# US 2014/0155485 A1 · Compositions and Methods for Treating Chronic Inflammation and Inflammatory Diseases

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- Number: US 2014/0155485 A1
- Document ID: US20140155485A1
- Status: Published application
- Kind: A1
- Application number: 14/155,042
- Filed: 2014-01-14
- Published: 2014-06-05
- Earliest claimed: 2010-10-29
- Assignees: Biocopea Limited
- Applicants: Biocopea Limited
- Inventors: Robin M. Bannister; John Brew; Wilson Caparros-Wanderely; Suzanne J. Dilly; Olga Pleguezeulos Mateo; Gregory A. Stoloff
- Web page: https://patentgrep.com/patent/US20140155485A1

## CPC

- A61K 47/14: Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 9/2013: {Organic compounds, e.g. phospholipids, fats}
- A61K 31/192: having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid {(cannabinoids A61K31/658)}
- A61K 31/60: Salicylic acid; Derivatives thereof
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/44: Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin (synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14)
- A61K 31/19: Carboxylic acids, e.g. valproic acid (salicylic acid A61K31/60)
- A61K 31/202: having three or more double bonds, e.g. linolenic (eicosanoids, e.g. leukotrienes A61K31/557)
- A61K 31/25: with polyoxyalkylated alcohols, e.g. esters of polyethylene glycol
- A61K 31/337: having four-membered rings, e.g. taxol
- A61K 31/704: attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin {(digitoxin A61K31/7048)}
- 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)

## Abstract

The present specification discloses pharmaceutical compositions, methods of preparing such pharmaceutical compositions, and methods and uses of treating a chronic inflammation and/or an inflammatory disease in an individual using such pharmaceutical compositions.

## Claims

### Claim 1

A pharmaceutical composition comprising: a) a therapeutic compound, wherein the therapeutic compound has an anti-inflammatory activity; b) a pharmaceutically-acceptable solvent comprises a pharmaceutically-acceptable glycol ether; and c) a pharmaceutically-acceptable adjuvant comprises a pharmaceutically-acceptable lipid, wherein the ratio of the pharmaceutically-acceptable solvent to pharmaceutically-acceptable adjuvant is in a range from about 0:1 to about 1:25.

### Claim 2 (depends on 1)

The pharmaceutical composition according to claim 1, wherein the pharmaceutically-acceptable glycol ether comprises diethylene glycol monomethyl ether (2-(2-methoxyethoxy)ethanol), diethylene glycol monoethyl ether (2-(2-ethoxyethoxy)ethanol), diethylene glycol monopropyl ether (2-(2-propoxyethoxy)ethanol), diethylene glycol monoisopropyl ether (2-(2-isopropoxyethoxy)ethanol), diethylene glycol mono-n-butyl ether (2-(2-butoxyethoxy)ethanol), or any combination thereof.

### Claim 3 (depends on 1)

The pharmaceutical composition according to claim 1, wherein the pharmaceutically-acceptable lipid comprises a pharmaceutically-acceptable glycerolipid, a pharmaceutically-acceptable glycol fatty acid ester, a pharmaceutically-acceptable polyether fatty acid ester, a mixture of pharmaceutically-acceptable lipids, or any combination thereof.

### Claim 4 (depends on 3)

The pharmaceutical composition according to claim 3, wherein the pharmaceutically-acceptable glycol fatty acid ester is a monoester of a glycol, a diester of a glycol, or a triester of a glycol.

### Claim 5 (depends on 3)

The pharmaceutical composition according to claim 3, wherein the pharmaceutically-acceptable glycol fatty acid ester is a ethylene glycol fatty acid ester, a diethylene glycol fatty acid ester, a propylene glycol fatty acid ester, and a dipropylene fatty acid ester.

### Claim 6 (depends on 3)

The pharmaceutical composition according to claim 3, wherein the pharmaceutically-acceptable polyether fatty acid ester is a mono-fatty acid ester of a polyether, a di-fatty acid ester of a polyether, or a tri-fatty acid ester of a polyether.

### Claim 7 (depends on 3)

The pharmaceutical composition according to claim 3, wherein the pharmaceutically-acceptable polyether fatty acid ester includes a PEG fatty acid ester, a PEG glyceryl fatty acid, a PEG fatty acid ester glyceride, a PPG fatty acid ester, a PPG glyceryl fatty acid, or a PPG fatty acid ester glyceride.

