Calcium Carbonate As A Replacement For Titanium Dioxide In Coating: The Importance Of Particle Engineering

By Alessandro Giuseppe Elia, Nicole Di Gallo, Anja-Nadine Knüttel, Dr. Thomas Kipping, and Almut von der Brelie, MilliporeSigma

Regulatory trends, sparked by safety concerns from the European Food Safety Authority (EFSA), are driving the need for alternatives to titanium dioxide in pharmaceutical coatings, as the substance is already banned in EU foods and dietary supplements. Since titanium dioxide is extensively used as a white opacifier in solid dosage forms, its possible removal from pharmaceuticals could impact an estimated 91,000 human medicinal products.

This has brought attention to calcium carbonate, the most likely alternative, which can achieve comparable opacity and process efficiency through particle engineering. A particle-engineered calcium carbonate excipient, Parteck® TA, demonstrates effective film coating with uniform coverage and low viscosity in the spraying liquid, which supports good process efficiency. Furthermore, the resulting tablets show galenical properties (friability, hardness) similar to those coated with titanium dioxide.

Explore the full white paper to understand how particle engineering can help you navigate regulatory changes with a viable alternative to titanium dioxide.