Pharmaceutical-Grade Domperidone Sustained-Release Pellets for Oral Multiparticulate Formulations
Domperidone SR Pellets are pharmaceutical-grade sustained-release multiparticulate pellets containing Domperidone as the active ingredient. Domperidone has CAS Number 57808-66-9, molecular formula C₂₂H₂₄ClN₅O₂, and molecular weight 425.91 g/mol.
The sustained-release pellet format is designed to modify the release of Domperidone over a defined period compared with an immediate-release pellet system. The release profile is achieved through the pellet composition and/or functional coating system, with the final dissolution behavior controlled according to the applicable product specification.
Commercial pharmaceutical pellet portfolios report 20% and 30% w/w Domperidone SR Pellets as established commercial strengths. Some manufacturers additionally list 40% formulations. These commercial values should not automatically be treated as SDP-approved strengths unless they match the current SDP product specification.
For SDP, the final Domperidone loading, dissolution profile, particle-size distribution, moisture and other release parameters should be controlled according to the applicable product specification.
Domperidone SR Pellets use a formulation approach intended to provide a prolonged release profile. The final release behavior depends on factors such as active loading, pellet-core composition, polymeric coating system, coating level, pellet size and dissolution conditions.
Because these variables differ between products, a single universal dissolution specification should not be assigned to every Domperidone SR Pellet.
Commercially documented Domperidone SR pellet strengths include 20% and 30% w/w, with additional commercial listings reporting 40% formulations.
Domperidone SR Pellets can be used for:
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Individual Impurity | NMT 0.5% |
| Water Content | NMT 0.5% |
| Melting Point | 150°C – 154°C |