Terahertz imaging and spectroscopy products could be employed to help regulatory authorities, law enforcement agencies and the industry screen for counterfeit drugs, according to TeraView, the pioneer and leader in terahertz technology and solutions for the pharmaceutical and life science industry.
The market for counterfeit drugs worldwide is estimated at around US$43bn, and is expected to grow by 13% per annum over the coming years. Comprehensive measures were launched recently by the World Health Organization (WHO) and more than 20 international partners forming IMPACT (the International Medical Products Anti-Counterfeiting Taskforce).
TeraView has undertaken a number of studies using terahertz imaging that demonstrate that the structure of tablet coatings and cores differ among different manufacturers and that non-brand name manufacturers tend to have less sophisticated coating layers than those from the more well-known companies. In a joint US FDA and TeraView study, the initial detected variations in the thickness of tablet coatings from products bought over the Internet.
'Every tablet has a fingerprint that is unique to the coating, the contents and potentially the manufacturer, which we can detect with our terahertz imaging technology,' explained Don Arnone, ceo of TeraView. 'We can not only determine whether the drug content is as described, checking for active constituents for example, but also differentiate brand name drugs from those of other manufacturers. We can do this without needing to add bar codes to individual tablets or re-engineer tablet production, or destroy tablets during testing.'
TeraView's imager uses the terahertz spectrum between light and radio waves and offers the advantage of being non-invasive and non-destructive.
The company predicts that in the future its terahertz products and know-how could be employed to help routinely screen tablets in geographic centres where there is a suspicion of counterfeiting. The ability of terahertz imaging to produce a '3D fingerprint' of a tablet bought over the counter or via the Internet, and compare this against a database of such fingerprints from known manufacturers, has the potential to address public safety and assist in the detection of the counterfeiters.
TeraView/US FDA study
The images shown are from a study undertaken with the FDA that revealed very large variations in tablet coating thickness in Internet-based products. An anticonvulsant drug, which can be useful in the treatment of epilepsy, with Phenytoin as the active ingredient was chosen.
The images are for three nominally identical tablets purchased by the FDA from an Internet source, and both large intra-tablet as well as tablet-to-tablet variations in coating thickness can be seen.
Whilet the product is not a known counterfeit, the data demonstrates that Terahertz imaging is a very good means of identifying whether a tablet has been manufactured by a 'brand name' pharma company, or by another source.
Similar work has been carried out on tablets manufactured by brand name and generic manufacturers.