WuXi PharmaTech Inc. and TruTag Technologies, Inc. announced results of joint testing of TruTag's on-dose authentication solution.
TruTags allow a digital scan of a drug to confirm its authenticity and reveal provenance information such as manufacturing location, dosage, images of packaging, expiration date, supply chain data, and lot or batch number. According to a press release, TruTags have a number of benefits for pharmaceutical manufacturers that were confirmed in this joint testing:
1) TruTags can be applied to qualifying solid oral dosage form (SODF) products using a consistent, repeatable process. No new manufacturing equipment and changes in manufacturing processes are needed.
2) After application on manufactured tablets, TruTags are successfully detected using TruTag's proprietary optical detection device.
3) Apart from this detection process, TruTags are covert and not visually identifiable and remain with the tablet for its entire life.
4) Once applied, the TruTag solution did not affect the stability or dissolution properties of API drugs in completed accelerated open and closed bottle testing.
5) Implementing the TruTag solution on existing drugs requires minimal regulatory reporting changes for drug manufacturers and complies with the physical-chemical identifier (PCID) guidance issued by the U.S. Food and Drug Administration in 2011.
WuXi and TruTag will now begin further testing of TruTags on additional API products. They will also produce a technical white paper for the industry detailing the results of the application method and practice, the detection process and data collection, and outcomes of dissolution and stability testing.
Read the full release