PHARMACEUTICAL EQUIVALENCE AND IN VITRO DISSOLUTION SIMILARITY STUDIES OF COMMERCIALLY AVAILABLE METOCLOPRAMIDE HYDROCHLORIDE TABLETS

The present study aimed to develop and characterize Metoclopramide Hydrochloride Mouth Dissolving Tablets (MDTs) to provide rapid drug release, quick onset of action, and improved patient compliance, particularly for paediatric, geriatric, and dysphagic patients. Mouth dissolving tablets were prepared by the direct compression method using croscarmellose sodium and sodium starch glycolate as super disintegrants at different concentrations. A total of eight formulations (F1–F8) were developed and evaluated. All formulations exhibited acceptable physical characteristics with friability values below 1%, indicating adequate mechanical strength. Among all formulations, F8, containing 40 mg of sodium starch glycolate, exhibited the best performance with 83.33% drug content, 23 seconds wetting time, 25 seconds disintegration time, and 98.75% cumulative drug release within 30 minutes. Drug release kinetic analysis revealed that the optimized formulation best fitted the Zero-order kinetic model (R² = 0.963), indicating a nearly constant drug release pattern. Accelerated stability studies conducted at 25°C/60% RH, 30°C/75% RH, and 40°C/75% RH for three months demonstrated no significant changes in the dissolution profile, with cumulative drug release remaining above 95%, confirming the stability of the optimized formulation. The study concludes that Metoclopramide Hydrochloride mouth dissolving tablets prepared by the direct compression method provide rapid disintegration, excellent drug release, satisfactory physicochemical properties, and good stability. The optimized formulation has the potential to improve patient compliance and therapeutic efficacy by providing a convenient and effective oral dosage form for the management of nausea, vomiting, and related gastrointestinal disorders. Keywords: Metoclopramide Hydrochloride, Direct compression method, FTIR Studies, In vitro drug release studies