Back in 2014, China-based WuXi and TruTags joined up to pilot test the edible tags, which can allow for a digital scan of a drug to confirm its authenticity and reveal other information such as manufacturing location, dosage, images of packaging, expiration date, supply chain data, and lot or batch number.
The alliance also included an investment by the WuXi Venture Fund in TruTag.
The testing found that, among other things, the TruTags can be applied to solid oral dosages without the use of new manufacturing equipment and did not affect the stability or dissolution properties of APIs (active pharmaceutical ingredients) in completed accelerated open and closed bottle testing.
Kent Mansfield, President of TruTag Technologies, said, "We are excited to confirm these results in testing conducted with our partner WuXi PharmaTech... 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. 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."
The companies also noted that applying the silicon dioxide tags on existing drugs requires minimal regulatory reporting changes for drug manufacturers and complies with the physical-chemical identifier (PCID) guidance issued by the US FDA in 2011. TruTag COO Peter Wong previously told us that the tags can be added to the coating mix of the tablet, which can be sprayed onto the pill.
WuXi and TruTag will now begin further testing of TruTags on additional APIs. The companies will also detail the successes of their pilot in a white paper, detailing the results of the application method and practice, the detection process and data collection, and outcomes of dissolution and stability testing.
TruTag is also working with several multinational pharma companies in pilot testing for broad deployment of this technology in marketed solid oral dosage drugs and candidates.
"One can think of TruTags as a form of edible PIATS, or Product Identification Authentication Tracking System, which can be embedded into a product like unique fingerprints," said Hank Wuh, TruTag Technologies' Founder and Chairman. "With our ability to securely identify individual goods without labels or packaging, we aim to dramatically improve the safety and traceability of critical products such as food and medicine and in the process to have a fundamental impact on big data."