通过机械造诱导的制药材料的多态转变:一篇评论
Mathieu Guerain1, Jean-François Willart1
1Université de Lille, CNRS, INRA, ENSCL, UMR8207, UMET, Unité Matériaux et Transformations, F-59650 Villeneuve d'Ascq, France.
Pharmaceutics
|July 30, 2025
概括
研磨制药材料可以通过两步机制诱导多态转变:初始无形化,然后再结晶. 这个过程受到材料的玻璃过渡温度和削条件的影响,影响药物配方和稳定性.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
- 固态化学 固态化学
背景情况:
- 多态转化在药物开发中至关重要,影响药物的有效性和稳定性.
- 机械削是一种已知的方法,用于诱导制药化合物的固态转化.
- 了解磨削诱导的多态变化的机制对于控制药物特性至关重要.
研究的目的:
- 审查和综合关于在制药材料中通过磨削诱导的多态转换的文献.
- 阐明磨削诱导的多态变化的潜在机制.
- 确定影响这些变化的动力学和发生的因素.
主要方法:
- 关于涉及制药材料研磨的研究的综合文献综述.
- 收集和分析来自18种不同的药物化合物的数据.
- 检查包括晶体形式,过渡温度和无形化行为在内的参数.
主要成果:
- 提出了两步转换机制:初始无形化,随后是无形相的再结晶.
- 转化动力学受磨削过程中最终晶体形式的偶然形成的影响.
- 暂时无形形态的观察与材料的玻璃过渡温度相对于磨温度相关.
结论:
- 拟议的两步机制 (形态化-再结晶) 似乎独立于多态形态的反转型或单转型性.
- 玻璃过渡温度和磨温度是控制短暂无形化的关键因素.
- 这种机制的理解有助于在制药加工过程中预测和控制固态转换.
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