# US 12,109,195 B2 · Compositions and methods for treatment of vaginal infections

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- Number: US 12,109,195 B2
- Document ID: US12109195B2
- Status: Granted
- Kind: B2
- Application number: 17/363,193
- Filed: 2021-06-30
- Published: 2021-12-30
- Granted: 2024-10-08
- Earliest claimed: 2020-06-30
- Assignees: Vireo Systems, Inc.
- Applicants: Vireo Systems, Inc.
- Inventors: Mark C. Faulkner; Deeannah Seymour
- Web page: https://patentgrep.com/patent/US12109195B2

## CPC

- A61K 31/4168: having a nitrogen attached in position 2, e.g. clonidine
- A61K 9/0034: {Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants}
- A61K 9/0036: {Devices retained in the vagina or cervix for a prolonged period, e.g. intravaginal rings, medicated tampons, medicated diaphragms}
- A61K 9/02: Suppositories; Bougies; Bases therefor; {Ovules}(apparatus for making A61J3/08; devices for introducing into the body A61M31/00)
- A61K 9/48: Preparations in capsules, e.g. of gelatin, of chocolate {(A61K9/0004 takes precedence; bite capsules A61K9/0056)}
- A61K 31/194: having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
- A61K 31/7016: Disaccharides, e.g. lactose, lactulose (lactobionic acid A61K31/7032)
- A61K 31/702: Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
- A61K 31/733: Fructosans, e.g. inulin
- A61K 33/22: Boron compounds
- A61K 35/747: Lactobacilli, e.g. L. acidophilus or L. brevis
- A61K 47/02: Inorganic compounds
- A61K 47/12: Carboxylic acids; Salts or anhydrides thereof
- A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61P 31/04: Antibacterial agents
- A61P 31/14: for RNA viruses
- A61P 31/20: for DNA viruses
- 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

Compositions and methods for treatment and prevention of vaginal infections where the compositions include creatinine, such as protonated creatinine or creatinine salts, and optionally one or more weak acids, such as boric acid. The compositions may be used to treat and/or prevent a vaginal infection, such as bacterial vaginosis, to prevent recurrence of a vaginal infection, to treat and/or prevent a sexually transmitted disease (STD) or sexually transmitted infection (STI), and reduce the incidence and/or risk of a subject transmitting a STI or STD.

## Claims

### Claim 1

A method for inhibiting growth of one or more species of bacteria associated with bacterial vaginosis, comprising:
preparing a composition consisting of protonated creatinine, a protonated creatinine salt, or combinations thereof, wherein the protonated creatinine, protonated creatinine salt, or combination thereof is present in the composition in an amount of about 10 mg to about 300 mg; and
subjecting the one or more species of bacteria to the composition.

### Claim 2 (depends on 1)

The method of claim 1, wherein the composition is formulated as a vaginal suppository, vaginal capsule, vaginal tablet, coated tampon, or coated condom.

### Claim 3 (depends on 1)

The method of claim 1, wherein the composition is formulated as a gel, lotion, spray, ointment, cream, paste, lubricant, or emulsion.

### Claim 4 (depends on 1)

The method of claim 1, wherein the composition is formulated for vaginal transmucosal administration.

### Claim 5

A method for killing one or more species of bacteria associated with bacterial vaginosis, comprising:
preparing a composition consisting of protonated creatinine, a protonated creatinine salt, or combinations thereof, and a weak acid, wherein the protonated creatinine, protonated creatinine salt, or combination thereof is present in the composition in an amount of about 10 mg to about 300 mg and the weak acid is present in the composition in an amount of about 500 mg to about 700 mg; and
subjecting the one or more species of bacteria to the composition.

### Claim 6 (depends on 5)

The method of claim 5, wherein the composition is formulated as a vaginal suppository, vaginal capsule, or vaginal tablet.

### Claim 7 (depends on 1)

The method of claim 1, wherein the one or more species of bacteria comprise Gardnerella vaginalis, Mobiluncus mulieris, or a combination thereof.

### Claim 8 (depends on 5)

The method of claim 5, wherein the weak acid is selected from the group consisting of boric acid, lactic acid, ascorbic acid, acetic acid, citric acid, hydrogen sulfide, propionic acid, and carbonic acid.

### Claim 9 (depends on 5)

The method of claim 5, wherein the one or more species of bacteria comprise Gardnerella vaginalis, Mobiluncus mulieris, or a combination thereof.

### Claim 10

A method for inhibiting growth of Gardnerella vaginalis, Mobiluncus mulieris, or a combination thereof, comprising:
preparing a composition consisting of (i) a protonated creatinine, a protonated creatinine salt, or combinations thereof, (ii) a weak acid, and (iii) a probiotic, prebiotic, or combinations thereof, wherein the protonated creatinine, protonated creatinine salt, or combination thereof is present in the composition in an amount of about 10 mg to about 300 mg and the weak acid is present in the composition in an amount of about 500 mg to about 700 mg; and
subjecting the Gardnerella vaginalis, Mobiluncus mulieris, or a combination thereof to the composition.

### Claim 11 (depends on 10)

The method of claim 10, wherein the weak acid is selected from the group consisting of boric acid, lactic acid, ascorbic acid, acetic acid, citric acid, hydrogen sulfide, propionic acid, carbonic acid, and combinations thereof.

### Claim 12 (depends on 10)

The method of claim 10, wherein the probiotic is of the Lactobacillus species.

### Claim 13 (depends on 10)

The method of claim 10, wherein the prebiotic is selected from the group consisting of short chain fructo-oligosaccharides, inulin, lactulose, galactooligosaccharide, isomalto-oligosaccharide, soy-oligosaccharide, and xylo-oligosaccharide.

### Claim 14 (depends on 5)

The method of claim 5, wherein the weak acid is boric acid.

### Claim 15 (depends on 10)

The method of claim 10, wherein the weak acid is boric acid.
