title: Tamper-proof tablets for distinction between counterfeit and originator drugs through PEG coding.
abstract: Counterfeit drugs are a major threat to public health. Current efforts focus on serialization of the secondary packaging which do not allow to trace the individual unit. As a proof of concept, we intended to mark each tablet for its unambiguous recognition. Spiking monodisperse PEGs into tablet coating solutions at concentrations as low as 3 ppm was instrumental to "write" a code into each tablet film which was readily read upon isolation and LC-MS/MS analysis. Different qualities and amounts of monodisperse polyethylene glycols can be used for coding solid drug products. The approach is limited to cases in which PEGs are not present for formulation purposes as excipients, as coding against this background was unfeasible.
authors.affiliation: Institute for Pharmacy and Food Chemistry, University of Wuerzburg, Am Hubland, DE-97074 Wuerzburg, Germany.
authors.forename: David
authors.initials: D
authors.lastname: Ilko
authors.affiliation: Institute for Pharmacy and Food Chemistry, University of Wuerzburg, Am Hubland, DE-97074 Wuerzburg, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Steiger
authors.affiliation: Kliniken der Stadt Köln, Zentrallabor, Ostheimerstr. 200, 51109 Köln, Germany.
authors.forename: Rupprecht
authors.initials: R
authors.lastname: Keller
authors.affiliation: Institute for Pharmacy and Food Chemistry, University of Wuerzburg, Am Hubland, DE-97074 Wuerzburg, Germany. Electronic address: ulrike.holzgrabe@uni-wuerzburg.de.
authors.forename: Ulrike
authors.initials: U
authors.lastname: Holzgrabe
authors.affiliation: Institute for Pharmacy and Food Chemistry, University of Wuerzburg, Am Hubland, DE-97074 Wuerzburg, Germany.
authors.forename: Lorenz
authors.initials: L
authors.lastname: Meinel
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods*; D058110:Counterfeit Drugs / Q000032:analysis* / Q000737:chemistry; D011092:Polyethylene Glycols / Q000032:analysis* / Q000737:chemistry / Q000592:standards; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods; D013607:Tablets / Q000032:analysis* / Q000737:chemistry / Q000592:standards; D053719:Tandem Mass Spectrometry / Q000379:methods
chemical_list: D058110:Counterfeit Drugs; D013607:Tablets; D011092:Polyethylene Glycols
keywords: Coating; Counterfeiting; Mass spectrometry; Polyethylene glycol; Tablet