DEVELOPMENT AND CHARACTERIZATION OF NOVEL SELFMICROEMULSION DRUG DELIVERY SYSTEM OF LOW SOLUBILITY DRUG “FENOFIBRATE†FOR IMPROVED ORAL BIOAVAILABILITY
Fenofibrate is insoluble in aqueous solution and the bioavailability after oral administration is low. Selfmicroemulsifying drug delivery systems (SMEDDS) containing fenofibrate have been successfully prepared to improve its bioavailability. SMEDDS is a mixture of lipid, surfactant, and cosurfactant, which are emulsified in aqueous medium under gentle digestive motility in the gastrointestinal tract. Pseudo-ternary phase diagrams composed of various excipients were plotted. Droplet sizes, zeta-potential and long-term physical stability of the formulations were investigated. The invitro drug release profile of self microemulsion was carried in phosphate buffer Ph 7.4 for 1 hr by using USP dissolution apparatus type-II device. From the invitro dissolution data, F15 formulation was found that the drug release is best and the cumulative % of drug release was 98.75% respectively. The promising formulation F15 was found by evaluation studies were compared with Marketed product (Lofibra 50mg), the F15 formulation gave 98.75% of the drug release and the Marketed product gave 47.56 % of drug release in 1 hr of dissolution study. The in-vitro intestinal permeability results exhibits the drug diffused at a faster rate from the self microemulsion system than from the capsule dosage form. After 1 hour of diffusion, 75.45% of drug was diffused from the self microemulsion system, as compared with 33.38% diffused from the capsule. Our studies indicate that the use of SMEDDS for the delivery of fenofibrate can improve its bioavailability.