Increasingly, drugmakers and regulators view on-dose defenses as essential components of a multilevel anticounterfeiting strategy.
With some forms of pill-level identification, it's possible to nondestructively authenticate pills anywhere in the supply
chain even if no packaging is present.
Not all on-dose authentication tools involve PCIDs such as inks or taggants. One additive-free solution makes nano-scale changes
to the coating of the solid dosage form without changing its dissolution or other characteristics. The encryption machine
is designed to be mounted on the production line and also can mark vial caps. Three levels of protection include semiovert,
covert, and forensic.
For those who know what to look for, semiovert marks are visible to the naked eye. Covert marks are visible at the micrometer
level and can be customized per dose, per drug, or per manufacturer. They are read with a handheld loupe or 20× microscope.
The forensic level is a nanoscale code that can carry large amounts of data, including batch identification, manufacturing
date and location, distribution country, and the serialized information from two-dimensional or pedigree barcodes. Decoding
requires proprietary equipment and software because the codes are so small that 350 of them can fit in the width of a human
hair (NanoEncryption technology, NanoGuardian).
FDA approved one drugmaker's supplemental new drug application that relied on nanoscale technology. Its commercial debut should
occur before the end of 2009 or early in 2010. To further enhance the nanomarking technology's ability to provide an early
warning about counterfeit and diverted product, it can be coupled with a pharmacy auditing program that is expected to be
in commercial use in 2010 (analytical services, SDI, Plymouth Meeting, PA, for Closed-Loop Protection market monitoring program,
Another on-dose, additive-free anticounterfeiting tool relies on high-magnification imaging to capture a picture of each dose
as it is blister packed. This image is stored in a database and linked to the serialized code on the primary package. To authenticate
product, a proprietary algorithm compares regions of interest on the tablet with images in the database. When a match is found,
users can quickly locate its history by linking to a pedigree database (ISTARx image storage, tracking, and recognition in
AuthentiTrack suite of anticounterfeiting technologies and services, Pharmorx Security, Southborough, MA). The system also
can be configured to print a unique code on each blister cell.
A similar technology relies on the fact that each punch-die set used in a tablet press has a unique fingerprint and imprints
it on each pill. A photo of the punch-die surface is taken by an ordinary flat-bed scanner or digital camera and stored in
a database on a secure server. To authenticate a pill, an image of its surface is captured by a scanner or camera and compared
with the stored punch-die images. A match confirms product authenticity (Fingerprint technology, AlpVision, Vevey, Switzerland).
Another on-dose technology prints a unique 12-character alphanumeric code on each solid dosage form using foodgrade ink. The
web-based authentication process requires only about 60 s. The consumer simply keys in the code on a computer or cellular
phone (Serialization technology, Pharmorx). However, because coding an existing product would require stability testing and
the filing of an abbreviated new drug application, this technology may be best suited for new products, according to Steve
Wood, president and chief executive officer of Pharmorx, which also supplies taggant-equipped labels in conjunction with its
partner, MSO Group (Belfast).