Abstract:
Rosuvastatin calcium, an antilipidemic agent exhibits poor water solubility, dissolution and flow properties. Thus, the aim of the present study was to improve the solubility and dissolution rate of Rosuvastatin calcium by preparing microspheres by spray drying technique using Pullulan having low viscosity and high Tg (Glass transition temperature) value. Rosuvastatin calcium Microspheres containing different ratios of pullulan were produced by spray-drying using methanol and water (1:2) as solvent system to enhance solubility and dissolution rate. The prepared formulations containing different ratios of drug and pullulan were evaluated for solubility and in-vitro dissolution. The prepared formulations were characterized by DSC, FTIR, XRD and SEM. Dissolution profile of the prepared spray dried microspheres was compared with its physical mixture and pure sample. The Rosuvastatin calcium microspheres containing 1:3 w/w (Rosuvastatin calcium: Pullulan) showed highest % of drug release and solubility compare to other ratio, physical mixture and pure sample of Rosuvastatin calcium. Stability results showed that prepared microspheres stable for 6 month as per ICH guidelines. Hence, from the above result it can be concluded that spray dried microspheres of Rosuvastatin calcium is a useful technique to improve the solubility and dissolution of poorly water soluble drug like Rosuvastatin calcium.

Keywords: Rosuvastatin Calcium, Pullulan, Spray Drying, Microsphere, Solubility.