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
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.