Esomeprazole EC

Product overview

Esomeprazole EC Pellets – Engineered for Controlled Acid Suppression and Formulation Flexibility. Rraynex’s esomeprazole enteric-coated (EC) pellets are developed with precision layering and stability optimization, ensuring consistent performance in acid-resistant formulations. Designed for fast scalability, these pellets help manufacturers deliver dependable proton pump inhibitor (PPI) therapies with reproducible pharmacokinetics and long-term stability. Overview: Esomeprazole magnesium trihydrate, the S-enantiomer of omeprazole, is a highly effective proton pump inhibitor that reduces gastric acid secretion by selectively blocking the H+/K+ ATPase enzyme system. Our EC pellets are formulated with a specialized sealing coat to protect the core API, followed by enteric polymers that dissolve at intestinal pH—guaranteeing precise drug release beyond the stomach and consistent bioavailability across dosage strengths. Key Features & Benefits: • Superior Enteric Protection: Dual-layer coating safeguards the API from acidic environments, enabling targeted release in the intestine. • Precise Pellet Engineering: Controlled particle size and optimized sphericity ensure smooth flow, low dust, and uniform capsule fill weights. • Consistent Assay Performance: In-process controls monitor assay uniformity, moisture content, and coating thickness for every batch. • Ready for Scale-Up: Optimized for capsules, sachets, or multiparticulate tablets with stable flow and compressibility. • Regulatory Data Support: Comparative dissolution studies, impurity profiling, and packaging validation included in documentation. • Market Compliance: Manufactured under cGMP, ISO, and ICH guidelines, with full nitrosamine risk assessments and photostability data. Technical Specifications: • API: Esomeprazole Magnesium Trihydrate • Assay: 98.0–102.0% • Pellet Size Range: 500–1180 μm (customizable) • Enteric Coating Polymer: Methacrylic acid copolymers (Eudragit L/S series) or equivalent systems • Loss on Drying: ≤1.5% • Packaging: 25 kg HDPE drums, foil-lined or nitrogen-flushed options available • Storage: Store below 25°C, away from light and moisture. Applications: • Pharmaceutical manufacturers producing enteric-coated PPIs for GERD, peptic ulcer, and acid reflux therapy. • CDMOs developing generic and branded PPI formulations with consistent dissolution profiles. • R&D teams requiring reliable pellet intermediates for sustained-release and combination therapy products. Educational Insight: Esomeprazole belongs to the class of proton pump inhibitors that reduce gastric acid secretion by targeting the final step in acid production. Its enteric-coated pellet form prevents degradation in the stomach, enabling efficient release in the small intestine for rapid symptom control and improved patient comfort. Rraynex’s EC technology enhances stability, dissolution precision, and regulatory readiness across formulations. SEO Keywords: esomeprazole pellets, esomeprazole EC pellets, enteric coated esomeprazole, PPI pellets, acid reflux pellets, GERD treatment raw material, esomeprazole magnesium trihydrate pellets, pharmaceutical pellets supplier, gastro resistant pellets, esomeprazole manufacturer, enteric pellets exporter Usage Note: For pharmaceutical manufacturing and educational purposes only. Esomeprazole-containing products should be developed and used under qualified medical supervision. Manufacturers are responsible for ensuring compliance with applicable pharmacopeial and regulatory standards prior to commercial release.