Expert view: 5 things you need to know about nitrosamines in drug formulation

• Nitrosamine risk mitigation is front of mind for many drug formulators following the discovery of N-nitrosodimethylamine (NDMA) in valsartan – a commonly used drug in the treatment of high blood pressure and heart failure.
• To learn more about the situation, DSM interviewed Prof. Gerhard Eisenbrand – Senior Research Professor (Retired) Food Chemistry & Toxicology – and leading expert in the field, to discuss what we know about nitrosamines in the pharmaceutical industry and the steps formulators can take to minimize the risk of contamination in their drug products.
• Read on for the latest expert insights, plus discover how – as a purpose-led partner – DSM can support drug developers with their mitigation strategies.

Below, we hear from Prof. Gerhard Eisenbrand – a retired Senior Research Professor Food Chemistry & Toxicology with extensive knowledge in the field of nitrosamines – on the implications of nitrosamine contamination for the pharmaceutical industry and how developers can address it quickly and safely.

What do we know about N-nitroso compounds?

N-nitroso compounds (NOC) are chemical contaminants which first became known almost 40 years ago when they were found to be present in foods treated with sodium nitrite – like bacon, cheese, cured meats and fish. The most common NOCs are N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) nitrosamines.

Evidence from laboratory studies, including animal studies, demonstrates that NOCs have the potential to cause cancer in multiple tissues in the body. In fact, more than 90% of 300+ NOCs are reported to be carcinogenic.[1] Some NOCs, like nitrosamines, require metabolic activation by CYP450 enzymes to become carcinogenic, whereas others, like N-nitroureas, are active without needing to be metabolized. As such, NOCs are one of the few chemicals classified by the ICH M7 as Cohort of Concern (CoC), which means they are considered highly potent mutagenic carcinogens and require strict control to minimize human exposure. The International Agency for Research on Cancer (IARC) also categorizes nitrosamines as ‘probably carcinogenic to humans’.

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