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.
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Meeting ID: 276 076 846 41
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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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