SOLUBILITY ENHANCEMENT OF FENOFIBRATE, A BCS CLASS II DRUG, BY SELF EMULSIFYING DRUG DELIVERY SYSTEMS

Abstract

The present work was aimed at the enhancement of solubility of Fenofibrate a BCS class II drug by Self Emulsifying Drug Delivery systems (SEDDS). The solubility of Fenofibrate in various excipients was determined. The excipients were screened for maximum solubility and compatibility. SEDDS formulations of Fenofibrate were developed using different Oils, Surfactants and Co-Surfactant combinations. Pseudoternary phase diagrams were drawn using Triplot software and by applying Pseudoternary phase diagrams, microemulsification area was evaluated.

Formulations were screened based on visual observances and phase diagrams. Seven formulations were selected for further evaluations like stability, effect of dilution, freeze- thawing, emulsion droplet size and zeta potential. Among the seven formulations three were optimized and In-Vitro dissolution was performed. The dissolution rate of SEDDS was compared with plain Fenofibrate (API). The study confirmed that the solubility and dissolution rate of Fenofibrate were remarkably increased when compared to that of plain drug. Hence SEDDS formulations can be a potential alternative to traditional oral drug delivery systems of Fenofibrate to improve its bioavailability