α-乳糖单水合物 - - 对暴露于温度和湿度的物理化学反应的新见解
Andrea Sanchez-Valencia1, Johanna Husman-Piirainen2, Päivi Kokkonen2
1Magle Chemoswed AB, Lund, Sweden; MVIC AB, Lund, Sweden.
International journal of pharmaceutics
|March 7, 2026
概括
环境条件如相对湿度 (RH) 和温度 (T) 影响制药乳糖. 这项研究确定结晶和放松是影响乳糖物质在储存和运输过程中的关键过程.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
- 物理化学 物理化学
背景情况:
- 药品级乳糖容易受到环境相对湿度 (RH) 和温度 (T) 引起的物理化学变化.
- 了解这些变化对于配方开发和确保药物产品稳定性至关重要.
- 控制的调节和不受控制的储存/运输场景都会影响乳糖材料的特性.
研究的目的:
- 在不同的环境条件下识别和描述影响制药乳糖的动态过程.
- 开发一种运动模型,以量化描述乳糖性质的变化.
- 阐明RH和T对乳糖结晶和放松现象的影响.
主要方法:
- 定量确定无形性,粒子大小分布,特定表面积,晶体结构和热性质.
- 在实验数据上应用一个两步动力适配模型.
- 控制环境调节和分析随着时间的推移物质变化.
主要成果:
- 确定和描述了两个主要的运动过程,即结晶和放松.
- 由无形再结晶驱动的结晶,可以导致粒子聚合和明显生长.
- 放松涉及结构重组和表面光滑,对特定的表面积产生长期影响.
- RH显著影响结晶和初始放松,而长期放松对RH和T的依赖性较小.
结论:
- 一个两步运动模型有效地捕捉了乳糖性质变化的实验趋势.
- 红是乳糖结晶和初始放松的主要驱动因素.
- 长期放松影响特定表面积,对环境因素不那么敏感,与无形性和粒子大小变化有部分相关性.
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