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US 2020/0368200 A1Published application
Enalapril formulations
AssigneeSilvergate Pharmaceuticals, Inc.
InventorsGerold L. MOSHER, David W. MILES
Life of this patent
Estimating the term…
Abstract
Provided herein are stable enalapril oral liquid formulations. Also provided herein are methods of using enalapril oral liquid formulations for the treatment of certain diseases including hypertension, heart failure and asymptomatic left ventricular dysfunction.
Claims30
A stable oral liquid formulation, consisting essentially of:
- (i) about 0.6 to about 1.2 mg/ml enalapril or a pharmaceutically acceptable salt or solvate thereof;
- (ii) a buffer to maintain the pH about 4.5 or below, wherein the buffer concentration is about 5 mM to about 20 mM;
- (iii) a preservative, wherein the preservative is a paraben or a mixture of parabens;
- and
- (iv) water;
- wherein the formulation optionally comprises a sweetener, a flavoring agent, or both;
- wherein the formulation is stable at about 5±3° C. for at least 12 months;
- and
- wherein the stable oral liquid formulation has about 95% w/w or greater of the initial enalapril amount and about 5% w/w or less total impurity or related substances at the end of the given storage period.
6 more elements
A stable oral liquid formulation, consisting essentially of:
- (i) about 0.6 to about 1.2 mg/ml enalapril or a pharmaceutically acceptable salt or solvate thereof;
- (ii) a buffer to maintain the pH about 4.5 or below, wherein the buffer concentration is about 5 mM to about 20 mM;
- (iii) a preservative, wherein the preservative is methylparaben, ethylparaben, propylparaben, butylparaben, or a combination thereof;
- and
- (iv) water;
- wherein the formulation optionally comprises a sweetener, a flavoring agent, or both;
- wherein the formulation is stable at about 5±3° C. for at least 12 months;
- and
- wherein the stable oral liquid formulation has about 95% w/w or greater of the initial enalapril amount and about 5% w/w or less total impurity or related substances at the end of the given storage period.
6 more elements
A stable oral liquid formulation, consisting essentially of:
- (i) about 0.6 to about 1.2 mg/ml enalapril or a pharmaceutically acceptable salt or solvate thereof;
- (ii) a buffer to maintain the pH about 4.5 or below;
- (iii) a preservative, wherein the preservative is methylparaben, ethylparaben, propylparaben, butylparaben, or a combination thereof;
- and
- (iv) water;
- wherein the formulation optionally comprises a sweetener, a flavoring agent, or both;
- wherein the formulation is stable at about 5±3° C. for at least 12 months;
- and
- wherein the stable oral liquid formulation has about 95% w/w or greater of the initial enalapril amount and about 5% w/w or less total impurity or related substances at the end of the given storage period.
6 more elements
Dependencies are inferred from the claim text.