Esomeprazole + Domperidone

Product overview

Esomeprazole + Domperidone Pellets – Integrated Dual-Action Solution for GERD and Reflux-Related Nausea. Rraynex’s combination pellets are engineered to deliver coordinated acid suppression and prokinetic relief through a dual-phase release system. Each API is processed independently to maintain chemical stability and controlled release, ensuring reliable therapeutic performance and formulation consistency across all scales of production. Overview: This dual-API system merges the acid-suppressing power of Esomeprazole, a leading proton pump inhibitor (PPI), with the prokinetic benefits of Domperidone, a dopamine D2 receptor antagonist that enhances gastric motility and mitigates nausea. The formulation supports patients experiencing reflux, bloating, and delayed gastric emptying, delivering sustained symptom relief through carefully synchronized drug delivery kinetics. Key Features & Benefits: • Dual-Phase Release: Enteric-coated Esomeprazole provides intestinal release, while Domperidone is released earlier in the gastric environment for rapid prokinetic effect. • Process Integrity: Each layer is isolated with precision barrier coatings to prevent cross-interaction and degradation during manufacturing or storage. • Density Harmonization: Both APIs are engineered for matched flow behavior, minimizing segregation during high-speed encapsulation and sachet filling. • Quality Assurance: Continuous monitoring of assay, residual solvents, friability, and dissolution profiles ensures consistency from pilot to commercial scale. • Regulatory Documentation: Dossiers include combined dissolution profiles, impurity management data, excipient compatibility studies, and stability evaluations under ICH zones. • Custom Packaging Options: Available in 25 kg moisture-barrier drums, nitrogen-purged containers, or small barrier bags for sampling and clinical-scale applications. Technical Specifications: • APIs: Esomeprazole Magnesium Trihydrate and Domperidone • Assay: 98.0–102.0% for both APIs • Pellet Size Range: 500–1100 μm (customizable) • Release Profile: Esomeprazole – enteric delayed release; Domperidone – gastric immediate release • Coating Polymers: Methacrylic acid copolymers, HPMC, or equivalent gastro-resistant systems • Loss on Drying: ≤1.5% • Packaging: HDPE moisture-proof drums, aluminum-lined or nitrogen-flushed bags • Storage: Store below 25°C, away from light, moisture, and heat. Applications: • Pharmaceutical manufacturers producing dual-action GERD formulations combining PPI and prokinetic therapy. • Contract developers (CDMOs) seeking validated multiparticulate platforms for gastro-resistant dosage forms. • Exporters and regulatory teams preparing CTD/ACTD submissions for international market approvals. Educational Insight: Esomeprazole reduces gastric acid secretion by inhibiting the H+/K+ ATPase enzyme, providing prolonged relief from acid reflux and heartburn. Domperidone complements this by increasing gastrointestinal motility, reducing bloating, and preventing nausea. Combined in a dual-release pellet form, they provide comprehensive reflux management—protecting the stomach while restoring normal gastric flow. Rraynex’s precision layering ensures controlled dissolution, stability, and regulatory compliance across all batches. SEO Keywords: esomeprazole domperidone pellets, dual release pellets, GERD combination pellets, acid reflux treatment pellets, prokinetic PPI pellets, enteric coated esomeprazole, domperidone pellets manufacturer, pharmaceutical pellets exporter, gastro resistant pellets supplier, combination PPI raw material, reflux therapy pellets Usage Note: For pharmaceutical manufacturing and educational purposes only. Esomeprazole + Domperidone formulations should be developed and administered under professional medical supervision. Manufacturers must ensure compliance with pharmacopeial and regional quality standards prior to market release.