# US 2010/0166918 A1 · Nutraceuticals containing nitro fatty acids

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- Number: US 2010/0166918 A1
- Document ID: US20100166918A1
- Status: Published application
- Kind: A1
- Application number: 12/651,079
- Filed: 2009-12-31
- Published: 2010-07-01
- Earliest claimed: 2008-12-31
- Assignees: Nitromega Corp.
- Inventors: Raymond A. Miller
- Web page: https://patentgrep.com/patent/US20100166918A1

## CPC

- A61K 31/201: having one or two double bonds, e.g. oleic, linoleic acids
- A23L 33/105: Plant extracts, their artificial duplicates or their derivatives
- A23L 33/12: Fatty acids or derivatives thereof
- A23L 33/15: Vitamins
- A23P 10/30: Encapsulation of particles, e.g. foodstuff additives
- A61K 8/40: containing nitrogen (quinones containing nitrogen A61K8/355)
- A61K 8/922: {of vegetable origin}
- A61K 9/4891: {Coated capsules; Multilayered drug free capsule shells (with drug coating for immediate release A61K9/4808; osmotic devices A61K9/0004)}
- A61K 31/015: carbocyclic
- A61K 31/07: Retinol compounds, e.g. vitamin A (retinoic acids A61K31/203)
- A61K 31/122: having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
- A61K 31/202: having three or more double bonds, e.g. linolenic (eicosanoids, e.g. leukotrienes A61K31/557)
- A61K 31/355: Tocopherols, e.g. vitamin E
- A61K 31/375: Ascorbic acid, i.e. vitamin C; Salts thereof
- A61K 31/4415: Pyridoxine, i.e. Vitamin B6 (pyridoxal phosphate A61K31/675)
- A61K 31/51: Thiamines, e.g. vitamin B1
- A61K 31/525: Isoalloxazines, e.g. riboflavins, vitamin B2
- A61K 31/714: Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
- A61K 36/30: Boraginaceae (Borage family), e.g. comfrey, lungwort or forget-me-not
- A61K 36/53: Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 1/02: Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 1/16: for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
- A61P 3/00: Drugs for disorders of the metabolism (of the blood or the extracellular fluid A61P7/00)
- A61P 3/02: Nutrients, e.g. vitamins, minerals
- A61P 3/04: Anorexiants; Antiobesity agents
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 7/10: Antioedematous agents; Diuretics
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 9/10: for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- A61P 9/12: Antihypertensives
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 11/06: Antiasthmatics
- A61P 11/16: Central respiratory analeptics
- A61P 13/12: of the kidneys
- A61P 17/00: Drugs for dermatological disorders
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 17/06: Antipsoriatics
- A61P 17/14: for baldness or alopecia
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 19/06: Antigout agents, e.g. antihyperuricemic or uricosuric agents
- A61P 19/10: for osteoporosis
- A61P 21/02: Muscle relaxants, e.g. for tetanus or cramps
- A61P 25/00: Drugs for disorders of the nervous system
- A61P 25/16: Anti-Parkinson drugs
- A61P 25/28: for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/04: Antibacterial agents
- A61P 31/12: Antivirals
- A61P 35/00: Antineoplastic agents
- A61P 35/02: specific for leukemia
- A61P 35/04: specific for metastasis
- A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61Q 19/00: Preparations for care of the skin
- A61K 2800/92: Oral administration
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- A23P: SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61Q: SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS

## Abstract

Activated fatty acids, nutraceutical compositions including activated fatty acids, methods for using activated fatty acids to treat a variety of diseases, and methods for preparing activated fatty acids are provided herein.

## Claims

### Claim 1

A dietary supplement comprising:
a fatty acid component enriched for one or more activated fatty acids; and
a nutraceutically acceptable excipient.

### Claim 2 (depends on 1)

The dietary supplement of claim 1, wherein the activated fatty acid is derived from an omega-3 fatty acid, an omega-6 fatty acid, an omega-9 fatty acid, and combinations thereof.

### Claim 3 (depends on 1)

The dietary supplement of claim 1, wherein the activated fatty acid is a nitro-fatty acid or a keto-fatty acid.

### Claim 4 (depends on 1)

The dietary supplement of claim 1, wherein the activated fatty acid is nitro-linoleic acid, nitro-α-linoleic acid, nitro-γ-linoleic acid, nitro-oleic acid, nitro-eicosapentaenoic acid, nitro-docosahexaenoic acid, keto-linoleic acid, keto-α-linoleic acid, keto-γ-linoleic acid, keto-oleic acid, keto-eicosapentaenoic acid, keto-docosahexaenoic acid or a derivative or combination thereof.

