According to the company, authentication technology like the SoteriaRx platform offers protect patients from counterfeit products. Additionally, the product enables pharmaceutical brands to guard their brand against damage to their reputation from a costly recall.
Counterfeit drugs pose a dangerous, expensive challenge to the pharmaceutical industry. The illicit drug supply industry holds an estimated value of $200b—about 2% of total industry revenue.
These inauthentic drugs also pose a serious threat to patients. The World Health Organization (WHO) estimates that 16% of counterfeit drugs contain the wrong ingredients, while 17% contain the wrong levels of active ingredients. Also, more than 30% of the counterfeit drugs discovered circulating in the market contain no active ingredients at all.
Counterfeit products frequently include toxic compounds, which can cause adverse health effects. According to a CNN report, between 100,000 and 1m people die each year from counterfeit drugs.
While brands and manufacturers incorporate traceability and security measures aimed at the packaging level, these may not be sufficient to block and detect fraud. This is a particular concern in low- and middle-income countries, where fraudulent medicines can comprise up to 70% of medications within their borders.
Kelly Boyer, general manager of film coatings for Colorcon, explains that the SoteriaRx provides a more integral way of tracking and tracing medicines to prove their authenticity.
“SoteriaRx on-dose authentication provides a powerful tool for tracking medicines from plant to patient and provides a level of supply chain authenticity and transparency not previously available. By incorporating microtags, the pill itself effectively becomes a barcode which can be digitally read and recorded, providing instant authentication,” she said.
According to the company, the incorporation of microtags essentially turns the pill itself into a barcode. This can be digitally read and recorded for authentication.
Using a ‘lock and key’ mechanism, the coated or printed dosage form becomes the lock and the corresponding detection method (unique for each taggant) is the key, which is held by Colorcon. The taggants are customer-specific and may be used on multiple drug products, or each drug product can be tagged.
Because the product itself is used as an anti-counterfeiting measure, there is no special branding to advertise this unique feature. Customers may opt to maintain anonymity regarding the use of authentication measures.
Colorcon reports it has formed technology partnerships with TruTag and Applied DNA Sciences to provide taggants for inclusion on-dosage. For drugs that are already on the market, the taggant technology can be added to its Opadry film coating or Opacode printing ink formulation and applied with existing equipment; it also can be included as part of a new drug development project.
Colorcon CEO Martti Hedman said, “The digitalization of medicines represents a major step forward in the fight against unauthorized and illegitimate pharmaceutical production and provides an opportunity to safeguard patients. This investment to bring on-dose authentication technology to market demonstrates Colorcon’s commitment to respond to the needs of the pharmaceutical industry by developing innovative solutions that are efficient to deliver and which offer dependable performance.”