Design and In-vitro Evaluation of fast Disintegrating Promethazine Theoclate Tablets

Promethazine theoclate, a first-generation H1 receptor blocker, is commonly prescribed for motion sickness and postoperative nausea. Its oral bioavailability is only about 25%, mainly because of poor solubility in water, which delays the onset of action. To overcome this limitation, orally disintegrating tablets (ODTs) of promethazine theoclate were developed. ODTs dissolve quickly in the mouth, improving drug absorption and making them especially useful for patients who have difficulty swallowing.In this study, ODTs were prepared using three different super disintegrantssodium starch glycolate, crospovidone, and croscarmellose sodiumused alone and in combination at different levels. Seventeen trial formulations were designed with the help of Design Expert software. Each formulation was tested for flow properties, hardness, friability, weight variation, drug content, disintegration time, and dissolution performance. Among the prepared formulations, formulation F8 showed the best results, with a rapid disintegration time of 30 seconds and almost complete drug release (99.89%). The optimized blend contained sodium starch glycolate (17.5 mg), croscarmellose sodium (30 mg), and crospovidone (30 mg). FT-IR analysis confirmed no interactions between drug and excipients. Stability testing over 90 days also showed no significant changes in quality or dissolution behavior. Overall, the optimized ODTs of promethazine theoclate achieved rapid tablet breakdown and nearly complete drug release, suggesting faster absorption and quicker relief of symptoms. This dosage form may provide a cost-effective, scalable, and patient-friendly alternative to conventional tablets, with the added benefit of better compliance and improved clinical outcomes.