Tramadol HCl IR Pellets are multiparticulate pharmaceutical pellets containing Tramadol Hydrochloride and designed for immediate-release oral dosage-form development. The pellet format provides a free-flowing multiparticulate system that can be incorporated into suitable capsule and other oral formulations.
Tramadol Hydrochloride has the molecular formula C₁₆H₂₆ClNO₂, molecular weight 299.84 g/mol, and CAS Number 36282-47-0. The identity and quality requirements of Tramadol Hydrochloride are addressed through applicable pharmaceutical specifications and dosage-form monographs. USP also maintains a Tramadol Hydrochloride reference standard and a monograph for Tramadol Hydrochloride Tablets.
Tramadol HCl IR Pellets can be considered for:
Immediate-release pellets can be manufactured using suitable pelletization, extrusion-spheronization, layering or other established multiparticulate processing technologies.
The final characteristics depend on formulation composition and processing conditions. Important parameters can include active loading, pellet size, particle-size distribution, moisture, mechanical strength, assay uniformity and release characteristics.
These parameters should be controlled according to the validated product specification rather than being inferred from the Tramadol Hydrochloride API specification.
Tramadol HCl IR Pellets may be evaluated for:
USP documentation for Tramadol Hydrochloride dosage forms includes testing for identification, assay, dosage-unit uniformity and organic impurities.
| 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 0.5% |
| Heavy Metals | NMT 10 ppm |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |