NIR shows its value at pharma company Roche

Phil Taylor, 05-Aug-2016

Roche has developed a complete database of near infrared (NIR) spectra for its oral medicines as a tool to detect counterfeits.

Working with scientists at the Swiss Federal Institute of Technology (ETH Zurich), the company prepared more than 7,100 reference spectra spanning 29 families of pharmaceutical products and 53 different formulations - accounting for its entire tablet portfolio.

NIR spectroscopy has become a go-to screening technology for the identification of oral dosage forms, as it can be carried out in the field using handheld instruments, works through packaging, and provides a yes/no answer on authenticity within a minute.

Moreover, it does not destroy the sample - so can be used when only one individual tablet is available - and gives a read-out on the chemical composition of the pill including active ingredients and inactive excipients.

Roche developed the spectra on two desktop Thermo Antaris Fourier Transform-NIR spectrometers - a primary and support unit - with both used to generate the spectra in order to introduce instrument variability and so enrich the database.

The NIR spectroscopy approach was able to distinguish between counterfeits, generics and placebo, and even formulations of the same drug which differ in their excipient profiles depending on their dosage, with 100 per cent accuracy, according to the researchers.

"NIR spectroscopy is a helpful technique that has now long demonstrated to be quick, specific and non-destructive," they write in the Journal of Pharmaceutical and Biomedical Analysis (September 5 edition), noting that more and more spectrometers are coming onto the market - including handheld devices - so the technology is becoming more readily available.

A key advantage of the technology is that the generated data can be used to profile counterfeits, and so detect common production sources.

"Such information could be included in forensic databases and definitely help make a step forward in the fight against medicine counterfeiting," they conclude.