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Claims for Patent: 8,101,599

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Claims for Patent: 8,101,599

Title:Pharmaceutical composition containing anti-hypertensive agents
Abstract: The present invention relates to a combination of organic compounds, a pharmaceutical composition and a kit of parts comprising said combination of organic compounds and to a method of treatment or prevention of certain conditions or diseases.
Inventor(s): Shetty; Suraj S (Far Hills, NJ), Webb; Randy L (Flemington, NJ)
Assignee: Novartis AG (Basel, CH)
Application Number:12/338,066
Patent Claims: 1. A pharmaceutical composition comprising (i) a pharmaceutically effective amount of valsartan or a pharmaceutically acceptable salt thereof, (ii) a pharmaceutically effective amount of amlodipine or a pharmaceutically acceptable salt thereof, and (iii) a pharmaceutically effective amount of hydrochlorothiazide or a pharmaceutically acceptable salt thereof.

2. The pharmaceutical composition of claim 1, wherein said composition is a fixed dose combination.

3. The pharmaceutical composition of claim 2, wherein said fixed dose combination is in the form of a capsule or tablet.

4. The pharmaceutical composition of claim 1, 2 or 3, wherein valsartan is present in an amount from about 20 to about 640 mg; amlodipine is present in an amount from about 1 mg to about 60 mg; and hydrochlorothiazide is present in an amount from about 5 mg to about 200 mg.

5. The pharmaceutical composition of claim 1, 2 or 3, wherein valsartan is present in an amount from about 40 to about 320 mg; amlodipine is present in an amount from about 2.5 mg to about 10 mg; and hydrochlorothiazide is present in an amount from about 5 mg to about 25 mg.

6. The pharmaceutical composition of claim 1, 2 or 3, wherein valsartan is present in an amount from about 160 to about 320 mg; amlodipine is present in an amount from about 5 to about 10 mg; and hydrochlorothiazide is present in an amount from about 12.5 to about 25 mg.

7. The pharmaceutical composition of claim 1, 2 or 3, wherein valsartan is present in an amount of about 160 mg; amlodipine is present in an amount of about 10 mg; and hydrochlorothiazide is present in an amount of about 12.5 mg.

8. The pharmaceutical composition of claim 1, 2 or 3, wherein valsartan is present in an amount of about 160 mg; amlodipine is present in an amount of about 10 mg; and hydrochlorothiazide is present in an amount of about 25 mg.

9. The pharmaceutical composition of claim 1, 2 or 3, wherein valsartan is present in an amount of about 320 mg; amlodipine is present in an amount of about 10 mg; and hydrochlorothiazide is present in an amount of about 25 mg.

10. The pharmaceutical composition of claim 1, 2 or 3, wherein valsartan is present in an amount of about 160 mg; amlodipine is present in an amount of about 5 mg; and hydrochlorothiazide is present in an amount of about 12.5 mg.

11. The pharmaceutical composition of claim 1, 2 or 3, wherein valsartan is present in an amount of about 160 mg; amlodipine is present in an amount of about 5 mg; and hydrochlorothiazide is present in an amount of about 25 mg.

12. The pharmaceutical composition of claim 7, wherein amlodipine is present in a pharmaceutically acceptable besylate salt form.

13. The pharmaceutical composition of claim 8, wherein amlodipine is present in a pharmaceutically acceptable besylate salt form.

14. The pharmaceutical composition of claim 9, wherein amlodipine is present in a pharmaceutically acceptable besylate salt form.

15. The pharmaceutical composition of claim 10, wherein amlodipine is present in a pharmaceutically acceptable besylate salt form.

16. The pharmaceutical composition of claim 11, wherein amlodipine is present in a pharmaceutically acceptable besylate salt form.

