Esomeprazole EC Pellets

Anti-Ulcerant (PPIs) • Pellets

Enteric-coated esomeprazole pellets with tight moisture control to maintain proton pump inhibition for GERD and erosive esophagitis regimens.

8.5%22.5%
  • GradeIP / BP / USP / EP
  • Pack Size25/50 kg
  • CertificationsWHO-GMP • ISO 9001

Product 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 characteristics

  • 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 information

  • 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.

Pharmaceutical 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.

How it works

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.

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.

Product specifications

Product
Esomeprazole EC Pellets
Form
enteric-coated Pellets
Therapeutic category
Anti-Ulcerant (PPIs)
Available strengths
8.5%, 22.5%
Grade
IP / BP / USP / EP
Pack size
25/50 kg
Site certifications
WHO-GMP, ISO 9001, ISO 14001

Detailed specifications, COA and technical documentation are shared on request.

Supply and enquiries

Rraynex supplies Esomeprazole EC Pellets to pharmaceutical manufacturers, formulation developers and CDMOs in 25/50 kg packs with batch traceability. Send your quantity, grade and documentation needs through the enquiry form and the commercial team will reply with specifications and a quotation. Rraynex is a B2B supplier and does not sell to consumers.

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