The objective of present research work was to develop self-micro emulsifying drug delivery system to improve the in vitro dissolution of a Biopharmaceutical Classification System Class II lipid lowering agent, simvastatin. Solubility study was performed to identify the potent oil, surfactant and co-surfactant showing highest solubility of simvastatin. The ternary phase diagrams were constructed for selected components to identify the area of microemulsion formation. D-optimal mixture design was applied for optimization using three formulation variables namely, oleic acid, Tween 80 and Cremophore EL. The liquid self-micro emulsifying drug delivery systems (SMEDDS) were evaluated for droplet size, self-emulsification time, percent transmittance and drug solubility. The optimized batch showed self-emulsification time and solubility. The optimized liquid formulation was solidified using Aerosil 200 to prepare solid SMEDDS. Solid SMEDDS showed good flow property and uniform drug content. Solid state characterization was performed by differential scanning calorimetry, X-ray diffraction study and scanning electron microscopy. The zeta potential and globule size was-3.66mV and 755.3 nm, respectively. The rate and extent of drug dissolution from solid SMEDDS was significantly higher than tablet formulation. The optimized formulation was found to be stable. These results demonstrate the potential of SMEDDS as a means of improving solubility and dissolution.
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