Development and Evaluation of Oil-Entrapped Gastro-Retentive Floating Beads of Esomeprazole for the Treatment of Ulcers

Background: Esomeprazole, a proton pump inhibitor, is primarily absorbed in the upper gastrointestinal tract and exhibits instability in the intestinal environment. Gastro-retentive drug delivery systems are an effective approach to enhance gastric residence time and improve therapeutic efficacy. The present study aimed to develop a gastro-retentive floating bead formulation of Esomeprazole for sustained drug release. Methods: Floating beads of Esomeprazole were prepared using the ionotropic gelation technique with sodium alginate as the polymer and calcium carbonate as the gas-forming agent. The prepared formulations (F1-F6) were evaluated for particle size, floating behavior, drug entrapment efficiency, surface morphology, and in-vitro drug release. The optimized formulation was subjected to release kinetic modeling using zero-order, first-order, Higuchi models. Results: Among all formulations, F5 was identified as the optimized batch, exhibiting high drug entrapment efficiency (98.05%), short floating lag time, prolonged floating duration (>12 h), and sustained drug release (98.69% over 12 h). Drug release kinetics of F5 showed the best fit with the Higuchi model, indicating a diffusion-controlled release mechanism. Stability studies confirmed formulation stability under accelerated conditions. Conclusion: The developed gastro-retentive floating beads of Esomeprazole demonstrated prolonged gastric retention and controlled drug release, making them a promising delivery system for improving patient compliance and therapeutic efficacy.