Compositions for alleviating inflammation and oxidative stress in a mammal

• US 20050226942A1
• Filed: 03/23/2005
• Published: 10/13/2005
• Est. Priority Date: 03/23/2004
• Status: Active Grant

• Current Assignee: Lifeline Nutraceuticals Corporation
• Original Assignee: Lifeline Nutraceuticals Corporation
• Inventors: Driscoll, William J., Myhill, Paul R.
• Granted Patent: US 7,241,461 B2
• Time in Patent Office: Days
• US Class Current: 424/725
• 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 36/16 Ginkgophyta, e.g. Ginkgoaceae (Ginkgo family)
• CPC Class Codes: A61K 36/23 Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
• CPC Class Codes: A61K 36/28 Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
• CPC Class Codes: A61K 36/63 Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
• CPC Class Codes: A61K 36/68 Plantaginaceae (Plantain Family)
• CPC Class Codes: A61K 36/80 Scrophulariaceae (Figwort family)
• CPC Class Codes: A61K 36/81 Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
• CPC Class Codes: A61K 36/82 Theaceae (Tea family), e.g. camellia
• CPC Class Codes: A61K 36/886 Aloeaceae (Aloe family), e.g. aloe vera
• CPC Class Codes: A61K 36/9066 Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
• CPC Class Codes: A61K 38/446 Superoxide dismutase (1.15)
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 31/04 : Antibacterial agents
• CPC Class Codes: A61P 31/18 : for HIV
• CPC Class Codes: A61P 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 37/00 : Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 39/00 : General protective or antinoxious agents
• CPC Class Codes: A61P 39/06 : Free radical scavengers or antioxidants
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 7/06 : Antianaemics
• CPC Class Codes: A61P 9/10 : for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• CPC Class Codes: A61P 9/12 : Antihypertensives

Abstract

An antioxidant-promoting composition that increases antioxidant defense potential in a subject is disclosed comprising Bacopa monniera extract; milk thistle extract, ashwagandha powder, green tea extract, Gotu kola powder, Ginko biloba leaf extract; Aloe vera powder; turmeric extract; and N-acetyl cysteine. The antioxidant-promoting composition of the invention safely induces cellular antioxidant potential to achieve an overall net decrease in oxidative stress without the undesirable side-effects associated with the individual components of the antioxidant-promoting composition. Also disclosed is a method for reducing the undesirable side-effects of free radicals in a subject by administering to a subject in need of such antioxidants an effective amount of antioxidant-promoting composition of the invention.

Claims

1. An antioxidant-promoting composition comprising active ingredients comprising Bacopa monniera extract;

milk thistle extract, ashwagandha powder, green tea extract, and turmeric extract, wherein the composition increases the enzyme activity level of at least one antioxidant enzyme selected from the group consisting of;

superoxide dismutase;

catalase; and

glutathione peroxidase and decreases the plasma concentration level of thiobarbituric acid reactive chemical species, when administered in an effective amount to a mammalian subject in need thereof.

2. The composition according to claim 1, wherein the Bacopa monniera extract is standardized extract prepared from the leaves of the Bacopa monniera plant.

3. The composition according to claim 2, wherein the standardized extract contains at least 20 percent bacosides.

4. The composition according to claim 1, wherein the Bacopa monniera extract is present at a concentration of about 5 weight percent to about 50 weight percent of the total dry weight of active ingredients of the composition.

5. The composition according to claim 1, wherein the Bacopa monniera extract is present at a concentration of about 10 weight percent to about 30 weight percent of the total dry weight of active ingredients of the composition.

6. The composition according to claim 1, wherein the Bacopa monniera extract is present at a concentration at least about 22 weight percent of the total dry weight of active ingredients of the composition.

7. The composition according to claim 1, wherein the Bacopa monniera extract is present at a concentration at least about 12 weight percent of the total dry weight of active ingredients of the composition.

8. The composition according to claim 1, wherein the milk thistle extract is standardized to contain at least about 70 weight percent silymarin.

9. The composition according to claim 1, wherein the milk thistle extract is present at a concentration from about 5 weight percent to about 60 weight percent of the total dry weight of active ingredients of the composition.

10. The composition according to claim 1, wherein the milk thistle extract is present at a concentration from about 10 weight percent to about 50 weight percent of the total dry weight of active ingredients of the composition.

11. The composition according to claim 1, wherein the milk thistle extract is present at a concentration at least about 33 weight percent of the total dry weight of active ingredients of the composition.

12. The composition according to claim 1, wherein the milk thistle extract is present at a concentration at least about 22 weight percent of the total dry weight of active ingredients of the composition.

13. The composition according to claim 1, wherein the ashwagandha powder is present at a concentration from about 5 weight percent to about 50 weight percent of the total dry weight of active ingredients of the composition.

14. The composition according to claim 1, wherein the ashwagandha powder is present at a concentration from about 10 weight percent to about 30 weight percent of the total dry weight of active ingredients of the composition.

15. The composition according to claim 1, wherein the ashwagandha powder is present at a concentration at least about 22 weight percent of the total dry weight of active ingredients of the composition.

16. The composition according to claim 1, wherein the ashwagandha powder is present at a concentration at least about 12 weight percent of the total dry weight of active ingredients of the composition.

