Getting Big Protection with Small Technologies

By Paul Thomas, Managing Editor

PharmaManufacturing.com

Keywords: pharmaceutical processing, pharmaceutical engineering, pharmaceutical manufacturing, product security, fda, rfid, nanotechnology, packaging, food and drug administration, supply chain, pharmaceuticals, stable isotopes, active pharmaceutical ingredients and pharmaceutical authentication

Covert nanotech measures are key to a multi-layered approach.

Editor's Note: To see FDA’s Moheb Nasr’s responses to Rittenburg’s questions surrounding the latest overt and covert security measures, click the "Download Now" button at the end of this article.

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While RFID gets all the hype, other product security technologies are providing more practical, cost-effective measures for manufacturers. Nanotechnology has tremendous potential as a covert and forensic foil to counterfeiters and diverters. One of the leading firms in this area is Authentix (Addison, Texas), formed in 2003 following a merger of Biocode, Calyx and Isotag.

Authentix uses quick and simple field testing to determine whether a drug has been counterfeited or adulterated.

Authentix offers a mixed bag of solutions, and works with pharmaceutical clients to tailor security programs to individual drugs and manufacturing processes. Most of the company’s technologies are applied to packaging, though some are added to the product itself. “We have applications out there where the markers are in tablets, capsules and APIs,” says Dr. Jim Rittenburg, VP for pharmaceuticals. “And they can also be on the coating or in the tablet itself. We have a client that’s marking the active ingredient that gets formulated into solid dosages.”

The markers do not impact product, Rittenburg adds. They consist of compounds on the FDA’s inactive ingredient list, and are used at trace levels. “Companies using the technologies will conduct accelerated stability testing, just to show that the inclusion of these markers has no impact on the active ingredient or their analytical methods,” Rittenburg says.

Among the company’s chief technologies:

• Quantum photonic markers. Primarily phosphors and specialized dye molecules, these markers can be added to inks and coatings and, when analyzed under certain lighting, provide a unique fingerprint for a product. They can be administered by inkjet and other commonly used printing methods.
  
  
• Mass differentiation markers. These markers involve modifying the molecular weight of compounds by creating stable isotopes, so the compounds can be detected within an ink formulation or coating — by lab analysts who know what they’re looking for. “It’s extremely difficult for anybody to detect or reverse engineer if they don’t know what compounds you’ve changed the molecular weight of,” says Rittenburg. “Knowing what we’ve done to the compound allows us to get a very clean chromatogram that shows whether or not that material is present. Another person would never see it, because it’s so far down in the noise. They would just see all the peaks from the other components present.”
  
  
• Molecular recognition technology. A molecular “lock and key” marker is inserted into the packaging or dosage form, and later can be recognized only by very specific receptor molecules and associated testing equipment.
  
  
• Color-changing inks. Colorless markers are incorporated into overt technologies such as holograms to provide layered security solutions. These colorless markers can be detected using special developing solutions which convert the markers from colorless to colored. Authentication can be quickly accomplished using simple handheld test pens.

The key consideration for clients is making implementation into current manufacturing and packaging lines simple, says Rittenburg. In one case, a manufacturer sends Authentix the ink that it uses for packaging. Security markers are added to the ink, which is then forwarded to the print house, which simply prints labels without altering its processes. In other cases, an additional print station might be needed for a manufacturer’s packaging line. “But product is still printed in the way it has always been,” Rittenburg notes.

Authentix is also partnering with Universal Solutions, Inc. (USI), a provider of supply chain services such as facilitating the return of expired product, package condition analysis, and recall management. USI's field force is now also being used to monitor and inspect products that carry Authentix technologies.

For more information, visit www.authentix.com.