Enalapril formulations

CAFC
  • US 9,669,008 B1
  • Filed: 03/25/2016
  • Issued: 06/06/2017
  • Est. Priority Date: 03/18/2016
  • Status: Active Grant
First Claim
Patent Images

1. 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 formulation is less than about 3.5; and

    wherein the formulation is stable at about 5±



    C. for at least 12 months;

    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.

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