Itraconazole IR Pellets are pharmaceutical-grade multiparticulate pellets containing Itraconazole and designed for immediate-release oral dosage-form development. The pellet format provides a practical platform for capsule filling and other multiparticulate pharmaceutical formulations.
Itraconazole has CAS Number 84625-61-6, molecular formula C₃₅H₃₈Cl₂N₈O₄, and molecular weight 705.63 g/mol. The USP-NF monograph defines Itraconazole at 98.0%–102.0%, calculated on the dried basis.
Itraconazole is also commercially available in pellet formats. Current Indian market references list Itraconazole IR Pellets at different active loadings, including 20%, 21.76%, 22%, 32.25%, 40% and 44%, demonstrating that pellet loading is formulation- and manufacturer-specific.
Itraconazole Immediate-Release Pellets provide a pellet-based formulation platform for pharmaceutical manufacturers developing oral multiparticulate dosage forms.
Itraconazole has relatively low aqueous solubility, and formulation research has investigated pellet-based approaches to improve dissolution and formulation performance. Research has demonstrated Itraconazole solid-dispersion pellets prepared using hot-melt extrusion and subsequent pelletization, with improved release characteristics compared with crystalline Itraconazole in the investigated formulation.
The final performance of Itraconazole Pharmaceutical Pellets depends on the formulation composition, active loading, pellet size, excipient system and manufacturing process. Therefore, the finished-pellet specification should be established separately from the Itraconazole API specification.
Itraconazole IR Pellets can be considered for:
Itraconazole IR Pellets may be produced using suitable pelletization, layering or other multiparticulate processing technologies.
Depending on the formulation design, important manufacturing parameters may include:
Commercial sources demonstrate that Itraconazole Pellet Manufacturer India products can be supplied at different active loadings. Therefore, an exact percentage should only be published when supported by the applicable SDP product specification.
Itraconazole IR Pellets may be evaluated for:
The USP-NF API monograph specifies 98.0%–102.0% Itraconazole on the dried basis. This is an API specification and should not automatically be used as the finished-pellet assay range.
Itraconazole IR Pellets from Swapnroop are positioned as pharmaceutical-grade multiparticulate pellets for immediate-release formulation development and capsule-filling applications.
Key considerations include:
Itraconazole IR Pellets can be supplied in suitable pharmaceutical bulk packaging according to the applicable product specification. Active loading, pellet size, packaging configuration and analytical requirements should be confirmed before commercial supply.
| 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% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 0.5% |