Chemical Confirmation

Analytical detection techniques help combat counterfeit drugs.
Aug 02, 2011
Volume 35, Issue 8

Pharmaceutical manufacturers can choose from a variety of anticounterfeiting technologies to deal with the ever-growing problem of counterfeit drugs in the supply chain. FDA and industry experts recommend a layered approach to protecting the integrity of the supply chain, which combines technologies for antitampering, serialization, and authentication (in the form of overt, covert, or forensic features) applied to the packaging or dosage form. Analytical detection methods can confirm the authenticity of a drug product by using technologies such as portable spectrometer-based readers that authenticate in the field, thin-layer chromatography kits that quickly verify the presence and amount of active pharmaceutical ingredient (API), or analytical laboratory screening services that offer extensive testing of packaging and finished dosage forms for counterfeits.

On-dose protection

TruTag Technologies in Honolulu developed an anticounterfeiting solution in the form of a covert silica microtag that is edible, economical, heat resistant, and can be mixed into a coating, dye, or ink. The microtag is encoded with a spectral pattern chosen from a library of up to a trillion unique patterns, Peter Wong, chief operating officer of TruTag Technologies, explains. "Therefore, our microtag is like a covert, 'edible barcode' and is as flexible a business tool as a traditional printed barcode," he says. The company's product was recently recognized as a promising new technology for anticounterfeiting by winning "Most Likely to Succeed" in the life sciences category at the Launch: Silicon Valley 2011 competition, an event focused on identifying emerging technology startups.

The microtags, which can be applied to a solid dosage form or to packaging components, are authenticated using a portable spectrometer-based optical reader. Wong says the company has received "quite a bit of interest" in applying the microtags to bulk API and are open to testing with an interested partner. TruTag's portable readers can confirm the authenticity of the product through a clear blister pack, so the product does not have to be destroyed. The microtags can also link to additional information stored in a manufacturer's database, such as e-Pedigree and track-and-trace systems.

Wong says that in the company's development work, the application of the microtags has been relatively straightforward. TruTag was able to combine small quantities of microtags with a tablet-coating mix, which was then sprayed onto solid oral dosage forms using standard industry pan coaters. Because silica (silicon dioxide) is a generally-recognized-as-safe (GRAS) material, says Wong, under the framework of FDA's draft guidance, Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting (1), the agency's filing process may be as simple as including the addition of TruTag microtags as an annual reportable change if the product already had silica as an ingredient, or require a CBE-30 supplement if silica is a new ingredient to the product.

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