Applied DNA Sciences Inc. is partnering with Colorcon Inc. to develop an on-dose authentication solution. Applied DNA’s SigNature DNA molecular taggants, which have already been incorporated into inks and varnishes for use in package printing, are now being incorporated into Colorcon’s specialty excipients for film coating, inks, and color dispersions for use in pharmaceutical and nutraceutical solid oral dosage forms. Combined with Applied DNA's encrypted fluorescence technology, the molecular taggants when applied to packaging can be scanned optically under ultraviolet light, the company reports.
“In the world we are in, we have to think about packaging in a more molecular way,” says Bob Miglani, chief of business development at Applied DNA. “We have to think differently.”
In this solution, “the coating becomes the package and gives you the information,” he tells PMP News. “The ‘molecular bar code’ can tell you whether the tablet is authentic, where it came from, and where it should be going.”
Traditionally, it has been a challenge to secure a tablet without a physical or chemical component, Miglani says. “Not a lot of tablets have inks,” he says.
But a large portion do utilize film coatings, he says. “We did our feasibility studies with Colorcon’s Opadry film coating, which is a thin layer in a range of styles. It is easily dissolvable or can disintegrate, and different properties are available per pharma needs,” he says. “Now we can go to a company and say look, you’re buying it already, and now you can have the molecular tag integrated with it.”
The addition is seamless, he says. “Change is very difficult, and it’s a complex supply chain. We are trying to make it a seamless solution. Essentially, we are blending our taggant into their normal process, so there is greater than 99.999% coating, and less than 0.0001% taggant.”
When asked whether the same molecular tags could be used in all levels, such as in a blister material, on a package varnish, and on the tablet, Miglani says that it depends upon the business need. “We haven’t limited ourselves to thinking of just one code. Some users may want the tag to include the batch number and expiry date. And others may want such codes as backups.”
However, “there is a lot of repackaging done in the United States, so that would be an instance in which the same code on a tablet and package could be useful,” he added.
Applied DNA is continuing its development work, but it has already done several shelf-life studies, and “it’s years,” Miglani says. “In military and other apps in extreme temperatures, it can survive in conditions ranging from -40 degrees to 150 degrees Celsius, and it is still stable. We’re expecting it to perform the same in coatings.”
The company is currently preparing its Drug Master File now, and SigNature DNA molecular taggants are expected to be classified as a Type IV excipient. The technology has a “self-affirmed GRAS status, backed by a 3rd party GRAS review,” he adds.
To see how pharmaceutical products could be authenticated in the field by pharmacists, please see this video.