Faculty of Pharmacy, Musashino University, 1-1-20 Shinmachi, Nishi-Tokyo 202-8585, Japan.
Research Institute of Electronics, Shizuoka University, 3-5-1 Johoku, Naka-ku, Hamamatsu 432-8011, Japan; Graduate School of Medical Photonics, Shizuoka University, 3-5-1 Johoku, Naka-ku, Hamamatsu 432-8011, Japan.
Int J Pharm. 2022 May 10;619:121689. doi: 10.1016/j.ijpharm.2022.121689. Epub 2022 Mar 21.
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).
采用近红外光谱(NIR)和可听声发射(AAE)在线实时测量颗粒水分含量(MC),对流化床干燥颗粒的过程进行了比较评估。通过将含有乳糖、淀粉、结晶纤维素和核黄素的粉末混合物与水混合来制备挤出颗粒。在流化床干燥器中以 35°C 干燥颗粒的同时,用 NIR 和 AAE 同时监测颗粒的 MC。通过测量颗粒的 MC 来验证 NIR 和 AAE 中偏最小二乘(PLS)的预测准确性。经过 NIR 和 AAE 评估,最好的校准模型由五个潜在变量组成,相关系数分别为 1.000 和 0.998,均方根误差分别为 0.259 和 0.615。经过外部验证,AAE 分析 MC 的准确性略低于 NIR,但仍可在实际中应用。此外,还使用 PLS 判别分析自动确定流化床干燥过程的终点。从上述结果可以得出结论,AAE 介导的颗粒干燥过程可以用足够的精度进行监测(与 NIR 相比)。