在iBCS: 3. 一个生物制药分类系统,用于口服吸入药物产品
Jayne E Hastedt1, Per Bäckman2, Antonio Cabal3
1JDP Pharma Consulting, San Carlos, California 94070, United States.
Molecular pharmaceutics
|December 7, 2023
概括
一个新的定量吸入生物制药分类系统 (iBCS) 为口服吸入药物提供了指导. 该系统有助于管理风险,并确定呼吸道药物开发的理想特性.
科学领域:
- 制药科学 制药科学
- 生物制药生物制药公司
- 药物运输 药物运输 药物运输
背景情况:
- 从历史上看,口服吸入药物产品的开发缺乏类似于口服药物的生物制药分类系统.
- 肺生理学的复杂性,药物沉积/处置的复杂性,以及输送装置的影响阻碍了发展指导.
- 产品质量研究所 (PQRI) 支持创建吸入式生物制药分类系统 (iBCS) 的倡议.
研究的目的:
- 建立口服吸入药物的定量生物制药分类系统.
- 为吸入科学家提供一个"经验准则",以了解所需的分子性质和CMC风险管理.
- 根据剂量数量和透性量化定义iBCS类.
主要方法:
- 使用剂量数和透性参数量化定义了iBCS类.
- 通过使用文献数据对销售的吸入药物进行分类来评估拟议的iBCS.
- 通过公布的数据和基于生理学的生物制药建模来评估分类的适当性.
主要成果:
- 通过使用定量iBCS框架成功分类销售的吸入药物.
- 讨论并说明了每个iBCS分类的吸入药物产品开发挑战.
- 强调了针对肺部沉积,溶解和透性的歧视性实验室方法的重要性.
结论:
- 定量化iBCS为简化和降低吸入药物开发风险提供了一个有价值的工具.
- 了解物理化学特性和肺剂量对于有效的iBCS应用至关重要.
- 进一步开发分析方法对于充分实现iBCS好处至关重要.
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