DISPERSIBLE MACROMOLECULE COMPOSITIONS AND METHODS FOR THEIR PREPARATION AND USE

摘要

Preparation of dispersible dry powders of biological macromolecules, comprises:(a) providing an evaporable liquid medium containing a predetermined concentration of the macromolecule and excipients; (b) atomising the liquid medium under conditions selected to form droplets having an average size below predetermined maximum; (c) drying the droplets under conditions selected to form dispersible particles of the composite material containing the biological macromolecules, the particles having a moisture content below a predetermined moisture content; and (d) collecting the particles with high yields. Also claimed are: (i) a dispersible macromolecule composition for inhalation into the alveolar regions of the lung, the composition comprising particles having an average particle size 5 ~mm and a rugosity measured by air permeametry above 2; and (ii) a unit dose of a macromolecule comprising a dose receptacle containing a macromolecule composition as above.