Pulmonary insulin crystals

Abstract

The present invention provides methods and compositions for treating diabetes by administering acylated insulin or an acylated insulin analog via a pulmonary route. The insulin or insulin analog may be in the form of a dry powder or a solution.

1 . A method of treating diabetes in a diabetic patient, the method comprising the steps of: 
 a. recovering from a solution a zinc free insulin crystals having a diameter in below 10 microns when recovered from solution;    b. providing the crystals to a patient for inhalation; and    c. instructing the patient to inhale the crystals.    
   
   
       2 . The method of  claim 1 , wherein the insulin crystals that are recovered have an as recovered diameter in the range below 5 microns.  
   
   
       3 . The method of claims  1  or  2 , wherein the recovered crystals are crystals of a rapid acting analog insulin.  
   
   
       4 . The method of  claim 3 , wherein the insulin is a Lys Pro human insulin.  
   
   
       5 . The method of claims  1  or  2  further comprising combining the insulin crystals with an enhancer.  
   
   
       6 . The method of  claim 3 , further comprising combing the Lys Pro crystals with an enhancer.  
   
   
       7 . The method of  claim 1 , further comprising, after step c, dispersing the insulin crystals with a compressed gas to form an aerosol further comprising the step of flowing the aerosol into the patient's respiratory track  
   
   
       8 . A method of treating diabetes in a diabetic patient, the method comprising the steps of: 
 a. providing a diabetic patient with an apparatus for inhaling powdered insulin comprised of insulin crystals that have a diameter of less than 10 microns;    b. providing insulin crystals having a diameter of less than 10 microns, wherein the crystals are recovered from a solution and wherein the crystals as recovered have a diameter of less than 10 microns;    c. aerosolizing the insulin crystals within the apparatus provided in step a;    d. flowing the aerosolized insulin crystals to the patient's respiratory track.    
   
   
       9 . A method of treating a diabetic patient to reduce blood glucose levels within the patient, the method comprising the steps of: 
 a. obtaining a solution containing insulin;    b. recovering from the solution a zinc free insulin crystal that when recovered has a diameter of less than 10 microns;    c. providing the zinc free crystal to a diabetic patient;    d. instructing the patient to inhale the crystal to reduce blood glucose levels.    
   
   
       10 . A plurality of insulin crystal comprising zinc free insulin crystals wherein the crystals have not been machined or milled and wherein the crystals have been recovered from a solution and wherein at least some of the crystals have an as recovered diameter of less than 10 microns.