Researchers develop way of removing acrolein from APIs
By using engineered particles based on silica and polystyrene
Scientists have reported a new procedure for removing almost 98% of an important impurity from drugs, the presence of which could adversely affect the health of patients.
The contamination of medications with so-called ‘genotoxic’ impurities (GTIs) have resulted in several major recent drug recalls. GTIs may be ingredients used to make drugs, or they may be formed during production of drugs, and can remain in the final product in minute amounts.
The presence of one GTI in the anti-viral medication Viracept distributed in the European Union forced a recall in 2007. With GTIs an ongoing serious concern for the pharmaceutical industry, scientists sought a better way to remove an important GTI called acrolein.
Ecevit Yilmaz and colleagues from MIP Technologies in Sweden (a subsidiary of Biotage), along with researchers from the INFU, Universität Dortmund, Germany, describe the development of a way to remove acrolein by using engineered particles based on silica and polystyrene.
Mixing the particles in a drug solution contaminated with acrolein for 20 minutes resulted in the removal of nearly 98% of the GTI without any substantial removal of the active pharmaceutical ingredient. They note that while the separation materials are readily available, there may be a need for more research on the method before using it to clean up pharmaceuticals on a commercial basis.
The paper ‘Removal of Acrolein from Active Pharmaceutical Ingredients Using Aldehyde Scavengers’ appeared in the June edition of the American Chemical Society (ACS) journal Organic Process Research & Development, 2012, 16 (6), pp1225–1229.
