立即释放的固体口服剂型的生物豁免专著:费克索芬纳丁
Naseem A Charoo1, N Selvasudha2, Zahira Nala Kath1
1Adcan Pharma LLC, ICAD III, Mussaffah, Abu Dhabi, United Arab Emirates.
Journal of pharmaceutical sciences
|June 10, 2024
概括
这项研究使用生物制药分类系统 (BCS) 评估fexofenadine化的生物等价性,没有对人进行试验. 费克索芬纳丁是BCS类IV,其溶解概况阻止了BCS-biowaiver获得仿制药批准.
科学领域:
- 药物动力学和生物制药学
- 药物开发和通用药物等效性
背景情况:
- 生物制药分类系统 (BCS) 框架为药理学研究提供了一个潜在的替代方案,用于评估口服剂型的生物等价性.
- 费克索芬纳丁化是一种抗胰岛素,通常以固体即时释放 (IR) 口服剂型配制.
研究的目的:
- 调查基于BCS的方法的适用性,以评估fexofenadine化IR口服剂型的生物等价性.
- 为了确定BCS-biowaiver是否对通用fexofenadine化产品可行,可能取代人类的药理动力学研究.
主要方法:
- 根据ICH,FDA和EMA的BCS建议,评估fexofenadine化的可溶性,透性和溶解特性.
- 对药理动力学和药理动力学特性,治疗指数,生物可用性和药物辅助剂相互作用的评估.
- 在各种pH介质 (1.2和4.5) 中分析参考产品的溶解概况.
主要成果:
- 由于溶解度和透度较低,费克索芬阿丁化被明确地归类为BCS IV类.
- 参考产品未能在pH 1.2和pH 4.5介质下在30分钟内释放≥85%的药物.
- 尽管BCS分类为第四类,但fexofenadine的药理动力学行为类似于BCS类I/III,并且它具有广泛的治疗指数.
结论:
- 根据目前的ICH指南,费克索芬阿丁化的BCS IV类名称和参考产品的溶解概况排除了其符合BCS-生物豁免的资格.
- 虽然fexofenadine具有有利的药理动力学和治疗特性,但通过BCS-biowaiver途径批准通用药物仍然存在监管障碍.
关键词:
生物制药品分类系统是生物制药品的分类系统.生物废弃物 生物废弃物有效性 有效性.费克索芬阿丁化标志 标志 表示 标志透性 透性的药理动力学是什么 药理动力学药理动力学 药理动力学多态性多态性多态性安全的安全的安全的安全的安全.可溶性 溶解度 可溶性 溶解度治疗指数 治疗指数更多相关视频
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