FORMULATION AND EVALUATION OF SELF-MICRO EMULSIFYING DRUG DELIVERY SYSTEM OF ATORVASTATIN CALCIUM

The present study focuses on the formulation and evaluation of a SelfMicroemulsifying Drug Delivery System (SMEDDS) of Atorvastatin Calcium to enhance its solubility and dissolution profile. Atorvastatin, a poorly watersoluble drug, was formulated using sunflower oil as the oil phase, Tween 80 as surfactant, and PEG 400 as co-surfactant. The prepared formulation wasevaluated for organoleptic properties, melting point, UV spectroscopy, solubility studies, pseudo-ternary phase diagram, FTIR, DSC, microscopic characteristics, globule size, zeta potential, and in-vitro dissolution study. The optimized SMEDDS showed good clarity and physical stability without phase separation for 35 days. FTIR and DSC studies confirmed compatibility between drug and excipients and indicated successful conversion of the drug into an amorphous form. The formulation exhibited a mean globule size of 173 nm with PDI 0.155 and zeta potential of –28.5 mV, indicating uniformity and stability. In-vitro dissolution studies demonstrated significantly enhanced drug release from SMEDDS (98.43% in 50 min) compared to pure Atorvastatin API (40.50%).The results concluded that the developed SMEDDS successfully improved the solubility, stability, and dissolution behaviour of Atorvastatin Calcium, thereby enhancing its potential oral bioavailability.