使用宽带声学共振溶解光谱 (BARDS) 快速确定悬浮配方中的活性药物成分 (API) 含量
Niamh O'Mahoney1, Ewelina Chmielak2, Dara Fitzpatrick1
1School of Chemistry, Analytical and Biological Chemistry Research Facility (ABCRF), University College Cork, Ireland.
International journal of pharmaceutics
|March 6, 2025
概括
宽带声学共振溶解光谱 (BARDS) 为口服悬浮剂提供了一种新的,具有成本效益的质量控制方法. 这种声学技术准确地跟踪药物负载和配方成分,提高产品测试的效率.
科学领域:
- 制药科学 制药科学
- 分析化学 分析化学
- 过程分析技术 (PAT) 是一种分析技术.
背景情况:
- 口服悬浮配方是儿童和老年患者的首选配方,因为易于管理.
- 目前用于悬浮的质量控制方法可能耗时且资源密集.
- 药品测试需要高效,成本效益和更绿色的分析技术.
研究的目的:
- 引入和验证宽带声学共振溶解光谱 (BARDS) 作为口服悬浮剂的替代质量控制方法.
- 为了证明BARDS在跟踪活性药物成分 (API) 装载和配方成分方面的能力.
- 探索BARDS作为一个潜在的过程分析技术 (PAT) 工具,用于过程中控制 (IPC).
主要方法:
- 利用宽带声学共振溶解光谱 (BARDS) 来监测声学共振频率.
- 研究的口服悬浮配方与不同的API和辅助剂.
- 与API剂量和配方特征相关的声学测量以评估溶解.
主要成果:
- 口服悬浮配方根据其制造和成分表现出独特的声学特征.
- 声学反应受到活性药物成分 (API) 度的直接影响.
- 巴德斯成功追踪了API加载和配方变化.
结论:
- 巴德斯为口服悬浮剂的质量控制提供了一个更绿色,更具成本效益和更节省时间的替代方案.
- 该技术显示出作为过程中控制 (IPC) 测试的替代品和过程分析技术 (PAT) 的承诺.
- BARDS还可以帮助评估患者的遵守性和检测药物沉.
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