How much nicotine remains in a nicotine pouch after months of storage? And can formulation design improve long-term stability?
In this presentation, Anna Balconi explores preliminary research comparing conventional microcrystalline cellulose (MCC)-based nicotine pouches with a novel semi-gel-based formulation developed by Alchem NicSelect. The study examines how nicotine content changes over time and investigates whether different pouch architectures can reduce degradation caused by oxidation and evaporation.
Transcription:
GFN Science Lab 1 — Anna Balconi
2026-06-04 · 11:30-13:00 (Europe/Warsaw) · Global Forum on Nicotine 2026
Gizelle Baker 0:00:10
So we've talked about how nicotine pouches are designed, what they contain, and how to interpret the evidence around them. This video is doing something slightly different. It's looking at a very practical question. Once the product is made, how stable is it? Does it reflect what's on the pack of the pouch afterwards? How much is there two months later, a year later?
I mean, these are really important questions, because once we put the product out there in the market, it becomes in a little bit more uncontrolled manner, and we have to understand what's happening over time. So this will affect the consumer experience on the other side. So let's open for that video, and then we'll hand it over to Anna to talk about.
Video 0:00:59
A comparative assessment of nicotine stability over time. Conventional MCC-based versus novel semi-gel-based nicotine pouch formulations. Alchem NicSelect is a leading manufacturer of nicotine solutions for the vape, pouch, and next-generation product industries.
Through its dedicated pouchology research center, the company advances pouch formulation and conducts applied research in emerging nicotine delivery technologies. In this study, we present a comparative assessment of nicotine stability over time in conventional MCC-based pouch formulations and a novel semi-gel-based formulation developed by Alchem NicSelect.
what happens to nicotine inside a pouch over time. Although consistent performance is expected, the physicochemical behaviour may vary. Nicotine degradation driven by evaporation and oxidative processes can influence product stability and performance.
In this preliminary assessment, nicotine stability over time was compared between conventional MCC-based and semi-gel-based pouch formulations. The aim was to evaluate the ability of each system to retain nicotine content during storage under controlled conditions.
Four cans of a leading commercial MCC-based nicotine pouch brand were purchased from retail and analysed at three months post-manufacture against labeled nicotine content. In parallel, nine semi-gel-based pouch formulations were produced and analysed at predefined intervals from T0 to six months using standardized methods.
All results were normalised and reported in milligrams per gram. Analysis of MCC-based samples showed a marked reduction in nicotine content at three months. Losses ranged from approximately 23% to over 40%, depending on the sample. These results indicate nicotine degradation over time, with possible contributions from oxidation and volatility-related losses.
In contrast, semi-gel-based samples showed improved stability profiles. Across multiple batches and formulations, nicotine loss remained low, ranging from approximately 0 to 6% over a six-month period, with several samples showing minimal deviation from baseline values.
These preliminary results indicate a lower rate of nicotine content change over time in semigel-based nicotine pouches compared with conventional MCC-based systems. The observed stability may be associated with the structural characteristics of the semigel matrix.
The semigel system forms a cohesive matrix that encapsulates nicotine within a semi-solid phase, potentially limits exposure to environmental oxygen, may reduce volatility-related losses, These findings suggest that formulation architecture may play a critical role in nicotine stability.
The semi-gel system appears to reduce key degradation pathways, including oxidation and volatility-related losses. Together, these results highlight the potential of formulation design in influencing stability outcomes in nicotine pouch systems. Further studies under extended conditions are warranted to confirm these observations.
Anna Balconi 0:05:00
So thank you very much for being here. Just to give you a little bit of a context about this experiment that we did in-house, and is absolutely preliminary, so the limited number of samples needs to be taken into account. really related to QC because one of the key activity of Alchem is to keep on innovating and proposing solution for the nicotine industry.
We do not manufacture finished product. We do manufacture nicotine and we do develop solution to support companies producing product containing nicotine. But one of the key point is to have products that pass QC control and that can be reliable. meaning that in a context of tobacco harm reduction, to be heard, you need to be a quality product to be placed on the market.
The semi-gel base that we developed was initially developed to propose an alternative, an innovative alternative, focusing on flavour and nicotine delivery. But of course, you cannot propose something without testing it and without proving it is stable, it is safe, it is nice to be used. And what we discovered in terms of stability of this product was surprisingly.
Because we normally run a QC study to see if our product has a stable content of nicotine over time before proposing it to our customer.
And when we saw the result, we decided to make a comparison to see if this novel base that we developed can be beneficial also for our customer in terms of an innovative solution, not only for the performances in terms of satisfaction of flavour and nicotine, but also on stability.
Because we do know that sometimes nicotine content in pouch due mainly to the packaging may vary over time. And this is a little bit the background of the study that we run. We are running another study with a bigger sample base following ICH guideline for stability so that the data can be substantiated by a scientific method recognised worldwide.
And we will likely present this data in the next iteration of GFN, hopefully next year.
