Patent ID: 6495167
Filing Date: 2002-12-17
Classification: A61K,A61P

Abstract:
A process of producing agglomerates comprising the steps of:(a) providing particles of a first material selected from the group consisting of formoterol, mometasone furoate, and a combination thereof, and particles of at least one solid binder, at least one of said first material and said solid binder having a preselected amount of convertible amorphous content which is capable of being converted to crystalline form upon exposure to a preselected stimulus, said convertible amorphous content being sufficient to allow for the formation of bridges between particles; (b) agglomerating said particles of said first material and said solid binder while maintaining said preselected amount of convertible amorphous content; and thereafter (c) exposing said convertible amorphous content within said agglomerates to said preselected stimulus so as to convert said convertible amorphous content to a crystalline form, wherein said agglomerates are used in a dosage form of a pharmacologically active agent useful for administration by oral inhalation therapy consisting essentially of: agglomerates of particles of a pharmacologically active agent and particles of crystalline solid binder, said particles having an average particle size of 10 &mgr;m or less and being provided in a weight ratio of between 100:1 to 1:500, said agglomerates having an average size of between 400 and 700 &mgr;m, a bulk density of between about 0.2 and about 0.4 g/cm3, and a crush strength of between 200 mg and about 1500 mg.