Lansoprazole EC Pellets
Pharmaceutical-Grade Lansoprazole Enteric-Coated Pellets for Delayed-Release Oral Multiparticulate Formulations
Lansoprazole EC Pellets are pharmaceutical-grade enteric-coated multiparticulate pellets containing Lansoprazole. Lansoprazole has CAS Number 103577-45-3, molecular formula C₁₆H₁₄F₃N₃O₂S, and molecular weight 369.36 g/mol. The USP monograph specifies Lansoprazole at NLT 98.0% and NMT 102.0% of the stated chemical substance.
Lansoprazole is acid-labile, making enteric protection an important part of its multiparticulate formulation. Lansoprazole delayed-release products use enteric-coated pellets designed to protect the active ingredient under acidic conditions and provide release after exposure to a higher-pH environment.
Commercial pharmaceutical pellet manufacturers report Lansoprazole EC Pellets in several active-load strengths. 8.5% and 10% w/w are specifically documented by commercial manufacturers, while other manufacturers report additional strengths.
For SDP, the finished-pellet strength should be published according to the actual SDP specification or COA. If SDP's product specification confirms 8.5% or 10%, these can be presented as available strengths.
Key Features
- Pharmaceutical-grade Lansoprazole EC Pellets
- Enteric-coated multiparticulate format
- Delayed-release formulation
- Acid-protective coating system
- Suitable for oral multiparticulate formulations
- Suitable for capsule-filling applications
- Product-specific Lansoprazole active loading
- Controlled particle-size distribution
- Product-specific coating weight gain
- Controlled gastric-resistance and dissolution characteristics
- Suitable for pharmaceutical formulation development
- Suitable for bulk pharmaceutical supply
Enteric-Coated Pellet Technology
The enteric coating provides protection against acidic conditions and allows the formulation to release Lansoprazole under appropriate higher-pH conditions.
Important formulation variables include:
- Lansoprazole active loading
- Pellet-core composition
- Seal or protective layer
- Enteric polymer
- Coating weight gain
- Coating uniformity
- Pellet size
- Moisture content
- Acid resistance
- Buffer-stage dissolution
Because these parameters vary between formulations, finished-pellet acceptance criteria should be taken from the actual product specification rather than applying API specifications to the complete pellet.
Why Lansoprazole EC Pellets from Swapnroop?
- Pharmaceutical-Grade Pellets: Designed for pharmaceutical formulation applications.
- Enteric-Coated Format: Suitable for delayed-release multiparticulate formulations requiring protection under acidic conditions.
- Product-Specific Active Loading: Lansoprazole 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 against the applicable formulation specification.
- Controlled Release Profile: Dissolution characteristics are established according to the applicable product and testing specification.
Applications
- Lansoprazole EC Pellets can be used for:
- Enteric-coated oral formulations
- Delayed-release multiparticulate formulations
- Capsule-filling applications
- Gastro-resistant pellet systems
- Pharmaceutical pellet coating
- Oral multiparticulate formulation development
- pH-dependent release formulations
- Delayed-release capsule development
- Customized enteric-coated formulations
Detailed Specifications
| Parameter |
Specification |
| Appearance |
white to off-white crystalline powder |
| Identification |
IR & HPLC compliant |
| Assay (HPLC) |
98.0% – 102.0% |
| Loss on Drying |
NMT 3.0% |
| Residue on Ignition |
NMT 0.1% |
| Individual Impurity |
NMT 0.5% |
| Total Impurities |
NMT 1.0% |
| Water Content |
NMT 3.0% |
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