Formulation for menopausal women

• US 20020137749A1
• Filed: 03/27/2002
• Published: 09/26/2002
• Est. Priority Date: 09/30/1999
• Status: Active Grant

• Current Assignee: Amag Pharma Usa Inc. (Apollo Global Management, Inc.)
• Original Assignee: DrugTech Corporation (PD International Holdings LLC)
• Inventors: Kirschner, Mitchell I., Levinson, R. Saul, Hermelin, Marc S.
• Granted Patent: US 7,687,485 B2
• Time in Patent Office: Days
• US Class Current: 514/251
• CPC Class Codes: A23L 33/12 Fatty acids or derivatives thereof
• CPC Class Codes: A23L 33/15 Vitamins
• 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 2200/224 Encapsulating agent
• CPC Class Codes: A23V 2250/156 Mineral combination undefined extract A23V2250/1638
• CPC Class Codes: A23V 2250/1578 Calcium
• CPC Class Codes: A23V 2250/1588 Copper
• CPC Class Codes: A23V 2250/1592 Iron
• CPC Class Codes: A23V 2250/161 Magnesium
• CPC Class Codes: A23V 2250/1626 Selenium
• CPC Class Codes: A23V 2250/1642 Zinc
• CPC Class Codes: A23V 2250/18 Lipids
• CPC Class Codes: A23V 2250/1868 Docosahexaenoic acid
• CPC Class Codes: A23V 2250/1872 Linoleic acid
• CPC Class Codes: A23V 2250/1874 Linolenic acid
• CPC Class Codes: A23V 2250/211 Carotene, carotenoids
• CPC Class Codes: A23V 2250/30 Other Organic compounds
• CPC Class Codes: A23V 2250/5432 Gelatine
• CPC Class Codes: A23V 2250/70 Vitamins
• CPC Class Codes: A23V 2250/704 : Vitamin B
• CPC Class Codes: A23V 2250/708 : Vitamin C
• CPC Class Codes: A23V 2250/71 : Vitamin D
• CPC Class Codes: A23V 2250/712 : Vitamin E
• CPC Class Codes: A61K 45/06 : Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 1/08 : for nausea, cinetosis or vertigo; Antiemetics
• CPC Class Codes: A61P 1/10 : Laxatives
• CPC Class Codes: A61P 1/12 : Antidiarrhoeals
• CPC Class Codes: A61P 15/00 : Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 15/12 : for climacteric disorders
• CPC Class Codes: A61P 19/02 : for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 21/00 : Drugs for disorders of the muscular or neuromuscular system
• CPC Class Codes: A61P 25/02 : for peripheral neuropathies
• CPC Class Codes: A61P 25/20 : Hypnotics; Sedatives
• CPC Class Codes: A61P 25/22 : Anxiolytics
• CPC Class Codes: A61P 25/24 : Antidepressants
• CPC Class Codes: A61P 29/02 : without antiinflammatory effect
• CPC Class Codes: A61P 3/02 : Nutrients, e.g. vitamins, minerals
• CPC Class Codes: A61P 5/30 : Oestrogens
• CPC Class Codes: A61P 5/34 : Gestagens
• CPC Class Codes: A61P 9/00 : Drugs for disorders of the cardiovascular system

Abstract

The present disclosure relates to novel compositions which provide improved nutritional support for premenopausal and menopausal women and/or relief from symptoms associated with menopause, as well as prophylactic effects, and methods for using same.

Claims

1. A composition for administration to premenopausal and menopausal women, which comprises:

an essential fatty acid compound selected from the group consisting of a linoleic acid compound, a linolenic acid compound, a docosahexaenoic acid compound, an omega-3 fatty acid compound, an omega-2 fatty acid compound, a derivative thereof and a combination thereof in an amount of about 10 mg to about 1,000 mg;

a calcium compound or derivative thereof in an amount of about 400 mg to about 2500 mg;

a folic acid compound or derivative thereof in an amount of about 0.4 mg to about 5.0 mg; and

wherein the weight ratio of the essential fatty acid compound to the calcium compound or derivative thereof is about 1;

0.4 to 250.

