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首页> 外文期刊>RSC Advances >Real-time monitoring of granule properties during high shear wet granulation by near-infrared spectroscopy with a chemometrics approach
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Real-time monitoring of granule properties during high shear wet granulation by near-infrared spectroscopy with a chemometrics approach

机译：使用化学计量学方法通过近红外光谱实时监测高剪切湿法制粒过程中的颗粒性质

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摘要

We developed an in-line near-infrared spectroscopy (NIRS) monitoring method enabling a rapid and non-invasive analysis of granule properties during the high shear wet granulation (HSWG) process. Eleven batches were manufactured and used as the calibration dataset and an additional batch was manufactured and used as the validation dataset. The HSWG process was directly monitored using an acousto-optical tunable filter (AOTF)-NIR spectrometer and the NIR spectra related to the physical and chemical changes of the granules were acquired. The particle size, tapped density, bulk density, and powder flowability of the granules were qualitatively and quantitatively evaluated by a chemometrics approach. Principal component analysis (PCA) and partial least square regression (PLSR) were applied for the qualitative and quantitative modelling of the granule properties. The PCA score plots showed a clear relationship between the granule properties and the granulation progress and provided an effective means for the endpoint determination of the manufacturing process. The PLSR models constructed for the quantitative evaluation of the granule properties were demonstrated to be predictive with high accuracy. These findings allow HSWG to be monitored in-line and controlled effectively. A better understanding of the process by NIRS with chemometrics will contribute to developing high-quality drug products using the required quality-by-design approach.
机译：我们开发了在线近红外光谱（NIRS）监测方法，可在高剪切湿法制粒（HSWG）过程中快速，无创地分析颗粒性质。制造了11个批次并将其用作校准数据集，另外一个批次已制造并用作验证数据集。使用声光可调滤光片（AOTF）-NIR光谱仪直接监测HSWG过程，并获得与颗粒的物理和化学变化有关的NIR光谱。通过化学计量学方法定性和定量地评价颗粒的粒度，堆积密度，堆积密度和粉末流动性。主成分分析（PCA）和偏最小二乘回归（PLSR）用于颗粒性质的定性和定量建模。 PCA评分图显示出颗粒性质与制粒进度之间的明确关系，并为确定制造过程的终点提供了有效手段。用于颗粒性质定量评估的PLSR模型被证明具有较高的预测性。这些发现使HSWG可以进行在线监测和有效控制。 NIRS和化学计量学对过程的更好理解将有助于使用所需的按质量设计方法开发高质量的药品。

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