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The X-rays that make pharmaceuticals safer and more effective (Press review)

Trieste – Bresso, 13 April 2010 – Collaborative efforts between Sincrotrone Trieste S.C.p.A. and Zach - Zambon Chemicals S.p.A., a company of the Zambon group, have brought about a new system to improve the efficacy and safety of pharmaceuticals through the qualitative and quantitative control of active ingredients in the production and characterization process.

 

The solution was found by a team of researchers from Sincrotrone Trieste S.C.p.A. who put together a protocol of analysis that can highlight the crystal structure of the active ingredients in the various phases of preparation of a pharmaceutical, up until the completed product in pill form.
The method requires the use of a synchrotron, a machine that can produce X-rays and other extremely intense light beams (up to 10 billion times more intense than sunlight) to analyze materials and their properties.

The efficacy of a drug and the way it works depend not only on the chemical composition of its active ingredient, but also on its crystal structure, or the way its molecules are arranged. Two drugs with the same chemical composition but a different crystal structure can have different effects on the same patient, and be more or less efficient, or even harmful. It is thus necessary to carefully analyze the crystal structure of active ingredients in order to be able to rule out the presence of undesired crystals.

“Through the diffraction of the X-rays emitted by our synchrotron– explains research team leader Maurizio Polentarutti – we managed to reach extreme levels: we can detect crystal forms present in the sample in tiny quantities, as little as less than 50 parts per million, with a sensitivity that is a thousand times higher than that of traditional instruments”.
“The opportunity to perform such an in-depth molecular analysis on active ingredients – concludes Livius Cotarca, R&D director for Zach - Zambon Chemicals – allows us to obtain a unique digital footprint for the presence of crystal forms found in the drug, with important consequences in terms of the control of pharmaceutical production processes, the patenting of active ingredients, and anti-counterfeit procedures to guarantee the safety of products that are available on the market”.

Last Updated on Thursday, 08 March 2012 17:11