### Claim 5 (depends on 1)

The dietary supplement of claim 1, further comprising one or more of linoleic acid, α-linoleic acid, γ-linoleic acid, oleic acid, eicosapentaenoic acid (EPA), docosahexaenoic acid (DIM), or derivatives thereof.

### Claim 6 (depends on 1)

The dietary supplement of claim 1, further comprising one or more nutraceuticals selected from vitamin A, vitamin B, vitamin B-1, vitamin B-2, vitamin B-6, vitamin B-12, vitamin C, vitamin D, vitamin D3, vitamin E, selenium, β-carotene, ginko biloba, goldenseal, valerian, ginseng, echinacea, grape seed extracts, ephedra, yucca concentrates, green tea extract, rice bran extract, wheat germ, wheat germ extract, beeswax, red yeast rice extract, stevia leaf extract, flaxseed oil, borage seed oil, coenzyme Q10, glucosamine derivatives, methylsulfonylmethane, pantothenic acid, biotin, thiamin, riboflavin, niacin, folic acid, palmitic acid, and derivatives thereof.

### Claim 7 (depends on 1)

The dietary supplement of claim 1, wherein the dietary supplement is a gel capsule.

### Claim 8 (depends on 7)

The dietary supplement of claim 7, wherein the one or more activated fatty acids comprise about 5% by weight to about 95% by weight of the total gel capsule.

### Claim 9 (depends on 1)

The dietary supplement of claim 1, comprising:
a first fatty acid component enriched for one or more activated fatty acid selected from nitro-linoleic acid, keto-linoleic acid, nitro-oleic acid, and keto-oleic acid: and
a second fatty acid component having one or more non-activated fatty acid selected from linoleic acid, α-linoleic acid, γ-linoleic acid, oleic acid, eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), or derivatives thereof.

### Claim 10 (depends on 10)

The dietary supplement of claim 10, further comprising vitamin E or a derivative thereof.

### Claim 11 (depends on 10)

The dietary supplement of claim 10, further comprising one or more secondary agents selected from vitamin A, vitamin B, vitamin B-1, vitamin B-2, vitamin B-6, vitamin B-12, vitamin C, vitamin D, vitamin D3, vitamin E, selenium, β-carotene, ginko biloba, goldenseal, valerian, ginseng, echinacea, grape seed extracts, ephedra, yucca concentrates, green tea extract, rice bran extract, wheat germ, wheat germ extract, beeswax, red yeast rice extract, stevia leaf extract, flaxseed oil, borage seed oil, coenzyme Q10, glucosamine derivatives, methylsulfonylmethane, pantothenic acid, biotin, thiamin, riboflavin, niacin, folic acid, palmitic acid, and derivatives thereof.

### Claim 12 (depends on 10)

The dietary supplement of claim 10, further comprising one or more secondary agents selected from policosanols, guggulipids, rice bran extract, wheat germ, wheat germ extract, beeswax, and red yeast rice extract, wherein the dietary supplement is formulated to promote a healthy heart and circulatory system.

### Claim 13 (depends on 10)

The dietary supplement of claim 10, further comprising one or more secondary agents selected from vitamin B-1, vitamin B-2, vitamin B-6, vitamin B-12, vitamin C, vitamin D, vitamin D3, vitamin E, selenium, goldenseal, valerian, ginseng, and echinacea, wherein the dietary supplement is formulated to promote healthy cell proliferation.

### Claim 14 (depends on 10)

The dietary supplement of claim 10, further comprising one or more secondary agents selected from vitamin A, vitamin C, vitamin E, and β-carotene, wherein the dietary supplement is formulated to promote healthy eyes.

### Claim 15 (depends on 10)

The dietary supplement of claim 10, further comprising one or more secondary agents selected from vitamin A, vitamin C, vitamin E, selenium, ginko biloba, goldenseal, valerian, ginseng, echinacea, ephedra, green tea extract, and yucca concentrate, wherein the dietary supplement is formulated to promote cognitive health or formulated as a neuroprotectant.

### Claim 16

A gel capsule comprising:
a core having a fatty acid component enriched for one or more activated fatty acids; and
one or more coating layers encapsulating the core.

### Claim 17 (depends on 16)

The gel capsule of claim 16, wherein the gel capsule is flavored.

### Claim 18 (depends on 17)

The gel capsule of claim 17, wherein the flavoring agent is a flavor selected from berry, strawberry, chocolate, cocoa, lemon, butter, almond, cashew, macadamia nut, coconut, blueberry, blackberry, raspberry, peach, lemon, lime, mint, orange, banana, chili pepper, pepper, cinnamon, and pineapple.

