ARmark Partners With Colorcon

ARmark Authentication Technologies (ARmark) and Colorcon have entered into an alliance in the development and introduction of ®mark On-Dose ID, an authentication technology that incorporates microscopic covert micro-tags into the immediate-release film coatings of solid oral dosage 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. The two companies collaborated to develop ®mark On-Dose ID.

The company added that 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.

The company said that ®mark covert marker technology has been available for more than two years in other markets, but the recent draft guidance issued by the FDA regarding the use of physical chemical identifiers (PCIDs) defines how the commercial utilisation of micro-tag technology can be used for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 to the FDA’s guidance document, 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.

Jeff Robertson, director and general manager of ARmark, said: “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. That means drug manufacturers can quickly begin using the On-Dose ID technology to protect their product without prior approval from the FDA.”

Kamlesh Oza, general manager of film coatings at Colorcon, said: “Colorcon’s studies have shown 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. This approach is in compliance to the FDA’s guidance, enabling pharmaceutical companies to provide patients with safe security augmentation. As companies adopt this anticounterfeiting technology to quickly secure their brands, our studies will help them note the addition of micro-tags in their annual reports as required by the FDA.”