Gary Pond
Global Product Authentication Lead
Colorcon
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View from the Top

Protection From Counterfeit Drugs Key to Patient Safety

By Miriam Bello | Mon, 06/21/2021 - 17:06

Q: What makes Colorcon’s specialty excipients superior to those of the competition?

A: Colorcon is the global leader in film coating for the pharmaceutical and nutritional sectors. Our best-in-class products and technologies are complemented by our extensive application data and value-added services to support all phases of solid oral dose design and development. We deliver superior product quality, unparalleled technical support, extensive regulatory assistance, and reliable supply from multiple locations.

Our focus on market issues and technology development has earned Colorcon an international reputation as a pharmaceutical supplier of choice.  That reputation is based on superior product quality, unparalleled technical support, extensive regulatory assistance, and reliable supply from multiple locations. Colorcon has a global supplier capacity through its 22 technical service centers and 11 global manufacturing facilities around the world.

We were the first company to develop a fully formulated tablet coating system, Opadry®, for the pharmaceutical and nutritional industries and we provide companies with a range of specialty ingredients (excipients), for oral solid drug products and nutritional supplements. Through our commitment to investing in enhanced dosage forms and advanced technology solutions, we are now positioned to introduce an innovative solution to help protect patients from counterfeit pharmaceuticals.

Q: What is the impact of counterfeiting drugs for the pharmaceutical industry?

A: Counterfeit drugs are a growing, relentless problem. Even though some clients have serialized their production in some countries, they are still seeing a significant increase in counterfeit and diverted drugs. Recent data show that due to the growth of illegal online pharmacies, the problem has worsened as the COVID-19 crisis makes more people buy online. Counterfeit drugs are not just a problem in developing markets; there is a lot of counterfeiting and diversion of products now through illegal internet pharmacies in major markets like Mexico, the US and the EU. Counterfeiters are also becoming much more sophisticated and are moving from high-value, and lifestyle products (like Viagra), which were previously their primary target. They are now going after some life-saving medications as in many cases, they are more expensive, and patients can buy them online at a lower cost. Patients are increasingly buying online medicines for cancer, heart disease, or diabetes.

Q: How can Colorcon protect companies from the dangers of counterfeit drugs?

A: While companies in some countries are required to implement serialization on their packaging, a product can easily be separated from its original packaging, or the packaging can be copied. Colorcon has developed covert microtaggant technologies, a molecular DNA taggant and a silica taggant, which are included directly onto the tablet itself via the film coating and are not detectable by the naked eye. This covert marker is then verified for the authenticity of the tablet itself. Pharmaceutical and nutraceutical companies can include on-dose authentication with little change to their typical film coating manufacturing process, as the microtaggants are added directly into the coating system. With this innovation, companies are now able to uniquely tag their tablets and authenticate them in the field using a desktop reader. A  smartphone application is under development which will broaden access and bring the smarter medicine capability forwards - leading the way for wider digitalization of medicines.

Mass digitalization of medicine is a cost-effective way to secure the supply chain and ensure patients get the right medication. The microtaggant we are utilizing is described by the FDA as a  physical-chemical identifier (PCID) and the agency recommends using these technologies in addition to serialization.

Following intensive application development of this technology over the past two years we are confident the system is robust and will work effectively. We are in discussion with several pharmaceutical companies in Mexico and other countries; once completed and approved, we will begin introducing it to the global market.

Q: What will be your first targets for this new technology?

A: Our first target is branded pharmaceutical products as these are the main target for counterfeiters. Our clients are also interested in our smartphone authentication technology, which will allow verification by quality teams and enforcement agencies, as well as enabling patients to verify the product by themselves. We have noticed that the smartphone solution has attracted a lot of attention as it could be used by patients using online marketplaces to ensure they are getting authentic medicine. In addition to authenticating their medicine, the company or care provider can connect with patients to share therapy education and support.

Q: As a supply chain provider, how will Colorcon continue securing supply continuity even amid a crisis?

A: Colorcon has a robust Business Continuity Plan (BCP) in place, which has been operating throughout the pandemic. Through our global supply chain, we have been able to support our pharmaceutical and nutraceutical partners around the world. All our manufacturing sites are fully integrated, which allows us to easily replicate the operation of a manufacturing center at another location if it became unable to operate, ensuring consistency of supply and customer support. Colorcon has done an outstanding job of managing and satisfying the needs of the supply chain. We are confident in the ability of our organization and operations to continue to support demand across our customer network.

 

Colorcon is a world leader in the design and development of specialty excipients and on-dose authentication solutions designed for solid oral dosages for the pharmaceutical and nutritional industries.

Miriam Bello Miriam Bello Journalist and Industry Analyst