PQRI Workshop: TiO2 Use in Pharmaceuticals – Global Regulatory and Technical Challenges – Presentations

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Day 1 – June 13, 2023

Welcome and Introductory Remarks
David Schoneker, IPEC-Americas, Black Diamond Regulatory Consulting LLC; Chair – PQRI Workshop Organizing Committee

Overview of the Potential EU Ban of TiO2 in Pharmaceuticals

Update on the History and Current Status of TiO2 (E171) in Europe (Foods and Pharmaceuticals) and Concerns Related to Excipients Containing Nanoparticles
Kevin Hughes, Colorcon Ltd (IPEC Europe) and Bram Baert, Lonza

Critical Considerations About the Basis for EFSA’s Opinion on TiO2 Safety in Foods
David Lockley, Venator (TDMA)

New TiO2 Safety Information since the EFSA Opinion

A Review of the Genotoxicity of Titanium Dioxide (TiO2)
David Kirkland, Kirkland Consulting

A Weight of Evidence Review of the Carcinogenicity of TiO2
Samuel Cohen, University of Nebraska Medical Center

Evaluation of the Immunologic and Intestinal Effects of Dietary E 171 (Food Grade Titanium Dioxide) Consumption
Lance K. Blevins, Institute for Integrative Toxicology, Michigan State University

Global Assessment of TiO2 Safety

FDA and other Regulator Perspective on TiO2 Safety – Current Global Status
David Schoneker, IPEC-Americas, Black Diamond Regulatory Consulting, LLC

Efforts in the US to Ban TiO2 in Various States and Through a Color Additive Petition
Jay West, Titanium Dioxide Stewardship Council

TDMA’s New Science Program for TiO2
David Kirkland, Kirkland Consulting & David Lockley, Venator (TDMA)

Breakout Session 1 – Scientific Understanding & Awareness of the Safety of TiO2Day 1 Breakout Summary SlidesModerators: Uma Bruen, Organon and George Collins Jr, Vanderbilt Chemicals LLC
Notetakers: Kevin Hughes, Colorcon and Courtney Callis, Eli Lilly and Company

Day 2 – June 14, 2023

Welcome to Day 2 and Review of Day 1 Breakouts
David Schoneker, IPEC-Americas, Black Diamond Regulatory Consulting, LLC; Chair – PQRI Workshop Organizing Committee

TiO2 (E171) and Currently Available Alternatives

Overview of Pharmaceutical Uses of TiO2 and Technical Challenges with the Use of Alternatives
Mike Tobyn, Bristol Myers Squibb

Technical Challenges Substituting TiO2 from Different Coating Producers’ Point of View
Charlie Cunningham, Colorcon

Replacing TiO2: Challenges and Opportunities From a Capsule Shell Producer Point of View
Bram Baert, Lonza

The Impact of Replacing TiO2 on Product Quality, Resources and Availability

Examples of Technical Challenges in Drug Products with Titanium Dioxide Alternatives
Jason Melnick, Eli Lilly and Company

Impact of Film Coating Change on Product Quality
Andreas Abend, Merck

Impact on a Large Global Pharmaceutical Manufacturer: Manufacturing, Supply, & Patient Implications of a TiO2 Ban in Pharmaceuticals
Bruno Hancock, Pfizer Inc.

Challenges to Providing Essential Drugs if a TiO2 Ban Takes Place: Generic Drug Manufacturer Perspective
David Cragin, Teva

What Could be Next

Potential for Expansion of Similar Concerns in Europe to Many Other Important Excipients based on the French ANSES list of Food Additives that May Contain Nanoparticles (Update on E172)
Thomas Broschard, EMD Serono Inc./EI72 Consortium

Breakout Session 2 – Experiences when Evaluating Alternatives (Materials or Approaches) for Use in Pharmaceutical Drug ProductsDay 2 Breakout Summary SlidesModerators: Jason Melnick, Eli Lilly and Company and Andreas Abend, Merck
Notetakers: Bram Baert, Lonza and Rohit Tiwari, Eli Lilly and Company

Review of Day 2, Summary of Key Points and Actions Needed and Closing Remarks
David Schoneker, IPEC-Americas, Black Diamond Regulatory Consulting, LLC; Chair – PQRI Workshop Organizing Committee