Patent ID: 7354913

Claim:
A pharmaceutical composition comprising, in admixture, a first active ingredient which is micronised formoterol optionally in the form of a salt or solvate of a salt, a second active ingredient which is a micronised glucocorticosteroid, and a pharmaceutically acceptable carrier/diluent, wherein the composition is obtained by a process comprising: (a) preparing a mixture of the first active ingredient and a first portion of the carrier/diluent, both being in micronized form, and having a mean particle size of less than 10 Î¼m; (b) adding the second active ingredient in pre-micronized form and having a mean particle size of less than 10 Î¼m, to the mixture of a step (a) and mixing; (c) subsequent to step (b), adding a second portion of the carrier/diluent, in coarse form, having a mean particle size of greater than 25 Î¼m, to form a composition; wherein no micronization step is performed subsequent to step (c), and wherein the composition is in the form of an ordered mixture in which each of the active ingredients has a particle size less than 10 Î¼m, the first portion of the carrier/diluent has a mean particle size of less than 10 Î¼m, and the second portion of the carrier/diluent has a mean particle size of greater than 25 Î¼m, and the composition has a high storage stability such that the decomposition of formoterol in the composition will be less than 10% when (i) the composition is stored in open dishes at 40Â° C. and 75% relative humidity for 6 months and (ii) the content of formoterol in the composition is less than 1.0% (w/w).