Nutritional supplements

• US 20020032234A1
• Filed: 06/21/2001
• Published: 03/14/2002
• Est. Priority Date: 06/01/1999
• Status: Active Grant

• Current Assignee: Amag Pharma Usa Inc. (Apollo Global Management, Inc.)
• Original Assignee: DrugTech Corporation (PD International Holdings LLC)
• Inventors: Levinson, R. Saul, Hermelin, Marc S., Paradissis, George
• Granted Patent: US 6,576,666 B2
• Time in Patent Office: Days
• US Class Current: 514/560
• CPC Class Codes: A23L 33/10 using additives addition of substantially indigestible substances A23L33/21
• CPC Class Codes: A23L 33/12 Fatty acids or derivatives thereof
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A23V 2250/156 Mineral combination undefined extract A23V2250/1638
• CPC Class Codes: A23V 2250/1592 Iron
• CPC Class Codes: A23V 2250/1872 Linoleic acid
• CPC Class Codes: A23V 2250/1874 Linolenic acid
• CPC Class Codes: A23V 2250/1882 Polyunsaturated fatty acids
• CPC Class Codes: A23V 2250/51084 Crystalline, microcrystalline cellulose
• CPC Class Codes: A23V 2250/51088 Other cellulose derivatives
• CPC Class Codes: A23V 2250/5118 Starch
• CPC Class Codes: A23V 2250/612 Lactose
• CPC Class Codes: A23V 2250/70 Vitamins
• CPC Class Codes: A61P 15/14 for lactation disorders, e.g. galactorrhoea
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 3/02 Nutrients, e.g. vitamins, minerals
• CPC Class Codes: A61P 3/14 for calcium homeostasis vitamin D A61P3/02; parathyroid hormones A61P5/18; calcitonin A61P5/22; osteoporosis A61P19/10; bone metastasis A61P35/04
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The present disclosure relates to novel nutritional compositions containing linoleic acid and/or linolenic acid which optimize child neurological development and provide improved nutritional support for women prior to and during lactation. The nutritional compositions are intended for use by women to optimize infant neurological development and provide improved nutritional support for women prior to, during and after lactation.

Claims

1. A composition for administration to a woman for enriching the breast milk of said woman to optimize neurological development of an infant breast-fed by the woman, which comprises:

about 10 mg to 1000 mg of a first fatty acid compound for each compound selected from the group consisting of a linoleic acid compound, a linolenic acid compound, a derivative thereof and a combination thereof;

about 10 mg to 1000 mg of a second 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; and

wherein the weight ratio of said first fatty acid compound to said second fatty acid compound is about 1;

0.01 to 10.

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

3. The composition of claim 2, 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 and combinations thereof.

4. The composition of claim 3, wherein said vitamin C compound is present in said composition in an amount ranging from about 25 mg to 500 mg.

5. The composition of claim 3, wherein said vitamin E compound is present in said composition in an amount ranging from about 10 mg to 400 mg.

6. The composition of claim 1, wherein said composition additionally contains a biologically-acceptable mineral compound or derivative thereof.

7. The composition of claim 1, wherein said biologically-acceptable mineral compound is selected from the group consisting of calcium, magnesium, iron and combinations thereof.

8. The composition of claim 7, wherein the calcium is present in said composition in an amount of about 300 mg to 2500 mg.

9. The composition of claim 1, wherein said composition additionally contains a biologically active substance.

10. The composition of claim 9, wherein the biologically active substance is a lactogen compound or derivative thereof.

11. The composition of claim 1, wherein said composition is administered during a period commencing no later than the tenth week of pregnancy.

12. The composition of claim 1, wherein said composition is administered during a period of time commencing at least at about the tenth week of pregnancy.

13. The composition of claim 1, wherein said composition is adapted to meet specific physiological needs of a breast-feeding mother.

14. The composition of claim 1, wherein said composition is in an oral dosage form.

15. The composition of claim 14, 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.

16. The composition of claim 14, 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, yogurts, gelatin, cereal and combinations thereof.

