使用拉曼光谱在现场开发化学模型,用于监测复杂多态景观的API不成比例
Shikhar Mohan1, Yi Li1, Kevin Chu2
1Gilead Sciences, Foster City, CA 94404, USA.
Pharmaceuticals (Basel, Switzerland)
|June 1, 2023
概括
一种新的现场拉曼方法量化了多种固体形式,包括转移稳定的形式,帮助药物开发. 这种技术可以实时监测多态转换,以获得最佳的活性成分.
科学领域:
- 分析化学 分析化学
- 材料科学 材料科学 材料科学
- 制药科学 制药科学
背景情况:
- 描述复杂的多态景观,具有多种转移稳定的形式,会带来重大的分析挑战.
- 现有的拉曼校准方法没有先例来量化两个以上的多态,特别是转移稳定的变体.
研究的目的:
- 开发一种新的现场拉曼光谱法,用于描述具有复杂多态形状的盐的不成比例.
- 建立一个强大的拉曼校准程序,用于准确地在现场定量多重多态,包括转移稳定的.
主要方法:
- 开发了一种现场拉曼方法,利用不成比例实验,在各种多态比率中生成校准样本.
- 结合在线拉曼测量与离线X射线衍射,用于准确的固体形式量化.
- 将固体度变化纳入校准数据集,以提高量化准确度.
主要成果:
- 成功开发并验证了一种能够准确量化复杂混合物中每个固体形式的现场拉曼方法.
- 证明了该方法的有效性,即使有多个转移稳定和稳定的自由基形式.
- 获得了对热力学驱动的多态转换的动力学见解.
结论:
- 开发的光谱和数学方法可以实时对多重多态的同时量化.
- 这种方法提供了至关重要的动力学理解,以指导盐的选择,以在药物产品中提供最佳的活性成分.
- 为制药开发中先进的固态特性和过程监测提供了有价值的工具.
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