Excipient screening initiative kicks off at FDA, IPEC

The US Food and Drug Administration (FDA) has enlisted the aid of industry to develop a screening programme for pharmaceutical excipients in order to prevent counterfeit, contaminated and mislabelled substances from entering the supply chain and causing patient harm.

The agency is working with IPEC Americas, an industry group representing manufacturers and users of pharmaceutical excipients, to develop a comprehensive library of excipient samples that will be used as reference standards in rapid screening of raw materials and finished products.

The overall aim is to develop ways to quickly identify materials that should be analysed in more depth and improve the efficiency of the FDA's monitoring and surveillance of the pharmaceutical supply chain.

The initial screening would be undertaken using portable instruments using four analytical technologies, namely: X-ray fluorescence for detection of toxic metals in drug substances and products; ion mobility spectrometry for detection of weight loss drugs in dietary supplements; and Raman and near-infrared (NIR) spectrometry for detection of contaminated or adulterated pharmaceutical raw materials.

The samples provided by IPEC Americas would form the heart of a database of spectra from certified reference material database which would be compared with the results obtained from screened containers to identify and verify samples.

Members of IPEC Americas' Excipient Qualification Committee will work with the Division of Pharmaceutical Analysis (DPA) within the US FDA's Centre for Drug Evaluation and Research (CDER) on the project, which will be headed by Cindy Buhse of the DPA and IPEC's Philip Merrell, technical marketing manager of Jost Chemical Co.

Last month, Dr. Buhse gave a presentation on the initiative, noting that "rapid screening will dramatically increase the number of containers of material that can be examined without a dramatic increase in personnel."

The DPA has been running evaluations on the portable devices that could be used for rapid screening, including field testing of four Raman devices: Thermo Fisher/Ahura's TruScan, Enwave Optronics' EZ-Raman, B&W Tek's MiniRam II and DeltaNu's ReporteR.

The aim has been to determine the sensitivity of the devices to contaminants in excipients in order to pick up cases of economically-motivated adulteration (EMA), such as the addition of diethylene glycol to excipients such as glycerine and propylene glycol.

Cases of EMA involving DEG contamination have led to hundreds of deaths around the world.  For example, in Nigeria in 2008, at least 84 children aged between 2 months and seven years died as a result of deliberate substitution of the glycerine with DEG in a teething mixture.

An incident in Panama the previous year led to the deaths of 21 people died after taking a cough syrup made with DEG that had again been mislabelled as glycerine. Another 38 people were affected by side effects including disorientation and kidney failure.