Enalapril formulations

  • US 11,040,023 B2
  • Filed: 01/15/2021
  • Issued: 06/22/2021
  • Est. Priority Date: 03/18/2016
  • Status: Active Grant
First Claim
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1. 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 sweetener;

    (iii) a preservative, wherein the preservative comprises sodium benzoate, a paraben or a mixture of parabens;

    (iv) water; and

    (v) optionally a flavoring agent;

    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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