Pharmaceutical-Grade Enteric-Coated Pellets for Oral Dosage Forms
Budesonide EC Pellets are pharmaceutical-grade enteric-coated multiparticulate pellets containing Budesonide, designed for pH-dependent release in oral dosage-form applications. The enteric coating helps protect the pellet formulation from release under acidic gastric conditions and supports release at the intended intestinal pH range according to the formulation design.
Budesonide is a corticosteroid active ingredient with the molecular formula C₂₅H₃₄O₆ and molecular weight approximately 430.54 g/mol. The CAS Number of Budesonide is 51333-22-3.
Enteric-coated Budesonide pellet systems have been studied using extrusion and spheronization followed by functional enteric coating. Published research describes the use of Eudragit S100 to develop pH-controlled intestinal-targeted Budesonide pellets.
Budesonide EC Pellets can be supplied in suitable pharmaceutical packaging for formulation development and bulk manufacturing applications. Packaging configuration, active-ingredient loading, pellet size, enteric-coating characteristics, dissolution profile and storage conditions should be confirmed according to the applicable product specification.
| 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 0.5% |