Compounds and compositions for delivering active agents

1. A compound having the following structure:

or a salt thereof.

2. The compound of claim 1 wherein said salt is a sodium salt.

3. A composition comprising:

(A) at least one active agent; and

(B) the compound of claim 1 .

4. The composition of claim 3 wherein said salt is a sodium salt.

5. The composition of claim 3 , wherein said active agent is selected from the group consisting of a biologically active agent, a chemically active agent, or a combination thereof.

6. The composition of claim 3 , wherein said biologically active agent comprises at least one protein, polypeptide, peptide, hormone, polysaccharide, mucopolysaccharide, carbohydrate, or lipid.

7. The composition of claim 6 , wherein said biologically active agent comprises a protein, polypeptide or peptide.

8. The composition of claim 6 , wherein said biologically active agent comprises a mucopolysaccharide.

9. The composition of claim 5 , wherein said biologically active agent is selected from the group consisting of: growth hormone, growth hormone-releasing hormones, interferons, interleukin-1, interleukin-2, insulin, insulin-like growth factor (IGF), heparin, calcitonin, erythropoietin (EPO), atrial naturetic factor, antigens, monoclonal antibodies, somatostatin, protease inhibitors, adrenocorticotropin, gonadotropin releasing hormone, oxytocin, leutinizing-hormone-releasing-hormone, follicle stimulating hormone, glucocerebrosidase, thrombopoietin, filgrastim, prostaglandins, cyclosporin, vasopressin, cromolyn sodium, vancomycin, desferrioxamine (DFO), parathyroid hormone (PTH), anti-microbial agents, anti-fungal agents; analogs, fragments, mimetics and polyethylene glycol (PEG)-modified derivatives of these compounds; and any combination thereof.

10. The composition of claim 9 , wherein said biologically active agent comprises a growth hormone, interferon, insulin, heparin, cromolyn sodium, an antigen, an anti-microbial agent, calcitonin, parathyroid hormone, erythropoietin, and combinations thereof.

11. The composition of claim 10 , wherein said growth hormone comprises human growth hormones (hGH), recombinant human growth hormones (rhGH), bovine growth hormones, porcine growth hormones, or a combination thereof.

12. The composition of claim 9 , wherein said biologically active agent comprises interferon.

13. The composition of claim 9 , wherein said biologically active agent comprises insulin.

14. The composition of claim 9 , wherein said insulin comprises porcine insulin, bovine insulin, human insulin, and human recombinant insulin.

15. The composition of claim 9 , wherein said biologically active agent comprises heparin.

16. The composition of claim 15 , wherein said heparin comprises low molecular weight heparin, very low molecular weight heparin, ultra low molecular weight heparin, heparinoids, dermatans, chondroitins, or a combination thereof.

17. The composition of claim 16 , wherein said biologically active agent comprises low molecular weight heparin.

18. The composition of claim 9 , wherein said biologically active agent comprises cromolyn sodium.

19. The composition of claim 18 , wherein said cromolyn sodium comprises sodium chromoglycate, disodium chromoglycate or a combination thereof.

20. The composition of claim 9 , wherein said biologically active agent comprises an antigen.

21. The composition of claim 9 , wherein said biologically active agent comprises an anti-microbial agent.

22. The composition of claim 9 , wherein said biologically active agent comprises calcitonin.

23. The composition of claim 22 , wherein said calcitonin comprises salmon calcitonin, eel calcitonin, human calcitonin or a combination thereof.

24. The composition of claim 9 , wherein said biologically active agent comprises parathyroid hormone.

25. The composition of claim 9 , wherein said biologically active agent comprises erythropoietin.

26. A dosage unit form comprising:

(A) a composition as defined in claim 3 ; and

(B) (a) an excipient

(b) a diluent,

(c) a disintegrant,

(d) a lubricant,

(e) a plasticizer,

(f) a colorant,

(g) a dosing vehicle, or

(h) any combination thereof.

27. The dosage unit form of claim 26 wherein said salt of said compound is a sodium salt.

28. The dosage unit form of claim 26 , comprising a powder.

29. The dosage unit form of claim 26 comprising a tablet.

30. The dosage unit form of claim 26 comprising a capsule.

31. The dosage unit form of claim 26 comprising a liquid.

32. The dosage unit form of claim 26 , wherein said active agent is selected from the group consisting of a biologically active agent, a chemically active agent, or a combination thereof.

