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Claims for Patent: 5,985,850

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Claims for Patent: 5,985,850

Title: Compositions comprising hyaluronic acid and drugs
Abstract:A dosage amount of a pharmaceutical composition comprising a therapeutically effective amount of an agent to treat a disease or condition involving underperfused tissue and pathological tissue in humans and a form of hyaluronic acid, wherein the form of hyaluronic acid is available to transport the agent from the point of administration to the site to be treated.
Inventor(s): Falk; Rudolf Edgar (Toronto, CA), Asculai; Samuel S. (Toronto, CA)
Assignee: Hyal Pharmaceuticals Corporation (Mississauga, CA)
Application Number:08/462,154
Patent Claims: 1. A dosage amount of a pharmaceutical composition containing a suitable pharmaceutically acceptable excipient comprising:

(1) a therapeutically effective amount of an agent to treat a disease or condition involving underperfused tissue and pathological tissue in humans;

and (2) a form of hyaluronic acid selected from the group consisting of hyaluronic acid and pharmaceutically acceptable salts thereof and combinations thereof

characterized in that said dosage amount of said composition

(a) is in a dosage form which is suitable for administration in humans;

and (b) is in a form in which (i) component (1) is in an effective dosage amount to treat said disease or condition involving underperfused tissue and pathological tissue by penetration at the site to be treated; and (ii) component (2) is available to transport component (1) from the point of administration to the site to be treated, and which component (2) is in an effective non-toxic amount to facilitate the transport of component (1) upon administration from the site of administration to the site in need of treatment, through the tissue, at the site to be treated and through cell membranes into individual cells to be treated, wherein said amount of component (2) is sufficient to provide a dosage of 10 mg to 3000 mg of component (2) and wherein the molecular weight of component (2) is less than 750,000 daltons and greater than 150,000 daltons.

2. The dosage of claim 1 wherein component (2) is sodium hyaluronate in an amount of between 10 mg and 1000 mg.

3. The dosage of claim 1 or 2 wherein the agent is selected from the group consisting of free radical scavengers, ascorbic acid (Vitamin C), anti-cancer drugs, chemotherapeutic drugs, anti-viral drugs, non-steroidal anti-inflammatory drugs (NSAID), steroidal anti-inflammatory drugs, anti-fungal drugs, detoxifying drugs, analgesics, bronchodilators, anti-bacterial drugs, antibiotic drugs for treatment of vascular ischemia, monoclonal antibodies, diuretics, immunosuppressants, lymphokines, .alpha. or .beta. interferon, insulin, estrogen, progestogen, anti-metabolites, calcium channel blockers, drugs for treatment of psoriasis and combinations thereof.

4. The dosage of claim 1 or 2 wherein the agent is selected from the group consisting of ascorbic acid, an anti-cancer drug, a non-steroidal anti-inflammatory drug, an antibiotic drug, a diuretic drug and combinations thereof.

5. The dosage of claim 1, wherein the form of hyaluronic acid is sodium hyaluronate having a concentration of 2% by weight.

