Process analytical technology, Merck & Co., Inc., Rahway, New Jersey, USA.
Graduate School of Pharmaceutical Sciences, Duquesne University, 600 Forbes Avenue, Pittsburgh, Pennsylvania, USA.
AAPS PharmSciTech. 2020 Jun 28;21(5):179. doi: 10.1208/s12249-020-01727-8.
Coating process is a critical unit operation for manufacturing solid oral dosage forms. For a long time, the coating weight gain has been discerned as the most important, if not only, characteristic describing the coating quality. As the introduction of quality by design (QbD) and advancement of process analytical technology (PAT), nowadays more techniques are available to analyze other quality attributes which have been overlooked but have substantial impacts on the performance of coated products. The techniques that permit rapid and non-destructive measurements are of particular importance to improve process operation and product quality. This article reviews the analytical techniques that have been and potentially could be used as PAT tools for characterizing the quality of pharmaceutical coating product. By identifying the challenges and pitfalls encountered during PAT application, the review aims at fostering the adoption of PAT for paving the way to enhanced quality and efficiency of the coating processes.
包衣工艺是制造固体制剂的关键单元操作。长期以来，包衣增重一直被视为描述包衣质量最重要的（如果不是唯一的）特征。随着质量源于设计（QbD）的引入和过程分析技术（PAT）的发展，现在有更多的技术可用于分析其他质量属性，这些属性以前被忽视，但对涂覆产品的性能有实质性影响。允许快速和非破坏性测量的技术对于改进工艺操作和产品质量尤为重要。本文综述了已被用作 PAT 工具和可能被用作 PAT 工具的分析技术，用于表征药物包衣产品的质量。通过确定在 PAT 应用中遇到的挑战和陷阱，该综述旨在促进 PAT 的采用，为提高包衣工艺的质量和效率铺平道路。
