Comparative study on the real-time monitoring of a fluid bed drying process of extruded granules using near-infrared spectroscopy and audible acoustic emission

被引:5
|
作者
Aoki, Hisayoshi [1 ]
Hattori, Yusuke [1 ]
Sasaki, Tetsuo [2 ,3 ]
Otsuka, Makoto [1 ,2 ]
机构
[1] Musashino Univ, Fac Pharm, 1-1-20 Shinmachi, Nishi Tokyo 2028585, Japan
[2] Shizuoka Univ, Res Inst Elect, Naka Ku, 3-5-1 Johoku, Hamamatsu, Shizuoka 4328011, Japan
[3] Shizuoka Univ, Grad Sch Med Photon, Naka Ku, 3-5-1 Johoku, Hamamatsu, Shizuoka 4328011, Japan
关键词
Process analytical technology; Calibration model robustness; Fluid-bed drying; Near-infrared spectroscopy; Audible acoustic emission; Partial least squares regression; Granule drying; DIFFUSE-REFLECTANCE SPECTROSCOPY; PROCESS ANALYTICAL TECHNOLOGY; PARTICLE-SIZE DISTRIBUTION; END-POINT DETERMINATION; PHARMACEUTICAL QUALITY; DISCRIMINANT-ANALYSIS; DRUG DISSOLUTION; TABLET HARDNESS; INTACT TABLETS; PREDICTION;
D O I
10.1016/j.ijpharm.2022.121689
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
The process of fluidized bed drying of granules was comparatively evaluated by on-line real-time measurements of granule moisture content (MC) using near-infrared spectroscopy (NIR) and audible acoustic emission (AAE). The extruded granules were prepared by kneading a powder blend containing lactose, starch, crystalline cellulose, and riboflavin, with water. The MC of the granules (while they were dried at 35 C in a fluidized bed dryer) was monitored simultaneously with NIR and AAE. The prediction accuracy of the NIR and AAE using partial least squares (PLS) was verified by measuring MC of the granules. The best calibration models following NIR and AAE evaluations consisted of five latent variables with correlation coefficients of 1.000 and 0.998 and root mean square error of 0.259 and 0.615, respectively. As a result of external verification, the accuracy of MC analysis by AAE was slightly lower than that of NIR; however, it was still applicable in practice. Furthermore, the end point of fluidized bed drying process was automatically determined using the PLS discriminant analysis. From the above results, it can be concluded that the AAE-mediated granule drying process can be monitored with sufficient accuracy (compared with NIR).
引用
收藏
页数:11
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