# US 10,765,691 B2 · Method for treating crohn's disease using triple antimicrobial all-in-one formulation

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- Number: US 10,765,691 B2
- Document ID: US10765691B2
- Status: Granted
- Kind: B2
- Application number: 16/554,201
- Filed: 2019-08-28
- Published: 2020-01-30
- Granted: 2020-09-08
- Earliest claimed: 2008-02-08
- Assignees: RedHill Biopharma Ltd.
- Applicants: RedHill Biopharma Ltd.
- Inventors: Thomas Julius Borody; Patrick Gosselin
- Web page: https://patentgrep.com/patent/US10765691B2

## CPC

- A61K 31/7048: having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin {, digitoxin or digoxin}
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/48: Preparations in capsules, e.g. of gelatin, of chocolate {(A61K9/0004 takes precedence; bite capsules A61K9/0056)}
- A61K 31/395: having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K 31/435: having six-membered rings with one nitrogen as the only ring hetero atom
- A61K 31/438: The ring being spiro-condensed with carbocyclic or heterocyclic ring systems
- A61K 31/44: Non condensed pyridines; Hydrogenated derivatives thereof
- A61K 31/498: Pyrazines or piperazines ortho- and peri-condensed with carbocyclic ring systems, e.g. quinoxaline, phenazine
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- 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

Oral administration of a solid dosage form of the present invention comprising an effective amount of rifabutin, an effective amount of clarithromycin, an effective amount of clofazimine, and an effective amount of an absorption enhancer, is used to treat a subject suffering from, or susceptible to, Mycobacterium avium subspecies paratuberculosis infection. In an embodiment, the solid dosage form is sufficiently designed to result in a reduction in the increased metabolism of clarithromycin caused by rifabutin. In an embodiment, the solid dosage form is sufficiently designed to result in a reduction in the metabolism of rifabutin caused by clarithromycin. In an embodiment, the solid dosage form is sufficiently designed to result in a reduction in risk of a subject developing leucopenia or uveitis as a result of rifabutin.

## Claims

### Claim 1

A method of treating Crohn's disease in a patient, the method comprising: administering a pharmaceutical composition to a patient in need thereof, wherein the pharmaceutical composition comprises a fixed-dose combination of rifabutin, clarithromycin, and a clofazimine-polymer solid dispersion, wherein the co-formulated fixed-dose combination comprises 30-60 mg rifabutin, 65-125 mg clarithromycin and 4-16 mg clofazimine.

### Claim 2 (depends on 1)

The method of claim 1, wherein rifabutin is at a dose of 45 mg, clarithromycin is at a dose of 95 mg, and clofazimine is at a dose of 10 mg.

### Claim 3 (depends on 1)

The method of claim 1, wherein the pharmaceutical composition is a capsule.