Cefixime belongs to the cephalosporin class of antibiotics, characterized by potent antibacterial activity, a broad spectrum of antimicrobial action, and extensive therapeutic applications. Its dispersible tablets represent a domestically unique dosage form. During the research process, DiQi Pharmaceuticals Co., Ltd compared various formulations with dispersible tablets in terms of administration methods, release behavior, pharmacokinetics, and other characteristics. The most comparable formulation was selected as the reference product, enabling the successful completion of the bioequivalence evaluation for this generic drug. This project stands as a representative achievement in consistency evaluation among “Three Reforms” products. Cefixime, classified as a BCS Class 4 compound, presents challenges due to its low solubility, poor bioavailability, and difficult dissolution testing. As a cephalosporin product, it involves complex impurity studies. Changing the dosage form necessitated formulation modifications, adding to the high development difficulty. Overall, this project posed significant development challenges.

DiQi Pharmaceuticals Co., Ltd has developed cost-effective formulations and processes tailored to product characteristics, establishing proprietary dissolution conditions. This approach successfully achieved consistency between in vitro dissolution and in vivo bioequivalence, enabling the bioequivalence study to pass on the first attempt! Congratulations to our partner, Zongsheng Pharmaceutical, and the DiQi Pharmaceuticals Co., Ltd project team.