Delayed release oral solid dosage forms developed with enteric coating provide either protection of the gastric mucosa from irritating actives or protection of drugs unstable in gastric fluids.
Applications include tablets and multiparticulate dosages for a range of drug products, including proton pump inhibitors (PPI) which are commonly used to treat acid reflux and ulcers of the stomach and the duodenum.
Acryl-EZE II extends Colorcon‘s line of aqueous enteric systems to provide specific applications for tablets and multiparticulate dosage forms with enhanced enteric protection up to a challenging level of pH 5.0 seen with patients taking PPIs, or when tested under fed conditions.
Kelly Boyer, General Manager Film Coatings, explains: “This extension to the Acryl-EZE portfolio of products represents an advance in delayed release coating technology to provide the pharmaceutical industry with added convenience for enteric coating."
"Acryl-EZE formulations provide significant time savings in both development and production; while enabling targeted drug delivery across a wide pH range.”
Dr Ali Rajabi-Siahboomi adds: “The formulation of enteric coatings is challenging; requiring multiple ingredients and process steps. Through Colorcon’s coating technology, this new Acryl-EZE II formulation provides simplified preparation and use, with enhanced protection up to pH 5.0 through the addition of a special top-coat."
"Coating performance has been validated through a human volunteer study in the most challenging fed state conditions, confirming bioavailability and in-vivo performance.”