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控制的API聚合物固化 (CAPS):一种新的制造工艺方法,以产生具有增强物理性能的无形固体分散

Tao Zhang¹, Corinne Jankovsky¹, Simone M Blattner²

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

Journal of pharmaceutical sciences

|October 15, 2025

概括

一种新的受控API-聚合物固化 (CAPS) 技术创造了具有更好的物理性质的无形固体分散 (ASD). 这简化了药物制造,并确保了与传统方法相比的生物等价性.

科学领域:

制药科学制药科学
材料科学材料科学材料科学
药物运输药物运输药物运输

背景情况:

许多新药候选药物 (NCE) 具有较差的水溶性,通常被归类为BCSII或IV类,这给配方带来了重大挑战.
提高难溶性药物的生物可用性是制药开发中的一个关键障碍.
目前的无形固体分散 (ASD) 制造方法,如热挤出 (HME) 和喷雾干燥,面临着材料性能和加工挑战.

研究的目的:

引入和评估一种用于制备ASDs的新型控制API-聚合物固化 (CAPS) 技术.
评估CAPS制备的ASD的物理性能和制造优势.
为了比较CAPS准备的ASD与传统方法的性能.

主要方法:

控制的API-聚合物固化 (CAPS) 技术的开发.
使用CAPS技术准备ASD.
描述ASD的物理特性 (密度,流动性,粒子大小).
在体外溶解和透研究.
在体内体外的药理动力学 (PK) 评估.

主要成果:

CAPS技术使得具有优越物理性质的ASD能够在成本上有效地制备,包括增强密度,流动性和颗粒大小分布.
这些改进的特性有助于简化药品制造,允许直接压缩药片.
用CAPS制备的ASD在体外和体外研究中证明了与喷雾干燥配方的生物等价性.

结论:

CAPS技术为ASD制造提供了一个可行的替代方案,克服了传统方法的局限性.
用CAPS制备的ASD的增强物理性能简化了下游加工,提高了制造效率.
CAPS技术对开发难溶性药物的生物可用配方具有前景.

关键词:

无形固体的分散性固体.共同处理共同处理控制的API-聚合物固化 (CAPS) 进行.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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