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KMID : 0370220160600020085
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Yakhak Hoeji
2016 Volume.60 No. 2 p.85 ~ p.91
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Online Real-Time Monitoring of Moisture in Pharmaceutical Granules During Fluidized Bed Drying Using Near-Infrared Spectroscopy
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Kim Jae-Jin
Kim Byung-Suk
Lim Young-Il
Woo Young-Ah
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Abstract
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Drying of granules for tablet formulation is one of the important unit operations. The loss on drying method is traditionally used for this purpose. However, it is a time-consuming method, requiring at least 1 h. Moreover, it is ineffective in monitoring the moisture content of granules during the drying process. In this study, online real-time monitoring of moisture content during the drying process was successfully performed using near-infrared (NIR) spectroscopy. NIR spectra were collected during 15 different drying batches for developing a reliable NIR spectroscopic method. Such a large number of batches were used to develop a more robust partial least squares (PLS) model. NIR spectra collected from 12 batches were used for developing the model that was validated by predicting the moisture content of the samples in the remaining 3 batches. The standard errors of predictions (SEPs) in the measurement of batch 1, batch 2, and batch 3 were 0.52%, 0.57%, and 0.56%, respectively. The online NIR spectroscopic method developed in this study was reliable and accurate in monitoring the moisture content during the drying process.
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KEYWORD
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drying process, near-infrared spectroscopy, Process Analytical Technologies (PAT), real-time monitoring, fluidized bed drying
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