Ready-To-Use Potassium Phosphates In Sodium Chloride Solutions
AssigneeNivagen Pharmaceuticals, Inc.
InventorsBrijeshkumar B. Pandya, Govind R. Jagadale, Dasaradhi Lakkaraju, Bala Tripura Sundari Chodavarapu, Anand Shukla, Jwalant Shukla
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Abstract
Ready-to-use (RTU) potassium phosphates solutions for phosphorus replacement therapy are presented that include potassium phosphate and sodium chloride at a fixed volume with 1.5 to 15 mmol/100 mL phosphorus, no more than 22 mEq/100 mL potassium and less than 50 mcg/L aluminum.
Claims20
A sterile ready-to-use (RTU) aqueous potassium phosphates solution, comprising potassium phosphates and sodium chloride, wherein the solution comprises between 1.5 mmol/100 mL (0.015 mmol/mL) and 15 mmol/100 ml phosphorus (0.15 mmol/mL) and equal or less than 50 mcg/L aluminum, and wherein the solution has a pH of between 6.2 and 6.8.
A sterile ready-to-use (RTU) premixed pharmaceutical product stored in a flexible polymeric container, wherein the pharmaceutical product comprises a potassium phosphates in an aqueous sodium chloride solution containing (a) less than 50 mcg/L aluminum, (b) between about 1.5 mmol/100 ml and 15 mmol/100 ml phosphorus, and (c) no more than about 22 mEq/100 mL potassium.
A method of administering phosphates to a patient in need of phosphorus replacement therapy, comprising:
- administering, without prior dilution, a sterile, and ready-to-use (RTU) solution comprising potassium phosphates and sodium chloride solution from a flexible container to the patient at a rate of infusion and by a route of administration corresponding to the patient's age and degree of need of phosphorus replacement;
- wherein the solution comprises between 1.5 mmol/100 mL and 15 mmol/100 ml phosphorus, no more than about 22 mEq/100 mL potassium, and less than 50 mcg/L aluminum.
Dependencies are inferred from the claim text.