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不溶性聚合物药物受体体中的乙烯基和甲基基被固态NMR识别和定量

Zhaoxi Zheng¹, Yongchao Su², Klaus Schmidt-Rohr¹

¹Department of Chemistry, Brandeis University, Waltham, MA 02453, USA.

Journal of pharmaceutical and biomedical analysis

|May 23, 2024

概括

帕蒂罗默分析显示出意想不到的乙烯基组和甲基部分,这表明在制造过程中反应不完整. 这些发现影响了对这种超血症治疗的理解.

科学领域:

聚合物化学聚合物化学
分析化学分析化学
制药科学制药科学

背景情况:

帕蒂罗默 (Veltassa®) 是一种非吸收性结合剂,已被批准用于治疗高血症.
它的交联,不溶性共聚合物结构是其功能的关键.
了解帕蒂罗默的精确成分对于质量控制和疗效至关重要.

研究的目的:

用先进的NMR技术量化分析受体体的固态成分.
识别和量化单体单位,交叉连接物和潜在的杂质.
提供详细的工作流程,用于受体分子的表征.

主要方法:

定量固态13C核磁共振 (NMR) 光谱学. 量子固态13C核磁共振 (NMR) 光谱学.
综合性峰值分配,组件量化和摩尔/重量分数计算.
用光谱编辑的NMR和2D 1H-13C异核相关性NMR进行详细的结构分析.

主要成果:

从未完全反应的Divinyl交叉连接器中确定了乙烯基组 (1.6%的碳).
检测到一个意想不到的OCH3部分 (1.2%的碳),可能是不完全的单体水解中的甲基.
量化的单体单位和检测到的微量克桑坦.

结论:

这项研究精确量化了帕蒂罗的结构成分,包括以前被忽视的乙烯基组和甲基杂质.
这些发现表明,受体聚合物合成过程中的反应不完整,影响了聚合物组成.
详细的NMR方法为分析类似的聚合物制药提供了一个强大的框架.

关键词:

交叉链接的共聚合物.进行NMR光谱编辑.聚合物药物聚合物药物定量固态核磁共振 (NMR) 在固态环境中进行.乙烯基组是乙烯基组的一个组成部分.

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