Pharmaceutical-Grade Dimethyl Fumarate DR Pellets for Delayed-Release Oral Formulations
Dimethyl Fumarate DR Pellets are multiparticulate pharmaceutical formulations designed for delayed-release oral dosage applications. Dimethyl Fumarate is identified by CAS Number 624-49-7, molecular formula C₆H₈O₄, and molecular weight 144.12 g/mol.
SDP's product portfolio lists Dimethyl Fumarate DR Pellets at 50% strength, providing a defined active-loading option for pharmaceutical formulation development.
Delayed-release pellet technology can use functional coating systems to control the release of the active ingredient according to the intended formulation profile. Published technical literature describes Dimethyl Fumarate delayed-release pellets using a pellet core, seal coating and delayed-release coating.
Dimethyl Fumarate is an ester of fumaric acid with the chemical formula C₆H₈O₄ and molecular weight 144.12 g/mol. Its CAS Number is 624-49-7.
For delayed-release pellet development, Dimethyl Fumarate can be incorporated into multiparticulate cores followed by appropriate functional coating systems. Published patent literature describes delayed-release Dimethyl Fumarate pellets manufactured through extrusion-spheronization or layering followed by seal coating and delayed-release coating.
The 50% strength refers to the active ingredient loading of the finished pellet product and should not be confused with the purity assay of the Dimethyl Fumarate raw material.
Dimethyl Fumarate DR Pellets — 50%
The 50% strength is listed for Dimethyl Fumarate DR Pellets in the referenced pellet product catalogue.
Dimethyl Fumarate DR Pellets can be considered for:
Dimethyl Fumarate DR Pellets can be supplied in suitable bulk packaging according to customer requirements. Strength, batch quantity, packaging configuration and applicable technical documentation can be specified according to the intended pharmaceutical formulation.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 95.0% – 105.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |