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热挤出:从理论到应用在制药配方-我们现在在哪里?

Hemlata Patil¹, Sateesh Kumar Vemula^2,3, Sagar Narala²

¹Department of Product Development, Catalent Pharma Solutions, 14 Schoolhouse Road, Somerset, New Jersey, 08873, USA.

AAPS PharmSciTech

|February 15, 2024

概括

热挤出 (HME) 提高了药物的生物可用性,并使连续制造成为可能. 双螺丝挤出机 (TSE) 适用于各种制药应用,包括新型配方和扩展挑战.

科学领域:

制药技术制药技术制药技术
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:

热挤出 (HME) 是提高难溶性药物的生物可用性的关键技术.
连续制造工艺在制药生产中提供了效率和稳定性.
双螺杆挤出机 (TSE) 是高度可定制的,用于各种制药应用.

研究的目的:

审查热挤出 (HME) 扩展的挑战和模型.
在HME过程中探索连续制造的好处.
讨论过程分析技术 (PAT) 和HME的监管考虑.

主要方法:

关于HME和TSE的学术和工业出版物的文献评论.
分析用于制药配方的TSE应用的创新.
缩放挑战,PAT和监管方面的总结.

主要成果:

通过TSE定制,可以实现多种应用,包括颗粒化,新型剂型和高级配方,如无形固体分散.
由行业和学术界的合作推动的HME技术已经出现了重大创新,并增加了出版/专利活动.
该审查综合了关于HME扩展,连续制造的好处,PAT和监管要求的信息.

结论:

双螺杆挤出机 (TSE) 在推进制药制造的热挤出 (HME) 中起到了关键作用.
HME提供了一个强大的平台,可以提高药物的生物可用性,并实现高效的连续生产.
预计进一步的研究和开发将扩大TSE在新药配方和工艺中的应用.

关键词:

通过3D打印打印3D打印.连续制造连续制造热挤出方式纳米挤出纳米挤出.扩大规模的扩大规模双螺丝颗粒剂的颗粒化方法

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