将分析程序集成到集中抗塑性化合物组合单元的常规实践中,以评估残留化合物药物的价值
Rita Patrizia Aquino1, Giovanni Falcone1, Paola Russo1
1Department of Pharmacy, University of Salerno, 84084 Fisciano, Italy.
Pharmaceutics
|January 25, 2025
概括
医院药剂师可以通过对残留复合药物的快速稳定性分析来扩大昂贵的抗癌药物的使用. 这项研究表明,这些药物通常的保质期比指定的要长,减少浪费,提高个性化治疗的成本效益.
科学领域:
- 制药科学 制药科学
- 分析化学 分析化学
- 在瘤学瘤学.
背景情况:
- 随机的抗癌药物配方对于个性化治疗至关重要,但由于稳定性不明而经常被丢弃.
- 其余的复合药物是大量的浪费,增加了医疗保健成本.
- 需要在临床实践中整合分析技术来评估药物稳定性.
研究的目的:
- 证明使用分析技术用于常规稳定性分析复合抗癌药物的可行性.
- 为了评估活性药物成分 (API) 在残留抗体药物中的稳定性,以便潜在的重复使用.
- 提高个性化抗癌治疗的成本效益.
主要方法:
- 对两种药物子组的分析:小分子和单克隆抗体.
- 优化用于小分子的二极管阵列检测 (HPLC-DAD) 的高性能液体染色学.
- 开发一种结合的液体染色学-并联质谱学 (LC-MS/MS) 和大小排除染色学方法,用于单克隆抗体.
主要成果:
- 产品摘要中现有的稳定性数据不足以确定复合抗癌药物的保质期.
- 稳定性测试显示,测试的复合药物的物理化学保质期比通常说的要长.
- 分析方法成功评估了残留化合物药物的API稳定性.
结论:
- 医院药剂师可以根据稳定性数据扩展复合抗癌药物的临床使用.
- 实施常规分析稳定性测试可以提高个性化抗癌治疗的成本效益.
- 这种方法减少了制药浪费,并优化了医疗保健中的资源利用.
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