US-based ARmark Authentication Technologies and Colorcon are to work together to develop a technology that adds microscopic covert micro-tags to the immediate-release film coatings of solid oral dosage forms (SODFs) to prevent counterfeiting.
Under the alliance, Colorcon of Harleysville, PA gains exclusive rights to ARmark's micro-tags for tablet film coatings and will market the "mark On-Dose ID" technology to pharmaceutical manufacturers.
ARmark of Glenrock, PA, says the micro-tags can be integrated into existing tablet film coating processes without additional manufacturing processes or investment. The technology also guarantees reliable placement on every tablet.
The micro-tags can be customised to hold brand owner 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.
According to ARmark the micro-tags are impossible to replicate or reverse engineer and are compatible with other covert or overt identification technologies. They 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 On-Dose micro-tags to an existing immediate release film coated tablet can now be considered to be a SUPAC Level 1 annual reportable change," said Jeff Robertson, director and general manager at ARmark Authentication Technologies. "This means drug manufacturers can quickly begin using the On-Dose ID technology to protect their product without prior approval from the Food and Drug Administration."
Recent draft guidance issued by the US FDA regarding the use of physical chemical identifiers (PCIDs) defines how the commercial utilisation of micro-tag technology can be used for on-dose authentication in the pharmaceutical industry.
In accordance with FDA guidance, ARmark manufactures the micro-tags from approved excipient materials generally regarded as safe (GRAS) or from the FDA's Inactive Ingredient Guide (IIG), under cGMP conditions.
"There is no impact on dissolution or stability when the mark On-Dose ID micro-tags are incorporated into an existing film-coated dosage form, an approach that complies with the FDA guidance," said Colorcon's general manager for film coatings, Dr Kamlesh Oza.
The micro-tags are invisible to the naked eye once they are incorporated into a tablet film coating, but are easily identified with optical viewing systems.