Optimization of promethazine theoclate fast dissolving tablet using pore forming technology by 3-factor, 3-level response surface-full factorial design.

The present research work was undertaken to optimize and formulate Promethazine Theoclate as a fast dissolving tablet using pore forming technology that disintegrates or dissolves rapidly and offer a suitable approach for the treatment of nausea and vomiting. Fast dissolving tablets of Promethazine Theoclate was prepared by increasing the solubility i.e. using beta-cyclodextrin, crospovidone, and menthol. A 3(3) full factorial design was employed to investigate the combined influence of these three independent variables, i.e., amount of menthol, crospovidone and beta-cyclodextrin on disintegration time, percentage friability and percentage drug release after 5 min. In the optimization study, multiple regression analysis has revealed that an optimum amount of menthol, crospovidone and beta-cyclodextrin gives a rapidly disintegrating/dissolving tablet. In order to prove the validity of the evolved mathematical model a checkpoint batch was also prepared. Optimized tablets were prepared with an optimum amount of beta-cyclodextrin, menthol and crospovidone which disintegrated in the 30 s, having friability 0.599% and released drug 89% after 5 min.