The Power Of X-Ray Analysis - Pharmaceutical Technology

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PharmTech Europe

The Power Of X-Ray Analysis

Pharmaceutical Technology Europe
Volume 22, Issue 7

Use in industry

XRPD is widely used in the pharmaceutical industry; 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. New-generation XRD instruments that include ultra-fast detectors, and pre-aligned stages and optical components for fast method set up and switching, have made the technique accessible to all. The development of control and analysis software that uses a familiar user interface and supports standard operating procedures has helped to 'demystify' the technique too. Despite its advantages, however, XRPD is not yet widely used for detecting counterfeit medicines, but the pharma industry has a history of broadening the use of any technique that is already established in the laboratory — an XRPD is certainly an available tool in all pharma companies. Additionally, a recent trial in Germany (data not yet published) has already been investigating the use of XRD for the rapid analysis of counterfeit medicines

Many governments and institutions are constantly reviewing new anti-counterfeiting methods and technologies. The European Commission launched a public consultation in 2008 in preparation for a legal proposal to combat counterfeit medicines. Other initiatives are in place around the world, including a major FDA task force that is exploring the use of modern technologies and other measures that will make it more difficult for counterfeit drugs to become integrated into the supply chain. In addition, the WHO established the first global initiative against counterfeit drugs — the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) — in February 2006. IMPACT aims to build coordinated networks to halt the production, trading and selling of fake medicines around the globe. The taskforce comprises a wide variety of international bodies, including non-governmental organisations, enforcement agencies, pharmaceutical manufacturers' associations and drug and regulatory authorities. IMPACT's vision is that all counterfeit drugs will be eradicated from the supply chain by 2015. To accomplish this goal, they are focused on five key areas, including assessing technologies that prevent, deter or detect counterfeit medicinal products.

Industry practice often runs ahead of 'official' recommendations and this may be the case with XRD in counterfeit analysis. However, with so much work going on, I believe it is simply a matter of time before firm technology recommendations emerge.

Dr Detlef Beckers Product Manager Scientific XRPD at PANalytical.


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