2. The composition of claim 1, wherein the calcium compound is selected from the group consisting of calcium carbonate, calcium citrate and combinations thereof.

3. The composition of claim 1, wherein the calcium compound is selected from the group consisting of bone meal, oyster shell and combinations thereof.

4. The composition of claim 1, wherein the calcium compound is calcium carbonate.

5. The composition of claim 4, wherein the calcium carbonate is present in said composition in an amount of about 1,000 mg to about 1,400 mg.

6. The composition of claim 1, wherein the essential fatty acid compound is present in said composition in an amount of about 10 mg to about 100 mg.

7. The composition of claim 1, wherein the essential fatty acid compound is present in said composition in an amount of about 20 mg to about 60 mg.

8. The composition of claim 1, wherein the weight ratio of the essential fatty acid compound to the calcium compound or derivative thereof is about 1:

1 to 20.

9. The composition of claim 1, wherein the weight ratio of the essential fatty acid compound to the calcium compound or derivative thereof is about 1:

5 to 15.

10. The composition of claim 1, wherein said composition additionally contains a vitamin compound or derivative thereof.

11. The composition of claim 10, wherein the vitamin compound is selected from the group consisting of a vitamin A compound, a B complex vitamin compound, a vitamin C compound, a vitamin D compound, a vitamin E compound, a derivative thereof and combinations thereof.

12. The composition of claim 11, wherein said vitamin C compound is present in said composition in an amount ranging from about 25 mg to about 500 mg.

13. The composition of claim 11, wherein said vitamin E compound is present in said composition in an amount ranging from about 10 mg to about 500 mg.

14. The composition of claim 1, wherein said composition additionally contains a mineral compound or derivative thereof.

15. The composition of claim 14, wherein said mineral compound is selected from the group consisting of copper, zinc, selenium, magnesium, molybdenum, bioflavonoid, manganese, chromium, iodine, iron and combinations thereof.

16. The composition of claim 1, wherein said composition additionally contains a non-nutritional active.

17. The composition of claim 16, wherein the non-nutritional active is selected from the group consisting of hormones, steroids, fiber, estrogens, progestins, sedative-hypnotics, barbiturates, benzodiazepines, antidepressants, tranquilizers, sedatives, osteoporotics, herbals, herbal derivatives, phyto-chemical derivatives, anti-platelets, aminobisphosphonates and combinations thereof.

18. The composition of claim 16, wherein the non-nutritional active is a hormone, and wherein the hormone is present in said composition in an amount ranging from about 0.15 mg to about 11.25 mg.

19. The composition of claim 16, wherein the non-nutritional active is selected from the group consisting of medroxyprogesterone acetate, megestrol acetate, clonidine, norethindrone acetate, ethinyl estradiol, conjugated estrogen, natural estrogen, synthetic estrogen, estradiol, progesterone, clomiphene, clomiphene citrate, zuclomiphene, zuclomiphene citrate, enclomiphene, enclomiphene citrate, calcitonin, aspirin, alendronate, etidronate, pamidronate, clodronate, tiludronate, residronate, ibandronate and combinations thereof.

20. The composition of claim 16, wherein the non-nutritional active is an osteoporotic, and wherein the osteoporotic is present in said composition in an amount ranging from about 2.5 mg to about 60 mg.

21. The composition of claim 1, wherein the composition additionally contains an amino acid compound or derivative thereof.

22. The composition of claim 21, wherein the amino acid compound is selected from the group consisting of leucine, isoleucine, valine and combinations thereof.

23. The composition of claim 1, wherein the composition is specifically adapted to meet the nutritional needs of menopausal women.

24. The composition of claim 1, wherein the composition is specifically adapted for treating conditions associated with menopause.

25. The composition of claim 1, wherein the composition is specifically adapted to maximize neurological maintenance of said woman.

26. The composition of claim 1, wherein the composition is in an oral dosage form.

27. The composition of claim 26, wherein said oral dosage form is selected from the group consisting of immediate release, extended release, pulsed release, variable release, delayed release, controlled release and combinations thereof.

