Nutritional supplement and use thereof

• US 20070254040A1
• Filed: 05/01/2006
• Published: 11/01/2007
• Est. Priority Date: 05/01/2006
• Status: Active Grant

• Current Assignee: ZyCal Bioceuticals Healthcare Company, Inc.
• Original Assignee: ZyCal Bioceuticals Healthcare Company, Inc.
• Inventors: Scaffidi, James
• Granted Patent: US 9,011,930 B2
• Time in Patent Office: Days
• US Class Current: 424/550
• 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 31/355 Tocopherols, e.g. vitamin E
• CPC Class Codes: A61K 31/4188 condensed with other heterocyclic ring systems, e.g. biotin, sorbinil
• CPC Class Codes: A61K 31/455 Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
• CPC Class Codes: A61K 35/32 Bones; Osteocytes; Osteoblasts; Tendons; Tenocytes; Teeth; Odontoblasts; Cartilage; Chondrocytes; Synovial membrane
• CPC Class Codes: A61K 38/18 Growth factors; Growth regulators
• CPC Class Codes: A61K 38/1875 Bone morphogenic factor; Osteogenins; Osteogenic factor; Bone-inducing factor
• CPC Class Codes: A61K 47/46 Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
• CPC Class Codes: Y10S 530/84 Bones; tendons; teeth; cartilage

Abstract

Nutritional supplements and methods for maintaining and/or improving the condition of bones or cartilage in a mammal, particularly a human. One such supplement comprises demineralized bone matrix (DBM) wherein the DBM comprises a bone growth improving amount of at least one osteoinductive growth factor. A preferred supplement composition further comprises at least one vitamin, such as vitamin E. One method comprises orally administering to the mammal on a periodic basis a supplement comprising DBM. In a preferred method the DBM composition is periodically administered and there is a further periodic administration of a therapeutically effective amount of a calcium-containing composition; the calcium-containing composition is administered temporally spaced apart from said DBM composition for maximum effectiveness.

Claims

1. A nutritional supplement comprising demineralized bone matrix (DBM).

2. The supplement of claim 1 wherein said DBM comprises bone growth improving amount of osteoinductive growth factor (OGF).

3. The supplement of claim 2 wherein said OGF is at least one member selected from the group consisting of bone morphogenetic proteins (BMP) and transforming growth factors-β

(TGF-β

) superfamily.

4. The supplement of claim 3 comprising at least one BMP wherein said DBM comprises less than about 6 wt % calcium.

5. The supplement of claim 1 comprising a therapeutically effective amount of DBM.

6. The supplement of claim 5 comprising about 50 mg to about 800 mg of DBM.

7. The supplement of claim 5 wherein said BMP is native or recombinant protein.

8. The supplement of claim 5 further comprising at least one vitamin, including salts, isomeric forms and derivatives of said vitamin.

9. The supplement of claim 8 wherein said at least one vitamin is selected from the group consisting of vitamin D;

vitamin E, B vitamins;

vitamin K;

carotene-containing compounds;

riboflavin;

niacin;

biotin;

pantothenic acid; and

combinations thereof.

10. The supplement of claim 3 wherein said DBM comprises collagen type I and at least one chondroblast or osteoblast stimulating growth factor.

11. The supplement of claim 10 wherein said growth factor is selected from the group consisting of TGF-β

2, TGF-β

1, BMP-2, BMP-3, BMP4, BMP-5, BMP-6, BMP-7, BMP-8, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, IGF-I, IGF-II, PDGF AA, PDGF BB, PDGF-AB and basic FGF.

12. The supplement of claim 5 for delivery in one or more doses over a suitable time interval.

13. The supplement of claim 8 comprising about 50 mg to about 800 mg of DBM for delivery in one or more doses over a suitable time interval.

14. The supplement of claim 13 wherein said DBM comprises a bone growth improving amount of at least one osteoinductive growth factor.

