Challenges of possible replacement for titanium dioxide in Dapoxetine film coating tablets
Abstract
Titanium dioxide (TiO2) is naturally occurring mineral widely used in many industries as an inert substance giving consistent homogenous colour. It is also an opacifying agent, which protects the photosensitive ingredients from light degradation and extending the shelf life of the product. Recently, European Food Safety Authority (EFSA) declared that TiO2 could not be considered safe for use as a food additive, despite scientific findings and data on nanoparticles. This is due to genotoxicity, possibly carcinogenic properties to humans and accumulation in the body due to their long half-life. Although the ban impacts products designated as food, there is currently no requirement to remove TiO2 from pharmaceuticals. European Medicines Agency (EMA) should apply a pragmatic approach in their evaluation on the use of TiO2 in the European Union/ European Economic Area (EU/EEA) to ensure product availability and patient supplies (AESGP, 2021). There is no guarantee that a replacement of TiO2 can be appropriate for every product and it would result in “significant medicine shortages” or withdrawals from the market (Taylor, 2021). TiO2 is monographed in the European Pharmacopoeia and it is considered as suitable for use in the medicinal products as an excipient. While other excipients could also be used for the same purposes in tablet coatings, TiO2 has unique properties enabling thinner, less brittle film coating and allowing rapid bioavailability of the active substance (EMA,…
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