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探索不同类别的注射配方的新和快速稳定性或相同性评估工具
Vaibhavi Patel1, Punita Aggarwal2, Jayrajsinh Sarvaiya3
1School of Engineering and Technology, National Forensic Sciences University, Gandhinagar, Gujarat, India.
与时间相关的单光子计数 (TCS-PC) 提供了一种快速,非破坏性的方法来评估可注射药物产品的稳定性和一致性. 这种技术可以有效地区分各种配方的初始和降解样本.
科学领域:
- 制药科学 制药科学
- 分析化学 分析化学
- 药物开发 药物开发
背景情况:
- 建立药物产品的稳定性和一致性对于仿制药配方开发和监管提交至关重要.
- 目前评估产品相同性的方法往往是具体的,耗时的.
研究的目的:
- 评估与时间相关的单光子计数 (TCS-PC) 技术作为一种快速,可靠和非破坏性的方法来确定可注射药物产品的相同性.
- 评估TCS-PC在不同类别的注射配方中的区分能力.
主要方法:
- 研究了三种可注射配方:安福特素B脂质体,埃诺沙巴林和铁糖.
- 样品在原生和人工降解状态下进行分析.
- 与已建立的方法进行TCS-PC比较,包括HPLC,DSC,NMR,光谱学,DLS,SAXS,ICP-OES和循环二元化.
主要成果:
- 对于所有测试的注射配方,TCS-PC显示了初始和降解后样本之间的显著区别.
- 该技术提供了快速分析,具有有前途的歧视力.
- 使用高性能液态染色学 (HPLC) 证实了降解.
结论:
- TCS-PC是一种可行的,快速的,非破坏性的分析工具,用于评估各种注射药物产品的稳定性和相同性.
- 这种方法有可能简化仿制药开发和监管流程.
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