Nitrosamines crisis in pharmaceuticals - insights on toxicological implications, root causes and risk assessment: A systematic review

IF 6.1 1区医学 Q1 PHARMACOLOGY & PHARMACY Journal of Pharmaceutical Analysis Pub Date : 2023-12-12 DOI:10.1016/j.jpha.2023.12.009

Hemanth P.R. Vikram, Tegginamath Pramod Kumar, Gunjan Kumar, Narasimha M. Beeraka, Rajashree Deka, Sheik Mohammed Suhail, Sandeep Jat, Namitha Bannimath, Gayatiri Padmanabhan, Ravandur S. Chandan, Pramod Kumar, Bannimath Gurupadayya

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Abstract

The presence of N-nitroso compounds, particularly N-nitrosamines, in pharmaceutical products has raised global safety concerns due to their significant genotoxic and mutagenic effects. This systematic review investigates their toxicity in active pharmaceutical ingredients, drug products, and pharmaceutical excipients, along with novel analytical strategies for detection, root cause analysis, reformulation strategies, and regulatory guidelines for nitrosamines. This review emphasizes the molecular toxicity of N-nitroso compounds, focusing on genotoxic, mutagenic, carcinogenic, and other physiological effects. Additionally, it addresses the ongoing nitrosamine crisis, the development of nitrosamine-free products, and the importance of sensitive detection methods and precise risk evaluation. This comprehensive overview will aid molecular biologists, analytical scientists, and formulation scientists in research and development sector, and researchers involved in management of nitrosamine-induced toxicity and promoting safer pharmaceutical products.

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药品中的亚硝胺危机--关于毒理学影响、根本原因和风险评估的见解：系统回顾

由于 N-亚硝基化合物（尤其是 N-亚硝胺）具有显著的基因毒性和致突变作用，其在医药产品中的存在已引起全球安全关注。本系统性综述研究了亚硝胺在活性药物成分、药物产品和药用辅料中的毒性，以及亚硝胺的新型检测分析策略、根本原因分析、重新配制策略和监管指南。本综述强调了 N-亚硝基化合物的分子毒性，重点是遗传毒性、诱变性、致癌性和其他生理效应。此外，它还讨论了当前的亚硝胺危机、无亚硝胺产品的开发以及灵敏检测方法和精确风险评估的重要性。这本全面的综述将为研发部门的分子生物学家、分析科学家和制剂科学家，以及参与亚硝胺毒性管理和推广更安全医药产品的研究人员提供帮助。

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来源期刊

Journal of Pharmaceutical Analysis Chemistry-Electrochemistry

CiteScore

16.20

自引率

2.30%

发文量

674

审稿时长

22 weeks

期刊介绍： The Journal of Pharmaceutical Analysis (JPA), established in 2011, serves as the official publication of Xi'an Jiaotong University. JPA is a monthly, peer-reviewed, open-access journal dedicated to disseminating noteworthy original research articles, review papers, short communications, news, research highlights, and editorials in the realm of Pharmacy Analysis. Encompassing a wide spectrum of topics, including Pharmaceutical Analysis, Analytical Techniques and Methods, Pharmacology, Metabolism, Drug Delivery, Cellular Imaging & Analysis, Natural Products, and Biosensing, JPA provides a comprehensive platform for scholarly discourse and innovation in the field.