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TiO2 Free Nutritional and Dietary Supplements

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A new, best-in-class Nutrafinish® TiO2 free coating for nutritional and dietary supplements, with superior opacity and whiteness, is now offered by Colorcon.

Titanium dioxide (TiO2) has been used for decades as a material for providing brightness and opacity in a multitude of applications, including tablet coatings. While there remains controversy about its continued as a food additive in France, the European Medicine Agencies (EMA) continues to endorse the use of TiO2 as E171 in food and pharmaceutical applications and support the European Food Safety Authority (EFSA) safety review process. Although no functionally direct replacement exists for TiO2 when used as an opacifier or pigment, Colorcon has developed alternative film coating systems, without its use.

Why Opacity is Important

Many commonly used micronutrient ingredients included in nutritional and dietary supplement products are described as being sensitive or highly sensitive to degradation by light.  Opacity in the film coating provides protection from light and consequently helps to extend product shelf-life and reduces the potential for degradation of the ingredients.

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Viable Alternatives

Colorcon launched the first Nutrafinish® TiO2 Free Film Coating in 2018 and has continued to innovate this product line to deliver visible improvements in opacity and whiteness. The elimination of TiO2 provides manufacturers with an alternative tablet coating solution that satisfies aesthetic requirements and addresses market concerns.

This new high opacity coating is recommended for use as a film coating at 20 percent solids w/w, with excellent coverage when applied to a weight gain of 3 – 4 percent. Results shown in Figure 1 demonstrate the excellent opacity and whiteness that can be achieved, even on the darkest or black tablet cores.

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Figure 1: Application of Nutrafinish® TiO2 Free Coating to Black Cores

In addition to white, Nutrafinish® TiO2 Free Coatings are also available as pigmented systems. Color aids consumers to identify their supplements and contributes to brand distinction and consumer loyalty. It can be challenging to directly match existing pigmented formulations without the use of TiO2 as a pigment or opacifier. However, be assured through Colorcon’s extensive regulatory and technical knowledge, the closest alternative match will be formulated using alternative components to meet functional and market needs.

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Our global regulatory team is available to provide support to any customer during re-registration filings. To learn more, contact your local Colorcon representative or simply select the film coating you’re interested in and contact Colorcon for a sample.