Resources to help educate reluctant excipient suppliers?

[Yosukemino]

Thank you for adding me to this interesting discussion, @Naiffer_Host.

IPEC position paper clearly explained MAH should take responsibility for risk assessment. Excipient manufacturers help with assessment but it is not an obligation for them. On the other hand, the IPEC and the Lhasa nitrite consortium held a collaborative meeting to solve this issue. I think now excipient manufacturers are more friendly than before.

Insights from the Lhasa Limited and IPEC Europe Nitrites collaborative meeting

“The meeting provided an opportunity to share our common difficulties and discuss solutions to establish robust and accurate methods for analysing nitrites in excipients.” It’s a wonderful opportunity for both pharmaceutical companies and excipient manufacturers. I want to hear more about this meeting. Can anyone comment about that?

Some excipient manufacturers such as IFF, DFE Pharma, and Asahi Kasei, provide low nitrite-grade excipients. To buy their products is another way.

Low nitrite excipients

What do you think of making a list of excipints brands that are offered as low-nitrite grade? for example AVICEL® PH LN: https://www.pharmaexcipients.com/wp-content/uploads/2023/07/iff.pdf I think we can start with fillers as are confirmed to be the largest source of nitrite in the drug products, for example: *Microcrystalline celloluse *Crosscarmellose sodium

And I want to add the recent discussion in the community. As far as I know, we do not have a magic bullet for this issue. Worst case estimation may be available but it is considered too conservative. MAH may test the amount of nitrite in their excipients by itself.

Potential Topic for an event concerning obtaining the right level of Nitrosamine Risk Assessment information from your CMOs

Thanks @DanitaBroyles for the idea… When we thought it was a thing of the past, the more we discussed risk assessment, the more gaps we identified. Allow me to express my concern. It has become increasingly common to encounter companies’ risk assessments founded solely upon terse, single-page documents provided by their suppliers, bearing the familiar refrain of being “free of ANY Nitrosamines.” While such assertions would be assuring if substantiated by robust investigation and accompanying da…