Nanoparticulates of Fenofibrate for Solubility Enhancement: Ex-Vivo Evaluation

Abstract

The aim of present research work was to formulate and evaluate nanosuspension of fenofibrate which is categorized as BCS class II agent. With an intention to increase solubility and dissolution rate of fenofibrate nanosuspension were prepared by high pressure homogenization method, a top down technique. Using poloxamer 188 and Tween 80 as a stabilizer. Formulation scheme was developed by Box Behnken Design. Formulation factor which affect the particle size includes Concentration of surfactant and processing parameters includes Homogenization pressure and Homogenization cycles. In this study practically water insoluble fenofibrate was nanosized and surfactant was added for their stabilizing effect. In vitro dissolution study showed that the increase in the release rate of fenofibrate from nanoparticles as compared to pure drug. Scanning electron microscopy study showed that the spherical morphology of nanoparticles. Particle size distribution, zeta potential, crystal form of formulated nanosuspension were studied by using particle size analyzer, and X-ray powder diffraction, Ex-vivo study for calculating absorption rate. The result showed that the drug dissolution rate in nanosuspension formulation is depends upon the crystal form, solubility, procedure involved, and stabilizer used.

Keywords: Solubility, Dissolution, high pressure homogenization, lyophilization, nanosuspension.