Gelita outlines the role of pharmaceutical gelatine and its growing importance in capsules and fortified gummies
Pharmaceutical gelatine offers manufacturers of drugs and supplements a versatile excipient that has been used in the pharmaceutical industry for decades. A key application is capsule production; approximately 90% of all pharmaceutical gelatine produced is processed into this widely used drug dosage form.
Gelita manufactures and supplies gelatine for all types of capsules. In many ways, because of the numerous advantages of the dosage format, the gelatine capsule is the ideal delivery vehicle for a variety of medicines and/or therapeutic agents. With Gelita RXL, the company claims that it has managed to overcome cross-linking issues in capsules. On top of this, more recently gelatine-based delivery system has risen in popularity among grown-ups – fortified gummies.
Advantages of capsules
Gelatine capsules are among the most popular dosage forms for drugs, over-the-counter (OTC) products and food supplements. Consumers appreciate the smooth surface of the capsules making them easy to swallow — an important aspect of patient compliance. Gelatine itself is highly compatible with other ingredients, is non-allergenic and comprises proteins that are easily digested in the gastrointestinal tract, which facilitates the release and absorption of active ingredients.
Gelatine capsules protect sensitive ingredients such as fish oil from oxygen, light, contamination and/or microbial growth. Although hard capsules are primarily used for powder applications, soft capsules are the preferred dosage form for liquid, paste-like or oil-based fills. Unlike any other type of capsules, soft gelatine versions are hermetically sealed and airtight, thereby masking any unpleasant taste or odour of the fills. This also makes the softgel format very tamper-evident while providing high dose accuracy.
One of the most widely recognised benefits of soft gelatine capsules is enhanced nutrient bioavailability. By encapsulating liquid- and paste-fill formulations with very low particle sizes, soft gel capsules provide opportunities to improve the absorption of poorly soluble drugs. Consumers not only benefit from a quicker onset of action, the higher bioavailability also translates into the ability to reduce the required amount of active ingredients.
Another key strength of softgels is their versatility. In general, soft shell capsules release their contents in five–15 minutes. However, by altering the formulation of the gelatine capsule shell, the specific effect, timing and duration can be modified and adapted to consumer needs. Plus, gelatine capsules show endless opportunities in terms of size, colour, shape or printing options, allowing for customised products and unique presentations.
Capsule technology innovation
Despite the advantages of gelatin capsules, certain types of reactive fillings and extreme storage conditions — such as high temperature and humidity — may cause the gelatine in the capsule to react and cross-link. With time, soft capsules become increasingly less soluble, which results in longer dissolution times in the GI tract and the slower release of the fills.
Now, the Gelita Pharmaceutical Competence Team has developed a new technology: Gelita RXL (Reduced Cross-Linking) that adds extra value to gelatin capsules. It significantly reduces the amount of cross-linking, thus enhancing the dissolution properties of the capsules as well as improving their shelf-life at high temperature and humidity. The new technology even allows the pharmaceutical industry to explore new capsule fillings and expand their distribution into regions that are exceptionally hot and humid.
Various attempts by the pharmaceutical industry to reduce cross-linking with additives have only been partially successful. Gelita, however, followed another route: it established that small, highly mobile gelatine molecules are, under suitable conditions, able to block the effects of the larger molecules — similar to interfering with the interaction between a key and its lock. The Gelita solution can be described as a sort of “self-defence mechanism,” brought about by a combination of large and small molecules. More precisely, Gelita has increased the concentration of collagen peptides that naturally occur in gelatine. These collagen peptides react with the gelatine and block it, making it no longer available for self-cross-linking reactions and/or reactions with other reactive groups, such as traces of aldehydes or chromium, alumina and copper, within the capsule.
Purity and safety
Gelita RXL is pure pharmaceutical-grade gelatine, free from any non-gelatine additives, which complies with all existing regulations. It meets all product specifications for gelatine capsule applications and is the ideal product for use with problematic fills or where normal gelatin cannot be used because of cross-linking. The use of Gelita RXL can also accelerate product development; it reduces the risk that a capsule formulation, once developed, will later be discovered to fail storage requirements.
Fortified gummies: not just for kids
Fortified gummies first made their appearance in the US in the late 1990s as an alternative delivery method or system for children’s vitamins and minerals. Traditionally administered as medicinal syrups or chalky and unpleasant chewable tablets, consumer compliance was often reduced by undesirable, inconvenient and bad tasting products. As such, the industry and young consumers alike quickly embraced these novel confectionery-like vitamins. As a result, manufacturers are now expanding the category into the adult world as well.
With the rising importance of issues such as convenience, dosage control and consumer acceptance, fortified gummies now dominate the US paediatric vitamin and mineral category by an overwhelming margin. Further market growth is expected as adults have become aware, and are now demanding, the same benefits for themselves. To drive innovation and demonstrate the potential of this young category, Gelita’s technical experts are constantly working on new fortified gummy concepts. From sugar reduced and tooth-friendly variants to solutions with minerals, omega-3s or fibres — the potential to create tailored products that match individual consumer needs is huge.
However, the production of fortified gummies is much more than just adding vitamins and minerals; it’s also about meeting the needs of elderly people, for example, by incorporating higher levels of important nutrients or even active ingredients. Today, protein-enhanced fruit gums or collagen peptide-based gummy applications for improved skin, joint or bone health are becoming increasingly relevant. The challenge with these product examples is to incorporate a sufficient amount into the gummies, using established gummy manufacturing process and equipment, without changing the overall taste and texture.