Antioxidants had No Effects on the In-Vitro Permeability of BCS III Model Drug Substances

Author:

Lu DongmeiORCID,Rege Bhagwant,Raw AndreORCID,Yang JingyueORCID,Alam Khondoker,Bode Chris,Zhao Liang,Faustino Patrick,Wu Fang,Shakleya Diaa,Nickum Elisa,Li Bing V.,Wang RongORCID,Stier Ethan,Miezeiewski Blair,Patel RachanaORCID,Boam AshleyORCID,Lionberger Robert,Keire DavidORCID,Yu Lawrence

Funder

U.S. Food and Drug Administration

Publisher

Elsevier BV

Reference24 articles.

1. Information about nitrosamine impurities in medications. Available from: https://www.fda.gov/drugs/drug-safety-and-availability/information-about-nitrosamine-impurities-medications.

2. FDA works to avoid shortage of sitagliptin following detection of nitrosamine impurity. Available from:https://www.fda.gov/drugs/drug-safety-and-availability/fda-works-avoid-shortage-sitagliptin-following-detection-nitrosamine-impurity.

3. Updates on possible mitigation strategies to reduce the risk of nitrosamine drug substance-related impurities in drug products. Available from:https://www.fda.gov/drugs/drug-safety-and-availability/updates-possible-mitigation-strategies-reduce-risk-nitrosamine-drug-substance-related-impurities.

4. Inhibition of N-nitrosamine formation in drug products: a model study;Nanda;J Pharm Sci,2021

5. Bumetanide as a model NDSRI substrate: N-nitrosobumetanide impurity formation and its inhibition in bumetanide tablets;Shakleya;J Pharm Sci,2023

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