### Claim 19 (depends on 16)

The gel capsule of claim 16, wherein at least one of the one or more coating layers comprises at least one flavoring agent.

### Claim 20 (depends on 16)

The gel capsule of claim 16, wherein the core comprises at least one flavoring agent.

### Claim 21 (depends on 16)

The gel capsule of claim 16, wherein at least one of the one or more coating layers comprises an enteric coating.

### Claim 22 (depends on 16)

The gel capsule of claim 16, wherein the core further comprises one or more agents selected from solubilizers, stabilizers, colorants, plastizers, diluents, fillers, disintegrants, binders, lubricants, surfactants, hydrophobic vehicles, water soluble vehicles, emulsifiers, buffers, humectants, moisturizers, antioxidants, or preservatives.

### Claim 23 (depends on 16)

The gel capsule of claim 16, wherein the core, at least one of the one or more coating layers, or a combination thereof further comprises one or more secondary agents.

### Claim 24 (depends on 16)

The gel capsule of claim 16, comprising:
a core having from about 10 mg to about 500 mg of one or more activated fatty acids and from about 10 mg to about 100 mg of vitamin C; and
one or more coating layers encapsulating the core;
wherein the core, at least one of the one or more coating layers, or combinations thereof include from about 0.25% by weight to about 3.0% by weight of one or more flavoring agents.

### Claim 25 (depends on 16)

The gel capsule of claim 16, comprising:
a core having from about 10 mg to about 500 mg of one or more activated tatty acids and from about 2 mg to about 50 mg of vitamin E; and
one or more coating layers encapsulating the core;
wherein the core, at least one of the one or more coating layers, or combinations thereof include from about 0.25% by weight to about 3.0% by weight of one or more flavoring agents.

### Claim 26

A method for improving the health of an individual comprising administering to the individual a dietary supplement comprising:
a fatty acid component enriched for one or more activated fatty acids: and
a nutraceutically acceptable excipient.

### Claim 27 (depends on 26)

The method of claim 26, wherein the dietary supplement comprises:
a first fatty acid component enriched for one or more activated fatty acids selected from nitro-linoleic acid, keto-linoleic acid, nitro-oleic acid, and keto-oleic acid: and
a second fatty acid component having one or more non-activated fatty acid selected from linoleic acid, α-linoleic acid, γ-linoleic acid, oleic acid, eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), or derivatives thereof.

### Claim 28 (depends on 27)

The method of claim 27, wherein the dietary supplement further comprises vitamin E or a derivative thereof.

### Claim 29 (depends on 27)

The method of claim 27, wherein the dietary supplement further comprises one or more secondary agents selected from vitamin A, vitamin B, vitamin B-1, vitamin B-2, vitamin B-6, vitamin B-12, vitamin C, vitamin D, vitamin D3, vitamin E, selenium, β-carotene, ginko biloba, goldenseal, valerian, ginseng, echinacea, grape seed extracts, ephedra, yucca concentrates, green tea extract, rice bran extract, wheat germ, wheat germ extract, beeswax, red yeast rice extract, stevia leaf extract, flaxseed oil, borage seed oil, coenzyme Q10, glucosamine derivatives, methylsulfonylmethane, pantothenic acid, biotin, thiamin, riboflavin, niacin, folic acid, palmitic acid, and derivatives thereof.

### Claim 30 (depends on 27)

The method of claim 27, wherein the dietary supplement further comprises one or more secondary agents selected from policosanols, guggulipids, rice bran extract, wheat germ, wheat germ extract, beeswax, and red yeast rice extract, wherein the dietary supplement is formulated to promote a healthy heart and circulatory system.

### Claim 31 (depends on 27)

The method of claim 27, wherein the dietary supplement further comprises one or more secondary agents selected from vitamin B-1, vitamin B-2, vitamin B-6, vitamin B-12, vitamin C, vitamin D, vitamin D3, vitamin E, selenium, goldenseal, valerian, ginseng, and echinacea, wherein the dietary supplement is formulated to promote healthy cell proliferation.

### Claim 32 (depends on 27)

The method of claim 27, wherein the dietary supplement further comprises one or more secondary agents selected from vitamin A, vitamin C, vitamin E, and β-carotene, wherein the dietary supplement is formulated to promote healthy eyes.

### Claim 33 (depends on 27)

The method of claim 27, wherein the dietary supplement further comprises one or more secondary agents selected from vitamin A, vitamin C, vitamin E, selenium, ginko biloba, goldenseal, valerian, ginseng, echinacea, ephedra, green tea extract, and yucca concentrate, wherein the dietary supplement is formulated to promote cognitive health or formulated as a neuroprotectant.