Probiotics - based Dosage form Development against H. Pylori induced Gastric Disorders

Background: Helicobacter pylori (H. pylori) infection is a major cause of gastric ulcers and gastric cancer. Conventional antibiotic therapy often faces limitations due to resistance and side effects. Probiotics such as Lactobacillus acidophilus can improve gastric health and enhance therapeutic efficacy. The present study aimed to develop and optimize an esomeprazole–probiotic mucoadhesive microsphere formulation for gastric delivery. Materials and Methods: Mucoadhesive microspheres were prepared using sodium alginate and Carbopol 934 by the ionic gelation method, with calcium chloride as the crosslinking agent. A Box–Behnken design was employed to optimize key formulation variables (polymer concentration and stirring speed) with entrapment efficiency, particle size, and yield as responses. The formulations were characterized for entrapment efficiency, probiotic survival in simulated gastric fluid (pH 2), swelling index, mucoadhesion on rat gastric mucosa, FTIR compatibility, SEM morphology, and in vitro drug release kinetics. Results: The optimized formulations (OM1 and OM2) demonstrated high entrapment efficiency (>94%), strong mucoadhesive strength, and excellent probiotic stability in acidic gastric conditions. FTIR confirmed drug–polymer compatibility, and SEM revealed spherical porous microspheres. In vitro release studies showed sustained drug release over 12h, following zero-order and Korsmeyer–Peppas kinetics. Conclusion: Esomeprazole–probiotic microspheres exhibited significant probiotic protection, controlled drug release, and good gastric mucoadhesion, indicating their potential as a promising alternative strategy for the management of H. pylori–induced gastric disorders.