Dipyridamole DR Pellets are pharmaceutical-grade delayed-release multiparticulate pellets developed for oral formulation applications. The pellets contain Dipyridamole as the active pharmaceutical ingredient and are designed for formulations requiring controlled release characteristics through a suitable pellet coating and formulation system.
Dipyridole has the CAS Number 58-32-2, molecular formula C₂₄H₄₀N₈O₄, and molecular weight 504.63 g/mol. In the finished pellet system, Dipyridamole is combined with appropriate excipients and a functional coating system to produce pellets with defined physical and release characteristics.
Dipyridamole DR Pellets provide a convenient multiparticulate formulation platform in which individual pellets can be engineered for controlled release performance. The delayed-release characteristics can be influenced by the pellet core composition, particle size, coating material, coating weight gain, coating thickness and coating uniformity.
The finished pellets can be developed with controlled particle-size distribution, bulk density, tapped density, friability, moisture level and surface characteristics according to the intended formulation requirements. These properties are important for downstream processing such as capsule filling, packaging and further formulation.
Dipyridamole DR Pellets can be considered for oral multiparticulate formulations where a delayed-release pellet system is required. The coated-pellet format allows individual pellet units to be incorporated into suitable dosage forms while maintaining defined physical and release characteristics.
The delayed-release performance of the pellets is formulation-specific. Functional coating systems may be designed to provide resistance to the intended initial dissolution environment followed by release under the specified conditions. Therefore, acid resistance, dissolution and release-profile requirements should be established according to the validated finished-product specification.
Dipyridamole DR Pellets can be used for:
Important quality attributes for Dipyridamole DR Pellets include active ingredient loading, assay, content uniformity, particle-size distribution, moisture, bulk density, tapped density, friability, pellet morphology, coating weight gain, coating uniformity and dissolution performance.
For delayed-release products, the release profile is particularly important. The finished pellets should therefore be evaluated using the validated dissolution method and acceptance criteria applicable to the specific product.
As a pharmaceutical pellet manufacturer and supplier, Swapnroop provides Dipyridamole DR Pellets for formulation and bulk pharmaceutical requirements. The product can be developed with product-specific active loading, pellet characteristics and coating performance according to the applicable specification.
The finished Dipyridamole DR Pellets can be evaluated for identification, HPLC assay, active loading, related substances, moisture, particle size, density, friability, coating uniformity, content uniformity and delayed-release dissolution.
Finished-pellet specifications should be based on the actual product formulation and validated manufacturing process. API specifications should not be directly substituted for finished-pellet specifications, because the finished pellet contains the active ingredient together with excipients and coating materials.
Dipyridamole DR Pellets can be supplied in suitable pharmaceutical bulk packaging according to the required batch quantity, pellet characteristics and customer specifications. Packaging and storage conditions should be selected according to the applicable finished-product specification.
| 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 20 ppm |
| pH (1% Solution) | 5.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Water Content | NMT 1.0% |