Folic acid supplement

• US 6,261,600 B1
• Filed: 04/30/1999
• Issued: 07/17/2001
• Est. Priority Date: 04/30/1999
• 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
• Primary Examiner(s): Webman, Edward J.
• Application Number:
  US09/303,000
• Time in Patent Office: 809 Days
• Field of Search: 424/464, 424/439, 424/440-41, 424/466, 424/489, 446/5, 514/249
• US Class Current: 424/466
• CPC Class Codes: A23K 20/174 Vitamins
• CPC Class Codes: A23L 33/15 Vitamins
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A23V 2250/1564 Aluminium
• CPC Class Codes: A23V 2250/1578 Calcium
• CPC Class Codes: A23V 2250/628 Saccharose, sucrose
• CPC Class Codes: A23V 2250/7056 Vitamin B8 Folic acid
• 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
• CPC Class Codes: A61K 9/2009 Inorganic compounds
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives

Abstract

The present invention is directed to novel chewable or dissolvable nutritional supplements for improving the absorption of folic acid in humans and other animals and methods of using said supplements. The nutritional supplements contain folic acid and non-toxic acid neutralizing alkaline compounds in chewable or dissolvable forms.

Claims

1. A nutritional supplement for optimizing absorption of folic acid in an animal, which consists essentially of:

a stable chewable, dissolvable form comprising a non-toxic acid neutralizing alkaline compound combined with a folic acid compound or derivative thereof;

wherein the non-toxic acid neutralizing alkaline compound has a total daily dosage of at least 2 meq of acid neutralizing capacity, and the folic acid compound or derivative thereof has a total daily dosage of at least 450 mcg.

2. The nutritional supplement of claim 1, wherein said non-toxic acid neutralizing alkaline compound surrounds said folic acid compound or derivative thereof.

3. The nutritional supplement of claim 1, wherein said 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.

4. The nutritional supplement of claim 1, wherein said non-toxic acid neutralizing alkaline 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 and mixtures thereof.

5. The nutritional supplement of claim 1, wherein said chewable or dissolvable form is selected from the group consisting of a chewable tablet, a quick dissolve tablet, an effervescent tablet, a particulate matrix, a microparticulate matrix and mixtures thereof.

6. The nutritional supplement of claim 1, wherein said folic acid compound or derivative thereof is microencapsulated.

7. The nutritional supplement of claim 1, wherein said nutritional supplement is formulated for an administration of at least once a day.

8. The nutritional supplement of claim 1, wherein said nutritional supplement is formulated for an administration of at least twice a day.

9. A nutritional supplement for optimizing absorption of a folic acid compound or derivative thereof in an animal, which consists essentially of:

a stable chewable, dissolvable form comprising a non-toxic acid neutralizing alkaline compound surrounding a folic acid compound or derivative thereof;

wherein the non-toxic acid neutralizing alkaline compound has a total daily dosage of at least 2 meq of acid neutralizing capacity, and the folic acid compound or derivative thereof has a total daily dosage of at least 450 mcg.

10. The nutritional supplement of claim 9, wherein said 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.

11. The nutritional supplement of claim 9, wherein said non-toxic acid neutralizing alkaline 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 and mixtures thereof.

12. The nutritional supplement of claim 9, wherein said chewable or dissolvable form is selected from the group consisting of a chewable tablet, a quick dissolve tablet, an effervescent tablet, a particulate matrix, a microparticulate matrix and mixtures thereof.

13. The nutritional supplement of claim 9, wherein said folic acid compound or derivative thereof is microencapsulated.

14. The nutritional supplement of claim 9, wherein said nutritional supplement is formulated for an administration of at least once a day.

15. The nutritional supplement of claim 9, wherein said nutritional supplement is formulated for an administration of at least twice a day.

16. A prenatal nutritional supplement for optimizing absorption of folic acid in a pregnant woman, which consists essentially of:

a stable chewable, dissolvable form comprising a non-toxic acid neutralizing alkaline compound surrounding a folic acid compound or derivative thereof;

wherein the non-toxic acid neutralizing alkaline compound has a total daily dosage of at least 2 meq of acid neutralizing capacity, and the folic acid compound or derivative thereof has a total daily dosage of at least 500 mcg.

17. A method for optimizing absorption of folic acid in a pregnant woman, which comprises ingesting:

stable chewable, dissolvable dosage form comprising a non-toxic acid neutralizing alkaline compound surrounding a folic acid compound or derivative thereof;

wherein the non-toxic acid neutralizing alkaline compound is present in said dosage form in a total daily dosage of at least 2 meq of acid neutralizing capacity, and the folic acid compound or derivative thereof is present in said dosage form in a total daily dosage of at least 450 mcg.

18. The method of claim 17, wherein said 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.

19. The method of claim 17, wherein said non-toxic acid neutralizing alkaline 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 and mixtures thereof.

20. The method of claim 17, wherein said chewable, dissolvable dosage form is selected from the group consisting of a chewable tablet, a quick dissolve tablet, an effervescent tablet, a particulate matrix, a microparticulate matrix and mixtures thereof.

21. The method of claim 17, wherein said folic acid compound or derivative thereof is microencapsulated.

22. The method of claim 17, wherein said dosage form is administered at least once a day.

23. The method of claim 17, wherein said dosage form is administered at least twice a day.

24. A prenatal chewable nutritional supplement for optimizing absorption of folic acid in a pregnant woman, which consists essentially of:

a stable chewable form comprising a non-toxic acid neutralizing alkaline compound 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 surrounding a folic acid compound or derivative thereof;

wherein the non-toxic acid neutralizing alkaline compound has a total daily dosage of at least 2 meq of acid neutralizing capacity, and the folic acid compound or derivative thereof has a total daily dosage of at least 500 mcg.

