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TiO2 EU Regulations and Pharmaceuticals: What's Next?

June 5, 2024

In 2022, the European Union banned the use of titanium dioxide (TiO2) in foods. The pharmaceutical industry has relied on TiO2 as an opacifier for tablet film coatings, and while this ruling did not affect pharma products, there has been growing concern that these TiO2 regulations could be expanded to the pharmaceutical industry.

To help pharma companies better understand the current regulatory environment surrounding TiO2 and how it impacts their industry, we spoke to David Bain, Senior Manager of Product Development at Colorcon. In the following Q&A, David will help you understand where regulations stand today, where they are going, and what alternatives to TiO2 are available to the pharmaceutical industry.

Q: Can you provide an overview of the recent EU TiO2 regulations and how they pertain to the pharmaceutical industry?

A: The question of titanium dioxide safety has been a part of the scientific discussion for a long time. At one point, there was an article published on animal studies suggesting there could be a risk of pre-cancer in animal studies, and this produced some momentum in the public that triggered various European agencies to get involved. I think the science got lost in the sentiment a bit, and then consequently there was a judgment made by the European Commission that titanium dioxide was no longer safe, including in dietary supplements.

Early in these discussions, we decided we wanted to get ahead of this situation early and started to build products without titanium dioxide. Now it’s been banned in dietary supplements. There is no review of its future use in pharmaceuticals, and my personal view is that it will continue to be allowed to be used in pharma. However, I think many companies will steer away from it.

Q: What impact does this have on pharma companies?

A: One of the consequences of losing titanium dioxide is in terms of the functionality of the material. You also lose a bit of your color palette, and you lose a bit of productivity. So the customer has to make significant compromises.

Removing titanium dioxide set back formulated film coatings by 15 to 20 years. Colorcon has been trying to recover that productivity loss and the loss of functionality. That’s really made up a lot of our efforts. We’ve continued to build a portfolio of titanium-free products.

We help the customer understand what’s happening and what’s going on with the regulations and what implications it may have for them, and of course how we’re de-risking their pipeline and their product development by creating titanium-free options.

My simplest advice to companies is to test titanium-free products against those with titanium dioxide in parallel. Most pharma companies are happy to do that given the relatively minor cost. Ultimately, they will have to make a decision when they get deeper into clinical trials to determine if they will use a formulation with titanium or without. If I’m a pharma company and I can formulate a product that doesn’t use titanium dioxide without compromising color, productivity, or functionality too much, I’m going to take that option.

Q: What are the benefits of having a titanium-free option?

A: I think the customer's benefit is that Colorcon continues to de-risk their pipeline. By having a titanium-free option, if there is a ruling potentially banning them, we’ve covered the customer and given them options that limit any compromise in functionality, color, or productivity.

That’s the benefit of our portfolio: the fact that we continue to add functionality and improve those aspects of the coating, as well as continue to help customers rediscover film coatings without titanium. The benefit has as much to do with the technical support as the product itself.

Q: What else should pharma companies understand about the regulatory environment?

A: The European Medicines Agency is expected to publish guidance soon on future of pharmaceuticals, and then that would be enacted in April next year. So I think that’s what people are waiting for.

In the initial panic, there was a request by the European Medicines Agency for companies to test all the alternatives, and they’ve all done that. And that actually helped us ultimately, because it did tend to show the superiority of our products side-by-side. It reaffirmed Colorcon’s commitment to film coating and our understanding of it, as well as our unrelenting desire to get the very best product for the customer.

Q: Why is Colorcon best positioned to help pharma companies through this regulatory environment?

A: Our advantage is we’re aware of what’s going on in the market. We keep our ears to the ground. In the future, if there are any other developments, we will be quick to assess the risk to the customer and enter into a measured dialogue with them early on, and we’ll continue to engage with them. I think the situation with titanium dioxide has further demonstrated that commitment.

bainAbout the author: David Bain is the Managing Director at Colorcon. He is based in Dartford, England.

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