(WO/2005/070463) COMPOSITIONS COMPRISING (S)-AMLODIPINE MALATE AND AN ANGIOTENSIN RECEPTOR BLOCKER AND METHODS OF THEIR USE

(WO/2005/070463) COMPOSITIONS COMPRISING (S)-AMLODIPINE MALATE AND AN ANGIOTENSIN RECEPTOR BLOCKER AND METHODS OF THEIR USE

CLAIMS What is claimed is: 1. A method of treating or managing a cardiovascular disease or disorder comprising administering to a patient in need of such treatment a therapeutically effective amount of : enantiomerically pure (S) -amlodipine malate, or a pharmaceutically acceptable solvate thereof; and an angiotensin receptor blocker, or a pharmaceutically acceptable prodrug, salt or solvate thereof ; wherein the angiotensin receptor blocker is candesartan, eprosartan, telmisartan, irbesartan, losartan, pratosartan, valsartan or olmesartan.

2. A method of preventing a cardiovascular disease or disorder comprising administering to a patient in need of such prevention a prophylactically effective amount of : enantiomerically pure (S) -amlodipine malate, or a pharmaceutically acceptable solvate thereof ; and an angiotensin receptor blocker, or a pharmaceutically acceptable prodrug, salt or solvate thereof; wherein the angiotensin receptor blocker is candesartan, eprosartan, telmisartan, irbesartan, losartan, pratosartan, valsartan or olmesartan.

3. A method of treating or managing a cardiovascular disease or disorder comprising administering to a patient in need of such treatment a therapeutically effective amount of : enantiomerically pure (S) -amlodipine malate, or a pharmaceutically acceptable solvate thereof; an angiotensin receptor blocker, or a pharmaceutically acceptable prodrug, salt or solvate thereof, wherein the angiotensin receptor blocker is candesartan, eprosartan, telmisartan, irbesartan, losartan, pratosartan, valsartan or olmesartan; and a diuretic agent.

4. A method of preventing a cardiovascular disease or disorder comprising administering to a patient in need of such prevention a prophylactically effective amount of : enantiomerically pure (S) -amlodipine malate, or a pharmaceutically acceptable solvate thereof; an angiotensin receptor blocker, or a pharmaceutically acceptable prodrug, salt or solvate thereof, wherein the angiotensin receptor blocker is candesartan, eprosartan, telmisartan, irbesartan, losartan, pratosartan, valsartan or olmesartan; and a diuretic agent.

5. The method of claim 1,2, 3, or 4, wherein the angiotensin receptor blocker is valsartan.

6. The method of claim 1, 2,3, or 4, wherein the angiotensin receptor blocker is eprosartan.

7. The method of claim 1,2, 3, or 4, wherein the angiotensin receptor blocker is irbesartan.

8. The method of claim 1,2, 3, or 4, wherein the angiotensin receptor blocker is telmisartan.

9. The method of claim 1,2, 3, or 4, wherein the angiotensin receptor blocker is candesartan, losartan, pratosartan, or olmesartan.

10. The method of claim 1,2, 3, or 4, wherein the patient is a human.

11. The method of claim 1,2, 3, or 4, wherein the disease or disorder is acute or chronic renal failure, angina pectoris, arterial spasm, cardiac arrhythmias, cardiac hypertrophy, cerebral ischemia, congestive heart failure, coronary myocardial infarction, hypertension, ischemia reperfusion injury, ischemic myocardial necrosis, stroke, Raynaud's phenomenon, diabetic nephropathy, or renal impairment.

12. The method of claim 11, wherein the disease or disorder is hypertension.

13. The method of claim 11, wherein the disease or disorder is angina.

14. The method of claim 1, 2,3, or 4, wherein the (S) -amlodipine malate is administered in an amount of from about 0.01 mg to about 100 mg per day.

15. The method of claim 14, wherein the (S) -amlodipine malate is administered in an amount of from about 0.25 mg to about 10 mg per day.

16. The method of claim 3 or 4, wherein the diuretic agent is acetazolamide, dichlorphenamide, methazolamide glycerin, isosorbide, mannitol, urea, furosemide, bumetanide, azosemide, piretanide, ethacrynic acid, muzolimine, torsemide, tripamide, bendroflumethiazide, chlorothiazide, hydrochlorothiazide, dihydrochlorothiazide, hydroflumethiazide, methylchlorthiazide, polythiazide, trichlormethiazide, chlorthalidone, indapamide, metolazone, quinethazone ; amiloride, triameterene, spironolactone, conivaptan, mozavaptan, or eplerenone.

