# US 11,872,216 B2 · Pharmaceutical formulation comprising cineole and amoxicillin

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- Number: US 11,872,216 B2
- Document ID: US11872216B2
- Status: Granted
- Kind: B2
- Application number: 16/306,262
- Filed: 2017-06-02
- Published: 2019-08-22
- Granted: 2024-01-16
- Earliest claimed: 2016-06-02
- Assignees: Advanced Scientific Developments
- Applicants: Advanced Scientific Developements
- Inventors: Adnane Remmal; Ahmed Amine Akhmouch
- Web page: https://patentgrep.com/patent/US11872216B2

## CPC

- A61K 31/43: Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula [IMAGE cpc-sch-A61K-0952.gif], e.g. penicillins, penems
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/0095: {Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches (A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006)}
- A61K 9/10: Dispersions; Emulsions
- A61K 9/145: {with organic compounds}
- A61K 9/146: {with organic macromolecular compounds}
- A61K 31/424: condensed with heterocyclic ring systems, e.g. clavulanic acid
- A61P 1/02: Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 13/00: Drugs for disorders of the urinary system
- A61P 13/10: of the bladder
- A61P 13/12: of the kidneys
- A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 19/08: for bone diseases, e.g. rachitism, Paget's disease
- A61P 27/16: Otologicals
- A61P 31/04: Antibacterial agents
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- 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

The present invention relates to a pharmaceutical formulation in powder form comprising amoxicillin, cineole and a pharmaceutically acceptable oil. The present formulation may also comprise clavulanic acid. It is intended for oral administration, preferably after suspension in an aqueous solvent. The present invention also relates to a combination of cineole and amoxicillin for use in the treatment of an infectious pathology, preferably a bacterial infection, in an individual. The present combination may also comprise a β-lactamase inhibitor, preferably clavulanic acid. The combination according to the invention makes it possible in particular to combat infections caused by bacteria that are resistant to antibiotics, preferably to antibiotics of the β-lactamine family.

## Claims

### Claim 1

A pharmaceutical formulation in powder form comprising cineole, amoxicillin, and groundnut oil, wherein the formulation comprises a cineole/groundnut oil mass ratio of between 0.1 and 5 and wherein the formulation does not comprise a detergent.

### Claim 2 (depends on 1)

The formulation according to claim 1, wherein said formulation also comprises a β-lactamase inhibitor.

### Claim 3 (depends on 1)

The formulation according to claim 1, wherein said formulation comprises between about 5 mg and about 100 mg of cineole per gram of powder.

### Claim 4 (depends on 1)

The formulation according to claim 1, wherein said formulation comprises between about 20 mg and about 500 mg of amoxicillin per gram of powder.

### Claim 5 (depends on 1)

The formulation according to claim 1, wherein said formulation comprises between about 2 mg and about 50 mg of groundnut oil per gram of powder.

### Claim 6 (depends on 2)

The formulation according to claim 2, wherein said β-lactamase inhibitor is clavulanic acid and said formulation comprises between about 1 mg and about 100 mg of clavulanic acid per gram of powder.

### Claim 7 (depends on 1)

The formulation according to claim 1, wherein the amoxicillin/cineole mass ratio is between 2 and 8.

### Claim 8 (depends on 1)

The formulation according to claim 1, wherein the amoxicillin/groundnut oil mass ratio is between 5 and 15.

### Claim 9 (depends on 2)

The formulation according to claim 2, wherein the amoxicillin/β-lactamase inhibitor mass ratio is between 5 and 11.

### Claim 10 (depends on 1)

The formulation according to claim 1, wherein said formulation also comprises at least one pharmaceutically acceptable excipient or support.

### Claim 11 (depends on 2)

The formulation according to claim 2, said formulation comprising groundnut oil, cineole, amoxicillin, and clavulanic acid.

### Claim 12 (depends on 1)

The formulation according to claim 1, wherein the cineole/groundnut oil mass ratio is about 2.

### Claim 13 (depends on 1)

A method of treating a bacterial infection in an individual comprising the administration of a formulation according to claim 1 to said individual.

### Claim 14 (depends on 13)

The method according to claim 13, wherein said bacterial infection is selected from the group consisting of cystitis, recurring acute cystitis, bacterial sinusitis, acute maxillary sinusitis, otitis, acute otitis media, bronchitis, chronic and/or acute bronchitis, bronchopneumopathy, chronic and/or acute bronchopneumopathy, pyelonephritis, upper genital tract infections, parodontitis, severe stomatological infections, abscesses, phlegmons, cellulites, animal bites, bone infections, joint infections, and osteomyelitis.