在2022年批准的新药的合成方法
Scott P France1, Erick A Lindsey2, Emma L McInturff3
1Process Research and Development, Merck & Co., Rahway, NJ 07065, United States.
Journal of medicinal chemistry
|March 15, 2024
概括
本综述详细介绍了主要监管机构在2022年批准的23种新型小分子药物的大规模合成策略. 它强调了这些新型治疗方法的实际制造方法.
科学领域:
- 药用化学 医学化学
- 过程化学 过程化学
- 药物发现和开发 药物发现和开发
背景情况:
- 在2022年,美国FDA,EMA,PMDA和NMPA等监管机构批准了23种新的小分子药物.
- 了解这些新化学实体的合成途径对于制药制造和药物可访问性至关重要.
- 之前的审查已经涵盖了早期的药物批准,因此需要对最新的治疗剂进行更新.
研究的目的:
- 记录和分析用于2022年批准的新型小分子药物的最大规模生产的合成方法.
- 提供与制药行业相关的实用和可扩展的合成方法的见解.
- 包括2021年和2020年批准的相关药物,以前没有涵盖.
主要方法:
- 进行了文献和专利搜索,以确定2022年,2021年和2020年的新药批准.
- 在专利或主要文献中描述的合成路线被分析了可扩展性.
- 专注于在每种药物的最大报告规模上展示的合成策略.
主要成果:
- 介绍了2022年批准的23种新型小分子药物的详细合成路径.
- 该审查涵盖2021年的10种新药和2020年的1种新药,扩大了范围.
- 实用的合成方法,包括适用于制造规模的方法,被强调为获得这些新药.
结论:
- 该综述提供了关于近期制药创新的大规模合成的宝贵资源.
- 鉴定到的合成策略为工艺化学家和药物制造商提供了实用的见解.
- 这项工作有助于理解小分子药物合成和生产的不断变化的景观.
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