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制药连续薄膜涂层当前的技术状况 - - 综述

Dorián László Galata¹, Orsolya Péterfi¹, Máté Ficzere¹

¹Department of Organic Chemistry and Technology, Faculty of Chemical Technology and Biotechnology, Budapest University of Technology and Economics, Műegyetem rkp. 3., H-1111 Budapest, Hungary.

International journal of pharmaceutics

|December 11, 2024

概括

连续制造是制药行业的一个关键趋势,需要先进的薄膜涂层工艺. 本研究探讨了固体剂型的连续薄膜涂层技术,挑战和实时质量控制传感器.

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.

背景情况:

连续制造是制药行业的一个重要趋势.
薄膜涂层是固体剂型加工的关键最后一步,影响外观,稳定性和药物释放.
开发连续薄膜涂层工艺对于集成连续生产线至关重要.

研究的目的:

对制药固体剂型的连续薄膜涂层技术的最新情况进行审查.
确定和讨论与连续薄膜涂层相关的主要挑战.
提供在线传感器的概述,以实时控制连续薄膜涂层的质量.

主要方法:

审查当前的连续薄膜涂层设备及其容量.
分析与过程相关的挑战,如废物产生和平板电脑弹性回收.
对用于监测涂层质量的先进直线传感技术的调查.

主要成果:

连续薄膜涂层可以提供高吞吐量 (1200-1500公斤/小时).
关键的挑战包括启动/关闭废弃物和直接压缩后涂层的问题.
各种内置传感器 (NIR,拉曼,TPI,OCT,紫外线,机器视觉) 可实现实时质量监测.

结论:

连续薄膜涂层是现代制药制造的可行和必要的技术.
解决过程挑战和实施先进的在线监控对于成功的连续涂层至关重要.
在线传感器为质量控制提供实时数据,确保一致和高质量的薄膜涂层产品.

关键词:

连续薄膜涂层连续膜涂层.连续技术技术连续技术技术薄膜片类药片的使用情况制药制造业制药制造业制药制造业过程分析技术过程分析技术

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