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Product Roundup: Mission Possible

PharmaManufacturing.com

The deadly business of drug counterfeiting is growing, but so are the options available to prevent and fight it.

No drug or pharmaceutical intermediate manufacturer today, anywhere in the world, is safe from the threat of counterfeiting. As recent events have shown, the threat affects not only finished pharmaceuticals but active ingredients and even pharmaceutical excipients.

In 2006, the documented cases of counterfeiting reported through the Pharmaceutical Security Institute (PSI) increased by 22%, according to Henk de Jong of Servier, who presented data at an April meeting of the International Pharmaceutical Excipients Council (IPEC). “If we lose trust in our pharmaceutical manufacturing and distribution chain, from the source of raw materials to the patients, then our whole system runs the risk of being undermined,” said de Jong.

However, he noted that prosecution efforts have intensified, with arrests for making counterfeits increasing 63% in 2006, and arrests for transporting fake drugs up 89%. As more drug companies develop anticounterfeiting strategies, they are also building portfolios based on a mix of imaging, coding, overt and covert security technologies. Here’s a very partial sampling of some of the latest anticounterfeiting technologies, of all types, that are now available.

Imaging

Real-Time Verification
The RxSpec 700Z is a tool that fits the FDA’s call for applying new technologies to distinguish legitimate drugs from counterfeits.
ASD, Inc., Boulder, Colo., www.asdi.com

Portable NIR Addresses Need for Speed
The 4-lb. Phazir RX offers a portable NIR solution allowing use of batteries that offer over 10 hours of operating life between charges. The devices allow analysis to be completed in 1-2 seconds and offer both qualitative and quantitative material analysis, including both identification and concentration level measurements. Polychromix, Inc., Wilmington, Mass., www.polychromix.com

Portable Convenience
TruScan is a handheld instrument which enables fieldbased identification of counterfeit pharmaceuticals. Already used worldwide for inspection of raw materials, this technology can instantly confirm or deny the identity of a given compound, even through blister packs or sealed bottles. Using Raman spectroscopy, TruScan can analyze and provide a highly accurate assessment of the validity of a pharmaceutical agent, even distinguishing between different polymorphs or generic versions of a drug. Ahura Scientific, Wilmington, Mass., www.ahurascientific.com

Simplified Sampling for Portable NIR
This manufacturer has worked with China’s SFDA to provide instrumentation for checking counterfeits. Offering a range of NIR, Raman, and NMR analyzers, the company recently introduced Mobile IR, a portable FT-IR spectrometer that can be used for both organic and inorganic materials.
Bruker Optics, Billerica, Mass., www.brukeroptics.com

Speedy Raman
SWIFT, short for Scanning With Incredibly Fast Times, enables per pixel measurement times as fast as 7ms. A 50,000 spectrum image can be obtained in six minutes. Horiba Jobin Yvon, Edison, N.J., www.jobinyvon.com

NIR, from Spectroscopy to Imaging
Chemical imaging combines traditional infrared spectroscopy with microscopic and macroscopic imaging capabilities, providing spatial and spectral information in a single measurement.
Malvern Instruments, Worcestershire, www.malvern.com

Covert

Covering All Bases
Guardmark was designed to provide the essential three levels of security: A covert recognizable image that can be magnified, encrypted data, and covert security measures. It is said to offer ultra high resolution images and optically varying effects, but it can also offer a multicolor digital signature and can be verified visually or by machine vision systems.
DataLase, Norcross, Ga., www.datalase.com

ROI within a year
Anchored by NanoInk’s NanoEncryption technology, NanoGuardian enables manufacturers to track, trace and authenticate the integrity of their products across the supply chain. Designed to work on the unit-dose level, nanoencryption is a layered pharmaceutical brand protection solution based on proprietary nanolithographic encryption technology. It incorporates semi-overt, covert and nanoscale forensic features. Authentication testing takes within 24-48 hours and is nondestructive. The encryption technology on each tablet is linked, directly, to batch-specific data, including serial number, manufacturing date, location and supply chain ship-to locations.
NanoInk, Chicago, Ill., www.nanoink.net

Bullish on RFID
Working with TAP Pharmaceuticals and Mayo Clinic, this manufacturer has expanded its pharmaceutical collaboration for track and trace systems based on RFID. Its platform uses an encrypted digital signature combined with a unique identifier at the manufacturing site to establish product authenticity, and that combination is decrypted and read at the dispensing site to validate authenticity.