ABSTRACT
Extrusion/spheronization is a process capable of producing spherical particles that have many uses in the preparation of pharmaceutical dosage forms. The process can be used to produce free-flowing granules for use in applications including controlled-release, readily deformable granules for compression, granules for filling into sachets, taste-masked particles for chewable dosage forms, fine particle, or solid solutions for improving solubility. Stability can be improved by isolating incompatible materials. The effect of formulation materials, such as microcrystalline cellulose, soluble and insoluble polymer gums, disintegrants, and waxes, are discussed. The use of process variables, including granulation, extrusion, spheronization, and drying variables, to produce particles having targeted physical properties is reviewed.
