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The Global Market Leader for Enteric Release Coatings

Enteric release outcomes to protect the API, boost compliance and ensure gastro-intestinal targeting

Evonik has been leading the market for enteric release for more than six decades thanks to a continuous pursuit for innovative coating solutions and value-adding services. Our broad, highly versatile portfolio of EUDRAGIT® functional polymers, together with best-in-class formulation services and drug delivery technologies, can be leveraged to enable or enhance the enteric release of APIs in a range of oral solid dosage forms. Whether you are seeking to protect acid-sensitive drugs from gastric fluid, safeguard the gastric mucosa against aggressive APIs, or ensure rapid dissolution at a specific gastrointestinal site - we have the oral excipients, processing capabilities and technical expertise to address your specific enteric release requirements.

A portfolio of enteric release solutions with distinct properties and strong track record

A broad, flexible portfolio of enteric release polymers is available under the EUDRAGIT® brand that feature well-defined dissolution characteristics to help optimize absorption of the API or enable precise drug targeting to avoid systemic side effects and reduce the daily dose. EUDRAGIT® enteric release polymers have gained a strong track record in avoiding irritation of the gastric mucosa during the gastro-intestinal transit of certain drugs such as non-steroidal, anti-inflammatory drugs (NSAIDs). They also have excellent gastro-resistant properties to avoid the degradation of acid-sensitive APIs such as enzymes, peptides or protein pump inhibitors in the stomach.

Easily combined for high-precision enteric release coatings

EUDRAGIT® polymers for enteric release can be easily combined either with each other, or with other polymers, to achieve a specific release profile for rapid pH-based dissolution at a target site such as the upper-to-middle small intestine or the colon. Supplied as either aqueous dispersions (30% w/w), organic solutions or fine powders, various EUDRAGIT® L, S, FS and FL polymer grades are available with dissolution properties between pH 5.5 and 7.0. EUDRAGIT® polymers for enteric release may also be used to develop modified release formulations with additional functionalities such as alcohol resistance, taste masking or the oral delivery of biologics. For these and other specific drug release requirements, Evonik has developed several drug delivery technologies based on its enteric EUDRAGIT® polymers.

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Highly stable, easy to process and widely accepted for use

EUDRAGIT® polymers for enteric release can be applied as thin films on a range of oral solid dosage forms including particles, tablets, multiparticulates and hard- and soft-gel capsules. Being entirely synthetic, EUDRAGIT® polymers provide highly stable product characteristics in narrow specification ranges. All common pharmaceutical processing technologies can be utilized based upon the specific polymer grade, including aqueous and organic film coating, hot melt extrusion, spray drying, direct compression and granulation. Processing can be done at low to moderate product temperatures to help reduce energy consumption and minimize thermic stress for the API. All EUDRAGIT® polymers utilized in the formation of enteric release coatings have a proven safety profile, with monographs that are widely accepted across North America, Europe and many Asia-Pacific markets.

EUDRAGIT® FL 30 D-55: The gold standard for enteric release has gone platinum

EUDRAGIT® FL 30 D-55 is a new combination polymer for enteric release developed utilizing our new Advanced Excipient Manufacturing Process (AEMP®) technology. Based upon two existing and widely accepted monographs, the advanced product takes the very best of EUDRAGIT® L 30 D-55 and adds excellent coating flexibility plus simpler processing. Being highly flexible, film formation can occur at low process temperatures with no additional plasticizer required. Smooth, fast processing is possible without the risk of sticking issues. Since the coating functionality is achieved at lowest coating levels, this new product also creates opportunities for high drug loadings.

Value-adding process and cleaning solutions for enteric release coatings

In addition to the EUDRAGIT® portfolio of enteric release coatings, Evonik also provides customers with additional value-adding opportunities to increase productivity and reduce drug manufacturing costs. PlasACRYL® HTP20 is an easy-to-use glidant and plasticizer premix specifically designed for EUDRAGIT® L 30 D-55 formulations to improve coating efficiency and reduce processing times. PlasACRYL® T20 offers the corresponding value for EUDRAGIT® FS 30 D formulations. In addition, the Chematic® L/S Cleaner is customized for the use after processing enteric EUDRAGIT® coatings to significantly reduce cleaning times and costs while increasing cleaning safety for both automatic and manual cleaning procedures.

Enteric release polymers

Product
Availability
Dissolution property
EUDRAGIT®
L 100-55
Powder
Dissolution above pH 5.5
EUDRAGIT®
L 30 D-55
Aqueous dispersion
Aqueous dispersion of a combination polymers,
flexible coatings without addition of plasticizer
PlasACRYL®
HTP 20
Easy-to-use glidant and plasticizer premix,
specifically designed for EUDRAGIT® L 30 D-55 formulations
Dissolution above pH 6.0
EUDRAGIT®
L 100
Powder
EUDRAGIT®
L 12,5
Organic solution
EUDRAGIT®
S 100
Powder
Dissolution above ph 7.0
EUDRAGIT®
S 12,5
Organic solution
EUDRAGIT®
FS 100
Powder
EUDRAGIT®
FS 30 D
Aqueous dispersion
PlasACRYL®
T20
Easy-to-use glidant and plasticizer premix,
specifically designed for EUDRAGIT® FS 30 D formulations