Crospovidone-Coated Pellets are pharmaceutical-grade excipient-based multiparticulate pellets incorporating Crospovidone within the pellet system and a suitable coating layer. Crospovidone is a water-insoluble, synthetic cross-linked 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 11.0%–12.8% nitrogen on the dried basis.
Crospovidone has been demonstrated as a suitable spheronization aid for pharmaceutical pellet preparation. Research has also evaluated crospovidone-based pellet cores with polymer coatings, including ethylcellulose coatings, for modified-release applications.
The final characteristics of Crospovidone-Coated Pellets depend on the Crospovidone grade, pellet-core composition, particle size, coating material, coating level and coating process.
Crospovidone-Coated Pellets can be considered for:
Crospovidone is a cross-linked polymer rather than a conventional low-molecular-weight active ingredient. Its pharmacopoeial quality is therefore characterized using parameters such as nitrogen content, loss on drying, residue on ignition, pH and residual monomer rather than an API-style HPLC assay.
USP identifies Crospovidone as (C₆H₉NO)n and classifies it into Type A and Type B according to particle-size characteristics.
For the finished coated pellet, coating weight gain, coating thickness, coating uniformity and release characteristics are formulation-specific and should not be assigned universal values.
Crospovidone-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 0.5% |
| Heavy Metals | NMT 10 ppm |
| Water Content | NMT 5.0% |