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The Utility of Colorimetry as a Quality Control Tool for the Identification of Pharmaceutical Tablets

机译:比色法作为药物片剂鉴定的质量控制工具

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There is an ongoing need for new or alternate approaches to identify innovative pharmaceutical products and distinguish them from counterfeit medicines. In this study we present data that demonstrate how quantitative measurement of the color on the surface of tablets could be used to accomplish this objective. Several proof-of-concept studies were performed in which ColorQuest XE colorimeter was used to measure the tristimulus L*, a*, and b* color values from the surface of pharmaceutical tablets. These values represent the red to green scale (a*), the blue to yellow scale (b*), and the lightness extreme (L*). In a preliminary experiment, significant differences were observed in the surface color of visually identical white tablets from four different products. These differences were found to be product and not batch specific. The utility of colorimetry in identifying imitator products was then demonstrated by comparing the color signatures of the innovator Viagra?? tablets to imitator Sildenafil tablets, which were procured from nine different online suppliers. While it is not a fool proof technique, data in this study demonstrates that colorimetry could be used as a simple inexpensive technique to identify innovative products and potentially alleviate the pandemic of counterfeit medicines, especially in areas around the world where counterfeiting is prevalent while sophisticated tools for their detection are not readily available.
机译:持续需要新的或替代的方法来识别创新药物并将其与假药区分开来。在这项研究中,我们提供的数据表明如何定量测量片剂表面的颜色可以用来实现这一目标。进行了几项概念验证研究,其中使用ColorQuest XE色度计测量药物片剂表面的三色L *,a *和b *颜色值。这些值代表红色到绿色的比例(a *),蓝色到黄色的比例(b *)和极端亮度(L *)。在初步实验中,观察到来自四种不同产品的视觉相同的白色药片的表面颜色存在显着差异。发现这些差异是产品而不是批次特定的。然后通过比较创新者伟哥的颜色特征证明了比色法在识别仿制品中的实用性。仿制药公司Sildenafil片剂,这些片剂是从9个不同的在线供应商那里购买的。尽管这不是一个简单的技术,但这项研究的数据表明,比色法可以用作一种简单廉价的技术,以识别创新产品并有可能减轻假药的流行,特别是在世界各地假冒盛行而工具复杂的地区对其进行检测尚不容易。

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