Development and Pharmacokinetic Evaluation of Drug-Loaded Mucoadhesive Microsphere For Enhanced Oral Bioavailability in Peptic Ulcer Management

The present study aimed to develop and evaluate Vonoprazan Fumarate-loaded mucoadhesive microspheres for sustained drug release and improved oral drug delivery in the management of peptic ulcer disease. The microspheres were prepared using the ionotropic gelation technique, employing sodium alginate as the primary polymer, chitosan as the mucoadhesive polymer, and calcium chloride as the cross-linking agent. The prepared formulations (F1–F5) were evaluated for percentage yield, particle size, drug entrapment efficiency, mucoadhesion, swelling index, surface morphology, in-vitro drug release, drug–excipient compatibility, and stability. Among the formulations, F4 was selected as the optimized formulation based on its overall formulation characteristics. F4 exhibited a percentage yield of 91.18 ± 0.94%, drug entrapment efficiency of 88.63 ± 1.12%, mucoadhesion of 93.18 ± 1.04%, and a swelling index of 172.94 ± 4.11%. The in-vitro drug release study demonstrated sustained drug release, reaching 88.64% at 24 hours. Differential scanning calorimetry indicated no significant drug–excipient incompatibility under the investigated conditions. During accelerated stability testing at 40 ± 2°C/75 ± 5% relative humidity for two months, the optimized formulation showed minimal changes in drug content and drug release. In the in-vivo evaluation, F4 demonstrated promising gastroprotective activity, with an ulcer index of 1.28 ± 0.12, ulcer protection of 85.19%, and gastric pH of 3.94 ± 0.16. The reported pharmacokinetic findings also indicated increased systemic exposure compared with the conventional drug suspension; however, numerical pharmacokinetic data are required for quantitative confirmation. Overall, the findings suggest that Vonoprazan Fumarate-loaded mucoadhesive microspheres may offer a promising approach for sustained drug release and gastroprotective delivery in peptic ulcer management. Further studies with complete pharmacokinetic data are necessary to confirm the improvement in oral bioavailability.