Patent ID: 7541021
Filing Date: 2009-06-02
Classification: A61K,A61P

Abstract:
1. A process for the preparation on an industrial scale of an aqueous suspension comprising particles of an active ingredient for use as a pharmaceutical formulation for inhalation by nebulization, which comprises: in a turboemulsifier apparatus comprised of a circular container having a base with an opening therein which receives a turbine device and which contains an aqueous solution, equipped with a vacuum pump, and a loading hopper, which contains a sterile micronized active ingredient, connected to said turbine by a conduit: a) applying a vacuum to the turboemulsifier; b) loading the sterile micronized active ingredient into the aqueous solution to form a dispersion of the micronized active ingredient; and c) stirring and homogenizing the micronized active ingredient in the aqueous suspension by operating the turbine, wherein the micronized active ingredient is loaded in the aqueous solution through the turbine, and whereby the median volumetric diameter of 90% of the suspended particles of the active ingredient is less than 8 micron and that of at least 50% ranges from 2 to 3.5 micron.