Ready-to-use potassium phosphates in sodium chloride solutions

11813,291

17/499001

October 12, 2021

A ready-to-use (RTU) potassium phosphates in sodium chloride solution for phosphorus replacement therapy includes potassium phosphate and sodium chloride at a fixed volume with 15 mmol/100 mL phosphorus and 22 mEq/100 mL potassium and less than 50 mcg/L aluminum.

Nivagen Pharmaceuticals, Inc. (Sacramento, CA, US)

NIVAGEN PHARMACEUTICALS, INC. (Sacramento, CA, US)

1. An isotonic sterile ready-to-use aqueous potassium phosphates solution, comprising potassium phosphates and sodium chloride, wherein the solution comprises 15 mmol/100 ml phosphorus and equal or less than 50 mcg/L aluminum.

2. The solution of claim 1 , wherein the potassium phosphates comprise potassium dihydrogen phosphate and potassium hydrogen phosphate, wherein the potassium dihydrogen phosphate is present in the solution an amount of about 1,120 mg/100 ml or 8.2 mmol/100 ml of Phosphorus and wherein the potassium hydrogen phosphate is present in the solution in an amount of about 1,180 mg/100 ml or 6.8 mmol/100 ml of Phosphorus.

3. The solution of claim 1 , wherein the potassium is present in the solution in an amount of about 22 mEq/100 mL.

4. The solution of claim 1 , wherein the sodium chloride is present in the solution in an amount of about 900 mg/100 ml.

5. The solution of claim 1 , wherein the solution has a pH of between 6.2 and 6.8.

6. The solution of claim 1 , wherein the solution has, after autoclaving and storage of at least 3 months at 25° C. and 40% relative humidity, a liquid particle count of no more than 360 and 30 for particles at 15 and 25 micrometer size, respectively.

7. The solution of claim 1 , wherein the solution has, after autoclaving and storage of at least 3 months at 25° C. and 40% relative humidity, a change in phosphorus of no more than 1% absolute.

8. The solution of claim 1 , wherein the solution has, after autoclaving and storage of at least 3 months at 25° C. and 40% relative humidity, a change in potassium of no more than 2% absolute.

9. The solution of claim 1 , wherein the solution is packaged in a flexible polyolefin container, optionally at a volume of 100 mL.

10. The solution of claim 9 , wherein the flexible polyolefin container is further contained in a secondary metallized overwrap.

11. A sterile ready-to-use 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) about 15 mmol/100 ml phosphorus, and (c) about 22 mEq/100 mL potassium.

12. The pharmaceutical product of claim 11 , wherein the potassium phosphates comprise potassium dihydrogen phosphate and potassium hydrogen phosphate, wherein the potassium dihydrogen phosphate is present in the solution an amount of about 1,120 mg/100 ml or 8.2 mmol/100 ml of Phosphorus, and wherein the potassium hydrogen phosphate is present in the solution in an amount of about 1,180 mg/100 ml or 6.8 mmol/100 ml of Phosphorus.

13. The pharmaceutical product of claim 12 , wherein the sodium chloride is present in the aqueous sodium chloride solution in an amount of about 900 mg/100 ml.

14. The pharmaceutical product of claim 11 , wherein the premixed pharmaceutical product in the flexible polymeric container has a volume of 100 mL.

15. The pharmaceutical product of claim 11 , wherein the flexible polymeric container is enclosed in a secondary metallized overwrap.

16. The pharmaceutical product of claim 11 , wherein the premixed pharmaceutical product comprises about 4.65 mg/mL of phosphorus, about 8.50 mg/mL of potassium, about 3.57 mg/mL of sodium, and about 5.43 mg/mL of chloride.

17. A method of administering phosphates to a patient in need of phosphorus replacement therapy, comprising: administering, without prior dilution, an isotonic, sterile, and ready-to-use 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 about 15 mmol/100 ml phosphorus, about 22 mEq/100 mL potassium, and less than 50 mcg/L aluminum.

18. The method of claim 17 , wherein the rate of infusion is 6.8 mmol phosphates per hour or 15 mmol phosphates per hour.

19. The method of claim 17 , wherein the route of administration is a central venous catheter.

20. The method of claim 17 , wherein the solution is administered after storage of at least 3 months at 25° C. and 40% relative humidity.

10342813 July 2019 Pizza
10632150 April 2020 Thomas et al.
11141430 October 2021 Koneru
20140364503 December 2014 Owoo et al.
106265499 January 2017

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