Design And Evaluation Of Gastroprotective Effervescent Granules Incorporating Hydrotalcite And Deglycyrrhizinated Licorice

Abstract

Gastrointestinal disorders such as gastroesophageal reflux disease (GERD), peptic ulcers, and functional dyspepsia persist as global health challenges requiring therapeutic approaches that address both symptomatic relief and mucosal healing. This study presents a novel gastroprotective formulation comprising effervescent granules containing hydrotalcite—a layered double hydroxide antacid—and deglycyrrhizinated licorice (DGL)—a mucosal protective phytoconstituent devoid of hypertensive glycyrrhizin. Utilizing a 3² factorial design, nine formulations were prepared by wet granulation, optimized for acid-neutralization and mucosal defense. The granules exhibited excellent flow properties (Carr’s index < 20%, Hausner’s ratio < 1.30), rapid effervescence (<120 s), and robust acid-neutralizing capacity (pH raised from 1.2 to 4.4 within 5 min). FTIR spectroscopy confirmed no significant drug-excipient interactions, supporting chemical stability. In vitro dissolution studies revealed a dual-phase release: hydrotalcite demonstrated immediate release (94.2% in 15 min), while DGL showed sustained release (87.9% in 60 min), mimicking the desired pharmacokinetic synergy. Among all, Formulation F6 (2:1 ratio) emerged as optimal, offering the best balance between rapid antacid action and prolonged mucosal protection. Stability studies at 40°C/75% RH over 3 months validated the formulation's physical and chemical integrity with minimal variation. These findings underscore the potential of hydrotalcite-DGL effervescent granules as a patient-compliant, dual-action therapy targeting both the acid-driven and inflammatory components of upper gastrointestinal disorders.