ARmark Authentication Technologies, LLC and Colorcon, Inc. Announc...(d tablet can now be considered to be a S...),Health

Date:11/9/2009

d 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."

®mark® covert marker technology has been available for more than two years in other markets, but the recent draft guidance issued by the Food and Drug Administration (FDA) regarding the use of physical chemical identifiers (PCIDs) defines how the commercial utilization of micro-tag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. 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.

According to Dr. Kamlesh Oza, Colorcon's General Manager of Film Coatings, "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."

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 destroy
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SOURCE ARmark Authentication Technologies, LLC Copyright©2009 PR Newswire. All rights reserved

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