Enalapril formulations
AssigneeSilvergate Pharmaceuticals, Inc.
InventorsGerold L. Mosher, David W. Miles
Life of this patent
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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 method of treating hypertension in a subject comprising administering to that subject a therapeutically effective amount of a stable oral liquid formulation comprising:
- (i) about 1 mg/ml enalapril maleate;
- (ii) a buffer comprising about 1.82 mg/ml citric acid and about 0.15 mg/ml sodium citrate dihydrate;
- (iii) about 1 mg/ml of a preservative that is sodium benzoate;
- and
- (iv) water;
- wherein the pH of the stable oral liquid formulation is less than about 3.5;
- wherein the stable oral liquid formulation is stable at about 5±3° C. for at least 12 months;
- and
- wherein the stable oral liquid formulation has about 95% or greater of the initial enalapril amount and about 5% w/w or less total impurities or related substances at the end of the given storage period.
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) about 1 mg/ml enalapril maleate;
- (ii) a buffer comprising about 1.82 mg/ml citric acid and about 0.15 mg/ml sodium citrate dihydrate;
- and
- (iii) about 1 mg/ml of a preservative that is sodium benzoate;
- and
- (iv) water;
- wherein the pH of the stable oral liquid formulation is less than about 3.5;
- wherein the stable oral liquid formulation is stable at about 5±3° C. for at least 12 months;
- and
- wherein the stable oral liquid formulation has about 95% or greater of the initial enalapril amount and about 5% w/w or less total impurities or related substances at the end of the given storage period.
A method of treating left ventricular dysfunction in a subject comprising administering to that subject a therapeutically effective amount of a stable oral liquid formulation comprising:
- (i) about 1 mg/ml enalapril maleate;
- (ii) a buffer comprising about 1.82 mg/ml citric acid and about 0.15 mg/ml sodium citrate dihydrate;
- and
- (iii) about 1 mg/ml of a preservative that is sodium benzoate;
- and
- (iv) water;
- wherein the pH of the stable oral liquid formulation is less than about 3.5;
- wherein the stable oral liquid formulation is stable at about 5±3° C. for at least 12 months;
- and
- wherein the stable oral liquid formulation has about 95% or greater of the initial enalapril amount and about 5% w/w or less total impurities or related substances at the end of the given storage period.
Dependencies are inferred from the claim text.