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Claims for Patent: 7,297,761

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Claims for Patent: 7,297,761

Title:Pharmaceutical compositions containing exendins
Abstract:Methods for treating conditions or disorders which can be alleviated by reducing food intake are disclosed which comprise administration of an effective amount of an exendin or an exendin agonist, alone or in conjunction with other compounds or compositions that affect satiety. The methods are useful for treating conditions or disorders, including obesity, Type II diabetes, eating disorders, and insulin-resistance syndrome. The methods are also useful for lowering the plasma glucose level, lowering the plasma lipid level, reducing the cardiac risk, reducing the appetite, and reducing the weight of subjects. Pharmaceutical compositions for use in the methods of the invention are also disclosed.
Inventor(s): Beeley; Nigel Robert Arnold (Solana Beach, CA), Prickett; Kathryn S. (San Diego, CA), Bhavsar; Sunil (San Diego, CA), Young; Andrew (La Jolla, CA), Gedulin; Bronislava (Del Mar, CA)
Assignee: Amylin Pharmaceuticals, Inc. (San Diego, CA)
Application Number:10/894,999
Patent Claims: 1. A pharmaceutical composition comprising an exendin-4 and an acetate buffer.

2. The composition of claim 1, wherein said composition has a pH from about 3.5 to about 5.

3. The composition of claim 1, wherein said pH is about 4.5.

4. The composition of claim 1, further comprising an isotonicity agent.

5. The composition of claim 4, wherein said isotonicity agent is selected from the group consisting of sodium chloride, dextrose, boric acid, sodium tartrate, propylene glycol, polyols, and any combination thereof.

6. The composition of claim 1, further comprising a pharmaceutically acceptable carrier or excipient selected from the group consisting of calcium carbonate, calcium phosphate, lactose, glucose, sucrose, starch, cellulose derivatives, gelatin, oils, polyethylene glycol, and any combination thereof.

7. The composition of claim 1, further comprising at least one additional substance other than an exendin that reduces food intake, appetite, body weight, obesity or any combination thereof.

8. The composition of claim 7, wherein said at least one additional substance is selected from the group consisting of amylin, an amylin agonist, a leptin, a cholecystokinin (CCK), CCK-8, a calcitonin, and any combination thereof.

9. The composition of claim 7, wherein said at least one additional substance comprises human amylin.

10. The composition of claim 1, wherein said composition is formulated to provide a daily dose of from about 0.1 .mu.g/kg to about 100 .mu.g/kg of said exendin in a single or divided dose.

11. The composition of claim 1, wherein said composition is formulated to provide a daily dose of from about 0.1 .mu.g/kg to about 10 .mu.g/kg of said exendin in a single or divided dose.

12. The composition of claim 1, wherein said composition is formulated to provide a daily dose of from about 0.1 .mu.g/kg to about 1 .mu.g/kg of said exendin in a single or divided dose.

13. The composition of claim 1, wherein said composition is formulated to provide a daily dose of from about 0.01 mg to about 5 mg of said exendin in a single or divided dose.

14. The composition of claim 1, wherein said composition is formulated to provide a daily dose of from about 0.01 mg to about 2 mg of said exendin in a single or divided dose.

15. The composition of claim 1, wherein said composition is formulated to provide a daily dose of from about 0.01 mg to about 1 mg of said exendin in a single or divided dose.

16. The composition of claim 1, wherein said composition is formulated to provide a daily dose of from about 0.01 mg to about 0.5 mg of said exendin in a single or divided dose.

17. The composition of claim 1, wherein said composition is formulated for intravenous, intraperitoneal, subcutaneous, intramuscular, oral, topical, transmucosal or pulmonary administration.

18. A pharmaceutical composition comprising exendin-4, mannitol, and an acetate buffer, wherein said composition has a pH from about 3.5 to about 5.0.

19. The composition of claim 18, wherein said composition is formulated to provide a daily dose of from about 0.1 .mu.g/kg to about 1 .mu.g/kg of said exendin-4 in a single or divided dose.

20. The composition of claim 18, wherein said composition is formulated to provide a daily dose of from about 0.01 mg to about 0.5 mg of said exendin-4 in a single or divided dose.

21. The composition of claim 18, further comprising at least one additional substance other than an exendin that reduces food intake, appetite, body weight, obesity or any combination thereof.

22. A pharmaceutical composition comprising a buffer and an exendin selected from at least one of the group consisting of an exendin-3, and an exendin-4, wherein said composition has a pH from about 3.5 to about 5.

23. The composition of claim 22, wherein said buffer comprises an acetate buffer.

24. The composition of claim 22, further comprising an isotonicity agent.

25. The composition of claim 22, wherein said isotonicity agent is selected from the group consisting of sodium chloride, dextrose, boric acid, sodium tartrate, propylene glycol, polyols, and any combination thereof.

26. The composition of claim 22, further comprising a pharmaceutically acceptable carrier or excipient selected from the group consisting of calcium carbonate, calcium phosphate, lactose, glucose, sucrose, starch, cellulose derivatives, gelatin, oils, polyethylene glycol, and any combination thereof.

27. The composition of claim 22, further comprising at least one additional substance other than an exendin that reduces food intake, appetite, body weight, obesity or any combination thereof.

28. The composition of claim 27, wherein said at least one additional substance is selected from the group consisting of amylin, an amylin agonist, a leptin, a cholecystokinin (CCK), CCK-8, a calcitonin, and any combination thereof.

29. The composition of claim 27, wherein said at least one additional substance comprises human amylin.

30. The composition of claim 22, wherein said composition is formulated to provide a daily dose of from about 0.1 .mu.g/kg to about 100 .mu.g/kg of said exendin in a single or divided dose.

31. The composition of claim 22, wherein said composition is formulated to provide a daily dose of from about 0.1 .mu.g/kg to about 10 .mu.g/kg of said exendin in a single or divided dose.

32. The composition of claim 22, wherein said composition is formulated to provide a daily dose of from about 0.1 .mu.g/kg to about 1 .mu.g/kg of said exendin in a single or divided dose.

33. The composition of claim 22, wherein said composition is formulated to provide a daily dose of from about 0.01 mg to about 0.5 mg of said exendin in a single or divided dose.

34. The composition of claim 22, wherein said composition is formulated to provide a daily dose of from about 0.01 mg to about 0.5 mg of said exendin in a single or divided dose.

35. The composition of claim 22, wherein said composition is formulated for intravenous, intraperitoneal, subcutaneous, intramuscular, oral, topical, transmucosal or pulmonary administration.

36. The pharmaceutical composition of claim 22, wherein said exendin-4 is selected from the group consisting of exendin-4 (1-30), exendin-4 (1-30) amide, exendin-4 (1-28) amide, .sub.14Leu, .sup.25Phe exendin-4 amide, .sup.14Leu, .sup.25Phe exendin-4 (1-28) amide, .sup.14Leu, .sup.22Ala, .sup.25Phe exendin-4 (1-28) amide, and any combination thereof.

37. The pharmaceutical composition of claim 22, wherein said exendin is exendin-4.
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