Optimization and Further Development of ConCordix Formulation Technology

Abstract

Food supplements are recommended for individuals lacking micronutrients in their diets, e.g., vegetarians, vegans, people with allergies, eating disorders, or bowel diseases, as well as pregnant or breastfeeding women, children, elderly, or people who do not have access to sufficient sunlight. Oral food supplements are commonly delivered in the form of tablets, hard or soft capsules, bulk oils (e.g., fish oil), or gummies. Many people have difficulties with swallowing tablets or capsules, whereas gummies generally contain a large amount of sugar and have a low payload. Liquid fish oils and gummies can also undergo oxidation after the packaging is opened. ConCordix (CCx) is a patented gelatin-based technology providing a user-friendly delivery form by combining water- and lipid-soluble active ingredients in a single dose protected from oxidation inside an airtight aluminum blister packaging. As CCx products have been manufactured and exported to different parts of the world, new climate zones and countries with various cultural backgrounds brought out new demands for the technology. This thesis focuses on three main objectives to address these demands: i) to develop a more heat stable gelatin CCx for warmer climates, ii) to develop a plant-based alternative to classic gelatin-based CCx, and iii) to evaluate whether a higher bioavailability could be obtained for certain lipid-soluble actives.

The stability of gelatin-based CCx products may be compromised if units are exposed to high temperatures during transportation and storage. With this work, it has been proven possible to improve the storage stability of gelatin based gels with the correct choice of gelatin type, Bloom strength and the inclusion of sugar alcohols. Ethical and ecological considerations have resulted in a search for mammalian gelatin alternatives. As opposed to gelatins from cold water species, gelatins from warm water fish species exhibit more similar physical properties to mammalian gelatins. It was shown that the stability of warm water fish gelatin gels can also be improved with the addition of sugar alcohols without compromising the processability. There has been increase in the number of individuals following a vegetarian or vegan diet due to religious, health, ethical, and ecological considerations, resulting in a high demand for a plant-based CCx. Plant-based CCx were prepared using agar (with citrem or plant proteins as emulsifiers) and pectin (with lecithin as emulsifier) as gelling agents. It has been proven that plant-based polysaccharides can be used to replace gelatin as matrix generators, although the physical and functional properties of the emulsion gels prepared with these polysaccharides will be different compared to gelatin-based ones. It was also shown that plant proteins have potential as emulsifiers in agar emulsion gels. The lipid-soluble active ingredients in a CCx are pre-emulsified and may be taken up more quickly compared to if they were delivered in bulk oil. The droplet size of the emulsion is important since the digestive enzymes can only work at the interface. This work has also shown that smaller oil droplets will be lipolyzed faster than larger oil droplets in vitro. However, this was not reflected to the in vivo uptake of the lipid-soluble active ingredients but was only valid for the TAGs. The findings in this thesis can be used to improve the stability, physical, and functional properties of chewable emulsion gels for the oral delivery of nutraceuticals.