Pharmaceutical Technology Europe - July 2010 - (Page 9)

The power of x-ray analysis X-ray powder diffraction (XRPD) is a versatile, non-destructive technique that analyses the complete composition of the tablet, including the excipient mixture, polymorphic form and crystallinity of the API. As such, it can clearly distinguish between tablets on the basis of type and amount of API, crystal structure of the API and/or composition of excipients. Importantly, because the technique uses X-rays, measurements can be made with the tablets in their original and intact packaging. The recent introduction of the world’s first 3D detector for use in an XRPD system (by PANalytical) brings further insight. Now, computed tomography (CT) images of the tablet under test can be generated in the same instrument as the diffraction data is collected. This allows the non-invasive analysis of size, shape and inner microstructure of tablets giving additional information about the production processes involved. How does it detect counterfeits? XRPD offers several advantages over other tablet analysis techniques. For instance, traditional wet chemistry methods, such as gas chromatography–mass spectrometry, are time consuming because of the need for sample preparation, “...the pharma industry has a history of broadening the use of any technique that is already established in the laboratory” and they also destroy the physical properties of the tablets. More advanced analytical techniques also have disadvantages. Infrared techniques often have problems with hydrate mixtures because of moisture content and while NIR is often promoted as being easy to use (particularly in the case of portable instruments), a proper evaluation of the resulting spectra requires advanced spectroscopy knowledge. Raman is another technique that is available as a portable instrument; however, it also suffers from problems with interference and issues with high moisture content samples. XRPD is widely used in the Dr Detlef Beckers pharmaceutical industry; PANalytical it has moved from being a technology that simply enables pharmaceutical companies to ‘tick a box’ (by providing the crystal pattern of a drug needed for patent and regulatory approval) to one that meets valuable applications across discovery, development and production control. Although it is not yet widely used Based on a contribution by Dr for detecting counterfeit medicines, Detlef Beckers, Product Manager the pharma industry has a history of Scientific XRPD at PANalytical. broadening the use of any technique that is already established in the To read the full version of this laboratory — an XRPD is certainly article, go to an available tool in all pharma www.pharmtech.com/beckers companies. PTE www.panalytical.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/beckers http://www.panalytical.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