Nutritional composition

• US 6,352,713 B1
• Filed: 12/01/1999
• Issued: 03/05/2002
• Est. Priority Date: 12/01/1999
• Status: Expired due to Term

• 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, Paradissis, George N.
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): TRAN, SUSAN T
• Application Number:
  US09/451,849
• Time in Patent Office: 825 Days
• Field of Search: 424/441, 424/439, 424/440, 426/73, 426/3, 426/321
• US Class Current: 424/441
• 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 2250/156 Mineral combination undefined extract A23V2250/1638
• CPC Class Codes: A23V 2250/1578 Calcium
• CPC Class Codes: A23V 2250/1586 Chromium
• CPC Class Codes: A23V 2250/1588 Copper
• CPC Class Codes: A23V 2250/1592 Iron
• CPC Class Codes: A23V 2250/16 Potassium
• CPC Class Codes: A23V 2250/1608 Molybdenum
• CPC Class Codes: A23V 2250/161 Magnesium
• CPC Class Codes: A23V 2250/1642 Zinc
• CPC Class Codes: A23V 2250/211 Carotene, carotenoids
• CPC Class Codes: A23V 2250/70 Vitamins
• CPC Class Codes: A23V 2250/702 Vitamin A
• CPC Class Codes: A23V 2250/704 Vitamin B
• CPC Class Codes: A23V 2250/705 Vitamin B5 pantothenic acid
• CPC Class Codes: A23V 2250/7052 Vitamin B6
• CPC Class Codes: A23V 2250/708 Vitamin C
• CPC Class Codes: A23V 2250/71 Vitamin D
• CPC Class Codes: A23V 2250/7106 : Vitamin D3
• CPC Class Codes: A23V 2250/712 : Vitamin E
• 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 33/30 : Zinc; Compounds thereof
• CPC Class Codes: A61K 9/0056 : Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals

Abstract

The present inventive subject matter is directed to novel chewable prenatal nutritional supplements which contain vitamin C, as well as novel methods for providing optimal vitamin C supplementation to pregnant women. The present invention is also directed to novel compositions and methods for providing nutritional supplementation to individuals planning to conceive a child.

Claims

1. A substantially non-acidic chewable prenatal nutritional tablet composition, which comprises:

a vitamin C derivative;

a folic acid compound present in an amount ranging from about 0.1 mg to about 5.0 mg;

a flavor, a sweetener, or combinations thereof;

wherein the vitamin C derivative and the folic acid compound are contained together within a stable chewable dosage form having a pH ranging from about 5.5 to about 9.5; and

wherein said sweetener is glycyrrizin and pharmaceutical salts thereof.

2. A substantially non-acidic chewable prenatal nutritional tablet composition, which comprises:

a vitamin C derivative;

a folic acid compound present in an amount ranging from about 0.1 mg to about 5.0 mg;

an anti-nausea agent; and

wherein the vitamin C derivative and the folic acid compound are contained together within a stable chewable dosage form having a pH ranging from about 5.5 to about 9.5.

3. A method of administering vitamin C to a pregnant woman without causing irritation to the esophagus or pharynx or gastrointestinal upset, which comprises:

administering to a pregnant woman a vitamin C derivative in an amount ranging from about 10 mg to about 1,000 mg;

said vitamin C derivative being contained in a stable chewable tablet dosage form having a pH ranging from about 5.5 to about 9.5;

wherein the vitamin C derivative provides vitamin C without causing gastrointestinal upset.

4. The method of claim 3, further comprising administering a folic acid compound simultaneously with said vitamin C derivative.

5. The method of claim 4, wherein said folic acid is administered in an amount ranging from about 0.1 mg to about 5.0 mg.

6. The method of claim 4, wherein said folic acid is contained together with the vitamin C derivative in said stable chewable tablet dosage form.

7. The method of claim 3, wherein the vitamin C derivative is a mineral ascorbate or a multi-mineral ascorbate.

8. The method of claim 3, wherein the vitamin C derivative is selected from the group consisting of calcium ascorbate, magnesium ascorbate, zinc ascorbate, potassium ascorbate, sodium ascorbate and combinations thereof.

9. The method of claim 3, wherein the vitamin C derivative is administered to the pregnant woman in an amount ranging from about 10 mg to about 1000 mg.

10. The method of claim 3, wherein the vitamin C derivative has a pH ranging from about 6.5 to about 9.0.

11. The method of claim 3, wherein the vitamin C derivative has a pH ranging from about 7.0 to about 8.5.

12. The method of claim 3, wherein the vitamin C derivative is pH neutral.

13. The method of claim 3, wherein the stable chewable tablet dosage form is selected from the group consisting of a chewable tablet, a chewable lozenge, a quick chew, a quick dissolve and combinations thereof.

14. The method of claim 3, further comprising administering a mineral compound to the pregnant woman.

15. The method of claim 3, wherein said mineral compound is selected from the group consisting of calcium carbonate, calcium citrate, calcium hydroxide, aluminum hydroxide, oyster shell calcium and combinations thereof.

16. The method of claim 3, wherein the calcium carbonate is administered to the pregnant woman in an amount ranging from about 20 mg to about 2,000 mg.

17. The method of claim 3, further comprising administering a mineral selected from the group consisting of calcium, magnesium, zinc, copper or combinations thereof to the pregnant woman.

18. The method of claim 3, further comprising administering a pharmaceutically acceptable iron compound to the pregnant woman.

