TiO2 free film coating

Brilliant white and colored coatings without titanium dioxide? Why not!

For decades, titanium dioxide (TiO2) has been used as a white pigment due to its very high opacity and brightness. Therefore, it has a wide range of applications, from being a coloring ingredient of pharmaceutical film coating, to food application coloring.

TiO2 free film coating sample, free of charge:

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Titanium dioxide free film coating systems

Take the chance! Current discussions and decisions on the new classification and labeling of TiO2 (E171) and its re-evaluation as a food additive in the EU present new challenges and opportunities. Why?

European Food Safety Authority’s (EFSA) updated assessment on the safety of titanium dioxide as a food additive (published in summer 2021) concludes, that concerns about the genotoxicity of TiO2 particles cannot be excluded. As a result, the European Commission issued Commission Regulation (EU) 2022/63 banning the use of titanium dioxide as a food additive (E171), which will come into force on February 7, 2022, with a six-month transition period until August 7, 2022. This regulatory change particularly affects the food and dietary supplement industry.

To address this issue, BIOGRUND has developed alternative formulations free of titanium dioxide for white and pigmented film coating systems.

With the upcoming reformulations of existing formulations, dietary supplement and OTC product manufacturers have the opportunity to address market trends and consumer demand for natural ingredients. Consumers looking for clean label products that are free of artificial, aluminium, chemical, nanoparticulate or undesired excipients (such as TiO2, talc, palm oil, artificial colors).

Although the pharmaceutical sector is not affected by this regulatory change, developers are already looking to the future and are increasingly trying to dispense with tablet coatings containing titanium dioxide here as well.

“Titanium dioxide free film coating systems – ready-to-use. Designed for easy formulation conversion that meets regulatory requirements and consumer demand. For food supplement and pharmceutical industry.”

AquaPolish® ready-to-use systems formulated with substitutes such as calcium carbonates, starches or phosphates offer an easy, fast and reliable TiO2 alternative by providing the following characteristics:

  • excellent white brightness
  • wide color range (customized)
  • opacity at low weight gain
  • productivity, due to high solid content
  • light & moisture protection
  • product stability

Customized formulation & free choice of coloring stuff (natural/artificial)

Faster spraying process, lower costs of spraying

The low viscosity of the AquaPolish® suspension for a white TiO2 free film coating enables a solid content of minimum 17%. Due to the combination of calcium carbonate and the right amount of stabilizers, a very good opacity can be achieved already at 4% weight gain. An opacity measurement according to the CIELAB method resulted in the following values (maximum is L100): Coating with TiO2 (100 kg batch) = L97  //  Coating TiO2 free (100 kg batch) = L95. Thus, the opacity is comparable to TiO2, the surface improves, and the lower viscosity improves the coating process and leads to lower costs.

“Direct replacement of titanium dioxide in film coating formulations is not possible to our current knowledge. However, with an alternative excipient premix such as our TiO2-free AquaPolish®, solid oral dosage forms can be film coated with equivalent opacity and very good light stability.”

Our Services:

Customized reformulation  |  Customized sampling  |  Consulting in choice of coloring stuff  |  Technical support

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