A process for the preparation of suspensions of drug particles for inhalation delivery

摘要

A process for the preparation of an aerosol inhalable suspension of particles is disclosed, wherein the process comprises: a) preparing a suspension of a steroid active ingredient, in a turboemulsifier provided with a turbine adapted for homogenising the suspension; b) optionally subjecting the resulting suspension to a further treatment in a high pressure homogeniser, thereby forming said aerosol inhalable suspension. The process provides particles of optimized particle size and distribution homogeneously dispersed in the carrier, and is also suitable for the preparation of sterile suspensions, includes the step of homogenizing and micronising the formulation in a turboemulsifier provided with a high-potency turbine, optionally followed by a treatment in a high-pressure homogeniser. A process for preparing micronised sterile beclomethasone dipropionate by gamma-irradiation is also disclosed.