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Gelatin softgel capsules are one of the most common delivery systems for over-the-counter (OTC) products and dietary supplements. Unlike other types of capsules, they are hermetically sealed and airtight to protect sensitive ingredients from oxygen, light and contamination. Furthermore, the plain, curved surface makes them easy to swallow, which appeals to consumers.

Gelatin is non-allergenic and highly compatible with other ingredients. It is, next to plasticiser like glycerol, the main component in the shell of a softgel and can easily be dissolved in the acidic environment of the stomach to enable the release of the active ingredients. However, standard gelatin based soft capsules are unsuitable for probiotics. Probiotic cultures are living organisms that are highly acid-sensitive and easily degraded or destroyed in the stomach. Probiotics require an enteric delivery system – one that releases them into the more neutral environment of the small intestine. This delayed release has been traditionally achieved by applying an acid-resistant coating to the gelatin capsule, creating what is known as an enteric capsule.

Challenges of the standard coating approach

However, there are problems associated with the enteric coating method. Coating involves the application of liquid solutions to the gelatin capsule, a step often performed by a third party. The process itself is challenging, with sticking and twinning among the problems commonly encountered.

Surface defects such as frosting, cracking and inhomogeneous coating layers are also an issue. The result is routine overdosing of colony-forming units (CFUs) to compensate for those destroyed in the stomach. It means that larger capsules – or an increased number of capsules – are required to ensure sufficient absorption of active content. This is a significant waste of raw materials. Nor does it appeal to consumers, who prefer smaller, single-dose capsules for convenience and ease of swallowing.

Additional process steps also require extra resources – such as dedicated equipment, energy for drying, and so on. If a third-party specialist coating facility is used, this also incurs increased transportation costs and a higher carbon footprint. Furthermore, the coating liquids are often based on petrochemical-derived materials (such as methacrylic or acetate phthalate) or harsh, chemically modified substances, such as HPMC (hydroxy-propyl-methyl-cellulose).

GELITA® EC: the optimal solution for probiotic delivery

To address all these issues, we have developed a unique, enteric-release technology called GELITA® EC. This gelatin product provides true enteric performance that enables the manufacture of gelatin capsules which are intrinsically acid-resistant, rendering the coating stage obsolete.

GELITA® EC capsules are based upon a proprietary blend of naturally derived biopolymers – pure gelatin and plant-based pectin. Combining the best properties of both materials, this creates a highly acid-resistant enteric capsule that can be manufactured using existing equipment in a one-step process. It requires less equipment, fewer raw materials, no transportation to and from a coating facility, and less energy and water, all of which improves the product’s carbon footprint.

Tests demonstrate that capsules made with GELITA® EC adhere to US (EU) Pharmacopeia dissolution parameters. This means they remain intact after one (two) hours in simulated gastric fluid at core body temperature of 37°C, but are fully dissolved within a maximum of 45 minutes in simulated intestinal fluid. Using such an effective gut-targeting system means it’s possible to significantly decrease the capsule size and the amount of fill. Expensive overdosing is no longer required, and consumers benefit from the convenience of a one-a-day solution for dietary supplements.

From the consumer’s point of view, smaller capsules are more desirable as they are easier to swallow. As a bonus, GELITA® EC capsules are transparent and clear, a feature popular with consumers who find coated versions too opaque and less visually appealing.

Less is certainly more with GELITA® EC.

For more information, please contact us!