Methods and compositions for oral administration of proteins

1. An oral dosage form for treating diabetes mellitus, comprising insulin, soybean trypsin inhibitor (SBTI), and EDTA, wherein said insulin, soybean trypsin inhibitor (SBTI), and EDTA are all in a water-free oily solution comprising an omega-3 fatty acid.

2. The oral dosage form of claim 1 , wherein said insulin is recombinant insulin.

3. The oral dosage form of claim 1 , wherein said oily solution is surrounded by a coating that inhibits digestion of said composition in a stomach of a subject.

4. The oral dosage form of claim 3 , wherein said coating is an enteric coating.

5. The oral dosage form of claim 1 , wherein said oily solution is surrounded by a gelatin coating.

6. The oral dosage form of claim 1 , wherein said oily solution is the only liquid component of said oral dosage form.

7. The oral dosage form of claim 1 , wherein the liquid phase of said oral dosage form consists of said insulin, said SBTI, said EDTA, and said oily solution.

8. A method for oral administration of insulin to a subject, comprising administering orally to said subject a pharmaceutical composition comprising said insulin, soybean trypsin inhibitor (SBTI), and EDTA, wherein said insulin, soybean trypsin inhibitor (SBTI), and EDTA are in a water-free oily solution comprising an omega-3 fatty acid.

9. The method of claim 8 , wherein said insulin is recombinant insulin.

10. The method of claim 8 , wherein said oily solution is surrounded by a coating that inhibits digestion of said composition in a stomach of a subject.

11. The method of claim 10 , wherein said coating is an enteric coating.

12. The method of claim 8 , wherein said oily solution is surrounded by a gelatin coating.

13. The method of claim 8 , wherein said oily solution is the only liquid component of said oral dosage form.

14. The method of claim 8 , wherein the liquid phase of said oral dosage form consists of said insulin, said SBTI, said EDTA, and said oily solution.

15. A method for treating diabetes mellitus in a subject, comprising administering orally to said subject a pharmaceutical composition comprising insulin, soybean trypsin inhibitor (SBTI), and EDTA, wherein said insulin, soybean trypsin inhibitor (SBTI), and EDTA are in a water-free oily solution comprising an omega-3 fatty acid, thereby treating diabetes mellitus.

16. The method of claim 15 , wherein said insulin is a recombinant insulin.

17. The method of claim 15 , wherein said oily solution is surrounded by a coating that inhibits digestion of said composition in a stomach of a subject.

18. The method of claim 17 , wherein said coating is an enteric coating.

19. The method of claim 15 , wherein said oily solution is surrounded by a gelatin coating.

20. The method of claim 15 , wherein said oily solution is the only liquid component of said oral dosage form.

21. The method of claim 15 , wherein the liquid phase of said oral dosage form consists of said insulin, said SBTI, said EDTA, and said oily solution.

22. The oral dosage form of claim 1 , wherein said oral dosage form is non-alcoholic.

23. The method of claim 8 , wherein said pharmaceutical composition is non-alcoholic.

24. The method of claim 15 , wherein said pharmaceutical composition is non-alcoholic.

25. An oral dosage form for treating diabetes mellitus, comprising a therapeutic amount of insulin, soybean trypsin inhibitor (SBTI), and EDTA, wherein said insulin, soybean trypsin inhibitor (SBTI), and EDTA are all in a fish oil comprising an omega-3 fatty acid.

26. The oral dosage form of claim 25 , wherein said insulin is recombinant insulin.

27. The oral dosage form of claim 25 , wherein said fish oil is surrounded by a coating that inhibits digestion of said composition in a stomach of a subject.

28. The oral dosage form of claim 27 , wherein said coating is an enteric coating.

29. The oral dosage form of claim 25 , wherein said fish oil is surrounded by a gelatin coating.

30. The oral dosage form of claim 25 , wherein said oral dosage form is non-aqueous and non-alcoholic.

31. The oral dosage form of claim 25 , wherein said fish oil is the only liquid component of said oral dosage form.

32. A method for oral administration of insulin to a subject, comprising administering orally to said subject a pharmaceutical composition comprising a therapeutic amount of said insulin, soybean trypsin inhibitor (SBTI), and EDTA, in a fish oil comprising an omega-3 fatty acid.

33. The method of claim 32 , wherein said insulin is recombinant insulin.

34. The method of claim 32 , wherein said fish oil is surrounded by a coating that inhibits digestion of said composition in a stomach of a subject.

35. The method of claim 34 , wherein said coating is an enteric coating.

36. The method of claim 32 , wherein said fish oil is surrounded by a gelatin coating.

37. The method of claim 32 , wherein said pharmaceutical composition is non-aqueous and non-alcoholic.

38. The method of claim 32 , wherein said fish oil is the only liquid component of said oral dosage form.

39. A method for treating diabetes mellitus in a subject, comprising administering orally to said subject a pharmaceutical composition comprising a therapeutic amount of insulin, soybean trypsin inhibitor (SBTI), and EDTA, wherein said insulin, soybean trypsin inhibitor (SBTI), and EDTA are in a fish oil comprising an omega-3 fatty acid, thereby treating diabetes mellitus.

40. The method of claim 39 , wherein said insulin is a recombinant insulin.

41. The method of claim 39 , wherein said fish oil is surrounded by a coating that inhibits digestion of said composition in a stomach of a subject.

42. The method of claim 41 , wherein said coating is an enteric coating.

43. The method of claim 39 , wherein said fish oil is surrounded by a gelatin coating.

44. The method of claim 39 , wherein said pharmaceutical composition is non-aqueous and non-alcoholic.

45. The method of claim 39 , wherein said fish oil is the only liquid component of said oral dosage form.