28. The composition of claim 26, wherein said oral dosage form is selected from the group consisting of chewable tablets, quick dissolve tablets, effervescent tablets, hard gelatin capsules, soft gelatin capsules, reconstitutable particles, microparticles, suspensions, elixirs, caplets, fortified foods, puddings, yogurts, gelatins, cereals, food coatings and combinations thereof.

29. The composition of claim 1, wherein the composition is formulated into a single dosage unit.

30. The composition of claim 1, wherein the composition is formulated into multiple dosage units.

31. The composition of claim 30, wherein the multiple dosage units contain uneven doses of the calcium compound or derivative thereof.

32. The composition of claim 1, wherein the composition is formulated for administration once during a twenty four hour period of time.

33. The composition of claim 1, wherein the composition is formulated for administration at least twice during a twenty four hour period of time.

34. The composition of claim 1, wherein the composition is provided with indicia indicating a time period of use.

35. The composition of claim 34, wherein the time period of use is prior to, during and after menopause.

36. The composition of claim 34, wherein the time period commences at the onset of menopause.

37. The composition of claim 34, wherein the time period commences at the onset of menopause and continues through the duration of menopause.

38. The composition of claim 34, wherein the time period commences when said woman is at least 40 years of age.

39. The composition of claim 34, wherein the time period of use commences when said woman is 40 to 50 years of age.

40. A composition for administration to a menopausal woman, which comprises:

a first fatty acid compound selected from the group consisting of a linoleic acid compound, a derivative thereof and a combination thereof in an amount of about 10 mg to about 1,000 mg;

a second fatty acid compound selected from the group consisting of a linolenic acid compound, a derivative thereof and combinations thereof in an amount of about 10 mg to about 1,000 mg;

a third fatty acid compound selected from the group consisting of a docosahexaenoic acid compound, an omega-3 fatty acid, an omega-2 fatty acid, a derivative thereof and a combination thereof in an amount of about 10 mg to about 1,000 mg;

a calcium compound or derivative thereof in an amount of about 400 mg to about 2500 mg;

a folic acid compound or derivative thereof in an amount of about 0.4 mg to about 5.0 mg;

a vitamin C compound or derivative thereof in an amount of about 25 mg to about 500 mg;

a vitamin E compound or derivative thereof in an amount of about 10 mg to about 500 mg;

wherein the weight ratio of the sum of the amounts of said first and second fatty acid compounds to the amount of said third fatty acid compound is about 1;

0.5 to 1.5; and

wherein the weight ratio of the sum of the amounts of said first, second and third fatty acid compounds to the amount of said calcium compound or derivative thereof is about 1;

0.4 to 50.

41. The composition of claim 40, wherein said composition additionally contains a non-nutritional active.

42. The composition of claim 41, wherein the non-nutritional active is selected from the group consisting of hormones, steroids, fiber, estrogens, progestins, sedative-hypnotics, barbiturates, benzodiazepines, antidepressants, tranquilizers, sedatives, aminobisphosphonates, osteoporotics, herbals, herbal derivatives, phyto-chemical derivatives, antiplatelets and combinations thereof.

43. The composition of claim 41, wherein the non-nutritional active is a hormone, and wherein the hormone is present in said composition in an amount ranging from about 0.15 mg to about 11.25 mg.

44. The composition of claim 41, wherein the non-nutritional active is selected from the group consisting of medroxyprogesterone acetate, megestrol acetate, clonidine, norethindrone acetate, ethinyl estradiol, conjugated estrogen, natural estrogen, synthetic estrogen, estradiol, progesterone, clomiphene, clomiphene citrate, zuclomiphene, zuclomiphene citrate, enclomiphene, enclomiphene citrate, calcitonin, aspirin, alendronate, etidronate, pamidronate, clodronate, tiludronate, residronate, ibandronate and combinations thereof.

45. The composition of claim 41, wherein the non-nutritional active is an osteoporotic, and wherein the osteoporotic is present in said composition in an amount ranging from about 2.5 mg to about 60 mg.

46. The composition of claim 40, wherein the composition additionally contains an amino acid compound or derivative thereof.

47. The composition of claim 46, wherein the amino acid compound is selected from the group consisting of leucine, isoleucine, valine and combinations thereof.

48. The composition of claim 40, wherein the composition is specifically adapted to meet the nutritional needs of menopausal women.

