Preparation and Quality Evaluation of m-Nisoldipine-Sulfobutyl Ether-β-Cyclodextrins Pellets by Extrusion-Spheronization Method

OBJECTIVE To prepare high solubility m-nisoldipine pellets. METHODS The m-nisoldipine-sulfobutyl ether (SBE)-β-cyclodextrins (CD) pellets were prepared by extrusion-spheronization, ethanol solvent with hydroxypropyl cellulose as a binder. The effects of key parameters on spheronization process were the proportion of extrusion speed and spheronisation speed, which were investigated to obtain optimal formulation. In vitro release of pellets and micromeritics of pellets were evaluated. RESULTS m-Nisoldipine pellets have good water soluble property, presented perfect sphericity and yield over 70%. CONCLUSION The m-nisoldipine-SBE-β-CD pellets are successfully prepared by extrusion-spheronization. It presents a method for poor water soluble drugs pellets.