通过塑料剂量注射器开发非破坏性拉曼方法,通过塑料剂量注射器量化口服悬浮中的活性药物成分
Jacquelyn North1, Raaidah Saari-Nordhaus1, Gregory Doddridge2
1Research & Development, AbbVie Inc, 1 N Waukegan Road, North Chicago, IL, 60064, USA.
AAPS PharmSciTech
|April 5, 2024
概括
非破坏性拉曼光谱技术,传输拉曼 (TRS) 和非接触光学 (NCO) 探针,为在剂量注射器内测量液体药品中的活性药物成分 (API) 提供了有效的替代方案,改善了稳定性测试.
科学领域:
- 制药分析 制药分析
- 分析化学是一种分析化学.
- 频谱学是一种光谱学.
背景情况:
- 液体药品的稳定性测试对于质量保证至关重要,遵循国际协调会议 (ICH) 和欧洲药品评估机构 (EMEA) 的指导方针.
- 目前使用中的稳定性测试涉及费力,耗时和易出错的传统染色学方法.
- 需要非破坏性分析方法来提高液体药物产品稳定性测试的效率.
研究的目的:
- 调查传输拉曼 (TRS) 和非接触式光学 (NCO) 探针拉曼技术作为在剂量注射器内的液体药物样本中量化活性药物成分 (API) 的非破坏性替代方案.
- 为了比较这些拉曼技术的性能与使用中的稳定性测试的传统UHPLC方法.
主要方法:
- 使用传输拉曼 (TRS) 和背散射拉曼与非接触式光学 (NCO) 探头.
- 在塑料口服剂量注射器内的液体样本中使用化学计量方法来量化API.
- 通过交叉验证和独立的试点工厂批量样本验证了线性和准确性.
主要成果:
- 通过TRS和NCO技术,通过塑料口服剂量注射器成功测量信号.
- 化学测量模型在60至80毫克/毫升的API度范围内显示出线性.
- 与独立样本的UHPLC测量值相比,API度的预测准确度在4%以内.
结论:
- 传输拉曼 (TRS) 和非接触式光学 (NCO) 探针拉曼光谱法是可行的非破坏性方法,用于在使用中的液体药物样本中的API量化.
- 这些技术在稳定性测试中比传统染色学显著提高了效率.
- 未来的工作可以探索不同的配方和样本呈现的增强探测器和更广泛的应用.
相关概念视频
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A conventional Raman spectrophotometer includes a laser source, a sample holding system, a wavelength selector, and a detector.
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The monochromatic laser source, typically using visible or near-infrared radiation, generates a highly focused beam of light. This light interacts with the molecules of the sample, scattering some of the light. Liquid and gaseous samples are usually tested in ordinary glass capillaries, while solids can be analyzed as powders packed in capillaries or as potassium...
332