A new report appearing in the journal Organic Process Research & Development describes the development of a new procedure for eliminating almost 98% of an impurity that can contaminate prescription drugs and potentially increase the risk for adverse health effects in patients.
According to Ecevit Yilmaz and colleagues, several major drug recalls have been the results of medication contaminations with so-called “genotoxic” impurities (GTIs). GTIs may be ingredients used to create drugs, or they may be formed during the process of producing the drugs. GTIs can remain in the final product in very small amounts. With GTIs an ongoing concern for the pharmaceutical industry, scientists pursued an improved process for removing an important GTI called acrolein.
Yilmaz and colleagues describe the removal of 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% of the GTI without any substantial loss to the active pharmaceutical ingredient. The authors note that while the separation materials are readily available, more method research is necessary before using the process to clean up pharmaceuticals on a commercial basis.
Source: ACS.