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Packaging analysis of counterfeit medicines

Dégardin, Klara and Guillemain, Aurélie and Klespe, Philippe and Hindelang, Florine and Zurbach, Raphaël and Roggo, Yves (2018) Packaging analysis of counterfeit medicines. Forensic Science International, 291. pp. 144-157. ISSN 03790738

Abstract

The authentication of the packaging represents an important step in the investigation of suspected
counterfeits of pharmaceutical products. The visual comparison with a retained sample is the
first step to
detect a counterfeited packaging. Due to the improvement of technologies like printing, the emergence of
counterfeits with a better appearance can be observed. Moreover counterfeits are nowadays often a
combination of fake and genuine parts that have been manipulated. Authenticating each part of the
product is important in the frame of the investigation to understand how the counterfeiters proceed, and
which prevention measures should be taken. Lab instruments like spectrometers can help confirm
counterfeits of packaging for packaging components on which visually, no difference with a reference
would be observed. In this study several analytical tools were evaluated to help support the
authentication of the primary and secondary packaging of one medicinal product as an example using
seven reference materials and
five counterfeits. In some cases, visual examination of the packaging
already enabled to detect counterfeits of the studied features. Also the boxes, leaflets and vials have been
analysed with Infrared (IR) spectroscopy, Raman microspectroscopy, X-ray
fluorescence (XRF)
spectroscopy, Scanning Electron Microscopy (SEM) and microcomputed tomography (microCT).
According to the obtained results, IR and XRF could support the visual examination of the different
packaging components. Despite the small amount of counterfeits, relevant links could also be detected
between the studied cases based on the packaging characteristics.

Item Type: Article
Date Deposited: 22 Sep 2018 00:45
Last Modified: 22 Sep 2018 00:45
URI: https://oak.novartis.com/id/eprint/37647

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