ASSESSMENT OF AEROSOL DELIVERY SYSTEMS FOR RECOMBINANT HUMAN DEOXYRIBONUCLEASE

Recombinant human deoxyribonuclease (rhDNase) is a new protein drug in tended for the inhalation treatment of diseases accompanied by the pre sence in the airways of purulent sputum containing high levels of DNA. This paper describes the characterization of the aerosol cloud formed by nebulization of aqueous solutions of rhDNase. It is shown that lar ge differences exist in the droplet size distributions produced by var ious delivery systems. The enzymatic activity and structural integrity of rhDNase is shown to be preserved when jet nebulizers are used to f orm the aerosols. However, some ultrasonic nebulizers cause denaturati on of the protein, probably due to elevated temperature in the equipme nt.