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Abstract

DESIGN, FORMULATION DEVELOPMENT AND SOLUBILITY ENHANCEMENT OF FENOFIBRATE, A WATER INSOLUBLE DRUG BY SOLID DISPERSION TECHNIQUE

Md. Zakaria Faruki*, Elizabeth Razzaque, Rishikesh, Rehana Akhter and MohiuddinAhmed Bhuiyan

ABSTRACT

Fenofibrate is a lipid lowering agent used in the treatment of hyperlipidemia. In order to improve the solubility and oral absorption of Fenofibrate in gastric fluid and to enhance its dissolution rate solid dispersion technique by solvent evaporation method has been designed and evaluated. Poloxamer 188, Poloxamer 407, Polyethylene glycol (PEG) 6000, Polyvinyl Pyrrolidone (PVP), Hydroxy propyl methyl cellulose (HPMC) and Mannitol have been used as the hydrophilic polymers which were employed as carriers for formulation of solid dispersion with model drug in ratio of (Drug: Cariers) 1:1, 1:3, 1:5, 1:7 and 1:10. The pure drug and solid dispersions with all their ratio were characterized using FTIR techniques. The effect of solvent evaporation methods preparing of solid dispersion on dissolution behavior was investigated. Dissolution studies indicated a significant increase in dissolution of Fenofibrate when dispersed in carriers. In all the cases solid dispersions showed improved dissolution of Fenofibrate compared to that of pure drug. It was observed that higher concentration of carriers in preparing solid dispersion showed higher release of Fenofibrate. Solid dispersion prepared with Poloxamer 188 showed fastest and maximum release (93.74%) among all formulations and solid dispersions with PVP, HPMC, Poloxamer 407, PEG 6000, Mannitol showed 88.21%, 88.14%, 82.87%, 76.50% and 65.77% release respectively in 1:10 ratio within 1 hour whereas pure Fenofibrate showed only 23.60% release. The release of drug was plotted in Zero order, First order, Korsmeyer and Higuchi release pattern. The correlation coefficients values of the trend lines of the graphs showed that the formulations best fit in Higuchian release pattern.

Keywords: Solid dispersion, Fenofibrate, Solvent evaporation method, Dissolution.


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