Hello Folks!
With my 35years of professional experiences Titanium Dioxide TiO2 is generally used for pharmaceutical products in the coating formulas to give a brilliant white appearance to any dull surface of compressed tablets specifically with mixtures of multiple granules or excipient. The amount used is very negligible even not in Nano gram per tablet. Considering it amounts and purpose of use I don't think it should be a concern. Whereas, in the food products its usage is in high percentage, it is almost in a few grams quantities per serving. Hence its possible concern of carcinogenic affected. Hope you will share this with the committee.
Masihuddin Jaigirdar
Pharmaceutics Expert Specializing in FDA & Industry Sector
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Masihuddin Jaigirdar
Pharmaceutics Expert (FDA & Industry Sector)
MJ Consultant
Silver Spring MD
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.MasihuddinMasihuddinMasihuddinMasihuddin
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Original Message:
Sent: 10-17-2022 09:24
From: Allison Radwick
Subject: Excipients Community Meeting, Tuesday, October 18 from 11:15 am–12:00 pm ET at PharmSci360
Potential Impact of the EU TiO2 Food Ban on Pharmaceuticals
Monday, October 17, 20223:45 PM - 4:00 PM
Room: 205 C
David R. Schoneker, M.S. - Black Diamond Regulatory Consulting/IPEC-Americas IPEC-Americas has been following what has been happening in Europe related to titanium dioxide for a number of years. The European ban on the use of titanium dioxide for food use has called into question its use in pharmaceutical products because its pharmaceutical use was predicated on its approval for food use. The European ban is not based on hard science, but rather the precautionary principle. There is no hard evidence from scientifically credible studies that titanium dioxide represents a real safety hazard in either the short or long term. If the ban is extended to pharma, then tens of thousands of products would have to be reformulated. In some cases, particularly with older products, and low volume products, it may not be economically feasible to reformulate, and the products will simply be withdrawn from the EU market to the detriment of patients, particularly for some orphan diseases. The cost of a major reformulation, a SUPAC level III change in the US and a Level IA or II variation in Europe may be up to 0.5 to 1.5 million Euros per
product depending on drug complexity. This is not a trivial cost for any product. In summary, a ban on the use of titanium dioxide in pharma products is not based on hard scientific evidence and will likely adversely affect patients without any actual improvement in patient safety that can currently be documented. What does industry need to do to make sure that good science is the basis of any decisions related to the use of titanium dioxide. This presentation will provide an overview of this developing situation and the actions being taken by industry to ensure that good science be the basis of any further decisions concerning the use of TiO2 in pharmaceuticals.
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Allison Radwick Ph.D.
Pharmacology SME
LearningMate
New York NY
[email protected]
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
Original Message:
Sent: 10-16-2022 16:37
From: Allison Radwick
Subject: Excipients Community Meeting, Tuesday, October 18 from 11:15 am–12:00 pm ET at PharmSci360
Join us for the Excipients Community Meeting on Tuesday, October 18 from 11:15 am–12:00 pm ET at PharmSci360 at Spotlight Stage 1, Solution Center at the Boston Convention and Exhibition Center. We are looking forward to seeing you in person.
Excipients Community Leadership
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Allison Radwick Ph.D.
Pharmacology SME
LearningMate
New York NY
[email protected]
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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