普雷塞利斯®进化均质化器 - - 一种用于在预制剂中研磨,混合和形态化药物的多功能工具
Jochem Alsenz1, Elisabeth Haenel1
1Roche Pharmaceutical Research & Early Development, Pre-Clinical CMC, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070 Basel, Switzerland.
概括
与Cryolys®一起的Bertin Precellys®进化同质化器简化了药物开发前配方. 它可以快速选和小规模制造各种药物配方,特别是难以溶解的化合物.
科学领域:
- 制药科学 制药科学
- 药物输送和配方 药物输送和配方
- 材料科学 材料科学 材料科学
背景情况:
- 预制是药物开发的关键,涉及早期的表征和配方设计.
- 传统方法可能耗时,需要大量的样本,对新型或不易溶解的化合物构成挑战.
研究的目的:
- 评估Bertin Precellys® Evolution同质化器与Cryolys®作为改进预制工作流程的工具.
- 证明其在查,小规模制造和各种药物配方的表征方面的实用性.
主要方法:
- 使用Bertin Precellys® Evolution同质化器与Cryolys®进行样本处理.
- 应用微型化方法来进行配方表征,包括悬浮选和微型板中的非沉没溶解测试.
主要成果:
- 同质化器有效支持对车辆进行微型和纳米悬浮的选.
- 证明了用于临床前研究的小规模悬浮制造能力.
- 促进药物无形化,无形系统的辅助剂识别,以及同质粉末混合物的制备.
- 实现了配方方法的快速,并行和化合物节约选,特别是对于低溶解性的化合物.
结论:
- 伯廷Precellys® Evolution同质化器与Cryolys®是一款用于增强药物开发预制剂的多功能工具.
- 它为配方选和小规模制造提供了高效的解决方案,为进一步的研究铺平了道路.
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