Compositions for alleviating inflammation and oxidative stress in a mammal

• US 8,221,805 B2
• Filed: 03/02/2011
• Issued: 07/17/2012
• Est. Priority Date: 03/23/2004
• Status: Active Grant

• Current Assignee: Lifeline Nutraceuticals Corporation
• Original Assignee: Lifeline Nutraceuticals Corporation
• Inventors: Myhill, Paul R., Driscoll, William J.
• Primary Examiner(s): HOFFMAN, SUSAN COE
• Application Number:
  US13/039,073
• Publication Number:
  US 20110151030A1
• Time in Patent Office: 503 Days
• Field of Search: None
• US Class Current: 424/729
• 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. A composition comprising:

Bacopa monniera extract having at least 20 percent bacosides, wherein the Bacopa monniera extract is in an amount selected from the group consisting of at least about 150 mg and about 22 weight percent;

Silybum marianum (milk thistle) extract having 70 percent to about 80 percent silymarin, wherein the milk thistle extract is in an amount selected from the group consisting of at least about 225 mg and about 33 weight percent;

Withania somnifera (ashwagandha) powder in an amount selected from the group consisting of at least about 150 mg and about 22 weight percent;

Camellia sinensis (green tea) extract in an amount selected from the group consisting of at least about 75 mg and about 11 weight percent, wherein said green tea extract is comprised of at least 40 percent epigallocatechin gallate and about 98% polyphenols; and

Curcuma longa (turmeric) extract, wherein said turmeric extract is comprised of at least about 95 percent curcumin and wherein the turmeric extract is in an amount selected from the group consisting of at least about 75 mg and about 11 weight percent;

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

superoxide dismutase and catalase 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 comprising about 22 percent Bacopa monniera extract, about 33 percent milk thistle extract, about 22 percent ashwagandha powder, about 11 percent green tea, and about 11 percent turmeric extract.

3. The composition according to claim 2 wherein the composition is formulated as an oral dosage form.

4. The composition according to claim 3, wherein the oral dosage form is selected from the group consisting of:

a tablet;

capsule; and

caplet.

5. The composition according to claim 1, further comprising one or more excipients selected from the group consisting of calcium carbonate;

croscarmellose sodium;

dicalcium phosphate;

magnesium stearate;

microcrystalline cellulose;

modified cellulose;

silica; and

stearic acid.

6. A composition comprising:

about 22 weight percent Bacopa monniera extract comprised of about 45 percent bacosides;

about 33 weight percent Silybum marianum(milk thistle) extract, wherein said milk thistle extract is comprised of between about 70 percent and about 80 percent silymarin;

about 22 weight percent Withania somnifera(ashwagandha) powder;

Camellia sinensis (green tea extract), wherein said green tea extract is comprised of 98 percent polyphenols;

said polyphenols comprised of 45 percent (−

)-epigallocatechin gallate;

Curcuma longa (turmeric) extract;

wherein said turmeric extract is comprised of about 95 percent curcumin;

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

superoxide dismutase and catalase 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.

7. The composition according to claim 6, further comprising one or more excipients selected from the group consisting of calcium carbonate;

croscarmellose sodium;

dicalcium phosphate;

magnesium stearate;

microcrystalline cellulose;

modified cellulose;

silica; and

stearic acid.

8. A composition comprising:

about 22 weight percent Bacopa monniera extract having 20 percent bacosides or greater;

about 33 weight percent Silybum marianum(milk thistle) extract having between about 70 percent and about 80 percent silymarin;

about 22 weight percent Withania somnifera(ashwagandha) powder;

about 11 weight percent Camellia sinensis (green tea) extract, wherein said green tea extract is comprised of about 45 percent epigallocatechin gallate and about 98% polyphenols; and

about 11 weight percent Curcuma longa (turmeric) extract, wherein said turmeric extract is comprised of about 95 percent curcumin;

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

superoxide dismutase and catalase 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.

9. The composition according to claim 8, wherein the composition is formulated as an oral dosage form.

10. The composition according to claim 9, wherein the oral dosage form is selected from the group consisting of:

a tablet;

capsule; and

caplet.

11. The composition according to claim 8, further comprising one or more excipients selected from the group consisting of calcium carbonate;

croscarmellose sodium;

dicalcium phosphate;

magnesium stearate;

microcrystalline cellulose;

modified cellulose;

silica; and

stearic acid.

12. The composition according to claim 8, wherein the turmeric extract is standardized to contain about 95 weight percent curcumin.