Abstract: Objective To compare the ethanol dose-dumping risk between generic and reference formulations of aspirin enteric-coated tablets from different manufacturers in accordance with the guidelines issued by the National Medical Products Administration (NMPA). Methods The gastric environment was simulated using 0.1 moL·L^-1 hydrochloric acid containing 0% to 40% ethanol. The in vitro release of aspirin was determined by high-performance liquid chromatography (HPLC). Dissolution profiles were generated, and the similarity of in vitro release between formulations was evaluated by calculating the similarity factor (f₂). Results In media containing 5% and 20% ethanol, the acid resistance of all the tested formulations proved satisfactory, with a cumulative release of ≤10% within 120 min. The in vitro release from the generic and reference formulations hardly changed. When the ethanol concentration was raised to 40%, the integrity of the enteric coating of all the formulations was disrupted, resulting in dose dumping (>90%) accompanied by drug degradation. Conclusion Ethanol at the concentration of 40% can induce dose dumping of aspirin enteric-coated tablets. The enteric coating material is believed to be the leading contributor to ethanol-induced dose dumping, which suggests a safety risk once these tablets are co-administered with alcoholic beverages.

Key words: Aspirin Enteric-Coated Tablets, Alcohol-Induced Dose Dumping, High Performance Liquid Chromatography (HPLC) Method, Safety Evaluation, In vitro Release Test