Titanium dioxide-free film coating systems for pharmaceutical applications. Ready for the future.
Background and current status of TiO2 regulation
What is titanium dioxide (TiO2)?
TiO2 is generally used as a white pigment and provides high opacity. In the food industry, it is used to improve the color and brightness of products such as sweets, baked goods and dairy products. In the pharmaceutical industry, TiO2 is used as a pigment/opacifier in tablet and capsule production.
Health concerns
Health concerns
Recent research has highlighted potential health risks associated with TiO2, particularly in the form of nanoparticles. The main concerns include:
– Inhalation risks: there are potential carcinogenic risks associated with inhalation of TiO2 nanoparticles – Ingestion risks: some studies suggest that ingestion of TiO2 nanoparticles may lead to genotoxic effects and other health problems, although the evidence is not yet conclusive.
Regulation in the food sector
Regulation in the food sector
European Union:
- EFSA evaluation: In May 2021, the European Food Safety Authority (EFSA) re-evaluated TiO2 as a food additive (E171) and concluded that it can no longer be considered safe due to concerns about its potential genotoxicity. Ban: Following EFSA’s opinion, the European Commission proposed a ban on the use of TiO2 as a food additive, which came into force in January 2022.
United States (USA):
- FDA approval: the U.S. Food and Drug Administration (FDA) allows the use of TiO2 as a food colorant provided it does not exceed 1% of food by weight.
- Ongoing review: The FDA continues to monitor new scientific data on the safety of TiO2.
Other regions:
- Canada: Health Canada allows the use of TiO2 as a food additive, but is actively reviewing new research and data on its safety.
- Australia and New Zealand: The Food Standards Australia New Zealand (FSANZ) allows the use of TiO2 as a food additive, but is conducting ongoing assessments to ensure its safety.
Regulation of medicinal products
Regulation of medicinal products
European Union
- EMA guidelines: The European Medicines Agency (EMA) recognizes the use of TiO2 in medicinal products due to its functional properties. So far there is no complete ban, but the agency is closely monitoring safety data. Replacement initiatives: There is an ongoing initiative to find safer alternatives to TiO2 in medicines, driven by the wider regulatory environment.
United States
- FDA guidelines: The FDA allows the use of TiO2 in drugs and considers it generally recognized as safe (GRAS) when used in accordance with certain guidelines. Surveillance: The FDA monitors scientific developments and may update its regulations based on new safety findings.
Other regions
- Canada: Health Canada allows the use of TiO2 in medicines and continues to review its safety. Australia and New Zealand: The Therapeutic Goods Administration (TGA) allows the use of TiO2 in medicines and continues to review whether it is safe for consumers.
Current status and developments
Current status and developments
- Scientific research: Ongoing research aims to clarify the potential health effects of TiO2, particularly in the form of nanoparticles, which could influence future regulatory decisions. Industry response: The pharmaceutical and food industries are exploring alternatives to TiO2 to comply with changing regulations and address consumer concerns. Regulatory evolution: Regulators around the world are closely monitoring the new data and may adjust their regulations accordingly. The precautionary approach taken in the EU could potentially have an impact in other regions if further evidence of risk emerges.
TiO2-free tablets therefore represent an important alternative for the pharmaceutical industry for several reasons:
New: Free TiO2 sample box
What is in the sample box?
- Comparison of the conventional TiO2 coating with the alternative TiO2-free coating
- Colored formulations for pharmaceutical/nutraceutical applications based on iron oxides
- Additional colors can be developed. Color matching and reformulation service
Are you curious to see what the tablets look like in reality?
Order your free sample box now.
The regulation of TiO2 in food and pharmaceuticals is characterized by a cautious approach due to potential health risks. The European Union (EU) has taken important steps by banning the use of TiO2 in food, while other regions such as the USA continue to allow the use of TiO2 under regulated conditions. TiO2 is still widely used in pharmaceuticals, but safer alternatives are increasingly being sought. As scientific research progresses, the regulatory framework is likely to evolve to ensure consumer safety.
Alternatives / Solutions
- Regardless of how the European Medicines Agency (EMA) or the EU decides on a TiO2 ban, BIOGRUND already offers titanium dioxide-free formulations for pharmaceutical film coatings.
- Our customized, ready-to-use film coating systems are easy, fast and reliable to use. We develop both white and colored formulations that meet current and future market requirements.
- The standard substitute for titanium dioxide is calcium carbonate. Depending on the ingredients and the active ingredient of your tablet, we adapt the film coating formulation. If, for example, acidic active ingredients such as salicylic acid, nicotinic acid or some antibiotics are used, the use of calcium carbonate in the formulation can cause an interaction (neutralization reaction). In such cases, we use TiO2-free alternatives that are free of minerals. This enables us to achieve a well-insulating and opaque film coating for the tablet core – whether white or colored.
Reformulation service
Based on the formulation conversions from titanium dioxide to alternatives in the area of food and dietary supplements, BIOGRUND can also advise you on pharmaceutical reformulations with a high level of expertise.
With our reformulation service, we support you in switching from titanium dioxide to alternative substitutes in pharmaceutical quality. Regardless of whether it is an existing formulation or an ongoing project.
Various polymers can be used for the individual formulation (e.g. PVA, hypromellose, acrylic acid copolymer). Our ready-to-use AquaPolish® film coating systems are available for immediate release profiles and enteric or moisture-protected formulations.
Switch from in-house to ready-to-use
In the course of upcoming reformulations or new developments, it is worth considering whether the development and production of the film coating should be outsourced for economic reasons.
Advantages of ready-to-use (R2U):
- Color development – almost any color is possible (batch-to-batch consistency)
- One material, one analysis certificate
- Short and simple preparation
- Reliable and reproducible quality
- Low supply chain risk
- Simple logistical processing
