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Last Updated: March 29, 2024

Claims for Patent: 6,991,798


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Summary for Patent: 6,991,798
Title:Compounds and compositions for delivering active agents
Abstract: Compounds and compositions for the delivery of active agents are provided. Methods of administration and preparation are provided as well.
Inventor(s): Gschneidner; David (Stamford, CT), Leone-Bay; Andrea (Ridgefield, CT), Wang; Eric (Perryhall, MD), Errigo; Lynn (Port Chester, NY), Ho; Koc-Kan (Mount Kisco, NY), Press; Jeffrey Bruce (Brewster, NY), Wang; Nai Fang (Long Island City, NY), Tang; Pingwah (Elmsford, NY)
Assignee: Emisphere Technologies, Inc. (Tarrytown, NY)
Application Number:09/762,067
Patent Claims:1. A compound having the following structure: ##STR00023## 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.

Details for Patent 6,991,798

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Eli Lilly And Company HUMULIN R U-100 insulin human Injection 018780 10/28/1982 ⤷  Try a Trial 2018-08-07
Eli Lilly And Company HUMULIN R U-500 insulin human Injection 018780 12/29/2015 ⤷  Try a Trial 2018-08-07
Eli Lilly And Company HUMULIN R U-100 insulin human Injection 018780 08/06/1998 ⤷  Try a Trial 2018-08-07
Eli Lilly And Company HUMULIN R U-500 insulin human Injection 018780 03/31/1994 ⤷  Try a Trial 2018-08-07
Eli Lilly And Company HUMULIN R U-100 insulin human Injection 018780 05/25/2018 ⤷  Try a Trial 2018-08-07
Amgen, Inc. NEUPOGEN filgrastim Injection 103353 02/20/1991 ⤷  Try a Trial 2018-08-07
Amgen, Inc. NEUPOGEN filgrastim Injection 103353 06/28/2000 ⤷  Try a Trial 2018-08-07
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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