According to the corporate, authentication know-how just like the SoteriaRx platform presents defend sufferers from counterfeit merchandise. Additionally, the product allows pharmaceutical manufacturers to protect their model in opposition to harm to their popularity from a expensive recall.
Counterfeit medication pose a harmful, costly problem to the pharmaceutical business. The illicit drug provide business holds an estimated worth of $200m—about 2% of whole business income.
These inauthentic medication additionally pose a critical menace to sufferers. The World Health Organization (WHO) estimates that 16% of counterfeit medication comprise the flawed elements, whereas 17% comprise the flawed ranges of energetic elements. Also, greater than 30% of the counterfeit medication found circulating available in the market comprise no energetic elements in any respect.
Counterfeit merchandise steadily embody poisonous compounds, which might trigger antagonistic well being results. According to a CNN report, between 100,000 and 1m individuals die annually from counterfeit medication.
While manufacturers and producers incorporate traceability and safety measures aimed on the packaging stage, these might not be enough to dam and detect fraud. This is a specific concern in low- and middle-income international locations, the place fraudulent medicines can comprise as much as 70% of medicines inside their borders.
Kelly Boyer, normal supervisor of movie coatings for Colorcon, explains that the SoteriaRx supplies a extra integral means of monitoring and tracing medicines to show 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 mentioned.
According to the corporate, the incorporation of microtags basically turns the tablet itself right into a barcode. This might be digitally learn and recorded for authentication.
Using a ‘lock and key’ mechanism, the coated or printed dosage kind turns into the lock and the corresponding detection technique (distinctive for every taggant) is the important thing, which is held by Colorcon. The taggants are customer-specific and could also be used on a number of drug merchandise, or every drug product might be tagged.
Because the product itself is used as an anti-counterfeiting measure, there is no such thing as a particular branding to promote this distinctive function. Customers could choose to keep up anonymity relating to the usage of authentication measures.
Colorcon stories it has shaped know-how partnerships with TruTag and Applied DNA Sciences to offer taggants for inclusion on-dosage. For medication which are already available on the market, the taggant know-how might be added to its Opadry movie coating or Opacode printing ink formulation and utilized with present tools; it additionally might be included as a part of a brand new drug growth mission.
Colorcon CEO Martti Hedman mentioned, “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.”