Erkennung und Vermeidung von Arzneimittelfälschungen durch Verwendung adäquater Wirk- und Hilfsstoffe
Ulrike Holzgrabe
Pharmazie, Universität Würzburg
Corresponding author: Prof. Dr. Ulrike Holzgrabe, Vorsitzende der Arbeitsgruppe „Arzneimittelsicherheit/Arzneimittelfälschungen“ der Deutschen Pharmazeutischen Gesellschaft, Institut für Pharmazie und Lebensmittelchemie, Universität Würzburg, Am Hubland, 97074 Würzburg (Germany), Fax 09 31 8 88 54 94, e-mail: u.holzgrabe@pharmazie.uni-wuerzburg.de
Detection and Avoidance of Counterfeited Drugs through the Use of Adequate Active Substances and Ingredients
For the last years the number of cases of counterfeit drugs is substantially increasing. Beside the classical categories of counterfeits, being fake packaging, wrong or no active pharmaceutical ingredient (API) or the wrong amount of API, a fifth category occurred recently, i. e. APIs of low quality. The contaminated heparin which has lead to deaths in the United States is a representative case and will not be the last one. The fact that 80 % of the APIs are produced in China and India will foster this development. Thus, methods orthogonal to the pharmacopoeia methods, such as NMR-, Raman, and near-infrared spectroscopy as well as powder X-ray-diffractometry, should be additionally applied to ensure the identity and quality of the APIs.
Key words Arzneimittelfälschungen • NIH-Spektroskopie • NMR-Spektroskopie • Pulverdiffraktrometrie • Raman-Spektroskopie • Wirkstoffe minderer Qualität |
