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Claims for Patent: 5,656,667

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Claims for Patent: 5,656,667

Title: Fatty acid composition
Abstract:Fatty acid composition comprising at least 80% by weight of omega-3-fatty acids, salts or derivatives thereof, wherein (all-Z)-5,8,11,14,17-eicosapentaenoic acid (EPA) and (all-Z)-4,7,10,13,16,19-docosahexaenoic acid comprises at least 75% by weight of the total fatty acids. The compositions can be used for the treatment or prophylaxis of multiple risk factors for cardiovascular diseases.
Inventor(s): Breivik; Harald (Skjelsvik, NO), B.o slashed.rretzen; Bernt (Porsgrunn, NO), Dahl; Knut Helk.ang.s (Ulefoss, NO), Krokan; Hans Einar (Sjetnemarka, NO), B.o slashed.naa; Kaare Harald (Troms.o slashed., NO)
Assignee: Norsk Hydro as (Oslo, NO)
Application Number:08/471,200
Patent Claims: 1. A method for elevating the HDL cholesterol level in the serum of a human patient, which comprises administering to the patient a pharmaceutical composition in which the active ingredients consist essentially of a mixture of fatty acids of which at least 80% by weight is comprised of a combination of (all-Z omega-3)-5,8,11,14,17-eicosapentaenoic acid (EPA) and (all-Z omega-3)-4,7,10,13,16,19-docosahexaenoic acid (DHA) in a weight ratio of EPA:DHA of from 1:2 to 2:1, said composition being administered in amounts providing a daily dosage of 1 to 10 grams of said mixture of fatty acids.

2. The method of claim 1, wherein at least 85% by weight of the mixture of fatty acids is comprised of long chain omega-3 fatty acids.

3. The method of claim 2, wherein the EPA constitutes 40 to 60% by weight of the mixture of fatty acids and the DHA constitutes 25 to 45% by weight of the mixture of fatty acids.

4. The method of claim 3, wherein the EPA and DHA are present in the composition in an EPA:DHA weight ratio of from 1:1 to 2:1.

5. The method of claim 4, wherein at least 3% by weight of the mixture of fatty acids is comprised of omega-3 fatty acids other than EPA and DHA that have 20, 21, or 22 carbon atoms.

6. The method of claim 4, wherein at least 1% by weight of the mixture of fatty acids is comprised of (all-Z omega-3)-6,9,12,15,18-heneicosapentaenoic acid.

7. The method of claim 6, wherein at least 85% by weight of the fatty acid content of the composition is comprised of the combination of EPA and DHA, and the fatty acids are present in the composition in ethyl ester form.

8. The method of claim 4, wherein the composition is administered orally.

9. The method of claim 4, wherein at least 4.5% by weight of the mixture of fatty acids is comprised of fatty acids other than EPA and DHA that have 20, 21, or 22 carbon atoms.

10. The method of any of claims 5, 6, or 9, wherein the fatty acids are present in the composition in esterified form.

11. The method of any of claims 5, 6, or 9, wherein the fatty acids are present in the composition in ethyl ester form.

12. The method of any of claims 5, 6, or 9, wherein the fatty acids are present in the composition in salt form.

13. The method of any of claims 5, 6, or 9, wherein the fatty acids are present in the composition in the free acid form.

14. A pharmaceutical mixed-fatty-acids composition in which

a) at least 80% by weight of the composition is comprised of a combination of (all-Z omega-3)-5,8,11,14,17-eicosapentaenoic acid (EPA) and (all-Z omega-3)-4,7,10,13,16,19-docosahexaenoic acid (DHA) in a weight ratio of EPA:DHA of from 1:2 to 2:1 and

b) (all-Z omega-3)-6,9,12,15,18-heneicosapentaenoic acid is present in an amount of at least one percent by weight.

15. The composition of claim 14, wherein at least 85% by weight of the composition is comprised of long chain omega-3 fatty acids.

16. The composition of claim 15, wherein the EPA constitutes 40 to 60% by weight of the composition and the DHA constitutes 25 to 45% by weight of the composition.

17. The composition of claim 16, wherein C 20:4 omega-6 fatty acid constitutes at least one percent by weight of the composition.

18. The composition of claim 17, wherein C 22:5 omega-3 fatty acid constitutes at least one percent by weight of the composition.