6. The dosage of claim 1 or 2 wherein the agent is an anti-cancer drug.

7. The dosage of claim 1 or 2 wherein the agent is an anti-viral drug.

8. The dosage of claim 1 or 2 wherein the agent is an anti-fungal drug.

9. The dosage of claim 1 or 2 wherein the agent is an analgesic drug.

10. The dosage of claim 1 or 2 wherein the agent is a bronchodilator drug.

11. The dosage of claim 1 or 2 wherein the agent is an anti-bacterial drug.

12. The dosage of claim 1 or 2 wherein the agent is an antibiotic drug.

13. The dosage of claim 1 or 2 wherein the agent is an anti-inflammatory drug.

14. The dosage of claim 1 or 2 wherein the agent is a monoclonal antibody.

15. The dosage of claim 1 or 2 wherein the agent is an immunosuppressant drug.

16. The dosage of claim 1 or 2 wherein the agent is a lymphokine.

17. The dosage of claim 16 wherein the lymphokine is interleukin-2.

18. The dosage of claim 1 or 2 wherein the agent is interferon.

19. The dosage of claim 1 or 2 wherein the agent is ascorbic acid (Vitamin C).

20. The dosage of claim 1 or 2 wherein the agent is a free radical scavenger.

21. The dosage of claim 1 or 2 wherein the agent is a chemotherapeutic drug.

22. The dosage of claim 21 or 2 wherein the agent is a non-ionic surfactant drug.

23. The dosage of claim 1 or 2 wherein the agent is a non-steroidal anti-inflammatory drug (NSAID).

24. The dosage of claim 1 or 2 wherein the agent is a steroidal anti-inflammatory drug.

25. The dosage of claim 1 or 2 wherein the agent is a detoxifying drug.

26. The dosage of claim 1 or 2 wherein the agent is a diuretic drug.

27. The dosage of claim 22 wherein the non-ionic surfactant is nonoxynol-9.

28. The dosage of claim 22 wherein the non-ionic surfactant contains an ether or an amide linkage between the hydrophilic and hydrophobic portions of the surfactant.

29. The dosage of claim 23 wherein the non-steroidal anti-inflammatory drug is selected from the group consisting of indomethacin, naproxen and ketorolac tromethamine salt and combinations thereof.

30. The dosage of claim 26 wherein the diuretic is furosemide.

31. The dosage of claim 1 or 2 wherein the method of administration is carried out intravenously, subcutaneously, intramuscularly or intratumourly.

32. The dosage of claim 1 or 2 wherein the method of administration is carried out topically.

33. The dosage of claim 1 or 2 wherein the agent is a surfactant selected from the group consisting of nonoxynol-9, cetyl pyridinium chloride and benzalkonium chloride.

34. The dosage of claim 1 or 2 wherein the agent is selected from estrogen replacement drugs.

35. The dosage of claim 1 or 2 wherein the amount of the form of hyaluronic acid is between 50 mg and 350 mg.

36. The dosage of claim 1, 2, or 5 wherein the dosage amount of the composition is formulated for topical administration.

37. The dosage of claim 1 or 2 wherein the composition is formulated for intravenous, intramuscular or injectible administration.

38. The dosage of claim 1 or 2 wherein the agent is a cytotoxic chemotherapeutic drug selected from the group consisting of adriamycin, methotrexate, mitomycin C, bleomycin, 5-Fluorouracil, novantrone, carbo and cis platinum, and combinations thereof.

39. The dosage of claim 1 or 2 further comprising an effective amount of dimethyl sulfoxide.

40. The dosage of claim 39 wherein the agent is selected from the group consisting of phloridzin, phloretin and 5-deoxyglucuronide of phloridzin, ascorbic acid and a non-steroidal anti-inflammatory drug.

41. The dosage of claim 2 wherein the agent is selected from the group consisting of phloridzin, phloretin and 5-deoxyglucuronide of phloridzin.

42. A dosage amount of a pharmaceutical composition for treating a condition or disease involving underperfused or pathological tissue comprising a therapeutically useful agent to a patient, the improvement which comprises additionally an amount of a form of hyaluronic acid selected from the group consisting of hyaluronic acid, pharmaceutically acceptable salts of hyaluronic acid and combinations thereof, wherein the amount is between 10 mg and 3000 mg and is sufficient to facilitate passage of the agent and the form of hyaluronic acid to the underperfused or pathological tissue, and wherein the molecular weight of the form of hyaluronic acid is less than 750,000 daltons but greater than 150,000 daltons.

43. The dosage of claim 42 wherein component (2) is sodium hyaluronate in an amount of between 10 mg and 1000 mg.

44. The dosage of claim 42 or 43 wherein the agent is selected from the group consisting of free radical scavengers, ascorbic acid (Vitamin C), anti-cancer drugs, chemotherapeutic drugs, anti-viral drugs, non-steroidal anti-inflammatory drugs (NSAID), steroidal anti-inflammatory drugs, anti-fungal drugs, detoxifying drugs, analgesics' bronchodilators, anti-bacterial drugs, antibiotic drugs for treatment of vascular ischemia, monoclonal antibodies, diuretics, immunosuppressants, lymphokines, .alpha. or .beta. interferon, insulin, estrogen, progestogen, anti-metabolites, calcium channel blockers, drugs for treatment of psoriasis and combinations thereof.

45. The dosage of claim 42 or 43 wherein the agent is selected from the group consisting of ascorbic acid, an anti-cancer drug, a non-steroidal anti-inflammatory drug, an antibiotic drug, a diuretic drug and combinations thereof.

46. The dosage amount of claim 42 wherein the form of hyaluronic acid is sodium hyaluronate having a concentration of 2% by weight.

