Tamper-proof tablets for distinction between counterfeit and originator drugs through PEG coding

Eur J Pharm Biopharm. 2016 Feb;99:1-6.

Ilko D¹, Steiger C¹, Keller R², Holzgrabe U³, Meinel L¹.

[expand title=”Show Affiliations”]

¹Institute for Pharmacy and Food Chemistry, University of Wuerzburg, Am Hubland, DE-97074 Wuerzburg, Germany.

²Kliniken der Stadt Köln, Zentrallabor, Ostheimerstr. 200, 51109 Köln, Germany.

³Institute for Pharmacy and Food Chemistry, University of Wuerzburg, Am Hubland, DE-97074 Wuerzburg, Germany. Electronic address: [email protected].

[/expand]

 

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.

Go To Eur J Pharm Biopharm