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Oral Drug Delivery - Oral Excipients - EUDRAGIT® Portfolio

EUDRAGIT® functional polymers for sustained release

Sustained release solutions to optimize drug effectiveness and improve patient compliance

Evonik has a strong commercial record in the development of functional coatings that can precisely match the target sustained release profile and dosage form. In particular, we have unrivalled expertise in the development and production of diffusion-controlled coated multiparticulates and matrix tablets. An extensive range of EUDRAGIT® polymers are available to provide sustained drug release by time control. These can be easily combined with other EUDRAGIT® polymers as well as other polymers or drug delivery technologies to control the rate of sustained release over a specific duration. The versatility of our sustained release polymers, combined with decades of technical expertise, can be leveraged to create enabling formulation solutions including once-per-day dosing.

A broad, flexible range of functional polymers for sustained release

A wide variety of EUDRAGIT® polymers for sustained release are available as granules, powders, aqueous dispersions or organic solutions for use with dosage forms including matrix tablets and multiparticulates. All are insoluble, with pH-independently swelling. EUDRAGIT® RL polymers with high permeability and EUDRAGIT® RS polymers with low permeability are often used in combination at different ratios to create the specific target permeability and thus the desired rate of intestinal absorption. The neutral EUDRAGIT® NM 30 D with low permeability is another attractive option as it can be formulated with all APIs no matter which ionic charge they have and in case highly flexible films are required for dosage forms such as multiparticulate tablets. Every EUDRAGIT® polymer grade for sustained release formulations has monographs that are widely accepted across North American, European and key Asian-Pacific markets, with high-quality production at established sites in Germany for global security of supply.

Versatility in diffusion control for sustained release formations

EUDRAGIT® polymers for sustained release provide high versatility in choosing a preferred process technology for multiparticulates and matrix systems due to their availability in various grades, their miscibility and compressibility, as well as excellent binding properties. Multiple polymer options are suitable for use with various process technologies including wet granulation. Evonik’s team of technical experts and global network of labs can also provide a range of capabilities and services to address specific bioavailability or functionality requirements such as reduced risk of alcohol induced dose dumping, improved GIT distribution, a lowering of the gastric residence times and better swallowability.

Options for pulsatile release and other custom sustained release profiles

The ease at which EUDRAGIT® polymers can be combined into single or multiple layer coatings creates attractive opportunities to design customized profiles for sustained release that can help to improve patient compliance. For example, EUDRAGIT® RL and RS coatings have been successfully used to create chronotherapeutic therapies based on pulsatile drug release. We also have extensive expertise at creating tailored dosage forms with custom release profiles such as zero-order kinetics, slow-quick and quick-slow release.

Value-adding process and cleaning solutions for sustained release coatings

In addition to the EUDRAGIT® portfolio of sustained release coatings, Evonik also provides customers with additional value-adding opportunities to increase productivity and reduce production costs. One example are Chematic® Cleaners which are customized for equipment cleaning after EUDRAGIT® RL, EUDRAGIT® RS and EUDRAGIT® NM processing. They can be applied for both automated and manual cleaning processes and enable significant reductions of cleaning time and efforts. 

Sustained release polymers

Product

Availability

Dissolution property

EUDRAGIT®
RL 100

Granules

Insoluble
High permeability
pH-independent swelling

EUDRAGIT®
RL PO

Powder

EUDRAGIT®
RL 30 D

Aqueous
Dispersion

EUDRAGIT®
RL 12,5

Organic
Solution

EUDRAGIT®
RS 100

Granules

Insoluble
Low permeability
pH-independent swelling

EUDRAGIT®
RS PO

Powder

EUDRAGIT®
RS 30 D

Aqueous
Dispersion

EUDRAGIT®
RS 12,5

Organic
Solution

EUDRAGIT®
NE 30 D

Aqueous
Dispersion

Insoluble, low permeability,
pH-independent swelling
No plasticizer required
Highly flexible

EUDRAGIT®
NE 40 D

Aqueous
Dispersion

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