Patent ID: 6427681
Filing Date: 2002-08-06
Classification: A61J,A61K,A61M

Abstract:
A method of improving reproducibility of a drug delivered via lungs by inhalation, comprising:(a) aerosolizing a formulation comprising monomeric insulin; (b) inhaling the aerosolized formulation into the lungs of a patient, the formulation being inhaled with a first total inhaled volume; (c) allowing particles of formulation to settle in the lungs, migrate into the patient's circulatory system and thereby increase the effect of the insulin to a first maximum level in the patient in a first period of time; (d) repeating the aerosolizing of formulation comprised of monomeric insulin; (e) inhaling the aerosolized formulation of (d) into the lungs of a patient, the formulation being inhaled with a second total inhaled volume different from the first total inhaled volume; (f) allowing particles of formulation to settle in the lungs, migrate into the patient's circulatory system and thereby increase the effect of the insulin to a second maximum level in the patient in a second period of time; repeating the (a) aerosolizing; (b) inhaling; and (c) allowing steps a plurality of times wherein at least one total inhaled volume is in a range of from about 2 to 2.5 liters providing a low inhaled volume and at least one total inhaled volume is in a range of from about 4 to about 5 liters providing a high inhaled volume; whereby the difference between the low volume and the high inhaled volume does not substantially effect the difference between the first maximum level of drug and the second maximum level of drug.