Liu Ronghua, Li Lian, Yin Wenping, Xu Dongbo, Zang Hengchang
School of Pharmaceutical Sciences, Shandong University, Wenhuaxi Road 44, Jinan, 250012, China.
School of Basic Medical Sciences, Shandong University, Wenhuaxi Road 44, Jinan, 250012, China.
Int J Pharm. 2017 Sep 15;530(1-2):308-315. doi: 10.1016/j.ijpharm.2017.07.051. Epub 2017 Jul 22.
The fluidized bed granulation and pellets coating technologies are widely used in pharmaceutical industry, because the particles made in a fluidized bed have good flowability, compressibility, and the coating thickness of pellets are homogeneous. With the popularization of process analytical technology (PAT), real-time analysis for critical quality attributes (CQA) was getting more attention. Near-infrared (NIR) spectroscopy, as a PAT tool, could realize the real-time monitoring and control during the granulating and coating processes, which could optimize the manufacturing processes. This article reviewed the application of NIR spectroscopy in CQA (moisture content, particle size and tablet/pellet thickness) monitoring during fluidized bed granulation and coating processes. Through this review, we would like to provide references for realizing automated control and intelligent production in fluidized bed granulation and pellets coating of pharmaceutical industry.
流化床制粒和微丸包衣技术在制药工业中广泛应用，因为流化床制备的颗粒具有良好的流动性、可压性，且微丸的包衣厚度均匀。随着过程分析技术（PAT）的普及，关键质量属性（CQA）的实时分析受到更多关注。近红外（NIR）光谱作为一种PAT工具，可在制粒和包衣过程中实现实时监测与控制，从而优化制造工艺。本文综述了近红外光谱在流化床制粒和包衣过程中对CQA（水分含量、粒度和片剂/微丸厚度）监测的应用。通过本综述，旨在为制药工业流化床制粒和微丸包衣实现自动化控制和智能化生产提供参考。