15. The supplement of claim 9 wherein said at least one vitamin is vitamin E.

16. The supplement of claim 15 wherein said vitamin E is present at about 5 IU to about 500 IU.

17. The supplement of claim 13 further comprising at least one additional nutritional supplement selected from the group consisting of glucosamine and chondroitin.

18. The supplement of claim 17 wherein said at least one additional supplement is present at about 100 mg to about 1000 mg.

19. The supplement of claim 8 comprising therapeutically effective amounts of said DBM and at least one vitamin wherein said supplement is for administration to a mammal.

20. The supplement of claim 19 wherein said mammal is a human.

21. A method for maintaining or improving the condition of bone or cartilage in a mammal comprising orally administering to said mammal on a periodic basis a composition comprising demineralized bone matrix (DBM).

22. The method of claim 21 wherein said mammal is a human.

23. The method of claim 22 wherein said composition comprises about 50 mg to about 800 mg of DBM.

24. The method of claim 23 wherein said composition further comprises about 5 IU to about 100 IU of vitamin E.

25. The method of claim 21 wherein said composition is periodically administered at a frequency selected from the group consisting of twice per day, once per day, once every two days, once every three days, once every four days, once every five days, once every six days, once per week, twice per week, three times per week, four times per week, twice per month, and once per month.

26. The method of claim 25 further including periodic administration of a therapeutically effective amount of a calcium-containing composition.

27. The method of claim 26 wherein said calcium-containing composition is administered temporally spaced apart from said DBM-containing composition.

28. The method of claim 27 wherein said calcium-containing composition is administered within not less than about 1 hour of the time that said DBM-containing composition is administered.

29. The method of claim 28 wherein administration of said calcium-containing composition is administered about 1 hour to about 4 hours from administration of said DBM-containing composition.

30. The method of claim 28 wherein said calcium-containing composition and said DBM-containing composition are administered on different days.

31. The method of claim 23 wherein said composition further comprises at least one compound selected from the group consisting of glucosamine and chondroitin.

32. The method of claim 31 wherein said composition to be administered comprises a ratio of DBM to glucosamine, DBM to chondroitin, or DBM to a mixture of glucosamine and chondroitin of about 1:

100 to about 100;

1.

33. The method of claim 32 wherein said ratio is about 1:

5 to about 1;

25.

34. A method for improving the condition of bone or cartilage in a mammal comprising administering in a temporally spaced apart sequence (1) at least one composition comprising demineralized bone matrix (DBM);

and (2) at least one composition comprising a therapeutically effective form of calcium.

35. The method of claim 34 wherein said DBM composition further comprises at least one vitamin.

36. The method of claim 35 wherein said at least one vitamin is vitamin E.

37. The method of claim 34 wherein said composition (2) further comprises at least one additional therapeutically effective supplement.

38. The method of claim 37 wherein said at least one additional therapeutically effective supplement is selected from the group consisting of vitamins, minerals, glucosamine and chondroitin.

39. The method of claim 38 wherein said vitamin is vitamin D3 and said mineral is selected from the group. consisting of magnesium, phosphorous and a mixture of magnesium and phosphorous.

40. The method of claim 37 wherein said at least one additional therapeutically effective supplement is selected from the group consisting of glucosamine, chondroitin and a mixture of glucosamine and chondroitin.

41. The method of claim 34 wherein said temporally spaced apart sequence is at least the amount of time required to avoid substantial interference with the absorption of said DBM by said calcium after ingestion of said DBM-containing composition.

42. The method of claim 41 wherein said temporally spaced apart sequence is about the time required for the stomach contents of said mammal to be emptied into the small intestine after ingestion of at least one of said composition (1) or said composition (2).

43. The method of claim 34 wherein said mammal is a human and said temporally spaced apart interval is about 1 hour to about 4 hours.

44. The method of claim 43 wherein said mammal is a human and said time interval is about 1.5 hours to about 3 hours.

45. The method of claim 34 wherein composition (1) and composition (2) are administered on different days.

46. An article of manufacture comprising an orally administerable form of demineralized bone matrix and an orally administerable form of calcium.