Update: Edible tags can authenticate pharma products

capsuleA pilot study has shown that edible, covert tags can be used to check whether tablets and capsules are genuine.

The study - conducted by TruTag Technologies and contract research and manufacturing company WuXi PharmaTech - showed that the tags can be applied to solid oral dosage forms without any changes to the manufacturing process.

Once added to the tablets, the tags are invisible but can be detected using a proprietary optical detection device, helping to prevent counterfeiting and diversion. TruTag and WuXi forged an alliance to bring the technology to pharma customers last year.

A spokesman for the company told that the tags "are pure silicon dioxide with embedded spectral data) which is considered a GRAS (Generally Recognised as Safe) substance by the FDA, and has been used for decades in pharma.

The tags can be unique at the dosage form or batch level," she added. "We can link the surface of each pill to provide information on the entire drug package insert using TruTags if so desired."

That means that in addition to authenticating the tablet or capsule, the tags can be linked to data such as manufacturing location, dosage, images of packaging, expiration date, supply chain data, and lot or batch number, for example.

Critically, the study revealed that adding the tags to the dosage form had no impact on the stability or solubility of the active pharmaceutical ingredient (API), the identity of which has not been disclosed. The API is apparently a common drug used in over-the-counter medicines) and will be revealed in a white paper due to be published later this year.

The researchers behind the work also intend to submit it for publication in a peer reviewed journal.

The pilot shows that the tags meet US FDA guidance finalised in 2011 on  physical-chemical identifiers (PCID), defined as a substance or combination of substances possessing a unique physical or chemical property that can be used to identify and authenticate a drug product or dosage.

The guidance encourages the use of PCIDs to allow dosage forms to be authenticated even if they have been separated from their packaging, as often occurs when opioid analgesics are diverted for misuse or when fake drugs are inserted into genuine packaging, for example.

TruTag said it is already working with several multinational pharmaceutical companies on additional pilot studies to investigate the use of the tags in solid oral dosage form products, and is carrying out additional studies involving a range of APIs.

"We have demonstrated the ability of our technology to integrate an edible and safe identification code directly into an oral solid drug, thereby indelibly marking the product with an internal code for its lifetime," commented TruTag's president Kent Mansfield.

"In the near term, this will allow drug manufacturers and distributors to have the ultimate audit of a drug's provenance and origin without reliance on packaging or laboratory chemical analysis," he added.

Other companies that have looked into this on-dose anti-counterfeiting approach include Authentix, Colorcon, Applied DNA Sciences, InfraTrac and now-defunct player NanoGuardian.

Image credit:
Shutterstock / anyaivanova

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