# US 11,992,555 B2 · Solid solution compositions and use in chronic inflammation

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- Number: US 11,992,555 B2
- Document ID: US11992555B2
- Status: Granted
- Kind: B2
- Application number: 17/448,263
- Filed: 2021-09-21
- Published: 2022-02-10
- Granted: 2024-05-28
- Earliest claimed: 2010-10-29
- Assignees: Infirst Healthcare Limited
- Applicants: Infirst Healthcare Limited
- Inventors: Robin M. Bannister; John Brew; Richard R. Reiley, III; Wilson Caparros Wanderley
- Web page: https://patentgrep.com/patent/US11992555B2

## CPC

- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 9/148: {with compounds of unknown constitution, e.g. material from plants or animals (with oils, fats, waxes, shellac A61K9/145)}
- A61K 31/12: Ketones
- A61K 31/137: Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone}
- A61K 31/167: having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
- A61K 31/192: having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid {(cannabinoids A61K31/658)}
- A61K 31/196: the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
- A61K 31/216: of acids having aromatic rings, e.g. benactizyne, clofibrate
- A61K 31/357: having two or more oxygen atoms in the same ring, e.g. crown ethers, guanadrel
- A61K 31/366: having six-membered rings, e.g. delta-lactones
- A61K 31/4178: not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
- A61K 31/4184: condensed with carbocyclic rings, e.g. benzimidazoles
- A61K 31/522: having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
- A61K 31/60: Salicylic acid; Derivatives thereof
- A61K 31/616: by carboxylic acids, e.g. acetylsalicylic acid
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/14: Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
- A61K 31/19: Carboxylic acids, e.g. valproic acid (salicylic acid A61K31/60)
- A61K 31/201: having one or two double bonds, e.g. oleic, linoleic acids
- 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 solid solution pharmaceutical composition comprising:
a) 25% to 31% by weight of an ibuprofen, or a pharmaceutically acceptable salt, solvate, or solvate of a salt thereof;
b) 34% to 40% by weight of one or more fats comprising a mixture of saturated C10-C18 triglycerides;
c) 22% to 28% by weight of one or more partially hydrolyzed liquid lipids comprising a mixture of monoglycerides, diglycerides and triglycerides; and
d) 7% to 13% by weight of a liquid polyethylene glycol polymer.

### Claim 2 (depends on 1)

The solid solution pharmaceutical composition according to claim 1, wherein the ibuprofen, or a pharmaceutically acceptable salt, solvate, or solvate of a salt thereof, is in an amount of 26% to 30% by weight.

### Claim 3 (depends on 2)

The solid solution pharmaceutical composition according to claim 2, wherein the ibuprofen, or a pharmaceutically acceptable salt, solvate, or solvate of a salt thereof, is in an amount of 27% to 29% by weight.

### Claim 4 (depends on 1)

The solid solution pharmaceutical composition according to claim 1, wherein the pharmaceutically acceptable salt, solvate, or solvate of a salt of ibuprofen is pharmaceutically acceptable ibuprofen salt.

### Claim 5 (depends on 1)

The solid solution pharmaceutical composition according to claim 1, wherein the one or more fats are in an amount of 35% to 39% by weight.

### Claim 6 (depends on 5)

The solid solution pharmaceutical composition according to claim 5, wherein the one or more fats are in an amount of 36% to 38% by weight.

### Claim 7 (depends on 1)

The solid solution pharmaceutical composition according to claim 1, wherein the one or more partially hydrolyzed liquid lipids is in an amount of 23% to 27%.

### Claim 8 (depends on 7)

The solid solution pharmaceutical composition according to claim 7, wherein the one or more partially hydrolyzed liquid lipids is in an amount of 24% to 26%.

### Claim 9 (depends on 1)

The solid solution pharmaceutical composition according to claim 1, wherein the one or more partially hydrolyzed liquid lipids includes a mixture of C16-C18 monoglycerides, diglycerides and triglycerides derived from corn oil.

### Claim 10 (depends on 1)

The solid solution pharmaceutical composition according to claim 1, wherein the mixture of monoglycerides, diglycerides and triglycerides includes a glycerol monolinoleate.

