Design, development, and evaluation of gastro-retentive Mangifera indica extract-loaded chitosan microspheres for the management of Helicobacter pylori-induced gastric ulcers

The primary cause of gastritis, gastrointestinal ulcers, and stomach cancer is Helicobacter pylori. Consequently, treatment of duodenal and stomach issues requires its suppression.This study addresses this urgency through the development of Mangifera indica extract loaded gastroretentive floating microspheres (MIEM’s) to enhance gastric retention and sustained release of bioactive compounds (rutin, quercetin) for ulcer management. These microspheres are designed to float on gastric fluids, thereby increasing their bioavailability and anti-ulcer efficacy. Chitosan-based microspheres were optimized via Box-Behnken design, evaluating concentration of chitosan (A: 1–2%), glutaraldehyde vol. (B: 1–5 mL), and stirrer speed (C: 800–1200 RPM) on responses: %yield, entrapment efficiency (%EE), particle size, and drug release. Optimized conditions (1.66% chitosan, 4.69 mL glutaraldehyde, 854 RPM) yielded microspheres with 86.19 ± 2.9% buoyancy, 40.1 ± 0.07 μm particle size, and high %EE (rutin: 86.93 ± 0.55%; quercetin: 85.09 ± 0.15%). FTIR, DSC, and XRD confirmed excipient compatibility and amorphous dispersion of the extract. SEM revealed spherical, smooth-surfaced microspheres. In vitro release demonstrated sustained drug release over 24 hours, contrasting rapid release from crude extract. Antimicrobial assays against H. pylori showed dose-dependent inhibition zones (23.8 ± 0.6 mm at 200 μg/mL), outperforming pure extract (15.3 ± 0.4 mm) and nearing that of the standard drug amoxicillin (28.6 ± 0.5 mm). ANOVA-validated models (R² > 0.9, p < 0.001) confirmed robustness. MIEM’s prolonged gastric retention and dual action sustained antioxidant release and antimicrobial efficacy highlight its potential as a natural alternative for ulcer management. Further in vivo studies are warranted to validate therapeutic efficacy.