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对药物在人工唾液中溶解的批判性观点:在线电子舌测量的一种可能应用。

Critical view on drug dissolution in artificial saliva: A possible use of in-line e-tongue measurements.

作者信息

Khaydukova Maria, Kirsanov Dmitry, Pein-Hackelbusch Miriam, Immohr L Isabell, Gilemkhanova Venera, Legin Andrey

机构信息

Institute of Chemistry, St. Petersburg State University, Universitetskaya nab. 7/9, Mendeleev Center, 199034 St. Petersburg, Russia; Laboratory of Artificial Sensory Systems, ITMO University, Kronverkskiy Pr., 49, 197101 St. Petersburg, Russia.

Institute of Chemistry, St. Petersburg State University, Universitetskaya nab. 7/9, Mendeleev Center, 199034 St. Petersburg, Russia; Laboratory of Artificial Sensory Systems, ITMO University, Kronverkskiy Pr., 49, 197101 St. Petersburg, Russia.

出版信息

Eur J Pharm Sci. 2017 Mar 1;99:266-271. doi: 10.1016/j.ejps.2016.12.028. Epub 2016 Dec 29.

DOI:10.1016/j.ejps.2016.12.028
PMID:28042103
Abstract

Proper monitoring of drug's dissolution is a prerequisite for assessing of taste masking efficacy of pharmaceuticals. Corresponding dissolution procedure is likely to be performed with water. Since the objective of these tests is to examine fate of a pharmaceutical formulation in oral cavity, this choice of solvent seems unsuitable because physical and chemical properties of human saliva are quite far from those of water. Obviously, dissolution profiles registered in water may differ significantly from what really happens with a drug in a mouth cavity. In order to address this discrepancy we examined three different compositions of artificial saliva in dissolution test context in present study. It was found that certain compositions preclude the employment of traditional UV-vis spectroscopy as a detection tool due to strong light scattering in the media caused by viscosity and protein composition modifiers. This issue was circumvented by the use of in-line applied potentiometric multisensor system (e-tongue) and the potential of this new approach for more biorelevant dissolution tests was demonstrated with two model formulations of quinine and ibuprofen.

摘要

对药物溶出度进行适当监测是评估药物掩味效果的前提条件。相应的溶出程序可能用水来进行。由于这些测试的目的是研究药物制剂在口腔中的情况,这种溶剂的选择似乎并不合适,因为人类唾液的物理和化学性质与水相差甚远。显然,在水中记录的溶出曲线可能与药物在口腔中的实际情况有很大差异。为了解决这一差异,在本研究中,我们在溶出度测试背景下研究了三种不同成分的人工唾液。结果发现,由于粘度和蛋白质成分调节剂导致介质中强烈的光散射,某些成分使得传统紫外可见光谱法无法作为检测工具使用。通过使用在线应用的电位多传感器系统(电子舌)解决了这个问题,并且用奎宁和布洛芬的两种模型制剂证明了这种新方法在更具生物相关性的溶出度测试中的潜力。

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