Esomeprazole Magnesium Trihydrate EC Pellets
Pharmaceutical-Grade Esomeprazole Magnesium Trihydrate Enteric-Coated Pellets for Delayed-Release Oral Multiparticulate Formulations
Esomeprazole Magnesium Trihydrate EC Pellets are pharmaceutical-grade enteric-coated multiparticulate pellets containing Esomeprazole Magnesium Trihydrate. The material has CAS Number 217087-09-7, molecular formula C₃₄H₄₂MgN₆O₉S₂, and molecular weight 767.20 g/mol.
The enteric-coated pellet format is designed to protect the active ingredient from acidic conditions and provide release under higher-pH conditions. Commercial delayed-release capsule formulations of esomeprazole magnesium use enteric-coated pellets, and regulatory documentation describes identification, assay, organic impurities, dissolution and microbiological quality as relevant finished-product controls.
Esomeprazole Magnesium Trihydrate EC Pellets are suitable for pharmaceutical multiparticulate formulation development, capsule filling and enteric-coated pellet applications. The final active loading, coating weight gain, particle-size distribution, gastric resistance and dissolution profile should be controlled according to the applicable product specification.
Key Features
- Pharmaceutical-grade Esomeprazole Magnesium Trihydrate EC Pellets
- Enteric-coated multiparticulate format
- pH-dependent delayed-release design
- Suitable for oral multiparticulate formulations
- Suitable for capsule-filling applications
- Product-specific Esomeprazole loading
- Controlled gastric resistance
- Product-specific enteric-coating system
- Controlled dissolution profile
- Suitable for pharmaceutical formulation development
- Suitable for bulk pharmaceutical supply
Enteric-Coated Pellet Technology
Esomeprazole is acid-sensitive, making protection from acidic conditions an important part of the formulation design. Enteric coating is therefore used to provide gastric resistance and facilitate release after exposure to an appropriate higher-pH environment.
Published formulation work has evaluated Esomeprazole Magnesium enteric-coated pellets using an acid-resistance stage followed by phosphate-buffer dissolution testing.
The final release profile depends on factors including:
- Pellet-core composition
- Esomeprazole active loading
- Seal/isolating layer
- Enteric-polymer type
- Coating weight gain
- Coating uniformity
- Pellet size
- Dissolution conditions
Why Esomeprazole Magnesium Trihydrate EC Pellets from Swapnroop?
- Pharmaceutical-Grade Pellets: Designed for pharmaceutical formulation applications.
- Enteric-Coated Format: Suitable for delayed-release multiparticulate formulations requiring protection from acidic conditions.
- Product-Specific Active Loading: Esomeprazole concentration is established according to the applicable product specification.
- Multiparticulate Format: Suitable for capsule-filling and oral formulation development.
- Controlled Pellet Characteristics: Particle size and other physical parameters can be controlled according to product requirements.
- Gastric-Resistance Control: Enteric-coating performance can be evaluated according to the applicable specification.
- Controlled Release Profile: Dissolution characteristics are established according to the applicable formulation and testing specification.
- Formulation Flexibility: Suitable for different enteric-coated formulation-development requirements.
- Bulk Pharmaceutical Supply: Suitable for pharmaceutical manufacturing and formulation requirements.
Applications
Esomeprazole Magnesium Trihydrate EC Pellets can be used for:
- Enteric-coated oral formulations
- Delayed-release multiparticulate formulations
- Capsule-filling applications
- Gastro-resistant pellet systems
- Pharmaceutical pellet coating
- Multiparticulate formulation development
- pH-dependent release formulations
- Customized delayed-release formulations
- Pharmaceutical manufacturing and bulk formulation
Detailed Specifications
| Parameter |
Specification |
| Appearance |
white to off-white crystalline powder |
| Identification |
IR & HPLC compliant |
| Loss on Drying |
NMT 3.0% |
| Residue on Ignition |
NMT 0.1% |
| Heavy Metals |
NMT 10 ppm |
| Individual Impurity |
NMT 0.5% |
| Water Content |
NMT 3.0% |
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