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一种针状活性药物成分的粒子工程成大小控制的聚合物:第I部分. 过程的可扩展性和开发发展

Bilal Ahmed¹, Vishal Raval¹, Mark McGowan¹

¹CMAC, University of Strathclyde, Glasgow G1 1RD, United Kingdom; Strathclyde Institute of Pharmacy & Biomedical Science, University of Strathclyde, Glasgow G4 0RE, United Kingdom.

International journal of pharmaceutics

|November 8, 2025

概括

这项研究引入了使用高剪切湿磨机的强化球形聚合过程,以创建小,均的药物晶体 (<300微米). 优化的方法改善了用于制药制造的粒子特性和流动性.

科学领域:

制药科学制药科学
化学工程是化学工程的重要组成部分.
材料科学材料科学材料科学

背景情况:

优化晶体大小和形状对于药物固体口服剂型至关重要.
球形聚合增强了粉末的性能,但面临着小型尺寸的可扩展性挑战.
活性药物成分 (API) 经常表现出具有挑战性的颗粒特征.

研究的目的:

开发和优化强化球形聚合工艺,以生产具有具有挑战性属性的API的小聚合物 (<300微米).
调查关键工艺变量对聚合物属性和散装粉末属性的影响.
评估开发过程的可扩展性和干燥效率.

主要方法:

球形聚合物与高剪率湿磨机集成.
多变量实验设计 (DOE) 研究过桥液添加时间,过桥液与固体的比率以及湿磨速度.
激动过器隔离和干燥研究.

主要成果:

优化条件产生了强大的聚合物,中位数大小为30-300微米.
该过程证明了在动水箱 (250毫升5升) 中的可扩展性,用于目标尺寸 (35微米,80微米,145微米).
实现了最小的残留溶剂和良好的流量性能;适当的干燥动保持了聚合物的完整性.

结论:

加强的球状聚合过程有效地设计了API粒子的大小,形状,密度和流动性.
这种粒子工程技术为制药制造和下游加工提供了巨大的潜力.
成功地证明了实现具有改进性质的小型可扩展聚合物大小.

关键词:

聚合物的属性聚合物的属性高剪切湿加工高剪切湿加工浸泡驱动的机制是浸泡驱动的机制.多变量 DoE 的情况.扩大规模 - 扩大规模球形聚合物是一种球形聚合物.

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