Gizelle Baker 0:07:31
So up to you. Well, looking forward to seeing that next year. But I just had a question based on something you said. You mentioned the packaging plays a role in the nicotine stability. So in this study, does it in any way, shape, or form control for the variability in the packaging between the different products?
Anna Balconi 0:07:48
To be honest, in order to make this first assessment, we use the same type of packaging as the product that we purchase from the market. Just for complete information, we did actually purchase product from a shop, because we would like to have real-life comparison. We know that the main packaging used for pouches is a can, is a plastic can.
We don't know actually if it is the best possible solution or not. But maybe this data can also be interesting to start a discussion on possible alternative packaging, not only on possible alternative bulk material, as the one that has been presented by and free, sorry. But, I mean, in a broader perspective, you know?
Gizelle Baker 0:08:47
Perfect. So let's open the floor for any questions for Anna.
Attendee 0:08:51
It was similar between the MCC and Saint-Michel.
Anna Balconi 0:08:56
It really depends on the form of nicotine that you use. As you know, nicotine pouches can be made with different types of nicotine, different forms of nicotine that behaves in a different way, not only in terms of delivery of nicotine. compound like polycrylex as a sustained release of nicotine while freebase tend to be more immediate and of course they have different pH.
When you do manufacture pouches with nicotine salt or nicotine polycrylex you tend to have pH that is lower while when you do manufacture pouches with freebase the pH is higher.
So our pouches are more or less aligned with a slightly lower pH than the MCC-based nicotine pouch, but this is by design, meaning that the semi-gel matrix has specific features related to the compound that are inside to form a gel matrix that have a slightly lower pH than MCC-based pouches.
Attendee 0:09:54
Okay. And one second question, if I may. And when it comes to the pouches with lower content of nicotine, is there also such a difference? Because you show 15 milligrams per gram here. Yes.
Anna Balconi 0:10:12
We are, as I was saying before, we are broadening a little bit the base of pouches to be used in the test that we are running now because, of course, Limiting the test to one nicotine content is not completely indicative. May show a trend, but cannot be definitive.
In the test that we are running now, we purchased 11 different types of nicotine pouches from the market made with different types of nicotine and with different moisture level. Because also comparing dry pouches and wet pouches may have a strong influence in the outcome of the stability over time.
And the same we are doing with the sample that we did manufacture with our technology. So it is important to check different types of nicotine, different level of nicotine, different level of moisture. Yeah.
Attendee 0:11:02
Okay. Thank you very much.
Gizelle Baker 0:11:03
Do you have a question?
Anna Masser 0:11:10
So when it comes to pouches and stability, we tend to look where we live. So in this climate, pouches tend to be very stable, but they should also be able to function in a rainforest or in Sahara. So I wonder what conditions did you test in?
Anna Balconi 0:11:33
We tested in this climate zone for this moment. The further testing that we are running are done in India, where we do have the bigger R&D center, where we do have the manufacturing plant and we plan to test different climate area.
But in this moment, the main point that we would like to explore is to see if there is a trend and a different behaviour of the platform that we developed compared to the basic MCC. is not, the aim of this study was not to have a complete stability study as per ICH, is to see if there is a trend.
We saw this trend and now we are broadening the investigation because it is worth to understand a little bit more what can happen. Also, this is interesting for us because being semi-gel based, temperature of the environment may play an important role on the consistency of the product. So this is something that we would like to investigate. Thank you.
Gizelle Baker 0:12:40
So I know we're running out of time, but I think we have time for one or two more questions.
Attendee 0:12:45
Yeah, in the... I'll say it. In the samples that showed a significant loss of nicotine, did you also see visual differences, discoloration, for example, or other quality signs?
Anna Balconi 0:13:00
Not really. The immediate feel was dryness.
Attendee 0:13:04
OK.
Anna Balconi 0:13:05
The immediate thing that we saw, it is the dryness. And of course, in the broader study, also parameters such as water content, water activity, and LOD are important to be taken into account.
Gizelle Baker 0:13:24
I think we have one question from back there.
Attendee 0:13:30
Yes, a very simple question. I mean, you showed graphs of the concentration of nicotine going down, but did you measure the weight of the actual pouch so there was no change?
Anna Balconi 0:13:39
Yes, there is a change in weight. We didn't display that. It will be part of the broader study, but of course there is a significant difference. modification in the weight. Also because, as I was saying, the dryness was clearly evident and there is a reduction of weight related to the evaporation of other compound, not only the nicotine.
Attendee 0:14:04
So when you calculated the actual content of nicotine, did it go down as much or it was more concentration?
Anna Balconi 0:14:10
Say it again, sorry.
Attendee 0:14:11
The actual content of the pouch, did that go down as well because you just showed the concentration?
Anna Balconi 0:14:16
Yes. When we did the study, we put together a method to quantify the exit weight of the pouches It is not shown. It's more technical. If you want to deepen it a little bit, I'm available for a more specific talk, and we can set up a call. But we did measure the exact amount of powder that is inside each pouch, because you have to consider that as well.
So not all the machineries are the same. Not all the weight of the pouches are the same, unfortunately. So this is something that needs to be taken into account.