|
Cambridge, UK – 29 November ’07 -
TeraView’s proprietary technology and expertise
have now been successfully applied to define product
and process specifications that affect the performance
of solid dosage forms. A series of successful
case studies with the pharmaceutical industry and
Food and Drug Administration (FDA) were used to illustrate
the benefits to the industry in terms of reducing
development time, ensuring rapid scale up into manufacture
and maintaining in-spec product with reduced risk
of regulatory non compliance.
A number of pharmaceutical companies
are now actively using terahertz to address issues
in solid dosage form development, scale up and QA
in manufacture.
Applications include a recently
published article by the FDA which shows how the
measurement of coating thickness and uniformity can
be used to understand and potentially predict wet
dissolution, an indicator of drug release and performance.
In another published study
with pharmaceutical collaborators at the Universities
of Dusseldorf and Otaga, scientists have demonstrated
how terahertz can be used to gain process understanding
and streamline the scale up process from small
to large batches of tablets. In
particular, these studies have also demonstrated
the ability of terahertz to measure the density of
a coating and how this changes across a tablet surface
as the process parameters are altered during scale-up.
Density is a key factor in determining product performance,
and terahertz is a unique and non-destructive means
of rapidly measuring this parameter.
At recent conferences including
the Heidelberg PAT Conference ‘07 in October,
both the FDA and customers such as GlaxoSmithKline
and Pfizer have discussed how they have deployed
Terahertz solutions to evaluate and establish the
correct process parameters for defining the integrity
of tablet cores during scale up, as well as address
coating integrity issues.
Other case studies with industry
leaders looked at the effect of changing spray rate
on film coating performance, formulation effects
on the adhesion between the layer of a bi- layer
tablet and the very early stages of the gel layer
in a modified release, hypromellose, matrix tablet.
A summary of these studies is
available from helen.thurley@teraview.com
TeraView uses its proprietary
platform and know-how to provide customers in the
pharmaceutical industry with solutions to their needs
in product development, scale up and quality assurance
of solid dosage forms.
For more information about
TeraView terahertz pulsed imaging solutions please
visit www.teraview.com/products or enquiries@teraview.com
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 using 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.
-ends-
Maireadh Pedersen
VP Business Development, pharmaceuticals
TeraView Ltd
Tel: +44 1223 435380
maireadh.pedersen@teraview.com
Helen Thurley
Marketing and Communications
TeraView Ltd
Tel: +44 1223 435584
helen.thurley@teraview.com
|
