Explore Lonza’s cutting-edge Titanium Dioxide-free products and services. As regulatory landscapes shift, Lonza can help you stay one step ahead. Download our brochure to learn more about our advanced Titanium Dioxide-free solutions for the pharmaceutical industry.
Do you need a contingency plan for TiO2-free formulations?
Effective August 2022, the European Union banned titanium dioxide (E171) as a colorant for the food sector, including food supplements. The status of TiO2 in medicinal products is still under review, with a decision anticipated by early 2025. Pharmaceutical companies were encouraged to explore alternative options.
Lonza prioritizes the highest standards of quality, service, and innovation. This dedication enables us to navigate the evolving titanium dioxide regulatory landscape, helping our customers stay ahead by offering various alternatives. We are raising the bar in capsule innovation with TiO2 replacement options that not only follow emerging regulatory trends, but also meet the required product functionality – two key aspects for reformulation and new product development.
Our range of TiO2-free products leverages innovation with known colorants, using the common TiO2-free alternative, iron oxides, and pursuing new avenues with innovative production technologies.
- Iron oxides act as semi or full opacifiers with a variety of color and shade options, either alone or in combination with other coloring agents. They provide a good balance of masking and light protection.
- Swedish orange iron-oxide based colorant provides a unique masking alternative to TiO2 within our advanced bi-layer hypromellose (HPMC) / hypromellose acetate succinate (HPMC-AS) capsules, allowing you to mask your formulations without sacrificing enteric performance.
- Phosphate salts Phosphate salts, approved as food additives but not explicitly listed for use as colorants, have enabled the creation of a white TiO2-free gelatin capsule that is indistinguishable from the white gelatin capsule colored with TiO2 in terms of color shade, brightness, masking ability, light protection, and opacity. This innovative solution provides a matching replacement for titanium dioxide in hard gelatin capsules without compromising on essential properties such as machinability, robustness, and dissolution performance.
Whether you are looking to reformulate or develop a new product, our Color Lab can assist by providing personalized color matching services to help you achieve the perfect titanium dioxide-free color formulation.
Ready to learn more about our comprehensive TiO2-free offering? Download the brochure.