Design, Development and Formulation of Self Emulsifying Drug Delivery System for Atorvastatin

Abstract

The aim of the present study is to develop self-micro-emulsifying drug delivery system (SMEDDS) of atorvastatin, a poorly water soluble anti-hyperlipidemic drug to enhance its oral bio-availability. Solubility of atorvastatin in various oils,surfactants and co-surfactants was determined. On the basis of solubility studies, Oleic acid, Labrasol and Transcutol were selected as oil, surfactant and co-surfactant, respectively. Ternary phase diagrams were constructed at different ratios using CHEMIX ® software to determine microemulsion region. The prepared SMEDDS were evaluated. The optimized formulation showed drug release of 93.51% in 0.1N HCl in 120 mins, droplet size of 180.1nm and zeta potential of -29.9mV. Drug release from all SMEDDS formulations was found to be higher compared to pure drug. The optimized liquid self micro-emulsifying drug delivery system formulation (F3) was converted into solid SMEDDS by adsorbing onto solid carriers like Aerosil 200, Fugicalin, and Neusilin US2 at various liquid SMEDDS to carrier ratios (1:1, 1:2 and2:1). Prepared S-SMEDDS was evaluated. The optimized S-SMEDDS (A2) showed drug release of 91.07%, dropletsize of258.1nm and zeta potential of -34.40mV. Compatibility study of drug and excipients was done by using FTIR. Solid state characterization was done by DSC and SEM. DSC thermo gram showed that there was no crystalline drug in S-SMEDDS. SEM photograph showed smooth surface of S- SMEDDS with less aggregation. Drug release was found to be higher as compared with that of pure drug and was comparable to liquid SMEDDS.
Keywords: SMEDDS, Atorvastatin, Self-emulsifying drug delivery system.