Oral Excipients to Unlock the Potential of Your API

A trusted solutions provider and development partner for oral excipients

As medicines continue to become more complex and personalized, pharmaceutical companies are increasingly partnering with oral excipient specialists who can enable, enhance and differentiate their oral solid dosage forms. For more than 60 years, Evonik has been leveraging its market-leading expertise in oral excipients and related drug delivery technologies to help customers generate specific functionality outcomes for their small molecules and biologics. In addition to applying our polymers, process technology and formulation expertise to match virtually any target release profile or address poor API solubility, we have a strong track record for global supply security and local regulatory support. By selecting EUDRAGIT® as your trusted brand for oral excipients, you gain access to the strength, flexibility and innovation of Evonik to help streamline your path to market and generate long-term value for patients, payers and prescribers.

The EUDRAGIT® portfolio of functional oral excipients

The poly(meth)acrylate chemistry behind the EUDRAGIT® portfolio delivers unrivalled versatility to unlock the potential of APIs targeted for use dosage forms including multiparticulates, tablets, capsules and films. Able to be used individually or in combination with other oral excipients or substances, EUDRAGIT® based formulations can be precisely tuned to a range of common release profiles including:

as well as customized profiles such as:

  • pulsatile release,
  • accelerated release,
  • and zero order release.

In addition to being well-defined synthetic polymers with narrow specifications, they are neither absorbable nor biodegradable, do not change in chemical structure while passing through the body and exhibit no toxicological effects. EUDRAGIT® polymers are available as aqueous dispersions, granules, organic solutions, or standard or pre-mixed powders for easy handling, and are compatible with all common process technologies.

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A global oral excipients leader for complex oral solid dosage forms

Evonik has been a global leader in complex oral solid dosage forms for more than six decades, including:

  • capsules filled with pellets,
  • mini-tablets,
  • solid dispersions or liquids,
  • multi-particulate and matrix tablets,
  • 2D films and 3D printed multi-compartment tablets.

We have the expertise and capabilities to rapidly optimize the development process and provide clinical batches for use across a range of areas including the development of orphan drugs, poorly soluble drugs, oncological drugs and pediatric formulations. We also provide broad capabilities in the production and handling of highly potent APIs and their drug products, as well as controlled substances, microbiota and enzymes. Our strong competenices across areas including particle engineering, amorphous solid dispersions, silica technologies, and downstreaming processes enable you to enhance API solubility and bioavailability. In addition to our proven Quality-by-Design approach and use of Design of Experiments (DOE) to reduce processing times and improve process quality, our analytical expertise can also help predict and accelerate your path to clinic and launch.

Oral excipient expertise across batch, continuous and additive manufacturing

In addition to having decades of oral excipient expertise to support pharmaceutical and biotechnology companies in the use of traditional batch processes, Evonik has established advanced capabilities for continuous manufacturing and additive manufacturing. EUDRAGIT® polymers are highly suitable for continuous processing, with a range of single and combination polymer options from immediate release tablets or capsules to more complex dosage forms including extended or modified release. The convergence of various 3D printing and formulation technologies also create significant opportunities to pioneer next-generation therapeutic solutions. EUDRAGIT® polymers have already accumulated more than a decade of published data relating to additive manufacturing, with hundreds of scientific articles published in recent years. Whether your project targets the use of batch, continuous or additive manufacturing, our global network of formulation and application labs can provide you with the right oral excipient solution, and serve you with clinical batch manufacturing, scale up and production transfer.