Hansuld E M, Briens L
Western University, London, Ontario N6A 5B9, Canada.
Western University, London, Ontario N6A 5B9, Canada.
Int J Pharm. 2014 Sep 10;472(1-2):192-201. doi: 10.1016/j.ijpharm.2014.06.027. Epub 2014 Jun 17.
High-shear wet granulation is commonly used in the pharmaceutical industry to improve powder properties for downstream processes such as tabletting. Granule growth, however, is difficult to predict because the process is sensitive to raw material properties and operating conditions. Development of process analytical technologies is encouraged by regulatory bodies to improve process understanding and monitor quality online. The primary technologies investigated for high-shear wet granulation monitoring include power consumption, near-infrared spectroscopy, Raman spectroscopy, capacitance measurements, microwave measurements, imaging, focused beam reflectance measurements, spatial filter velocimetry, stress and vibration measurements, as well as acoustic emissions. This review summarizes relevant research related to each of these technologies and discusses the challenges associated with each approach as a possible process analytical technology tool for high-shear wet granulation.
高剪切湿法制粒在制药行业中普遍用于改善粉末性质，以适用于诸如压片等下游工艺。然而，颗粒生长难以预测，因为该过程对原材料性质和操作条件敏感。监管机构鼓励开发过程分析技术，以增进对过程的理解并在线监测质量。用于高剪切湿法制粒监测的主要技术包括功耗、近红外光谱法、拉曼光谱法、电容测量、微波测量、成像、聚焦光束反射测量、空间滤波测速、应力和振动测量以及声发射测量。本综述总结了与这些技术中的每一项相关的研究，并讨论了作为高剪切湿法制粒可能的过程分析技术工具，每种方法所面临的挑战。
