ENHANCEMENT OF SOLUBILITY AND DISSOLUTION CHARACTERISTICS OF FENOFIBRATE BY SOLID DISPERSION TECHNIQUE

Abstract

The solubility/dissolution behavior of a drug is key factor influencing its oral bioavailability, being the rate-limiting step for absorption of drugs from the gastrointestinal tract. For effective pharmacological action, aqueous solubility is the most important criteria for prompt dissolution and good absorption. The present study was aimed to enhance the solubility of poorly water soluble drug (BCS Class II) Fenofibrate individually using water soluble polymers like Poly ethylene glycol (PEG 6000) (fusion method) and Poly vinyl pyrrolidone (PVP K30) (solvent evaporation method) in various ratios like 1:1, 1:2, 1:3 and 1:4 separately. Initially, pre-formulation studies like drug excipient compatibility studies by FTIR, DSC and determination of saturation solubility of drug individually in various media like distilled water, 0.1N hydrochloric acid and pH 7.4 phosphate buffer. The formulated solid dispersions were evaluated for percentage yield, drug content and in vitro dissolution studies. From the results of pre-formulation studies it was revealed that there was no interaction between drug and excipients and the pure drug was poorly soluble in water. The percentage yield of all formulations was in the range of 60-96 % and drug content was in the range of 56-82 mg. The solid dispersion containing polyvinyl pyrrolidone K 30 in 1:4 ratio showed highest amount of drug release at the end of 30 minutes than other formulations. Finally it was concluded that solid dispersion prepared with PVP K-30 in 1:4 ratio by solvent evaporation method was more soluble than by fusion method.