A recent US Food and Drug Administration study has shown that Cambridge-based TeraView’s Terahertz imaging system can be used in conjunction with wet dissolution testing to accelerate the product development time of tablets and capsules.
The study focussed on the drug Asacol, a treatment for ulcerative colitis and Crohn’s disease, which uses coatings that breakdown and release the drug in the lower intestinal tract. Release of the drug in the stomach and upper small intestine is undesirable, as this will lead to premature absorption and consequent drug wastage as well as possible side effects.
The tablets were found to dissolve in an erratic fashion during conventional wet dissolution measurements. TeraView’s terahertz imaging was used alongside dissolution to accurately map the coating thickness, and the mean dissolution times were found to correlate with the average tablet coating thickness, suggesting that the coating thickness played a significant role in product design and performance.
‘This study, published in the Journal of Pharmaceutical Sciences, demonstrates that Terahertz technology has a potential role to play alongside dissolution to measure the effectiveness of drugs during product development, as well as routine assessment of production quality to ensure uniformity between production lots,’ said Professor Sir Michael Pepper, chief scientific 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 the performance of a product, thereby minimising the risk of regulatory non compliance for the industry and more rapidly providing consumers with improved pharmaceutical products,’ added Dr Don Arnone, Terahertz’ chief executive officer.
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 using conventional techniques.
Terahertz light is unique in its ability to non-destructively image tablets. X-ray and infrared frequently lack sensitivity or penetration and cannot produce such images without first destroying the tablet.
TeraView is currently working closely with blue chip customers in the pharmaceuticals industry who are exploring the use of Terahertz in drug development and quality control in tablet manufacturing.