WuXi and TruTag complete tests on an edible on-dose authentication solution for pharmaceuticals

Covert, edible technology can be used to manage the pharmaceutical supply chain, prevent counterfeiting and provide product informatics

WuXi PharmaTech and TruTag Technologies have announced the successful completion of tests on TruTag's on-dose authentication solution.

TruTags offer a unique solution for drug manufacturers, allowing a drug to be digitally scanned to confirm its authenticity and provide provenance information such as manufacturing location, dosage, packaging images, expiration date, supply chain data and lot or batch number.

TruTags offer a number of benefits, including

• TruTags can be applied to qualifying solid oral dosage form (SODF) products using a consistent, repeatable process
• no new manufacturing equipment or processes are needed
• after application, TruTags can be detected using TruTag's proprietary optical detection device
• apart from this detection process, TruTags are covert, not visually identifiable and remain with the tablet for its entire lifecycle
• once applied, the TruTag solution did not affect the stability or dissolution properties of APIs during accelerated open and closed bottle testing
• implementing the TruTag solution on existing drugs requires minimal regulatory reporting changes and complies with the physical-chemical identifier (PCID) guidance issued by the US FDA in 2011.

‘We are very excited about these results,’ said Dr Ge Li, Chairman and CEO of WuXi PharmaTech. ‘At WuXi, we are always looking for cutting-edge solutions such as TruTags to support the development and protection of our customers' innovative products.’

Kent Mansfield, President of TruTag Technologies, commented: ‘We are excited to confirm these results in tests conducted with 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.’

Hank Wuh, MD, MPH, TruTag Technologies' Founder and Chairman, added: ‘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, at the same time, have a fundamental impact on big data.’

Companies

• WuXi AppTec (Shanghai) Co