Design Optimization and Evaluation of Vonoprazan Fumarate Medicated Chewing Gum by Direct Compression Method

The present study aimed to formulate and evaluate medicated chewing gum containing Vonoprazan Fumarate as a novel oral drug delivery system for improved patient compliance and rapid drug release. Preformulation studies including melting point, solubility, FTIR, DSC, and UV spectroscopy confirmed the identity, purity, and compatibility of the drug with selected excipients. The λmax of Vonoprazan Fumarate was observed at 281 nm, and the calibration curve showed good linearity within the concentration range of 5–25 µg/mL. Medicated chewing gum formulations were prepared by direct compression using PVA, mannitol, glycerine, sucralose, peppermint, and talc. The formulations were evaluated for pre- and post-compression parameters and found within acceptable limits. Among all batches, formulation B2 showed optimum performance with satisfactory physicochemical properties and nearly 99.00 % drug release within 60 minutes. Optimization using Central Composite Design confirmed the significant effect of formulation variables. Stability studies indicated that the optimized formulation remained stable during storage conditions.