Laske Stephan, Paudel Amrit, Scheibelhofer Otto
Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria.
Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria.
J Pharm Sci. 2017 Mar;106(3):667-712. doi: 10.1016/j.xphs.2016.11.011. Epub 2016 Nov 22.
Pharmaceutical solid oral dosage product manufacturing is a well-established, yet revolutionizing area. To this end, process analytical technology (PAT) involves interdisciplinary and multivariate (chemical, physical, microbiological, and mathematical) methods for material (e.g., materials, intermediates, products) and process (e.g., temperature, pressure, throughput, etc.) analysis. This supports rational process modeling and enhanced control strategies for improved product quality and process efficiency. Therefore, it is often difficult to orient and find the relevant, integrated aspects of the current state-of-the-art. Especially, the link between fundamental research, in terms of sensor and control system development, to the application both in laboratory and manufacturing scale, is difficult to comprehend. This review compiles a nonexhaustive overview on current approaches from the recognized academia and industrial practices of PAT, including screening, selection, and final implementations in solid oral dosage manufacturing, through a wide diversity of use cases. Finally, the authors attempt to extract a common consensus toward developing PAT application guidance for different unit operations of drug product manufacturing.
药物固体口服制剂生产是一个成熟但仍在变革的领域。为此，过程分析技术（PAT）涉及用于物料（如原料、中间体、产品）和工艺（如温度、压力、产量等）分析的跨学科和多变量（化学、物理、微生物和数学）方法。这有助于进行合理的工艺建模和增强控制策略，以提高产品质量和工艺效率。因此，通常很难确定方向并找到当前技术水平中相关的、综合的方面。特别是，在传感器和控制系统开发方面的基础研究与实验室规模和生产规模应用之间的联系很难理解。本综述通过广泛的用例，对来自公认的学术界和工业实践中PAT的当前方法进行了非详尽的概述，包括在固体口服制剂生产中的筛选、选择和最终实施。最后，作者试图就为药品生产的不同单元操作制定PAT应用指南达成共识。
