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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.
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.
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.
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.
– ends – For further information, please contact:
Dr Don Arnone, Chief Executive Officer, TeraView
Ltd
Tel: +44 (0)1223 435383
don.arnone@teraview.com
Press enquiries to:
Salli Roskilly
Saffron Communications Limited
+44
(0)1763 208708 salli at saffroncoms.com
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