Aptar’s N-Sorb Nitrosamine Mitigation Solution Accepted to US FDA’s Emerging Technology Program

Drug and consumer product technologies developer AptarGroup said that its N-Sorb nitrosamine mitigation solution has been accepted into the US Food and Drug Administration’s (FDA) Emerging Technology Program (ETP).

The programme aims to support new methods of pharmaceutical product design and manufacturing.

N-Sorb nitrosamine mitigation solution uses the 3-Phase Activ-Polymer platform technology of Aptar CSP Technologies, a unit of AptarGroup. The technology is designed to tackle N-nitrosamine impurities in pharmaceuticals.

These impurities are probable human carcinogens, raising regulatory concerns and leading to drug recalls.

Nitrosamines can form during storage or transport, which poses risks to patient health.

N-Sorb technology, launched in early 2020, can be deployed into various formats by combining active material science with polymers.

It can be incorporated into a blister pack that uses N-Sorb Activ-Film material in each Activ-Blister cavity.

This technology protects sensitive Active Pharmaceutical Ingredients (APIs) from moisture and oxygen.

It can also be used in container closure systems. N-Sorb reacts with nitrosamine precursors in packaging to inhibit nitrosamine formation and scavenge existing impurities after they have formed.

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Thanks a lot Yosuke for this update, it looks very interesting.
What i cannot figure out, even from their ‘‘white paper’’ is if in this N-sorb technology, a nitrite scavenger is also included.
If not, then the phrase ‘‘scavenge existing impurities after they have formed.’’ is not valid, is it?
Do you have any idea on this?
thanks again

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Hi Chrischar,

The N-Sorb technology platform is tailored to each specific drug and reaction. Given the numerous variables involved in nitrosamine formation, we utilize specific active agents or processed porous materials to achieve an overall reduction or prevent the growth of the targeted nitrosamine. Our team at this time has been able to evaluate 300+ actives. Our active agents can be employed to react, buffer, scavenge, adsorb, and more, depending on the specific application. If nitrite is identified as the primary contributor to nitrosamine formation, we incorporate an active agent that has been evaluated and proven effective in mitigation or preventing nitrite. The methodology is similarly applied to lower molecular weight nitrosamines.

Hope this helps!
Ivy

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Ivy,
thanks a lot for your detailed explanation, it is much appreciated.
christos

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Hi Ivy,
How do you control or confirm that the blister is not leaching nitrosamines or other nitrogen derivates with the time?
Thanks.

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Hi Frabaneda,

If I understand your question, you’re asking how/if we quantify what nitrosamine or nitrosating agents may be leaching out of the blister? In this case we have a study that was just completed that targeted a similar question. We measured against a control with our films in blister over the course of 18 weeks in accelerated aging and did, in fact, see this phenomenon. We are hoping to share more details in a publication soon!

Thanks!

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Thanks Ivy.
Really appreciate.
If you can share the paper with the group here will be great from your side.
Waiting for your news.
BR

1 Like