19. The composition of claim 16, wherein the (all-Z omega-3) -6,9,12,15,18-heneicosapentaenoic acid is present in an amount of from 1 to 4% by weight.

20. The composition of any of claims 17, 18, or 19, wherein the EPA and DHA are present in an EPA:DHA weight ratio of from 1:1 to 2:1.

21. The composition of claim 19, wherein C 22:5 omega-3 fatty acid constitutes 1 to 3% by weight of the composition.

22. The composition of claim 21, wherein the EPA and DHA are present in an EPA:DHA weight ratio of from 1:1 to 2:1.

23. The composition of any of claims 14, 15, or 16, wherein the EPA and DHA are present in an EPA:DHA weight ratio of from 1:1 to 2:1.

24. A mixed-fatty-acids composition for the treatment or prophylaxis of multiple risk factors for cardiovascular diseases in which

a) at least 80% by weight of the composition is comprised of omega-3 fatty acids,

b) at least 80% by weight of the total fatty acid content of the composition is comprised of a combination of (all-Z omega-3)-5,8,11,14,17-eicosapentaenoic acid (EPA) and (all-Z omega-3)-4,7,10,13,16,19-docosahexaenoic acid (DHA) in a weight ratio of EPA:DHA of from 1:2 to 2:1, and

c) omega-3 fatty acids other than EPA and DHA are present in an amount of at least 1.5% by weight of the total fatty acids.

25. The composition according to claim 24, wherein other long chain fatty acids present are selected from the group consisting of (all-Z omega-3)-6,9,12,15,18-heneicosapentaenoic acid, (all-Z omega-3)-7,10,13,16,19-docosapentaenoic acid, and (all-Z omega-3)-6,9,12,15-octadecatetraenoic acid.

26. The composition of any of claims 14, 22, or 25, wherein the fatty acids are present in ethyl ester form.

27. The composition of any of claims 14, 22, or 25, wherein the fatty acids are present in the free acid form.

28. A pharmaceutical mixed-fatty-acids composition in which

a) at least 80% by weight of the composition is comprised of a combination of (all-Z omega-3)-5,8,11,14,17-eicosapentaenoic acid (EPA) and (all-Z omega-3)-4,7,10,13,16,19-docosahexaenoic acid (DHA) in a weight ratio of EPA:DHA of from 1:2 to 2:1 and

b) at least 3% by weight of the composition is comprised of omega-3 fatty acids other than EPA and DHA that have 20, 21, or 22 carbon atoms.

29. The composition of claim 28, wherein 3 to 5% by weight of the composition is comprised of omega-3 fatty acids other than EPA and DHA that have 20, 21, or 22 carbon atoms.

30. The composition of claim 28, wherein at least 85% by weight of the composition is comprised of long chain omega-3 fatty acids.

31. The composition of claim 30, wherein the EPA constitutes 40 to 60% by weight of the composition and the DHA constitutes 25 to 45% by weight of the composition.

32. The composition of claim 31, wherein C 20:4 omega-6 fatty acid constitutes at least one percent by weight of the composition.

33. The composition of claim 31, wherein C 22:5 omega-3 fatty acid constitutes at least one percent by weight of the composition.

34. The composition of claim 33, wherein C 22:5 omega-3 fatty acid constitutes 1 to 3% by weight of the composition.

35. The composition of claim 34, wherein the EPA and DHA are present in an EPA:DHA weight ratio of from 1:1 to 2:1.

36. The composition of claim 35, wherein the fatty acids are present in the free acid form.

37. The composition of claim 31, wherein the fatty acids are present in the free acid form.

38. The composition of claim 31, wherein (all-Z omega-3)-6,9,12,15,18-heneicosapentaenoic acid is present in an amount of at least one percent by weight.

39. The composition of any of claims 32, 33, or 38, wherein the EPA and DHA are present in an EPA:DHA weight ratio of from 1:1 to 2:1.

40. The composition of claim 38, wherein the (all-Z omega-3)-6,9,12,15,18-heneicosapentaenoic acid is present in an amount of from 1 to 4% by weight.

41. The composition of any of claims 28, 30, or 31, wherein the EPA and DHA are present in an EPA:DHA weight ratio of from 1:1 to 2:1.

