PEO and MPEG in high drug load extruded and spheronized beads that are devoid of MCC

A means to produce extruded–spheronized beads, devoid of microcrystalline cellulose (MCC) and with a high drug load (greater than 80%, w/w), is presented. Immediate release bead product with a high yield (greater than 60% of 1 mm diameter beads) and low friability (mass loss less than 4.0%) that were spherical to the naked eye (roundness score less than 1.20) were obtained. The formulation consists only of water-soluble components, taking advantage of the properties of soluble polyethylene oxide (PEO) and methoxypolyethylene glycol (MPEG). This approach incorporates minimal processing aids, with wetted PEO providing the apparent plasticity and cohesiveness, and MPEG550 providing the apparent self-lubricating characteristics necessary for successful extrusion and subsequent spheronization into beads. The success of this approach has important implications in cases where high drug load beads are desired, but where MCC cannot be used due to chemical incompatibility or where complete release cannot be achieved with MCC-containing beads.