Compositions and methods for prophylactic and therapeutic supplementation of nutrition in subjects

• US 6,863,904 B2
• Filed: 10/14/2003
• Issued: 03/08/2005
• Est. Priority Date: 06/29/2001
• Status: Expired due to Term

• Current Assignee: Exeltis USA, Inc. (Chemo Iberica, S.A.)
• Original Assignee: Everett Laboratories Incorporated (Chemo Iberica, S.A.)
• Inventors: Giordano, John A., Balzer, Charles
• Primary Examiner(s): Pak, John
• Application Number:
  US10/682,927
• Publication Number:
  US 20040086574A1
• Time in Patent Office: 511 Days
• Field of Search: 424630-635, 424637-641, 424/643, 424/655, 424682-683, 424/686, 424688-689, 424/692, 424/697, 424/702, 514/52, 514/167, 514/168, 514/249, 514/251, 514/276, 514/345, 514/355, 514/356, 514/387, 514/440, 514/458, 514/474, 514/494, 514/499, 514/500, 514/505, 514/563, 514/706, 514/725, 514/729, 514/763, 514/824, 514/837, 514/838, 514/866, 514/893, 514/894, 514/902, 514/904, 514/905, 514/909, 514/910, 514/911, 514/925
• US Class Current: 424/638
• CPC Class Codes: A23L 33/12 Fatty acids or derivatives thereof
• CPC Class Codes: A23L 33/15 Vitamins
• CPC Class Codes: A23L 33/155 Vitamins A or D
• CPC Class Codes: A23L 33/16 Inorganic salts, minerals or trace elements
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A23V 2200/334 treating the effects of consuming alcohol, narcotics or other addictive behavior, e.g. treating hangover or reducing blood alcohol levels
• CPC Class Codes: A23V 2250/026 Alpha lipoic acid, thioctic acid
• CPC Class Codes: A23V 2250/1638 Undefined mineral extract
• CPC Class Codes: A23V 2250/70 Vitamins
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca

Abstract

The present invention relates to compositions without added iron and methods for prophylactic nutritional supplementation and therapeutic nutritional supplementation. Specifically, the method involves administering to an individual a composition comprising carotenoids, vitamin E, vitamin D, vitamin C, thiamine, riboflavin, niacin, folic acid, pyridoxine, biotin, pantothenic acid, cobalamin, magnesium, manganese, zinc, selenium, chromium, copper, alpha lipoic acid, and lutein, wherein the composition is free of added iron.

Claims

1. A composition for supplementing nutritional deficiencies in a patient or person in need thereof, comprising about 2400 IU carotenoids or more, vitamin E, vitamin D, vitamin C, thiamine, riboflavin, niacin, more than 0.8 mg folic acid, pyridoxine, biotin, pantothenic acid, cobalamin, magnesium, manganese, zinc, selenium, chromium, copper, alpha lipoic acid, and about 4 mg lutein or more, wherein said composition is free of any other added minerals and any other added vitamins.

2. The composition of claim 1, wherein said carotenoids are present in the range of about 2400 IU to about 3600 IU.

3. The composition of claim 1, wherein said carotenoids comprise at least one carotenoid selected from the group consisting of alpha-carotene, beta-carotene, cryptoxanthin, lutein, and zeaxanthin.

