IP Library Granted Patent US 7,589,064
Granted Patent B2
US 7,589,064 · App. 11/777,849 · Granted Sep 15, 2009

Formulations of ramipril

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Quick Facts
Patent No.
US 7,589,064
App. No.
11/777,849
Granted
Sep 15, 2009
Kind
B2
Abstract

The present invention relates to stable tablet formulations of ramipril, optionally in combination with a diuretic.

Claims (56)

1. A tablet formulation comprising:

a) 1.25 mg ramipril, wherein the amount of ramipril is 0.5-1.5% w/w,

b) 85-90% w/w of calcium sulphate dihydrate,

c) 0.5-1.5% w/w of sodium hydrogen carbonate,

d) 7-13% w/w starch pregelatinised, and

e) 0.5-1.5% w/w sodium stearyl fumarate.

2. The tablet formulation of claim 1 , further comprising a diuretic.

3. The tablet formulation of claim 2 , wherein the diuretic is hydrochiorothiazide.

4. The tablet formulation of claim 2 , wherein the diuretic is piretanide.

5. A tablet formulation comprising:

(a) 2.5 mg, 5 mg or 10 mg ramipril, wherein the amount of ramipril is 1.4-2.5% w/w,

(b) 78-95% w/w calcium sulphate dihydrate,

(c) 1.4-2.5% w/w sodium hydrogen carbonate,

(d) 7-13% w/w starch pregelatinised, and

(e) 0.5-1.5% w/w sodium stearyl fumarate.

6. A tablet formulation comprising:

(a) 2.5 mg ramipril/12.5 mg hydrochiorothiazide or 5 mg ramipril/25 mg hydrochlorothiazide, wherein the amount of ramipril is 1.4-2.5% w/w,

(b) 8.5-10.5% w/w hydrochlorothiazide,

(c) 65-75% w/w calcium sulphate dihydrate,

(d) 1.0-2.5% w/w sodium hydrogen carbonate,

(e) 12-18% w/w starch pregelatinised, and

(f) 0.5-1.5% w/w sodium stearyl fumarate.

7. A tablet formulation comprising:

(a) 5 mg ramipril and 6 mg piretanide, wherein the amount of ramipril is 1.5-2.5% w/w and the amount of piretanide is 1.8-3.0% w/w,

(b) 65-85% w/w calcium sulphate dihydrate,

(c) 3.0-5.0% w/w sodium hydrogen carbonate,

(d) 10-20% w/w starch pregelatinised, and

(e) 0.5-1.5% w/w sodium stearyl fumarate.

8. The tablet formulation of claim 5 , further comprising a diuretic.

9. The tablet formulation of claim 8 , wherein the diuretic is hydrochlorothiazide.

10. The tablet formulation of claim 8 , wherein the diuretic is piretanide.

11. The tablet formulation of claim 1 , consisting essentially of:

a) 1.25 mg ramipril, wherein the amount of ramipril is 0.5-1.5% w/w,

b) 8 5-90% w/w of calcium sulphate dihydrate,

c) 0.5-1.5% w/w of sodium hydrogen carbonate,

d) 7-13% w/w starch pregelatinised, and

e) 0.5-1.5% w/w sodium stearyl fumarate.

12. The tablet formulation of claim 5 , consisting essentially of:

(a) 2.5 mg, 5 mg or 10 mg ramipril, wherein the amount of ramipril is 1.4-2.5% w/w,

(b) 78-95% w/w calcium sulphate dihydrate,

(c) 1.4-2.5% w/w sodium hydrogen carbonate,

(d) 7-13% w/w starch pregelatinised, and

(e) 0.5-1.5% w/w sodium stearyl fumarate.

13. The tablet formulation of claim 6 , consisting essentially of:

(a) 2.5 mg ramipril/12.5 mg hydrochlorothiazide or 5 mg ramipril/25 mg hydrochiorothiazide, wherein the amount of ramipril is 1.4-2.5% w/w,

(b) 8.5-10.5% w/w hydrochlorothiazide,

(c) 65-75% w/w calcium sulphate dihydrate,

(d) 1.0-2.5% w/w sodium hydrogen carbonate,

(e) 12-18% w/w starch pregelatinised, and

(f) 0.5-1.5% w/w sodium stearyl fumarate.

14. The tablet formulation of claim 7 , consisting essentially of:

(a) 5 mg ramipril and 6 mg piretanide, wherein the amount of ramipril is 1.5-2.5% w/w and the amount of piretanide is 1.8-3.0% w/w,

(b) 65-85% w/w calcium sulphate dihydrate,

(c) 3.0-5.0% w/w sodium hydrogen carbonate,

(d) 10-20% w/w starch pregelatinised, and

(e) 0.5-1.5% w/w sodium stearyl fumarate.