Recent FDA study suggests that Terahertz tablet imaging could replace wet dissolution testing

Terahertz imaging and spectroscopy products from TeraView, the pioneer and leader in Terahertz technology and solutions for the pharmaceutical and life science industries, 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.”

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.

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.”