Crospovidone-Based Coated Pellets are pharmaceutical-grade excipient-based multiparticulate pellets containing Crospovidone as a formulation component and incorporating a suitable coating system. Crospovidone is a cross-linked, water-insoluble homopolymer of N-vinyl-2-pyrrolidone and is used as a pharmaceutical excipient and pelletization aid. USP identifies Crospovidone under CAS 9003-39-8 and specifies nitrogen content of 11.0%–12.8% on the dried basis.
Crospovidone can be used in extrusion-spheronization and pellet-development processes. Research has demonstrated its use as a pelletization aid, while coated crospovidone-containing pellets have also been investigated with coating systems such as ethylcellulose for modified-release applications.
The final properties of Crospovidone-Based Coated Pellets depend on the Crospovidone grade, core composition, particle size, coating material, coating level, coating uniformity and manufacturing process.
Crospovidone-Based Coated Pellets can be considered for:
Published research specifically demonstrates crospovidone-based pellet cores coated with ethylcellulose for sustained-release applications.
Crospovidone is a water-insoluble, cross-linked polymer and is available as Type A and Type B according to particle-size characteristics.
Because this is a coated pellet system, the raw Crospovidone specifications should not be confused with finished-pellet specifications. Coating weight gain, coating thickness, coating uniformity and release performance are formulation-specific.
Crospovidone-Based Coated Pellets can be supplied according to the required Crospovidone grade, particle-size range, coating requirements, quantity, packaging configuration and applicable product specification.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 11.0%–12.8% on dried basis |
| Loss on Drying | NMT 5.0% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 5.0–8.0 |
| Water Content | NMT 5.0% |