Pharma manufacturers may turn to a new technology -- edible microtags -- as way to help manufacturers root out counterfeit drugs and protect patients.
The technology from TruTag allows silicon dioxide tags to be added to coatings or ingredients and used as a forensic marker to be read and verified by authorized security or quality assurance personnel.
“Our microtags are manufactured via a proprietary electrochemical encoding process starting with silicon wafers, similar to what is found in the semiconductor industry, and converting them into nano-porous micro particles of silicon dioxide,” TruTag COO Peter Wong told In-Pharmatechnologist.com. “Silicon dioxide has been affirmed as GRAS (generally recognized as safe) by the FDA and has been used as an excipient in food and drugs for decades.”
In fact, the FDA’s physical-chemical identifier guidance for anti-counterfeiting measures from 2011 makes a reference to the technology.
Each product, dosage type, manufacturing plant, or lot/batch number can be separately coded with a unique ID.
In terms of how pharma manufacturers and suppliers might be able to add the tags to their products, Wong explained that they “can be easily added to the coating mix of a table, which is then sprayed onto pill cores via industry standard pan coaters.”
“There is no change required to the tablet manufacturing equipment or the SOP, other than the added pinch of microtags to the coating mix. For forensic applications, microtags can be similarly added to the ingredients of the pill core or the capsule fill material for later recovery and verification,” Wong said.
Pharma regulators in Africa and southeast Asia may turn to TruTag technology to help fight a growing counterfeit industry for anti-malarials and HIV drugs
But Wong cautioned, “Those products are often shipped in bulk or are separated from original packaging prior to distribution, thus rendering the packaging tracking/security measures obsolete.”
TruTag may have to compete with other companies developing RFID (radio frequency identification) technologies to stem the spread of counterfeits.
One Chinese company patented an RFID electronic tag as a drug information carrier and key management system provided by PKI (public key infrastructure) to encrypt and decrypt information in the tag for verifying the legitimacy of the RFID electronic tag so as to tell if a drug to which the RFID electronic tag attaches is true or fake.