ABSTRACT:
Vonoprazan fumarate is an innovative potassium-competitive acid blocker (P-CAB) that delivers rapid onset and prolonged acid suppression, thereby emerging as a superior therapeutic alternative to conventional proton pump inhibitors in the management of gastritis. This research aims to develop and evaluate immediate-release tablets of recently approved vonoprazan fumarate using a QbD approach and to compare its release pattern with available marketed products. In this research, a 32 full factorial design was employed using Design Expert software where croscarmellose sodium (CCS) and pregelatinized starch were taken as independent variables and percent drug release in 0.1N HCl after 45 minutes was selected as a response. Pre-formulation studies using FTIR, XRD, and DSC revealed no drug-excipient interactions, affirming the compatibility of vonoprazan fumarate with the selected excipients. The tablets were then prepared by wet granulation method and in-vitro dissolution was assessed for the evaluation. Out of nine formulations (F1-F9) an optimized batch was identified using response surface methodology of statistical analysis, containing 20% CCS and 6% pregelatinized starch. Finally, the optimized formulation was compared to the marketed formulations which showed faster release profile highlighting its potential advantage over marketed products, paving the way for future advancements in gastritis management.