Formulation, Optimization, and Evaluation of Mouth Dissolving Tablet of Promethazine Hcl

Abstract

This study uses the effervescent technique to formulate and evaluate mouth dissolving tablets (MDTs)of promethazine HCl. MDTs are preferred for their ease of use, especially in patients with swallowing difficulties. The formulation process using various excipients, including crospovidone, sodium bicarbonate, and microcrystalline cellulose, was optimized through a Box-Behnken design. The study assessed pre-compression and post-compression parameters, including flow properties, hardness, friability, disintegration time, and in vitro drug release. Results indicated that the optimized formulation (B-16) achieved a disintegration time of 40 seconds and a cumulative drug release of 98.34% within 15 minutes, demonstrating the effectiveness of the effervescent technique in enhancing drug bioavailability. The findings suggest that the developed MDTs can provide rapid therapeutic effects, making them suitable for pediatric and geriatric patients.