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Oral Drug Delivery Systems

A Commercially-Proven Colon Targeted Drug Delivery System

Enabling colon targeted drug delivery via a dual layer of enteric and sustained-release polymers

Evonik provides pharmaceutical and biotechnology companies with a strong portfolio of functional polymers, proprietary technologies and formulation expertise to enable and enhance colon targeted drug delivery for oral solid dosage forms. EUDRATEC® COL is a pH-dependent, sustained release technology that facilitates the precise delivery of an API along the colon. The proprietary system consists of an outer layer of an enteric polymer and an inner layer of a sustained release polymer. This multi-layer combination creates a range of formulation opportunities to improve drug efficacy, including the creation of once daily dosing formulations, the reduction of the total dose, and more constant plasma concentrations.

Colon targeted drug delivery systems provide a range of positive clinical implications

As a specific region in the gastrointestinal tract, the colon represents an attractive environment for targeted drug delivery due to the relatively low levels of diversity and intensity for digestive enzymes. Compared to the small intestine, proteolytic activity of colon mucosa is also minimal. The colon therefore represents an ideal absorption site for sensitive drugs such as peptides and proteins. Accordingly, EUDRATEC® COL can help to enable and enhance the localized treatment of colonic diseases such as Inflammatory Bowel Disease or colon cancer, as well as the systemic delivery for sensitive APIs where absorption in the colon is desirable.

Combining drug protection through the GIT with a colon targeted drug delivery system

EUDRATEC® COL can reliably deliver APIs safely through the gastrointestinal tract where it provides sustained release of the API along the colonic transit. The dual-layer colon targeted drug delivery system consists of an outer layer of a pH–dependent soluble coating for enteric protection and colon targeting such as EUDRAGIT® FS 30 D, and an inner layer coating of a sustained release polymer such as EUDRAGIT® RL or EUDRAGIT® RS. After passing intact through the stomach, dosage forms formulated with EUDRATEC® COL reach the jejunum where the pH environment is between six and seven. The pH-controlled release of the outer layer is then fully triggered within the Ileum, where the pH environment is seven. Following its arrival in the colon, where the pH is greater than seven, the inner coating is then able to deliver the API by diffusion over its designated sustained release profile.

A commercially available and patent-protected colon targeted drug delivery system

With the first oral drug product utilizing EUDRATEC® COL having reached the market in 2017, the technology represents a reliable and commercially proven system to enable colon targeted drug delivery. EUDRATEC® COL is suitable for use as coated pellets that can be filled into capsules and compressed into multiparticulates, as well as other oral dosage forms. The simple formulation process allows companies to formulate small molecules and biologics using conventional equipment and internationally accepted technologies.

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