title: Physical profiling and IR spectroscopy: simple and effective methods to discriminate between genuine and counterfeit samples of Viagra® and Cialis®.
abstract: Counterfeit medicines are a global threat to public health. High amounts enter the European market, enforcing the need for simple techniques to help customs detect these pharmaceuticals. This study focused on physical profiling and IR spectroscopy to obtain a prime discrimination between genuine and illegal Viagra® and Cialis® medicines. Five post-tableting characteristics were explored: colour, mass, long length, short length, and thickness. Hypothesis testing showed that most illegal samples (between 60 and 100%) significantly differ from the genuine medicines, in particular for mass and long length. Classification and Regression Trees (CART) analysis resulted in a good discrimination between genuine and illegal medicines (98.93% correct classification rate for Viagra®, 99.42% for Cialis®). Moreover, CART confirmed the observation that mass and long length are the key physical characteristics which determine the observed discrimination. IR analysis was performed on tablets without blister and on tablets in intact blister. These data were analyzed using Soft Independent Modelling of Class Analogy (SIMCA) and Partial Least Squares - Discriminant Analysis (PLS-DA). Supervised techniques needed to be applied since Principal Component Analysis (PCA) was not able to generate the desired discrimination. Our study shows that a perfect discrimination between genuine and illegal medicines can be made by both SIMCA and PLS-DA without removing the tablets from the blister. This approach has the advantage of keeping the blister intact. Our study demonstrates that these user friendly techniques are reliable methods to aid customs to obtain a prime distinction between genuine and illegal samples on the spot. Copyright © 2015 John Wiley & Sons, Ltd.
authors.affiliation: Division of Food, Medicines and Consumer Safety, Section Medicinal Products, Scientific Institute of Public Health (WIV-ISP), J. Wytsmanstraat 14, B-1050, Brussels, Belgium.|Research Group NatuRA (Natural products and Food - Research and Analysis), Department of Pharmaceutical Sciences, University of Antwerp, Universiteitsplein 1, B-2610, Wilrijk, Belgium.
authors.forename: Deborah
authors.initials: D
authors.lastname: Custers
authors.affiliation: Division of Food, Medicines and Consumer Safety, Section Medicinal Products, Scientific Institute of Public Health (WIV-ISP), J. Wytsmanstraat 14, B-1050, Brussels, Belgium.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Vandemoortele
authors.affiliation: Division of Food, Medicines and Consumer Safety, Section Medicinal Products, Scientific Institute of Public Health (WIV-ISP), J. Wytsmanstraat 14, B-1050, Brussels, Belgium.
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Bothy
authors.affiliation: Division of Food, Medicines and Consumer Safety, Section Medicinal Products, Scientific Institute of Public Health (WIV-ISP), J. Wytsmanstraat 14, B-1050, Brussels, Belgium.
authors.forename: Jacques O
authors.initials: JO
authors.lastname: De Beer
authors.affiliation: Division of Food, Medicines and Consumer Safety, Section Medicinal Products, Scientific Institute of Public Health (WIV-ISP), J. Wytsmanstraat 14, B-1050, Brussels, Belgium.
authors.forename: Patricia
authors.initials: P
authors.lastname: Courselle
authors.affiliation: Research Group NatuRA (Natural products and Food - Research and Analysis), Department of Pharmaceutical Sciences, University of Antwerp, Universiteitsplein 1, B-2610, Wilrijk, Belgium.
authors.forename: Sandra
authors.initials: S
authors.lastname: Apers
authors.affiliation: Division of Food, Medicines and Consumer Safety, Section Medicinal Products, Scientific Institute of Public Health (WIV-ISP), J. Wytsmanstraat 14, B-1050, Brussels, Belgium.
authors.forename: Eric
authors.initials: E
authors.lastname: Deconinck
mesh_terms: D058110:Counterfeit Drugs / Q000032:analysis*; D004349:Drug Packaging; D016018:Least-Squares Analysis; D025341:Principal Component Analysis; D015203:Reproducibility of Results; D000068677:Sildenafil Citrate / Q000032:analysis*; D013055:Spectrophotometry, Infrared / Q000379:methods*; D013607:Tablets; D000068581:Tadalafil / Q000032:analysis*
chemical_list: D058110:Counterfeit Drugs; D013607:Tablets; D000068581:Tadalafil; D000068677:Sildenafil Citrate
keywords: Cialis®; IR spectroscopy; Viagra®; counterfeit medicines; physical profiling