FORMULATION AND EVALUATION OF SELF NANOEMULSION DRUG DELIVERY SYSTEM OF LOW SOLUBILITY DRUG “SIMVASTATIN†FOR IMPROVED SOLUBILITY AND BIOAVAILABILITY
The aim of the present work was to prepare a novel self nanoemulsion drug delivery system (NE) to enhance the solubility, dissolution rate and ultimately the oral bioavailability of a poorly water soluble drug, Simvastatin. The prepared self nanoemulsion of simvastatin was charactriesed by using techniques like FTIR analysis for investigating the drug-excipients interactions, zeta potential, viscosity determination, drug entrapment efficiency and thermodynamic stability studies. The invitro drug release profile of self-nanoemulsion was carried in phosphate buffer Ph 7.4 for 1 hr by using USP dissolution apparatus type-II device. From the invitro dissolution data, F5 formulation was found that the drug release is best and the cumulative % of drug release was 98.62% respectively. The promising formulation F5 was found by evaluation studies were compared with Marketed product (Simvas 10mg), the F5 formulation gave 98.62% of the drug release and the Marketed product gave 45.19 % 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 nanoemulsion system than from the tablet dosage form. After 1 hour of diffusion, 76.54% of drug was diffused from the self nanoemulsion system, as compared with 34.23% diffused from the tablets. Therefore the developed ME formulation improved the Solubility and in-vitro drug release of Simvastatin when compared with commercial tablet formulation.