Self-emulsifying Drug Delivery System of Rosuvastatin Calcium

Madhura Mestry, Dr. Meenal Rane*, Dr. Pramod Kadu, Snehal More

Running title: Self-emulsifying drug delivery system of Rosuvastatin Calcium. Introduction: Oral route is the preferred route for higher patient compliance. Rosuvastatin Calcium is BCS class II drug and its oral bioavailability is 20%. To overcome this problem, studies were performed to enhance the solubility of the Rosuvastatin Calcium in order to improve the bioavailability. Materials and methods: Different permutations and combinations of oils such as Castor oil, Cottonseed oil, Olive oil, Soyabean oil, Olyl alcohol, Peceol, Rice bran and Sunflower oil, surfactants Tween 20, Tween 80, Kollisolve PEG 400, Cremophore RH 40, Cremophore EL and co-surfactants PEG 200, PEG 400, Transcutol HP were tried in order to deduce the compatible oils and (co)surfactants to prepare pseudo-ternary phase diagram. Results and discussion: The optimized batch of Rosuvastatin Calcium SEDDS was prepared using Peceol (10%), Tween-20 (30%) and Transcutol (30%) having average particle size 76.88nm, polydispersibility index 0.555 and zeta potential of -24.5 mV. In addition, drug entrapment in the optimized batch was found to be 95.89%. The stability studies data of 3 months shows that the emulsion was stable for at least 3 months with drug entrapment 91.60 ± 0.02%. The formulation showed approximately 95% drug release within 15 min as compared to the pure drug, which showed drug release of 36.56% in phosphate buffer pH 6.8. Conclusion: From the above study, it can be concluded that SEDDs can be a promising approach to improve the solubility and in order to improve the oral bioavailability of Rosuvastatin Calcium.