Film coating and tableting ingredient premixes for solid oral dosage forms.
Free of undesired excipients, such as:
- Titanium dioxide
- Magnesium stearate
- Palm oil
- Stearic acid
- Synthetic colors
In general, Clean Label is a consumer driven movement, demanding a return to real food and transparency through authenticity. For dietary supplements, this means that they should contain natural, familiar, simple ingredients that are easy to recognize, understand and pronounce. But the pharmaceutical industry is also beginning to reconsider the use of synthetic excipients.
Replacement of undesired excipients
BIOGRUND offers market-driven solutions that are tailored to changing requirements and challenges. As a solutions provider, we gladly support you to replace excipients that are undesired.
From the beginning, we are a member of the Clean Label Alliance, which was developed out of the increasing demand from consumers for cleaner labels on dietary supplements. Savvy consumers have made the connection between food as nutrition and dietary supplements as nutrition, and desire the same clean label as they have for food with dietary supplements.
However, as dietary supplement makers transition to clean labels, some are experiencing production challenges. Leaders within the dietary supplement industry joined forces to collectively serve producers seeking to develop or transition to clean label by providing support and problem-solving solutions. The purpose of the Clean Label Alliance is to offer assistance and guidance to dietary supplement companies by providing top-of-the-line resources and solutions to efficiently produce clean label supplements.
BIOGRUND offers tailor-made solutions for your clean label formulation needs.
Ready-to-use Film Coating Systems
Various AquaPolish® film coating systems are available free of TiO2 without losing the usual opacity and brightness on your product. The customized formulations can be offered as e.g. immediate release, moisture protection or taste covering coatings. Also free of talc, minerals, synthetic polymers and colors. Natural and lightstable colors can be selected to achieve a wide range of customized colors.
- HPMC-based film coating for fast-dissolving tablets.
- Reliable protection for tablet cores.
- Improves the appearance of the tablet surface.
- Customized colors that enhance your brand identity.
- Improves the packaging process (better slip, less dust).
- Brilliant white formulations without titanium dioxide (TiO₂)
- Achieves a smooth film layer, which facilitates the swallowability
For an improvement in appearance and finish of nutritional supplements (such as extracts, minerals or vitamins). Certified with USDA and EU-label for organic food.
Free of: polymers, talc, titanium dioxide, palm oil, maltodextrin, synthetic plasticizers.
The clear ready-to-use film coating formulation for solid oral dosage forms provides a simple and fast aqueous preparation of the powder compound and easy application of the suspension. For an immediate release profile. Coated tablets improve the packaging process because of better slip and no more dust formation. The organic and natural formulas will support your clean labeling strategies (e.g. Non-GMO, Non-Allergen, EU-/USDA label for organic food). The clear coating gives your product more brilliance and facilitates a better swallowability.
- Organic certified.
- Simple and fast aqueous preparation.
- Immediate release profile.
- The clear film coating gives your product more brilliance.
- For better swallowability of the tablet.
- Improves the packaging process (better slip, less dust).
- Enhanced appearance of dietary supplements (shiny surface).
- For dietary supplements such as extracts, vitamins or minerals.
Based on natural ingredients, this dry binder premix for direct compression supports clean label strategies for nutritional applications. By using this premix, typical tableting ingredients like Hydroxypropyl cellulose or Polyvinylpyrrolidone can be replaced in the core formulation.
CompactCel® is also available in some formulations which are certified with the USDA- and EU-label for organic food. Therefore, it is well suited for organic dietary supplements. The mix of selected organic ingredients increases the hardness and improves the friability of the tablet as well as the compaction.
Based on natural and/or certified organic ingredients, this disintegrant premix for direct compression can be used for replacing synthetic excipients like crosslinked polymers, crosscarmellose sodium or sodium starch glycolate. It is suited for the use in tablet, capsule and granule formulations. To correspond to the requirements of a fast release dosage form, CompactCel® DIS enables a rapid break-up of solid oral dosage forms when they come into contact with moisture.
Tableting & Capsule filling
The ready-to-use powder premix of natural ingredients decreases friction at the interface between tablet and die wall, reduces wear on punches and prevents sticking to punch faces. By eliminating magnesium stearate, which is often the cause of many problems with solid oral dosage forms, undesirable side effects can be reduced to a minimum. It can also be used as an alternative to stearic acid. The compound provides a good lubrication without influencing the requirements of the tablet. A fluent compression process will be achieved.
Also for the filling and closing of hard gelatin capsules it acts as an excellent lubricant to achieve a smooth filling process.
A separating agent which loosens up powder mixtures and improves their flowability. It replaces synthetic excipients like silicon dioxide – for a consumer-friendly label. CompactCel® FLO provides a clean funnel flow of the powder mass to be processed during both tableting process and capsule filling. A bridge formation during flow from hopper can be avoided.
Formulations in natural or organic food quality available.
Certified with the EU and US label for organic food
Dry powder compound of additives for less problems due to humidity in the powder blend. Superior moisture absorbent properties to prevent clumping of the powder before and during the tableting or capsule filling process. Acts loosening and improves the flowability of the blend.
Dry powder compound of additives for oil absorption. The high absorbent properties are used to make oily substances suitable for the tableting or capsule filling process. Prevents clumping of the powder oil blend.
Depending on project requirements CompactCel® MAB can be based on synthetic ingredients or natural/organic food raw materials (silica free, for clean label).
Customized tableting premix based on natural or organic ingredients. The fully formulated tableting/encapsulation dry powdered compound exists of e.g. filler, binder, glidant, lubricant, pigment/dye. These ingredients contain the necessary characteristics to produce a label-friendly and high-quality solid oral dosage form.
Easy handling and processing, economic savings and higher productivity because it’s a ready-to-use and tailor-made system.
Tablet film coating with natural, light-resistent colors? Why not! Alternatives for titanium dioxide & iron oxide pigments
- Clean Labeling – an important topic
- Consumers, customers and the industry are paying more attention to the listed ingredients
- Now looking for new solutions & alternatives: find and replace new ingredients to continue to use a consumer-friendly label that does not require additional declarations
- Changes in the regulatory requirements lead to an adaptation of existing formulations
That’s why we’ve developed a wide range of AquaPolish® film coatings without titanium dioxide and iron oxides.
Light stability sample box: For light stability studies, we sprayed natural colored film coatings on placebo tablets and exposed them to sunlight for six and twelve hours with a Suntester (equivalent to 45 and 60 hours of real sunlight, respectively).
The measured color deviations from the reference tablet (not exposed to sunlight) are within our specification of Δ E <3.50.
Questions about the light stability of natural pigments? We are happy to assist you with the reformulation of existing formulations or new developments.
Contact us: Choose your country for the correct online contact form.
Member of the Clean Label Alliance
Take a look at the website of the Clean Label Alliance to find out more about “Your lifeline for a clean product line.”