Chemical Confirmation - Pharmaceutical Technology

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Chemical Confirmation
Analytical detection techniques help combat counterfeit drugs.


Pharmaceutical Technology
Volume 35, Issue 8, pp. 48-50

Conclusion

Counterfeiters are hard at work finding ways to replicate, trick, mimic, and dodge each new technology that stands in their way. Drug companies must continue to fight back with constant vigilance and new security methods to protect the pharmaceutical supply.

"The rising number of counterfeit drugs reaching even legitimate distribution channels coupled with the increasing sophistication of these copies, means that reliable and advanced analytical detection is a key part of a drug manufacturer's overall strategy to combat this problem," Norman says.

Combining anticounterfeiting measures designed to prevent counterfeits from reaching consumers such as anti-tamper packaging and overt authentication features, a robust serialization system, and technologies that detect the presence of adulterated and substandard medicines, drug manufacturers can work to protect their supply chains, brands, and customers.

Alexis Pellek is the custom digital content manager for the pharmaceutical group of Advanstar Communications and is a regular contributor to Pharmaceutical Technology.

Reference

1. FDA, Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting (Rockville, MD, July 2009).

Detection of counterfeits in developing countries

One solution for detecting counterfeit pharmaceuticals in developing countries is the use of thin-layer chromatography (TLC) methods. The World Health Organization estimates that potentially more than 30% of pharmaceuticals in developing nations could be counterfeit. Portable TLC kits are economical, do not require extensive training for use, and allow for rapid screening of product in the field (1). An example of such a portable laboratory is the GPHF-Minilab, which was developed by the Global Pharma Health Fund (GPHF), a charitable organization funded by Merck KGaA.

Thomas P. Layloff, PhD, senior quality assurance advisor for the Supply Chain Management System, part of the President's Emergency Plan for AIDS Relief, explains the advantages of TLC in protecting consumers from counterfeit pharmaceuticals. "The use of TLC to determine whether the right drug is present in approximately the right amount is very widespread because of ease of application, sustainability, low cost and very minimal support infrastructure required. For example, more than 300 GPHF TLC-based Minilabs have been sold and put in use all over the world. The Minilab technology requires no laboratory facilities or electricity; detection is based on visual comparisons. Since the TLC plates are single use, there is no maintenance of the chromatographic media."

Other technologies, he says, are more expensive and require more training but are also more accurate. A limitation of TLC, for example, is that "cogeners of the parent drug cannot be discerned by the technology, but fortunately these types of counterfeit products are expensive to manufacture and they occur in the high-cost markets such as the United States," he says. "The TLC stands out for speed and cost but there is a tradeoff in the ability to detect sophisticated counterfeit products."

To read the full Q&A with Layloff, see the expanded version of this sidebar.

Source

1. J. Sherma, Acta Chromatographica, 19, 5–20 (2007).


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