Galata Dorián László, Péterfi Orsolya, Ficzere Máté, Szabó-Szőcs Bence, Szabó Edina, Nagy Zsombor Kristóf
Department of Organic Chemistry and Technology, Faculty of Chemical Technology and Biotechnology, Budapest University of Technology and Economics, Műegyetem rkp. 3., H-1111 Budapest, Hungary.
Department of Organic Chemistry and Technology, Faculty of Chemical Technology and Biotechnology, Budapest University of Technology and Economics, Műegyetem rkp. 3., H-1111 Budapest, Hungary.
Int J Pharm. 2025 Jan 25;669:125052. doi: 10.1016/j.ijpharm.2024.125052. Epub 2024 Dec 9.
In this decade, one of the major trends in the pharmaceutical industry is the adoption of continuous manufacturing. This requires the development of continuous equivalents of essential pharmaceutical processes such as film coating. The process of film coating is the last step of the processing of solid dosage forms and is critical because it determines the visual appearance of the end product, along with ensuring its stability and possibly even defining the rate of drug release. Several manufacturers advertise continuous solutions for film coating, these include semi-continuous and fully continuous appliances. State-of-the-art continuous coaters can match the throughput of continuous manufacturing lines, because largest appliances have a capacity of 1200-1500 kg/h. The paper also describes the main challenges related to continuous film coating including waste production at the beginning and end of the process and the problem caused by elastic recovery of the tablets when film coating is performed immediately after tablet compression. Lastly, we give an overview of the in-line sensors that can be used to monitor the quality of the film coated tablets, enabling real-time quality control of the process. Near-infrared and Raman spectroscopy can measure the mass gain of the tablets, while terahertz pulsed imaging and optical coherence tomography enable coating thickness measurement of individual tablets and even the characterization of intra-tablet coating thickness variability. UV imaging and machine vision can also measure coating thickness, and they are also excellent for detecting tablets with defective coating.
在这十年间，制药行业的主要趋势之一是采用连续制造。这需要开发诸如薄膜包衣等基本制药工艺的连续等效工艺。薄膜包衣工艺是固体剂型加工的最后一步，至关重要，因为它决定了最终产品的外观，同时确保其稳定性，甚至可能决定药物释放速率。几家制造商宣传薄膜包衣的连续解决方案，其中包括半连续和全连续设备。最先进的连续包衣机能够匹配连续生产线的产量，因为最大的设备产能为1200 - 1500千克/小时。本文还描述了与连续薄膜包衣相关的主要挑战，包括工艺开始和结束时的废料产生，以及片剂压片后立即进行薄膜包衣时片剂弹性恢复所导致的问题。最后，我们概述了可用于监测薄膜包衣片剂质量的在线传感器，从而实现该工艺的实时质量控制。近红外和拉曼光谱可测量片剂的质量增加，而太赫兹脉冲成像和光学相干断层扫描能够测量单个片剂的包衣厚度，甚至能够表征片剂内部包衣厚度的变异性。紫外成像和机器视觉也可测量包衣厚度，并且在检测包衣有缺陷的片剂方面也非常出色。
