PREPARATION AND EVALUATION OF COPROCESSED SUPERDISINTEGRANT IN THE DESIGN OF PROCHLORPERAZINE MALEATE FAST DISSOLVING TABLETS

Abstract

The demand for fast dissolving tablet (FDT) has been growing during the last decade especially for elderly, children and patients who have swallowing difficulties. This dosage form is placed in the mouth, allowed to disperse or dissolve in the saliva, and then swallowed without the need of water. The problem of certain FDT is their low resistance and high friability. FDT having alone superdisintegrant have slow disintegration and high friability.  The purpose of this study was to prepare and evaluate the coprocessed superdisintegrant in promoting tablet disintegration and having low friability.  Attempt was made to develop FDT of Prochlorperazine Maleate with the help of coprocessed superdisintegrant. The tablets were evaluated for its percentage friability, disintegration time, wetting time, and hardness. In the investigation, a 3² full factorial design was used to investigate the combined influence of two formulation variables: amount of sodium starch glycolate and crospovidone. The results of multiple linear regression analysis revealed that for obtaining a hard and rapidly disintegrating dosage form. A checkpoint batch was also prepared to prove the validity of the evolved mathematical model. The concentration was optimized at which FDT disintegrate within 30 seconds and having friability 0.60%. A response surface plot is also presented to graphically represent the effect of the independent variables on the disintegration time and percentage friability. Optimized FDT should be prepared using an optimum concentration of sodium starch glycolate and crospovidone. Short-term stability studies indicated that there are no significant changes in drug content and in vitro disintegration time. The optimized tablet was found to be stable and shelf life is predicted more than two years.