Melt Spheronization is a technique in which a drug substance along with excipients is transformed into a molten or semi-molten state, and then shaped using suitable equipment to create solid spheres or pellets.
Initially, the drug substance is mixed with the relevant pharmaceutical excipients, including polymers and waxes, and then extruded at a specific pharmaceutical temperature. This extrusion temperature must be sufficiently high to melt at least one or more components of the formulation.
The extrudate is then sliced into uniform cylindrical segments using a cutter. These segments are subsequently spheronized in a jacketed Spheronizer to produce uniformly sized pellets.