ABSTRACT

The years since the early 1990s have seen many new scientific and engineering

developments related to the therapeutic inhalation technology, especially for

systemic delivery of drugs to the lungs. From novel inhaler to novel particle

design [1], these developments have focused largely on improving the efficiency

of the delivery of inhaled drugs to the lungs while limiting inhaler system user

complexity. In the most successful delivery systems, lung deposition efficiencies,

measured relative to the nominal dose of drug in the inhaler, have increased from

approximately 10% to 60% [1], and delivery reproducibility has improved as

well. Nevertheless, while early reports of inhaled insulin biovailability in

animals suggested numbers as high as 50% [2] and sustained pharmacodynamic

action following deposition in the lungs of several days [3], published results

from the most advanced human insulin trials [4] show relative biopotencies of

less than 5%, and no public data have yet emerged from the clinic to confirm the

feasibility of long-acting insulin delivery through the lungs. These circumstances

point to the need for continued scientific and technological innovation if inhaled

delivery of drugs for systemic application is to achieve widespread commercial

use.