Pharmaceutical dosage form comprising nifedipine or nisoldipine and an angiotensin II antagonist and/or a diuretic

1. A pharmaceutical dosage form capsule or tablet comprising:

a core comprising:

an osmotic release system comprising nifedipine or nisoldipine and an osmotic membrane comprising cellulose acetate or a mixture of cellulose acetate and polyethylene glycol, wherein the nifedipine or the nisoldipine is released in a controlled manner; and

a mantle coating around the core, the mantle coating comprising at least one film-forming polymer suitable for the rapid release of active ingredients and an angiotensin II antagonist, wherein the angiotensin II antagonist is released rapidly and wherein the film-forming polymer is partially hydrolyzed polyvinyl alcohol, wherein the thickness of the mantle coating is from 50 to 1500 μm,

wherein 5 to 17% (by weight) of the nifedipine or nisoldipine is released within 4 hours, 45 to 75% (by weight) of the nifedipine or nisoldipine is released within 12 hours, at least 85% (by weight) of the nifedipine or nisoldipine is released over a period of 24 hours, and the rapid release of active ingredients includes at least 60% (by weight) of the angiotensin II antagonist being released over a period of 30 minutes when assayed according to a USP release method using apparatus 2 (paddle) at 75 revolutions per minute in 900 ml of a suitable medium.

2. The pharmaceutical dosage form according to claim 1 , wherein the angiotensin II antagonist is selected from the group consisting of candesartan, losartan, telmisartan, irbesartan, embursartan, eprosartan, valsartan, or olmesartan or a prodrug of one of these angiotensin II antagonists.

3. The pharmaceutical dosage form according to claim 2 , where any candesartan is in the form of candesartan cilexetil and any olmesartan is in the form of olmesartan medoxomil.

4. The pharmaceutical dosage form according to claim 1 , the nifedipine or nisoldipine is employed in a minimum dose of 5 mg and a maximum dose of 90 mg and the angiotensin II antagonist is employed in a minimum dose of 2 mg and a maximum dose of 500 mg.

5. The pharmaceutical dosage form according to claim 1 , wherein the proportion of angiotensin II antagonist in the mantle coating is from 10 to 50%, based on the dry weight of the mantle coating.

6. The pharmaceutical dosage form according to claim 1 , wherein the weight of the mantle coating in the dosage form according to the invention is from 20 to 300 mg.

7. The pharmaceutical dosage form according to claim 1 , wherein the angiotensin II antagonist is candesartan.

8. The pharmaceutical dosage form according to claim 7 , wherein the candesartan is in the form of candesartan cilexetil.

9. The pharmaceutical dosage form acording to claim 8 , wherein the amount of nifedipine is 20 mg, and the amount of candesartan cilexetil is 4 mg.

10. The pharmaceutical dosage form according to claim 8 , wherein the amount of nifedipine is 20 mg, and the amount of candesartan cilexetil is 8 mg.

11. The pharmaceutical dosage form according to claim 8 , wherein the amount of nifedipine is 20 mg, and the amount of candesartan cilexetil is 16 mg.

12. The pharmaceutical dosage form according to claim 8 , wherein the amount of nifedipine is 20 mg, and the amount of candesartan cilexetil is 32 mg.

13. The pharmaceutical dosage form according to claim 8 , wherein the amount of nifedipine is 30 mg and the amount of candesartan cilexetil is 4 mg.

14. The pharmaceutical dosage form according to claim 8 , wherein the amount of nifedipine is 30 mg and the amount of candesartan cilexetil is 8 mg.

15. The pharmaceutical dosage form according to claim 8 , wherein the amount of nifedipine is 30 mg and the amount of candesartan cilexetil is 16 mg.

16. The pharmaceutical dosage form according to claim 8 , wherein the amount of nifedipine is 30 mg, and the amount of candesartan cilexetil is 32 mg.

17. The pharmaceutical dosage form according to claim 8 , wherein the amount of nifedipine is 60 mg, and the amount of candesartan cilexetil is 4 mg.

18. The pharmaceutical dosage form according to claim 8 , wherein the amount of nifedipine is 60 mg and the amount of candesartan cilexetil is 8 mg.

19. The pharmaceutical dosage form according to claim 8 , wherein the amount of nifedipine is 60 mg, and the amount of candesartan cilexetil is 16 mg.

20. The pharmaceutical dosage form according to claim 8 , wherein the amount of nifedipine is 60 mg, and the amount of candesartan cilexetil is 32 mg.

21. The pharmaceutical dosage form according to claim 1 , wherein the osmotic release system is an osmotic single-chamber system.

22. The pharmaceutical dosage form according to claim 1 , wherein the osmotic release system is a single-chamber system comprising:

the core, comprising:

5 to 50% of the active ingredient nifedipine or nisoldipine,

10 to 50% xanthan,

5 to 40% of a vinylpyrrolidone-vinyl acetate copolymer; and

the osmotic membrane consisting of a water-permeable material which is impermeable for the components of the core and has at least one orifice.

23. The pharmaceutical dosage form according to claim 1 , wherein the osmotic release system is an osmotic two-chamber system.

24. The pharmaceutical dosage form according to claim 23 , the two-chamber system comprising:

a core having an active ingredient layer, comprising:

5-50% of the nifedipine or the nisoldipine, and

40% to 95% of at least one osmotically active polymer;

an osmosis layer comprising:

40 to 95% of at least one osmotically active polymer, and

5 to 40% of an osmotically active additive; and

an osmotic membrane consisting of a water-permeable material which is impermeable for the components of the core and has at least one orifice.

25. The pharmaceutical dosage according to claim 1 , wherein the thickness of the mantle coating is from 75 μm to 1200 μm.

26. The pharmaceutical dosage according to claim 1 , wherein the thickness of the mantle coating is from 100 μm to 1000 μm.