Formulation and optimization of fenofibrate lipospheres using Taguchi's experimental design.

Fenofibrate lipospheres were prepared by the melt dispersion technique. Critical parameters influencing particle size and entrapment efficiency were optimized by applying the L9 Taguchi experimental design. Entrapment efficiency of up to 87 % was obtained for the optimized formulation on increasing olive oil up to 30 % in the lipid carrier. Particle size analysis by microscopy and SEM revealed narrow particle size distribution and formation of discrete lipospheres of superior morphology. In vitro dissolution data best fitted the Higuchi model, indicating diffusion controlled release from porous lipid matrices. Prolonged release was obtained from stearic acid-olive oil lipospheres compared to cetyl alcohol-olive oil lipospheres due to the relatively hydrophobic matrix formed by stearic acid. Lipid lowering studies in Triton induced hyperlipidemia rat model demonstrated higher lipid lowering ability for fenofibrate lipospheres compared to the commercial product and plain drug.