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连续微流体抗溶剂结晶作为一个自下而上的解决方案,用于开发长效注射配方

Snehashis Nandi^1,2,3, Laura Verstrepen^1,4, Mariana Hugo Silva^1,2,3

¹Janssen Pharmaceutica NV, Johnson & Johnson Innovative Medicine, 2340 Beerse, Belgium.

|March 28, 2024

概括

一种新的Secoya微流体结晶技术 (SCT-CLASC) 提供了一种可持续的,经济高效的自下而上的方法,用于生产具有更高药物度和更少辅助剂的长效注射微悬浮剂 (LAI).

科学领域:

制药技术制药技术制药技术
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:

长效注射剂 (LAI) 的传统上下制造方法在成本效益和可持续性方面存在局限性.
定制药物特性和优化制造工艺对于开发先进的LAI配方至关重要.

研究的目的:

研究使用Secoya微流体结晶技术 (SCT-CLASC) 来生产LAI微悬浮的自下而上的方法.
将SCT-CLASC工艺与基于微通道反应器的连续液体抗溶剂结晶 (MCR-CLASC) 装置进行比较.
优化SCT-CLASC过程,以提高药物负载和减少在伊特拉科纳 (ITZ) 微悬浮中辅助剂的使用.

主要方法:

使用SCT-CLASC技术的连续液体抗溶剂结晶,以伊特拉科纳 (ITZ) 为模型药物.
优化操作参数和下游加工以获得微悬浮度.
监测颗粒大小分布 (PSD),固态形式和颗粒形态,以进行质量控制.

主要成果:

使用SCT-CLASC实现了稳定的ITZ微悬浮,最终固体负荷为300毫克ITZ/g悬浮.
优化的SCT-CLASC工艺产生了40毫克ITZ/g的降水后料悬浮液,药物与辅助剂的比例为53:1.
这与MCR-CLASC组合相比显著改进,该组合实现了10毫克ITZ/g和2:1的比率,表明药物度更高,辅助剂使用更低.
保持了粒子特征,包括PSD (1-10微米),延长的板状形态,以及ITZ稳定的I型固态.

结论:

SCT-CLASC工艺是一种强大的,可重复的,节能的自下而上的方法,用于制造LAI微悬浮.
这项技术使药物度更高,辅助剂需求减少,为工业规模生产ITZ LAI配方铺平了道路.
优化的过程确保了药物在微悬浮中的稳定性和所需的固态形式.

关键词:

在 LAI LAI 找律师这是一个PSD,PSD是PSD.在SCT-CLASC之间.维生素 E TPGS 1000 种类这是伊特拉可纳.这是一种微悬浮微悬浮.

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