Experts panel discussion on the future use of Titanium Dioxide (E171) in Pharma

We have kept reporting on the latest TiO2 developments, from the 2019 ban in France, over the 2021 EFSA decision in food and feed, to our FAQ on TiO2.

To properly address this important topic, we decided to host a panel discussion on Titanium Dioxide at ExciPerience 2022. The experts Dr. Mahmud Yunis, Dave Schoneker, Dr. David Lockley and Dr. Jason Teckoe joined their host Philippe Tschopp to talk about the future use of E171.

Watch the first 10 minutes here and read the transcript or watch the full panel on Titanium Dioxide directly below the transcript to enhance your knowledge!

Transcript (first 10 minutes):

Philippe Tschopp: It’s interesting. Two weeks ago, I did the same poll on LinkedIn and there was a 45%. vote for exchange for new products only and exchange for all formulations. Now, this might have to do with the audience. Now we have a clear voting that over 60% would exchange it for new products only. So pretty interesting. Now this takes me to the lead or to the topic. This goes to all of you. What do we have to do? Because there seems to be quite some scientific background worked out by TDMA and others. Is it really necessary to to exchange it or not? So what do we have to do together with or between the excipients industry and the pharmaceutical industry? What will be your take on that? And I potentially start with Dave.

Dave Schoneker: Sure. Yeah. Thanks. I think it’s a really good question. And I think your poll actually doesn’t surprise me, given what everybody just heard, which is probably not what people who, you know, fill out your survey before where I didn’t have access to all the information that the audiences just heard about the facts – right? Basically, remember the poll I did in the beginning? You know, there’s a lot of misconceptions about what’s in the media and whether there’s really a safety problem or not. So I think to your question, though, you know, what does the industry need to do? Well, and I think Jason sort of some summed it up pretty good. You have to consider the fact that it could be banned in Europe in three years. And then you need to make a decision about, your own company’s strategy. Do you want to co-develop something with a TiO2 option that may actually provide beneficial properties if it’s a new product versus, you know, an alternative in case it’s banned? But I think the real question, a new product development, I would say that’s probably the smart thing to do. If your product is such that the alternatives work perfectly fine, then there’s no reason not to go to the alternative on the new product. But but again, remember, it’s not just about color. Right? And a lot of the information that was discussed here was about color. Okay? And stability of the color. And that’s obviously important. But the most important part is the stability of the API. And is the API light sensitive because you can match the color with alternatives sometimes, but that doesn’t mean that you have the same API protection that you’re going to get from TiO2. So each case is going to be different. It’s got to be looked at, but I think you really need to separate what do I need to do for new product development where I actually have a choice and I can develop something where, you know, from the beginning with new product and new alternatives versus this concept of exchanging existing products. And I think, it’s changing existing or changing out or converting existing products comes with many difficulties, as have been outlined by Mahmud and the rest of us. And you really have to look at, how much you want to be prepared for a ban versus is it a product where you actually see any economic reason to continue it in Europe if that ban takes place? And I think that’s going to be a big decision point.

Philippe Tschopp: Now, this leads me to question to Mahmud and Jason directly, because you’re in touch with with the pharmaceutical industry. How does this look like in your daily business? Mahmud. Is the demand of TiO2 free coatings increasing? Or do you see this in specific markets only? How would you look at that?

Dr. Mahmud Yunis: So this is our daily work, I would say. So that means the industry is coming to us and looking for alternatives and we are developing alternatives for major pharmaceutical companies, smaller pharmaceutical companies, not only for older products, but also for new projects which are not launched now and at the EMA. So we thought this is really what we are doing daily. And what I said, each medicinal product needs is individual review and individual solution. It is not that easy. You can see the formulation that I showed that this is working with all of these products. So therefore, it is a lot of work and a lot of money which is wasted here.

Philippe Tschopp: Absolutely. Jason – Well, I think you see the same movements on the market, right?

Dr. Jason Teckoe: Oh yeah, absolutely. I mean, we’ve been in conversations with – I mean, we firstly saw it with with obviously food and dietary supplements. That happened probably last year – I would say. But we’re still seeing a lot of movement in that area in terms of number of samples and request conversations with customers. And then this year, I would say we’ve seen a significant increase in the number of pharmaceutical customers now asking us for samples. And we are, as Mahmud said, we’re kind of we’re in the middle of a storm in terms of the number of sample requests that are coming in right now, because a lot of customers are demanding – not only they want the one that’s closest to their existing product. Like: just take the TiO2 out and switch it for something else. They also, you know, they’re like: oh, can I have a …? What is better, even it is not quite the same? And I’m sure Mahmud will echo what I’m hearing. You know, we’re having these conversations where they want two or three samples for every product they have. And the lab is really kind of churning these things out very quickly to keep people keep up to speed. So it’s a real challenge, a good one to have, I suppose, in many ways. But but equally, we’re seeing a lot of interest in pharma customers right now.

Philippe Tschopp: So it’s it’s really a big shift in the coating industry, as I as I understand. So big challenges ahead for everybody. There is a question from the audience and I would like to address this to David Lockley. It’s a little bit into the future. Do you think that EMA or pharma regulatory bodies could continue to allow TiO2 after April 2024, but TiO2 suppliers would need to show maximum percentage of nanoparticles on the. So could we imagine, that there might be, let’s let’s call it “a way out” if everybody works together in the right way?

Dr. David Lockley: As it’s a fascinating area. And within Venator, we’ve been looking at this for quite a while because the obsession with in France is really about the nano content. So all of all the materials that are listed on Dave’s table, the French list, they all contain a nano tail. So that isn’t going to go away any time soon. So one of the things we’ve been developing in Venator is a lower nano content E171 and we have it. It is available. And in a way it was sort of developed at a time, in the interim, before the new EFSA opinion. So we thought, well, this is an opportunity because there’s so much flack around Nano. We will make a low nano material. So conventionally E171 is around about 40% by number. The new version that we make is 8% by number. Well, and we haven’t really pushed it in a big way. We’ve done more in cosmetics than we have in the pharma area. But this is something that we are thinking of putting into the mix is, you know, if if Davy Kirkland’s panel come back and say this study X, Y and Z that you need to do and we do that and there’s no real issue. – There’s a nano debate. What about the new version? So in theory, you know, we could put the particle size distribution information on safety data sheets, on labels. We have a version that’s a lower version of Nano, so it is available. And yeah – the bottom question is , would a slightly larger particle size, the new E171 we make do it? It obviously has what’s called crystal control technology. So we control the size of the crystals. It reduces the level of nano. As you can appreciate, our commercial directors are still wondering at the moment exactly what to do. You know, we have this flow now material, but what do you do with it? So I was in a position where that really well.