ARmark Authentication Technologies, LLC, and Colorcon, Inc. has announced an alliance in the development and introduction of ®mark® On-Dose ID(tm), an authentication technology that incorporates microscopic covert micro-tags into the immediate-release film coatings of solid oral dose forms (SODFs) to prevent counterfeiting. The alliance provides Colorcon exclusive rights to market ARmark's micro-tags for tablet film coatings and to market this technology to pharmaceutical manufacturers globally.
By leveraging the tablet coating expertise of Colorcon, a world leader in the manufacture and development of specialized film coatings, and ARmark's customized micro-tag authentication technology, the two companies collaborated to develop ®mark® On-Dose ID. The micro-tags are seamlessly integrated into existing tablet film coating processes without additional manufacturing steps or capital investments. By incorporating the micro-tags directly into a tablet's film coating, drug manufacturers achieve reliable placement on each and every tablet.
The customized micro-tags can hold significant amounts of brand-owner specific, encrypted information such as lot and batch ID numbers, logos and other text, patterns, shapes and symbols, in a particle the size of 75-110 microns, a space smaller than the diameter of a human hair. Nearly impossible to replicate or reverse engineer, the markers are compatible with other covert or overt identification technologies and can also be incorporated as part of labels, bottles, paper and blister packaging.
"The availability of this authentication technology is significant to drug manufacturers because adding ®mark micro-tags to an existing immediate release film coated tablet can now be considered to be a SUPAC Level 1 annual reportable change," states Jeff Robertson, Director and General Manager at ARmark Authentication Technologies, LLC. "That means drug manufacturers can quickly begin using the On-Dose ID technology to protect their product without prior approval from the FDA."
The covert marker technology has been available for more than two years in other markets, but the recent draft guidance issued by the Food and Drug Administration (FDA) regarding the use of physical chemical identifiers (PCIDs) defines how the commercial utilization of micro-tag technology can be used for on-dose authentication in the pharmaceutical industry.
The ®mark On-Dose ID micro-tags are invisible to the naked eye once they are incorporated into a tablet film coating, but are easily identified with ®vision® optical viewing systems. These portable tools authenticate products by magnifying the micro-tags at any stage following the tablet coating process. The ®vision system enables accurate, in-field detection within a matter of seconds without destroying the SODF sample.
