Compositions for the treatment of hypertension

• US 10,369,156 B2
• Filed: 11/15/2016
• Issued: 08/06/2019
• Est. Priority Date: 11/15/2016
• Status: Active Grant

• Current Assignee: University of Sydney
• Original Assignee: The George Institute For Global Health
• Inventors: Rodgers, Anthony, Chow, Clara
• Primary Examiner(s): Ricci, Craig D
• Application Number:
  US15/352,425
• Publication Number:
  US 20180133227A1
• Time in Patent Office: 994 Days
• Field of Search: None
• CPC Class Codes: A61K 31/138 Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine atenolol A61K31/165; pindolol A61K31/404; timolol A61K31/5377
• CPC Class Codes: A61K 31/165 having aromatic rings, e.g. colchicine, atenolol, progabide
• CPC Class Codes: A61K 31/4035 Isoindoles, e.g. phthalimide
• CPC Class Codes: A61K 31/404 Indoles, e.g. pindolol
• CPC Class Codes: A61K 31/4184 condensed with carbocyclic rings, e.g. benzimidazoles
• CPC Class Codes: A61K 31/4422 1,4-Dihydropyridines, e.g. nifedipine, nicardipine
• CPC Class Codes: A61K 31/549 having two or more nitrogen atoms in the same ring, e.g. hydrochlorothiazide
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61K 9/48 Preparations in capsules, e.g. of gelatin, of chocolate A61K9/0004 takes precedence; bite capsules A61K9/0056
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 7/10 Antioedematous agents; Diuretics
• CPC Class Codes: A61P 9/12 Antihypertensives

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

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.

2. 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.

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

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.

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

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