Colorcon partners with TruTag on pharma authentication

Colorcon has partnered with TruTag to use its silica microtags on tablets, adding to its stable of pharma authentication technologies.

Under the terms of the deal, Colorcon will be able to use TruTag’s edible “optical barcodes” in its tablet coatings, allowing individual pills to be verified using either a smartphone app or dedicated, proprietary reader.

Each silicon dioxide particle carries an optical signature that is manufactured into the microtags – without the use of additional additives or markers – and according to Colorcon can be used to “instantly and unequivocally authenticate products when suspect events occur.”

The technology can “specifically address the problems of counterfeiting, product diversion, returns monitoring, quality control and product recalls in pharmaceuticals and nutraceuticals,” it says.

Colorcon has signed a series of agreements with authentication technology providers to layer anti-counterfeit functions into its formulations business. The Trutag agreement follows a deal with Applied DNA Sciences last year which focused on the use of DNA markers in film coatings for tablets, as well as in inks ad colourants.

Colorcon has been evaluating ways to add an on-dose authentication technology to its portfolio that meets the requirements of the FDA’s physical-chemical identifier (PCID) guidance, which was published several years ago.

It previously signed an agreement with Adhesive Research (AR) unit ARmark for microtag technology has since fallen by the wayside.

Trutag has completed studies which show that its tags can be applied to solid oral dosage forms without any changes to the manufacturing process and are considered a GRAS (Generally Recognised as Safe) substance by the FDA, indicating they are safe for ingestion.

“On-dose authentication technology represents the next generation in pharmaceutical supply chain security by providing a powerful tool for tracking product from plant to patient,” said Kelly Boyer, general manager, film coatings, at Colorcon.

“By seamlessly enabling authentication, these digitised coatings confirm the quality and origin of medicines thereby safeguarding both patients and brands.”