Abstract

FORMULATION DEVELOPMENT AND EVALUATION OF FEXOFENADINE SOLID DISPERSION TABLETS

K. Manasa* and D. Dhachinamoorthi

ABSTRACT

Fexofenadine is an BCS class II drug having absolute bioavailability of Fexofenadine is approximately 33%. To improve the biological performance of Fexofenadine solid dispersion with oral disintegrating tablet was formulated by using mannitol, PEG 4000. Solid dispersions of Fexofenadine were prepared with different carriers in different ratios of drug and carrier (1:0.5, 1; 1 and 1:1.5). Results of prepared solid dispersions of Fexofenadine by solvent evaporation method were discussed which includes solubility, melting point determination, drug content uniformity, entrapment efficiency and in vitro dissolution studies. Characterization in solid state was done by various analytical techniques such as FT-IR studies. Finally by comparing all the formulations (SD1-SD6) formulation(SD3) containing Fexofenadine + mannitol (1:1.5) shows better results by solvent evaporation method at the end of 60 min with drug release of 97.42%, hence it was selected as the best formulation. From the optimized formulation the immediate release tablets were formulated using different disintegrants in different concentrations. The pre compression and post compression parameters were studied and the results were given. All the results are in the acceptable limit. The in vitro drug release of the formulated tablets were performed using 6.8pH buffer. F6 formulation containing SSG (18mg) shows 98.02% drug release in 30mins. The optimized formulation follows Zero order release kinetis.

Keywords: Fexofenadine, Mannitol, PEG 4000, Lycoat, SSG.