Granted Patent B1

US 9,463,183 · App. 14/934,752 · Granted Oct 11, 2016

Abstract

Claims (34)

1. A stable oral liquid formulation, comprising:

(i) about 1 mg/ml lisinopril or a pharmaceutically acceptable salt or solvate thereof;

(ii) about 150 mg/ml of a sweetener that is xylitol;

(iii) a buffer comprising about 0.86 mg/ml citric acid and about 1.44 mg/ml sodium citrate;

(iv) about 0.8 mg/ml of a preservative that is sodium benzoate; and

(v) water;

wherein the pH of the formulation is between about 4 and about 5; and

wherein the formulation is stable at about 25±5° C. for at least 12 months.

2. The formulation of claim 1 , wherein the lisinopril is lisinopril dihydrate.

3. The formulation of claim 1 , wherein the pH is about 4.9.

4. The formulation of claim 1 , wherein the formulation is stable at about 25±5° C. for at least 18 months.

5. The formulation of claim 1 , wherein the formulation is stable at about 25±5° C. for at least 24 months.

6. A stable oral liquid formulation, comprising:

(i) about 0.7% (w/w of solids) lisinopril or a pharmaceutically acceptable salt or solvate thereof;

(ii) about 97.3% (w/w of solids) of a sweetener that is xylitol;

(iii) a buffer comprising about 0.01 molar citrate;

(iv) about 0.52% (w/w of solids) of a preservative that is sodium benzoate; and

(v) water;

wherein the pH of the formulation is between about 4 and about 5; and

wherein the formulation is stable at about 25±5° C. for at least 12 months.

7. The formulation of claim 6 , wherein the lisinopril is lisinopril dihydrate.

8. The formulation of claim 6 , wherein the buffer comprises citric acid and sodium citrate.

9. The formulation of claim 6 , wherein the pH is about 4.9.

10. The formulation of claim 6 , wherein the formulation is stable at about 25±5° C. for at least 18 months.

11. The formulation of claim 6 , wherein the formulation is stable at about 25±5° C. for at least 24 months.

12. A stable oral liquid formulation, consisting of:

(i) about 1 mg/ml lisinopril or a pharmaceutically acceptable salt or solvate thereof;

(ii) about 150 mg/ml of a sweetener that is xylitol;

(iii) a buffer comprising about 0.86 mg/ml citric acid and about 1.44 mg/ml sodium citrate;

(iv) about 0.8 mg/ml of a preservative that is sodium benzoate;

(v) and water;

wherein the pH of the formulation is between about 4 and about 5 adjusted by sodium hydroxide or hydrochloric acid; and

wherein the formulation is stable at about 25±5° C. for at least 12 months.

13. The formulation of claim 12 , wherein the pH is about 4.9.

Assignments (11)