Introducing morphologically directed Raman spectroscopy

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.

Counterfeiting and its associated challenges

The production of counterfeit drugs is a growing concern for the pharmaceutical industry and affects a wide range of pharmaceutical products, from relatively inexpensive and high-volume generics, through to high-value drugs still under patent. Recipients are often duped by the near-identical appearance of the counterfeit to its genuine generic or innovator counterpart, which can make identification very difficult.

Although convincingly similar in external appearance, the components used to formulate counterfeits may differ substantially from those used to produce the original, and counterfeits are, of course, unregulated, creating a high risk of unexpected and potentially harmful outcomes for the individual. In this way, counterfeiting erodes confidence in the genuine product and also in its manufacturer.

Criminalists are increasingly interested in investigating counterfeit products, with the ultimate aim of identifying their source and eradicating them from the market. However, such investigations can present a complex challenge. The accurate identification and quantification of one or more individual components within a counterfeit pharmaceutical product can be difficult and often unreliable in the absence of appropriate technologies and methodologies.

The pharmacopoeial analyses specified to investigate falsified products are often expensive, and there is a call for simple alternatives that offer optimal sensitivity and specificity to maximise information flow at reasonable cost. During the investigation of counterfeit drugs, it is first and foremost the identification and quantification of actives, excipients and potential contaminants that is vital, as these studies determine the performance and therapeutic profile of the pharmaceutical product.

In counterfeit products, components are often less controlled in terms of quantity and particle size and shape distribution. Techniques that measure these metrics for individual components within a blend, with a high level of specificity, can therefore provide insight to help criminalists successfully penetrate the superficial appearance of a counterfeit drug and determine its source.