Montelukast Sodium Pellets are multiparticulate pharmaceutical formulations containing Montelukast Sodium as the active pharmaceutical ingredient. Pellets provide a versatile format for incorporation into oral dosage forms and formulation-development applications.
Montelukast Sodium is represented in the USP-NF monograph by the molecular formula C₃₅H₃₅ClNNaO₃S and molecular weight 608.17 g/mol. The USP-NF monograph identifies CAS 151767-02-1 for Montelukast Sodium and defines the material at 98.0%–102.0%, calculated on an anhydrous and solvent-free basis.
Montelukast Sodium pellet products are commercially listed within the pharmaceutical pellet industry. One Indian pellet manufacturer lists Montelukast Sodium Pellets at 0.05 as a product specification/loading, demonstrating that pellet loading can be expressed differently between manufacturers. This should not be treated as an SDP strength unless confirmed by SDP's product specification.
Montelukast Sodium Pellets can be considered for:
Montelukast Sodium Pellets may be produced using suitable pelletization and layering technologies depending on the required formulation characteristics. Manufacturing parameters such as active loading, pellet size, particle-size distribution, moisture, mechanical properties and release characteristics are product-specific.
Commercial pellet listings demonstrate that Montelukast Sodium is available in pellet form, while USP separately recognizes Montelukast Sodium Oral Granules as a dosage-form category. The USP oral-granule monograph defines the product based on labeled Montelukast equivalent rather than using the API assay specification directly.
Montelukast Sodium Pellets may be evaluated for:
The 98.0%–102.0% value from the USP monograph applies to Montelukast Sodium API, not automatically to finished Montelukast Sodium Pellets.
Pelletization provides a flexible multiparticulate platform for formulation developers seeking consistent particle characteristics and convenient incorporation into oral dosage forms. The pellet format can also support formulation approaches requiring specific particle-size, coating or release characteristics.
Montelukast Sodium Pellets can be supplied in suitable bulk pharmaceutical packaging according to the applicable product specification. Active loading, pellet size, packaging configuration and other technical parameters 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 1.0% |