US2012277151A1PendingUtilityA1

Glp-1 pharmaceutical compositions

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Assignee: ALLOZA MIRAVETE RESURRECCIONPriority: Jun 30, 2005Filed: Jul 9, 2012Published: Nov 1, 2012
Est. expiryJun 30, 2025(expired)· nominal 20-yr term from priority
Inventors:Resurreccion Alloza MiraveteRoland Cherif-CheikhJose-Antonio Cordero RigolZheng Xin DongFrederic LacombeMaria Dolores Tobalina Maestre
A61K 38/26A61K 45/06A61P 3/10A61K 33/30A61K 9/08
43
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Claims

Abstract

The present invention is directed to peptide analogues of glucagon-like peptide-1, the pharmaceutically-acceptable salts thereof, to methods of using such analogues to treat mammals and to pharmaceutical compositions useful therefore comprising said analogues.

Claims

exact text as granted — not AI-modified
1 - 63 . (canceled) 
     
     
         64 . A pharmaceutical composition comprising an analog of glucagon-like peptide-1 according to the formula:
   [Aib 8,35 ]hGLP-1(7-36)NH 2 ;   
       together with zinc and a pharmaceutically acceptable carrier or diluent, wherein said diluent comprises a pharmaceutically acceptable aqueous solution and said pharmaceutical composition is a clear solution when said composition is administered, said analog of glucagon-like peptide-1 is released within said subject for at least approximately 5 to approximately 7 days, with the proviso that said composition does not consist of a clear aqueous ZnCl 2  solution having pH 4 in which said [Aib 8,35 ]hGLP-1(7-36)NH 2  is present at a concentration of 4 mg/ml and said ZnCI 2  is present at a concentration of 0.5 mg/ml. 
     
     
         65 . The pharmaceutical composition according to  claim 64 , wherein said zinc is present in a concentration from 0.0005 mg/mL to 50 mg/mL. 
     
     
         66 . The pharmaceutical composition according to  claim 65 , wherein said zinc is present in a concentration from 0.01 mg/mL to 0.50 mg/mL. 
     
     
         67 . The pharmaceutical composition according to  claim 64 , wherein said diluent comprises sterile water. 
     
     
         68 . The pharmaceutical composition according to  claim 64 , wherein said pharmaceutical composition comprises an aqueous mixture, suspension or solution, and wherein said analog of glucagon-like peptide-1 is present at a concentration of approximately 0.5%-30% (w/w). 
     
     
         69 . The pharmaceutical composition according to  claim 68 , wherein the concentration of said analog of glucagon-like peptide-1 in said aqueous mixture, suspension or solution is approximately 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%, or 30% (w/w). 
     
     
         70 . The pharmaceutical composition according to  claim 69 , wherein the concentration of said analog of glucagon-like peptide-1 in said aqueous solution is approximately 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 14%, 15%, 16%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 29%, or 30% (w/w). 
     
     
         71 . The pharmaceutical composition according to  claim 70 , wherein the concentration of said analog of glucagon-like peptide-1 in said aqueous solution is approximately 1%, 2%, 3%, 4%, 5%, 6%, 9%, 10%, 11%, 22%, 23%, 24%, 25% or 26% (w/w). 
     
     
         72 . The pharmaceutical composition according to  claim 71 , wherein the concentration of said analog of glucagon-like peptide-1 in said aqueous solution is approximately 1%, 2%, 3%, 4%, 5%, 6%, 10%, 22%, 23%, 24%, 25%, or 26% (w/w). 
     
     
         73 . The pharmaceutical composition according to  claim 72 , wherein the concentration of said analog of glucagon-like peptide-1 in said aqueous solution is approximately 1%, 2%, 5%, 10%, 23% or 25% (w/w). 
     
     
         74 . The pharmaceutical composition according to  claim 68 , wherein the molar ratio of said analog of glucagon-like peptide-1 to zinc in said pharmaceutical composition ranges from approximately 6:1 to approximately 1:1. 
     
     
         75 . The pharmaceutical composition according to  claim 74 , wherein said ratio ranges from approximately 5.5:1 to approximately 1:1. 
     
     
         76 . The pharmaceutical composition according to  claim 75 , wherein said ratio ranges from approximately 5.4:1 to approximately 1.5:1. 
     
     
         77 . The pharmaceutical composition according to  claim 76 , wherein said ratio is approximately 5.4:1, 4.0:1, or 1.5:1. 
     
     
         78 . The pharmaceutical composition according to  claim 77 , wherein said ratio is approximately 1.5:1. 
     
     
         79 . The pharmaceutical composition according to  claim 68 , wherein said zinc is provided as zinc chloride or zinc acetate. 
     
     
         80 . The pharmaceutical composition according to  claim 79 , wherein said zinc acetate is provided as ZnAc 2 .2H 2 O. 
     
