|
TeraView,
the pioneer and leader in Terahertz technology and
solutions for the pharmaceutical and life science
industries, says its Terahertz imaging and spectroscopy
products can be used in conjunction with wet dissolution
testing to accelerate product development of tablets
and capsules, and maintain in-spec performance during
pharmaceutical manufacture.
The announcement comes in the wake of a recent paper
by the Food and Drug Administration (FDA) in the
US, which states that the speed and ease of Terahertz
imaging may make it an attractive potential replacement
for wet dissolution testing both in product development
and eventually for process analysis.
The FDA study focussed upon
a delayed release dosage form which employs coatings
that are engineered to breakdown and release the
drug in the lower intestinal tract. The product
is a treatment for Ulcerative Colitis and Crohn’s
Disease, and undesirable release of drug in the
stomach and upper small intestine will lead to
premature absorption and possible systemic side
effects for the consumer. The FDA found the tablets
to dissolve erratically during conventional wet
dissolution measurements so Terahertz imaging was
used to accurately map the coating thickness. The
mean dissolution times were found to correlate
with the average tablet coating thickness, suggesting
that the coating thickness played a significant role
to product design and performance.
The study has recently been
published in the Journal of Pharmaceutical Sciences.
Professor Sir Michael Pepper,
chief scientific officer of TeraView said: “This
study demonstrates that Terahertz technology has
a potential role to play alongside dissolution
in the optimisation of therapeutic effectiveness
of dosage forms during product development and
stability assessment, as well as routine assessment
of production quality to ensure uniformity between
production lots.
According to Dr Don Arnone,
chief executive officer of TeraView: “Additional
studies are required to demonstrate and understand
to what extent Terahertz can be used alongside
dissolution in other contexts. However, the evidence
here suggests that our Terahertz products have
the capacity to reduce drug development times and
help ensure in-spec performance of product, thereby
minimising the risk of regulatory non compliance
for the industry and more rapidly providing consumers
with improved pharmaceutical products.”
TeraView’s tablet
imaging technology uses the Terahertz spectrum
between light and radio waves and offers the advantage
of being non-invasive and non-destructive. Past
studies have demonstrated how Terahertz uniquely
provides structural images and chemical information
on the contents of tablets and capsules which are
invisible with conventional techniques.
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.
* US Food and Drug Administration and TeraView study
Tablet images and copy of FDA paper can be supplied
upon request.
– ends –
For further information, please contact:
In the EU/Asia Pacific:
Maireadh Pedersen, VP of Pharmaceutical Applications
Tel: +44 (0)1223 435383
maireadh.pedersen@teraview.com
In North America:
Ed Pankau
Account manger, North America
Tel: +1 847-426-6247
edward.pankau@teraview.com
Press enquiries to:
Salli Roskilly, Saffron Communications Limited
+44
(0)1763 208708
salli at saffroncoms.com
|
