Oral liquid compositions including valsartan
AssigneeEci Pharmaceuticals, LLC
InventorNirali R. Bhatt
Life of this patent
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Abstract
The present disclosure provides an oral liquid composition comprising valsartan with enhanced solubility and stability. Also, provided herein are methods of using the oral liquid compositions for the treatment of hypertension, treatment of heart failure and reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction.
Claims42
An oral liquid composition consisting of:
- about 60 mg/mL to about 68 mg/mL valsartan or a pharmaceutically acceptable salt or solvate thereof;
- about 1.0 mg/mL to about 100 mg/mL cyclodextrin;
- alkali salt;
- optionally, sorbate salt;
- optionally, paraben;
- optionally, at least one sweetener selected from the group consisting of glucose, fructose, sucrose, tagatose, sucralose, trehalose, maltodextrin, polydextrose, inulin, maltol, acesulfame, alitame, aspartame, neotame, sodium cyclamate, saccharin, neohesperidin dihydrochalcone, stevioside, and thaumatin;
- optionally, at least one flavoring agent selected from the group consisting of almond, anise, apple, apricot, bergamot, blackberry, blackcurrant, blueberry, bubblegum, cacao, caramel, cherry, cinnamon, clove, coffee, coriander, cranberry, cumin, dill, eucalyptus, fennel, fig, ginger, grape, grapefruit, guava, hop, lemon, licorice, lime, malt, mandarin, molasses, nutmeg, orange, peach, pear, peppermint, pineapple, raspberry, rose, spearmint, strawberry, tangerine, tea, tutti-frutti, vanilla, and wintergreen;
- and
- water;
- provided that a pH of the oral liquid composition is 7.5 to 9.0 and the valsartan or pharmaceutically acceptable salt or solvate thereof is fully solubilized in the oral liquid composition.
An oral liquid composition consisting of:
- about 28 mg/mL to about 36 mg/mL valsartan or a pharmaceutically acceptable salt or solvate thereof;
- about 1.0 mg/mL to about 100 mg/mL cyclodextrin;
- alkali salt;
- optionally, sorbate salt;
- optionally, paraben;
- optionally, at least one sweetener selected from the group consisting of glucose, fructose, sucrose, tagatose, sucralose, trehalose, maltodextrin, polydextrose, inulin, maltol, acesulfame, alitame, aspartame, neotame, sodium cyclamate, saccharin, neohesperidin dihydrochalcone, stevioside, and thaumatin;
- optionally, at least one flavoring agent selected from the group consisting of almond, anise, apple, apricot, bergamot, blackberry, blackcurrant, blueberry, bubblegum, cacao, caramel, cherry, cinnamon, clove, coffee, coriander, cranberry, cumin, dill, eucalyptus, fennel, fig, ginger, grape, grapefruit, guava, hop, lemon, licorice, lime, malt, mandarin, molasses, nutmeg, orange, peach, pear, peppermint, pineapple, raspberry, rose, spearmint, strawberry, tangerine, tea, tutti-frutti, vanilla, and wintergreen;
- and
- water;
- provided that a pH of the oral liquid composition is 7.5 to 9.0 and the valsartan or pharmaceutically acceptable salt or solvate thereof is fully solubilized in the oral liquid composition.
A method of treating coronary artery disease comprising administering to a patient in need thereof an oral liquid composition consisting of:
- about 60 mg/mL to about 68 mg/mL valsartan or a pharmaceutically acceptable salt or solvate thereof;
- about 1.0 mg/mL to about 100 mg/mL cyclodextrin;
- alkali salt;
- optionally, sorbate salt;
- optionally, paraben;
- optionally, at least one sweetener selected from the group consisting of glucose, fructose, sucrose, tagatose, sucralose, trehalose, maltodextrin, polydextrose, inulin, maltol, acesulfame, alitame, aspartame, neotame, sodium cyclamate, saccharin, neohesperidin dihydrochalcone, stevioside, and thaumatin;
- optionally, at least one flavoring agent selected from the group consisting of almond, anise, apple, apricot, bergamot, blackberry, blackcurrant, blueberry, bubblegum, cacao, caramel, cherry, cinnamon, clove, coffee, coriander, cranberry, cumin, dill, eucalyptus, fennel, fig, ginger, grape, grapefruit, guava, hop, lemon, licorice, lime, malt, mandarin, molasses, nutmeg, orange, peach, pear, peppermint, pineapple, raspberry, rose, spearmint, strawberry, tangerine, tea, tutti-frutti, vanilla, and wintergreen;
- and
- water;
- provided that a pH of the oral liquid composition is 7.5 to 9.0 and the valsartan or pharmaceutically acceptable salt or solvate thereof is fully solubilized in the oral liquid composition.
Dependencies are inferred from the claim text.