President/Owner/Consultant & Chair of IPEC-Americas QbD Committee Black Diamond Regulatory Consulting/IPEC-Americas Lansdale, Pennsylvania
The European ban on the use of titanium dioxide for food use has called into question its use in pharmaceutical products because its pharmaceutical use was predicated on its approval for food use. The European ban is not based on hard science, but rather the precautionary principle. There is no hard evidence from scientifically credible studies that titanium dioxide represents a real safety hazard in either the short or long term. If the ban is extended to pharma, then tens of thousands of products would have to be reformulated. In some cases, particularly with older products, and low volume products, it may not be economically feasible to reformulate, and the products will simply be withdrawn from the EU market to the detriment of patients, particularly for some orphan diseases.
Existing alternatives to TiO2 will typically not give as good protection to the API against light as those containing titanium dioxide. This is not just an issue of color matching. It may not be possible to reformulate some drug products to have equivalent shelf life and appearance to existing products.
This presentation will provide an overview of the issue, the facts related to TiO2 safety, the potential impact of a ban on European patients, what’s happening globally, and the work that IPEC and other organizations are doing to push for good scientific re-evaluations by world-wide regulators.
Learning Objectives:
Participants will understand what has happened in Europe with TiO2 (E171) and how the food ban in Europe may potentially impact patients and the pharmaceutical industry.
People will find out how global regulators feel about the EFSA Opinion that drove the food ban of Tio2 in Europe.
Participants will gain knowledge about the limitations of the various TiO2 alternatives and what impact their use might have on drug quality, stability, manufacturing and costs.
Information will be shared about what drug products may be reformulated and what ones will not be be which will result in major drug shortages.
Information will be shared about Industry actions to prevent the spread of this unscientific precautionary ban on TiO2 from impacting pharmaceuticals.