EUDRACAP® functional capsules leverage the functional versatility and safety of EUDRAGIT® for fast oral drug development
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.
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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.
The benefits of EUDRACAP® functional ready-to-fill coated HPMC capsules:
- Precise pH targeting
- Effective acid resistance for up to 4 hours
- Optimized absorption rates
- Reduced clinical risk
- Accelerated time to market
Our EUDRACAP® product range at a glance
EUDRACAP® enteric
Functional capsules to optimize gastric resistance, boost intestinal absorption and enhance bioavailability
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.
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EUDRACAP® colon
Functional capsules targeting the ileo-colonic region
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.
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EUDRACAP® preclinic
Functional capsules to reduce risks and variables in preclinical trials
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.
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EUDRACAP® Select
Custom capsules for tailored coatings, formulation development and cGMP scale-up
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.
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How it works: EUDRACAP® colon functional capsules targeting the ileo-colonic region
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White paper: EUDRACAP® Select - Examining a case from development to clinical trial
Download this white paper to find out how a suitable oral delivery system for a full ecosystem of fecal microbiota was developed using EUDRACAP® Select and then tested.
This white paper was the result of a collaboration with the biotechnology company MaaT Pharma.
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Trust EUDRACAP® and Evonik to help you bring your product to market
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 our global team of oral drug delivery experts.
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"Our global team of experts is ready to support you with all questions around our product and service portfolio for oral drug delivery. Contact us to profit from more than 70 years of application know-how!"
Felix Hofmann
Director Formulation & Application Services
