Identification of counterfeit pharmaceuticals using the ramanstation 400
Identification of CounterfeitPharmaceuticals Using the
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• Re-packaged, out-of-date but genuine pharmaceuticals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
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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
analyzing repackaged, out-of-date product.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.
Comparison of Raman spectra of ink on outer cardboard pack-
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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