     
         81 . The pharmaceutical composition according to  claim 64 , wherein when said composition is administered to said subject in need thereof, said analog of glucagon-like peptide-1 is released within said subject for at least approximately 6 days. 
     
     
         82 . The pharmaceutical composition according to  claim 64 , wherein when said composition is administered to said subject in need thereof, the analog of glucagon-like peptide-1 is released within said subject for at least approximately 7 days. 
     
     
         83 . The pharmaceutical composition according to  claim 75 , wherein when said composition is administered to said subject in need thereof, said analog of glucagon-like peptide-1 is released within said subject for at least approximately 6 days. 
     
     
         84 . The pharmaceutical composition according to  claim 75 , wherein when said composition is administered to said subject in need thereof, the analog of glucagon-like peptide-1 is released within said subject for at least approximately 7 days. 
     
     
         85 . The pharmaceutical composition according to anyone of  claim 81 ,  82 ,  83  or  84 , wherein said subject is a mammal. 
     
     
         86 . The pharmaceutical composition according to anyone of  claim 64 , wherein said subject is a mammal. 
     
     
         87 . The composition according to  claim 78 , wherein the concentration of [Aib 8,35 ]hGLP-1(7-36)NH 2  in said composition is about 1% (weight/volume). 
     
     
         88 . The composition according to  claim 78 , wherein the concentration of [Aib 8,35 ]hGLP-1(7-36)NH 2  in said composition is about 2% (weight/volume). 
     
     
         89 . The composition according to  claim 78 , wherein the concentration of [Aib 8,35 ]hGLP-1(7-36)NH 2  in said composition is about 10% (weight/volume). 
     
     
         90 . The composition according to  claim 78 , wherein the concentration of [Aib 8,35 ]hGLP-1(7-36)NH 2  in said composition is about 25% (weight/volume); 
     
     
         91 . The composition according to  claim 77 , wherein the concentration of [Aib 8,35 ]hGLP-1(7-36)NH 2  in said composition is about 5% (weight/volume) and said ratio is approximately 5.4:1. 
     
     
         92 . The composition according to  claim 77 , wherein the concentration of [Aib 8,35 ]hGLP-1(7-36)NH 2  in said composition is about 5% (weight/volume) and said ratio is approximately 4.0:1. 
     
     
         93 . The composition according to  claim 77 , wherein the concentration [Aib 8,35 ]hGLP-1(7-36)NH 2  in said composition is about 10% (weight/volume) and said ratio is approximately 5.4:1. 
     
     
         94 . The composition according to  claim 77 , wherein the concentration of [Aib 8,35 ]hGLP-1(7-36)NH 2  in said composition is about 23% (weight/volume) and said ratio is approximately 4.0:1. 
     
     
         95 . The composition according to  claim 78 , wherein the concentration of [Aib 8,35 ]hGLP-1(7-36)NH 2  in said composition is about 23% (weight/volume). 
     
     
         96 . The pharmaceutical composition according to  claim 85 , wherein said subject is a human. 
     
     
         97 . The pharmaceutical composition according to  claim 86 , wherein said subject is a human. 
     
     
         98 . The composition according to  claim 78 , wherein the concentration of [Aib 8,35 ]hGLP-1(7-36)NH 2  in said pharmaceutical composition is about 10% (weight/volume) and the molar ratio of [Aib 8,35 ]hGLP-1(7-36)NH 2  to zinc is about 1.5:1. 
     
     
         99 . A method of treating a subject afflicted with Type I diabetes, Type II diabetes or gestational diabetes comprising administering to said subject the pharmaceutical composition according to  claim 64 . 
     
     
         100 . The method according to  claim 99 , wherein said subject is a human being. 
     
     
         101 . The method according to  claim 100 , wherein said disease is Type I diabetes or Type II diabetes. 
     
     
         102 . A method of stimulating beta-cell proliferation or reducing beta-cell deterioration comprising administering to a subject in need thereof the pharmaceutical composition according to  claim 64 . 
     
     
         103 . The method according to  claim 102 , wherein said subject is a human being. 
     
     
         104 . A method of treating a subject afflicted with Type I diabetes, Type II diabetes or gestational diabetes comprising administering to said subject the pharmaceutical composition according to  claim 68 . 
     
     
         105 . The method according to  claim 104 , wherein said subject is a human being. 
     
     
         106 . The method according to  claim 105 , wherein said disease is Type I diabetes or Type II diabetes. 
     
     
         107 . A method of stimulating beta-cell proliferation or reducing beta-cell deterioration comprising administering to a subject in need thereof the pharmaceutical composition according to  claim 68 . 
     
     
         108 . The method according to  claim 107 , wherein said subject is a human being.

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