PROCESS FOR PRODUCING RAPIDLY DISINTEGRATING SPHEROIDS (PELLETS), GRANULES AND/OR MIXTURES THEREOF

摘要

Process for producing rapidly disintegrating spheroids (pellets), granules and/or mixtures thereof, which disintegrate in less than 15 minutes. The spheroids comprise at least one active pharmaceutical ingredient, a spheronizing aid material and a solid Polyethylene glycol (PEG) with mean molecular weight (MW) of over 1,000. The process comprises a direct pelletization step in a fluidized bed rotogranulator, using aqueous binding media whilst the temperature of the process does not exceed the melting point of the solid PEG.