OUTSTANDING PHARMA SOLUTIONS FOR EVERY APPLICATION
Give or take a few minor differences in shape or size, one gelatine capsule looks to be the same as another to the average consumer. But, to an expert, this couldn’t be further from the truth.
As a truly versatile excipient, gelatine can be tailored to provide capsules with a broad spectrum of specific attributes. From rapid release in the stomach to enteric release for fills with an unpleasant aftertaste, GELITA’s Release Profile Portfolio enables soft capsule manufacturers to define the timing and location of fill release. In addition, specific capsule gelatines reduce cross-linking behavior in the capsule and enhance shelf-life stability.
Gelatine capsules are among the most popular dosage forms for drugs, over-the-counter (OTC) products and dietary supplements. Consumers appreciate the smooth surface that makes them easy to swallow, which enhances patient compliance. Gelatine itself is extremely compatible with other ingredients, is non-allergenic and consists of proteins that are easily digestible in the gastrointestinal tract, which facilitates the release and absorption of active ingredients.
Despite the overwhelming advantages of gelatine capsules, however, certain types of reactive fills and extreme storage conditions — such as high temperatures 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 undesirable longer dissolution times in the gastrointestinal tract and slower fill release.
Designed to address this issue, GELITA® RXL (Reduced Cross-Linking) is a special gelatine grade that significantly reduces the number of cross-linking issues, thus enhancing the dissolution properties of the capsules. The GELITA solution can be described as a type of “self-defense mechanism” achieved by an optimized molecular weight distribution that protects the gelatine from self-cross-linking reactions and/or reactions with other substances within the fill formulation.
To guarantee long-term capsule stability for very critical fills, the gelatine manufacturer has additionally developed GELITA® RXL advanced, the next generation of its reduced cross-linking technology. This product provides a further reduction of a formation of less soluble pellicles which, in turn, minimizes cross-linking potential and supports controlled fill release performance during the entire shelf-life of the capsule.
And, with cross-linking under control, the next goal was to increase the delivery rate of the active. So, revolutionary release (R²) performance was invented! In close co-operation with the University of Heidelberg, new formulations were tested and analyzed for up to 12 months under different ICH storage conditions.
The results clearly showed that, even under demanding storage conditions, GELITA® RXL R2 gelatine offers up to 3 times faster fill release rates for both fresh and aged capsules. Hence, it provides significant benefits for the development of soft gelatine capsules for which revolutionary release in combination with long-term stability is required.
Cross-linking issues aside, when it comes to encapsulating stomach-irritating or sensitive ingredients such as probiotics and omega-3 fatty acids, one issue has blighted the use of softgel capsules: delivering the intact active to the appropriate site! To address this problem, GELITA developed a new technology: GELITA® EC. This novel approach allows the production of enteric capsules that dissolve in the small intestine instead of in the stomach.
Tests have shown that GELITA® EC capsules remain intact for up to 2 hours in 37 °C simulated gastric fluid, but are fully dissolved within 45 minutes in simulated intestinal fluid. These circumstances enable manufacturers to produce brilliantly clear enteric dosage forms using existing equipment in a one-step process. What’s more, they can also be used to taste mask unpleasant flavors as well.
With its standard EC, RXL, RXL advanced and RXL R2 products, GELITA offers a wide range of pharmaceutical-grade gelatines (Ph. Eur. / USP-NF) that fulfill almost all possible demands and properties and comply with current regulations. When it comes to finding the best gelatine grade for each application and designated use, GELITA’s experts help customers with their in-depth knowledge and expertise in technical service. This not only accelerates product development, but also reduces the risk that a capsule formulation, once developed, will be found to fail dissolution or storage requirements or not fulfill consumer expectations.
Want to get the very best performance from your soft capsule formulations? Contact us today for the solutions you Need.