Inhaled insulin dosage control delivery enhanced by controlling total inhaled volume

Abstract

Dosages of inhaled insulin are controlled within a narrow range by controlling the total volume of air inhaled by a patient. By repeatedly delivering aerosolized insulin with the same total inhaled volume of air, the amount of insulin delivered to the patient each time is consistent. A device for delivering insulin by inhalation is disclosed which device comprises a means for measuring inhaled volume and for halting inhalation at a pre-determined point. The device also comprises an adjustable means for applying various amounts of force to a container of formulation to expel different amounts of drug from the container based on the force applied.

1 .- 20 . (canceled)  
   
   
       21 . A method of administering a formulation to a human patient by inhalation, comprising: 
 (a) aerosolizing a formulation comprised of insulin wherein the aerosol is comprised of particles having a diameter in a range of about 0.5 to  6 . 0  microns;    (b) inhaling the aerosolized insulin formulation with a known volume of air,    (c) repeating (a) and (b) a plurality of times over a period of time; 
 wherein the known volume of air with aerosolized insulin formulation inhaled in each step (b) is substantially the same for each step (b) and further wherein the inhaled volume of air in step (b) is determined by the patient inhaling the known volume which inhaling of the known volume is repeated for each step (b).  
   
   
   
       22 . The method of  claim 21  wherein said period of time is daily.  
   
   
       23 . The method of  claim 21  wherein said period of time is weekly.  
   
   
       24 . The method of  claim 21  wherein said repeating in step (c) is at meal times.