49. A composition for administration to a menopausal woman, which comprises:

a first fatty acid compound selected from the group consisting of a linoleic acid compound, a derivative thereof and a combination thereof in an amount of about 10 mg to about 1,000 mg;

a second fatty acid compound selected from the group consisting of a linolenic acid compound, a derivative thereof and combinations thereof in an amount of about 10 mg to about 1,000 mg;

a third fatty acid compound selected from the group consisting of a docosahexaenoic acid compound, an omega-3 fatty acid, an omega-2 fatty acid, a derivative thereof and a combination thereof in an amount of about 10 mg to about 1,000 mg;

a calcium compound or derivative thereof in an amount of about 400 mg to about 2500 mg;

a folic acid compound or derivative thereof in an amount of about 0.4 mg to about 5.0 mg;

a vitamin C compound or derivative thereof in an amount of about 25 mg to about 500 mg;

a vitamin E compound or derivative thereof in an amount of about 10 mg to about 500 mg;

a vitamin A compound or derivative thereof in an amount of about 2,500 IU to about 6,500 IU;

wherein the weight ratio of the sum of the amounts of said first and second fatty acid compounds to the amount of said third fatty acid compound is about 1;

0.5 to 1.5; and

wherein the weight ratio of the sum of said first, second and third fatty acid compounds to the amount of said calcium compound or derivative thereof is about 1;

0.4 to 50.

50. A composition for administration to a menopausal woman, which comprises:

a first fatty acid compound selected from the group consisting of a linoleic acid compound, a derivative thereof and a combination thereof in an amount of about 10 mg to about 1,000 mg;

a second fatty acid compound selected from the group consisting of a linolenic acid compound, a derivative thereof and combinations thereof in an amount of about 10 mg to about 1,000 mg;

a third fatty acid compound selected from the group consisting of a docosahexaenoic acid compound, an omega-3 fatty acid, an omega-2 fatty acid, a derivative thereof and a combination thereof in an amount of about 10 mg to about 1,000 mg;

a calcium compound or derivative thereof in an amount of about 400 mg to about 2500 mg;

a folic acid compound or derivative thereof in an amount of about 0.4 mg to about 5.0 mg;

a vitamin C compound or ester derivative thereof in an amount of about 25 mg to about 500 mg;

a vitamin E compound or derivative thereof in an amount of about 10 mg to about 500 mg;

a vitamin B6 compound or derivative thereof in an amount of about 10 mg to about 50 mg;

a vitamin B12 compound or derivative thereof in an amount of about 25 mcg to about 75 mcg;

a vitamin D compound or derivative thereof in an amount of about 200 IU to about 625 IU;

wherein the weight ratio of the sum of the amounts of said first and second fatty acid compounds to the amount of said third fatty acid compound is about 1;

0.5 to 1.5; and

wherein the weight ratio of the sum of the amounts of said first, second and third fatty acid compounds to the amount of said calcium compound or derivative thereof is about 1;

0.4 to 50.

51. A composition for administration to a menopausal woman, which comprises:

a biologically active substance for treating symptoms of menopause;

a calcium compound or derivative thereof in an amount of about 400 mg to about 2500 mg;

a folic acid compound or derivative thereof in an amount of about 0.4 mg to about 5.0 mg.

52. The composition of claim 51, wherein the biologically active substance is selected from the group consisting of a hormone, steroid, fiber, estrogen, progestin, sedative-hypnotic, barbiturate, benzodiazepine, antidepressant, tranquilizer, sedative, osteoporotic, anti-platelet and combinations thereof.

53. The composition of claim 51, wherein the non-nutritional active is selected from the group consisting of medroxyprogesterone acetate, megestrol acetate, clonidine, norethindrone acetate, ethinyl estradiol, conjugated estrogen, natural estrogen, synthetic estrogen, estradiol, progesterone, clomiphene, clomiphene citrate, zuclomiphene, zuclomiphene citrate, enclomiphene, enclomiphene citrate, calcitonin, aspirin, aminobisphosphonate, herbal, herbal derivative, phyto-chemical derivative, alendronate, etidronate, pamidronate, clodronate, tiludronate, residronate, ibandronate and combinations thereof.

