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US 12,721,843 B2Granted
Amlodipine formulations
AssigneeAzurity Pharmaceuticals, Inc.
InventorsScott Brauer, Gerold L. Mosher
Life of this patent
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Abstract
Provided herein are stable amlodipine oral liquid formulations. Also provided herein are methods of using amlodipine oral liquid formulations for the treatment of certain diseases including hypertension and Coronary Artery Disease (CAD).
Claims20
An oral liquid formulation comprises:
- (i) amlodipine benzoate in an amount corresponding to 1.0 mg/ml amlodipine freebase;
- (ii) 0.2 mg/ml to 10 mg/ml of sodium benzoate;
- (iii) a suspension aid comprising silicon dioxide, hydroxypropyl methylcellulose, methylcellulose, microcrystalline cellulose, carboxymethyl cellulose sodium, polyvinylpyrrolidone, xanthan gum, or any combination thereof;
- (iv) a non-ionic surfactant that is present at about 0.1 mg/ml to about 3.0 mg/ml in the oral liquid formulation;
- (v) optionally one or more selected from a buffer, a flavoring agent, a sweetener, a preservative;
- and
- (vi) water;
- wherein the oral liquid formulation is stable at 5±5° C. for a storage period of 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.
6 more elements
Dependencies are inferred from the claim text.