通过质量设计,物理化学监测,分子模拟和机器学习,改善无形分散性能的最新技术
Hari Prasad Bhatta1, Hyo-Kyung Han1, Ravi Maharjan2
1College of Pharmacy, Dongguk University, Goyang 10326, Republic of Korea.
Pharmaceutics
|October 29, 2025
概括
无形固体分散 (ASDs) 增强了药物的溶解性. 先进的计算工具和制造技术提高了ASD的稳定性,并预测了药物-聚合物相互作用,加速了药物开发.
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:
- 水溶性较差的药物在制药开发中存在重大生物可用性挑战.
- 无形固体分散 (ASDs) 提供了一个有前途的配方策略,以克服这些可溶性限制.
研究的目的:
- 为管理ASD稳定性的物理化学原理提供全面的综述.
- 讨论ASD的制造技术,先进的设计方法和表征方法.
- 突出ASD配方开发中的挑战和未来方向.
主要方法:
- 关于ASD物理化学原理,制造技术 (热挤出,喷雾干燥,KinetiSol®) 和高级表征 (固态NMR,IR,介电光谱) 的文献综述.
- 分析计算方法,包括分子建模,in silico预测,机器学习 (ML) 和人工智能 (AI).
- 讨论综合配方设计框架,如生理学基础药理动力学 (PBPK) 建模和加速稳定性测试.
主要成果:
- 物理化学原理,如药物聚合物混合性,分子流动性和热力学对于ASD稳定性至关重要.
- 制造方法显著影响配方的一致性和可扩展性.
- ML/AI平台能够准确预测药物聚合物相互作用和物理稳定性,减少试错.
- 先进的表征提供了对相位分离和再结晶动态的洞察.
结论:
- 确保长期的ASD稳定性和维持超和仍然是关键的挑战.
- 综合配方设计和计算进步对于完善ASD策略至关重要.
- 跨学科合作和数据驱动的方法对于加速临床转化和释放自闭症治疗潜力至关重要.
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