Real Time In-line Measurement of Tablet Coating Thickness Variability Within a Coating Pan
TeraView, along with its partners Oystar Manesty, Liverpool University and Cambridge University have successfully demonstrated the ability to measure in-line the coating thickness distribution on a batch of tablets within a production scale coating pan in real time.
TeraView’s proprietary terahertz sensor technology is rapid and can measure multiple coatings and layers. The measurements require no calibration and are made on individual tablets, enabling tablet to tablet and batch to batch variability to be assessed. Existing techniques, such as NIR spectroscopy, require calibrating prior to each and every process, formulation or product change. Rather than providing a measurement of single tablets they measure multiple tablets and hence are unable to look at tablet-to-tablet variability within the batch during the process.
Knowing and managing thickness variability is a key quality attribute for products whose coating thickness is directly related to their performance (e.g. controlled release products). Accessing quality based on the average thickness alone can lead to tablets being out of specification or excessively coated.
The TeraView system is unique in its ability to measure this variability in-line. The flexibility and speed of the system make it ideal for use in process development, scale up, technology transfers and manufacturing. The unit also complements TeraView’s existing off-line tablet imaging system, the TPI imaga 2000.
The TPI imaga 2000 was developed specifically to study coating variability within individual tablets and between tablets off-line and as such is perfect for product design. The new system allows for the measurement, and ultimately the control, of thecoatings in-line.
“We are very excited about the team’s achievements” said Dr Don Arnone, TeraView’s Chief Executive Officer. ” It is well documented that not all tablets in a batch are of the same quality, and this now offers a quick and easy way of measuring and ultimately controlling this variability. It builds on the considerable body of work to date with our existing pharma customers and with the FDA”.
Note for editors
The above project has been supported by the UK Technology Strategy Board (TSB). Previous studies reviewing TeraView’s know-how and applications expertise, including the FDA’s “Delayed Release Tablet Dissolution Related To Coating Thickness By Terahertz Pulsed Image Mapping” have been published in the Journal of Pharmaceutical Sciences and other leading pharmaceutical and scientific journals.
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. TeraView currently works closely with blue chip customers in the pharmaceutical and other industries who are exploring the use of terahertz in product and process development and quality control of finished product in manufacturing.
TeraView is the world’s first company devoted to the application of Terahertz 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, defense 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.
About OYSTAR Manesty
OYSTAR Manesty has been supplying innovative tablet manufacturing and coating equipment to the international pharmaceutical industry for over 80 years. Designed to the highest standards and based on state-of-the-art technology, its equipment enables customers to manufacture high-quality products. Headquartered in Knowsley near Liverpool in the U.K., the company operates internationally and is one of the world’s leading providers of pharmaceutical equipment in its field.
About Cambridge University Department of Chemical Engineering
The terahertz applications group at the Department of Chemical Engineering and Biotechnology at the University of Cambridge (www.ceb.cam.ac.uk/) is one of the leading academic groups in the development of novel terahertz applications in the pharmaceutical and materials sector. It has extensive expertise in terahertz spectroscopy and imaging and is closely networked within the pharmaceutical research community through the Pharmaceutical Solid State Research Cluster (www.pssrc.org).
About Liverpool University
The University of Liverpool is a member of the Russell Group of leading research-intensive institutions in the UK. It attracts collaborative and contract research commissions from a wide range of national and international organisations valued at more than £93 million annually.