US2011046053A1PendingUtilityA1

Methods and compositions for oral administration of exenatide

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Assignee: ORAMED LTDPriority: May 5, 2008Filed: May 3, 2009Published: Feb 24, 2011
Est. expiryMay 5, 2028(~1.8 yrs left)· nominal 20-yr term from priority
Inventors:Miriam Kidron
A61P 5/50A61P 9/12A61P 9/10A61P 43/00A61P 3/10A61P 5/48A61P 3/04A61P 19/02A61P 1/00A61K 9/0053A61K 38/57A61K 9/0031A61K 9/2846A61K 9/4866A61K 38/26A61K 38/22A61K 31/202A61K 38/56A61K 9/2853A61K 31/22A61K 47/12A61K 9/4858A61K 9/2013
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Claims

Abstract

This invention provides compositions comprising a byetta, fish oil, and a protease inhibitor, method for treating diabetes mellitus, comprising administering same, and methods for oral or rectal administration of a byetta.

Claims

exact text as granted — not AI-modified
1 - 71 . (canceled) 
     
     
         72 . A composition comprising an exenatide, a protease inhibitor, and an omega-3 fatty acid, wherein said composition is an oral pharmaceutical composition. 
     
     
         73 . The composition of  claim 72 , wherein said omega-3 fatty acid is derived from fish oil. 
     
     
         74 . The composition of  claim 72 , wherein said inhibitor is soybean trypsin inhibitor (SBTI). 
     
     
         75 . The composition of  claim 72 , wherein said protease is a serine protease. 
     
     
         76 . The composition of  claim 72 , wherein said protease is trypsin. 
     
     
         77 . The composition of  claim 72 , further comprising a substance that enhances absorption of said exenatide through an intestinal mucosal barrier. 
     
     
         78 . The composition of  claim 77 , wherein said substance is EDTA or a salt thereof. 
     
     
         79 . The composition of  claim 77 , wherein said substance is a bile acid or alkali metal salt thereof. 
     
     
         80 . The composition of  claim 72 , further comprising a coating that inhibits digestion of said exenatide in a stomach of a subject. 
     
     
         81 . The composition of  claim 80 , wherein said coating is an enteric coating or gelatin coating. 
     
     
         82 . A method for oral administration of exenatide to a subject, whereby a substantial fraction of said exenatide retains its activity after absorption through an intestinal mucosal barrier of said subject, comprising administering orally to said subject a pharmaceutical composition comprising said exenatide, a protease inhibitor, and an omega-3 fatty acid. 
     
     
         83 . The method of  claim 82 , wherein said omega-3 fatty acid is derived from fish oil. 
     
     
         84 . The method of  claim 82 , wherein said protease is trypsin. 
     
     
         85 . The method of  claim 82 , wherein said pharmaceutical composition further comprises EDTA or a salt thereof. 
     
     
         86 . The method of  claim 82 , wherein said pharmaceutical composition further comprises an enteric coating or gelatin coating. 
     
     
         87 . The method of  claim 82 , whereby food intake in said subject is reduced. 
     
     
         88 . A method for treating diabetes mellitus in a subject, comprising administering orally to said subject a pharmaceutical composition comprising exenatide, a protease inhibitor, and an omega-3 fatty acid, thereby treating diabetes mellitus. 
     
     
         89 . The method of  claim 88 , wherein said omega-3 fatty acid is derived from fish oil. 
     
     
         90 . The method of  claim 88 , wherein said protease is trypsin. 
     
     
         91 . The method of  claim 88 , wherein said pharmaceutical composition further comprises EDTA or a salt thereof. 
     
     
         92 . The method of  claim 88 , wherein said pharmaceutical composition further comprises an enteric coating or gelatin coating.

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