Surface technology firm CSMA has developed the only commercially available way of seeing the differences between drug tablets of the same composition that have been manufactured by two different routes.
The work, carried out in collaboration with GlaxoSmithKline, was conducted in response to requests from the US Food & Drug Administration (FDA) for more action to tackle the growing problem of counterfeit drugs, which, according to the World Health Organisation, currently accounts for ten per cent of the global pharmaceuticals market.
The new method, which is available for commercialisation, detects differences in manufacturing routes, thus spotting drugs produced using methods other than those employed by the original pharmaceutical companies.
CSMA's technology uses complex surface analysis techniques, in particular X-ray photoelectron spectroscopy and time-of-flight secondary ionisation mass spectrometry, to look at the finished tablets.
Although further development of the detection system is required, the British company said the research is already being hailed as a major breakthrough.
"The technique involves CSMA analysing genuine tablets and suspected counterfeits and looking for differences," Rob Mitchell, who led the research programme, told In-PharmaTechnologist.com.
"How expensive this is depends on what you want, there's a straight-forward analysis or CSMA can be involved in consultancy."
CSMA's surface analysis techniques can also be used validate the cleanliness of pharmaceutical products, process equipment and materials, and product packaging.
In addition, they offer rapid identification of contamination, its source and cause, and can contribute to the evaluation of product and packaging stability.
Furthemore, these methods can help with the assessment of sterilisation effects on products and packaging and the optimisation and acceleration of new product development.
The company also has powerful secondary ion mass spectrometry imaging techniques that enable surface chemistry to be mapped at high spatial resolution, in a complex active drug species on an excipient species for example, so detailed mapping of this kind is invaluable in the development of drug delivery systems.
CSMA is a subsidiary of CERAM, a global non-profit distributing company for materials and technology, offering its services on a contract or membership basis.