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 (TiO 2), a commonly used component of pharmaceutical film coatings. The European Union has recently prohibited the application of this material in the food industry, and it is anticipated that the same will happen in the pharmaceutical industry. For this reason, pharmaceutical manufacturers have to consider the possible impact of removing TiO 2 from the film coating of tablets. In this paper, we present a case study of a commercially produced tablet where the film coating containing TiO 2 was replaced with a coating using calcium carbonate (CaCO 3) or with a transparent coating. The performance of the coatings was compared by measuring the moisture absorption rate and the dissolution profile of the tablets. In these regards, there were negligible differences between the coating types. The tablets contained a highly photosensitive drug, the ability of the coatings to protect the drug was evaluated through environmental stability and photostability measurements. The HPLC results showed that the inclusion of TiO 2 does not provide additional benefits, when humidity and thermal stress is applied, however its role was vital in protecting the drug from external light. There were several decomposition products which appeared in large quantities when TiO 2 was missing from the coating. These results imply that photosensitivity is an issue, replacing TiO 2 will be challenging, though its absence can be tolerated when the drug does not need to be protected from light. [Display omitted] [ABSTRACT FROM AUTHOR]