Reformulation of pharmaceutical and nutraceutical formulations.
BIOGRUND supports you in replacing unwanted excipients such as titanium dioxide (TiO2), silicon dioxide (SiO2), magnesium stearate (MgSt), talc, palm oil, stearic acid, synthetic colors, etc. in your products. With our comprehensive reformulation service, your food supplements and pharmaceutical products comply with current trends and regulatory requirements.
- Excipient mixtures for film coatings, direct tabletting, capsule filling, coloring and coating
- Change of dosage form, e.g. from capsule to tablet.
- Changeover from in-house solutions to ready-to-use systems.
- Regulatory requirements: Increasingly stringent regulations require the removal or replacement of certain ingredients such as titanium dioxide (TiO2) in the EU.
- Health concerns: Consumers are increasingly demanding products without potentially harmful or controversial ingredients.
- Clean label trend: The desire for “clean” labels without unnecessary additives is constantly growing, especially in the food supplement and pharmaceutical industries.
Application examples for the replacement of:
Titanium dioxide (TiO2) gives tablets a uniform white appearance and ensures good opacity. Its use in food has been banned in the European Union (EU) since August 2022. However, the consumer trend goes beyond the borders of the EU and consumers are increasingly paying attention to the list of ingredients.
With AquaPolish® TiO2 free, the customer receives a reliable film coating that offers a convincing alternative in terms of both opacity and whiteness. For both nutraceutical and pharmaceutical formulations.
Silicon dioxide (SiO2)
The proven superplasticizer, which is mostly used in direct tableting and capsule filling, has been under discussion for some time with regard to nanoparticles and possible health risks.
CompactCel® FLO offers a natural alternative here. The ready-to-use excipient mixture loosens up powder mixtures and improves their flowability. It replaces synthetic additives such as silicon dioxide – for a consumer-friendly label (clean label). It also ensures a clean funnel flow of the powder mass to be processed, both during the tableting process and during capsule filling. Bridging when flowing out of the funnel can be avoided. Formulations available in natural or organic food quality.
The natural superplasticizer can be used, for example, in Acerola, Alfa Alfa, Ashwagandha- L-Arginine formulations as an SiO2 alternative.
Magnesium stearate (MgSt) and talc
They act as lubricants in the manufacture of tablets and capsules. They prevent the substances from sticking to each other and thus make it easier to squeeze and fill the capsules.
Discussion points for magnesium stearate:
– Bioavailability. MgSt can delay the dissolution of the tablet
– Veganism/Halal. MgSt is often of animal origin and therefore poses a problem for vegans and people who follow halal guidelines.
Discussion points for talc:
– Respiratory aspects. Inhalation of talcum dust (e.g. during production) can cause irritation of the respiratory tract
– Asbestos contamination. Despite strict regulations, there may be a residual risk.
– Skin contact. Direct skin contact can lead to irritation. As an alternative,
CompactCel® LUB offers a ready-to-use lubricant mix of sustainable, plant-based, gluten-free and vegan ingredients. It reduces friction between the tablet and the compression matrix, reduces wear on the punches and prevents sticking to the punch heads. The compound provides good lubricity without compromising tablet requirements. A smooth pressing process is achieved. It also acts as an excellent lubricant for a smooth filling process when filling and closing hard gelatine capsules.
Our services:
- Individual reformulation: Adaptation of your existing products to replace unwanted additives without compromising product quality.
- Development of TiO2-free coating systems: For a clean label and improved consumer acceptance.
- Optimization of flow agents and lubricants: Replacement of MgSt and talc to improve production processes.
- Consulting and technical support: Support throughout the reformulation process, from development to market launch.
- Regulatory compliance: We help you comply with the latest regulations and minimize potential legal risks.
- Market advantage: Clean, transparent wording sets you apart from the competition.
- Expertise and experience: Benefit from over 25 years of experience in the development and optimization of excipients and coating systems.
Frequently asked questions
Why should TiO2 be replaced?
TiO2 is under increasing regulatory pressure and has been classified as unsafe for use in food in the EU since August 2022. There is a global consumer trend towards clean product labeling (clean label). As a result, questionable ingredients should no longer appear in the list of ingredients. The pharmaceutical industry is also following this trend and is paying increasing attention to the use of TiO2 in new developments.
How long does the reformulation process take?
The process varies depending on the customer’s requirements. The formulation can be successfully changed within 14 days. However, projects often involve replacing several raw materials at the same time. Trials of the new formulations can be tested directly in-house and the results analyzed. Additional stability tests can extend the reformulation process.
Is the reformulation service free of charge?
As a rule, our service is free of charge. However, development costs may vary depending on the scope of the project and requirements. We will be happy to provide you with an individual quote.
Get in touch now and start reformulating!
Let’s work together to make your products future-proof. Contact us for a non-binding consultation.
