Optimization and Formulation Design with In-Vitro Evaluation of Fast Disintegrating Tablets Containing Candesartan Solid Dispersions

The aim of this study was to assess the effects of processing parameters on the release of solid dispersion formulation from a fast dissolving tablet dosage form. Graphical and mathematical analysis such as the response surface methodology (RSM) and multiple response optimizations utilizing the polynomial equation were used to search for the optimal formulation and to quantify the effect of each formulation variables. To optimize the influence of superdisintegrant (crospovidone) and subliming agent (camphor) on the prediction of disintegration time (Y1), percentage friability (Y2) and wetting time (Y3), a two factor, three levels (32) full factorial design was used. Results of multiple regression analysis revealed that an optimum concentration of camphor and a higher percentage of crospovidone are required for obtaining rapidly disintegrating tablets. The optimized formulation was subsequently subjected to a short-term accelerated stability study. Processing parameters have shown a profound effect on the release of solid dispersion formulations from its hydrophilic carrier. The observed results of Y1, Y2 and Y3 coincided well with the predictions in the RSM optimization technique, indicating it was quite useful for optimizing pharmaceutical formulation. The release kinetic of drug from fast dissolving tablets followed the first-order release pattern. Experimental values obtained from the optimized formulations were in close to the predicted values, thus confirming the validity of the generated mathematical model. In conclusion, this study demonstrated the potential of statistical experimental design in elucidating the effects of the formulation variables on the rapidly disintegrating tablets containing solid dispersion of a hydrophobic drug.