4. The composition of claim 3, wherein said carotenoid is present in the amount of about 3000 IU.

5. The composition of claim 1, wherein said vitamin E is present in the range of about 80 IU to about 120 IU.

6. The composition of claim 1, wherein said vitamin E comprises d-alpha tocopheryl succinate.

7. The composition of claim 6, wherein said vitamin E is present in the amount of about 100 IU.

8. The composition of claim 1, wherein said vitamin D is in the range of about 320 IU to about 480 IU.

9. The composition of claim 1, wherein said vitamin D comprises vitamin D₃.

10. The composition of claim 9, wherein said vitamin D is present in the amount of about 400 IU.

11. The composition of claim 1, wherein said vitamin C is in the range of about 240 mg to about 360 mg.

12. The composition of claim 1, wherein said vitamin C is in the amount of about 300 mg.

13. The composition of claim 1, wherein said thiamine is in the range of about 16 mg to about 24 mg.

14. The composition of claim 1, wherein said thiamine comprises thiamine HCl.

15. The composition of claim 14, wherein said thiamine is present in the amount of about 20 mg.

16. The composition of claim 1, wherein said riboflavin is present in the range of about 4 mg to about 6 mg.

17. The composition of claim 1, wherein said riboflavin is present in the amount of about 5 mg.

18. The composition of claim 1, wherein said niacin is present in the range of about 20 mg to about 30 mg.

19. The composition of claim 1, wherein said niacin comprises niacinamide.

20. The composition of claim 19, wherein said niacin is present in the amount of about 25 mg.

21. The composition of claim 1, wherein folic acid is present in the range of more than 0.8 mg to about 1.0 mg.

22. The composition of claim 1, wherein said folic acid is present in the amount of about 1 mg.

23. The composition of claim 1, wherein said pyridoxine is present in the range of about 20 mg to about 30 mg.

24. The composition of claim 1, wherein said pyridoxine comprises pyridoxine HCl.

25. The composition of claim 24, wherein said pyridoxine is present in the amount of about 25 mg.

26. The composition of claim 1, wherein said biotin is present in the range of about 80 μ

g to about 120 μ

g.

27. The composition of claim 1, wherein said biotin is present in the amount of about 100 μ

g.

28. The composition of claim 1, wherein said pantothenic acid is present in the range of about 12 mg to about 18 mg.

29. The composition of claim 1, wherein said pantothenic acid comprises calcium pantothenate.

30. The composition of claim 29, wherein said pantothenic acid is present in the amount of about 15 mg.

31. The composition of claim 1, wherein said cobalamin is present in the range of about 40 μ

g to about 60 μ

g.

32. The composition of claim 1, wherein said cobalamin comprises cyanocobalamin.

33. The composition of claim 32, wherein said cobalamin is present in the amount of about 50 μ

g.

34. The composition of claim 1, wherein said magnesium is present in the range of about 40 mg to about 60 mg.

35. The composition of claim 1, wherein said magnesium comprises magnesium oxide.

36. The composition of claim 35, wherein said magnesium is present in the amount of about 50 mg.

37. The composition of claim 1, wherein said manganese is present in the range of about 1.2 mg to about 1.8 mg.

38. The composition of claim 1, wherein said manganese comprises manganese sulfate.

39. The composition of claim 38, wherein said manganese is present in the amount of about 1.5 mg.

40. The composition of claim 1, wherein said zinc is present in the range of about 20 mg to about 30 mg.

41. The composition of claim 1, wherein said zinc comprises zinc oxide.

42. The composition of claim 41, wherein said zinc is present in the amount of about 25 mg.

43. The composition of claim 1, wherein said selenium is present in the range of about 80 μ

g to about 120 μ

g.

44. The composition of claim 1, wherein said selenium comprises sodium selenate.

45. The composition of claim 44, wherein said selenium is present in the amount of about 100 μ

g.

46. The composition of claim 1, wherein said chromium is present in the range of about 40 μ

g to about 60 μ

g.

47. The composition of claim 1, wherein said chromium comprises chromium chloride.

48. The composition of claim 47, wherein said chromium is present in the amount of about 50 μ

g.

49. The composition of claim 1, wherein said copper is present in the range of about 1.2 mg to about 1.8 mg.

50. The composition of claim 1, wherein said copper comprises cupric sulfate.

51. The composition of claim 50, wherein said copper is present in the amount of about 1.5 mg.

52. The composition of claim 1, wherein said alpha lipoic acid is present in the range of about 12 mg to about 18 mg.

53. The composition of claim 1, wherein said alpha lipoic acid is present in the amount of about 15 mg.

54. The composition of claim 1, wherein said lutein is in the range of about 4 mg to about 6 mg.

55. The composition of claim 1, wherein said lutein is present in the amount of about 5 mg.

56. A method for supplementing nutritional deficiencies in a patient or person in need thereof, comprising administering to a patient or a person a composition comprising about 2400 IU carotenoids or more, vitamin E, vitamin D, vitamin C, thiamine, riboflavin, niacin, more than 0.8 mg folic acid, pyridoxine, biotin, pantothenic acid, cobalamin, magnesium, manganese, zinc, selenium, chromium, copper, alpha lipoic acid, and about 4 mg lutein or more, wherein said composition is free of any other added minerals and any other added vitamins.

57. The method of claim 56, wherein said carotenoids are present in the range of about 2400 IU to about 3600 IU.

58. The method of claim 56, wherein said carotenoids comprise at least one carotenoid selected from the group consisting of alpha-carotene, beta-carotene, cryptoxanthin, lutein, and zeaxanthin.