17. A pharmaceutical composition comprising: enantiomerically pure (S) -amlodipine malate, or a pharmaceutically acceptable solvate thereof ; and an angiotensin receptor blocker, or a pharmaceutically acceptable prodrug, salt or solvate thereof; wherein the angiotensin receptor blocker is candesartan, eprosartan, telmisartan, losartan, irbesartan, pratosartan, valsartan or olmesartan.

18. A pharmaceutical composition comprising : enantiomerically pure (S) -amlodipine malate, or a pharmaceutically acceptable solvate thereof; an angiotensin receptor blocker, or a pharmaceutically acceptable prodrug, salt or solvate thereof, wherein the angiotensin receptor blocker is candesartan, eprosartan, telmisartan, losartan, irbesartan, pratosartan, valsartan or olmesartan ; and a diuretic agent.

19. The pharmaceutical composition of claim 18, wherein the diuretic agent is acetazolamide, dichlorphenamide, methazolamide glycerin, isosorbide, mannitol, urea, furosemide, bumetanide, azosemide, piretanide, ethacrynic acid, muzolimine, torsemide, tripamide, bendroflumethiazide, chlorothiazide, hydrochlorothiazide, dihydrochlorothiazide, hydroflumethiazide, methylchlorthiazide, polythiazide, trichlormethiazide, chlorthalidone, indapamide, metolazone, quinethazone; amiloride, triameterene, spironolactone, conicaptan, mozavaptan, or eplerenone.

20. The pharmaceutical composition of claim 17 or 18, wherein the angiotensin receptor blocker is valsartan.

21. The pharmaceutical composition of claim 17 or 18, wherein the angiotensin receptor blocker is eprosartan.

22. The pharmaceutical composition of claim 17 or 18, wherein the angiotensin receptor blocker is irbesartan.

23. The pharmaceutical composition of claim 17 or 18, wherein the angiotensin receptor blocker is telmisartan.

24. The pharmaceutical composition of claim 17 or 18, wherein the angiotensin receptor blocker is candesartan, losartan, pratosartan, or olmesartan.

25. The pharmaceutical composition of claim 17 or 18, which further comprises one or more pharmaceutically acceptable excipients.

26. The pharmaceutical composition of claim 25, wherein said excipient is a surfactant.

27. A single unit dosage form comprising: enantiomerically pure (S)-amlodipine malate, or a pharmaceutically acceptable solvate thereof; and an angiotensin receptor blocker, or a pharmaceutically acceptable prodrug, salt or solvate thereof; wherein the angiotensin receptor blocker is candesartan, eprosartan, telmisartan, losartan, irbesartan, pratosartan, valsartan or olmesartan.

28. A single unit dosage form comprising: enantiomerically pure (S) -amlodipine malate, or a pharmaceutically acceptable solvate thereof; an angiotensin receptor blocker, or a pharmaceutically acceptable prodrug, salt or solvate thereof ; wherein the angiotensin receptor blocker is candesartan, eprosartan, telmisartan, losartan, irbesartan, pratosartan, valsartan or olmesartan; and a diuretic agent.

29. The dosage form of claim 28, wherein the diuretic agent is acetazolamide, dichlorphenamide, methazolamide glycerin, isosorbide, mannitol, urea, furosemide, bumetanide, azosemide, piretanide, ethacrynic acid, muzolimine, torsemide, tripamide, bendroflumethiazide, chlorothiazide, hydrochlorothiazide, dihydrochlorothiazide, hydroflumethiazide, methylchlorthiazide, polythiazide, trichlormethiazide, chlorthalidone, indapamide, metolazone, quinethazone ; amiloride, triameterene, spironolactone, conivaptan, mozavaptan, or eplerenone.

30. The dosage form of claim 27 or 28, wherein the angiotensin receptor blocker is valsartan.

31. The dosage form of claim 27 or 28, wherein the angiotensin receptor blocker is eprosartan.

32. The dosage form of claim 27 or 28, wherein the angiotensin receptor blocker is irbesartan.

33. The dosage form of claim 27 or 28, wherein the angiotensin receptor blocker is telmisartan.

34. The dosage form of claim 27 or 28, wherein the angiotensin receptor blocker is candesartan, losartan, pratosartan, or olmesartan.

35. The dosage form of claim 27 or 28, wherein the dosage from is suitable for oral or parenteral administration.

36. A method treating, preventing, or managing a cardiovascular disease or disorder comprising administering to a patient in need of such treatment a pharmaceutical composition of claim 17 or 18.

37. A method of treating, preventing or managing a cardiovascular disease or disorder comprising administering to a patient in need of such treatment a single unit dosage form of claim 27 or 28.

38. The method of claim 36 or 37, wherein the cardiovascular disease or disorder is hypertension.

39. The method of claim 36 or 37, wherein the cardiovascular disease or disorder is angina.

PATENTSCOPE®

Related Links

E-Newsletters