Titanium Dioxide Free Drug Products: Challenges During Drug Product Development

When:  Oct 5, 2023 from 12:30 to 14:00 (ET)
Associated with  Regulatory Sciences Community

The European Medicines Agency is evaluating a ban on TiO2 in pharmaceutical products by 2024 due to genotoxicity concerns about nanoparticles which are present in grades not relevant to pharmaceutical uses. TiO2-based film coats have been around for a long time. And therefore, pharmaceutical companies have understood the risks and limitations of the various film-coats and improved upon them. TiO2 present in these film-coats provide uniform elegant appearance and serves as an effective opacifier to help mitigate the photostability risk of a drug substance where there is a liability for it. All the benefits can be achieved by using minimum weight gain that helps with processibility too. However, film coats with an alternative opacifier, such as CaCO3, rice starch, and MgCO3, may pose risks for drug product development because of lack of experience, effectiveness as an opacifier, and potential for the basic pH microenvironment leading to chemical stability risk. As the industry is gaining experience, there is a realization that the alternative opacifiers need a much higher weight gain to achieve a uniform film coat and to act as an effective opacifier but the appearance is still not as good as the TiO2 film coat. The rice starch-based film coat does not work as a good opacifier to help with photostability risk. CaCO3 works as a relatively better opacifier but having a basic pH microenvironment creates a stability risk for the drug which is prone to hydrolysis. The symposia focusing on the potential use of TiO2-free coatings will provide benefits to scientists from industry, academia, and regulatory agencies to help share the information/learning and navigate through the challenge being faced by the industry, if TiO2 were to be banned in pharmaceutical applications.

Learning Objectives:

  • The current solutions available for Titanium Dioxide free film coatings - benefits and limitations
  • Education on the challenges gained through industry experience can be shared
  • Members will have an opportunity to engage in one of the current major challenges
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