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一个连续的微型料器,用于凝聚性制药材料
P Hou1, M O Besenhard2, G Halbert1
1Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow G1 1XQ, UK; Centre for Continuous Manufacturing and Advanced Crystallisation (CMAC), University of Strathclyde, Glasgow G1 1RD, UK.
International journal of pharmaceutics
|July 28, 2024
概括
一种新型的微型料器有效地解决了制药连续制造的挑战,通过以低速率 (<20 g/h) 持续料不良流动的粉末. 这种多功能解决方案在没有反控制的情况下运行,确保了凝聚性和不流动材料的准确性.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 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:
- 连续制造正在制药行业获得引力.
- 在粉末混合和料操作中,挑战仍然存在,特别是在低吞吐量时.
- 稳定地以低剂量食固体药物物质和助剂是一个重大障碍.
研究的目的:
- 展示一种微型料系统,用于连续和一致地料流动不良的制药粉末.
- 为了评估微型料器在低料速率下使用各种粉末类型的性能.
- 评估系统的可靠性和适用于制药应用的多功能性.
主要方法:
- 研究了一种设计用于低料率粉末输送的微型料系统.
- 使用三种药物粉末测试了该系统:croscarmellose (凝聚性),酸 (非常凝聚性) 和 (不流动).
- 分析了20g/h以下的流量时的食一致性和可变性.
主要成果:
- 微型料器以低速率 (<20 g/h) 实现了连续和一致的粉末料.
- 观察到的变化很低:非流动材料<10%,凝聚性材料<5%.
- 该系统在没有反控制的情况下有效运行,并且不会受到补充的影响.
结论:
- 开发的微型料器成功地克服了准确和一致的粉末料在低速率的挑战.
- 该系统的强大性能使其成为制药连续制造的多功能和行业相关的解决方案.
- 这项技术为需要精确的低通量粉末处理的单元操作提供了显著的进步.
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