N-nitrosamine Mitigation with Nitrite Scavengers in Oral Pharmaceutical Drug Products.
Antioxidants
Drug design
Drug-excipient interactions
Excipient(s)
Inhibition
Nitrosamine formation
Stability
Tablet(s)
Journal
Journal of pharmaceutical sciences
ISSN: 1520-6017
Titre abrégé: J Pharm Sci
Pays: United States
ID NLM: 2985195R
Informations de publication
Date de publication:
07 2023
07 2023
Historique:
received:
09
01
2023
revised:
16
03
2023
accepted:
29
03
2023
medline:
19
6
2023
pubmed:
7
4
2023
entrez:
6
4
2023
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 37023856
pii: S0022-3549(23)00142-9
doi: 10.1016/j.xphs.2023.03.022
pii:
doi:
Substances chimiques
Nitrosamines
0
Nitrites
0
Antioxidants
0
Ascorbic Acid
PQ6CK8PD0R
Pharmaceutical Preparations
0
Types de publication
Journal Article
Review
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1794-1800Informations de copyright
Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
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.