Identification of counterfeit pharmaceuticals using the ramanstation 400

Identification of CounterfeitPharmaceuticals Using the TION NOTE
In recent years there has been significant growth in the counterfeiting of clothing, computer games, music and alcohol. Since the early days of counterfeiting, organized crime has become heavily involved and the practice now There are three main types of counterfeit pharmaceuticals: • Re-packaged, out-of-date but genuine pharmaceuticals The result of pharmaceutical counterfeiting might be as subtleas the drug’s failure to cure a headache. However, if a counter-feit material is used to treat serious illness such as malaria orHIV/AIDS, the result could be fatal.
In the developed world, counterfeiting is mainly restricted to easily recognized products such as Viagra™ or Tylenol™. In the developing world however the practice of counterfeitingis widespread. The World Health Organization estimated the sales of counterfeit drugs to be worth up to $40 billion in 2006.1 w w w. p e r k i n e l m e r. c o m
Raman analysis of tablets and packaging
However, analysis of the tablets themselves is the mostdiscriminatory. In order to maximize profit, forgers will Raman spectroscopy is particularly suited to the analysis either forego the use of API in the product or use a cheap of counterfeit materials as it is non-destructive and can API such as aspirin or acetaminophen. More expert be used to assess both the authenticity of the packaging forgers might use the correct API, but have the incorrect blend of fillers (e.g. lactose) and lubricating agents (e.g.
It is often the case that the packaging is printed to look authentic but the inks used are seldom the same as on As can be seen in Figure 2, the genuine pharmaceutical the genuine product. Raman analysis of ink used in the tablet gives a spectrum of a complex blend of API and packaging can be a simple discriminator when identifying excipients while the counterfeit material shows a Raman counterfeit products. In Figure 1 the differences can spectrum consisting entirely of lactose and cellulose.
clearly be seen between the red ink from the authenticpackaging and the ink from an identical-looking counter-feit package. This technique is particularly useful if References
analyzing repackaged, out-of-date product. Analysis of 1. Katie Merx, “Can you tell which pills are fake?”, the polymers in blister packs can also be used to identify Detroit Free Press, July 26, 2006, and Judy Alta, “Counterfeit Drugs Seen as Growing Problem,” The United States Mission to the European Union,November 16, 2006.
Figure 1. Comparison of Raman spectra of ink on outer cardboard pack- Figure 2. Raman spectra of authentic (upper spectrum) and counterfeit aging of authentic (upper spectrm) and counterfeit (lower spectrum) (lower spectrum) tablets, analyzed on RamanStation 400.
pharmaceuticals, analyzed on RamanStation 400.
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