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Alternatives to titanium dioxide in tablet coating
Juliana Radtke1, Raphael Wiedey1, Peter Kleinebudde1
1Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University, Universitaetsstrasse 1, Duesseldorf, Germany.
Pharmaceutical Development and Technology
|August 13, 2021
Summary
Concerns over titanium dioxide (TiO2) safety necessitate alternatives for pharmaceutical coatings. While no substitute matched TiO2
Area of Science:
- Pharmaceutical Sciences
- Materials Science
- Analytical Chemistry
Background:
- Titanium dioxide (TiO2) is a prevalent pharmaceutical excipient, widely utilized as a white pigment in tablet and pellet coatings.
- Recent concerns regarding TiO2's potential carcinogenicity raise questions about its continued availability for drug products.
- The pharmaceutical industry requires effective and safe alternatives for TiO2 in coatings and for protecting photosensitive compounds.
Purpose of the Study:
- To evaluate alternative pigments as replacements for titanium dioxide (TiO2) in pharmaceutical tablet coatings.
- To assess the covering potential, protective capabilities for photosensitive ingredients, and suitability for in-line Raman spectroscopy of alternative pigments.
- To identify viable substitutes for TiO2 considering both aesthetic and functional requirements in drug product manufacturing.
Main Methods:
- Multiple alternative pigments were applied as coatings to tablets.
- The covering potential and efficiency of each pigment were analyzed.
- The ability of pigments to protect photosensitive active ingredients from degradation was evaluated.
- The performance of alternative pigments as markers for in-line Raman spectroscopy was assessed for process analytical technology.
Main Results:
- No alternative pigment demonstrated effectiveness and efficiency comparable to TiO2.
- A calcium carbonate/calcium phosphate (CaCO3/CaHPO4)-based coating exhibited the second-best results in terms of covering potential.
- Zinc oxide (ZnO) offered comparable protection for photosensitive active ingredients as TiO2; other pigments were ineffective.
- The CaCO3/CaHPO4-based coating was the only alternative yielding satisfactory results for in-line Raman spectroscopy, while others caused high prediction errors.
Conclusions:
- Currently, no single alternative pigment fully replicates the multifaceted performance of titanium dioxide (TiO2) in pharmaceutical applications.
- Calcium carbonate/calcium phosphate (CaCO3/CaHPO4)-based coatings show promise as a partial substitute, particularly for covering properties and process analytical technology.
- Zinc oxide (ZnO) is a viable alternative specifically for protecting photosensitive ingredients, but not for general coating purposes.
- Further research is needed to develop alternative pigments that meet all the functional and safety requirements currently fulfilled by TiO2.
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