Abstract

Simvastatin is classified as a biopharmaceutics classification system class II drug. Emulgel is a superior alternative for biopharmaceutics classification system class II drugs with low solubility and high permeability. For emulgel preparation, the solubility of simvastatin was assessed in sesame, groundnut and olive oil. The maximum solubility of simvastatin is found in sesame oil (21.06 mg/ml). Simvastatin emulgel was prepared and optimized using a three-factor, three-level Box-Behnken design. For optimization, concentrations of carbopol 934, sesame oil and surfactant (Tween 80) were selected as independent variable and viscosity, spreadability and in vitro drug release was selected as dependent variables, which are critical components of any semisolid formulation, as well as patient compliance. The optimized formulation was evaluated for viscosity, spreadability, pH, drug content and ex vivo release. The optimized formulation had 6875±531.21 mPas of viscosity, spreadability of 10.1446±0.31 gcm/s and in vitro drug release of 40.75±0.42 %, respectively. Ex vivo release investigations revealed that 42.15±0.32 % of simvastatin was released in 24 h. The study results demonstrated that the simvastatin emulgel might be an alternative the conventional topical administration form.