调节曼尼托尔在冷溶液中结晶的物理形式:可溶性和加工的作用
Chaowang Zeng1, Jinghan Li1, Jiawanjun Shi2
1Department of Pharmaceutics, College of Pharmacy, University of Minnesota, Minneapolis, Minnesota 55455, United States.
Molecular pharmaceutics
|February 13, 2025
概括
糖和蛋白质等非结晶化溶解物抑制了冷化配方中的曼尼托尔结晶. 糖类更有效,保留无形的曼尼,而蛋白质则促进特定的曼尼多态形成.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
背景情况:
- 曼尼托尔是冷化制药配方中的重要填充剂.
- 控制曼尼托尔结晶对于配方的稳定性和有效性至关重要.
研究的目的:
- 为了研究非结晶的溶解物对曼尼托尔的结晶抑制.
- 评估糖和蛋白质对冷溶液中曼尼多态形成的影响.
主要方法:
- 差分扫描热量计 (DSC) 用于热分析.
- 用X射线衍光测量 (XRD) 进行结构识别.
- 在糖糖,三糖,溶酶,牛血清白蛋白和免疫球蛋白G的存在下分析曼尼托尔结晶.
主要成果:
- 糖 (糖糖,三糖) 显示出比蛋白质更强的结晶抑制.
- 蛋白质促进了delta-mannitol的形成,而糖则有利于曼尼托尔半水合物 (MHH).
- 在-25°C的化有利于MHH,而-10°C则加速了结晶到delta-polymorph.
结论:
- 溶解物类型显著影响曼尼托尔结晶行为和多态选择.
- 高度的糖可以保持曼尼托在无形状态,即使在回火后.
- 了解这些相互作用是优化冷化过程的关键.
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