Recent developments of Raman spectroscopy for the qualitative analysis of falsified and substandard medicines
Posted: 2 January 2019 | Charlotte De Bleye (University of Liege Belgium), Elodie Dumont (University of Liege Belgium), Eric Ziemons (University of Liege Belgium), Hermane Avohou (University of Liege Belgium), Laureen Coic (University of Liege Belgium), Philippe Hubert (University of Liege Belgium), Pierre-Yves Sacre (University of Liege Belgium), Riccardo Deidda (University of Liege Belgium), Roland Marini (University of Liege Belgium) | No comments yet
Quality medicines are essential to any healthcare system and are the final goal of any pharmaceutical manufacturer. Unfortunately, as stated recently by the World Health Organization (WHO), one in 10 medical products circulating in low and middle-income countries is either substandard or falsified (SF products).1 Although the exact prevalence of SF products is unknown in high-income countries, it remains a major risk,2 especially because the internet market is difficult to control.3
BROADLY speaking, marketed medicines are expected to be compliant with local market specifications. These specifications ensure the correct active ingredient (identity testing) is present in the right amount (assay testing); the active pharmaceutical ingredient (API) is bioavailable (dissolution testing); and the amount of impurities is low enough (impurity testing). Although it is sometimes possible to visually identify SF products, only the pharmaceutical product testing following the complete pharmacopoeia monographs ensures the final quality and safety for the patient. However, this testing is lengthy and requires high-level equipment and staff. These limitations reduce the quantity of possibly tested samples and are impossible to implement for field testing during inspections. There is therefore an increasing need for fast, reliable and, if possible, portable solutions to detect SF products.
The rest of this content is restricted - login or subscribe free to access
Thank you for visiting our website. To access this content in full you'll need to login. It's completely free to subscribe, and in less than a minute you can continue reading. If you've already subscribed, great - just login.
Why subscribe? Join our growing community of thousands of industry professionals and gain access to:
- bi-monthly issues in print and/or digital format
- case studies, whitepapers, webinars and industry-leading content
- breaking news and features
- our extensive online archive of thousands of articles and years of past issues
- ...And it's all free!