# US 10,117,885 B2 · Chewable lipid supplements for treating pain and fibromyalgia

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- Number: US 10,117,885 B2
- Document ID: US10117885B2
- Status: Granted
- Kind: B2
- Application number: 15/662,212
- Filed: 2017-07-27
- Published: 2017-11-09
- Granted: 2018-11-06
- Earliest claimed: 2011-08-11
- Assignees: Allergy Research Group, LLC
- Applicants: Allergy Research Group, LLC
- Inventors: Robert A. Settineri
- Web page: https://patentgrep.com/patent/US10117885B2

## CPC

- A61K 31/702: Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
- A23D 9/013: Other fatty acid esters, e.g. phosphatides
- A23L 29/10: containing emulsifiers
- A23L 29/244: from corms, tubers or roots, e.g. glucomannan (starch A23L29/212)
- A23L 33/105: Plant extracts, their artificial duplicates or their derivatives
- A23L 33/115: Fatty acids or derivatives thereof; Fats or oils
- A23L 33/12: Fatty acids or derivatives thereof
- A61K 9/0056: {Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals}
- A61K 9/006: {Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays}
- A61K 31/122: having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
- A61K 31/16: Amides, e.g. hydroxamic acids
- A61K 31/375: Ascorbic acid, i.e. vitamin C; Salts thereof
- A61K 31/385: having two or more sulfur atoms in the same ring
- A61K 31/522: having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
- A61K 31/593: 9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
- A61K 31/66: Phosphorus compounds
- A61K 31/661: Phosphorus acids or esters thereof not having P—C bonds, e.g. fosfosal, dichlorvos, malathion {or mevinphos}
- A61K 31/683: Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols
- A61K 31/685: one of the hydroxy compounds having nitrogen atoms, e.g. phosphatidylserine, lecithin
- A61K 31/7028: Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K 31/716: Glucans
- A61K 31/733: Fructosans, e.g. inulin
- A61K 33/22: Boron compounds
- A61K 38/28: Insulins
- A61K 38/44: Oxidoreductases (1)
- A61K 38/446: {Superoxide dismutase (1.15)}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 47/12: Carboxylic acids; Salts or anhydrides thereof
- A61K 47/24: containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A61P 21/00: Drugs for disorders of the muscular or neuromuscular system
- A61P 39/06: Free radical scavengers or antioxidants
- C12Y 111/01006: Catalase (1.11.1.6)
- C12Y 115/01001: Superoxide dismutase (1.15.1.1)
- A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs
- 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)
- A23D: EDIBLE OILS OR FATS, e.g. MARGARINES, SHORTENINGS OR COOKING OILS (preservation thereof A23B20/00; production, refinement or preservation of animal or vegetable fats or oils C11B, C11C)
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12Y: ENZYMES
- A23V: INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION

## Abstract

Composition, preferably, in the form of capsules or chewable wafers in quantities suitable for relieving the symptoms of fibromyalgia comprise formulations of phospholipids, specifically identified concentrations of phosphatidylglycerol, phosphatidic acid, phosphatidylethanolamine, phosphatidylcholine, glycolipids and phosphatidylserine along with inulin and other desirable active ingredients are described.

## Claims

### Claim 1

A composition comprising:
a) a base composition comprising a combination of inulin, and phospholipids in therapeutically effective amounts for relieving the symptoms of fibromyalgia, and
b) a carrier for the base composition comprising xylitol, a flavoring agent, stearic acid and/or vegetable stearate,
wherein the composition is formulated as a tablet, a capsule, a powder or an edible wafer, said composition effective, when consumed by an individual, for treating fibromyalgia and/or decreasing systemic and abdominal pain due to fibromyalgia, wherein the base composition comprises a combination of phospholipids comprising about 19-29% phosphatidylcholine, 15-25% phosphatidylethanolamine, 3.5-10% phosphatidic acid, 10-18% phosphatidylinositol, 2-10% phosphatidylglycerol, 10-20% glycolipids and phosphatidylserine.

### Claim 2 (depends on 1)

The composition of claim 1 wherein an effective unit dose comprises at least about 1 g the phospholipids.

### Claim 3 (depends on 2)

The composition of claim 2 in the form of an edible wafer.

### Claim 4 (depends on 3)

The composition of claim 3 wherein an effective daily dosage is 4 wafers in a 24-hour period.

### Claim 5 (depends on 1)

The composition of claim 1 further comprising a colorant.

### Claim 6

A composition comprising:
a combination of inulin, and phospholipids in therapeutically effective amounts for relieving the symptoms of fibromyalgia, and
wherein the composition is formulated as a tablet, a capsule, a powder or an edible wafer, said composition effective, when consumed by an individual, for treating fibromyalgia and/or decreasing systemic and abdominal pain due to fibromyalgia, wherein the composition comprises a combination of phospholipids comprising about 19-29% phosphatidylcholine, 15-25% phosphatidylethanolamine, 3.5-10% phosphatidic acid, 10-18% phosphatidylinositol, 2-10% phosphatidylglycerol, 10-20% glycolipids and phosphatidylserine.

### Claim 7 (depends on 6)

The composition of claim 6 comprising an effective unit dose containing at least about 1 g the phospholipids.

### Claim 8 (depends on 7)

The composition of claim 7 wherein an effective daily dosage comprises delivery of four 1 g unit doses of the phospholipids in a 24-hour period.

### Claim 9

A method for decreasing the symptoms of fibromyalgia and/or systemic and abdominal pain due to fibromyalgia, comprising delivering to an individual: a composition comprising:
a combination of inulin, and phospholipids in therapeutically effective amounts for relieving the symptoms of fibromyalgia, and
wherein the composition is formulated as a tablet, a capsule, a powder or an edible wafer, said composition effective, when consumed by an individual, for treating fibromyalgia and/or decreasing systemic and abdominal pain due to fibromyalgia, wherein the composition comprises a combination of phospholipids comprising about 19-29% phosphatidylcholine, 15-25% phosphatidylethanolamine, 3.5-10% phosphatidic acid, 10-18% phosphatidylinositol, 2-10% phosphatidylglycerol, 10-20% glycolipids and phosphatidylserine.

### Claim 10 (depends on 9)

The method of claim 9 wherein an effective unit dose contains at least about 1 g of the phospholipids.

### Claim 11 (depends on 10)

The method of claim 10 wherein an effective daily dosage comprises delivery of four 1 g unit doses of the phospholipids in a 24-hour period.

### Claim 12 (depends on 1)

The composition of claim 1 wherein the base composition further includes caffeine.

### Claim 13 (depends on 6)

The composition of claim 6 wherein said composition further includes caffeine.

### Claim 14 (depends on 9)

The method of claim 9 wherein the composition further includes caffeine.