Multi-particulate Drug Delivery Systems of Fenofibric Acid: Optimization of Formulation Using Statistical Experimental Design

The objective of the present research work was to develop a multi-particulate modified release system of Fenofibric acid using Wurster (Bottom spray fluid bed coating) process. Impact of various formulation variables was assessed by using statistical interpretation such as ANOVA. A 33 (three factor, three level) face centered central composite design was employed to study the effect of independent variables (concentration of ER Polymer, plasticizer and pore former), on dependent variables (drug release at 2.5th h & 6th h). Optimization of the formulation variables was done by fitting experimental data to the software program (Design Expert). The design space for formulation variables was developed. Fabricated pellets were characterized for various physico-chemical parameters. In vitro release data of the optimized formulation was fitted into various kinetic equations. The optimized formulation showed a desired  drug release at both 2.5th h and 6th h as 17.5 ± 2.28% & 87.1 ± 0.75% respectively. The drug release from the capsules followed first order kinetics and controlled by non fickian transport. The information acquired in this study recommends that the multi-particulates of Fenofibric acid can be effectively intended to give a delayed  release of Fenofibric acid and thus enhanced bioavailability.