Directly compressible high functionality granular microcrystalline cellulose based excipient, manufacturing process and use thereof

摘要

Disclosed is a composition comprising substantially homogeneous particles including: about 75-98% microcrystalline cellulose; about 1-10% at least one binder; and about 1-15% at least one disintegrant, wherein the microcrystalline cellulose, binder and disintegrant are indistinguishable when viewed with a SEM, thereby forming substantially homogeneous, substantially spherical particles. Also disclosed is a method of making an excipient comprising: mixing microcrystalline cellulose, at least one binder and at least on disintegrant in the presence of water to form a homogenous slurry; and spray dry granulating the homogeneous slurry to form substantially homogeneous particles of excipient.