42. The composition of any of claims 28, 31, or 35, wherein the composition is in oral dosage form.

43. The composition of any of claims 28, 31, or 35, wherein the fatty acids are present in esterified form.

44. The composition of any of claims 28, 31, or 35, wherein the fatty acids are present in ethyl ester form.

45. The composition of any of claims 28, 31, or 35, wherein the fatty acids are present in salt form.

46. The composition of claim 28, wherein the fatty acids are present in the free acid form.

47. A mixed-fatty-acids composition for the treatment or prophylaxis of multiple risk factors for cardiovascular diseases in which

a) at least 80% by weight of the composition is comprised of a combination of (all-Z omega-3)-5,8,11,14,17-eicosapentaenoic acid (EPA) and (all-Z omega-3)-4,7,10,13,16,19-docosahexaenoic acid (DHA) in a weight ratio of EPA:DHA of from 1:2 to 2:1 and

b) at least 3% by weight of the composition is comprised of omega-3 fatty acids other than EPA and DHA that have 20, 21, or 22 carbon atoms.

48. The composition of claim 47, wherein 3 to 5% by weight of the composition is comprised of omega-3 fatty acids other than EPA and DHA that have 20, 21, or 22 carbon atoms.

49. A pharmaceutical mixed-fatty-acids composition in which

a) at least 90% by weight of the composition is comprised of long chain, polyunsaturated, omega-3 fatty acids;

b) at least 80% by weight of the composition is comprised of a combination of (all-Z omega-3)-5,8,11,14,17-eicosapentaenoic acid (EPA) and (all-Z omega-3)-4,7,10,13,16,19-docosahexaenoic acid (DHA) in a weight ratio of EPA:DHA of from 1:1 to 2:1, with the EPA constituting 40 to 60% by weight of the composition and the DHA constituting 25 to 45% by weight of the composition;

c) at least 4.5% by weight of the composition is comprised of omega-3 fatty acids other than EPA and DHA that have 20, 21, or 22 carbon atoms;

d) from 1 to 4% by weight of the composition is comprised of (all-Z omega-3)-6,9,12,15,18-heneicosapentaenoic acid; and

e) the composition is in oral dosage form and includes an effective amount of a pharmaceutically acceptable antioxidant.

50. The composition of claim 49, wherein the fatty acids are present in ethyl ester form.

51. The composition of claim 50, wherein at least 85% by weight of the fatty acid content of the composition is comprised of the combination of EPA and DHA.

52. The composition of either of claims 50 or 51, wherein the antioxidant is tocopherol.

53. The composition of any of claims 14, 22, or 24, wherein the composition is in oral dosage form.

54. The composition of any of claims 14, 22, or 25, wherein the fatty acids are present in esterified form.

55. The composition of claim 54, wherein the fatty acids are present in salt form.

56. The composition according to claim 24 or claim 25, wherein the total concentration of long chain omega-3 fatty acids is at least 90% by weight, the combined weight of the EPA and DHA constitutes at least 85% by weight of the total fatty acids, the EPA and DHA are present in a weight ratio of EPA:DHA of from 1:1 to 2:1, and the other long chain omega-3 C 20, C 21 and C 22 acids constitute at least 4.5% by weight of the composition.

57. The composition according to claim 24, wherein the total concentration of long chain omega-3 fatty acids is at least 95% by weight, the combined weight of the EPA and DHA constitutes at least 90% by weight of the total fatty acids, and the other long chain C 20, C 21 and C 22 acids constitute at least 4.5% by weight of the composition.

58. The composition according to claim 57, wherein EPA and DHA are present in a weight ratio of EPA:DHA of from 1:1 to 2:1.

59. The composition according to claim 24 or claim 25, wherein the total concentration of long chain omega-3 fatty acids is at least 85% by weight and the other long chain C 20, C 21 and C 22 acids constitute at least 4.5% by weight of the composition.

60. The composition according to claim 24, wherein the fatty acids are present in the form of pharmaceutically acceptable salts.

61. The composition according to claim 24, wherein the fatty acids are present in the form of an ester.

62. The composition according to claim 61, wherein the fatty acids are present in the form of ethyl esters.

63. The composition according to claim 61, wherein the ester is an alkyl ester.
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