Rapid detection and quantification of falsified Viagra using cloud-based portable NIR technology and machine learning

IF 3.1 3区 医学 Q2 CHEMISTRY, ANALYTICAL
Hervé Rais , Pierre Esseiva , Olivier Delémont , Cédric Schelling , Stefan Stanojevic , Serge Rudaz , Florentin Coppey
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引用次数: 0

Abstract

The prevalence of falsified medications remains a global health challenge, intensified by globalization, internet accessibility, and the high profitability associated with low risks for this type of trafficking. This study demonstrates the innovative integration of portable Near-Infrared (NIR) spectroscopy with a cloud-based advanced data processing and management architecture, offering a rapid, non-destructive, and reliable solution for on-site detection and quantification of falsified Viagra tablets. Leveraging the advantages of portable NIR technology—such as its speed, ease of use, and ability to deliver nearly instantaneous results—this approach not only differentiates authentic from falsified tablets but also accurately determines their absolute sildenafil content. Utilizing data from authentic and seized falsified samples, Principal Component Analysis (PCA), Euclidean distance measurements and Support Vector Machine (SVM) highlight the capability of portable NIR devices to effectively distinguish between these groups. Such models can be seamlessly integrated into an online system paired with a mobile application, enhancing accessibility and efficiency in field settings. Furthermore, machine learning models were developed to quantify sildenafil content in falsified tablets, achieving excellent accuracy compared to a reference chromatographic method. These findings underscore the potential of portable NIR spectroscopy, combined with advanced data treatment, as a transformative tool for field deployment, empowering regulatory bodies and healthcare providers to ensure medication quality and safety with greater speed and precision.
使用云端便携式近红外技术和机器学习快速检测和量化伪造伟哥
假药的普遍存在仍然是一项全球健康挑战,全球化、互联网可及性以及这类贩运的低风险带来的高盈利能力加剧了这一挑战。本研究展示了便携式近红外(NIR)光谱与基于云的先进数据处理和管理架构的创新集成,为伪造伟哥片剂的现场检测和定量提供了快速、无损和可靠的解决方案。利用便携式近红外技术的优势,如其速度,易用性和提供几乎即时结果的能力,这种方法不仅区分了真实的药片和伪造的药片,而且准确地确定了它们的绝对西地那非含量。利用来自真实和查获的伪造样品的数据,主成分分析(PCA),欧几里得距离测量和支持向量机(SVM)突出了便携式近红外设备有效区分这些组的能力。这些模型可以无缝地集成到与移动应用程序配对的在线系统中,从而提高现场设置的可访问性和效率。此外,开发了机器学习模型来量化伪造片剂中的西地那非含量,与参考色谱方法相比,获得了极好的准确性。这些发现强调了便携式近红外光谱与先进数据处理相结合,作为现场部署的变革性工具的潜力,使监管机构和医疗保健提供者能够以更快、更精确的速度确保药物质量和安全。
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来源期刊
CiteScore
6.70
自引率
5.90%
发文量
588
审稿时长
37 days
期刊介绍: This journal is an international medium directed towards the needs of academic, clinical, government and industrial analysis by publishing original research reports and critical reviews on pharmaceutical and biomedical analysis. It covers the interdisciplinary aspects of analysis in the pharmaceutical, biomedical and clinical sciences, including developments in analytical methodology, instrumentation, computation and interpretation. Submissions on novel applications focusing on drug purity and stability studies, pharmacokinetics, therapeutic monitoring, metabolic profiling; drug-related aspects of analytical biochemistry and forensic toxicology; quality assurance in the pharmaceutical industry are also welcome. Studies from areas of well established and poorly selective methods, such as UV-VIS spectrophotometry (including derivative and multi-wavelength measurements), basic electroanalytical (potentiometric, polarographic and voltammetric) methods, fluorimetry, flow-injection analysis, etc. are accepted for publication in exceptional cases only, if a unique and substantial advantage over presently known systems is demonstrated. The same applies to the assay of simple drug formulations by any kind of methods and the determination of drugs in biological samples based merely on spiked samples. Drug purity/stability studies should contain information on the structure elucidation of the impurities/degradants.
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