Design and development of self microemulsifying tablet of rosuvastatin

Self-microemulsifying drug delivery system (SMEDDS) of rosuvastatin calcium was aimed to overcome the problems of poor solubility and bioavailability of the drug. The solubility of drug was determined in various oily vehicles. The selection of components (oil, surfactant and cosurfactant) for the formulation development was based on saturated solubility studies and emulsification ability. Pseudoternary phase diagrams were plotted to identify the selfemulsifying region. Clove oil as oil phase, tween 80 and transcutol as surfactant and cosurfactant (S/CoS mix) (in ratio of 2:1) respectively were selected as optimized components for the SMEDDS formulation. The formulated liquid SMEDDS was evaluated for its selfemulsification time, phase separation, viscosity, cloud point and droplet size. The liquid SMEDDS were converted to solid SMEDDS by adsorbing on Neusilin US2 particles. Solid SMEDDS were further characterized for SEM, XRD, FTIR and evaluated for drug content, micromeritic properties. Further optimized solid-SMEDDS were compressed into tablet dosage form. In vitro drug release of liquid SMEDDS, solid-SMEDDS, and optimized tablet batch was carried out in buffer of pH 6.8. The optimized formulation exhibited almost 100% drug release in 30 min which was significantly higher than that of pure drug. The study revealed the significance of rosuvastatin calcium solid SMEDDS as potential carriers with enhanced dissolution characteristics for oral administration.