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Titanium Dioxide – TiO2
Effects of omitting titanium dioxide from the film coating of a pharmaceutical tablet
An industrial case study of attempting to comply with EU regulation 2022/63
Recently, concerns have been raised about the safety of titanium dioxide (TiO2), a commonly used component of pharmaceutical film coatings. The European Union has recently prohibited the application of this material in the…
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The Potential for a Ban on TiO2 (E171) use in Pharmaceuticals
POTENTIAL TiO2 BAN
STATUS AND IMPLICATIONS
The EU considers banning TiO2 in pharmaceuticals, potentially impacting over 91,000 drug products and causing shortages.
Titanium dioxide, also known as E171 or TiO2, has long been used across the cosmetics, medicine, and food industries without safety…
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Alternative For Prohibited Food Additive TiO2
The discussion about the excipient titanium dioxide in the European food industry is already several years old. TiO2 was banned from food products in the EU and other countries since 2022 as being maybe carcinogenic . This even had consequences for the pharmaceutical industry. Several suppliers now…
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Changes in Tablet Color Due to Light Irradiation: Photodegradation of the Coating Polymer,…
The color of the tablets and capsules produced by pharmaceutical companies is important from the perspectives of product branding and counterfeiting. According to some studies, light can change tablet color during storage. In this study, tablets comprising amlodipine besylate (AB), a well-known…
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Oral toxicological study of titanium dioxide nanoparticles with a crystallite diameter of 6 nm in…
Background
Though titanium dioxide (TiO2) is generally considered to have a low impact in the human body, the safety of TiO2 containing nanosized particles (NPs) has attracted attention. We found that the toxicity of silver NPs markedly varied depending on their particle size, as silver NPs with a…
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Parteck® TA (Calcium Carbonate): Enhanced opacity with ideal particle properties
Titanium dioxide is extensively used in solid dosage forms as an opacifier and colorant. Due to regulatory developments and restrictions by authorities, formulators are increasingly interested in titanium dioxide-free solutions for both dietary supplements and medicinal products. Uniform colored and…
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Calcium carbonate as a replacement for titanium dioxide in coating: the importance of particle…
Uniform colored and white coatings applied to tablets create a homogeneous appearance across batches, improving aesthetics and patient compliance. Titanium dioxide is used extensively in solid dosage forms for this purpose, serving as an opacifier and colorant. Due to its high refractive index, it…
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The General Court annuls the Commission Delegated Regulation of 2019 in so far as it concerns the…
Judgment of the General Court in Joined Cases T-279/20, T-288/20 and T-283/20 | CWS Powder Coatings
and Others v Commission
First, the Commission made a manifest error in its assessment of the reliability and acceptability of the study on which the classification was based and, second, it…
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Sepifilm NATurally COLored
Film-coating agent formulated without TiO2, aluminium and artificial colors
Current solutions in tablet coating make it hard to both meet the growing demand for naturalness from consumers and to comply with stricter regulations, especially in Europe.
SEPIFILM™ NATurally COLored by Seppic are…
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A weight of evidence review of the genotoxicity of titanium dioxide (TiO₂)
Titanium dioxide is a ubiquitous white material found in a diverse range of products from foods to sunscreens, as a pigment and thickener, amongst other uses. Titanium dioxide has been considered no longer safe for use in foods (nano and microparticles of E171) by the European Food Safety Authority…
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