Pharmaceutical Technology Europe - July 2010 - (Page 10)

NIR chemical imaging could hold key data Near-infrared chemical imaging (NIRCI) was initially deployed by the pharma industry in formulation development and root-cause analysis of performance failure. However, the technology can also be used to identify counterfeit pharmaceuticals, and offers key advantages over traditional analytical techniques for counterfeit detection and sourcing. NIRCI can measure the structure and the chemical composition of ingredients, including APIs evaluate how many and most excipients, at counterfeiting factories once. Simply put, tablets were involved in their made with the same production! This is ingredients in the same possible because NIRCI factory and following the can measure both same process will have API and excipients; very similar chemical counterfeiters may compositions and not all use the same structures. excipients, even if they Dr Janie Dubois Tablets made with the use the right API. Even Malvern Instruments same ingredients, but more importantly, using different process since it is expected that machinery will probably show the geographically-close counterfeiters same chemical composition and probably obtain their supplies from consequently pass HPLC and NIR a small number of sources, there is spectroscopy tests, but will most a good chance that their products likely have a different structure will contain similar excipients from (Figure 1). Only spectroscopic imaging the same or different sources. It is can provide this level of information, also likely that they purchased their and only when it is performed in the manufacturing equipment from surplus NIR can it be done quickly and easily. and other inexpensive sources, which It has also been demonstrated that, almost guarantees they don’t all have when using NIRCI, it is possible to the same equipment. The “signature” not only determine that a group of of the equipment will be seen in the products are counterfeit, but also to structure of the tablets. It is not unreasonable to think that a database of chemical composition and physical structure could be built for original products, and compared with seized lots to determine their legality. A similar database of seized counterfeits could help build an understanding of the movement of these products across borders and markets. PTE Figure 1: Array of tablets with the same chemical composition showing a similar spatial distribution. Based on a contribution Dr Janie Dubois, Product Manager Americas, Analytical Imaging at Malvern Instruments. To read the full version of this article, go to www.pharmtech.com/jdubois www.malvern.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/jdubois http://www.malvern.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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