A Hybrid Event June 13-14, 2023
PQRI TiO2 Position Paper
The PQRI TiO2 Workshop Organizing Committee and workshop speakers prepared a PQRI position paper derived from the PQRI June 2023 TiO2 Workshop. The position paper provides an overview of the significant information that was presented by the expert speakers who participated in the workshop as well as ideas that were discussed during breakout sessions held to obtain broad feedback from the workshop participants on several key points related to TiO2 safety and the challenges of using TiO2 alternatives in many drug applications.
Click to view the Workshop Summary
Link to International Pharmaceutical Quality (IPQ) article on Workshop
PQRI hosted a hybrid workshop – TiO2 Use in Pharmaceuticals – Global Regulatory and Technical Challenges to be held on June 13- 14, 2023 at the Bethesda Marriott (5151 Pooks Hill Road, Bethesda, MD).
Workshop Objective:
This workshop brought together material suppliers, the pharmaceutical industry, and regulatory experts to discuss the impact removing titanium dioxide would have along with the benefits and challenges of the alternatives to titanium dioxide for use in solid oral dosage forms. This workshop addressed the following key areas:
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- Build awareness for the industry by giving an overview of the issue, an interpretation of the data related to TiO2 safety, and the potential impact a ban out titanium dioxide would have on patients.
- Overview of what is happening globally because of the EU regulation.
- Present the technical challenges that pharmaceutical companies are likely facing when trying to formulate new and reformulate existing drug products with the currently available alternatives. Discuss alternatives for oral solids and oral suspensions.
- Identify areas that need further research to support technical initiatives related to possible additional safety study requirements to support continued safe use of TiO2 or technologies related to the use of TiO2 alternatives where desired.
- Possible classification of titanium dioxide as something other than a colorant.
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Workshop Materials
The Final Program is available here. (As of 6/8/23)
A Workshop Summary is available here.
Presentations
Presentations are available for registered attendees only. (Registered attendees received a password from the Conference Organizers.) Click here to access the presentations.
Recordings
If you missed the workshop and would like access to the Workshop recordings, please complete this registration for access (for a nominal fee).
Questions
Please contact the PQRI Secretariat if you have any questions at +1(202) 230-5607 or PQRISecretariat@pqri.org.