Esomeprazole + Levosulpiride

Product overview

Esomeprazole + Levosulpiride Pellets – Dual-Action Gastrointestinal Therapy with Coordinated Release Control. Rraynex’s combination pellets deliver synchronized acid suppression and prokinetic activity through a precisely engineered dual-layer system. Manufactured under controlled environmental conditions, each API is isolated and layered independently to prevent interaction while maintaining uniform pellet density and consistent dissolution behavior across batches. Overview: This dual-API system combines Esomeprazole, a potent proton pump inhibitor (PPI) that suppresses gastric acid secretion, with Levosulpiride, a selective D2 receptor antagonist that enhances gastrointestinal motility. The result is an advanced formulation platform for comprehensive management of GERD, dyspepsia, and other upper gastrointestinal disorders requiring both acid control and prokinetic support. Key Features & Benefits: • Dual-Layer Design: Esomeprazole is protected by an enteric coat for intestinal release, while Levosulpiride is exposed for early gastric availability. • Chemical Isolation: Dedicated barrier layers prevent cross-degradation and maintain assay compliance within tight regulatory limits. • Density-Matched Pellets: Controlled spheronization ensures both APIs distribute evenly in capsule fills, sachets, or multiparticulate systems. • Coordinated Dissolution: Verified through dual-media dissolution studies to ensure simultaneous therapeutic onset and sustained duration. • High Stability Profile: Robust long-term and accelerated stability data confirm impurity control under ICH climatic conditions. • Regulatory Support: Comprehensive CTD documentation, validated analytical methods, and excipient compatibility data provided. Technical Specifications: • APIs: Esomeprazole Magnesium Trihydrate and Levosulpiride • Assay: 98.0–102.0% for both APIs • Pellet Size Range: 500–1100 μm (customizable) • Release Profile: Esomeprazole – enteric delayed release; Levosulpiride – immediate gastric release • Coating Polymers: Methacrylic acid copolymers (Eudragit L/S series) and HPMC barrier systems • Loss on Drying: ≤1.5% • Packaging: Segregated or unified barrier bags, moisture-proof HDPE drums, or nitrogen-flushed containers • Storage: Store below 25°C, protected from light and humidity. Applications: • Pharmaceutical manufacturers producing combination PPI–prokinetic formulations for GERD and dyspepsia management. • CDMOs developing dual-release multiparticulate systems with controlled pharmacokinetic behavior. • R&D and regulatory teams preparing CTD/ACTD dossiers for global market submissions. Educational Insight: Esomeprazole suppresses acid secretion by irreversibly blocking gastric proton pumps, providing long-lasting relief from reflux symptoms. Levosulpiride acts as a prokinetic by enhancing gastric emptying and reducing nausea through dopaminergic receptor modulation. Together, they offer a synergistic treatment for reflux disorders involving both hyperacidity and delayed gastric motility. Pelletization ensures precise delivery of each API with reduced variability and improved bioavailability. SEO Keywords: esomeprazole levosulpiride pellets, dual release pellets, combination PPI pellets, GERD treatment pellets, dyspepsia therapy raw material, prokinetic acid suppressant pellets, enteric coated esomeprazole pellets, levosulpiride granules, pharmaceutical pellets manufacturer, dual API pellets exporter, gastro resistant pellets supplier Usage Note: For pharmaceutical manufacturing and educational reference only. Esomeprazole + Levosulpiride formulations should be developed, validated, and marketed under appropriate medical and regulatory supervision. Manufacturers are responsible for ensuring compliance with all pharmacopeial and regional quality standards.