用近红外光谱和化学计量学预测压片用混合粉末的粒径和流动特性

R. Iovanov, A. Vonica, I. Tomuță
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引用次数: 0

摘要

本研究的目的是将近红外光谱与化学计量学相结合,预测用于压片的美洛昔康粉末混合物的粒度和流动特性。为了开发颗粒尺寸(平均颗粒尺寸、多分散指数)和流动特性(休止角和流动时间)预测的校准模型,通过偏最小二乘回归和leave-out交叉验证,使用不同的预处理方法分析了根据实验设计制备的不同美洛昔康粉末共混物的近红外反射光谱。在没有应用预处理谱的开发模型中,发现对平均粒径、多分散指数、休止角和流动时间的预测能力非常好。此外,还发现了对光谱的预处理,如对颗粒尺寸特性的平滑移动平均,以及对粉末流动特性的单位向量归一化,都有很好的预测效果。因此,本工作中开发的近红外化学计量方法可用于预测美洛昔康粉末混合物的粒度特性和与流动性相关的参数,并可作为美洛昔康片生产过程控制的过程分析技术(PAT)工具。
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Prediction of the particle size and flow characteristics of powder blends for tableting by near-infrared spectroscopy and chemometrics
The purpose of this research was to apply near-infrared (NIR) spectroscopy in combination with chemometrics to predict particle size and flow characteristics of a meloxicam powder blends for tableting. In order to develop calibration models for particle size (mean particle size, poly-dispersion index), and flow properties (angle of repose and time of flow) prediction, the NIR reflection spectra of different meloxicam powder blends prepared according to an experimental design were analyzed using different preprocessing methods by partial last-square (PLS) regression followed by leaveone-out cross-validation. Very good prediction ability was found for mean particle size, poly-dispersion index, angle of repose, and time of flow in models in whose development no preprocessing spectrum was applied. Also, a good prediction was found preprocessing spectrum such smoothing - moving average for particle size characteristics, and unit vector normalization for powder flow properties. Therefore, NIR-chemometric methods developed in this work can be useful for the prediction of the granulometric properties and parameters related to the flowability of the meloxicam powder blends and may be used as process analytical technology (PAT) tools for process control during meloxicam tablets manufacturing.
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审稿时长
4 weeks
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