33. The dosage unit form of claim 32 , wherein said biologically active agent comprises at least one protein, polypeptide, peptide, hormone, polysaccharide, mucopolysaccharide, carbohydrate, or lipid.

34. The dosage unit form of claim 33 , wherein said biologically active agent comprises a protein, polypeptide or peptide.

35. The dosage unit form of claim 33 , wherein said biologically active agent comprises a mucopolysaccharide.

36. The dosage unit form of claim 26 , wherein said dosing vehicle is selected from the group consisting of water, 1,2-propane diol, ethanol, olive oil or any combination thereof.

37. The dosage unit form of claim 26 , wherein said biologically active agent is selected from the group consisting of: growth hormone, growth hormone-releasing hormones, interferons, interleukin-1, interleukin-2, insulin, insulin-like growth factor(IGF), heparin, calcitonin, erythropoietin (EPO), atrial naturetic factor, antigens, monoclonal antibodies, somatostatin, protease inhibitors, adrenocorticotropin, gonadotropin releasing hormone, oxytocin, leutinizing-hormone-releasing-hormone, follicle stimulating hormone, glucocerebrosidase, thrombopoietin, filgrastim, prostaglandins, cyclosporin, vasopressin, cromolyn sodium, vancomycin, desferrioxamine (DFO), parathyroid hormone (PTH), anti-microbials agents, anti-fungal agents; analogs, fragments, mimetics and polyethylene glycol (PEG)-modified derivatives of these compounds; and any combination thereof.

38. The dosage unit form of claim 37 , wherein said biologically active agent comprises a growth hormone, interferon, insulin, heparin, cromolyn sodium, an antigen, an anti-microbial agent, calcitonin, parathyroid hormone, erythropoietin, and combinations thereof.

39. The dosage unit form of claim 37 , wherein said growth hormone comprises human growth hormones (hGH), recombinant human growth hormones (rhGH), bovine growth hormones, porcine growth hormones, or a combination thereof.

40. The dosage unit form of claim 37 , wherein said biologically active agent comprises interferon.

41. The dosage unit form of claim 37 , wherein said biologically active agent comprises insulin.

42. The dosage unit form of claim 41 , wherein said insulin comprises porcine insulin, bovine insulin, human insulin, and human recombinant insulin.

43. The dosage unit form of claim 37 , wherein said biologically active agent comprises heparin.

44. The dosage unit form of claim 43 , wherein said heparin comprises low molecular weight heparin, very low molecular weight heparin, ultra low molecular weight heparin, heparinoids, dermatans, chondroitins, or a combination thereof.

45. The dosage unit form of claim 44 , wherein said biologically active agent comprises low molecular weight heparin.

46. The dosage unit form of claim 37 , wherein said biologically active agent comprises cromolyn sodium.

47. The dosage unit form of claim 46 , wherein said cromolyn sodium comprises sodium chromoglycate, disodium chromoglycate or a combination thereof.

48. The dosage unit form of claim 37 , wherein said biologically active agent comprises an antigen.

49. The dosage unit form of claim 37 , wherein said biologically active agent comprises an anti-microbial agent.

50. The dosage unit form of claim 37 , wherein said biologically active agent comprises calcitonin.

51. The dosage unit form of claim 37 , wherein said calcitonin comprises salmon calcitonin, eel calcitonin, human calcitonin or a combination thereof.

52. The dosage unit form of claim 37 , wherein said biologically active agent comprises parathyroid hormone.

53. The dosage unit form of claim 37 , wherein said biologically active agent comprises erythropoietin.

54. A method for administering a biologically-active agent to an animal in need of said agent, said method comprising administering to said animal the composition of claim 3 .

55. The method of claim 54 wherein said salt of said compound is a sodium salt.

56. The method of claim 54 , wherein said biologically-active agent is administered by a route which is: oral, intranasal, sublingual, intraduodenal, subcutaneous, buccal, intracolonic, rectal, vaginal, mucosal, pulmonary, transdermal, intradermal, parenteral, intravenous, intramuscular and intraocular.

57. The method of claim 54 , wherein said biologically-active agent is administered by oral route.

58. The method of claim 54 , wherein said active agent is selected from the group consisting of a biologically active agent, a chemically active agent, or a combination thereof.

59. The method of claim 54 , wherein said biologically active agent comprises at least one protein, polypeptide, peptide, hormone, polysaccharide, mucopolysaccharide, carbohydrate, or lipid.

