Preparation of compositions to alleviate inflammation and oxidative stress in a mammal

• US 20060008543A1
• Filed: 08/31/2005
• Published: 01/12/2006
• 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 7,384,655 B2
• Time in Patent Office: Days
• US Class Current: 424/756
• 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

1-44. -44. (canceled)

45. A process for manufacturing an antioxidant-promoting composition comprising:

obtaining at least two active compounds selected from the group consisting of Bacopa monniera extract, milk thistle extract, ashwagandha powder, green tea extract, and turmeric extract, and admixing the compounds, thereby obtaining a composition that increases the level of antioxidant enzyme activity in the plasma, erythrocytes, liver or brain of a subject, above the level of antioxidant enzyme activity resulting from administration of one individual active compound to the subject.

46. The process of claim 45, wherein the composition, when manufactured with two or more active compounds provides at least an additive increase in the level of antioxidant enzyme activity in the plasma, erythrocytes, liver or brain of a subject relative to the increased level of antioxidant enzyme activity resulting from administration of one individual active to the subject.

47. The process of claim 46, wherein the composition, when manufactured with two or more active compounds provides a grater than additive increase in the level of antioxidant enzyme activity in the plasma, erythrocytes, liver or brain of a subject relative to the increased level of antioxidant enzyme activity resulting from administration of one individual active to the subject.

48. The process of claim 47, wherein the greater than additive increase in the level of antioxidant enzyme activity in the plasma, erythrocytes, liver or brain of a subject relative to the increased level of antioxidant enzyme activity resulting from administration of one individual active to the subject, permits the two or more active compounds to be provided in reduced amounts, thereby lowering the toxicity associated with higher amounts of each individual active agent.

49. The process of claim 45, wherein the composition further comprises:

two or more active agents including at least 150 milligrams Bacopa monniera extract having 45 percent bacosides or greater;

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

at least 150 mg ashwagandha powder;

at least 75 milligrams green tea extract having 98 percent polyphenols and 45 percent epigallocatechin gallate; and

at least 75 milligrams turmeric extract having 95 percent curcumin.

50. The process of claim 49, wherein the composition comprises equivalent quantities of two or more active agents, where equivalency is assessed by percent weight of bacosides, silymarin, polyphenols, epigallocatechin gallate or curcumin in the composition.

51. The process of claim 45, further comprising preparing the admixed compounds into oral dose formulations.

52. The process of claim 51, wherein the oral dose formulation is prepared to contain from 50 mg to 5000 mg of the antioxidant-promoting composition per dose.

53. The process of claim 51, wherein the oral dose formulation is prepared to contain from 250 mg to 2500 mg of the antioxidant-promoting composition per dose.

54. The process of claim 51, wherein the oral dose formulation is prepared to contain from 500 mg to 1500 mg of the antioxidant-promoting composition per dose.

55. The process of claim 51, wherein the composition includes one or more excipients including:

calcium carbonate;

croscarmellose sodium;

dicalcium phosphate;

magnesium stearate;

microcrystalline cellulose;

modified cellulose;

silica; and

stearic acid.

56. The process of claim 51, wherein the oral dose formulation is prepared for at least once per day dosing of the subject, the dosing sufficient to ameliorate tissue damage in the subject resulting from oxidative stress occurring in connection with inflammation in the subject.

57. The process of claim 51, wherein the oral dose formulation is prepared for at least once per day dosing of the subject, the dosing sufficient to ameliorate tissue damage in the subject resulting from oxidative stress occurring in connection with inflammation, the inflammation caused by an infection in the subject.

58. The process of claim 51, wherein the oral dose formulation is prepared for at least once per day dosing of the subject, the dosing sufficient to ameliorate tissue damage in the subject resulting from oxidative stress occurring in connection with inflammation, the inflammation caused by radiation injury in the subject.

59. The process of claim 51, wherein the oral dose formulation is prepared for at least once per day dosing of the subject, the dosing sufficient to ameliorate oxidative stress in the subject, thereby reducing plaque formation in the vasculature of the subject and thereby preventing or reducing excessive atherosclerosis or hypertension in the subject.

60. The process of claim 51, wherein the oral dose formulation is prepared for at least once per day dosing of the subject, the dosing sufficient to ameliorate oxidative stress in the brain or neurons of the subject, thereby preventing or reducing neurological disorders in the subject.

61. The process of claim 51, wherein the oral dose formulation is prepared for at least once per day dosing of the subject, the dosing sufficient to ameliorate damage in the subject resulting from oxidative stress occurring in connection with ischemia in the subject.

62. The process of claim 61, wherein the ischemia results from a blood clot, trauma, anemia or diabetes mellitus.

63. The process of claim 61, wherein the oxidative stress results from reperfusion of an ischemic tissue in subject.

64. The process of claim 51, wherein the composition ameliorates tissue damage in the subject resulting from oxidative stress occurring in connection with aging.

65. The process of claim 45, wherein the composition further comprises:

two or more active agents including up to 500 milligrams Bacopa monniera extract having 45 percent bacosides or greater;

up to 750 milligrams milk thistle extract having between 70 percent and 80 percent silymarin;

up to 500 mg ashwagandha powder;

up to 500 milligrams green tea extract having 98 percent polyphenols and 45 percent epigallocatechin gallate; and

up to 500 milligrams turmeric extract having 95 percent curcumin, or the equivalent weight percentage of total active agents.