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US 10,478,422 B1Granted
Oral liquid compositions including valsartan
AssigneeEci Pharmaceuticals, LLC
InventorGreg Thomas
Life of this patent
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Abstract
An aspect of the present disclosure is directed to an oral liquid composition comprising valsartan with enhanced solubility and stability. Other aspects are directed to 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.
Claims27
An oral liquid solution comprising:
- 3.6 mg/mL to 4.4 mg/mL valsartan or a pharmaceutically acceptable salt or solvate thereof;
- and
- 9.3 mg/mL to 10.7 mg/mL citrate salt;
- provided that a pH of the oral liquid solution is from 5.8 to 6.1 and the oral liquid solution exhibits a stability for 18 months;
- provided that the valsartan or the pharmaceutically acceptable salt or solvate thereof is fully solubilized in the oral liquid solution;
- and
- provided that administration of a 320 mg dose of the oral liquid solution to a patient provides an in vivo plasma profile having a valsartan AUCinf in a range from 35,162 ng*hr/mL to 72,130 ng*hr/m L.
4 more elements
An oral liquid solution comprising:
- 3.6 mg/mL to 4.4 mg/mL valsartan or a pharmaceutically acceptable salt or solvate thereof;
- and
- 9.3 mg/mL to 10.7 mg/mL citrate salt;
- provided that a pH of the oral liquid solution is from 5.8 to 6.1 and the oral liquid solution exhibits a stability for 18 months;
- provided that the valsartan or the pharmaceutically acceptable salt or solvate thereof is fully solubilized in the oral liquid solution;
- and
- provided that administration of a dose of the oral liquid solution to a patient provides an in vivo plasma profile with a valsartan AUCinf within a range of 114% to 136% of the valsartan AUCinf resulting from administration of an oral tablet dosage form including the same dosage of valsartan to the patient.
4 more elements
An oral liquid solution comprising:
- 3.6 mg/mL to 4.4 mg/mL valsartan or a pharmaceutically acceptable salt or solvate thereof;
- and
- 9.3 mg/mL to 10.7 mg/mL citrate salt;
- provided that a pH of the oral liquid solution is from 5.8 to 6.1 and the oral liquid solution exhibits a stability for 24 months;
- provided that the valsartan or the pharmaceutically acceptable salt or solvate thereof is fully solubilized in the oral liquid solution;
- and
- provided that administration of a 320 mg dose of the oral liquid solution to a patient provides an in vivo plasma profile having a valsartan AUCinf in a range from 35,162 ng*hr/mL to 72,130 ng*hr/m L.
4 more elements
An oral liquid solution comprising:
- 3.6 mg/mL to 4.4 mg/mL valsartan or a pharmaceutically acceptable salt or solvate thereof;
- and
- 9.3 mg/mL to 10.7 mg/mL citrate salt;
- provided that a pH of the oral liquid solution is from 5.8 to 6.1 and the oral liquid solution exhibits a stability for 24 months;
- provided that the valsartan or the pharmaceutically acceptable salt or solvate thereof is fully solubilized in the oral liquid solution;
- and
- provided that administration of a dose of the oral liquid solution to a patient provides an in vivo plasma profile with a valsartan AUCinf within a range of 114% to 136% of the valsartan AUCinf resulting from administration of an oral tablet dosage form including the same dosage of valsartan to the patient.
4 more elements
Dependencies are inferred from the claim text.