DEVELOPMENT AND OPTIMIZATION OF FAST DISSOLVING TABLETS OF PROMETHAZINE THEOCLATE USING 32 FULL FACTORIAL DESIGN

This research work aimed at developing and optimizing fast dissolving tablets of Promethazine Thecolate by direct compression technique. In the investigation, a 3² full factorial design was used to investigate the joint influence of two formulation variables (amount of superdisintegrants): amount of sodium starch glycolate and crospovidone. The tablets were evaluated for its percent friability and their disintegration time. The results of multiple linear regression analysis revealed that for obtaining a rapidly disintegrating dosage form, tablets should be prepared using an optimum concentration of sodium starch glycolate and a crospovidone. A contour plot was also presented to graphically represent the effect of the independent variables on the disintegration time 30 s and percent friability 0.5 %. A checkpoint batch was also prepared to prove the validity of the evolved mathematical model. The optimized tablet should be prepared with an optimum amount of Sodium starch Glycolate (2.75 mg), and Crospovidone (2.72 mg) which disintegrated in the 30 seconds, with friability of 0.5% and of drug release within 5 min. The optimized approach aided both the formulation of fast dissolving tablets and the understanding of the effect of formulation processing variables on the development of formulation.