19. The method of claim 18, wherein said pharmaceutically acceptable iron compound is selected from the group consisting of of ferrous fumarate, ferrous sulfate, ferric chloride, ferrous gluconate, ferrous lactate, ferrous tartrate, iron-sugar-carboxylate complexes, ferrous succinate, ferrous glutamate, ferrous citrate, ferrous pyrophosphate, ferrous cholinisocitrate, ferrous carbonate, carbonyl iron and mixtures thereof.

20. The method of claim 18, wherein the pharmaceutically acceptable iron compound is administered in an amount ranging from about 10 mg to 200 mg.

21. The method of claim 3, further comprising administering one or more B vitamins to the pregnant woman.

22. The method of claim 21, wherein the B vitamin is pyridoxine and is administered in an amount ranging from about 0.1 mg to about 50 mg.

23. The method of claim 3, further comprising administering vitamin D in amount ranging from about 100 IU to about 600 IU to the pregnant woman.

24. The method of claim 3, further comprising administering vitamin E in an amount ranging from about 1 IU to about 50 IU to the pregnant woman.

25. The method of claim 3, further comprising administering an aldono-lactone compound to the pregnant woman.

26. The method of claim 3, further comprising administering an edible salt of an aldonic acid to the pregnant woman.

27. The method of claim 26, wherein said aldonic acid is selected from the group consisting of L-threonic acid, L-xylonic acid, L-lyxonic acid and combinations thereof.

28. The method of claim 3, wherein the stable chewable tablet dosage form is a prenatal dietary supplement.

29. The method of claim 3, further comprising administering a pH buffering agent.

30. The method of claim 3, wherein the solubility of folic acid administered simultaneously with the vitamin C derivative is increased in the body of the pregnant woman.

31. The method of claim 3, further comprising administration of a dietary supplement to the pregnant woman.

32. The method of claim 3, further comprising a therapeutic or nutritional regimen for the pregnant woman.

33. The method of claim 3, where in said vitamin C derivative is provided in a blister pack.

34. The method of claim 3, wherein said vitamin C derivative is dosed for nighttime administration.

35. The method of claim 3, wherein the pregnant woman has low ascorbic acid tolerance.

36. The method of claim 3, wherein the pregnant woman has a tendency to form kidney stones.

38. The method of claim 3, wherein the pregnant woman has high blood pressure or cardiovascular disease.

39. The method of claim 3, wherein pregnancy presents a high risk for the pregnant woman.

40. The method of claim 3, wherein the pregnant woman is immuno-compromised.

41. The method of claim 3, wherein said method provides vitamin C without causing diarrhea or gastric inflammation.

42. The method of claim 3, wherein normal or above-normal levels of vitamin C are established and maintained in the body of the pregnant woman.

43. The method of claim 3, wherein said method increases the pregnant woman'"'"'s tolerance to vitamin C.

37. The method of claim wherein the pregnant woman has enhanced vitamin C requirements.

44. A method of administering vitamin C to a pregnant woman without causing gastrointestinal upset or tooth enamel erosion, which comprises:

administering to the pregnant woman an amount of ascorbic acid ranging from about 25 mg to about 2,000 mg;

a non-toxic acid neutralizing alkaline compound in an amount sufficient to neutralize the acidity of the ascorbic acid; and

a folic acid compound in an amount ranging from about 0.1 mg to about 5.0 mg; and

wherein the ascorbic acid, the non-toxic acid neutralizing alkaline compound and the folic acid compound are each contained in a stable chewable tablet dosage form having a pH ranging from about 5.5 to about 9.5.

45. The method of claim 44, wherein the non-toxic acid neutralizing alkaline compound has a total daily dosage of at least the amount required to substantially neutralize the ascorbic acid present in the stable chewable dosage form.

46. The method of claim 44, wherein the non-toxic acid neutralizing alkaline compound is a mineral compound.

47. The method of claim 46, wherein the mineral compound is selected from the group consisting of aluminum carbonate, aluminum hydroxide, aluminum phosphate, aluminum hydroxy carbonate, aluminum citrate, dihydroxyaluminum sodium carbonate, aluminum magnesium glycinate, dihydroxyaluminum aminoacetate, dihydroxyaluminum aminoacetic acid, bismuth aluminate, bismuth carbonate, bismuth subcarbonate, bismuth subgallate, bismuth subnitrate, calcium carbonate, calcium hydroxide, calcium phosphate, calcium citrate, calcium citrate malate, hydrated magnesium aluminate, activated sulfate, magnesium aluminate, magnesium aluminosilicates, magnesium carbonate, magnesium glycinate, magnesium hydroxide, magnesium oxide, magnesium trisilicate, potassium carbonate, potassium phosphate, potassium citrate, sodium carbonate, sodium bicarbonate, sodium phosphate, sodium citrate, oyster shell calcium and mixtures thereof.

48. The method of claim 44, wherein the non-toxic acid neutralizing alkaline compound is selected from the group consisting of calcium-based compounds, antacids, aluminum-based compounds, magnesium-based compounds, sodium-based compounds, potassium-based compounds and mixtures thereof.

49. The method of claim 44, further comprising a vitamin C derivative.

50. The method of claim 44, wherein the stable chewable tablet dosage form is selected from the group consisting of a chewable tablet, a chewable lozenge, a quick chew, a quick dissolve and combinations thereof.

51. A method of administering vitamin C to a pregnant woman without causing tooth enamel erosion, which comprises:

administering to the pregnant woman a vitamin C derivative in an amount ranging from about 10 mg to about 1,000 mg; and

a non-toxic acid neutralizing alkaline compound in an amount sufficient to neutralize the acidity of the vitamin C derivative;

said vitamin C derivative being contained in a stable chewable tablet dosage form having a pH ranging from about 5.5 to about 9.5;

wherein the vitamin C derivative provides vitamin C without causing tooth enamel erosion.