Pharmaceutical-Grade Domperidone Immediate-Release Pellets for Oral Multiparticulate Formulations
Domperidone IR Pellets are pharmaceutical-grade immediate-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 immediate-release pellet format provides a multiparticulate platform for oral formulation development and capsule-filling applications. Domperidone pellets can be formulated with controlled active loading and defined physical characteristics according to the intended pharmaceutical application.
Commercial pharmaceutical pellet portfolios document Domperidone IR pellet strengths including 10%, 13.5% and 20%, with 20% appearing in multiple Indian commercial listings. Other manufacturers report additional strengths. These values represent commercially documented pellet strengths and should not automatically be treated as SDP specifications.
For SDP, the finished-pellet strength should therefore be entered according to the current SDP specification or COA.
Domperidone IR Pellets can be used for:
In an immediate-release pellet system, the formulation is designed to make the active ingredient available without the prolonged release characteristics associated with sustained-release pellets. Pellet size, surface characteristics, active loading and excipient composition can influence the final dissolution behavior.
The finished Domperidone IR Pellets should therefore be evaluated against a product-specific dissolution specification rather than assigning a generic numerical dissolution value.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 97.0% – 103.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| Individual Impurity | NMT 0.5% |
| Water Content | NMT 1.0% |