WuXi, TruTag Complete Edible Tag Testing for Solid Dosage Products
WuXi PharmaTech (Cayman) Inc. a contract research organization, and TruTag Technologies, Inc., developer of an edible security platform for pharmaceuticals, have completed joint testing of TruTag’s on-dose authentication solution. TruTags offer a mechanism that allows 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. WuXi and TruTag Technologies announced their alliance in 2014, including an investment by the WuXi Venture Fund in TruTag.
The company said that the testing revealed that the TruTag can be applied to oral, solid dosage form products and that no new manufacturing equipment or changes in manufacturing processes are required. After application on manufactured tablets, TruTags are detected using TruTag’s proprietary optical detection device. Apart from this detection process, TruTags are covert and not visually identifiable and remain with the tablet for its entire life. Once applied, the TruTag solution did not affect the stability or dissolution properties of drugs in completed accelerated open and closed bottle testing. The solution complies with the physical-chemical identifier guidance issued by the US Food and Drug Administration in 2011.
WuXi and TruTag will begin further testing of TruTags on additional active pharmaceutical ingredients. They will also produce a technical white paper for the industry to detail the results of the application method and practice, the detection process and data collection, and outcomes of dissolution and stability testing. TruTag is already working with several multinational pharmaceutical companies in pilot testing for broad deployment of this technology in marketed oral solid.
Source: WuXi PharmaTech