The discovery of nitrosamine contaminants in commonly used drug products in 2018 shook the pharmaceutical industry and made formulation and reformulation for low nitrosamine content a key topic for drug manufacturers. Since then, there have been many scientific and regulatory developments that are paving the way for companies to follow. We interviewed leading experts from DSM, Zdravka Misic (Principal Scientist), to discuss the latest science emerging from the field of nitrosamine risk mitigation and Bruna Matteucci (Market Development Manager Pharma), to explore important touch points for customers navigating the nitrosamine mitigation process. Read on to gain valuable insights from our conversation with the experts.
Since the discovery of nitrosamines in Ranitidine, Valsartan and Metformin, additional research has been conducted to assess the presence of such contaminants in other pharmaceutical products. The latest estimates from a large in-silico study have predicted that the risk of nitrosamine contamination in regularly prescribed drug products is more common than previously thought, with 40.4% of active pharmaceutical ingredients (API) and 29.6% of API impurities being classified as potential nitrosamine precursors.1 Furthermore, recent evidence has identified certain types of packaging as sources of nitrosamine contamination and new nitrosamine impurities within sitagliptin medicines.2,3
Despite the growing concerns about nitrosamine impurities in pharmaceuticals, there have been positive findings pointing towards an effective solution to mitigate contamination. Two studies have conducted a screening of known nitrite scavengers and investigated their effectiveness against nitrosamine formation. 45 These studies have shown that antioxidants, particularly ascorbic acid, can be used to mitigate nitrosamine formation effectively.
Nitrosamine mitigation is a process that requires pharmaceutical companies to evaluate the risk associated with each drug product and develop a safe and reliable mitigating strategy that meets the regulatory standards. This already challenging process is accompanied by the looming deadline, as most companies will have to present mitigation strategies by the end of the year. Our conversations with customers have revealed three primary concerns in the context of nitrosamine risk mitigation:
DSM supports its customers with the reformulation of existing and formulation of new drug products. Depending on the level of support required, DSM offers:
DSM offers tailored solutions to customers for their individual portfolios, whether their drug product is already on the market or in development.
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05 May 2023
4 min read