60. The method of claim 59 , wherein said biologically active agent comprises a protein, polypeptide, peptide.

61. The method of claim 59 , wherein said biologically active agent comprises a mucopolysaccharide.

62. The method of claim 58 , wherein said biologically active agent is selected from the group consisting of: growth hormone, growth hormone-releasing hormones, interferons, interleukin-1, interleukin-2, insulin, insulin-like growth factor(IGF), heparin, calcitonin, erythropoietin (EPO), atrial naturetic factor, antigens, monoclonal antibodies, somatostatin, protease inhibitors, adrenocorticotropin, gonadotropin releasing hormone, oxytocin, leutinizing-hormone-releasing-hormone, follicle stimulating hormone, glucocerebrosidase, thrombopoietin, filgrastim, prostaglandins, cyclosporin, vasopressin, cromolyn sodium, vancomycin, desferrioxamine (DFO), parathyroid hormone (PTH), anti-microbial agents, anti-fungal agents; analogs, fragments, mimetics and polyethylene glycol (PEG)-modified derivatives of these compounds; and any combination thereof.

63. The method of claim 62 , wherein said biologically active agent comprises a growth hormone, interferon, insulin, heparin, cromolyn sodium, an antigen, an anti-microbial agent, calcitonin, parathyroid hormone, erythropoietin, and combinations thereof.

64. The method of claim 62 , wherein said growth hormone comprises human growth hormones (hGH), recombinant human growth hormones (rhGH), bovine growth hormones, porcine growth hormones, or a combination thereof.

65. The method of claim 62 , wherein said biologically active agent comprises interferon.

66. The method of claim 62 , wherein said biologically active agent comprises insulin.

67. The method of claim 66 , wherein said insulin comprises porcine insulin, bovine insulin, human insulin, and human recombinant insulin.

68. The method of claim 62 , wherein said biologically active agent comprises heparin.

69. The method of claim 68 , wherein said heparin comprises low molecular weight heparin, very low molecular weight heparin, ultra low molecular weight heparin, heparinoids, dermatans, chondroitins, or a combination thereof.

70. The method of claim 69 , wherein said biologically active agent comprises low molecular weight heparin.

71. The method of claim 62 , wherein said biologically active agent comprises cromolyn sodium.

72. The method of claim 71 , wherein said cromolyn sodium comprises sodium chromoglycate, disodium chromoglycate or a combination thereof.

73. The method of claim 62 , wherein said biologically active agent comprises an antigen.

74. The method of claim 62 , wherein said biologically active agent comprises an anti-microbial agent.

75. The method of claim 62 , wherein said biologically active agent comprises calcitonin.

76. The method of claim 75 , wherein said calcitonin comprises salmon calcitonin, eel calcitonin, human calcitonin or a combination thereof.

77. The method of claim 62 , wherein said biologically active agent comprises parathyroid hormone.

78. The method of claim 62 , wherein said biologically active agent comprises erythropoietin.

79. A method for preparing a composition, said method comprising mixing:

(A) at least one active agent;

(B) at least one compound as defined in claim 1 ; and

(C) optionally, a dosing vehicle.

80. The method of claim 79 wherein said salt of said compound is a sodium salt.

81. The method of claim 79 , wherein said active agent is selected from the group consisting of a biologically active agent, a chemically active agent, or a combination thereof.

82. The method of claim 81 , wherein said biologically active agent comprises at least one protein, polypeptide, peptide, hormone, polysaccharide, mucopolysaccharide, carbohydrate, or lipid.

83. The method of claim 82 , wherein said biologically active agent comprises a protein, polypeptide or peptide.

84. The method of claim 82 , wherein said biologically active agent comprises a mucopolysaccharide.

85. The method of claim 81 , wherein said biologically active agent is selected from the group consisting of: growth hormone, growth hormone-releasing hormones, interferons, interleukin-1, interleukin-2, insulin, insulin-like growth factor(IGF), heparin, calcitonin, erythropoietin (EPO), atrial naturetic factor, antigens, monoclonal antibodies, somatostatin, protease inhibitors, adrenocorticotropin, gonadotropin releasing hormone, oxytocin, leutinizing-hormone-releasing-hormone, follicle stimulating hormone, glucocerebrosidase, thrombopoietin, filgrastim, prostaglandins, cyclosporin, vasopressin, cromolyn sodium, vancomycin, desferrioxamine (DFO), parathyroid hormone (PTH), antimicrobials, anti-fungal agents; analogs, fragments, mimetics and polyethylene glycol (PEG)-modified derivatives of these compounds; and any combination thereof.