Crystal monitoring could save manufacturers millions
crystal monitoring technology, according to research published in
Crystal Growth and Design.
Researchers at the University of Leeds have developed the technique which could assist the pharmaceutical industry in controlling crystal formation. A great number of pharmaceuticals are crystalline and changes to the structure can affect the safety and the efficiency of the product. Dr Robert Hammond, leader of the research team, said: "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." Undetected fluctuations in the system can alter the crystal structure, which is highly undesirable for pharmaceutical manufacturers. One consequence is that the drug may be delayed in coming to market, resulting in significant costs for the manufacturer. In addition polymorphism, different crystalline structures, has created conflicts over intellectual property in the past. Lupin was involved in a drawn out patent dispute with Abbott Laboratories and Astellas Pharma over the antibiotic cefdinir. Abbott claimed Lupin was marketing a crystalline version of cefindir, which was still under patent until 2011, a claim Lupin disputed. The case was eventually settled last year, with Lupin allowed to continue marketing the drug. It is desirable for companies to avoid cases such as this owing to the potential costs for parties on both sides. The researchers believe their technology could help prevent or resolve similar disputes. The system utilises powder X-ray diffraction, which monitors the crystal structure as the crystalline slurry passes through a temperature controlled flow cell. Further development is necessary before the commercialisation of the technique but the team is keen to push ahead. Hammond said: "There's enormous commercial potential for this technology, for example it could be developed to work at manufacturing plant scales and can be applied to speciality chemical industries as well. "We're interested in talking to pharmaceutical and speciality chemical companies that can help us drive this forward."
