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在热挤出无形固体分散的配方和工艺设计中,质学的作用

Abu Zayed Md Badruddoza¹, Dana E Moseson¹, Hong-Guann Lee¹

¹Pharmaceutical Sciences Small Molecule, Worldwide Research and Development, Pfizer Inc., Groton, CT 06340, USA.

International journal of pharmaceutics

|September 1, 2024

概括

本综述强调了热挤出 (HME) 工艺优化时,质性质是如何至关重要的. 了解这些特性可以改善无形固体分散剂 (ASD) 的制造,从而提高药物的生物可用性.

科学领域:

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

背景情况:

热挤出 (HME) 是一种用于制药剂型的多功能连续制造工艺.
HME是创造无形固体分散 (ASD) 的关键,增强水溶性较差的药物的生物可用性.
药物聚合物混合物质学严重影响HME可加工性和最终产品属性,如稳定性和药物释放性.

研究的目的:

审查在HME中评估药物聚合物混合物的风湿学技术和特性.
探索质学如何告知配方特征 (相互作用,可混合性,可塑性) 以改善HME.
通过HME讨论ASD的热力学,动力学,扩展和过程建模,强调类风学的作用.

主要方法:

对适用于制药配方的已建立的风湿学技术的审查.
分析风湿学数据如何预测HME可处理性和ASD特征.
检查 HME 期间 ASD 形成的热力学和动力学原理.

主要成果:

风学性质作为HME流动行为和可处理性的关键指标.
特定的风湿学参数可以预测药物聚合物相互作用,可混合性和可塑化效应.
了解风病学有助于优化HME条件,以实现一致的ASD生产和性能.

结论:

风病学评估对于HME中成功的配方设计和流程开发至关重要.
风病学特性作为优化HME处理参数的预测工具.
这一综述强调了风病学在推进用于制药制造的HME技术方面的重要性.

关键词:

无形固体分散 (ASD) (无形固体分散)药物与辅助剂的相互作用挤出挤出挤出配方配方是一种配方.在模型建模.物理化学特性物理化学特性聚合物 (((s) 的使用类风病学类风病学类风病学粘度粘度粘度粘度粘度

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