# US 10,369,156 B2 · Compositions for the treatment of hypertension

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- Number: US 10,369,156 B2
- Document ID: US10369156B2
- Status: Granted
- Kind: B2
- Application number: 15/352,425
- Filed: 2016-11-15
- Published: 2018-05-17
- Granted: 2019-08-06
- Earliest claimed: 2016-11-15
- Assignees: The George Institute for Global Health; The University of Sydney
- Applicants: The George Institute for Global Health; The University of Sydney
- Inventors: Anthony Rodgers; Clara Chow
- Web page: https://patentgrep.com/patent/US10369156B2

## CPC

- A61K 31/549: having two or more nitrogen atoms in the same ring, e.g. hydrochlorothiazide
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 31/138: Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine (atenolol A61K31/165; pindolol A61K31/404; timolol A61K31/5377)
- A61K 31/165: having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K 31/4035: Isoindoles, e.g. phthalimide
- A61K 31/404: Indoles, e.g. pindolol
- A61K 31/4184: condensed with carbocyclic rings, e.g. benzimidazoles
- A61K 31/4422: 1,4-Dihydropyridines, e.g. nifedipine, nicardipine
- A61P 7/10: Antioedematous agents; Diuretics
- A61P 9/12: Antihypertensives
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61K 9/48: Preparations in capsules, e.g. of gelatin, of chocolate {(A61K9/0004 takes precedence; bite capsules A61K9/0056)}
- 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

Provided herein are pharmaceutical compositions that are useful for the treatment of hypertension comprising an angiotensin II receptor blocker, a diuretic, a calcium channel blocker, and a beta-blocker, wherein the dose of each component is below the lowest dose approved for the treatment of hypertension for the component.

## Claims

### Claim 1

A pharmaceutical composition comprising
(a) irbesartan;
(b) hydrochlorothiazide;
(c) amlodipine besylate; and
(d) atenolol;
wherein the dose of irbesartan is about 37.5 mg, the dose of hydrochlorothiazide is about 6.25 mg, the dose of amlodipine besylate is about 1.25 mg, and the dose of atenolol is about 12.5 mg, wherein (a), (b), (c) and (d) are provided in one formulation.

### Claim 2 (depends on 1)

The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is essentially free of a lipid-regulating agent, platelet function altering agent, a serum homocysteine lowering agent, or a combination thereof.

### Claim 3 (depends on 1)

The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is suitable for oral administration.

### Claim 4

A method of treating hypertension in a subject in need thereof comprising administering the pharmaceutical composition comprising:
(a) irbesartan;
(b) hydrochlorothiazide;
(c) amlodipine besylate; and
(d) atenolol;
wherein the dose of irbesartan is about 37.5 mg, the dose of hydrochlorothiazide is about 6.25 mg, the dose of amlodipine besylate is about 1.25 mg, and the dose of atenolol is about 12.5 mg, wherein (a), (b), (c) and (d) are provided in one formulation.

### Claim 5 (depends on 4)

The method of claim 4, wherein the treatment results in a reduction of systolic blood pressure (SBP) of about 10 mmHg or greater.

### Claim 6 (depends on 4)

The method of claim 4, wherein the treatment results in a reduction of diastolic blood pressure (DBP) of about 5 mmHg or greater.