The current study aimed to explore the impact of buffer species on the dissolution behavior of orally disintegrating tablets (ODT) containing a basic polymer and its influence on bioequivalence (BE) prediction. Fexofenadine hydrochloride ODT formulations were used as the model formulations, Allegra^® as the reference formulation, and generic formulations A and B as the test formulations. Allegra^®, generic A, and generic B are ODT formulations that contain aminoalkyl methacrylate copolymers E (Eudragit^® E, EUD-E), a basic polymer commonly used to mask the bitter taste of drugs. Both generic A and generic B have been known to be bioequivalent to Allegra^®. The dissolution tests were conducted using a compendial paddle, with either bicarbonate (10 mM, pH 6.8) or phosphate buffer (25 mM, pH 6.8) as the dissolution media. A floating lid was employed to cover the surface of the bicarbonate buffer to prevent volatilization. Results indicated that in phosphate buffer, the dissolution profiles of Allegra and generic B significantly varied from that of generic A, whereas in the bicarbonate buffer, the dissolution profiles of Allegra, generic A, and generic B were comparable. These findings suggest that the use of bicarbonate buffer may offer a more precise prediction of human bioequivalence compared to phosphate buffer.

本研究旨在探讨缓冲剂种类对含有碱性聚合物的口腔崩解片（ODT）溶出行为的影响及其对生物等效性（BE）预测的影响。盐酸非索非那定ODT制剂作为模型制剂，Allegra®^作为参比制剂，通用制剂A和B作为试验制剂。Allegra ^®、仿制药 A 和仿制药 B 是含有氨基烷基甲基丙烯酸酯共聚物 E（Eudragit ^® E、EUD-E）的 ODT 制剂，这是一种通常用于掩盖药物苦味的基本聚合物。已知仿制药 A 和仿制药 B 均与 Allegra ^®具有生物等效性。使用药典桨进行溶出度测试，以碳酸氢盐（10 mM，pH 6.8）或磷酸盐缓冲液（25 mM，pH 6.8）作为溶出介质。采用浮盖覆盖碳酸氢盐缓冲液的表面以防止挥发。结果表明，在磷酸盐缓冲液中，Allegra 和仿制药 B 的溶出曲线与仿制药 A 显着不同，而在碳酸氢盐缓冲液中，Allegra、仿制药 A 和仿制药 B 的溶出曲线相当。这些发现表明，与磷酸盐缓冲液相比，使用碳酸氢盐缓冲液可以更准确地预测人体生物等效性。