Interesting article from our team. Our hypothesis is that by removing gaseous NOx, we effectively remove nitrite as the system reequilibrates. Would love to hear your thoughts.
Dear Jason Brown,
Greetingsā¦
I have gone through the article and hypothesis study of packaging-based solution to nitrosamine mitigation. The study conducted is really informative.
But there are few points which needs to be considered in the further studies.
It is already mentioned in the conclusion of this article that there is no established correlation between the temperature and humidity conditions used in this study. This is important as the adsorption process on N-Sorbs films can be reversed at higher temperatures (desorption process to achieve equilibration). This might give variation in results when there is a temperature variation over a true shelf life.
Further the study has to be done to check the capacity of these N-Sorbs films to adsorb NOx gases from the sample /bottle (headspace) without nitrite-free humidity.
Lastly, the āNitritesā present in the excipients are directly reacting first with the Drug substance present in the tablets (in compact form) as Drug is in direct contact with these excipients. This āNitritesā helps to generates either smaller Nitrosamines or NDSIRs over the shelf life. So how much of this entrapped NOx (in excipients) will get directly adsorb on the N-Sorb films needs to be studied, especially in Tablet formulations, which I feel is a challenge.
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Agreed. We really wanted everyone to understand it was a proof of concept study only. A lot of further work is needed.
Dear Jason,
Indeed it is a new concept and needs more research on it. So understanding the future requirements, we at our R&D have already requested these N-Sorbs samples from Aptar CSP for evaluation purpose. By mid of this month we are expecting to get the samples.
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Hi Jason,
is it something relative to the below?
thanks!!
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Yes, it is. The technology works, and there definitely is a specific space where this would be the best path forward.
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Thank you all for the great discussionā¦ I would like to open this question to all interested parties: Is there interest in R&D collaboration in this area? The community has served as an incubator os several of these collaborative projects before.
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thanks for the confirmation Jason. We have communicated with people from Aptar about this and we have been convinced that this could work. Is no nice to see in practice the basic rules of chemistryā¦Le Chatelierās rules 
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Agreed. Iām more than happy to talk through what we did and our thoughts on the next phase of development with anyone who may be interested in moving this forward.
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There is an ongoing study at our facilities, too. From theoretical point of view, and based on some results I have seen, I donāt see it as a magic bullet, but a mild mitigating factor which in some circumstances may have an utility, as a brake on the development of nitrosamines during storage.
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Jason, do you know if this technology is ready to be applied in the manufacturing process? Could someone to use this in a commercial product? As i remember from the discussion we have done with Aptar before sometime it was not been approved yet from FDA and was not available for commercial usage.
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Thatās a great question. My understanding is that they have a similar technology for humidity control and oxygen scavenging currently commercialized. However, I got the impression that they are still in prototypes entirely.
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