A non-destructive method of carrying out a series of tests on solid dosage forms, developed by UK firm Teraview, can be carried out in real time on the production line and could be used in continuous processing systems, according to a new study.
Teraview, which is headquartered in Cambridge, UK, and was a spin off from the Toshiba Cambridge Research Laboratory in April 2001, developed its online system based on its terahertz technology to carry out high speed measurements of the thickness of the coating of tablets, and recently won an important endorsement from the US Food and Drug Administration.
Pharmaceutical companies are forever striving to increase their quality. In the production of tablets quality checks are carried out routinely during the process and batches are closely inspected and sampled against any problems. This can be quite an intensive process but it is still absolutely essential to maintain the expected quality standards.
Teraview's system can also be used to measure other characteristics of the tablet such as core density, or delamination (other studies published in conjunction with the FDA have suggested that terahertz systems could replace wet dissolution testing).
Now, Teraview in conjunction with its partners have carried out "successful proof of principle for high speed measurements of coating thickness on tablets applicable to on-line tablet inspection".
Dr Don Arnone, chief executive of TeraView, commented: "This study is exciting news for our pharmaceutical customers. It enables us to provide Terahertz solutions to address their business issues from early stage product development all the way through to assuring product performance during manufacture. It is also good news for the company because it has the potential to expand our footprint in the pharmaceutical manufacturing market in the future."
So how does it work?
The terahertz system works by using a series of spectroscopic sensors operating in the terahertz spectrum of electromagnetic radiation that is between visible light and radio waves. The sensors have proven that they can be used to measure both quickly and accurately the coating thickness of tablets that are in rapid motion in a coating vessel.
This leads to the next stage where the terahertz sensors could be used to control the tablet coating/production process using simple feedback systems. Clearly it would be useful to have accurate and rapid sensors to control continuous processing systems.
The pharmaceutical industry is becoming interested in continuous processing as has been seen recently with the Massachusetts Institute of Technology (MIT)/Novartis link up worth $65 million to MIT to develop a continuous manufacturing pharmaceutical facility (announced in September 2007).
Teraview has already shown in numerous studies with the FDA and several large pharmaceutical companies that the terahertz system can provide structural and chemical information on the tablet and capsule contents that cannot be attained by commonly used techniques. The technology appears now to be maturing to a state where it can be widely adopted.