Formulation and Optimization of Oro dispersible Tablet of Pentoprazole Sodium as Proton Pump Inhibitor

In the present study, the aim was to formulate and optimize an orodispersible formulation of pantoprazole sodium using a combination of superdisintegrants. cThe tablets were made by direct compression technique with superdisintegrants i.e. crosspovidone and sodium starch glycolate incorporated in it. Differential Scanning Calorimetry (DSC) studies exhibited physiochemical compatibility between pantoprazole sodium and various excipients used in the tablet formulation. In an attempt to construct a statistical model for the prediction of disintegration time and percentage friability, a 32 randomized full and reduced factorial design was used to optimize the influence of theamounts of superdisintegrants. Amount of crosspovidone and sodium starch glycolate were taken as independent variables and disintegration time and fribility as dependent responses. Concerning the optimization study, the multiple regression analysis revealed that an optimum concentration of crosspovidone and a higher percentage of sodium starch glycolate are required for obtaining rapidly disintegrating tablets with adequate friability and mechanical strength. A checkpoint batch was also prepared to prove the validity of the evolved mathematical modelStability studies carried out as per ICH Q1 A guidelines suggested the stable formulations for the tested time period of 3 months accelerated study. In conclusion, this investigation demonstrated the potential of experimental design in understanding the effect of the formulation variables on the quality of mouth dissolve tablets.