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采用近红外光谱法测定药物粉末的流动性能。

Determination of flow properties of pharmaceutical powders by near infrared spectroscopy.

机构信息

REQUIMTE, Serviço de Química-Física, Faculdade de Farmácia, Universidade do Porto, R. Aníbal Cunha No. 164, 4099-030 Porto, Portugal.

出版信息

J Pharm Biomed Anal. 2010 Aug 1;52(4):484-92. doi: 10.1016/j.jpba.2010.01.038. Epub 2010 Feb 1.

Abstract

The physical properties of pharmaceutical powders are of upmost importance in the pharmaceutical industry. The knowledge of their flow properties is of critical significance in operations such as blending, tablet compression, capsule filling, transportation, and in scale-up operations. Powders flow properties are measured using a number of parameters such as, angle of repose, compressibility index (Carr's index) and Hausner ratio. To estimate these properties, specific and expensive equipment with time-consuming analysis is required. Near infrared spectroscopy is a fast and low-cost analytical technique thoroughly used in the pharmaceutical industry in the quantification and qualification of products. To establish the potential of this technique to determine the parameters associated with the flow properties of pharmaceutical powders, blended powders based on paracetamol as the active pharmaceutical ingredient were constructed in pilot scale. Spectra were recorded on a Fourier-transform near infrared spectrometer in reflectance mode. The parameters studied were the angle of repose, aerated and tapped bulk density. The correlation between the reference method values and the near infrared spectrum was performed by partial least squares and optimized in terms of latent variables using cross-validation. The near infrared based properties predictions were compared with the reference methods results. Prediction errors, which varied between 2.35% for the angle of repose, 2.51% for the tapped density and 3.18% for the aerated density, show the potential of NIR spectroscopy in the determination of physical properties affecting the flowability of pharmaceutical powders.

摘要

药物粉末的物理性质在制药工业中至关重要。了解其流动性质对于混合、片剂压缩、胶囊填充、运输以及放大操作等操作具有关键意义。粉末流动性质使用多个参数来测量,例如休止角、可压缩性指数(卡尔指数)和豪斯纳比。为了估计这些性质,需要使用特定的、昂贵的设备,并进行耗时的分析。近红外光谱技术是一种快速且低成本的分析技术,在制药行业中广泛用于产品的定量和定性分析。为了确定该技术在确定与药物粉末流动性质相关的参数方面的潜力,以对乙酰氨基酚为活性药物成分的混合粉末在中试规模下构建。在反射模式下使用傅里叶变换近红外光谱仪记录光谱。研究的参数包括休止角、充气和敲击堆密度。通过偏最小二乘法(PLS)对参考方法值与近红外光谱之间的相关性进行分析,并通过交叉验证在潜在变量方面进行优化。将基于近红外的性质预测与参考方法的结果进行比较。预测误差在 2.35%(休止角)至 3.18%(充气密度)之间变化,这表明近红外光谱技术在确定影响药物粉末流动性的物理性质方面具有潜力。

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