A similar closed-loop system securely generates a unique alphanumeric code for each item so consumers can verify its authenticity by texting it or typing it in on a website. A consumer registering a code for the first time will receive confirmation by a return text message, but if the code has already been registered or is not recorded in the database, an instant text message delivers a warning. The manufacturer also can send product or promotional information, reminders to take a dose, or alerts about product changes. As well as being suitable for use wherever cell service is available, the multilingual system automatically adjusts the language and message content according to the message received (Pro-tex, Chesapeake).

Not all smartphone-based product authentication methods rely on alphanumeric codes or barcodes. Another option involves printing or molding microdots on a product or package, capturing an image of the random pattern, and then storing it in a database. When it's time to authenticate the product, the consumer scans the pattern with his or her smartphone, transmits the image, and receives confirmation seconds later (Cryptoglyph pattern, Fingerprint technology, and remote verification processes, AlpVision).

The fingerprint concept also is used for a security label that combines labelstock with copper threads and a 2D barcode. A free mobile software application specifically developed for this technology enables end users to confirm authenticity without a network connection. As a result, authentication can be done for free anywhere in the world.

When the label is scanned to confirm authenticity, the software immediately detects whether the content of the code matches the pattern of the neighboring copper threads. The application also displays the corresponding brand, the product name, and the size of the packaging. It can supply additional product-specific information as well. For example, the expiration date or batch number can be integrated into the code and accessed in parallel to the authenticity check. If desired, weblinks also can be delivered to give consumers access to product or manufacturer websites.

A quota system prevents misuse and simplifies label reconciliation counts by specifying in advance how many items can be labeled at a time and what product information can be encoded. The quota is specified through a secure Internet connection and can be redefined quickly and easily each day.

Covert protection

Other anticounterfeiting methods currently capturing attention incorporate tiny identifiers into the package, label, or the product itself. Some of these covert tools rely on smartphone scanning, while others require devices such as portable magnifiers.

One nanotechnology-based covert solution randomly distributes micro- and nanoparticles in a material to create machine-readable fingerprints. A proprietary, handheld scanning device scans the fingerprint and instantly communicates the encrypted information to a secure server through mobility platforms such as GPRS, 3G, or Broadband, which returns a complete authentication report to a cell phone or computer (nonClonableID, Bilcare Technologies).

A pill-level solution blends microtags into immediate-release film coatings for solid dosage forms. The customized microtags can hold significant amounts of brand-owner-specific, encrypted information, such as lot and batch numbers, logos, and other text, patterns, shapes, and symbols in a particle smaller than the diameter of a human hair. Invisible to the naked eye, the microtags are readily detectable with portable magnifiers.

The microtags consist of materials generally regarded as safe or from FDA's Inactive Ingredients Database. They have no effect on dissolution or stability and integrate seamlessly into the coating process. As a result, adding the microtags to an existing coating is considered a Level I annual reportable change under the scale-up and postapproval changes guidance. Drug manufacturers can adopt the technology without prior approval from FDA (mark On-Dose ID covert marker technology and vision Optical Viewing systems, ARmark Authentication Technologies, and coatings, Colorcon).

Michigan State University fights counterfeiting

A multidisciplinary program at Michigan State University (MSU) performs research to counter counterfeiting. MSU’s Anti-Counterfeiting and Product Protection Program (A-CAPPP) ranks as the first academic body to focus its attention on this global problem. A Counterfeit Incident Database, one of the group’s first research projects, will support much of its work developing counterstrategies. Composed of scholars of consumer behavior, packaging, criminal justice, supply-chain management, international business, forensic sciences, engineering, food safety, public health, intellectual-property-rights law, standards, and risk communication, A-CAPPP also organizes outreach activities, such as webinars and seminars. In addition, A-CAPPP publishes background papers, such as “Pharmaceutical Counterfeiting in the US: Differentiating Dimensions of Risk.”

Hallie Forcinio is Pharmaceutical Technology's Packaging Forum editor, 4708 Morningside Drive, Cleveland, OH 44109, tel. 216.351.5824, fax 216.351.5684, editorhal@cs.com
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References

1. MarketsandMarkets, Global Anti Counterfeit Market for Food and Pharmaceuticals report, (MarketsandMarkets, Dallas, TX, 2011).

2. IMS Research, Mobile Handset Market Intelligence Service & Database (IMS Research, Austin, TX, 2011)

3. W. Llewellyn, Packaging Digest (2011), http://www.packagingdigest.com/article/518765-New_technology_aids_fight_against_counterfeiters.php accessed Aug. 11, 2011.