17. A kit comprising: (i) a pharmaceutically acceptable dose unit comprising a pharmaceutically effective amount of valsartan or a pharmaceutically acceptable salt thereof, (ii) a pharmaceutically acceptable dose unit comprising a pharmaceutically effective amount of amlodipine or a pharmaceutically acceptable salt thereof, and (iii) a pharmaceutically acceptable dose unit comprising a pharmaceutically effective amount of hydrochlorothiazide or a pharmaceutically acceptable salt thereof, wherein two of said pharmaceutically acceptable dose units can optionally take the form of a single pharmaceutically acceptable dose unit.

18. The kit of claim 17 wherein amlodipine is present in a pharmaceutically acceptable besylate salt form.

19. The kit of claim 17 or 18, wherein the amount of valsartan present in one of said dose units is from about 20 to about 640 mg; the amount of amlodipine present in one of said dose units is from about 1 mg to about 60 mg; and the amount of hydrochlorothiazide present in one of said dose units is from about 5 mg to about 200 mg.

20. The kit of claim 17 or 18, wherein the amount of valsartan present in one of said dose units is from about 40 to about 320 mg; the amount of amlodipine present in one of said dose units is from about 2.5 mg to about 10 mg; and the amount of hydrochlorothiazide present in one of said dose units is from about 5 mg to about 25 mg.

21. The kit of claim 17 or 18, wherein the amount of valsartan present in one of said dose units is from about 160 to about 320 mg; the amount of amlodipine present in one of said dose units is from about 5 to about 10 mg; and the amount of hydrochlorothiazide present in one of said dose units is from about 12.5 to about 25 mg.

22. The kit of claim 17 or 18, wherein the amount of valsartan present in one of said dose units is about 160 mg; the amount of amlodipine present in one of said dose units is about 10 mg; and the amount of hydrochlorothiazide present in one of said dose units is about 12.5 mg.

23. The kit of claim 17 or 18, wherein the amount of valsartan present in one of said dose units is about 160 mg; the amount of amlodipine present in one of said dose units is about 10 mg; and the amount of hydrochlorothiazide present in one of said dose units is about 25 mg.

24. The kit of claim 17 or 18, wherein the amount of valsartan present in one of said dose units is about 320 mg; the amount of amlodipine present in one of said dose units is about 10 mg; and the amount of hydrochlorothiazide present in one of said dose units is about 25 mg.

25. The kit of claim 17 or 18, wherein the amount of valsartan present in one of said dose units is about 160 mg; the amount of amlodipine present in one of said dose units is about 5 mg; and the amount of hydrochlorothiazide present in one of said dose units is about 12.5 mg.

26. The kit of claim 17 or 18, wherein the amount of valsartan present in one of said dose units is about 160 mg; the amount of amlodipine present in one of said dose units is about 5 mg; and the amount of hydrochlorothiazide present in one of said dose units is about 25 mg.

27. The kit of claim 17 or 18 further comprising a set of instructions, wherein said instructions provide guidance on the use of said dose units for either: (A) the treatment of or delaying the onset of a condition or disease selected from the group consisting of hypertension, peripheral edema, heart failure, congestive heart failure, left ventricular dysfunction, hypertrophic cardiomyopathy, diabetic cardiac myopathy, supraventricular arrhythmia, ventricular arrhythmia, atrial fibrillation, atrial flutter, detrimental vascular remodeling, myocardial infarction, sequelae of myocardial infarction, atherosclerosis, angina, renal insufficiency, angina pectoris, diabetes, secondary aldosteronism, pulmonary hypertension, and renal failure; or (B) the management of a condition or disease selected from the group consisting of migraine, peripheral vascular disease, Raynaud's disease, luminal hyperplasia, cognitive dysfunction, glaucoma and stroke.

28. The kit of claim 27, wherein said instructions provide guidance on the use of said dose units for the treatment of or delaying the onset of a condition or disease selected from the group consisting of hypertension and peripheral edema.

29. The kit of claim 28, wherein said instructions provide guidance on the use of said dose units for the treatment of or delaying the onset of hypertension.

30. The kit of claim 28, wherein said instructions provide guidance on the use of said dose units for the treatment of or delaying the onset of peripheral edema.
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