Free Webinar: Nitrosamines in Drug Products

Events / Workshops / Webinars
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Dear All,

We are hosting a free webinar series beginning Tuesday, September 19, 2023 and it will include the following topics:

  • New Approaches to set AI for NDSRI
  • Use of an in silico tool to determine the molecular susceptibility of compounds forming nitrosamine degradation products
  • N-Nitrosamine formation in pharmaceutical solid drug products
  • The Chemistry of N-Nitrosamines: Insights and Implications

More information and registration can be found here:

We hope you can join us!

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It was a fantastic webinar, today. I am interested in the prediction of nitrosamine formation with insilico software, Zeneth. The presenter, Rachael, explained that impurity nitrite in the acesulfame K is inevitable due to its manufacturing process. We should pay attention to such excipients.

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Thank you for your feedback and question. Please find below the response from the speaker, Rachel Hemingway:

“Thank you for your kind words Yosuke, I’m glad you enjoyed the webinar. For transparency the example I showed regarding an assessment of the potential interaction between varenicline and acesulfame potassium was purely illustrative – what I mean by that, is that I don’t know that this is actually a ‘good’ pairing for a formulation in an industrial setting. However, the point around acesulfame potassium containing a nitrite impurity comes directly from data in the nitrites database i.e., at least one member of the nitrites consortium has detected nitrite in acesulfame potassium. On that basis yes, I think that where there is data for nitrite levels in excipients be that from experimental data, literature data or the nitrites database this should be a consideration when doing a nitrosamine risk assessment. I direct you to this paper for more information: A Nitrite Excipient Database: A Useful Tool to Support N-Nitrosamine Risk Assessments for Drug Products, Boetzel et al, J. Pharm. Sci., 2023, 112, 1615-1624.”

All the best,

Dave

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Great resource!, thanks @dplucey

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I will add that this series is ongoing. It has been very helpful. Additionally, the videos and slides are available on demand.

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It’s fantastic if you can share the recording and presentation materials here for the rest of the community members. Truly appreciate!

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Simply follow the same link on the original post. They made it really easy to find everything.

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The recording and slides of the last presentation by Dr. Garry Scivens were updated. It was a fantastic webinar. He focused on the volatility of nitrite and the effect of humidity in the air on nitrosamine formation. He also demonstrated the availability of the ASAP approach for predicting long-term stability.

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He approached nitrosamine formation in solid-state drug products from several scientific angles. It may look a bit complex, but it is worth looking at. I want to know more. Great Presentation!!

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Thank you Yosukemino for the notification regarding dr Scrivens presentation. It is really interesting.
I remark some ingenious experimental work, fresh ideas and a few intriguing results presented on the slides.

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This was really a very informative webinar. The link at the top comment brings you to the on demand video & slides.

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Thank you Yosuke and Jason, your feedback and support are much appreciated!

Dave

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Really can’t recommend enough watching this presentation if you are working on nitrosamines in solid dose products.

I hadn’t considered the salt solutions as “sinks” for NOx in ASAP studies - going to have to be on the look out for that.

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  • I love the idea about studying the solid phase reactivity of the APIs, additionally to the standard NAP and IQ solution tests.
  • The effect of humidity on the loss of nitrite from MCC is a surprising result
  • The fact the API base is more reactive toward nitrosating agents is counterintuitive, as mentioned in the presentation, and against the concept that HCl in the salt form, for example, is a proton source needed to convert NO2- in active species and Cl- a catalyst. I understand that when it is about volatile nitrosating species reacting with solid API, but not when it is about MCC+API mixture.
  • Moreover, the results in the presence of the basic excipient MgCO3 are also intriguing. A CH2O catalyzed reaction occurs or there is only MgCO3 with high nitrite content and the free-base API present in the formulation?
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