US2004120897A1PendingUtilityA1

Method for administering insulinotropic peptides

Priority: Aug 28, 1998Filed: Dec 10, 2003Published: Jun 24, 2004
Est. expiryAug 28, 2018(expired)· nominal 20-yr term from priority
A61K 9/0073A61K 38/26
57
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Claims

Abstract

The claimed invention relates to a method of administering glucagon-like peptide-1 molecules by inhalation, a method for treating diabetes by administering glucagon-like peptide-1 molecules by inhalation, and a method for treating hyperglycemia by administering glucagon-like peptide-1 molecules by inhalation.

Claims

exact text as granted — not AI-modified
We claim:  
     
         1 . A method of administering a glucagon-like peptide-1(GLP-1) molecule comprising, administering an effective amount of a GLP-1 molecule selected from the group consisting of GLP-1, GLP-1 analogs, or GLP-1 derivatives to a patient in need thereof by pulmonary means.  
     
     
         2 . The method of  claim 1 , wherein the GLP-1 molecule is delivered to lower airwaya of the patient.  
     
     
         3 . The method of  claim 2 , wherein the GLP-1 molecule is deposited in the alveoli.  
     
     
         4 . The method of claim-1, wherein the GLP-1 molecule is inhaled through the mouth of the patient.  
     
     
         5 . The method of  claim 1 , wherein the GLP-1 molecule is administered as a pharmaceutical formulation comprising the GLP-1 molecule in a pharmaceutically acceptable carrier.  
     
     
         6 . The method of  claim 5 , wherein the formulation is selected from the group consisting of a solution in an aqueous medium and a suspension in a non-aqueous medium.  
     
     
         7 . The method of  claim 6 , wherein the formulation is administered as an aerosol.  
     
     
         8 . The method of  claim 5 , wherein the formulation is in the form of a dry powder.  
     
     
         9 . The method of  claim 5 , wherein the GLP-1 molecule has a particle size of less than about 10 microns MMAD.  
     
     
         10 . The method of  claim 9 , wherein the GLP-1 molecule has a particle size of about 1 to about 5 microns MMAD.  
     
     
         11 . The method of  claim 10 , wherein the GLP-1 molecule has a particle size of about 2 to about 3 microns MMAD.  
     
     
         12 . The method of  claim 1 , wherein at least about 10% of the GLP-1 molecule delivered is deposited in the lung.  
     
     
         13 . The method of  claim 1 , wherein the GLP-1 molecule is delivered from an inhalation device suitable for pulmonary administration and capable of depositing the GLP-1 molecule in the lungs of the patient.  
     
     
         14 . The method of  claim 13 , wherein the device is selected from the group consisting of a nebulizer, a metered-dose inhaler, a dry powder inhaler, and a sprayer.  
     
     
         15 . The method of  claim 14 , wherein the device is a dry powder inhaler.  
     
     
         16 . The method of  claim 1  wherein the GLP-1 molecule is selected from the group consisting of GLP-1 analogs and GLP-1 derivatives.  
     
     
         17 . The method of  claim 16  wherein the GLP-1 molecule is a GLP-1 analog.  
     
     
         18 . The method of  claim 17  wherein the GLP-1 analog is selected from the group consisting of Val 8 -GLP-1(7-37)OH, Gly 8 -GLP-1 (7-37)OH, and Asp 8 -GLP-1 (7-37)OH.  
     
     
         19 . The method of  claim 18 , wherein the GLP-1 analog is Val 8 -GLP-1 (7-37) OH.  
     
     
         20 . The method of  claim 18 , wherein the GLP-1 analog is Gly 8 -GLP-1 (7-37)OH.  
     
     
         21 . A method for treating diabetes comprising, administering an effective dose of a GLP-1 molecule to a patient in need thereof by pulmonary delivery.  
     
     
         22 . The method of  claim 21 , wherein the GLP-1 molecule is administered as a pharmaceutical formulation comprising the GLP-1 molecule in a pharmaceutically acceptable carrier.  
     
     
         23 . The method of  claim 21 , wherein the GLP-1 molecule is Val 8 -GLP-1 (7-37)OH.  
     
     
         24 . The method of  claim 21 , wherein the GLP-1 molecule is Gly 8 -GLP-1 (7-37)OH.  
     
     
         25 . The method of  claim 21 , wherein the GLP-1 molecule is delivered from an inhalation device suitable for pulmonary administration and capable of depositing the GLP-1 molecule in the lungs of the patient.  
     
     
         26 . The method of  claim 25 , wherein the device is a sprayer or a dry powder inhaler.  
     
     
         27 . The method of  claim 25 , wherein an actuation of the device administers about 40 μg to about 4,000 μg of a GLP-1 molecule.  
     
     
         28 . The method of  claim 25 , wherein an actuation of the device administers about 80 μg to about 2,000 μg of a GLP-1 molecule.  
     
     
         29 . The method of  claim 25 , wherein an actuation of the device administers about 160 μg to about 1,000 μg of a GLP-1 molecule.  
     
     
         30 . The method of  claim 25 , wherein an actuation of the device administers about 320 μg to about 500 μg of a GLP-1 molecule.  
     
     
         31 . A method for treating hyperglycemia comprising, administering an effective dose of a GLP-1 molecule to a patient in need thereof by pulmonary means.  
     
     
         32 . The method of  claim 31 , wherein the GLP-1 molecule is administered as a pharmaceutical formulation comprising the GLP-1 molecule in a pharmaceutically acceptable carrier.  
     
     
         33 . The method of  claim 31 , wherein the GLP-1 molecule is Val 8 -GLP-1 (7-37)OH.  
     
     
         34 . The method of  claim 31 , wherein the GLP-1 molecule is Gly 8 -GLP-1 (7-37) OH.  
     
     
         35 . The method of  claim 31 , wherein the GLP-1 molecule is delivered from an inhalation device suitable for pulmonary administration and capable of depositing the GLP-1 molecule in the lungs of the patient.  
     
     
         36 . The method of  claim 35 , wherein the device is selected from the group consisting of a sprayer and a dry powder inhaler.  
     
     
         37 . The method of  claim 35 , wherein an actuation of the device administers about 40 μg to about 4,000 μg of GLP-1 molecule.  
     
     
         38 . The method of  claim 35 , wherein an actuation of the device administers about 8.0 μg to about 2,000 μg of the GLP-1 molecule.  
     
     
         39 . The method of  claim 35 , wherein an actuation of the device administers about 160 μg to about 1,000 μg of GLP-1 molecule.  
     
     
         40 . The method of  claim 35 , wherein an actuation of the device administers about 320 μg to about 500 μg of the GLP-1 molecule.

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