Pellets by Extrusion-spheronization Method

OBJECTIVE:To prepare Indomethacin sustained-release pellets and to investigate drug release behavior of it in vitro.METHODS:The pellets were prepared by extrusion-spheronization method.The extrusion velocity,spheronization velocity and spheronization time were optimized with the field of pellets as index.The formula of excipients was optimized by single-factor experiment with drug release curves as index and the amount of MCC,HPMC and water as factors.The validation test of formula was conducted and drug release behavior mechanism was studied.RESULTS:The optimal technology parameters were as follows:extrusion velocity of 65 r·min-1,spheronization velocity of 650 r·min-1,spheronization time of 3 min.Optimal formula was as follows:MCC 19%,HPMC 20%,water 6 mL.Drug release behavior of prepared Indomethacin sustained-release pellets had good reproducibility and was up to requirement of sustained-release preparation.The drug release mechanism of pellet was drug diffusion and skeleton corrosion mechanism.CONCLUSIONS:The extrusion-spheronization method is feasible for the preparation of Indomethacin sustained-release pellets with sustained release characteristics.