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通过使用半孔载体辅助粒子工程方法使内在无形API的隔离成为可能

Tao Zhang¹, Wei Ruan², Joe Gao¹

¹Material & Analytical Sciences, Boehringer-Ingelheim, Ridgefield 06877 CT, United States.

Journal of pharmaceutical sciences

|June 27, 2025

概括

本研究提出了一种新的中孔携带者辅助方法,用于隔离无形化合物X,改善其物理性能. 这种方法通过直接压缩来增强药品制造,并加速开发时间表.

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:

本质无形活性药物成分 (API) 由于其不良的物理化学特性,在隔离和下游加工中经常存在挑战.
开发可扩展和高效的方法来处理无形API对于药物开发至关重要.

研究的目的:

开发和优化一个半孔二氧化辅助隔离方法,用于无形的API (化合物X).
增强分离的API的物理化学特性,促进药物制造.
使用先进的分析工具来证明开发过程的可扩展性和实用性.

主要方法:

使用半孔作为API隔离的载体.
使用现场过程分析工具 (PAT) 来调查关键过程参数.
系统地研究载体类型,溶剂成分,API-to-carrier比率和抗溶剂添加.
在5L反应堆中,将优化过程从克拉尺度扩展到200克尺度.

主要成果:

实现无形化合物X的高效隔离,以1:1的API-to-carrier比率提高流动性和散装密度.
在载体表面表现出均的API沉积.
成功地扩展了该过程,证实了其适用于更大规模生产的可行性.
共同加工的材料表现出极好的压缩性,平板性和兼容性 (CTC),使直接压缩成为可能.
在生物相关介质中观察到药物完全释放 (FaSSIF-V1).

结论:

载体辅助的API隔离,特别是与半孔,为无形化合物提供了显著的优势.
整合PAT可以加速流程开发和优化.
协同加工的API简化了下游制药产品的制造,使直接压缩成为可能.
该战略解决了开发内在无形API的关键挑战.

关键词:

载体颗粒是载体粒子中的一个.共同处理共同处理内在的无形活性药物成分是药物的内在无形活性成分.粒子工程是什么?粒子工程是什么?过程分析技术过程分析技术

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