Development and Optimization of Orodispersible tablets of Fexofenadine hydrochloride by Box-Behnken Statistical Design

Abstract

The aim of the present study was to formulate orodispersible tablets (ODT) of fexofenadine Hydrochloride by studying the effect of the variable for response with the help of Box-Behnken design (BBD). A total of 17 formulations were prepared by altering the proportion of crospovidone, sodium starch glycolate and mannitol by direct compression technique. BBD was employed to study the relations among the variables and to statistically optimize the formulation parameter for ODT tablets of fexofenadine Hydrochloride. Response surface and contour plots were plotted based on BBD and relationship between the variables and responses were established. Further evaluation of responses with respect to variables was made with 3D surface plot that allows evaluating a blend selected variables at a time and assessing the effect of variation and interaction on responses. In conclusion, an optimized model was obtained based on predicted and observed response for the three dependent variables.