Expert interview: Are nitrosamine formation inhibitors the key to successful mitigation plans?

[Image courtesy of Getty Images]

The presence of toxic nitrosamine impurities in drug substances and drug products has become a significant focus for the pharmaceutical industry following their identification above permitted limits in common drug products prescribed for type 2 diabetes, high blood pressure and heartburn. To learn more about the situation, we interviewed David Elder – CMC consultant – who explained what we know about nitrosamine impurities, how they form, and the steps formulators can take to minimize the risk of formation in existing drug products and future developments.

Elder has 45 years of service within the pharmaceutical industry, with Sterling, Syntex and 23 years with GSK. He is now an independent CMC consultant and has broad based experience in impurity control, formulation (including stabilization strategies) and analytical method development.

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  • July 25, 2022
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First Zantac trial slated for February 2023

[Image courtesy of Wikimedia Commons]

The California State Court Judge overseeing litigation related to Zantac (ranitidine) issued a pretrial order scheduling the first of four bellwether trials for February 13, 2022, in Oakland.

Honorable Judge Evelio M. Grillo for the California Superior Court of Alameda County will preside over the litigation. Before the cases head to trial, Judge Grillo will verify that the experts tapped by the plaintiffs and defendants used sound logic in arriving at their scientific conclusions. Then, if plaintiffs’ experts persuade the judge, the first bellwether trial will proceed.

The heartburn medication Zantac, launched in 1983, was the best-selling drug in history in 1996. First developed by Glaxo Holdings Ltd, ranitidine remained popular until FDA yanked it from the market in 2020. The agency noted that the drug frequently contained the potentially cancer-causing contamin…

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  • June 28, 2022
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