59. The method of claim 58, wherein said carotenoid is present in the amount of about 3000 IU.

60. The method of claim 56, wherein said vitamin E is present in the range of about 80 IU to about 120 IU.

61. The method of claim 56, wherein said vitamin E comprises d-alpha tocopheryl succinate.

62. The method of claim 61, wherein said vitamin E is present in the amount of about 100 IU.

63. The method of claim 56, wherein said vitamin D is present in the range of about 320 IU to about 480 IU.

64. The method of claim 56, wherein said vitamin D comprises D₃.

65. The method of claim 64, wherein said vitamin D is present in the amount of about 400 IU.

66. The method of claim 56, wherein said vitamin C is present in the range of about 240 mg to about 360 mg.

67. The method of claim 56, wherein said vitamin C is present in the amount of about 300 mg.

68. The method of claim 56, wherein said thiamine is present in the range of about 16 mg to about 24 mg.

69. The method of claim 56, wherein said thiamine comprises thiamine HCl.

70. The method of claim 69, wherein said thiamine is present in the amount of about 20 mg.

71. The method of claim 56, wherein said riboflavin is present in the range of about 4 mg to about 6 mg.

72. The method of claim 56, wherein said riboflavin is in the amount of about 5 mg.

73. The method of claim 56, wherein said niacin is present in the range of about 20 mg to about 30 mg.

74. The method of claim 56, wherein said niacin comprises niacinamide.

75. The method of claim 74, wherein said niacin is present in the amount of about 25 mg.

76. The method of claim 56, wherein folic acid is present in the range of more than 0.8 mg to about 1.0 mg.

77. The method of claim 56, wherein said folic acid is present in the amount of about 1 mg.

78. The method of claim 56, wherein said pyridoxine is present in the range of about 20 mg to about 30 mg.

79. The method of claim 56, wherein said pyridoxine comprises pyridoxine HCl.

80. The method of claim 79, wherein said pyridoxine is present in the amount of about 25 mg.

81. The method of claim 56, wherein said biotin is present in the range of about 80 μ

g to about 120 μ

g.

82. The method of claim 56, wherein said biotin is present in the amount of about 100 μ

g.

83. The method of claim 56, wherein said pantothenic acid is present in the range of about 12 mg to about 18 mg.

84. The method of claim 56, wherein said pantothenic acid comprises calcium pantothenate.

85. The method of claim 84, wherein said pantothenic acid is present in the amount of about 15 mg.

86. The method of claim 56, wherein said cobalamin is present in the range of about 40 μ

g to about 60 μ

g.

87. The method of claim 56, wherein said cobalamin comprises cyanocobalamin.

88. The method of claim 87, wherein said cobalamin is present in the amount of about 50 μ

g.

89. The method of claim 56, wherein said magnesium is present in the range of about 40 mg to about 60 mg.

90. The method of claim 56, wherein said magnesium comprises magnesium oxide.

91. The method of claim 90, wherein said magnesium is present in the amount of about 50 mg.

92. The method of claim 56, wherein said manganese is present in the range of about 1.2 mg to about 1.8 mg.

93. The method of claim 56, wherein said manganese comprises manganese sulfate.

94. The method of claim 93, wherein said manganese is present in the amount of about 1.5 mg.

95. The method of claim 56, wherein said zinc is present in the range of about 20 mg to about 30 mg.

96. The method of claim 56, wherein said zinc comprises zinc oxide.

97. The method of claim 96, wherein said zinc is present in the amount of about 25 mg.

98. The method of claim 56, wherein said selenium is present in the range of about 80 μ

g to about 120 μ

g.

99. The method of claim 56, wherein said selenium comprises sodium selenate.

100. The method of claim 99, wherein said selenium is present in the amount of about 100 μ

g.

101. The method of claim 56, wherein said chromium is present in the range of about 40 μ

g to about 60 μ

g.

102. The method of claim 56, wherein said chromium comprises chromium chloride.

103. The method of claim 102, wherein said chromium is present in the amount of about 50 μ

g.

104. The method of claim 56, wherein said copper is present in the range of about 1.2 mg to about 1.8 mg.

105. The method of claim 56, wherein said copper comprises cupric sulfate.

106. The method of claim 105, wherein said copper is present in the amount of about 1.5 mg.

107. The method of claim 56, wherein said alpha lipoic acid is present in the range of about 12 mg to about 18 mg.

108. The method of claim 56, wherein said alpha lipoic acid is present in the amount of about 15 mg.

109. The method of claim 56, wherein said lutein is present in the range of about 4 mg to about 6 mg.

110. The method of claim 56, wherein said lutein is present in the amount of about 5 mg.