FORMULATION AND DEVELOPMENT OF FENOFIBRATE LOADED LIPOSPHERE SYSTEM

Abstract

Lipospheres offers a new approach to improve the solubility of poorly soluble drug. Fenofibrate is a third-generation fibric acid derivative belonging to BCS class-II, employed clinically as a hypolipidemic agent to lessen the risk caused by atherosclerosis. An attempt was made to improve aqueous solubility of FNO by aid of stearic acid and Paraffin oil.  The liposphere of FNO was prepared by melt dispersion technique using ultra turrax with %yield of 38% to 46% followed by their evaluation for saturation solubility, IR spectra, DSC, in-vitro study. Saturation solubility of FNO (92µg/ml) had improved to 184.31µg/ml with physical mixture of stearic and paraffin oil. Therefore, lipospheres of FNO were prepared using melt dispersion technique. The factorial batches were formulated using 3² factorial design with variables X1- concentration of stearic acid and X2- concentration of paraffin oil and responses Y1 - % Drug Entrapment (%DE) and Y2 - % Drug Release (% DR). The optimized batch was formulated and evaluated for Saturation Solublity, % DR, Invivo Study Thus from the present study it can be concluded that solubility of BCS class-II drugs can be improved by liposphere system.

aid } �tapf�pÍ©and Paraffin oil.  The liposphere of FNO was prepared by melt dispersion technique using ultra turrax with %yield of 38% to 46% followed by their evaluation for saturation solubility, IR spectra, DSC, in-vitro study. Saturation solubility of FNO (92µg/ml) had improved to 184.31µg/ml with physical mixture of stearic and paraffin oil. Therefore, lipospheres of FNO were prepared using melt dispersion technique. The factorial batches were formulated using 3² factorial design with variables X1- concentration of stearic acid and X2- concentration of paraffin oil and responses Y1 - % Drug Entrapment (%DE) and Y2 - % Drug Release (% DR). The optimized batch was formulated and evaluated for Saturation Solublity, % DR, Invivo Study Thus from the present study it can be concluded that solubility of BCS class-II drugs can be improved by liposphere system.

Keyword: Fenofibrate, Melt dispersion Technique, Liposphere.