25. A method for optimizing absorption of folic acid in an animal, which comprises ingesting:

stable chewable dosage form comprising a non-toxic acid neutralizing alkaline compound 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 surrounding a folic acid compound or derivative thereof;

wherein the non-toxic acid neutralizing alkaline compound is present in said dosage form in a total daily dosage of at least 2 meq of acid neutralizing capacity, and the folic acid compound or derivative thereof is present in said dosage form in a total daily dosage of at least 450 mcg.

26. The method of claim 25, wherein said animal is a mammal.

27. The method of claim 25, wherein said animal is a pregnant female.

28. The method of claim 25, wherein said animal is a non-pregnant female.

29. The method of claim 25, wherein said animal is a male animal.

30. A method for optimizing absorption of folic acid in a pregnant woman, which comprises:

stable chewable dosage form comprising a non-toxic acid neutralizing alkaline compound 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 surrounding a folic acid compound or derivative thereof;

wherein the non-toxic acid neutralizing alkaline compound is present in said dosage form in a total daily dosage of at least 2 meq of acid neutralizing capacity, and the folic acid compound or derivative thereof is present in said dosage form in a total daily dosage of at least 500 mcg.

31. A method of optimizing the absorption of folic acid administered to an animal in a nutritional supplement, which comprises:

administering at least once during a day to the animal a stable chewable, dissolvable form comprising a folic acid compound or derivative thereof in combination with a non-toxic acid neutralizing alkaline compound;

wherein the total dosage of said folic acid compound or derivative thereof administered during the day is at least 450 mcg, and the total dosage of said non-toxic acid neutralizing alkaline compound administered during the day has at least 2 meq of acid neutralizing capacity.

32. The method of claim 31, wherein said animal is a mammal.

33. The method of claim 31, wherein said animal is of a female gender.

34. The method of claim 31, wherein said animal is a pregnant female.

35. The method of claim 31, wherein said animal is a non-pregnant female.

36. The method of claim 31, wherein said animal is of a male gender.

37. The method of claim 31, wherein said 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.

38. The method of claim 31, wherein said non-toxic acid neutralizing alkaline 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 and mixtures thereof.

39. The method of claim 31, wherein said chewable or dissolvable form is selected from the group consisting of a chewable tablet, a quick dissolve tablet, an effervescent tablet, a particulate matrix, a microparticulate matrix and mixtures thereof.

40. The method of claim 31, wherein said folic acid compound or derivative thereof is microencapsulated.

41. The method of claim 31, wherein said nutritional supplement is administered at least once a day.

42. The method of claim 31, wherein said nutritional supplement is administered at least twice a day.

43. A method of optimizing the absorption of folic acid administered to a pregnant woman in a nutritional supplement, which comprises:

administering at least once during a day to the pregnant woman a stable chewable, dissolvable form comprising a folic acid compound or derivative thereof in combination with a non-toxic acid neutralizing alkaline compound;

wherein the total dosage of said folic acid compound or derivative thereof administered during the day is at least 500 mcg, and the total dosage of said non-toxic acid neutralizing alkaline compound administered during the day has at least 2 meq of acid neutralizing capacity.

44. A method of preventing or treating folic acid deficiency in a pregnant woman, which comprises:

administering at least once during a day to the pregnant woman a stable chewable, dissolvable form comprising a folic acid compound or derivative thereof in combination with a non-toxic acid neutralizing alkaline compound;

wherein the total dosage of said folic acid compound or derivative thereof administered during the day is at least 500 mcg, and the total dosage of said non-toxic acid neutralizing alkaline compound administered during the day has at least 2 meq of acid neutralizing capacity.

45. A method of optimizing the absorption of folic acid administered to an animal in a nutritional supplement, which comprises:

administering at least once during a day to the mammal a stable chewable form comprising a folic acid compound or derivative thereof in combination with a non-toxic acid neutralizing alkaline compound 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;

wherein the total dosage of said folic acid compound or derivative thereof administered during the day is at least 450 mcg, and the total dosage of said non-toxic acid neutralizing alkaline compound administered during the day has at least 2 meq of acid neutralizing capacity.

46. A method of optimizing the absorption of folic acid administered to a pregnant woman in a nutritional supplement, which comprises:

administering at least once during a day to the pregnant woman a stable chewable form comprising a folic acid compound or derivative thereof in combination with a non-toxic acid neutralizing alkaline compound 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;

wherein the total dosage of said folic acid compound or derivative thereof administered during the day is greater than 500 mcg, and the total dosage of said non-toxic acid neutralizing alkaline compound administered during the day has at least 2 meq of acid neutralizing capacity.

47. A method of preventing or treating folic acid deficiency in a pregnant woman, which comprises:

administering at least once during a day to the pregnant woman a stable chewable form comprising a folic acid compound or derivative thereof in combination with a non-toxic acid neutralizing alkaline compound 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;

wherein the total dosage of said folic acid compound or derivative thereof administered during the day is at least 500 mcg, and the total dosage of said non-toxic acid neutralizing alkaline compound administered during the day has at least 2 meq of acid neutralizing capacity.

48. A method of preventing or treating a condition where treatment with folic acid is indicated in an animal, which comprises:

administering at least once during a day to the animal a stable chewable, dissolvable from comprising a folic acid compound or derivative thereof in combination with a non-toxic acid neutralizing alkaline compound;

wherein the total dosage of said folic acid compound or derivative thereof administered during the day is at least 450 mcg, and the total dosage of said non-toxic acid neutralizing alkaline compound administered during the day has at least 2 meq of acid neutralizing capacity.