Patent ID: 7736670

Claim:
A method for making composite active particles for use in a pharmaceutical composition for pulmonary administration, the method comprising a milling step in which particles of active material are milled in the presence of particles of an additive material so as to ensure a sufficient break-up of agglomerates of both active material and additive material, dispersal and even distribution of the additive material over the active material, and so that the particles of additive material become fused to the surface of the particles of active material; wherein the additive material is suitable for the promotion of the dispersal of the composite active particles upon actuation of an inhaler, wherein the milling step comprises: (a) passing a mixture of particles of additive material and particles of active material, in a fluid, through a constriction under pressure; (b) compressing a mixture of particles of additive material and particles of active material in a gap of predetermined width; or (c) jet milling particles of additive material with particles of active material to provide a break-up of agglomerates of both active material and additive material, dispersal and distribution of the additive material over the active material, such that the particles of additive material become fused to the surface of the particles of active material, wherein the additive material is suitable for the promotion of the dispersal of the composite active particles upon actuation of an inhaler.