METHODS AND COMPOSITIONS FOR ORAL ADMINISTRATION OF EXENATIDE
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.
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.