A Fresh Coat: Innovation in Excipients - Pharmaceutical Technology

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PharmTech Europe

A Fresh Coat: Innovation in Excipients
Sophisticated excipient development, especially for coatings, is staying on top of new challenges and meeting expanding industry needs.


Pharmaceutical Technology
Volume 32, Issue 11, pp. 46-56


(IMAGES ARE COURTESY OF COLORCON.)
Encryption. In 2000, the company NanoInk (Chicago, IL) was founded by licensing technology from the Northwestern School of Nanotechnology to place nanoscale features on certain substrates in a patterned manner. NanoGuardian, the brand protection division of NanoInk, used many of the aspects of that initial technology to develop pharmaceutical NanoEncryption, a state-of-the-art technology that places micron-scale and nano-scale security features on-dosage via manipulation of a finished product's coating. A proprietary "NanoEncrypter" typically located at the manufacturer's site, works to manipulate the coating of tablets (as well as capsules and vial caps) to place multitiered security features on each dose without affecting bioavailability, dissolution, and other performance characteristics. The technology has also been proven with uncoated tablets.

As Dean Hart, executive vice-president at NanoGuardian explains, the technology places three levels of security within the coating. The first is an overt feature, meaning it can be seen with the naked eye by authorities, pharmacies, investigators, and others just by knowing what to look for. The second level is a covert feature, which is a security mark placed within the easily visible overt mark. Detection of the covert mark requires the use of a handheld tool such as a microscope or jeweler's loupe.

The final security feature is at the forensic level and consists of specific "NanoCodes" placed within the coating. According to Hart, approximately 350 NanoCodes can fit in the width of a human hair, and NanoCodes can be associated with an unlimited amount of information. "A NanoCode can be associated with, for example, 30 different data points, and those data points can be manufacturing oriented such as batch number, lot number, production location and production date; product oriented such as strength and expiration date; or distribution oriented such as the state or country of distribution, and even the specific wholesaler or distributor to whom the product was sent. And once e-pedigree gets its legs, the NanoCode can be associated with the on-package RFID code, or two-dimensional barcode," says Hart.

"There are two things that pharmaceutical manufacturers need to accomplish to ensure protection of their products," says Hart. "The first is authenticity, which is easily done by NanoGuardian's overt and covert security features. The second is the ability to track and trace each product along the supply chain." NanoGuardian's forensic NanoCodes help manufacturers achieve that second 'need' by capturing an unlimited amount of distribution data on each dosage, thereby giving manufacturers the ability to trace each tablet, capsule, or vial back to its original packaging.

"When you look at the value of coatings, and the benefits of on-dosage security, that is where the real value of this technology comes into play," says Hart. "ePedigree will only tell you that this is the same piece of cardboard and piece of plastic that came from the plant all the way down the supply chain to the pharmacist. It doesn't really tell you that this is the same pill that was in that bottle to begin with. That is a risky assumption at the heart of ePedigree. But if you can take each dose and connect it to the on-package ePedigree technology that was used to track it through the supply chain, you remove that assumption and you have a closed loop of security that protects the medication from plant to patient."


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