For pharmaceutical companies who are bringing a new oral drug product to market, the selection of the right coated capsule formulation can help to boost functional performance and accelerate speed to market. By leveraging more than 60 years of industry leadership for functional polymers and the development of oral solid dosage forms, Evonik has created a best-in-class portfolio of functional ready-to-fill 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.
A versatile, high-quality range of functional ready-to-fill HPMC capsules for your oral dosage forms
Each standard or custom EUDRACAP® configuration features a smooth, homogeneous coating of EUDRAGIT® for precise pH targeting of sites including the mid-to-upper small intestine and colon. 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. Together with the regulatory excellence of EUDRAGIT® and Evonik’s local market knowhow, these USP and EP compliant EUDRACAP® capsules can help you to reduce clinical risk and accelerate time to market.
The benefits of EUDRACAP®
- Precise pH targeting
- Effective acid resistance for up to 4 hours
- Optimized absorption rates
- Reduce clinical risk
- Accelerate time to market
Download this white paper to find out how a suitable oral delivery system for a full ecosystem of fecal microbiota was developed using EUDRACAP(R) Select and then tested. This white paper was the result of a collaboration with the biotechnology company MaaT Pharma.
Let EUDRACAP® 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 are designed for targeted release in the upper small intestine. The high-quality capsules feature a precisely tailored enteric coating and are fully USP and EP compliant. Dissolution testing confirms that no drug release occurs during the acid stage. Rapid release then reliably occurs after conversion to pH 6.8.
FROM PRECLINICAL TO COMMERCIAL. OPTIMIZE DRUG DEVELOPMENT BY REDUCING RISKS AND VARIABLES IN PRECLINICAL TRIALS
Evonik also offers a tiny capsule suitable for use in preclinical trials. EUDRACAP® preclinic enteric is a robust and quick solution for preclinical formulations. 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.
Evonik can also support you with custom capsule coatings, formulation development and cGMP scale-up
In addition to standard EUDRACAP® functional coated capsule products, EUDRACAP® Select delivers a flexible range of custom options to match your specific 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.
Given the strong technical expertise across areas including colonic delivery, microbiome delivery, bioavailability enhancement and personalized dosage forms, Evonik Health Care can also help to bring your product to market. Services include fast-track feasibility studies, prototype samples, GMP clinical batches, analytical method development and technical transfer.
To speak with a member of Evonik’s expert technical team, contact us.