Evonik Launches EUDRACAP Preclinic Functional Oral Capsule for Preclinical Trials

Evonik is launching a functional, ready-to-fill oral capsule designed for use in preclinical trials. EUDRACAP preclinic enteric is a very small size 9h (5.1 mm), technical-grade capsule suitable for passing through the gastrointestinal tract of preclinical animal models. The enteric-coated capsule enables pharmaceutical companies to optimize drug development by reducing cost, time, and variables during preclinical trials. Companies can also move seamlessly from preclinical to clinical and commercial stages using the EUDRACAP platform.

EUDRACAP preclinic enteric is the latest addition to Evonik’s EUDRACAP platform of easy-to-handle capsules. The platform leverages the established EUDRAGIT functional coatings for optimized release profiles of oral drug products. With its long-standing experience in functional excipients, formulation and applications services, Evonik provides System Solutions to its customers. System Solutions are multi-component offerings across products, technologies and services that provide customers with end-to-end development and manufacturing services for complex drug products. It is the vision of Evonik’s life sciences division, Nutrition & Care, to increase its share of System Solutions from 20% to 70% by 2032.

“Every extra step in the drug development process costs time and adds risk. The latest addition to our EUDRACAP platform is an easy way for our customers to reduce complexity and streamline the whole development process. We look forward to seeing the positive impact in the industry and patients it serves,” said Axel Schroeder, Head of Global Business Segment Oral Drug Delivery Solutions at Evonik Health Care.

Preclinical trials are a cost-effective way to ensure that only the most promising drugs move forward to clinical trials, ultimately leading to the development of safe and effective drugs for patients. The gastrointestinal tract (GIT) conditions of animals used in preclinical trials have a significant impact on targeted drug delivery, as does the size of the capsules.

By offering a ready-to-fill capsule that can be used for any drug candidate demanding protection from the acid environment in the stomach, drug developers reduce costs and time, as well as variables such as additional coating steps and the need to subject sensitive active ingredients to heat and moisture during the coating process. EUDRACAP preclinic is available with enteric dissolution profile, as a clear, size 9h capsule. For additional sizes and dissolution profiles, the tailor-made EUDRACAP Select remains an option. Seamless transition to first-in-human trials is possible thanks to the EUDRACAP platform, which offers the same delivery technology from preclinical to commercial phase.

EUDRACAP preclinic enteric is the latest addition to a portfolio of innovations for oral drug delivery, launched by the Health Care business at Evonik over the past few years. In 2022, Evonik began marketing EUDRATEC SoluFlow, a new microparticle technology to enhance the solubility of active pharmaceutical ingredients in oral drug products. EUDRACAP enteric and EUDRACAP Select were launched in 2021.

Evonik Health Care is one of the world’s leading contract development and manufacturing organizations (CDMO) for complex oral and parenteral drug products requiring advanced drug delivery solutions. It is also one of the world’s largest suppliers of active pharmaceutical ingredients (APIs), amino acids, cell culture ingredients, medical device excipients and is a leading global CDMO for APIs and intermediates.

Evonik is one of the world leaders in specialty chemicals. The company is active in more than 100 countries around the world and generated sales of €18.5 billion and an operating profit (adjusted EBITDA) of €2.49 billion in 2022. Evonik goes far beyond chemistry to create innovative, profitable, and sustainable solutions for customers. About 34,000 employees work together for a common purpose: We want to improve life today and tomorrow.