COMPOSITIONS FOR THE TREATMENT OF HYPERTENSION

• US 20190314383A1
• Filed: 12/11/2018
• Published: 10/17/2019
• Est. Priority Date: 11/15/2016
• Status: Abandoned Application

• Current Assignee: The George Institute For Global Health, University of Sydney
• Original Assignee: The George Institute For Global Health, University of Sydney
• Inventors: RODGERS, Anthony, CHOW, Clara
• Application Number:
  US16/216,840
• Publication Number:
  US 20190314383A1
• Time in Patent Office: Days
• 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) indapamide;

(c) amlodipine besylate; and

(d) bisoprolol fumarate;

wherein the dose of irbesartan is about 30 mg to about 45 mg, the dose of indapamide is about 0.5 mg to about 0.75 mg, the dose of amlodipine besylate is about 1 mg to about 1.5 mg, and the dose of bisoprolol fumarate is about 2 mg to about 3 mg, and wherein (a), (b), (c) and (d) are provided in one formulation.

3. 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.

9. The pharmaceutical composition of claim 1, wherein the dose of the indapamide is about 0.625 mg.

13. The pharmaceutical composition of claim 1, wherein the dose of amlodipine besylate is about 1.25 mg.

17. The pharmaceutical composition of claim 1, wherein the dose of bisoprolol fumarate is about 2.5 mg.

20. The pharmaceutical composition of claim 1, wherein the dose of the irbesartan is about 37.5 mg.

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

2. (canceled)

4-8. -8. (canceled)

10-12. -12. (canceled)

14-16. -16. (canceled)

18-19. -19. (canceled)

21-26. -26.

28. A method of treating hypertension in a subject in need thereof comprising administering the pharmaceutical composition, comprising.

(a) irbesartan;

(b) indapamide;

(c) amlodipine besylate; and

(d) bisoprolol fumarate;

wherein the dose of irbesartan is about 30 mg to about 45 mg, the dose of indapamide is about 0.5 mg to about 0.75 mg, the dose of amlodipine besylate is about 1 mg to about 1.5 mg, and the dose of bisoprolol fumarate is about 2 mg to about 3 mg, and wherein (a), (b), (c) and (d) are provided in one formulation.

29. The method of claim 28, wherein the treatment results in a reduction of systolic blood pressure (SBP) of about 10 mmHg or greater.

30. The method of claim 28, wherein the treatment results in a reduction of diastolic blood pressure (DBP) of about 5 mmHg or greater.

31. The method of claim 28, wherein the dose of the indapamide is about 0.625 mg.

32. The method of claim 28, wherein the dose of amlodipine besylate is about 1.25 mg.

33. The method of claim 28, wherein the dose of bisoprolol fumarate is about 2.5 mg.

34. The method of claim 28, wherein the dose of the irbesartan is about 37.5 mg.