Dipyridamole SR Pellets are pharmaceutical-grade sustained-release multiparticulate pellets containing Dipyridamole as the active pharmaceutical ingredient. The pellet system is designed for oral formulations where a controlled and prolonged release profile is required.
Dipyridamole has CAS Number 58-32-2, molecular formula C₂₄H₄₀N₈O₄, and molecular weight 504.63 g/mol. The current USP-NF monograph specifies Dipyridamole at 98.0%–102.0% on a dried basis. This is an API specification and should not be transferred directly to the finished SR pellet assay.
In a sustained-release pellet formulation, Dipyridamole is incorporated into individual pellet units and the release profile is controlled through the pellet composition and/or release-controlling coating system. Important formulation variables can include pellet size, active loading, polymer type, polymer concentration, coating weight gain, coating thickness and coating uniformity.
Commercial pharmaceutical pellet references specifically report Dipyridamole SR Pellets at 40% w/w. One commercial product also lists Dipyridamole SR 40% + Aspirin IR 51% w/w as a combination pellet system. Another current commercial portfolio lists Dipyridamole SR Pellets 40% w/w.
For the SDP product page, 40% w/w should be displayed as an available strength only if it matches the current SDP product specification or COA.
Dipyridamole SR Pellets provide a multiparticulate platform for sustained-release oral formulation development. Individual pellet units can provide flexibility in controlling active loading, pellet size, coating characteristics and release performance.
The finished pellets can be evaluated for assay, content uniformity, particle-size distribution, moisture, bulk density, tapped density, friability, pellet morphology and sustained-release dissolution.
The release profile is formulation-specific. Therefore, a universal dissolution percentage or time-point should not be published without the actual validated SDP finished-product specification.
Dipyridamole SR Pellets can be considered for:
Important finished-product quality attributes include:
These parameters should be controlled according to the specific finished-product specification.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.1% |
| Individual Impurity | NMT 0.5% |
| Water Content | NMT 1.0% |