HIGH IBUPROFEN CONTENT GRANULES AND THEIR PREPARATION AND THEIR USE IN PHARMACEUTICAL DOSAGE FORMS.

摘要

Described are granules composed at least of a substantial amount of ibuprofen, at least one pharmaceutically-acceptable super disintegrant, and at least one pharmaceuticallya cceptable binder, which binder is different from the super disintegrant(s), wherein the super disintegrant is, or the super disintegrants are, substantially uniformly dispersed throughout the granules. The granules can be prepared by (a) forming a mixture from, or obtaining a mixture of, finely-divided ibuprofen and at least one finely-divided pharmaceutically-acceptable super disintegrant; (b) fluidizing mixture from (a) with gaseous fluidizing agent to thereby form a substantially homogeneous dry mixture comprised of ibuprofen and at least one pharmaceutically-acceptable super disintegrant; (c) while fluidizing homogeneous dry mixture formed in (b) with heated gaseous fluidizing agent, spraying onto the fluidized mixture an aqueous solution, dispersion, or suspension of at least one pharmaceutically-acceptable binder which is different from said super disintegrant, to form wet granules comprised of ibuprofen, at least one pharmaceutically-acceptable super disintegrant, and at least one pharmaceutically acceptable binder which is different from the at least one pharmaceutically-acceptable super disintegrant; and (d) fluidizing wet granules from (c) with heated gaseous fluidizing agent to produce granules having a moisture content of less than 5 wt% based on the weight of the granules. The granules are useful in forming solid dosage forms such as filled capsules or compressed solid dosage forms.