Pharmaceutical Technology Europe - July 2010 - (Page 8)

Authenticating drugs with edible microtags On-dose authentication, such as edible microtags, is a relatively new market that has been quietly developing but has the capability to provide new forms of anti-counterfeiting tools. Most of the authentication formats in use today are packaging-oriented, but many of these are proving inadequate as counterfeiters become more sophisticated and more accustomed to traditionally-used authentication technologies. As such, attention has now turned to on-dose technologies; for instance, ARmark Authentication Technologies and Colorcon have developed covert microtags, and Capsugel has licensed a technology that uses nanoembossing from NanoGuardian (a division of NanoInk). Last summer, the FDA issued draft guidance entitled “Incorporation of Physical-Chemical Identifiers (PCIDs) into Solid Oral Dosage Form Drug Products for Anti-Counterfeiting”, which both validates industry interest in on-dose technologies and calls for the use of safe and well-studied food additives when using such technologies. spectrum can also be linked to (and verified by) other information printed on the package. Thanks to the maturity of the Manufacturing microtags silicon wafer industry, Edible microtags made of silica microtags silica, which has been safely can be produced Mike O’Neil used as an ingredient in inexpensively using TruTag Technologies food and drugs for decades the electrochemical at a limit of up to 2% by etch of a silicon weight, can be applied in or on an wafer and then heating the silicon. individual unit dose to help identify, Importantly, as no modifications to authenticate and ensure the quality existing manufacturing processes of a medicinal product. Microtags can or the product formulation are be manufactured to produce a unique required, microtags can be added as spectral signature that can be read a post-approval change to the tablet using a simple spectrometer-based and would require only an annual reader. Line of sight is all that is report update. required, meaning that tablets in Novel on-dose technologies will be a clear blister pack, for example, welcomed by manufacturers because would not need to be removed from they can provide authentication their packaging to be verified. This confidence that can be used for quality assurance applications, returns monitoring and anti-counterfeiting purposes. Consumers in particular should also welcome new technologies that help ensure their health and safety, especially those that are based on well-studied and accepted materials. PTE Based on a contribution by Mike O’Neil, Chief Technology Officer of TruTag Technologies. To read the full version of this article, go to www.pharmtech.com/oneil www.trutags.com 1 CONTENTS 8 EDIBLE MICROTAGS 3 OVERCOMING OBSTACLES 9 X-RAY ANALYSIS 4 EU LEGISLATION 11 RAMAN SPECTROSCOPY 6 DATA MATRIX CODES 14 TOP TECHNOLOGIES http://www.pharmtech.com/oneil http://www.trutags.com

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - July 2010

Pharmaceutical Technology Europe - July 2010
Can Pharma Keep Pace with the Counterfeiters?
Obstacles to Implementing an Effective Anti-Counterfeit Strategy: Can They Be Overcome?
EU Anti-Counterfeiting Legislation on its Way
You Can't Control What You Can't Measure
Data Matrix Barcodes: Points to Consider
Authenticating Drugs with Edible Microtags
The Power of X-Ray Analysis
NIR Chemical Imaging Could Hold Key Data
How Raman Spectroscopy is Benefitting Developing and Developed Countries
Overt Versus Convert Technologies
Serialisation is Here to Stay
Eight Latest Technologies Showcased

Pharmaceutical Technology Europe - July 2010

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