Development and Evaluation of a Gastroretentive Polyherbal Capsule for the Management of Aspirin-Induced Gastric Ulcers in Experimental Rats

Abstract

Peptic ulcer disease is one of the most common gastrointestinal disorders caused by an imbalance between aggressive factors and gastric mucosal defense mechanisms. The present study aimed to develop a gastroretentive polyherbal capsule (GPHC20) containing extracts of Glycyrrhiza glabra, Zingiber zerumbet, Andrographis echinoides, Holarrhena mitis, and Aegle marmelos and to evaluate its gastroprotective efficacy in aspirin-induced gastric ulcer rats. Carbopol 971P was employed as the gastroretentive polymer to prolong gastric residence time and improve therapeutic efficacy. Acute oral toxicity was performed according to OECD guideline 423. Gastroprotective activity was evaluated using aspirin-induced gastric ulceration by estimating gastric pH, gastric volume, total acidity, free acidity, ulcer index, histopathology, and inflammatory cytokines (TNF-α, IL-1β, and IL-10). The optimized formulation (GPHC20) demonstrated excellent safety up to 2000 mg/kg and produced significant (p < 0.05) gastroprotection by increasing gastric pH while reducing gastric volume, acidity, ulcer index, and mucosal damage. Histopathological examination confirmed marked protection of gastric mucosa. ELISA analysis further demonstrated significant suppression of TNF-α and IL-1β with elevation of IL-10, indicating potent anti-inflammatory activity. The gastroretentive formulation exhibited superior antiulcer efficacy compared with the marketed polyherbal formulation and produced gastroprotective effects comparable to omeprazole. The findings suggest that gastroretentive delivery substantially improves the therapeutic performance of polyherbal preparations in gastric ulcer management.

Keywords: Gastroretentive capsule, Polyherbal formulation, Aspirin-induced ulcer, Carbopol 971P, ELISA, Gastroprotection.