### Claim 11 (depends on 1)

The solid solution pharmaceutical composition according to claim 1, wherein the liquid polyethylene glycol polymer is in an amount of 8% to 12% by weight.

### Claim 12 (depends on 11)

The pharmaceutical composition according to claim 11, wherein the liquid polyethylene glycol polymer is in an amount of 9% to 11% by weight.

### Claim 13 (depends on 1)

The solid solution pharmaceutical composition according to claim 1, wherein the polyethylene glycol polymer has a molecular weight of no more than 1,000 g/mol.

### Claim 14 (depends on 13)

The solid solution pharmaceutical composition according to claim 13, wherein the polyethylene glycol polymer comprises PEG 100, PEG 200, PEG 300, PEG 400, PEG 500, PEG 600, PEG 700, PEG 800, PEG 900, PEG 1000, or any combination thereof.

### Claim 15 (depends on 14)

The solid solution pharmaceutical composition according to claim 14, wherein the polyethylene glycol polymer is PEG 400.

### Claim 16

A solid solution pharmaceutical composition comprising:
a) 26% to 30% by weight of an ibuprofen, or a pharmaceutically acceptable salt, solvate, or solvate of a salt thereof;
b) 35% to 39% by weight of one or more fats comprising a mixture of saturated C10-C18 triglycerides;
c) 23% to 27% by weight of a partially hydrolyzed liquid lipids comprising a mixture of monoglycerides, diglycerides and triglycerides, the mixture of monoglycerides, diglycerides and triglycerides including a glycerol monolinoleate; and
d) 8% to 12% by weight of a liquid polyethylene glycol polymer, the liquid polyethylene glycol having a molecular weight of no more than 800 g/mol.

### Claim 17 (depends on 16)

The solid solution pharmaceutical composition according to claim 16, wherein the pharmaceutical composition comprises:
a) 27% to 29% by weight of the ibuprofen, or the pharmaceutically acceptable salt, solvate, or solvate of a salt thereof;
b) 36% to 38% by weight of the one or more fats;
c) 24% to 26% by weight of the partially hydrolyzed liquid lipids; and
d) 9% to 11% by weight of the liquid polyethylene glycol polymer, the liquid polyethylene glycol polymer having a weight of about 400 g/mol.

### Claim 18 (depends on 16)

The solid solution pharmaceutical composition according to claim 16, wherein the pharmaceutical composition comprises:
a) 27% to 29% by weight of the ibuprofen, or the pharmaceutically acceptable salt, solvate, or solvate of a salt thereof;
b) 36% to 38% by weight of the one or more fats;
c) 24% to 26% by weight of the partially hydrolyzed liquid lipids; and
d) 9% to 11% by weight of the liquid polyethylene glycol polymer, the liquid polyethylene glycol polymer being PEG 400.

### Claim 19

A solid solution pharmaceutical composition comprising:
a) 26% to 30% by weight of an ibuprofen, or a pharmaceutically acceptable salt, solvate, or solvate of a salt thereof;
b) 35% to 39% by weight of one or more fats comprising a mixture of saturated C10-C18 triglycerides;
c) 23% to 27% by weight of a partially hydrolyzed liquid lipids comprising a mixture of C16-C18 monoglycerides, diglycerides and derived from corn oil, the mixture of C16-C18 monoglycerides, diglycerides and triglycerides including a glycerol monolinoleate; and
d) 8% to 12% by weight of a liquid polyethylene glycol polymer, the liquid polyethylene glycol polymer including a PEG 200, a PEG 300, a PEG 400, a PEG 500, a PEG 600, a PEG 700, a PEG 800, or any combination thereof.

### Claim 20 (depends on 19)

The solid solution pharmaceutical composition according to claim 19, wherein the pharmaceutical composition comprises:
a) 27% to 29% by weight of the ibuprofen, or the pharmaceutically acceptable salt, solvate, or solvate of a salt thereof;
b) 36% to 38% by weight of the one or more fats;
c) 24% to 26% by weight of the partially hydrolyzed liquid lipids; and
d) 9% to 11% by weight of the liquid polyethylene glycol polymer, the liquid polyethylene glycol polymer being PEG 400.
