FORMULATION AND DEVELOPMENT OF DISINTEGRATING TABLET FOR ORAL REHYDRATION THERAPY (ORT) FOR ZINC SULPHATE

Zinc supplementation plays a critical role in reducing the duration and severity of acute diarrhea, particularly in pediatric patients. However, conventional zinc sulphate tablets often suffer from poor palatability and low patient compliance, especially among children. The present study aims to formulate and evaluate mouth disintegrating tablets (MDTs) of Zinc Sulphate, designed to enhance ease of administration, improve patient compliance, and deliver rapid therapeutic action as part of Oral Rehydration Therapy (ORT). Five formulations (F1–F5) were developed using direct compression technique, incorporating Zinc Sulphate Monohydrate (equivalent to 20 mg elemental zinc) along with suitable excipients. Superdisintegrants were varied across formulations to assess their impact on disintegration and drug release. Angle of repose, bulk/tapped density, compressibility index, and other pre-compression characteristics were assessed for each batch. Post-compression measurements included in-vitro dissolution, drug content uniformity, weight variation, disintegration time, tablet hardness, and friability. With a disintegration time of less than 30 seconds, a drug content of 99.2%, and a drug release of more than 99% within 15 minutes, Formulation F5 was the finest of all. FTIR studies revealed no drug–excipient interaction, despite stability tests over three months in accelerated conditions (40 ± 2 °C / 75 ± 5% RH) showing the formulation remained stable in terms of appearance, drug content, and release profile.