Process for preparation of aqueous suspension comprising beclometasone diproprionate as active ingredient in form of particles of size suitable for pulmonary or nasal inhalation

摘要

A process for the preparation of an aqueous suspension for the treatment of respiratory diseases by pulmonary or nasal inhalation comprising beclometasone diproprionate as active ingredient in the form of particles of a size suitable for inhalation, whereby said process comprising dispersing an aqueous solution in a turboemulsifier apparatus; adding the micronized active ingredient to the aqueous phase; dispersing the micronized particles of the active ingredient in said aqueous phase by applying aspeed comprised between 2000 and 3000 rpm for a time of 15 to 20 minutes; and further subjecting the obtained aqueous suspension to an homogenisation treatment under high-pressure with an homogenizer apparatus including a high pressure pump supplying a pressure up to 150 MPa (1500 bar).