Claims for Patent: 11,179,434

Summary for Patent: 11,179,434

Title:	Lisinopril formulations
Abstract:	Provided herein are stable lisinopril oral liquid formulations. Also provided herein are methods of using lisinopril oral liquid formulations for the treatment of certain diseases including hypertension, heart failure and acute myocardial infarction.
Inventor(s):	Gerold L. Mosher, David W. Miles
Assignee:	Azurity Pharmaceuticals Inc
Application Number:	US17/194,021
Patent Claims:	1. A stable oral liquid formulation, comprising: (i) about 1 mg/ml lisinopril or a pharmaceutically acceptable salt or solvate thereof; (ii) a preservative selected from the group consisting of sodium benzoate, benzoic acid, sorbic acid, methylparaben, ethylparaben, propylparaben, butylparaben, and pharmaceutically acceptable salts thereof; (iii) a liquid vehicle, wherein the liquid vehicle comprises water; and (iv) optionally a sweetener; wherein the formulation is stable at about 25±5° C. for at least 6 months. 2. The formulation of claim 1, wherein the lisinopril is lisinopril dihydrate. 3. The formulation of claim 1, wherein the pH of the formulation is between about 4 and about 5.2. 4. The formulation of claim 1, wherein the pH of the formulation is higher than 4. 5. The formulation of claim 1, wherein the formulation is stable at about 25±5° C. for at least 18 months. 6. The formulation of claim 1, wherein the formulation is stable at about 25±5° C. for at least 24 months. 7. The formulation of claim 1, wherein the liquid vehicle further comprises glycerin, propylene glycol, or syrup. 8. The formulation of claim 1, wherein the formulation further comprises a thickener. 9. The formulation of claim 1, wherein the formulation comprises a sweetener selected from the group consisting of xylitol, mannitol, sucralose, saccharin, and pharmaceutically acceptable salts thereof. 10. The formulation of claim 1, wherein the formulation comprises a sweetener that is xylitol, sucralose, or saccharin. 11. The formulation of claim 10, wherein the xylitol is present in the formulation at about 140 mg/ml to about 160 mg/ml. 12. The formulation of claim 10, wherein the sucralose is present in the formulation at about 0.5 mg/ml to about 3 mg/ml. 13. The formulation of claim 1, wherein the preservative is present in the formulation at about 0.1 mg/ml to about 2 mg/ml. 14. A stable oral liquid formulation, consisting essentially of: (i) about 0.5 w/w to about 1% w/w lisinopril or a pharmaceutically acceptable salt or solvate thereof; (ii) a preservative selected from the group consisting of sodium benzoate, benzoic acid, sorbic acid, methylparaben, ethylparaben, propylparaben, butylparaben, pharmaceutically acceptable salts thereof, and any combination of the foregoing; (iii) a liquid vehicle, wherein the liquid vehicle comprises water; (iv) optionally a sweetener; and (v) optionally a thickener; wherein the formulation is stable at about 25±5° C. for at least 6 months. 15. The formulation of claim 14, wherein the pH of the formulation is between about 4 and about 5.2. 16. The formulation of claim 14, wherein the formulation is stable at about 25±5° C. for at least 18 months. 17. The formulation of claim 14, wherein the liquid vehicle further comprises glycerin or propylene glycol. 18. The formulation of claim 14, wherein the formulation comprises a sweetener selected from the group consisting of xylitol, mannitol, sucralose, saccharin, and pharmaceutically acceptable salts thereof.