Gastric Floating Controlled Released Tablet of Diuresis Drug : Formulation and In-Vitro Evaluation

The present study focuses on the formulation and evaluation of a gastro-retentive floating controlled release tablet of Amiloride, aimed at enhancing gastric residence time and improving bioavailability. Okra gum and HPMC K4M were used as polymeric matrix formers, Avicel PH 102 as a directly compressible excipient, citric acid to create an acidic microenvironment, and sodium bicarbonate as a gas-generating agent to impart buoyancy. Tablets were prepared by direct compression and evaluated for pre- and post-compression parameters, buoyancy lag time, total floating time, swelling index, in-vitro drug release, and stability. All formulations exhibited acceptable physical characteristics, with floating lag times below 100 seconds and floating durations exceeding 12 hours. The optimized batch (F8) demonstrated a controlled drug release of 95.42% over 12 hours, fitting the Korsmeyer–Peppas and Higuchi release models, indicating anomalous transport. Stability studies confirmed no significant change in physical or release characteristics over three months at 40 °C/75% RH. The developed gastro-retentive system shows potential to reduce dosing frequency, enhance therapeutic efficacy, and minimize side effects associated with Amiloride therapy.