Formulation Design and Optimization of Fast Dissolving Tablets of Prochlorperazine Maleate Using Pore Forming Technique

Abstract
The purpose of this research was to develop fast dissolving tablets of Prochlorperazine Maleate. Tablets contain prochlorperazine maleate, menthol, crospovidone, microcrystalline cellulose and lactose prepared by direct compression technique. Menthol was sublimed from the tablets by exposure to vacuum. 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 menthol and crospovidone. The results of multiple linear regression analysis revealed that for obtaining a rapidly disintegrating dosage form, which 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. A checkpoint batch was also prepared to prove the validity of the evolved mathematical model. Optimized tablet should be prepared using an optimum concentration of menthol and Crospovidone. Short-term stability studies indicated that there are no significant changes in drug content and in vitro disintegration time (p<0.05).The optimized tablet was found to be stable and shelf life predicted more than two years. The systematic formulation approach helped in understanding the effect of formulation processing variables.

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