Lisinopril formulations
AssigneeAzurity Pharmaceuticals, Inc.
InventorsGerold L. MOSHER, David W. MILES
Life of this patent
Estimating the term…
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.
Claims30
-19. (canceled)
A method of treating hypertension in a subject comprising administering to that subject a therapeutically effective amount of a stable oral liquid formulation, comprising:
- (i) lisinopril or a pharmaceutically acceptable salt thereof;
- (ii) a means for providing anti-microbial activity in the oral liquid formulation;
- (iii) a liquid vehicle, wherein the liquid vehicle comprises water;
- (iv) a sweetener, wherein the sweetener comprises xylitol, mannitol, sorbitol, glycerin, maltitol, sucrose, aspartame sucralose, saccharin, acesulfame, or a pharmaceutically acceptable salt thereof;
- and
- wherein the pH of the formulation is between about 4 and about 8;
- wherein the formulation is stable at about 25=5° C. for at least 6 months.
A method of treating heart failure in a subject comprising administering to that subject a therapeutically effective amount of a stable oral liquid formulation, comprising:
- (i) lisinopril or a pharmaceutically acceptable salt thereof;
- (ii) a means for providing anti-microbial activity in the oral liquid formulation;
- (iii) a liquid vehicle, wherein the liquid vehicle comprises water;
- (iv) a sweetener, wherein the sweetener comprises xylitol, mannitol, sorbitol, glycerin, maltitol, sucrose, aspartame sucralose, saccharin, acesulfame, or a pharmaceutically acceptable salt thereof;
- and
- wherein the pH of the formulation is between about 4 and about 8;
- wherein the formulation is stable at about 25±5° C. for at least 6 months.
A method of treating a hemodynamically stable subject within 24 hours of acute myocardial infarction comprising administering to that subject a therapeutically effective amount of a stable oral liquid formulation, comprising:
- (i) lisinopril or a pharmaceutically acceptable salt thereof;
- (ii) a means for providing anti-microbial activity in the oral liquid formulation;
- (iii) a liquid vehicle, wherein the liquid vehicle comprises water;
- (iv) a sweetener, wherein the sweetener comprises xylitol, mannitol, sorbitol, glycerin, maltitol, sucrose, aspartame sucralose, saccharin, acesulfame, or a pharmaceutically acceptable salt thereof;
- and
- wherein the pH of the formulation is between about 4 and about 8;
- wherein the formulation is stable at about 25=5° C. for at least 6 months.
Dependencies are inferred from the claim text.