54. A drug delivery regimen, which comprises:

a first dosage form comprising a first biologically active substance to be administered to a menopausal woman at a predetermined time period;

a second dosage form comprising a second biologically active substance to be administered to the menopausal woman simultaneously with said first dosage form;

wherein said first biologically active substance and said second biologically active substance are incompatible substances.

55. The drug delivery regimen of claim 54, wherein the first dosage form is a soft gelatin capsule and the second dosage form is a tablet.

56. The drug delivery regimen of claim 54, wherein the first biologically active substance or the second biologically active substance is effective in treating menopause-related symptoms.

57. The drug delivery regimen of claim 54, wherein the first and second biologically active substance are independently selected from the group consisting of a linoleic acid compound, a linolenic acid compound, a docosahexanoic acid compound, an omega-2 fatty acid compound, an omega-3 fatty acid compound, a vitamin A compound, a B complex vitamin compound, a vitamin C compound, a vitamin D compound, a vitamin E compound, a hormone, a steroid, fiber, estrogen, progestin, a sedative-hypnotic, a barbiturate, benzodiazepine, an antidepressant, a tranquilizer, a sedative, an osteoporotic, an anti-platelet, a derivative thereof and a combination thereof.

58. The drug delivery regimen of claim 54, wherein the first biologically active substance is selected from the group consisting of a hydrophobic compound, an olefinic compound, a pH sensitive compound, a substance requiring an anhydrous environment, an acidic drug, an effervescent tablet, a gelatin capsule, a quaternary ammonium compound and a combination thereof, and wherein the second biologically active substance is selected from the group consisting of a hydrophilic compound, a non-olefinic compound, a non-pH sensitive compound, a substance requiring a non-anhydrous environment, a basic drug, a high water content drug or dosage form, an aldehyde, an anionic substance and a combination thereof.

59. The drug delivery regimen of claim 54, wherein the first biologically active substance is ascorbic acid, citric acid, folic acid, activated charcoal, gelatin capsules, gelatine capsules, konicin chloride, etylpyridinium chloride, and wherein the second biologically active substance is aluminum hydroxide, sodium bicarbonate, sodium carbonate, calcium carbonate, amyl nitrate, formaldehyde, gluteraldehyde, soap, etylpyridinium, sodium stearate and combinations thereof.

60. The drug delivery regimen of claim 54, wherein the predetermined time period is selected from the group consisting of morning, afternoon, evening, day, daytime, night, nighttime, AM and PM.

61. The drug delivery regimen of claim 54, wherein said first and second dosage form are provided together in a blister pack.

62. The drug delivery regimen of claim 54, further comprising a third dosage form to be administered to the menopausal woman at a time prior to or after the predetermined time.

63. The drug delivery regimen of claim 62, wherein said time prior to or after the predetermined time is selected from the group consisting of morning, afternoon, evening, day, daytime, night, nighttime, AM and PM.

64. The drug delivery regimen of claim 54, wherein the first dosage form is a soft gelatin capsule containing an essential fatty acid compound and the second dosage form is a tablet essentially containing calcium carbonate.

65. A method for providing nutritional supplementation to a menopausal woman, which comprises:

administering an essential fatty acid compound to the woman during the period commencing at the onset of perimenopause, said essential fatty acid compound being selected from the group consisting of a linoleic acid compound, a linolenic acid compound, a docosahexaenoic acid compound, an omega-3 fatty acid compound, an omega-2 fatty acid compound, a derivative thereof and a combination thereof;

administering about 400 mg to about 2500 mg of a calcium compound or derivative thereof to the woman during the period commencing at the onset of perimenopause;

administering about 0.4 mg to about 5.0 mg of a folic acid compound or derivative thereof to the woman during the period commencing at the onset of perimenopause; and

wherein the weight ratio of the essential fatty acid compound to the calcium compound or derivative thereof is about 1;

0.4 to 250.

66. The method of claim 65, wherein the method additionally comprises providing a vitamin compound or derivative thereof to said woman together with said first, second and third fatty acid compounds.

