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Oct 14, 2024

Advancing Pharmaceutical Security: The Role of SECURtracers in On-Dose Authentication - Pharmaceutical Technology

On-dose authentication, the practice of integrating traceable markers directly into or onto pharmaceutical products, is yet to be implemented within the pharmaceutical industry. However, significant

On-dose authentication, the practice of integrating traceable markers directly into or onto pharmaceutical products, is yet to be implemented within the pharmaceutical industry. However, significant progress is being made, especially through the efforts of San Francisco-based Micro-Tracers, Inc. with its SECURtracers technology.

SECURtracers are ethyl cellulose-based tracer particles that can be integrated into drug coatings, pill or tablet matrices, or the shells and band seals of hard or soft capsules. These particles fluoresce under UV light, enabling rapid, on-the-spot authentication while remaining invisible under normal lighting conditions. Each particle is customized with ten or more micro-engraved alphanumeric characters or symbols, which can be read using a hand-held microscope after being isolated by magnetic separation. SECURtracers comply with US FDA guidelines for incorporating Physical Chemical Identifiers (PCIDs) into solid oral dosage drugs. Details about PCIDs and SECURtracers can be found in the second article of this series. Any pharmacy equipped with a basic detection kit can authenticate a drug formulated with SECURtracers in as little as five minutes.

Marketing SECURtracers in the US and EU faces significant regulatory challenges. In these markets, both the FDA and European Medicines Agency (EMA) will only consider a new pharmaceutical excipient as part of a pharmaceutical manufacturer’s New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA). No pharmaceutical company wants to delay new drug approvals or reopen an approved drug’s file for such a review. Once a “first user” receives FDA approval to include SECURtracers in their product, for example, the tracers will be added to the FDA’s Inactive Ingredient Guide (IIG), streamlining the process for future manufacturers to adopt the technology via post-approval changes.

In January 2022, Micro-Tracers successfully filed a Drug Master File (DMF) with the US FDA. While this does not constitute formal approval, it is a key step in facilitating FDA review of the excipient. The DMF requires extensive information on the quality, safety, and efficacy of the excipient and outlines how this information must be organized for submission. This will simplify the FDA’s review process if a pharmaceutical manufacturer includes SECURtracers in an NDA, ANDA, or similar submission.

Beyond the DMF filing, Micro-Tracers achieved ISO 9001:2015 and EXCIPACT accreditation in May 2024, underscoring that its manufacturing processes meet rigorous pharmaceutical excipient standards. This accreditation, conducted by third-party auditor SGS, involved a thorough review of manufacturing practices, procedures, facilities, and staff—from raw material sourcing to final product testing—demonstrating Micro-Tracers’ commitment to quality, safety, and consistency.

The use of SECURtracers is not limited to pharmaceuticals. In June 2024, the US FDA approved Micro-Tracers’ Food Additive Petition (FAP), permitting the use of ethyl cellulose as a matrix scaffolding for curcumin and iron as tracers in animal feeds. The approval included an extensive review of the safety and efficacy of SECURtracers in animal feeds. However, the FDA required a second FAP specifically for SECURtracer use in animal feeds, and Micro-Tracers is currently working on this submission.

Additionally, the company has developed SECURtracer variants for product labeling, with ongoing R&D trials in progress. However, its primary focus remains on their use in oral solid dosage drugs.

To further validate the safety and efficacy of SECURtracers, Micro-Tracers has formed key partnerships. A notable collaboration is with the Bombay College of Pharmacy, where researchers have studied the chemical stability of the ingredients of SECURtracers during the manufacturing process using photolithography and gas-plasma etching technologies. Early results suggest that SECURtracers remain unchanged during this process, with only minor degradation of curcumin (about 0.15%) and no harmful degradation compounds identified. Ongoing trials are testing various conditions to ensure the tracers, made from three Generally Recognized As Safe (GRAS) materials—ethyl cellulose, curcumin, and carbonyl iron—remain stable throughout production.

In addition to the chemical stability studies, Micro-Tracers is conducting in vivo animal trials in collaboration with the Nigerian Institute of Medical Research (NIMR) to demonstrate the safety of SECURtracers in animals. The company is also preparing for limited clinical trials, though the EMA has advised that clinical trials may not be necessary in a received Scientific Advice.

Previous animal trials conducted in partnership with the University of California, Davis found no adverse effects from adding high levels of SECURtracers to mice feed.

Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) has expressed a willingness to consider New Drug Applications incorporating SECURtracers, even if they have not yet received FDA or EMA approval, provided the animal and clinical trials show no safety concerns. Several Nigerian pharmaceutical manufacturers have shown strong interest in adopting SECURtracers, and Micro-Tracers has signed a Memorandum of Understanding with one of them.

Meanwhile, Colombia’s Health Ministry has indicated that pre-approval for SECURtracers in human drugs is not necessary. It has reviewed a submission and believes SECURtracers could help prevent counterfeit drugs, relying on the pharmaceutical manufacturers to ensure safety and efficacy.

Micro-Tracers is actively seeking a pharmaceutical manufacturer to collaborate with for the first large-scale trial of SECURtracers in a solid oral dosage form. A key advantage of the SECURtracers technology is its ease of integration into existing manufacturing processes. Pharmaceutical companies can incorporate SECURtracers without requiring any new equipment or changes to their existing processes for tablet or capsule production, making it an attractive option for manufacturers looking to enhance product security with minimal disruption.

Trials with Colorcon and Evonik have already demonstrated that SECURtracers can be added to pill and tablet coatings or incorporated into the matrix of drug products.

To encourage pharmaceutical manufacturers to be a “first user” of SECURtracers, Micro-Tracers is offering several incentives. Micro-Tracers is willing to provide SECURtracers free of charge for at least three years, along with up to 200 detection kits to evaluate the tracers’ practical use by pharmacies, hospitals, consumers, and government agencies. Micro-Tracers will also cover reasonable costs related to registration changes, trials, and commercialization efforts, while supporting promotional activities aimed at raising awareness of SECURtracers’ benefits, reducing counterfeiting, and boosting manufacturers’ profits.

As the pharmaceutical industry continues to face challenges related to counterfeit drugs, even with tracking systems and packaging solutions in place, on-dose authentication solutions like SECURtracers offer a promising way forward. With patents secured in key markets including the US, Europe, China, and India, Micro-Tracers is well-positioned to initiate an industry transition toward enhancing drug safety and integrity at the dose level. By partnering with pharmaceutical manufacturers, Micro-Tracers aims to bring SECURtracers to market, improving patient safety and setting a new standard for pharmaceutical traceability.