# US 2023/0057782 A1 · Compositions and methods of use thereof for treatment of mastitis

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- Number: US 2023/0057782 A1
- Document ID: US20230057782A1
- Status: Published application
- Kind: A1
- Application number: 17/796,599
- Filed: 2021-02-02
- Published: 2023-02-23
- Earliest claimed: 2020-02-03
- Assignees: CureMast, Inc.
- Applicants: CureMast, Inc.
- Inventors: Thomas Harry Barrows
- Web page: https://patentgrep.com/patent/US20230057782A1

## CPC

- A61K 9/0041: {Mammary glands, e.g. breasts, udder; Intramammary administration}
- A61K 9/1274: Non-vesicle bilayer structures, e.g. liquid crystals, tubules, cubic phases or cochleates; Sponge phases
- A61K 31/198: Alpha-amino acids, e.g. alanine or edetic acid [EDTA] (betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00)
- A61K 31/722: Chitin, chitosan
- A61K 31/785: Polymers containing nitrogen
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 47/14: Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
- A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61P 17/00: Drugs for dermatological disorders
- 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

Disclosed herein are compositions and methods of use thereof for the treatment of mastitis in dairy cattle. The compositions and methods can have improved effectiveness and duration of activity against mastitis-causing bacteria. In particular embodiments, the methods include treating mastitis infection by intramammary infusion of a disclosed composition.

## Claims

### Claim 1

A composition for the treatment of mastitis comprising an emulsion of a liquid crystal-forming substance and an antimicrobial substance.

### Claim 2 (depends on 1)

The composition of claim 1 further comprising a mucoadhesive substance.

### Claim 3 (depends on 2)

The composition of claim 2 further comprising an anti-biofilm substance.

### Claim 4 (depends on 3)

The composition of claim 3, wherein the liquid crystal-forming substance is monoolein.

### Claim 5 (depends on 3)

The composition of claim 3, wherein the liquid crystal-forming substance is phytantriol.

### Claim 6 (depends on 3)

The composition of claim 3, wherein the liquid crystal-forming substance is phosphatidyl choline.

### Claim 7 (depends on 4)

The composition of claim 4 comprising nanoparticles formed of the liquid crystal-forming substance.

### Claim 8 (depends on 7)

The composition of claim 7, wherein the nanoparticles comprise or consist of cubosomes.

### Claim 9 (depends on 7)

The composition of claim 7, wherein the antimicrobial is selected from the group comprising PHMB, N-acetyl-L-cysteine, polyaminopropyl biguanide, chlorhexidine, benzalkonium chloride, stearalkonium chloride, amoxicillin, ceftiofur, cephapirin, cloxicillin, hetacillin, pirlimycin, and penicillin.

### Claim 10 (depends on 9)

The composition of claim 9, wherein the mucoadhesive is selected from the group comprising polyethyleneimine (“PEI”), branched and dendrimeric forms of PEI, protamine, benzathine, spermidine, spermine, and chitosan.

### Claim 11 (depends on 10)

The composition of claim 10, wherein the mucoadhesive is chitosan and the antimicrobial is PHMB.

### Claim 12 (depends on 11)

The composition of claim 11, wherein the anti-biofilm substance is comprised of one or more substances of the group comprising PHMB, chitosan, N-acetyl-L-cysteine, 4-ethoxy benzoic acid, ethyl 4-ethoxybenzoate, methyl gallate, methyl paraben, 4-hydroxy-4-methyl-2-pentanone, adipic acid, phytol, phytol acetate, ellagic acid, esculetin, fisetin, reserpine, quercetin, linoleic acid, berberine, eugenol, and curcumin.

### Claim 13 (depends on 12)

The composition of claim 12 comprising N-acetyl-L-cysteine.

### Claim 14 (depends on 1)

The composition of claim 1, in a formulation according to Table 1:Ingredient% composition (weight/volume)Liquid crystal substance (e.g., monoolein)5-50Surfactant (e.g., non-ionic copolymer surfactant such as F-127)0.5-10Mucoadhesive (e.g., chitosan)0-10First Anti-biofilm and/or antimicrobial substance (e.g., PHMB)0.05-0.25Optional Second Anti-biofilm and/or antimicrobial substance (e.g., NAC)0-10Aqueous carrier (e.g., water)Volume/volume (e.g., q.s. to 100%).

### Claim 15 (depends on 14)

The composition of claim 14, in a formulation according to Table 2:Ingredient% composition (weight/volume)monoolein20-25F-1270.5-3chitosan0.5-3PHMB0.05-0.2NAC0.5-3waterq.s. to 100% (volume/volume).

### Claim 16 (depends on 15)

The composition of claim 15, in a formulation according to Table 3:Ingredient% composition (weight/volume)water75.35 (volume/ volume)monoolein21.18F-1272.35NAC1.00PHMB0.12
or Table 4:Ingredient% composition (weight/volume)water73.17 (volume/volume)monoolein21.20F-1272.35chitosan1.81NAC1.33PHMB0.14.

### Claim 17 (depends on 1)

The composition of claim 1, wherein the mastitis is cow mastitis (i.e., bovine mastitis) or goat mastitis.

### Claim 18 (depends on 1)

A method of treating an animal for mastitis comprising administering the animal an effective amount of the composition of claim 1.

### Claim 19 (depends on 18)

The method of claim 18, wherein the animal is a cow or a goat.

### Claim 20 (depends on 19)

The method of claim 19, wherein the cow is a dairy cow.

### Claim 21 (depends on 18)

The method of claim 18, wherein the composition is administered directly or indirectly to the mammary gland.

### Claim 22 (depends on 18)

The method of claim 18, wherein the composition is administered by infusion.

### Claim 23 (depends on 18)

The method of claim 18, wherein the composition is administered via the teat canal.

### Claim 24 (depends on 1)

A method of treating mastitis in a dairy cow or goat by infusing the composition of claim 1 into the mammary gland of the cow or goat via the teat canal.

### Claim 25 (depends on 24)

The method of claim 24, further comprising administering the animal an antibiotic.