67. The method of claim 66, wherein the vitamin compound is selected from the group consisting of a vitamin A compound, a B complex vitamin compound, a vitamin C compound, a vitamin D compound, a vitamin E compound, a derivative thereof and a combination thereof.

68. The method of claim 67, wherein the vitamin C compound is present in said composition in an amount ranging from about 25 mg to about 500 mg.

69. The method of claim 67, wherein the vitamin E compound is present in said composition in an amount ranging from about 10 mg to about 400 mg.

70. The method of claim 65, wherein the method further comprises providing a mineral compound or derivative thereof to said woman together with said first, second and third fatty acid compounds.

71. The method of claim 70, wherein the mineral compound is selected from the group consisting of copper, zinc, selenium, magnesium, molybdenum, bioflavonoid, manganese, chromium, iodine, iron and combinations thereof.

72. The method of claim 65, wherein the method further comprises providing to said woman a non-nutritional active.

73. The method of claim 72, wherein the non-nutritional active is selected from the group consisting of hormones, steroids, fiber, estrogens, progestins, sedative-hypnotics, barbiturates, benzodiazepines, antidepressants, tranquilizers, sedatives, aminobisphosphonates, herbals, herbal derivatives, phyto-chemical derivatives, osteoporotics, antiplatelets and combinations thereof.

74. The method of claim 73, wherein the non-nutritional active is selected from the group consisting of medroxyprogesterone acetate, megestrol acetate, clonidine, norethindrone acetate, ethinyl estradiol, conjugated estrogen, natural estrogen, synthetic estrogen, estradiol, progesterone, clomiphene, clomiphene citrate, zuclomiphene, zuclomiphene citrate, enclomiphene, enclomiphene citrate, aspirin, calcitonin, alendronate, etidronate, pamidronate, clodronate, tiludronate, residronate, ibandronate and combinations thereof.

75. The method of claim 65, wherein the method is specifically adapted to meet the nutritional needs of menopausal women.

76. The method of claim 65, wherein the method is specifically adapted for treating conditions associated with menopause.

77. The method of claim 65, wherein the method is adapted to maximize neurological maintenance of said woman.

78. The method of claim 65, wherein each of the first, second and third fatty acids are provided in an oral dosage form.

79. The method of claim 65, wherein said oral dosage form is selected from the group consisting of immediate release, extended release, pulsed release, delayed release, controlled release and combinations thereof.

80. The method of claim 65, wherein said oral dosage form is selected from the group consisting of a chewable tablet, quick dissolve tablet, an effervescent tablet, a hard gelatin capsule, a soft gelatin capsule, reconstitutable particles, microparticles, a suspension, an elixir, a caplet, a fortified food, pudding, yogurt, gelatin, cereal and combinations thereof.

81. The method of claim 65, wherein each of the first, second and third fatty acids are administered once during a twenty four hour period of time.

82. The method of claim 65, wherein each of the first, second and third fatty acids are administered at least twice during a twenty four hour period of time.

83. The method of claim 65, wherein each of the first, second and third fatty acids are administered in uneven doses during the twenty four hour period of time.

84. The method of claim 65, wherein the calcium compound or derivative thereof is administered once during a twenty four hour period of time.

85. The method of claim 65, wherein the calcium compound or derivative thereof is administered at least twice during a twenty four hour period of time.

86. The method of claim 65, wherein the calcium compound or derivative thereof is administered in uneven doses during the twenty four hour period of time.

87. The method of claim 65, wherein said method inhibits loss in bone mass.

88. The method of claim 65, wherein said method prevents deficiency of essential fatty acids in the menopausal woman.

89. The method of claim 65, wherein said method further comprises providing indicia indicating a time period for administration of said first, second and third fatty acid compounds.

90. The method of claim 65, wherein the method further comprises a therapeutic therapy or therapeutic regimen.

91. The method of claim 65, wherein the therapeutic therapy or therapeutic regimen is for treating symptoms associated with menopause.

92. The method of claim 65, further comprising administering a non-nutritional active to the menopausal woman using a mode of administration selected from the group consisting of oral, injectible, transdermal, inhalable, buccal, vaginal, urinary and anal.

