# US 10,765,630 B2 · Methods and compositions to treat enteropathic arthritis

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- Number: US 10,765,630 B2
- Document ID: US10765630B2
- Status: Granted
- Kind: B2
- Application number: 16/355,147
- Filed: 2019-03-15
- Published: 2019-09-19
- Granted: 2020-09-08
- Earliest claimed: 2018-03-16
- Assignees: Sen-Jam Pharmaceutical LLC
- Applicants: Sen-Jam Pharmaceutical LLC
- Inventors: Jacqueline Iversen; Thomas A. Dahl
- Web page: https://patentgrep.com/patent/US10765630B2

## CPC

- A61K 9/0058: {Chewing gums (non-medicinal aspects, preparing chewing gum A23G4/00; chewing gum for care of the teeth or oral cavity, e.g. with breath freshener A61Q11/00)}
- A61K 9/0056: {Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals}
- A61K 31/192: having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid {(cannabinoids A61K31/658)}
- A61K 31/445: Non condensed piperidines, e.g. piperocaine
- A61K 31/4465: only substituted in position 4
- A61K 31/4535: containing a heterocyclic ring having sulfur as a ring hetero atom, e.g. pizotifen
- A61K 31/4545: containing a six-membered ring with nitrogen as a ring hetero atom, e.g. pipamperone, anabasine
- A61K 31/616: by carboxylic acids, e.g. acetylsalicylic acid
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 19/00: Drugs for skeletal disorders
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- 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 is a method of treating enteropathic arthritis in a human subject in need thereof. The method comprises administering an effective amount of a pharmaceutical composition to the subject, wherein the pharmaceutical composition comprises: a) a non-steroidal anti-inflammatory drug (NSAID), and/or a salt thereof; and b) a co-agent selected from the group consisting of: fexofenadine, ketotifen, desloratadine, cetirizine, salts thereof and combinations thereof.

## Claims

### Claim 1

A method of treating enteropathic arthritis in a human subject in need thereof, comprising:
administering an effective amount of a pharmaceutical composition to the subject, wherein the pharmaceutical composition consists of:
a) a non-steroidal anti-inflammatory drug (NSAID), and/or a salt thereof;
b) a co-agent selected from the group consisting of: fexofenadine, ketotifen, desloratadine, cetirizine, salts thereof and combinations thereof; and
c) optionally, a pharmaceutical carrier, a pharmaceutical excipient, a sweetening agent, a flavoring agent, a taste masking ingredient, a diluent, alum, a stabilizer, a buffer, a coloring agent, a breath neutralizer, an emulsifying agent, a suspending agent, and combinations thereof,
wherein enteropathic arthritis is treated.

### Claim 2 (depends on 1)

The method of claim 1, wherein the NSAID is selected from the group consisting of: aspirin, ibuprofen, naproxen, diclofenac, diflunisal, etodolac, indomethacin, ketoprofen, ketorolac, meloxicam, nabumetone, oxaprozin, piroxicam, salsalate, sulindac, and tolmetin.

### Claim 3 (depends on 1)

The method of claim 1, wherein the NSAID is naproxen sodium and the co-agent is fexofenadine.

### Claim 4 (depends on 3)

The method of claim 3, wherein the amount of naproxen sodium is about 220 mg to about 880 mg, and the amount of fexofenadine is about 60 mg to about 180 mg.

### Claim 5 (depends on 4)

The method of claim 4, wherein the naproxen sodium and the fexofenadine are combined into a one unit dose.

### Claim 6 (depends on 5)

The method of claim 5, wherein the naproxen sodium and the fexofenadine are in the form of an orally-dissolving tablet, lozenge or chewing gum.

### Claim 7 (depends on 2)

The method of claim 2, wherein the amount of ibuprofen is about 200 mg to about 800 mg.

### Claim 8 (depends on 2)

The method of claim 2, wherein the amount of aspirin is about 325 mg to about 1000 mg.

### Claim 9 (depends on 1)

The method of claim 1, wherein the amount of ketotifen is about 0.5 mg to about 3 mg.

### Claim 10 (depends on 1)

The method of claim 1, wherein the amount of desloratidine is about 5 mg to about 10 mg.

### Claim 11

A method of treating enteropathic arthritis in a subject in need thereof, comprising:
administering to the subject an effective amount of a pharmaceutical composition, wherein the pharmaceutical composition consists of:
a) about 220 mg to about 880 mg of naproxen sodium, and about 60 mg to about 180 mg fexofenadine; and
b) optionally, a pharmaceutical carrier, a pharmaceutical excipient, a sweetening agent, a flavoring agent, a taste masking ingredient, a diluent, alum, a stabilizer, a buffer, a coloring agent, a breath neutralizer, an emulsifying agent, a suspending agent, and combinations thereof,
wherein the enteropathic arthritis is treated.

### Claim 12

A pharmaceutical composition consisting of: a) an NSAID, and/or a salt thereof; b) a co-agent selected from the group consisting of:
fexofenadine, ketotifen, desloratadine, cetirizine salts thereof and combinations thereof; and c) optionally, a pharmaceutical carrier, a pharmaceutical excipient, a sweetening agent, a flavoring agent, a taste masking ingredient, a diluent, alum, a stabilizer, a buffer, a coloring agent, a breath neutralizer, an emulsifying agent, a suspending agent, and combinations thereof.

### Claim 13 (depends on 12)

The pharmaceutical composition of claim 12, wherein the composition is in the form of an orally-dissolving tablet or lozenge.

### Claim 14 (depends on 12)

The pharmaceutical composition of claim 12, wherein the NSAID is selected from the group consisting of: aspirin, ibuprofen, naproxen, diclofenac, diflunisal, etodolac, indomethacin, ketoprofen, ketorolac, meloxicam, nabumetone, oxaprozin, piroxicam, salsalate, sulindac, and tolmetin.

### Claim 15 (depends on 12)

The pharmaceutical composition of claim 12, wherein the NSAID is naproxen sodium and the co-agent is fexofenadine.

### Claim 16 (depends on 15)

The pharmaceutical composition of claim 15, wherein the amount of naproxen sodium is about 110 mg to about 900 mg, and the amount of fexofenadine is about 25 mg to about 200 mg.