Tablet Fingerprinting to Play Role In the Fight Against Counterfeit drugs, says TeraView
TeraView, the pioneer and leader in terahertz technology and solutions for the pharmaceutical and life science industry, says its terahertz imaging and spectroscopy products could be employed to help regulatory authorities, law enforcement agencies and the industry screen for counterfeit drugs.
50 per cent of drugs bought from the Internet are counterfeit says WHO.
The announcement comes in the wake of the comprehensive measures launched by the World Health Organization (WHO) and more than 20 international partners forming IMPACT (the International Medical Products Anti-Counterfeiting Taskforce) at its inaugural meeting in Bonn, (15 November 2006) to help national authorities safeguard their populations from the dangers of counterfeit medicines. WHO and its IMPACT partners are creating principles for model legislation to help countries adapt their laws to the gravity of the crime.
Don Arnone, chief executive officer of TeraView said: “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. 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.
TeraView 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 to a database of such fingerprints from known manufacturers, has the potential to address public safety and assist in the detection of the counterfeiters.
The market for counterfeit drugs worldwide is estimated at around $43B, and is expected to grow by 13% per annum over the coming years, comparable to the growth of brand name products. It has traditionally hit the poorest nations the hardest; however with the growth in illegal drug sales over the Internet, now anyone, anywhere could be putting themselves at risk.
The latest estimates on the scale of the problem, jointly outlined by WHO, the Organisation for Economic Co-operation and Development (OECD), and the Pharmaceutical Security Institute show that more than 30% of medicines in some areas of Latin America, South East Asia and Sub-Saharan Africa are counterfeit. In emerging economies, the proportion is estimated at 10% but in many of the former Soviet republics it can be as high as 20%. In wealthy countries, with strong regulatory mechanisms, counterfeits account for less than 1% of the market value, but 50% of illegal Internet sales are counterfeit.
TeraView has undertaken a number of studies using terahertz imaging which demonstrate that the structure of tablet coatings and cores tends to be different between 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 Food and Drug Administration and TeraView study, the initial results presented at at a recent IFPAC (International Foundation Process Analytical Chemistry) conference on pharmaceutical manufacturing technologies in the US detected variations in the thickness of tablet coatings from products bought over the Internet.
Don Arnone said: ”This work indicates that there is a potential role for terahertz imaging in the fight against the counterfeiters who put patients at risk and undermine public confidence in medicines and the pharmaceutical supply chain.”
TeraView is the world’s first company devoted to the application of THz light for spectroscopy and imaging in pharmaceutical drug development and manufacture. TeraView’s technology can improve the quality of pharmaceutical products and decrease the risk of regulatory non-compliance, leading to potentially safer tablets and savings arising from faster times to market and volume production of higher quality, stable products. Other markets for the technology exist in early stage cancer detection, defence and industrial inspection which are explored via commercial partners. Headquartered in Cambridge, UK, TeraView was spun-out of the Toshiba Cambridge Research Laboratory in April 2001. Sales and support are available throughout Europe, North America and the Far East either directly or through a network of distributors.
Notes for editors
Terahertz light is unique in its ability to non-destructively image tablets and other dosage forms. X-ray and infrared frequently lack sensitivity or penetration and cannot produce such images without first destroying the tablet. TeraView currently works closely with blue chip customers in the pharma industry who are exploring the use of terahertz in drug development and quality control in tablet manufacturing.
* US Food and Drug Administration and TeraView study
The images shown below are from a study undertaken with the FDA (St Louis office) which looked at coating thickness variations on Internet-based products and revealed very large variations in tablet coating thickness. An anticonvulsant drug which can be useful in the treatment of epilepsy with Phenytoin as the active ingredient was chosen.
The images are for 3 nominally identical tablets purchased by the FDA from an internet source, and one can see that there are both large intra-tablet as well as tablet to tablet variations in coating thickness.
Tablets from brand name manufacturers typically have more uniform coatings.
The same approach can be used for images of tablet cores for product differentiation.
Whilst the above product is not a known counterfeit, the data above 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.