PQRI Workshop: TiO2 Use in Pharmaceuticals – Global Regulatory and Technical Challenges
PQRI hosted a hybrid workshop –
TiO2 Use in Pharmaceuticals – Global Regulatory and Technical Challenges on June 13- 14, 2023 and brought together material suppliers, toxicologists and safety experts, the pharmaceutical industry, and regulatory experts to discuss the impact removing titanium dioxide from pharmaceuticals would have along with the benefits and challenges of the alternatives to titanium dioxide for use in solid oral dosage forms. Many experts from around the world provided significant scientific information regarding these topics and the participants discussed their experiences in attempting to use TiO2 alternatives in drug product formulations.
A summary of some key discussions and outcomes from the workshop, include:
- An overview of the current regulatory issues concerning the use of TiO2 in foods in Europe was discussed and how this situation could potentially lead to a ban in pharmaceuticals.
- Information was presented related to flaws in the EFSA Opinion and the current ban of TiO2 (E171) in foods in Europe.
- Key expert scientific opinions on TiO2 safety studies (in particular genotoxicity, carcinogenicity and immunotoxicity) were provided showing that TiO2 (E171) is safe for use in foods and pharmaceuticals.
- The current views of many other global regulatory agencies regarding TiO2 safety were shared showing that they did not have any safety concerns with TiO2.
- Formulation experts discussed the significant limitations of all alternatives to TiO2 and the challenges to drug development that occur when trying to work with TiO2 alternatives.
- The potential impact a ban in pharma would have on patients, the industry and global regulators was highlighted, stressing that a TiO2 ban WOULD lead to significant drug shortages since over 91,000 drug products on the market in the EU alone would be impacted.
PQRI is pleased to offer an opportunity to view the recorded presentations, ON DEMAND, for a nominal fee of $250. Once you complete the registration and pay the fee, you will receive the information on how to access the recordings. (Discount codes are available to government/FDA and other regulatory agencies. Please contact the
PQRI Secretariat for information.)