N-nitrosamine Mitigation with Nitrite Scavengers in Oral Pharmaceutical Drug Products

N-nitrosamines are likely human carcinogens. After N-nitrosamine contaminants were detected in pharmaceutical products in 2018, regulatory authorities set a framework for the risk assessment, testing and mitigation of N-nitrosamines in drug products. One strategy to inhibit the formation of N-nitros...

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Bibliographic Details
Published in:Journal of pharmaceutical sciences 2023-07, Vol.112 (7), p.1794-1800
Main Authors: Bayne, Anne-Cécile V., Misic, Zdravka, Stemmler, René T., Wittner, Marc, Frerichs, Margarita, Bird, Julia K., Besheer, Ahmed
Format: Article
Language:English
Subjects:
Antioxidants
Drug design
Drug-excipient interactions
Excipient(s)
Inhibition
Nitrosamine formation
Stability
Tablet(s)
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Summary:N-nitrosamines are likely human carcinogens. After N-nitrosamine contaminants were detected in pharmaceutical products in 2018, regulatory authorities set a framework for the risk assessment, testing and mitigation of N-nitrosamines in drug products. One strategy to inhibit the formation of N-nitrosamines during the manufacture and storage of drug products involves the incorporation of nitrite scavengers in the formulation. Diverse molecules have been tested in screening studies including the antioxidant vitamins ascorbic acid and α-tocopherol, amino acids, and other antioxidants used in foods or drugs, for inclusion into drug products to mitigate N-nitrosamine formation. This review article outlines key considerations for the inclusion of nitrite scavengers in oral drug product formulations.
ISSN:0022-3549
1520-6017
DOI:10.1016/j.xphs.2023.03.022