Omeprazole EC Pellets are pharmaceutical-grade enteric-coated multiparticulate pellets containing Omeprazole as the active ingredient. Omeprazole is a proton-pump inhibitor used in oral pharmaceutical formulations and has CAS Number 73590-58-6, molecular formula C₁₇H₁₉N₃O₃S, and molecular weight 345.42 g/mol.
The enteric-coated pellet system is designed to protect Omeprazole from acidic gastric conditions and provide a delayed-release profile after passage through the stomach. The formulation generally uses a functional enteric coating over the active-loaded pellet core, with coating composition and weight gain determining acid resistance and subsequent release characteristics.
Omeprazole EC Pellets are suitable for capsule filling, multiparticulate oral dosage forms, MUPS development and pharmaceutical formulation manufacturing. Commercial pellet portfolios report several Omeprazole loadings, including 7.5%, 8.5%, 10%, 15%, 20%, 22% and 22.5%, depending on the manufacturer and formulation. These market values should not be treated as confirmed SDP strengths unless they match the current SDP specification.
The final product specification should control active loading, pellet size, moisture, coating weight gain, acid resistance, dissolution and impurity profile. This allows pharmaceutical manufacturers to select a pellet grade appropriate for their intended dosage-form and release requirements.
Omeprazole EC Pellets are designed for oral formulations requiring protection of the active ingredient from acidic gastric conditions.
The multiparticulate format can be used for capsule-filling applications, subject to the selected pellet strength and final formulation requirements.
Omeprazole enteric-coated pellets can be incorporated into multiparticulate dosage forms where individual coated pellets provide the required delayed-release characteristics.
The pellets can be used as a ready-to-process formulation intermediate for development, scale-up and manufacturing of oral dosage forms.
Omeprazole EC Pellets can be supplied in bulk according to the required active loading, pellet size and quality specification.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 0.5% |
| Water Content | NMT 0.5% |