Pharmaceutical companies launching new oral drugs need the right coated capsule formulation to enhance performance and accelerate speed to market. With over 60 years of expertise in functional polymers and oral dosage forms, Evonik has developed an exceptional range of ready-to-fill functional capsules. EUDRACAP® pre-locked capsules are suitable for the filling of drug forms including powders, pellets and granules. They are easy to open and close on standard capsule filling systems.

Each standard or custom EUDRACAP® configuration features a smooth, homogeneous coating of EUDRAGIT® for precise pH targeting. The safety, reliability and versatility of EUDRAGIT® functional polymers can help to match your specific release profile requirements, with effective acid resistance for up to four hours.

An increasing number of active ingredients are also sensitive to heat, moisture, gastric acids or certain processing conditions. Here, EUDRACAP® can help protect the active ingredient to optimize rates of absorption and avoid premature dissolution. We have built on our strong track record of regulatory excellence for EUDRAGIT® as well as our local market knowhow.

EUDRACAP® enteric is designed to optimize gastric resistance and improve absorption for oral drug products that target release in the upper small intestine. The high-quality capsules feature a precisely tailored enteric coating and are fully US Pharmacopeia (USP) and European Pharmacopeia (Ph. Eur) compliant. Dissolution testing confirms that no drug release occurs during the acid stage. Rapid release then reliably occurs after conversion to pH 6.8.

EUDRACAP® colon is designed for drug products targeted for release in the ileo-colonic region. Like EUDRACAP® enteric, it provides reliable gastric resistance to protect sensitive ingredients. However, in contrast to EUDRACAP® enteric, which shows fast release at pH 6.8, EUDRACAP® colon provides significantly more delayed release at a higher pH EUDRACAP® colon also provides reliable protection and targeted delivery of sensitive actives like live biotherapeutics, polypeptides and proteins (biologics), and nucleotides.

Evonik also offers EUDRACAP® as a tiny capsule suitable for preclinical trials. This capsule is available for enteric protection as EUDRACAP® preclinic enteric. Whenever you need to test an enteric formulation in animal trials, our empty, ready-to-fill, size 9h (5.1 mm) gelatin-based hard capsule is designed to provide robust low gastrointestinal (GI) delivery in preclinical animal models. EUDRACAP® preclinic enteric does not require additional coating steps to achieve enteric functionality, it simplifies the formulation, eliminates the need of additional excipients and banding and, therefore, reduces the variables and risks in preclinical studies. 

EUDRACAP® preclinic enteric uses the same coating technology and has a similar dissolution profile to EUDRACAP® enteric. This means you can move seamlessly from preclinical to clinical and commercial stages, reducing complexity and streamlining the whole drug development process.

Alongside our standard EUDRACAP® functional coated capsules, we also offer EUDRACAP® Select. This customizable capsule delivers a range of options to match your specific active pharmaceutical ingredient (API), formulation and brand requirements. Different capsule sizes, colors and other tailored options are possible. A range of different EUDRAGIT® polymers, drug delivery technologies and process technologies, as well as other solubility and bioavailability options, are also available to help optimize your release profile.

We have strong technical expertise across areas including colonic delivery, microbiome delivery, bioavailability enhancement and personalized dosage forms. Our services include fast-track feasibility studies, prototype samples, GMP (Good Manufacturing Practices) clinical batches, analytical method development and technical transfer.

Want to learn more? Get in touch with us to discuss your individual needs with one of our oral drug delivery experts.