GEA-NUS Pharmaceutical Processing Research Laboratory, Department of Pharmacy, National University of Singapore, 18 Science Drive 4, Singapore 117543.
J Pharm Sci. 2013 Aug;102(8):2667-78. doi: 10.1002/jps.23635. Epub 2013 Jun 6.
The application of near infrared (NIR) spectroscopy for real-time monitoring of the critical quality attributes of ribbed roller compacted ribbons was studied. Three NIR probes (QR 200, QR 400, and QR 600) of lens diameters, 200, 400, and 600 μm, respectively were used at various fixed distances from the ribbon surface to determine the calibration model with optimum predictive ability for monitoring the roller compaction process. The ribbon attributes studied were micronized chlorpheniramine maleate concentration, roll force, roll speed, ribbon density, and tensile strength. The custom-made belt conveying system was used to simulate the ribbon manufacturing process for NIR spectra capture. Simulation results obtained were then compared with the experimental results. The outcome of this study indicated that QR 400 was the best NIR probe for modeling, followed by QR 200 and QR 600. Of the five spectra measuring distance settings (d = 0.3, 0.6, 0.9, 1.2, and 1.5 mm), there was good correlation between simulation and experimental findings indicating that the calibration models for bigger probe sizes were better if the measuring distance was smaller.
研究了近红外(NIR)光谱法在实时监测肋形轧辊压制成形条带关键质量属性中的应用。使用了三个透镜直径分别为 200、400 和 600μm 的 NIR 探头(QR 200、QR 400 和 QR 600),分别在距条带表面的不同固定距离处进行了测量,以确定具有最佳预测能力的校准模型,用于监测轧辊压实过程。研究的条带属性包括马来酸氯苯那敏的微粉化浓度、轧辊力、轧辊速度、条带密度和拉伸强度。定制的皮带输送系统用于模拟 NIR 光谱采集的条带制造过程。然后将模拟结果与实验结果进行比较。这项研究的结果表明,QR 400 是建模的最佳 NIR 探头,其次是 QR 200 和 QR 600。在五个光谱测量距离设置(d = 0.3、0.6、0.9、1.2 和 1.5mm)中,模拟和实验结果之间存在良好的相关性,表明如果测量距离较小,则较大探头尺寸的校准模型更好。