Analysis of Counterfeit Coated Tablets and Multi-Layer Packaging Materials Using Infrared Microspectroscopic Imaging

Area of Science:

• Analytical Chemistry
• Spectroscopy
• Materials Science

Background:

• Counterfeit medicines pose a significant global health risk.
• Authenticity verification of pharmaceutical products and packaging is crucial.
• Advanced analytical techniques are needed for detailed material characterization.

Purpose of the Study:

• To develop and demonstrate an effective method for detecting and characterizing counterfeit finished dosage forms and packaging materials.
• To compare suspect counterfeit materials directly with authentic products using spectroscopic imaging.
• To assess the capability of the method for analyzing micro-scale structures.

Main Methods:

• Attenuated Total Internal Reflection Fourier Transform Infrared (ATR-FTIR) spectroscopic imaging was employed.
• Analysis included tablet coatings, cores, multi-layered foil safety seals, bottle labels, and cigarette tear tapes.
• Suspect counterfeit materials were directly compared with stored authentic product samples.

Main Results:

• The ATR-FTIR spectroscopic imaging method successfully detected and characterized counterfeit materials.
• Molecular information was effectively obtained from diverse packaging components.
• The technique demonstrated sensitivity for analyzing structures as small as 6 μm.

Conclusions:

• ATR-FTIR spectroscopic imaging is a powerful tool for identifying counterfeit pharmaceutical products and packaging.
• The method provides detailed molecular insights for authenticity assessment.
• This technique offers a reliable approach for forensic analysis in the pharmaceutical industry.