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首页> 外文期刊>Journal of pharmaceutical sciences. >Process analytical technology: nondestructive evaluation of cyclosporine A and phospholipid solid dispersions by near infrared spectroscopy and imaging.
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Process analytical technology: nondestructive evaluation of cyclosporine A and phospholipid solid dispersions by near infrared spectroscopy and imaging.

机译：工艺分析技术：通过近红外光谱和成像技术对环孢菌素A和磷脂固体分散体进行无损评估。

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摘要

The objective of this study was to evaluate near infrared (NIR) spectroscopy and imaging as approaches to assess phospholipid compartment within its solid dispersion with cyclosporine A (CyA). By varying dimyristoyl phosphatidylcholine (DMPC) to CyA weight ratio, five batches were prepared by the kneading technique and characterized by DSC and FTIR. A drug/DMPC ratio of 50:1 provided an enhanced dissolution of CyA. FTIR spectra and DSC thermograms revealed a significant interaction between the drug and DMPC which suggested incorporation of CyA within the formed DMPC liposomes. The developed NIR calibration model was able to assess DMPC concentrations within the kneaded products. The calibration and prediction linear plots showed slopes of 0.9711 and 0.9915, offsets of 0.1247 and 0.1080, correlation coefficients of 0.9854 and 0.9889 and root mean square standard errors of 0.43% and 0.42%, respectively. In contrast, NIR spectral imaging was capable of clearly distinguishing the kneaded products, both qualitatively and quantitatively. NIR imaging revealed the poor powder blending efficiency of the method used to prepare physical mixture compared to the efficient distribution of the kneaded products. In conclusion, NIR spectral imaging system provides a rapid approach for acquiring high-resolution spatial and spectral information on solid dispersions.
机译：这项研究的目的是评估近红外（NIR）光谱学和成像技术，以评估其与环孢菌素A（CyA）的固体分散体中的磷脂区室。通过改变二豆蔻酰基磷脂酰胆碱（DMPC）与CyA的重量比，通过捏合技术制备了五批，并通过DSC和FTIR对其进行了表征。 50：1的药物/ DMPC比可增强CyA的溶出度。 FTIR光谱和DSC热分析图显示了药物与DMPC之间的显着相互作用，这表明CyA在形成的DMPC脂质体内掺入。开发的NIR校准模型能够评估捏合产品中的DMPC浓度。校准和预测线性图显示的斜率分别为0.9711和0.9915，偏差为0.1247和0.1080，相关系数为0.9854和0.9889，均方根标准误差为0.43％和0.42％。相比之下，NIR光谱成像能够在定性和定量上清楚地区分捏合产物。 NIR成像显示，与有效分配捏合产品相比，用于制备物理混合物的方法的粉末混合效率低。总之，NIR光谱成像系统为获取有关固体分散体的高分辨率空间和光谱信息提供了一种快速方法。

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