Anne-Cecile Bayne, global science & innovation lead Pharma & Medical Nutrition, DSM discusses the benefits of using antioxidants to block nitrosamine development in drug products, and futureproof pharma formulations.
Key insights:
- Drug developers have a legal obligation to perform a thorough risk assessment for both new and existing products and implement an appropriate control strategy.
- Drug formulations that include any excipient containing secondary or tertiary amines, or quaternary ammonium salts, are likely to form nitrosamines.
- Manufacturers may look to block nitrosamine formation in drug products. This is considered the best way to mitigate the risk and ensure that impurity levels are below allowable limits.
- Adding ascorbic acid and α-tocopherol as antioxidants is one of the options recommended by the FDA as a mitigation strategy for pharmaceutical drug products.
Nitrosamine contamination of drug products has emerged as a major regulatory issue for the global pharmaceutical industry in recent years – with upcoming legal deadlines requiring drug developers to take time-sensitive action.