Packaging analysis of counterfeit medicines.

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.