AMLODIPINE FORMULATIONS

  • US 20200338055A1
  • Filed: 07/13/2020
  • Published: 10/29/2020
  • Est. Priority Date: 10/07/2016
  • Status: Active Grant
First Claim
Patent Images

1. An oral liquid formulation, comprising:

  • (i) amlodipine benzoate in an amount corresponding to 1.0 mg/ml amlodipine freebase;

    (ii) a buffer that maintains a pH value of the formulation between 4 and 6;

    (iii) 0.2 mg/ml to 10 mg/ml of sodium benzoate;

    (iv) a suspension aid that is selected from silicon dioxide, hydroxypropyl methylcellulose, methylcellulose, microcrystalline cellulose, carboxymethyl cellulose sodium, polyvinylpyrrolidone, xanthan gum, or a combination thereof;

    (v) 0.05 mg/ml to 1.0 mg/ml of simethicone;

    (vi) 0.1 mg/ml to 3.0 mg/ml of polysorbate 80; and

    (vii) water;

    wherein the formulation is stable at 5±



    C. for at least 12 months; and

    wherein the stable oral liquid formulation has 95% w/w or greater of the initial amlodipine amount and 5% w/w or less total impurities or related substances at the end of the given storage period.

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