# US 8,568,795 B2 · Stabilized formulation comprising omega-3 fatty acids for skin care and/or wound care

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- Number: US 8,568,795 B2
- Document ID: US8568795B2
- Status: Granted
- Kind: B2
- Application number: 13/114,106
- Filed: 2011-05-24
- Published: 2011-12-01
- Granted: 2013-10-29
- Earliest claimed: 2010-05-26
- Assignees: Kerecis EHF
- Applicants: Gudmundur Fertram Sigurjonsson; Biljana Ilievska; Baldur Tumi Baldursson
- Inventors: Gudmundur Fertram Sigurjonsson; Biljana Ilievska; Baldur Tumi Baldursson
- Web page: https://patentgrep.com/patent/US8568795B2

## CPC

- A61K 31/202: having three or more double bonds, e.g. linolenic (eicosanoids, e.g. leukotrienes A61K31/557)
- A61K 31/085: having an ether linkage to aromatic ring nuclear carbon
- A61K 31/19: Carboxylic acids, e.g. valproic acid (salicylic acid A61K31/60)
- A61K 31/355: Tocopherols, e.g. vitamin E
- A61K 31/375: Ascorbic acid, i.e. vitamin C; Salts thereof
- 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
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/22: Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
- A61K 47/46: Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 17/00: Drugs for dermatological disorders
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

A stabilized formulation for skin care, wound care and/or other tissue healing applications and methods for making the same is described. The stabilized formulation stabilizes omega-3 polyunsaturated fatty acids and is constituted of the omega-3 polyunsaturated fatty acids in combination with tocopherol (Vitamin E), ascorbic acid (Vitamin C), herb extract, and a fat-soluble antioxidant. Methods for making and using the stabilized formulation are also described.

## Claims

### Claim 1

A composition comprising:
(i) a stabilized formulation comprising:
0.05% to 0.25% tocopherol;
1% to 3% vitamin C;
0.25% to 0.5% of an herb extract;
0.1% to 0.5 of a fat-soluble antioxidant selected from the group consisting of BHT (butylated hydroxytoluene), BHA (butylated hydroxyanisole), TBHQ (tertiary butyl hydroquinone), and combinations thereof; and
a balance of fish oil, wherein the fish oil comprises omega-3 polyunsaturated fatty acids; and
(ii) one or more emollients, humectants, or any combination thereof, wherein the composition includes 1% to 5% of the stabilized formulation and is formulated for topical administration.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the omega-3 polyunsaturated fatty acids comprise one or more of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).

### Claim 3 (depends on 1)

The composition of claim 1, wherein the herb extract is selected from the group consisting of rosemary, oregano, basil, marjoram, thyme, black pepper, caraway, cardamom, chives, colorifico, coriander, cumin, dill, garlic, ginger, laurel, nutmeg, onion, parsley, sage, savory and tarragon extracts, and combinations thereof.

### Claim 4 (depends on 3)

The composition of claim 3, wherein the herb extract is a rosemary extract.

### Claim 5 (depends on 1)

The composition of claim 1, wherein the fat-soluble antioxidant is BHT.

### Claim 6 (depends on 1)

The composition of claim 1, wherein the composition further comprises one or more additional active agents and/or one or more pharmaceutically acceptable diluents, excipients and carriers.

### Claim 7 (depends on 6)

The composition of claim 6, wherein the composition comprises one or more exfoliates, moisturizers, antiseptics, antimicrobial agents, antivirals, antifungals, antiparasitics, anti-inflammatory agents, antioxidants, drugs, proteins, peptides, or combinations thereof.

### Claim 8 (depends on 6)

The composition of claim 6, wherein the composition comprises alpha hydroxy acid (AHA).

### Claim 9 (depends on 8)

The composition of claim 8, wherein the composition comprises AHA and urea.

### Claim 10 (depends on 6)

The composition of claim 6, wherein the composition comprises polyacrylic acid.

### Claim 11 (depends on 8)

The composition of claim 8, wherein the AHA is one of glycolic acid or lactic acid.

### Claim 12 (depends on 11)

The composition of claim 11, wherein glycolic acid is added to the composition in amount ranging from about 5% to 9%.

### Claim 13

A wound dressing comprising:
I. a stabilized formulation comprising:
0.05% to 0.25% tocopherol;
1% to 3% vitamin C;
0.25% to 0.5% herb extract;
0.1% to 0.5 of a fat-soluble antioxidant selected from the group consisting of BHT (butylated hydroxytoluene), BHA (butylated hydroxyanisole), TBHQ (tertiary butyl hydroquinone), and combinations thereof; and
a balance of fish oil, wherein the fish oil comprises omega-3 polyunsaturated fatty acids; and
II. a solid or semi-solid substrate, wherein the stabilized formulation is added to the solid or semi-solid substrate to form the wound dressing prepared for application to a wound for protection, absorbance, drainage, or improvement of cell environment.

### Claim 14 (depends on 13)

The wound dressing of claim 13, wherein the solid or semi-solid substrate includes at least one of a film, a hydrocolloid, a hydrogel, a foam, an alginate, a silicone, collagen, keratin, cellophane, a fish skin extracellular matrix (ECM), or a polyurethane wound dressing.

### Claim 15 (depends on 1)

A method for treating a skin condition and/or wound, comprising applying the composition of claim 1 to the skin condition and/or wound.

### Claim 16 (depends on 15)

The method of claim 15, wherein the skin condition and/or wound is selected from the group consisting of dry skin, atopic dermatitis, allergic contact dermatitis, radiation dermatitis, first and second degree wounds, sunburns, superficial injuries, abrasions, cuts, surgical wounds, pressure ulcers, venous stasis ulcers, ulcers caused by mixed etiologies, diabetic ulcers, donor sites, and grafts.

### Claim 17 (depends on 16)

The method of claim 16, wherein the skin condition and/or wound is a diabetic ulcer.

### Claim 18 (depends on 17)

The method of claim 17, wherein the diabetic ulcer is a foot ulcer.