Packaging analysis of counterfeit medicines.
Klara Dégardin1, Aurélie Guillemain1, Philippe Klespe1
1F. Hoffmann-La Roche Ltd., Bldg 250 Room 3.504.01, Wurmisweg, 4303 Kaiseraugst, Switzerland.
Forensic Science International
|September 12, 2018
Summary
Investigating pharmaceutical product counterfeits requires packaging authentication. Analytical tools like Infrared (IR) and X-ray fluorescence (XRF) spectroscopy effectively support visual inspection to detect sophisticated fake medicines.
Area of Science:
- Pharmaceutical analysis
- Forensic science
- Analytical chemistry
Background:
- Packaging authentication is crucial for detecting pharmaceutical counterfeits.
- Advanced printing technologies and part manipulation make counterfeit detection challenging.
- Visual inspection alone is often insufficient to identify sophisticated fakes.
Purpose of the Study:
- To evaluate analytical tools for authenticating primary and secondary pharmaceutical packaging.
- To identify methods that can support visual inspection in detecting counterfeit products.
- To understand counterfeiter methodologies and inform prevention strategies.
Main Methods:
- Visual examination of packaging components.
- Analysis using Infrared (IR) spectroscopy, Raman microspectroscopy, X-ray fluorescence (XRF) spectroscopy, Scanning Electron Microscopy (SEM), and microcomputed tomography (microCT).
- Comparison of seven reference materials against five counterfeit samples.
Main Results:
- Visual inspection successfully identified some counterfeits.
- Infrared (IR) spectroscopy and X-ray fluorescence (XRF) spectroscopy proved effective in supporting visual authentication.
- Analytical methods revealed links between counterfeit cases based on packaging characteristics.
Conclusions:
- Analytical techniques, particularly IR and XRF spectroscopy, significantly enhance the ability to authenticate pharmaceutical packaging.
- A multi-faceted approach combining visual inspection and advanced analytical methods is essential for robust counterfeit detection.
- Understanding packaging characteristics aids in tracing counterfeiter methods and developing countermeasures.
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