The global market leader for enteric release coatings
Enteric release outcomes to protect the API, boost compliance and improve 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 passage of certain types of drug product 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 within the stomach.
Easily combined for high-precision enteric release coatings
EUDRAGIT® polymers for enteric release can be easily combined either with each other, or additional excipients and drug delivery technologies, to achieve a specific release profile for rapid pH-based dissolution at a target site such as the upper-to-middle small intestine or colon. Supplied as either aqueous dispersions (30%) or 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, or with additional functionalities such as alcohol resistance, improved taste masking or the oral delivery of biologics.
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-shell capsules. Being entirely synthetic, EUDRAGIT® polymers provide highly stable product characteristics in narrow specification ranges. A range of processing technologies can be utilized based upon the specific polymer grade, including hot melt extrusion, spray drying, direct compression and granulation. Processing can also be done at low to moderate 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 even higher levels of enteric release 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 risk of sticking issues. Being able to be applied as a thin film for enteric protection at low polymer amounts 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 cost. 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. In addition, Chematic® Cleaners are customized for use with specific EUDRAGIT® enteric release coatings to significantly reduce cleaning times and improve energy efficiency.
Dissolution above pH 5.5
Aqueous dispersion of a combination polymer,
PlasACRYL® HTP 20
Easy-to-use glidant and plasticizer premix, specifically designed for EUDRAGIT® L 30 D-55 formulations
EUDRAGIT® L 100
Dissolution above pH 6.0
EUDRAGIT® L 12,5
EUDRAGIT® S 100
Dissolution above pH 7.0
EUDRAGIT® S 12,5
EUDRAGIT® FS 100
EUDRAGIT® FS 30 D
Easy-to-use glidant and plasticizer premix, specifically
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