Itopride HCl SR Pellets
Pharmaceutical-Grade Itopride Hydrochloride Sustained-Release Pellets for Oral Multiparticulate Formulations
Itopride HCl SR Pellets are pharmaceutical-grade sustained-release multiparticulate pellets containing Itopride Hydrochloride. Itopride Hydrochloride has CAS Number 122892-31-3, molecular formula C₂₀H₂₇ClN₂O₄, and molecular weight 394.90 g/mol.
The sustained-release pellet format is designed to provide a controlled release profile compared with an immediate-release pellet system. Release characteristics are influenced by the active loading, pellet core, excipient composition, functional coating system, coating level, pellet size and dissolution conditions.
Commercial pharmaceutical pellet manufacturers document 60% w/w Itopride Hydrochloride SR Pellets. Other commercial listings report 50%, 60% and 70% Itopride pellet formulations, demonstrating that active loading can vary between manufacturers and formulations.
For SDP, 60% w/w is the strongest commercially documented strength for Itopride HCl SR Pellets and is suitable to mention as an available strength only if it matches SDP's own product specification/COA.
Key Features
- Pharmaceutical-grade Itopride HCl SR Pellets
- Sustained-release multiparticulate format
- Itopride Hydrochloride-based pellet formulation
- Suitable for oral multiparticulate formulations
- Suitable for capsule-filling applications
- Controlled release characteristics
- Product-specific active loading
- Product-specific particle-size distribution
- Suitable for formulation development
- Suitable for bulk pharmaceutical supply
Sustained-Release Pellet Technology
Itopride HCl SR Pellets are designed to modify the release of Itopride Hydrochloride over a defined period. The sustained-release profile can be achieved through the pellet matrix, functional coating, membrane characteristics or a combination of formulation approaches.
Important quality attributes can include:
- Active ingredient loading
- Pellet size distribution
- Coating weight gain
- Coating uniformity
- Moisture content
- Bulk and tapped density
- Friability
- Dissolution profile
- Release consistency
These parameters should be controlled against the specific finished-pellet specification rather than applying a universal value to every Itopride HCl SR formulation.
Why Itopride HCl SR Pellets from Swapnroop?
- Pharmaceutical-Grade Pellets: Designed for pharmaceutical formulation applications.
- Sustained-Release Format: Suitable for sustained-release multiparticulate formulations.
- Product-Specific Active Loading: Itopride Hydrochloride 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.
- Controlled Release Profile: Release characteristics are established according to the applicable formulation and dissolution specification.
- Formulation Flexibility: Suitable for different sustained-release formulation-development requirements.
- Bulk Pharmaceutical Supply: Suitable for pharmaceutical manufacturing and formulation requirements.
Applications
Itopride HCl SR Pellets can be used for:
- Sustained-release oral formulations
- Multiparticulate capsule formulations
- Capsule-filling applications
- Sustained-release pellet systems
- Oral pharmaceutical formulation development
- Functional coating applications
- Controlled-release formulation development
- Customized release-profile formulations
- Pharmaceutical manufacturing and bulk formulation
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% |
| Heavy Metals |
NMT 10 ppm |
| Individual Impurity |
NMT 0.5% |
| Water Content |
NMT 3.0% |
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