17. The composition of claim 1, wherein said composition is administered once during a twenty four hour period of time.

18. The composition of claim 1, wherein said composition is administered at least twice during a twenty four hour period of time.

19. The composition of claim 1, wherein said composition increases lactogenesis.

20. The composition of claim 1, wherein said composition increases the quantity of breast milk produced during lactation.

21. The composition of claim 1, wherein said composition prevents deficiency of essential fatty acids in the woman.

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

23. The composition of claim 22, wherein said time period of use is prior to, during and after lactation.

24. The composition of claim 22, wherein said time period commences at about the tenth week of pregnancy.

25. The composition of claim 1, wherein said composition extends the duration of the period of lactation.

26. The composition of claim 1, wherein said composition improves quality of said breast milk.

27. The composition of claim 1, wherein said composition achieves enrichment of said breast milk through a natural biological pathway.

28. A composition for administration to a woman for enriching the breast milk of said woman to optimize neurological development of an infant breast-fed by the woman, which comprises:

a) about 10 mg to 100 mg of a first fatty acid compound selected from the group consisting of a fatty acid compound, a derivative thereof and a combination thereof;

b) about 10 mg to 1000 mg of a second fatty acid compound for each 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;

c) about 20 mg to 125 mg of a vitamin B₆ compound or derivative thereof;

d) about 0.1 mg to 3 mg of a folic acid compound or derivative thereof;

e) about 100 mg to 2,000 mg of a calcium compound or derivative thereof; and

wherein the weight ratio of said first fatty acid compound to said second fatty acid compound is about 1;

0.1 to 10.

29. A composition for administration to a woman for enriching the breast milk of said woman to optimize neurological development of an infant breast-fed by the woman, which comprises:

a) about 10 mg to 100 mg of a first fatty acid compound for each compound selected from the group consisting of a linoleic acid compound, a linolenic acid compound, a derivative thereof and a combination thereof;

b) about 10 mg to 100 mg of a second 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;

c) about 20 mg to 125 mg of a vitamin B₆ compound or derivative thereof;

d) about 0.1 mg to 3 mg of a folic acid compound or derivative thereof;

e) about 100 mg to 2,000 mg of a calcium compound or derivative thereof;

f) about 25 mg to 400 mg of a magnesium compound or derivative thereof;

g) about 25 mg to 500 mg of a vitamin C compound or derivative thereof;

h) about 10 mg to 400 mg of a vitamin E compound or derivative thereof; and

wherein the weight ratio of said first fatty acid compound to said second fatty acid compound is about 1;

0.1 to 10.

30. A composition for administration to a female mammal for enriching the milk of said female mammal to optimize neurological development of a neonate being nursed by the female mammal, which comprises:

about 10 mg to 1000 mg per 55 kg of said mammal'"'"'s body weight of a first fatty acid compound for each compound selected from the group consisting of a linoleic acid compound, a linolenic acid compound, a derivative thereof and a combination thereof;

about 10 mg to 1000 mg per 55 kg of said mammal'"'"'s body weight of a second 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; and

wherein the weight ratio of said first fatty acid compound to said second fatty acid compound is about 1;

0.01 to 10.

31. A composition for administration to a woman for enriching the breast milk of said woman to optimize neurological development of an infant breast-fed by the woman, which comprises:

about 10 mg to 1000 mg of a first fatty acid compound for each compound selected from the group consisting of a linoleic acid compound, a derivative thereof and a combination thereof;

about 10 mg to 1000 mg of a second 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; and

wherein the weight ratio of said first fatty acid compound to said second fatty acid compound is about 1;

0.01 to 10.

32. A method for enriching the breast milk of a woman to optimize neurological development of an infant breast-fed by said woman, which comprises:

administering a first fatty acid compound to the woman during a period commencing at least at about the tenth week of pregnancy and terminating at the conclusion of breast-feeding, said first fatty acid compound being selected from the group consisting of a linoleic acid compound, a linolenic acid compound, a derivative thereof and a combination thereof;

administering a second fatty acid compound to said woman during the period commencing at least at about the tenth week of pregnancy and terminating at the conclusion of breast-feeding, said second 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 second fatty acid compound being provided to the woman together with said first fatty acid compound;

and wherein the weight ratio of said first fatty acid compound to said second fatty acid compound is about 1;

0.1 to 10.

