inXitu brings portable XRD analysis to pharma counterfeit fight

A US company which has developed instrumentation for the USA's Mars Rover project has now turned its attention to helping drugmakers guard against medicine counterfeiting.

inXitu of Mountain View, California,  specialises in portable X-ray diffraction (XRD) and claims to have developed  the world’s first truly field portable X-ray diffractometer.

SecuringPharma.com spoke with the firm's president, Bradley Boyer, about the role of the technology in pharma.

SP.com: When was Terra launched and what was its first application? 

BB: Terra was launched in the fall of 2008.  We initially focused on the use of Terra for field portable minerals and mining applications, but quickly discovered that there are quite a number of applications for XRD where field portability is useful. Along the way, and through projects with US government bodies, such as the US Food and Drug Administration (FDA), as well as major pharmaceutical companies, we discovered Terra is well suited for the rapid identification of genuine/fake pharmaceuticals.

SP.com: Have any modifications been made to Terra to adapt it for use in the pharmaceutical sector? 

BB: Only minor changes which predominately relate to the selection of the search/match database used for identification.  It’s useful to remind ourselves that XRD has been around for a long time.  It was the technique which was used to discover the structure of DNA and over the years, hundreds of thousands of x-ray diffraction patterns have been captured and made available in “search/match” databases, such as those available from the international centre for diffraction data (ICDD). Therefore, a tailored version of Terra for the pharma industry is really down to just ensuring the instrument has the correct database available.

SP.com: Can you describe how the unit works in the pharma environment? 

BB: Terra requires around 15mg of loose, dry powder to perform an analysis.  The sample is introduced into Terra and the data collection begins.  With no moving parts or parameters to select the acquisition is truly a one button operation.  After two to three minutes the acquisition is complete and the resulting diffraction pattern file is ready for processing with the software we include with the instrument.  The software uses the acquired pattern and searches the database for a match.  This can involve several phases.  The result is a report which indicates what has been identified and its approximate concentration. 

In one example of its application, we received what were believed to be fake samples of erectile dysfunction drugs.  In only a couple of minutes we confirmed the absence of the active ingredients as well as the identification of the material used in its place.  In this case, it was CaSO4, or the common mineral found in drywall.

SP.com: Who are the likely end-users? 

BB: So far the main interest in Terra has been coming from governmental agencies such as FDA, US Customs, etc.  With respect to counterfeit pharma we have had a a great deal of interest from the pharmaceutical companies themselves and are working closely with several.  We’re also reaching out to the World Health organization, etc as we feel Terra has an important role to play in ensuring a safe supply of medications, such as malaria drugs.

SP.com: How does the X-ray diffraction technology compare against near infrared or Raman spectroscopy? 

BB: NIR and Raman are great tools for rapidly determining if a drug is real or fake.  They look for a fingerprint pattern and if it is absent, it’s fake.  That said, they are not particularly good at either quantification (how much) or identifying what else is in the sample.  We see the role of Terra as one of greater utility. Our instrument not only can ascertain genuine from fake, but also go further and identify what the sample is comprised of and the respective concentration. 

If the counterfeit material is a diluted version of the genuine material, we can measure for that.  If the counterfeit material is comprised of another pharmaceutical compound, but repackaged, we can identify this as well.  That's import when you consider that, according to the Centers for Disease Control (CDC) in Atlanta, unscrupulous organisations are taking expired pharmaceutical products and repackaging them as genuine malaria drugs.  So, the intended patient not only does not receive the correct product but also ends up ingesting another drug with sometime very severe consequences. 

The CDC is interested in field portable XRD to help them identify these compounds to aid in finding the source as well as treating the patients who have ingested the counterfeit products.

SP.com: How much does the unit cost? 

BB: All in, about $75,000. It’s more expensive than Raman or NIR but we believe it provides greater utility.