47. The dosage of claim 42 or 43 wherein the agent is an anti-cancer drug.

48. The dosage of claim 42 or 43 wherein the agent is an anti-viral drug.

49. The dosage of claim 42 or 43 wherein the agent is an anti-fungal drug.

50. The dosage of claim 42 or 43 wherein the agent is an analgesic drug.

51. The dosage of claim 42 or 43 wherein the agent is a bronchodilator drug.

52. The dosage of claim 42 or 43 wherein the agent is an anti-bacterial drug.

53. The dosage of claim 42 or 43 wherein the agent is an antibiotic drug.

54. The dosage of claim 42 or 43 wherein the agent is an anti-inflammatory drug.

55. The dosage of claim 42 or 43 wherein the agent is a monoclonal antibody.

56. The dosage of claim 42 or 43 wherein the agent is an immunosuppressant drug.

57. The dosage of claim 42 or 43 wherein the agent is a lymphokine.

58. The dosage of claim 57 wherein the lymphokine is interleukin-2.

59. The dosage of claim 42 or 43 wherein the agent is interferon.

60. The dosage of claim 42 or 43 wherein the agent is ascorbic acid (Vitamin C).

61. The dosage of claim 42 or 43 wherein the agent is a free radical scavenger.

62. The dosage of claim 42 or 43 wherein the agent is a chemotherapeutic drug.

63. The dosage of claim 42 or 43 wherein the agent is a non-ionic surfactant drug.

64. The dosage of claim 42 or 43 wherein the agent is a non-steroidal anti-inflammatory drug (NSAID).

65. The dosage of claim 42 or 43 wherein the agent is a steroidal anti-inflammatory drug.

66. The dosage of claim 42 or 43 wherein the agent is a detoxifying drug.

67. The dosage of claim 42 or 43 wherein the agent is a diuretic drug.

68. The dosage of claim 63 wherein the non-ionic surfactant is nonoxynol-9.

69. The dosage of claim 63 wherein the non-ionic surfactant further comprises an ether or an amide linkage between the hydrophilic and hydrophobic portions of the surfactant.

70. The dosage of claim 64 wherein the non-steroidal anti-inflammatory drug is selected from the group consisting of indomethacin, naproxen and ketorolac tromethamine salt and combinations thereof.

71. The dosage of claim 67 wherein the diuretic is furosemide.

72. The dosage of claim 42 or 43 wherein the method of administration is carried out intravenously, subcutaneously, intramuscularly or intratumourly.

73. The dosage of claim 42 or 43 wherein the method of administration is carried out topically.

74. The dosage of claim 42 or 43 wherein the agent is a surfactant selected from the group consisting of nonoxynol-9, cetyl pyridinium chloride and benzalkonium chloride.

75. The dosage of claim 42 or 43 wherein the agent is selected from estrogen replacement drugs.

76. The dosage of claim 42 or 43 wherein the amount of the form of hyaluronic acid is between 50 mg and 350 mg.

77. The dosage of claim 42, 43 or 46 wherein the dosage amount of the composition is formulated for topical administration.

78. The dosage of claim 42 or 43 wherein the composition is formulated for intravenous, intramuscular or injectible administration.

79. The dosage of claim 42 or 43 wherein the agent is a cytotoxic chemotherapeutic drug selected from the group consisting of adriamycin, methotrexate, mitomycin C, bleomycin, 5-Fluorouracil, novantrone, carbo and cis platinum, and combinations thereof.

80. The dosage of claim 42 or 43 further comprising an effective amount of dimethyl sulfoxide.

81. The dosage of claim 80 wherein the agent is selected from the group consisting of phloridzin, phloretin and 5-deoxyglucuronide of phloridzin, ascorbic acid and a non-steroidal anti-inflammatory drug.

82. The dosage of claim 43 wherein the agent is selected from the group consisting of phloridzin, phloretin and 5-deoxyglucuronide of phloridzin.

