Paracetamol Pellets are multiparticulate pharmaceutical formulations containing Paracetamol (Acetaminophen) as the active pharmaceutical ingredient. Pellets are designed as free-flowing, spherical or near-spherical particles that can be incorporated into capsules, sachets, multiparticulate dosage forms and other oral formulations.
Paracetamol has the chemical formula C₈H₉NO₂, molecular weight 151.16 g/mol, and CAS Number 103-90-2. The current USP-NF monograph specifies Paracetamol/Acetaminophen at 98.0%–102.0% on the dried basis for the pharmaceutical substance. This API limit should not be directly used as the finished-pellet assay specification because pellet composition depends on active loading and excipient/coating composition.
Paracetamol pellets can be developed using pelletization approaches such as extrusion-spheronization and active-ingredient layering. Published formulation research has demonstrated Paracetamol pellet production using extrusion-spheronization with excipients including microcrystalline cellulose and polymeric binders.
Pellet technology provides a useful platform for controlling particle characteristics, improving flow properties and developing different release profiles. Research has also demonstrated Paracetamol layered onto pellet cores followed by functional coating for modified-release applications.
Paracetamol Pellets may be used for:
Paracetamol pellets can be produced through technologies such as extrusion-spheronization, layering and fluid-bed processing, depending on the required formulation characteristics.
Published research has demonstrated Paracetamol pellet preparation by extrusion-spheronization, while other research has investigated Paracetamol-layered pellet cores followed by functional polymer coating.
The final pellet characteristics—including active loading, particle-size distribution, moisture, coating weight gain, mechanical properties and release profile—are product-specific and should therefore be established through the applicable formulation and quality-control specifications.
Quality evaluation of Paracetamol Pellets can include:
For reference, the USP Acetaminophen monograph specifies an API assay of 98.0%–102.0% on the dried basis. Historical USP modernization documentation also lists water NMT 0.5%, residue on ignition NMT 0.1%, and melting range 168–172°C for the API. These values relate to Acetaminophen API, not automatically to finished Paracetamol Pellets.
Paracetamol Pellets provide a flexible multiparticulate platform for formulation developers requiring controlled particle characteristics and convenient incorporation into oral dosage forms. Pelletization can also allow functional coating technologies to be applied when a specific release profile or taste-masking approach is required.
Paracetamol Pellets can be supplied in suitable bulk pharmaceutical packaging according to product requirements. Packaging configuration, active loading, pellet size, coating system and other technical parameters should be confirmed against the applicable product specification 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% |
| Heavy Metals | NMT 10 ppm |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |
| Melting Point | 168–172°C |