DEVELOPMENT AND CHARACTERIZATION OF BELZUTIFAN FLOATING DRUG DELIVERY SYSTEM FOR IMPROVED GASTRIC RETENTION

The present study aimed to develop and characterize a floating drug delivery system (FDDS) of Belzutifan to improve gastric retention, provide sustained drug release, and enhance oral bioavailability. Belzutifan floating tablets were prepared by the direct compression method using sodium alginate (F1–F4) and Tragacanth (F5–F8) as matrix-forming polymers, while sodium bicarbonate and citric acid were incorporated as gas-generating agents to impart buoyancy. All formulations exhibited acceptable physical characteristics with weight variation between 399–401 mg, hardness ranging from 5.2–6.9 kg/cm², and friability below 1%, indicating adequate mechanical strength. Floating lag time ranged from 40 to 57 seconds, confirming rapid buoyancy. In vitro dissolution studies showed sustained drug release over 8 hours, with cumulative drug release ranging from 93.25% to 98.58%. Among all formulations, F7 demonstrated the highest drug release (98.58%), shortest floating lag time (40 seconds), and superior overall performance. Accelerated stability studies conducted according to ICH guidelines demonstrated that the optimized formulation remained stable over three months without significant changes in drug release characteristics. The optimized formulation (F7) showed promising physicochemical properties, buoyancy, controlled-release behaviour, and stability, indicating its potential as an effective gastro-retentive oral delivery system for Belzutifan. Keywords: Belzutifan, Floating Drug Delivery System, Gastro-retentive Drug Delivery System, Floating Tablets, Sodium Alginate, Tragacanth, Sustained Release, Direct Compression, Drug Release Kinetics.