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May 15th Monthly Meeting: Update on Potential Ban on Titanium Dioxide in Medicines

  • 1.  May 15th Monthly Meeting: Update on Potential Ban on Titanium Dioxide in Medicines

    Community Leadership
    Posted 05-14-2025 21:36

    Dear all,

      Please join us tomorrow at 12-1pm EST with Jason Melnick from Eli Lilly to get the update on potential ban of titanium dioxide in medicines in Europe. Please see presentation abstract and meeting link below.  

       Title:  Pharmaceutical Industry's Response to the Potential Ban on Titanium Dioxide in Medicines in Europe: Update

       Presenter: Jason Melnick, Senior Director at Eli Lilly and Company

     

    Abstract: In January 2022, Europe imposed a ban on the use of titanium dioxide in foods due to concerns over its potential health risks. Titanium dioxide (TiO2), commonly used as an opacifier and colorant, has long been a staple in the pharmaceutical industry. It is widely utilized in drug formulations, primarily in film coatings and hard capsules shells to protect dosage forms from light degradation and to provide a distinct appearance. The ban in foods marked a significant regulatory shift, prompting considerable efforts within the pharmaceutical sector since Regulation 2022/63 requested the "pharmaceutical industry makes any possible efforts to accelerate the research and development of alternatives that would be used as a replacement for titanium dioxide (E 171) in medicinal products, and to submit the necessary variation to the terms of the marketing authorisations concerned".

    Pharmaceutical companies swiftly initiated research with our suppliers of film coatings and hard capsule shells into alternative substances that could substitute titanium dioxide without compromising the quality of medicines. Extensive studies were carried out with the available alternatives to determine the capability of these to serve as a suitable replacement for TiO2.

    This presentation will share the journey the pharmaceutical industry embarked upon by providing an update on the regulatory landscape for TiO2, why and how TiO2 is used in solid oral dosage forms, the various alternatives and industry experiences using replacements.

    Microsoft Teams Need help?

    Join the meeting now

    Meeting ID: 276 076 846 41

    Passcode: qb6Mw9tp


    Dial in by phone

    +1 219-293-4410,,831473683# United States, Gary

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    Phone conference ID: 831 473 683#

    Join on a video conferencing device

    Tenant key: [email protected]

    Video ID: 114 462 010 9

    More info



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    Jiaying Liu Ph.D.
    Associate Principal Scientist
    Merck & Co, Inc - Rahway, NJ
    Rahway NJ
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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  • 2.  RE: May 15th Monthly Meeting: Update on Potential Ban on Titanium Dioxide in Medicines

    Community Leadership
    Posted 05-16-2025 13:45
      |   view attached

    Yesterday, Jason provided a comprehensive overview and latest updates on current regulatory status, alternatives and application of TiO2 in medical products. If you missed this great talk, please check attached slides for more!

    Jiaying on behalf of AAPS Excipient Community LT. 



    ------------------------------
    Jiaying Liu Ph.D.
    Associate Principal Scientist
    Merck & Co, Inc - Rahway, NJ
    Rahway NJ
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
    ------------------------------