Because of the pain, inconvenience, and disruption of lifestyle associated
with the injection of insulin, many patients with diabetes are noncompliant
in terms of treatment regimens that require daily multiple injections. To
eliminate the pain and to improve treatment outcome, there has been increas
ing interest in the development of aerosolized insulin to replace subcutane
ously (SC) delivered formulations. Recent studies in human volunteers have
shown that when aerosolized insulin is effectively delivered to the alveola
r region of the lung, absorption rates and decreases in glucose levels are
similar to those achieved with SC-delivered insulin during the fasting stat
e. Other human trials have shown that inhaled insulin also effectively cont
rols postprandial glucose levels. Aerosolized insulin is well-tolerated, an
d there is no evidence of irritation, hypoglycemia, or changes in pulmonary
function when administered over short periods. At present, limitations in
the delivery device result in less efficient administration of insulin aero
sol compared to SC dosing. However, new devices and different formulations
of insulin, which are currently, under development, should improve the effi
ciency. It is likely that the treatment of diabetes with aerosolized insuli
n will provide an effective alternative means for controlling plasma glucos
e levels in diabetic individuals. Aerosolized insulin also will serve as a
developmental model for this route of administration for a number of other
therapeutic peptides that are currently administered by injection only.