17. The composition according to claim 1, wherein the turmeric extract is standardized to contain at least about 95 weight percent curcumin.

18. The composition according to claim 1, wherein the turmeric extract is present at a concentration from about 2.5 weight percent to about 25 weight percent of the total dry weight of active ingredients of the composition.

19. The composition according to claim 1, wherein the turmeric extract is present at a concentration from about 5 weight percent to about 15 weight percent of the total dry weight of active ingredients of the composition.

20. The composition according to claim 1, wherein the turmeric extract is present at a concentration at least about 11 weight percent of the total dry weight of active ingredients of the composition.

21. The composition according to claim 1, wherein the turmeric extract is present at a concentration at least about 6 weight percent of the total dry weight of active ingredients of the composition.

22. The composition according to claim 1, wherein the green tea extract is standardized to contain at least about 40 percent polyphenols.

23. The composition according to claim 22, wherein the polyphenol is (−

)-epigallocatechin gallate.

24. The composition according to claim 1, wherein the green tea extract is present at a concentration from about 2.5 weight percent to about 25 weight percent of the total dry weight of active ingredients of the composition.

25. The composition according to claim 1, wherein the green tea extract is present at a concentration from about 5 weight percent to about 15 weight percent of the total dry weight of active ingredients of the composition.

26. The composition according to claim 1, wherein the green tea extract is present at a concentration at least about 11 weight percent of the total dry weight of active ingredients of the composition.

27. The composition according to claim 1, wherein the green tea extract is present at a concentration at least about 6 weight percent of the total dry weight of active ingredients of the composition.

28. The composition according to claim 1, further comprising at least one excipient.

29. The composition according to claim 28, wherein the at least one excipient is selected from the group consisting of:

calcium carbonate;

croscarmellose sodium;

dicalcium phosphate;

magnesium stearate;

microcrystalline cellulose;

modified cellulose;

silica; and

stearic acid.

30. The composition according to claim 1, further comprising the active ingredients Gotu kola powder, Ginko biloba leaf extract and Aloe vera powder.

31. The composition according to claim 30, wherein the Gotu kola powder is present at a concentration from at least about 5 weight percent to about 50 weight percent of the total dry weight of active ingredients of the composition.

32. The composition according to claim 30, wherein the Gotu kola powder is present at a concentration from at least about 10 weight percent to about 30 weight percent of the total dry weight of active ingredients of the composition.

33. The composition according to claim 30, wherein the Gotu kola powder extract is present at a concentration at least about 12 weight percent of the total dry weight of active ingredients of the composition.

34. The composition according to claim 30, wherein the Ginko biloba leaf extract is present at a concentration from at least about 5 weight percent to about 50 weight percent of the total dry weight of active ingredients of the composition.

35. The composition according to claim 30, wherein the Ginko biloba leaf extract is present at a concentration from at least about 10 weight percent to about 30 weight percent of the total dry weight of active ingredients of the composition.

36. The composition according to claim 30, wherein the Ginko biloba leaf extract is present at a concentration at least about 12 weight percent of the total dry weight of active ingredients of the composition.

37. The composition according to claim 30, wherein the Aloe vera powder is present at a concentration from at least about 5 weight percent to about 50 weight percent of the total dry weight of active ingredients of the composition.

38. The composition according to claim 30, wherein the Aloe vera powder is present at a concentration from at least about 10 weight percent to about 30 weight percent of the total dry weight of active ingredients of the composition.

39. The composition according to claim 30, wherein the Aloe vera powder is present at a concentration at least about 12 weight percent of the total dry weight of active ingredients of the composition.

40. The composition according to claim 30, further comprising at least one excipient.

41. The composition according to claim 30, wherein the at least one excipient is selected from the group consisting of:

calcium carbonate;

croscarmellose sodium;

dicalcium phosphate;

magnesium stearate;

microcrystalline cellulose;

modified cellulose;

silica; and

stearic acid.

42. An antioxidant-promoting composition comprising:

(a) active ingredients comprising at least about 150 milligrams Bacopa monniera, extract 45 percent bacosides;

at least about 225 milligrams milk thistle extract, between about 70 percent and about 80 percent silymarin;

at least about 150 mg ashwagandha powder;

at least about 75 milligrams green tea extract;

98 percent polyphenols;

45 percent (−

)-epigallocatechin gallate;

at least about 75 milligrams turmeric extract;

95 percent curcumin; and

(b) other ingredients comprising calcium carbonate;

croscarmellose sodium;

dicalcium phosphate;

magnesium stearate;

microcrystalline cellulose;

modified cellulose;

silica; and

stearic acid;

wherein the composition increases the enzyme activity level of at least one antioxidant enzyme selected from the group consisting of;

superoxide dismutase;

catalase; and

glutathione peroxidase and decreases the plasma concentration level of thiobarbituric acid reactive chemical species, when administered in an effective amount to a mammalian subject in need thereof.

43. The composition according to claim 42, wherein the composition is formulated as an oral dosage form.

44. The composition according to claim 43, wherein the oral dosage form is selected from the group consisting of:

a tablet;

capsule; and

caplet.