The Forensic Analysis of Counterfeit Pharmaceutical Packaging

Pharmaceutical packaging is the coordinated system that encloses and protects a dosage form. Counterfeit drugs have caused deaths, and lead to the failure of public trust in the healthcare system and the pharmaceutical manufacturers. The authentication of packaging materials requires a trained forensic approach. Advanced instrumentation has become expensive, for example with hyper- and multi-spectral techniques, and multivariate data interpretation can be non-standard. There is always a need for rapid screening of suspect materials, particularly across market surveys where rapid, non-destructive determination counterfeits is required to segregate and allow further downstream forensic analysis.

The development of Fourier transfer infra-red (FT-IR) spectroscopy in the 1970's facilitated the rapid data capture and analysis of solids and liquids. Since then thousands of spectra are commercially available for identification purposes based on transmission and, more recently, attenuated total reflectance (ATR) analysis modes. ATR is a rapid technique requiring pressure exerted from a crystal onto a sample to create a spectrum. Specular reflectance is a third analysis mode that does not require such force to obtain a spectrum.

It was found that the ExoScan FT-IR in specular reflectance mode combined with a similarity identification algorithm was most successful for confirming the presence of counterfeit Reductil cartons. Results were in less than a minute with no damage inflicted on the suspect with this non-destructive technique. Results can be shown overlaid or stacked, together with a similarity (hit) value. The repeatability for a single control carton was 0.16% for six replicates.

The use of external reflectance FT-IR has been shown to be able to rapidly uncover counterfeit packaging materials, with the application of bespoke, easy to create libraries. The technique is non-destructive and especially suited to carbon based solids.