Method for administering glp-1 molecules

Abstract

The invention relates to formulations that demonstrate the feasibility of oral absorption comprising glucose-like peptide-1 compounds and specified delivery agents, and to methods of stimulating GLP-1 receptor in a subject in need of such stimulation, by administration of the formulation of the present invention.

1 . An oral pharmaceutical composition comprising
 (i) a GLP-1 compound; and   (ii) a delivery agent selected from the group consisting of delivery agent 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, and pharmaceutically acceptable salts thereof.   
     
     
         2 . The oral pharmaceutical composition of  claim 1 , wherein the GLP-1 compound is selected from the group consisting of GLP-1 compounds of SEQ ID NO:1, SEQ ID NO:2, SEQ ID NO:3, SEQ ID NO:4, SEQ ID NO:5, SEQ ID NO:6, SEQ ID NO:7, SEQ ID NO:8, SEQ ID NO:9, SEQ ID NO:10, SEQ ID NO:11, SEQ ID NO:12, SEQ ID NO:13, and SEQ ID NO:14. 
     
     
         3 . The oral pharmaceutical composition of  claim 1 , wherein the GLP-1 compound is selected from the group consisting of GLP-1 compounds of SEQ ID NO:2, SEQ ID NO:3, SEQ ID NO:4, SEQ ID NO:5, SEQ ID NO:6, SEQ ID NO:12, SEQ ID NO:13, and SEQ ID NO:14. 
     
     
         4 . The oral pharmaceutical composition of  claim 1 , wherein the GLP-1 compound is selected from the group consisting of GLP-1 compounds of SEQ ID NO:2, SEQ ID NO:12, SEQ ID NO:13, and SEQ ID NO:14. 
     
     
         5 . The oral pharmaceutical composition of  claim 1 , wherein the GLP-1 compound is of SEQ ID NO: 13 or SEQ ID NO: 14. 
     
     
         6 . The oral pharmaceutical composition of  claim 1 , wherein the GLP-1 compound is a GLP-1 analog. 
     
     
         7 . The oral pharmaceutical composition of  claim 1 , wherein the GLP-1 compound is a GLP-1 fragment. 
     
     
         8 . The oral pharmaceutical composition of  claim 1 , wherein the GLP-1 compound is a GLP-1 derivative. 
     
     
         9 . The oral pharmaceutical composition of  claim 1 , wherein the GLP-1 compound is DPP IV resistant. 
     
     
         10 . The oral pharmaceutical composition of  claim 1 , wherein the delivery agent is selected from the group consisting of: 
       
         
           
           
               
               
           
         
       
       and pharmaceutically acceptable salts thereof. 
     
     
         11 . The oral pharmaceutical composition of  claim 1 , wherein the delivery agent is selected from the group consisting of 
       
         
           
           
               
               
           
         
       
     
     
         12 . A method of treating non-insulin dependent diabetes comprising administering to a patient in need thereof a therapeutically effective amount of the oral pharmaceutical composition of  claim 1 . 
     
     
         13 . A method of treating obesity comprising administering to a patient in need thereof a therapeutically effective amount of the oral pharmaceutical composition of  claim 1 . 
     
     
         14 . A method of treating a disorder selected from the group consisting of insulin dependent diabetes, stroke, myocardial infarction, catabolic changes after surgery, functional dyspepsia and irritable bowel syndrome comprising administering to a patient in need thereof a therapeutically effective amount of the oral pharmaceutical composition of  claim 8 . 
     
     
         15 . A method of treating non-insulin dependent diabetes comprising administering to a patient in need thereof a therapeutically effective amount of the oral pharmaceutical composition of  claim 1 . 
     
     
         16 . A method of treating obesity comprising administering to a patient in need thereof a therapeutically effective amount of the oral pharmaceutical composition of  claim 8 . 
     
     
         17 . A method of treating a disorder selected from the group consisting of insulin dependent diabetes, stroke, myocardial infarction, catabolic changes after surgery, functional dyspepsia and irritable bowel syndrome comprising administering to a patient in need thereof a therapeutically effective amount of the oral pharmaceutical composition of  claim 8 .