Omeprazole EC
Delayed release pellets for GERD, erosive esophagitis, and H. pylori regimens. Tight pellet sizing and durable enteric layers secure acid resistance for MUPS and capsule filling.
Product overview
Omeprazole EC pellets are tuned for GERD, erosive esophagitis, and H. pylori regimens, keeping acid uptake below pharmacopeial limits while supporting multiple dosage formats. Manufacturing combines inert core preparation, active layering, and enteric coating under tightly controlled humidity to protect the acid-labile benzimidazole. Pellets exhibit narrow size distribution and low ash content, enabling smooth capsule filling, MUPS compression, or sachet use. In-process analytics monitor assay, loss on drying, and coating thickness, ensuring reliable gastric resistance across strengths. Rraynex provides comprehensive data packages covering dissolution in acidic and neutral media, impurity trends, and stability studies through climatic zones II to IV. Packaging choices range from 25 kilogram drums to foil-lined bags, each validated for international shipping. Technical liaisons assist with method transfer, capsule formulation, and compatibility checks for excipients such as HPMC, MCC, or sucralose-based flavor systems. Transparent change-control processes keep regulatory files current, helping partners launch or expand omeprazole offerings without supply-chain surprises.
Technical specifications
- Grade
- IP / BP / USP / EP
- Type
- Pellets
- Category
- Anti-Ulcerant (Ppls)
- Pack size
- 25/50 kg
- Available strengths
- 7.5%, 8.5%, 10%, 15%, 22.5%
- Certifications
- WHO-GMP, ISO 9001, ISO 14001
