Drug formulation, an integral step in the regulated pharmaceutical industry, involves the careful blending and processing of precisely specified and measured components to create a final product that can be administered to deliver the required clinical dose. The production of counterfeit drugs is a major challenge to the industry and has the potential to endanger health, threaten reputation and, in the long-term, reduce the funds needed to drive pharmaceutical innovation. Counterfeit products, although often packaged convincingly, may have specific components replaced or altogether removed, and/or additional components included.
Investigation of the composition of illegal drugs provides insight into their provenance to criminalists working in this area. However, it can be difficult to robustly detect and identify fake actives, contaminants and/or bulking agents, hampering efforts to investigate the associated crimes. Tracking down and halting counterfeiting operations is a substantial and complex activity and calls for highly effective analytical strategies.
Morphologically-Directed Raman Spectroscopy (MDRS) is a powerful technique that combines automated particle imaging with Raman spectroscopy to provide particle size, shape and chemical identification. These capabilities make MDRS a novel and valuable tool for the investigation of counterfeit pharmaceuticals and subsequent adjudications.
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