SOLUBILITY IMPROVEMENT OF POORLY WATER SOLUBLE DRUG FENOFIBRATE BY SOLID DISPERSION IN POLYETHYLENE GLYCOL-HYDROXY PROPYLE METHYLE CELLULOSE MIXTURE

Abstract

The objective of this study is to formulate solid dispersion of fenofibrate by hot melt extrusion method for improving aqueous solubility. Different formulation was prepared mixing microcrystalline drug, Poly Ethylene Glycol (PEG) and other excipient at specific ratio. The drug was dissolved in the melt of excipient at 65-70^oC, cooled below 40^oC, and grinded to prepare fine powder. The solid system was characterized by Differential Scanning Calorimetry (DSC), Scanning Electron Microscope (SEM), Fourier Transform Infrared Spectroscopy (FTIR), the dispersion testing in the water and simulated gastric fluid. It was confirmed that there is no chemical interaction between drug and excipient. In-vitro release testing showed that 76.85 % of the drug dissolved in distilled water in 60 minutes. Almost 100 % of drug release was found within 20 minutes and 30 minutes in 2 % Sodium Lauryl Sulfate and 1 % Tween-80 simulated gastric fluid respectively for drug, PEG and HPMC ratio 1:7.5:2.5. Thus, the aqueous solubility of this poorly water-soluble drug was greatly enhanced by solid dispersion in a surface-active carrier.