A new study published in the Organic Process Research & Development journal reveals that researchers have developed a new procedure that can remove 98 percent of a type of impurity in prescription drugs that could prove to be harmful in patients.
Ecevit Yilmaz and colleagues note that 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, the scientists sought a better way to remove an important GTI called acrolein.
They describe 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 removal of nearly 98 percent 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 the need for more research on the method before using it to clean up pharmaceuticals on a commercial basis.