See a video demonstration at the end of this article
Maximizing physical-chemical identifiers: Colorcon and ARmark's visual and covert film-coating technologies
The regulatory landscape for improving anticounterfeiting technologies has greatly improved in recent years, especially with regard to solid-dosage coatings. According to John D'Ottavio, quality and regulatory affairs manager for ARmark Authentication Technologies, LLC, FDA's 2009 draft guidance on physical–chemical identifiers (PCIDs), Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting, opened the door to new security options for the pharmaceutical industry."The majority of anticounterfeiting or authentication approaches used today focus on primary packaging and labeling, and not the product itself," he says. "But the guidance offers specific recommendations regarding the use of inks, pigments, flavors, and other molecular taggants in immediate-release film coatings on solid oral-dosage forms."
PCIDs offer several benefits to industry. "In the fight against counterfeiting, one of the more interesting breakthroughs in PCID technology can be seen in the development of (R)mark On-Dose ID microtags, a technology created by ARmark Authentication Technologies, LLC and Colorcon, Inc. By leveraging the tablet coating expertise of Colorcon, a world leader in the manufacture and development of specialized film coatings, and ARmark's customized microtag authentication technology, the two companies collaborated to enable greater security by authenticating solid oral dose pharmaceuticals.
The microtags are embedded with unique information for the purpose of authenticating solid oral-dosage forms, explains D'Ottavio. "The microtags are applied directly to pharmaceutical tablets during the film-coating process for reliable placement on each and every tablet without changing any aspect of the existing film-coating process of an approved product. This flexibility can save ample costs in terms of additional machinery."
Adds Kamlesh Oza, film-coating general manager at Colorcon, the covert microtags are custom-developed from approved excipient materials listed in FDA's Inactive Ingredient Database (IID). "Their unique physical–chemical characteristic make it possible to authenticate legitimate dosage forms and identify counterfeits under magnification. These markers are invisible to the naked eye," says Oza.
The microtags function as a unique hidden fingerprint embedded with information specified by the brand owner, explains D'Ottavio. The tags are compatible with other covert or overt identification technologies, and are made to hold significant amounts of information in a space of 75 to 120 µg (i.e., smaller than the diameter of a human hair). "The information included in the microtags is customized to each client and may contain multiple levels of security, such as lot and batch ID numbers, country codes, dates, and logos as well as other text, patterns, shapes, and symbols. These types of forensic-coded signatures offer an additional level of security that makes the technology virtually impossible to replicate," says D'Ottavio.
ARmark's trademarked (R)vision systems allow for easy identification of the microtags. Simple hand-held optical tools authenticate a product by magnifying the microtags at any stage following the coating process. "The simplicity and portability of the (R)vision system enables accurate, in-field detection within a matter of seconds without destroying the drug sample," says D'Ottavio. "Another major benefit of this system is its interoperability. For example, the system does not require sophisticated external databases, communication networks, or integration into complicated data systems or laboratory sites to authenticate a product. All that is required is a visual confirmation that the microtags are present and contain the correct information."