Scientists applied a new method for drugs quality control, purer medicines and a better health


Stressful lifestyle results in many cardio-vascular diseases that are nowadays among main causes of death. A way to overcome this problem is to study, design and produce the purest medications as possible in order to reduce their side effects.

Nevertheless, manufacturing of pure drugs is very expensive and methodologies are limited to prove effective purity indicating impurities of pharmaceuticals below the detecting limit. The team of scientists led by Aden Hodzic, scientific and technology transfer officer at CERIC-ERIC, has applied a novel way to better test and control the purity of medicines and their structure by simultaneously analyzing the thermal behavior, purity, and structural properties of active pharmaceutical ingredients (APIs).

SAXS heating scans spectra of pentoxifylline in the temperature range of 80 to 140°C: a SAXS heating scan, b) SAXS scattered intensity versus temperature. (SAXS exposure time one minute per frame, which corresponds to two°C per frame).

The international team of researchers combined both Small- and Wide-Angle X-ray Scattering (SWAXS) techniques with the Differential Scanning Calorimetry (DSC), with the goal to conduct API purity quality control of pentoxifylline, a synthetic drug used for the treatment of peripheral vascular diseases, the management of cerebrovascular insufficiency, sickle cell disease and diabetic neuropathy. SWAXS gives information about the structure of the analyzed material, i.e. API polymorphism, whereas DSC deals with thermodynamic and calorimetric properties indicating thermal drug transition, which gives again information about drug purity. The idea to combine these techniques in one single analytical tool for a simultaneous analysis of these aspects of the material has demonstrated to be very effective for ensuring a complete and reliable quality control of medicals before their commercialization. Indeed, a strict testing to ensure the absence of destructive impurities is highly relevant for any further pharmaceutical procedure. The effectiveness of the experimental method, highlighting both the thermodynamic and the structural changes of APIs related to purity when metabolized, will guarantee better medicines for us and for our health.

The research has been the result of a scientific collaboration between CERIC-ERIC, the Graz University of Technology, the Research Centre for Pharmaceutical Engineering, the Institute of Pharmaceutical Sciences at the University of Graz and the company GL-Pharma. SWAXS and DCS are available also in CERIC laboratories at the Austrian beamline installed at Elettra in Trieste, Italy.

Original article

A. Hodzic, M. Kriechbaum, S. Schrank, F. Reiter, Monitoring of Pentoxifylline Thermal Behavior by Novel Simultaneous Laboratory Small and Wide X-Ray Scattering (SWAXS) and Differential Scanning Calorimetry (DSC), published on PLOS One, Volume 11, Issue 7, July 2016, Article number e0159840

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