Researchers from the University of Leeds and Bede, a non-destructive X-ray metrology systems manufacturer out of Durham, UK, have been working on a technology to examine the crystalline structure of drugs during production. The technology promises to speed up the development of new drugs, and may lead to higher quality control of manufactured pharmaceuticals.
“If you were to use a pencil to write on glass you wouldn’t get very far, but use a diamond and you could write your name. Yet both are pure forms of carbon. It’s the same with different solid forms of the same drug; they can have completely different properties,” says Dr Robert Hammond of the University’s Faculty of Engineering, who leads the research team.
“Drug molecules are becoming increasingly complex and the challenges involved in processing them means that it is not always possible to successfully produce the desired form reliably. That’s why there’s such enormous potential for our system. We’re now able to look at crystals as they are forming in a reactor, something that has never been done before.”
The new technology identifies and monitors changes in crystal structures on-line, providing a method of ensuring production of the desired drug compounds. The bespoke system has been developed by engineers at the University of Leeds in collaboration with Bede X-Ray Metrology as part of the EPSRC funded Chemicals Behaving Badly programme.
Called polymorphism, changes in crystal structure during processing can lead to huge delays in bringing drugs to market, costing drug companies many millions of pounds. It can also lead to challenges to intellectual property protection. There have been a number of high profile cases where patents have been challenged by companies making an established formulation using a different polymorph.
Full story: Crystal clear savings for drug giants…
Abstract: An Examination of the Kinetics of the Solution-Mediated Polymorphic Phase Transformation between α- and β-Forms of L-Glutamic Acid as Determined Using Online Powder X-ray Diffraction
(hat tip: The Engineer)