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US 10,894,039 B2Granted
Amlodipine formulations
AssigneeSilvergate 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).
Claims19
A method of treating hypertension in a subject comprising administering to the subject an oral liquid formulation, wherein the oral liquid formulation comprises:
- (i) amlodipine benzoate in an amount corresponding to 1.0 mg/ml amlodipine freebase;
- (ii) 3 mM of a citrate buffer;
- (iii) 0.2 mg/ml to about 10 mg/ml of sodium benzoate;
- (iv) 0.5 mg/ml of silicon dioxide;
- (v) 7.5 mg/ml of hydroxypropyl methylcellulose;
- (vi) 0.15 mg/ml simethicone;
- (vii) 1.0 mg/ml of polysorbate 80;
- and
- (viii) water;
- wherein the pH of the formulation is between 4 and 6, and wherein the formulation is stable at 5±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.
8 more elements
Dependencies are inferred from the claim text.