83. A dosage amount of a pharmaceutical composition in a suitable pharmaceutically acceptable excipient therefor comprising an agent selected from the group consisting of a medicinal agent and a therapeutic agent and combinations thereof, and a form of hyaluronic acid, the improvement comprising that the dosage amount of the composition is suitable for treating a condition or disease involving tissue selected from the group consisting of underperfused tissues and pathological tissue in a human, wherein a therapeutically effective amount of the agent is provided in combination with an effective amount of a form of hyaluronic acid selected from the group consisting of hyaluronic acid, pharmaceutically acceptable salts thereof and combinations thereof sufficient to facilitate transportation of the agent to the site to be treated through the tissue and cell membranes into individual cells to be treated, wherein said amount of the form of hyaluronic acid is present in an amount of between 10 mg and 1000 mg of the form of hyaluronic acid, and wherein the molecular weight of the form of hyaluronic acid is less than 750,000 daltons and greater than 150,000 daltons.

84. A dosage amount of a pharmaceutical composition in a suitable pharmaceutically acceptable excipient therefor for treating a disease or condition involving tissue selected from the group consisting of underperfused and pathological tissue in a human comprising an effective amount of an agent selected from the group consisting of a free radical scavenger, ascorbic acid, Vitamin C, an anti-cancer agent, chemotherapeutic agent, anti-viral agents, non-steroidal anti-inflammatory drugs (NSAIDS), steroidal anti-inflammatory drugs, anti-fungal agent, detoxifying agents, analgesic, bronchodilator, anti-bacterial agent, antibiotics, drugs for the treatment of vascular ischemia monoclonal antibody, diuretics, immunosuppressants, lymphokines, .alpha. and .beta. interferon, insulin, estrogen, progestogen, anti-metabolites, calcium channel blockers, drugs for the treatment of psoriasis and combinations thereof and an effective amount of a form of hyaluronic acid selected from the group consisting of hyaluronic acid, pharmaceutically acceptable salts thereof and combinations thereof sufficient to facilitate the agent's penetration through tissue including scar tissue, at site to be treated, through cell membranes into individual cells to be treated, wherein said amount of the form of hyaluronic acid is sufficient to provide a dosage between 10 mg and 1000 mg of the form of hyaluronic acid and wherein the molecular weight of the form of hyaluronic acid is less than 750,000 daltons and greater than 150,000 daltons, with the proviso that if the agent selected is phloretin, it is solubilized.

85. The dosage of claim 83 or 84 wherein the agent is selected from the group consisting of a free radical scavenger, ascorbic acid, Vitamin C, an anti-cancer agent, chemotherapeutic agent, anti-viral agents, non-steroidal anti-inflammatory drugs (NSAID), steroidal anti-inflammatory drugs, anti-fungal agent, detoxifying agents, analgesic, bronchodilator, anti-bacterial agent, antibiotics, drugs for the treatment of vascular ischemia monoclonal antibody, diuretics, immunosuppressants, lymphokines, .alpha. and .beta. interferon, insulin, estrogen, progestogen, anti-metabolites, calcium channel blockers, drugs for the treatment of psoriasis and combinations thereof.

86. The dosage of claim 83 or 84 wherein the dosage amount of the composition is formulated for topical administration.

87. The dosage of claim 83 or 84 wherein the composition is formulated for intravenous, intramuscular or subcutaneous injectible, intra-arterial, intradermal, intraperitoneal, or intrapleural administration.

88. The dosage of claim 83 or 84 wherein the form of hyaluronic acid is utilized in an amount of 100 mg.

89. The dosage of claim 83 or 84 wherein the form of hyaluronic acid is utilized in an amount in excess of 200 mg.

90. The dosage of claim 83 or 84 wherein the form of hyaluronic acid is utilized in an amount in excess of 350 mg.

91. The dosage of claim 83 or 84 wherein the form of hyaluronic acid is utilized at a dose less than 3000 mg.

92. A dosage of a pharmaceutical composition comprising an effective amount of an agent selected from the group consisting of phloridzin, phloretin, and 5-deoxyglucuronide of phloridzin; Vitamin C; and a non-steroidal anti-inflammatory drug, and combinations thereof to competitively block glucose transport in neoplastic cells and an amount of a form of hyaluronic acid selected from the group consisting of hyaluronic acid and pharmaceutically acceptable salts thereof and combinations thereof sufficient to facilitate the agent's penetration through tissue at a site to be treated, through cell membranes into individual cells to be treated and where phloretin is the selected agent, it is solubilized by a solubilizing agent, wherein said amount of the form of hyaluronic acid is sufficient to provide a dosage of 10 mg to 1000 mg of the form of hyaluronic acid and wherein the molecular weight of the form of hyaluronic acid is less than 750,000 daltons and greater than 150,000 daltons.
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