Peripheral deposition of α-protease inhibitor using commercial inhalation devices

Patients with hereditary alpha(1)-proteinase inhibitor (alpha(1)-PI) deficiency are at risk of developing lung emphysema. To prevent the development of this disease, alpha(1)-PI replacement therapy via inhalation may be a more convenient and effective therapy than the intravenous administration of the drug. In order to optimise this treatment approach, lung deposition of inhaled radiolabelled alpha(1)-PI (Prolastin(R)) was studied using four different commercial inhalation devices (PARI-LC Star(R), HaloLite(R), and AKITA(R) system in combination with LC Star(R) and Sidestream(R)) in six patients with alpha(1)-PI deficiency and mild-to-severe chronic obstructive pulmonary disease. The time required to deposit 50 mg of the Prolastin(R) (5% solution) in the lung periphery was used as a measure for the efficiency of delivery. The time was calculated from measurements of total and peripheral lung deposition of the radiolabelled alpha(1)-PI. This time was shortest for the AKITA(R) system (18-24 min) and significantly higher for the PARI-LC Star(R) (44 min) and the HaloLite(R) (100 min). The higher efficiency of drug delivery using the AKITA(R) system is due to the fact that this device controls breathing patterns, which are optimised for each patient individually.