93. The method of claim 65, wherein said non-nutritional active is provided in a blister pack.

94. A method for providing nutritional supplementation to a menopausal woman while reducing symptoms associated with menopause, which comprises:

administering a fatty acid compound to the woman during a period commencing at the onset of menopause, said fatty acid compound being selected from the group consisting of a linoleic acid compound, a linolenic acid compound, a docosahexaenoic acid compound, an omega-3 fatty acid, an omega-2 fatty acid, a derivative thereof and a combination thereof;

administering about 400 mg to 2500 mg of a calcium compound or derivative thereof to said woman; and

administering a non-nutritional active to said woman.

95. The method of claim 94, which further comprises folic acid.

96. A method for providing nutritional supplementation to a menopausal woman while reducing symptoms associated with menopause, which comprises:

administering a first fatty acid compound to the woman during a period commencing at the onset of menopause, said first fatty acid compound being selected from the group consisting of a linoleic acid compound, a derivative thereof and a combination thereof;

administering a second fatty acid compound to said woman during the period commencing at the onset of menopause, said second fatty acid compound being selected from the group consisting of a linolenic acid compound, a derivative thereof and a combination thereof;

administering a third fatty acid compound to said woman during the period commencing at the onset of menopause, said third fatty acid compound being selected from the group consisting of a docosahexaenoic acid compound, an omega-3 fatty acid, an omega-2 fatty acid, a derivative thereof and a combination thereof, and said third fatty acid compound being provided to the woman together with said first and second fatty acid compounds;

administering about 400 mg to 2500 mg of a calcium compound or derivative thereof to said woman;

administering a non-nutritional active to said woman;

wherein the weight ratio of the sum of the amounts of said first and second fatty acid compounds to the amount of said third fatty acid compound is about 1;

0.5 to 1.5; and

wherein the weight ratio of the sum of said first, second and third fatty acid compound to the amount of said calcium compound or derivative thereof is about 1;

0.4 to 50.

97. The method of claim 96, wherein the non-nutritional active is selected from the group consisting of hormones, steroids, fiber, estrogens, progestins, sedative-hypnotics, barbiturates, benzodiazepines, antidepressants, tranquilizers, sedatives, antirheumatics, herbals, herbal derivatives, aminobisphosphonates, phyto-chemical derivatives, osteoporotics, antiplatelets and combinations thereof.

98. The method of claim 96, wherein the non-nutritional active is selected from the group consisting of medroxyprogesterone acetate, megestrol acetate, clonidine, norethindrone acetate, ethinyl estradiol, conjugated estrogen, natural estrogen, synthetic estrogen, estradiol, progesterone, clomiphene, clomiphene citrate, zuclomiphene, zuclomiphene citrate, enclomiphene, enclomiphene citrate, aspirin, calcitonin, alendronate, etidronate, pamidronate, clodronate, tiludronate, residronate, ibandronate and combinations thereof.

99. A method for delaying the onset of menopause, which comprises:

administering an essential fatty acid to a woman prior to menopause, said fatty acid being selected from the group consisting of a linoleic acid compound, a linolenic acid compound, a docosahexaenoic acid compound, an omega-3 fatty acid compound, an omega-2 fatty acid compound, a derivative thereof and a combination thereof;

wherein said essential fatty acid is administered in an amount sufficient to delay the onset of menopause.

100. A method for reducing the possibility of premature menopause, which comprises:

administering an essential fatty acid to a woman prior to menopause, said fatty acid being selected from the group consisting of a linoleic acid compound, a linolenic acid compound, a docosahexaenoic acid compound, an omega-3 fatty acid compound, an omega-2 fatty acid compound, a derivative thereof and a combination thereof;

wherein said essential fatty acid is administered in an amount sufficient to reduce the risk of premature menopause.

101. A method for providing nutritional supplementation to a premenopausal woman or a menopausal woman, which comprises:

administering to the premenopausal woman or menopausal woman a biologically active substance for treating symptoms of menopause;

administering to the premenopausal woman or menopausal woman a calcium compound or derivative thereof in an amount of 400 mg to about 2500; and

administering to the premenopausal woman or menopausal woman a folic acid compound or derivative thereof in an amount of about 0.4 mg to about 5.0 mg.