Colorcon Inc., a Pennsylvania-based developer and supplier of film coating systems and excipients, has launched its Acryl-Eze II line of enteric coatings. With the release, the company now offers a broader pH range across its enteric coatings for pharmaceutical applications.
According to the company, delayed-release oral solid-dosage forms developed with enteric coatings such as these provide either protection of the gastric mucosa from irritating actives, or protection of drugs unstable in gastric fluids. Applications the coatings are suited for include tablets and multi-particulate dosages for a range of drug products, including proton pump inhibitors (commonly used to treat acid reflux and ulcers of the stomach and the duodenum).
Deborah Taylor, director of global market communications at Colorcon, told Outsourcing-Pharma that one of the chief benefits of using the Acryl-Eze II coatings is that each coating is fully formulated.
“All components are included as a one-step system that brings benefits to users by reducing the inventory of raw materials, less QC testing, color consistency for pigmented coatings, and batch to batch reliability,” she explained.
The Acryl-Eze II aqueous enteric systems reportedly can provide specific applications for tablets and multi-particulate 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, Colorcon’s general manager of film coatings, added, “Acryl-EZE formulations provide significant time savings in both development and production; while enabling targeted drug delivery across a wide pH range.”
According to Colorcon vice president and chief scientific officer Ali Rajabi-Siahboomi, enteric coatings tend to be challenging, due to 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,” he said. “Coating performance has been validated through a human volunteer study in the most challenging fed state conditions, confirming bioavailability and in-vivo performance.”