实体形态景观的调查:各种实体形态的发生和分布的趋势和实体形态选择的挑战
Z Jane Li1, Yue Lu1, Ruiping Wang1
1Material Sciences Department, Pharmaron, 6 Taihe Road, Beijing 100176, China.
Journal of pharmaceutical sciences
|November 4, 2024
概括
这项研究分析了476种新化学实体 (NCE) 的固体选. 确定了多态性,盐形成和分子量 (MW) 分布的关键趋势,突出了制药开发中的不断变化的挑战.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
- 化学工程是化学工程的重要组成部分.
背景情况:
- 固体形式选对于选择最佳候选药物至关重要.
- 了解多态,盐形成和结晶对于药物开发至关重要.
- 历史数据为固体形式选择的当前趋势提供了背景.
研究的目的:
- 分析2016-2023年新化学实体 (NCE) 固体选趋势.
- 为了识别多态性,盐形成,结晶和分子重量 (MW) 随时间的分布的变化.
- 讨论选择制药应用的开发形式的复杂性和挑战.
主要方法:
- 对476个NCE的固体形式选数据进行了全面分析.
- 评估多态性,盐形成,结晶行为和MW分布.
- 将当前数据与固体形式选择的历史趋势进行比较.
主要成果:
- 确定了NCE多态性,盐形成和MW分布的显著趋势.
- 观察到固体形态景观的复杂性增加以及结晶的挑战.
- 记录了研究期间出现和消失的多态体的发生情况.
结论:
- 固体形式的选和选择在制药开发中提出了不断变化的挑战.
- 对结晶和形式选择策略的洞察对于未来的药物开发至关重要.
- 该研究为优化固体形式选择过程提供了有价值的数据.
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