ENALAPRIL FORMULATIONS

  • US 20180289669A1
  • Filed: 06/08/2018
  • Published: 10/11/2018
  • Est. Priority Date: 03/18/2016
  • Status: Active Grant
First Claim
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1. A method of treating hypertension in a subject comprising administering to that subject a therapeutically effective amount of a stable oral liquid formulation, the stable oral liquid formulation comprising:

  • (i) about 0.6 to about 1.2 mg/ml enalapril or a pharmaceutically acceptable salt or solvate thereof;

    (ii) a buffer comprising about 0.8 to about 3.5 mg/ml citric acid and about 0.1 to about 0.8 mg/ml sodium citrate;

    (iii) about 0.7 to about 1.2 mg/ml sodium benzoate; and

    (iv) water;

    wherein the formulation is stable at about 5±



    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.

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