### Claim 8 (depends on 3)

The pharmaceutical composition according to claim 3, wherein the mixture of pharmaceutically-acceptable lipids is a mixture of mono-, di-, and triglycerides and PEG fatty acid esters having a melting point of about 39° C.

### Claim 9 (depends on 3)

The pharmaceutical composition according to claim 3, wherein the mixture of pharmaceutically-acceptable lipids is a mixture of pharmaceutically-acceptable lipids includes mono-, di-, and triglycerides and PEG fatty acid esters having a melting point of about 43° C.

### Claim 10

A solid pharmaceutical composition comprising: a) a non-steroidal anti-inflammatory drug (NSAID), wherein the NSAID has an anti-inflammatory activity; b) a pharmaceutically-acceptable solvent comprising a pharmaceutically-acceptable glycol ether; and c) a pharmaceutically-acceptable adjuvant comprising a mixture of pharmaceutically-acceptable lipids, wherein the ratio of the pharmaceutically-acceptable solvent to pharmaceutically-acceptable adjuvant is in a range from about 0:1 to about 1:25.

### Claim 11 (depends on 10)

The solid pharmaceutical composition according to claim 10, wherein the pharmaceutically-acceptable glycol ether comprises diethylene glycol monomethyl ether (2-(2-methoxyethoxy)ethanol), diethylene glycol monoethyl ether (2-(2-ethoxyethoxy)ethanol), diethylene glycol monopropyl ether (2-(2-propoxyethoxy)ethanol), diethylene glycol monoisopropyl ether (2-(2-isopropoxyethoxy)ethanol), diethylene glycol mono-n-butyl ether (2-(2-butoxyethoxy)ethanol), or any combination thereof.

### Claim 12 (depends on 10)

The solid pharmaceutical composition according to claim 10, wherein the mixture of pharmaceutically-acceptable lipids is a mixture of mono-, di-, and triglycerides and PEG fatty acid esters having a melting point of about 39° C.

### Claim 13 (depends on 10)

The solid pharmaceutical composition according to claim 10, wherein the mixture of pharmaceutically-acceptable lipids is a mixture of pharmaceutically-acceptable lipids includes mono-, di-, and triglycerides and PEG fatty acid esters having a melting point of about 43° C.

### Claim 14

A solid pharmaceutical composition comprising: a) about 10% to 30% by weight of a non-steroidal anti-inflammatory drug (NSAID), wherein the NSAID has an anti-inflammatory activity; b) about 20% to about 50% by weight of a mixture of mono-, di-, and triglycerides and PEG fatty acid esters; c) about 10% to about 30% by weight of a glyceryl monolinoleate, and d) about 5% to about 15% of a PEG.

### Claim 15 (depends on 14)

The solid pharmaceutical composition according to claim 14, wherein the NSAID is about 20% to about 30% by weight of the pharmaceutical composition.

### Claim 16 (depends on 14)

The solid pharmaceutical composition according to claim 14, wherein the mixture of mono-, di-, and triglycerides and PEG fatty acid esters is about 35% to about 45% by weight of the pharmaceutical composition.

### Claim 17 (depends on 14)

The solid pharmaceutical composition according to claim 14, wherein the glyceryl monolinoleate is about 15% to about 25% by weight of the pharmaceutical composition.

### Claim 18 (depends on 14)

The solid pharmaceutical composition according to claim 14, wherein the PEG is about 7% to about 13% by weight of the pharmaceutical composition.

### Claim 19 (depends on 14)

The solid pharmaceutical composition according to claim 14, wherein the NSAID is about 23% to about 27% by weight of the pharmaceutical composition, the mixture of mono-, di-, and triglycerides and PEG fatty acid esters is about 41% to about 47% by weight of the pharmaceutical composition, the glyceryl monolinoleate is about 18% to about 22% by weight of the pharmaceutical composition, and the PEG is about 9% to about 11% by weight of the pharmaceutical composition.

### Claim 20 (depends on 14)

The solid pharmaceutical composition according to claim 14, wherein the solid pharmaceutical composition further comprises about 5% to about 15% propylene glycol.
