Jørgensen Anna Kirstine, Ong Jun Jie, Parhizkar Maryam, Goyanes Alvaro, Basit Abdul W
Department of Pharmaceutics, UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK.
Department of Pharmaceutics, UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK; Departamento de Farmacología, Farmacia y Tecnología Farmacéutica, I+D Farma (GI-1645), Facultad de Farmacia, Instituto de Materiales (iMATUS) and Health Research Institute of Santiago de Compostela (IDIS), Universidade de Santiago de Compostela, 15782 Santiago de Compostela, Spain; FabRx Ltd., Henwood House, Henwood, Ashford TN24 8DH, UK; FabRx Artificial Intelligence, Carretera de Escairón 14, 27543 Currelos (O Saviñao) Lugo, Spain.
Trends Pharmacol Sci. 2023 Jun;44(6):379-393. doi: 10.1016/j.tips.2023.03.006. Epub 2023 Apr 24.
Pharmaceutical 3D printing (3DP) has attracted significant interest over the past decade for its ability to produce personalised medicines on demand. However, current quality control (QC) requirements for traditional large-scale pharmaceutical manufacturing are irreconcilable with the production offered by 3DP. The US Food and Drug Administration (FDA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) have recently published documents supporting the implementation of 3DP for point-of-care (PoC) manufacturing along with regulatory hurdles. The importance of process analytical technology (PAT) and non-destructive analytical tools in translating pharmaceutical 3DP has experienced a surge in recognition. This review seeks to highlight the most recent research on non-destructive pharmaceutical 3DP analysis, while also proposing plausible QC systems that complement the pharmaceutical 3DP workflow. In closing, outstanding challenges in integrating these analytical tools into pharmaceutical 3DP workflows are discussed.
在过去十年中，药物三维打印（3DP）因其能够按需生产个性化药物而备受关注。然而，传统大规模药物制造的当前质量控制（QC）要求与3DP提供的生产方式无法协调。美国食品药品监督管理局（FDA）和英国药品和医疗产品监管局（MHRA）最近发布了文件，支持在床边护理（PoC）制造中实施3DP以及监管障碍。过程分析技术（PAT）和无损分析工具在药物3DP转化中的重要性已得到越来越多的认可。本综述旨在突出关于无损药物3DP分析的最新研究，同时提出合理的质量控制体系，以补充药物3DP工作流程。最后，讨论了将这些分析工具集成到药物3DP工作流程中所面临的突出挑战。
