Titanium dioxide (TiO2) eu regulations and drugs: should know
Over the years, the pharmaceutical industry has relied on titanium dioxide (TiO2), it is used as tablet film coating sunscreen.Titanium dioxide can provide white tablet surface, covering the biltong pill core, makes the pill more market, at the same time prevent the active component degradation.But recently, regulatory developments of TiO2 pharmaceutical industry press the pause button.
The eu has made relevant provision, forbidden to continue using E171 (TiO2) as a food additive.Although not directly applicable to the pharmaceutical industry, but the rules or raise concerns many companies in the field of the use of titanium dioxide.This guide will describe for you why pharmaceutical companies should take note, and what are the alternatives to choose from.
What is a titanium dioxide (TiO2)?
Titanium dioxide is a kind of exist in the ore, sand and metal compounds in the soil, usually use as many different product, the active ingredient, especially used for blocking the sun's uv sunscreen.It is also used as a food coloring (E171), as well as for nutrition, dietary supplements and tablets of thin film coating.
Titanium dioxide for tablet what function?
In the pharmaceutical industry, for the tablet thin film coating, titanium dioxide is a kind of valuable elements, because it provides a high opacity of bright white tablets (and also can prevent the ultraviolet degradation of active ingredient).TiO2 has improve the appearance and the most important function of marketability, so improving products at the same time protect the products from light degradation and damage.
Titanium dioxide eu classification and regulations: the status quo
The European commission banned in the eu to use titanium dioxide (E171) as a food additive, then, will gradually stop using titanium dioxide in the food industry.The ban only in view of the food industry, has yet to affect the pharmaceutical industry.However, with the European drug administration (EMA) to work with European Union officials required to provide more about titanium dioxide usage as well as whether there are alternative materials data, the move means titanium dioxide could face a similar ban in the future.
As a result, pharmaceutical companies are considering their options, now begin to explore substitute for titanium dioxide.
Titanium dioxide used in tablet is safe?
There is no any strong evidence to prove that the titanium dioxide is not safe to human body when it is used in tablet.The European Union's ruling applies only to food additives, does not apply to drugs.In fact, the U.S. food and drug administration has approved titanium dioxide as food colorants added to the pills.In the tablet formulation, titanium dioxide account for less than 1%.
The eu's decision, however, suggests that a sign that people concern about the titanium dioxide, on the whole, is on the rise, industry began to abandon the titanium dioxide to ensure security is also reasonable, especially in the case of alternatives have emerged.
In 2019, the commission announced that to ensure the safety of the staff in the titanium dioxide is in the form of some powder inhalation, mark it as a carcinogen (Reg 2020/217).But in November 2022, the European court of justice on the basis of abolishing the provisions:
"First of all, the committee on the classification evaluation based on the study of the reliability and the acceptability of made an obvious mistake, second, it violates the intrinsic characteristics classification can only be involved with carcinogenic substances standards."
The abolition of the classification and labelling regulations have nothing to do with the eu ban on adding titanium dioxide in food, which is still valid, no doubt to the drugs used in the titanium dioxide casts a shadow.
Titanium dioxide replacement
When talking about titanium dioxide and thin film coating, the eu legislation is a challenge for the industry,But it is also an opportunity.Card nu-lax can offer titanium dioxide alternatives to help youGet rid of TiO2 from OTC products, by improving the product to be swallowed, color stability, opacity and productivity to improve consumer experience.
Titanium dioxide natural alternative
Do not contain titanium dioxide thin film coating system for nutrition newt Fiji ® seriesIs a kind of do not contain titanium dioxide natural alternative, can also attract the attention of consumers.
Card nu-lax experts specializing in the tablet, do not contain titanium dioxide recipe found to contain calcium carbonate (a kind of natural white mineral) rather than a coating of titanium dioxide is a good way to prevent the photodegradation, can minimize the color change, at the same time improve the shelf life and stability.
Situation is tend to be opposed to the use of titanium dioxide, so now it is time to seek titanium dioxide alternatives.This is a good opportunity to explore new coating, it can in the future for many years in the service of your brand, but also no risk of regulatory barriers.
Please contact us and learn more aboutCard nu-lax titanium dioxide replacementHow to improve the stability of the product and provide information on product productivity.Or,Dialogue card nu-lax experts consultationTo understand how we can help you.
