Formulation Development and Evaluation of Fenofibrate Capsule

The present study An antilipemic agent, fenofibrate decreases the levels of fatty substances in the blood. Fenofibrate compound belongs to BCS-II classification (drug with very low solubility and has high lipophilicity). Dissolution rate of fenofibrate is expected to limit its absorption from GIT. Three major approaches available to overcome the bioavailability problem like pharmaceutic,pharmacokinetic and biologic approaches. In the objective of present study to enhance dissolution of fenofibrate by pharmaceutic method with different approaches. BCS Class-II drug, Fenofibrate solubility as well as dissolution profile was improved by micronization, addition of surfactant and wet granulation method were prepared and formulated as capsule dosage form. Among these, F09 is considered to be the optimized formulation with the desired drug release and improved dissolution profile. The polymers which have been used in the best formulation (F09) are Polyplasdone, Microcrystalline cellulose, Starch and Poly vinyl pyrollidine with small quantity of granulating fluid. The micronized fenofibrate analysed by FTIR, Compactibility study, Density parameter analysis, Solubility studies, Crystal properties, Particle size, Surface area and Analytical properties were evaluated, which shows better results than Non-micronized form. The granules were evaluated for Physical parameters, Particle size distribution, Moisture content, Contact angle measurement and Related substances determination. Dosage form evaluation parameters like Weight variation, Cap lock length indicated that the capsules so prepared were physically stable and complied with necessary Pharmacopoeial specification. Drug content uniformity also found to be under Pharmacopoeial specification. The dissolution of all formulation was carried out as per Pharmacopoeial specification and data indicated that dissolution increased in all cases. Also shows that the drug release profile of the final optimized formulation was similar to that of marketed innovator product. It can be concluded that similar in-vitro release results will give similar in-vivo release profile. DSC analysis reveals that there is no physical interaction between drug and excipients so there may not be chances of any incompatibility in the formulation. The phenomenon of optimized drug release follows Korsemeyer-Peppas model with non-fickian diffusion.