QbD Enabled Chebulinic Acid Solid Dispersions Encapsulated in Modified Xanthan Gum Coated Sodium Alginate Beads for Enhanced Gastric Ulcer Therapy

Background: Terminalia chebula is widely used in Ayurvedic medicine, and chebulinic acid has been identified as a key bioactive constituent with notable antiulcer activity, owing to its antisecretory, antioxidant, and anti-inflammatory properties. However, chebulinic acid’s poor aqueous solubility and hydrophobic nature limit its pharmaceutical application. Objectives: This study aimed to enhance the solubility, gastric retention, and therapeutic efficacy of chebulinic acid by developing chebulinic acid-loaded solid dispersions (CASD) incorporated into modified xanthan gum-coated sodium alginate-based gastroretentive beads for improved gastric ulcer treatment. Methods: CASDs were prepared with PVP K30 via solvent evaporation and characterized using FTIR, XRD, and DSC. The optimized dispersion was incorporated into modified xanthan gum-coated sodium alginate gastroretentive floating beads through ionotropic gelation. Optimization was conducted using a Quality by Design approach with a Box–Behnken design. The resulting beads were evaluated for bead size, buoyancy, swelling, drug entrapment efficiency, surface morphology, in vitro drug release, and anti-ulcer activity to determine formulation performance. Results: The optimized CASD demonstrated improved solubility (59.31 mg/mL) and % cumulative drug release (93.03% within 2 h) compared to pure chebulinic acid. Modified xanthan gum-coated sodium alginate beads achieved an encapsulation efficiency of 62.42%, a floating lag time of 6.1 s, a density of 0.602 g/cm³, a floating duration exceeding 24 h, and sustained drug release of 74.8% over 8 h. Quality by Design (QbD) optimization yielded a r² value greater than 0.9. In vivo studies showed 80.28% ulcer protection, comparable to that of omeprazole (82.04%). Conclusions: CASD-loaded gastroretentive beads effectively enhanced the solubility, gastric retention, and antiulcer efficacy of chebulinic acid, highlighting their potential as an advanced delivery system for gastric ulcer management.