Technologie Servier, Orléans, France.
Indatech, Clapiers, France.
Anal Bioanal Chem. 2017 Jan;409(3):683-691. doi: 10.1007/s00216-016-9756-9. Epub 2016 Jul 15.
Near-infrared (NIR) spectroscopy is a non-destructive analytical technique that enables better-understanding and optimization of pharmaceutical processes and final drug products. The use in line is often limited by acquisition speed and sampling area. This work focuses on performing a multipoint measurement at high acquisition speed at the end of the manufacturing process on a conveyor belt system to control both the distribution and the content of active pharmaceutical ingredient within final drug products, i.e., tablets. A specially designed probe with several collection fibers was developed for this study. By measuring spectral and spatial information, it provides physical and chemical knowledge on the final drug product. The NIR probe was installed on a conveyor belt system that enables the analysis of a lot of tablets. The use of these NIR multipoint measurement probes on a conveyor belt system provided an innovative method that has the potential to be used as a new paradigm to ensure the drug product quality at the end of the manufacturing process and as a new analytical method for the real-time release control strategy. Graphical abstract Use of near-infrared spectroscopy and multipoint measurements for quality control of pharmaceutical drug products.
近红外（NIR）光谱分析是一种非破坏性的分析技术，可帮助更好地理解和优化制药工艺及最终药物产品。该技术通常在线应用受到采集速度和采样面积的限制。本工作重点是在制造工艺末端的输送带上系统中以高速进行多点测量，以控制最终药物产品（例如片剂）中活性药物成分的分布和含量。为此研究专门设计了一个带有多个收集光纤的探头。通过测量光谱和空间信息，它提供了关于最终药物产品的物理和化学知识。NIR 探头安装在一个输送系统上，可用于分析大量片剂。在输送带上系统中使用这些 NIR 多点测量探头提供了一种创新的方法，有可能被用作确保制造工艺末端药物产品质量的新范例，以及实时放行控制策略的新分析方法。
