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3D打印剂量灵活的晶体固体分散片,适用于临床前和首次对人体进行研究

Khalid Garba-Mohammed¹, Carlos Bendicho-Lavilla², Anna Worsley²

¹FABRX Ltd., Henwood House, Henwood, Ashford, Kent, TN24 8DH, UK.

Journal of pharmaceutical sciences

|August 9, 2025

概括

半固体挤出 (SSE) 3D打印提供了一种具有成本效益的方法,以创建用于早期药物开发的小批量剂量灵活片. 这种自动化方法保持了药物的结晶性,并确保了临床前和首次在人体研究中立即释放的特性.

科学领域:

制药技术制药技术制药技术
药物输送系统药物输送系统
3D打印在医学中的应用

背景情况:

准备早期研究的固体口服剂型的传统方法是劳动密集的.
保持药物的固态状态对于持续的生物制药性能至关重要.
对于高效的临床前和首次在人体 (FIH) 研究,需要自动化,小批量制造.

研究的目的:

评估半固体挤出 (SSE) 3D打印用于生产剂量灵活的片.
评估SSE在固体分散中保持药物结晶性的能力.
展示用于药物开发早期阶段的口服固体剂型的自动化,小批量生产.

主要方法:

开发的药物装载的药物墨水含有乙氨基 (0.22%,23% w/w) 和赛莱可西布 (0.2%,30% w/w).
在室温下利用SSE 3D打印来生产剂量灵活的平板电脑.
分析了药物释放概况,X射线衍射 (XRD) 和差分扫描热量计 (DSC) 来确认属性.

主要成果:

通过SSE的3D打印,成功地生产了乙氨基 (0.5毫克,150毫克,250毫克) 和赛莱可西布 (0.5毫克,100毫克,200毫克) 的剂量灵活的片.
在体外药物释放证实了即时释放特征.
XRD和DSC证实了乙氨基和切莱科西布在印刷后的结晶状态.

结论:

SSE 3D 打印是一种简单,具有成本效益的技术,用于按需,小批量生产口服固体剂型.
该技术有效地保持了活性药物成分 (API) 的结晶性.
在早期药物开发和临床试验中,SSE能够实现灵活的剂量,这对于药物开发和临床试验至关重要.

关键词:

切莱科克西布打印小册子按需制造药品的制造业个性化的剂量定制.制造制药添加剂制造制造制药添加剂制造第1期临床试验临床试验.帕拉塞他配方的三维打印方法

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