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Review
. 2023 Jul;112(7):1794-1800.
doi: 10.1016/j.xphs.2023.03.022. Epub 2023 Apr 5.

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

Anne-Cécile V Bayne  1 , Zdravka Misic  2 , René T Stemmler  2 , Marc Wittner  2 , Margarita Frerichs  2 , Julia K Bird  3 , Ahmed Besheer  2
Affiliations
Free article
Review

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

Anne-Cécile V Bayne et al. J Pharm Sci. 2023 Jul.
Free article

Abstract

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.

Keywords: Antioxidants; Drug design; Drug-excipient interactions; Excipient(s); Inhibition; Nitrosamine formation; Stability; Tablet(s).

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Conflict of interest statement

Declaration of Interests The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: A.-C.V.B, Z.M., R.T.S., M.W., M.F. and A.B. are employees of DSM Nutritional Products Ltd., Kaiseraugst, Switzerland. J.K.B is a consultant for and former employee of DSM Nutritional Products Ltd. Kaiseraugst, Switzerland.

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