Antioxidant as a risk mitigation strategy

As a part of risk mitigation strategy, Innovator have added antioxidant to control NDSRI. In general addition of any new excipient in generic approved formulation call for bioequivalence study.
Any lead to justify bio-waiver for revised generic formulation for approved drug product w.r.t. addition of antioxidant (less than 0.5 % of total formulation) to control NDSRI.

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Lack of effect of antioxidants on Biopharmaceutics Classification System (BCS) Class III drug permeability -Pub - New Scientific Knowledge & Development - Nitrosamines Exchange (


Thanks a lot for sharing a very interesting and insightful article.

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No problem.

I don’t think it is 100% an answer (yet) but may be used to help build a case around whether or not a BE study is needed, and what can be used as alternative proof for applying for a waiver for a BE study.

You might find this useful as well:
Mitigation Strategies for Nitrosamine Drug Substance Related Impurities: Quality and Bioequivalence Considerations for Generic Products - The Center for Research on Complex Generics (CRCG)


Many thanks for providing link for concerned topic.