33. The method of claim 32, wherein said method additionally comprises providing a vitamin compound or derivative thereof to said woman together with said first and second fatty acid compounds.

34. The method of claim 33, 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 and combinations thereof.

35. The method of claim 34, wherein said vitamin C compound is present in said composition in an amount ranging from about 25 mg to 400 mg.

36. The method of claim 34, wherein said vitamin E compound is present in said composition in an amount ranging from about 10 mg to 400 mg.

37. The method of claim 32, wherein said method further comprises providing a biologically-acceptable mineral compound or derivative thereof to said woman together with said first and second fatty acid compounds.

38. The method of claim 37, wherein said biologically-acceptable mineral compound is selected from the group consisting of calcium, magnesium, iron and combinations thereof.

39. The method of claim 38, wherein the calcium is present in said composition in an amount of about 300 mg to 2500 mg.

40. The method of claim 32, wherein said method further comprises providing to said woman a biologically active substance together with said first and second fatty acid compounds.

41. The method of claim 40, wherein the biologically active substance is a lactogen compound or derivative thereof.

42. The method of claim 32, wherein said method is adapted to meet specific physiological needs of a breast-feeding mother.

43. The method of claim 32, wherein said first and second fatty acids are provided in an oral dosage form.

44. The method of claim 43, 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.

45. The method of claim 43, 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.

46. The method of claim 32, wherein said first and second fatty acids are administered once during a twenty four hour period of time.

47. The method of claim 32, wherein said first and second fatty acids are administered at least twice during a twenty four hour period of time.

48. The method of claim 32, wherein said method increases lactogenesis.

49. The method of claim 32, wherein said method increases the quantity of breast milk produced during lactation.

50. The method of claim 32, wherein said methods prevents deficiency of essential fatty acids in the woman.

51. The method of claim 32, wherein said method further comprises providing indicia indicating a time period for administration of said first and second a combination thereof and provided in an amount of about 10 mg to 100 mg, and said second fatty acid compound being administered together with said first fatty acid compound;

and

wherein the weight ratio of said first fatty acid compound to said second fatty acid compound is about 1;

0.1 to 10.

54. A method for enriching the breast milk of a woman to optimize neurological development of an infant breast-fed by said woman, which comprises:

administering a first fatty acid compound to the woman during a period commencing at least at about the tenth week of pregnancy, said first fatty acid compound being selected from the group consisting of a linoleic acid compound, a linolenic acid compound, a derivative thereof and a combination thereof and provided in an amount of about 10 mg to 100 mg;

administering a second fatty acid compound to said woman during the period commencing at least at about the tenth week of pregnancy, said second 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 provided in about 10 mg to 100 mg, said second fatty acid compound being administered together with said first fatty acid compound;

administering a nutritional compound to said woman during the period commencing at least at about the tenth week of pregnancy, said nutritional compound being selected from the group consisting of a vitamin compound, a biologically-acceptable mineral compound, a derivative thereof and a combination thereof, and said nutritional compound being administered together with said first and said second fatty acid compounds;

wherein the weight ratio of said first fatty acid compound to said second fatty acid compound is about 1;

0.1 to 10.

55. A method for enriching the milk of a female mammal to optimize neurological development of a neonate being nursed by the female mammal, which comprises:

administering a first fatty acid compound to the female mammal during a period commencing at least at about the tenth week of gestation, said first fatty acid compound being selected from the group consisting of a linoleic acid compound, a linolenic acid compound, a derivative thereof and a combination thereof;

administering a second fatly acid compound to said female mammal during the period commencing at least at about the tenth week of gestation, said second 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 second fatty acid compound being provided to the female mammal together with said first fatty acid compound;

and wherein the weight ratio of said first fatty acid compound to said second fatty acid compound is about 1;

0.1 to 10.