Potassium phosphates composition for injection

1. A sterile composition for injection, consisting of:

(a) 175 mg/mL potassium monobasic phosphate;

(b) 300 mg/mL of potassium dibasic phosphate; and

(c) a sufficient amount of a sterile water vehicle;

wherein the sterile composition has a total amount of phosphate content of 3 mmol/mL, a potassium content of 185 mg/mL, and an aluminum content of not more than 15 ppm;

wherein the sterile composition for injection has no visible particles after (i) storage at 4-8° C. for 24-months or (ii) storage at 25° C. and 60% relative humidity for 24-months;

wherein the composition is contained in a vial; and

wherein the vial is comprised of glass or plastic.

2. The composition of claim 1 , wherein the sterile composition for injection has a pH of about from 6.5 to about 7.5.

3. The composition of claim 1 , wherein the sterile composition for injection has a pH of about from 6.8 to about 7.0.

4. The composition of claim 1 , wherein the vial is comprised of glass and wherein the sterile composition for injection has an aluminum content of not more than 15 ppm after storage at 4-8° C. for 24-months.

5. The composition of claim 1 , wherein the vial is comprised of plastic and wherein the sterile composition for injection has an aluminum content of not more than 5 ppm after storage for 48-months either at 4-8° C. or at 25° C. and 60% relative humidity.

6. The composition of claim 1 , wherein a volume of the sterile composition for injection is 5 mL, 7.5 mL, 15 mL, or 50 mL.

7. The composition of claim 1 , wherein a volume of the sterile composition for injection ranges from 15 mL to 16 mL.

8. A sterile composition for injection, consisting of:

(a) 175 mg/mL potassium monobasic phosphate;

(b) 300 mg/mL of potassium dibasic phosphate; and

(c) a sufficient amount of a sterile water vehicle;

wherein the sterile composition for injection has a phosphate content of 3 mmol/mL, a potassium content of 185 mg/mL, and an aluminum content of not more than 15 ppm; wherein the composition is contained in a glass vial; and

wherein the sterile composition for injection has no visible particles after (i) storage at 4-8° C. for 24-months or (ii) storage at 25° C. and 60% relative humidity for 24-months.

9. The composition claim 8 , wherein the sterile composition for injection has a pH that ranges from 6.8 to 7.0.

10. The composition of claim 8 , wherein a volume of the sterile composition for injection is 5 mL, 7.5 mL, 15 mL, or 50 mL.

11. The composition of claim 8 , wherein a volume of the sterile composition for injection ranges from 15 mL to 16 mL.

12. A sterile composition for injection, consisting of: a potassium phosphate solution in a sterile water vehicle;

wherein the sterile composition for injection has: (i) a pH of from 6.5 to 7.5, (ii) a phosphate content of 3 mmol/mL, (iii) a potassium content of 4.7 mEq/mL, and (iv) an aluminum content of not more than 15 ppm;

wherein the sterile composition for injection has no visible particles after (a) storage at 4-8° C. for 24-months or (b) storage at 25° C. and 60% relative humidity for 24-months; wherein the composition is contained in a vial; and

wherein the vial is comprised of glass or plastic.

13. The composition of claim 12 , wherein the sterile composition has a pH of from 6.8 to 7.0.

14. The composition of claim 12 , wherein a volume of the sterile composition is 5 mL, 7.5 mL, 15 mL, or 50 mL.

15. The composition of claim 12 , wherein the vial is comprised of glass and wherein the sterile composition for injection has an aluminum content of not more than 15 ppm after storage at 4-8° C. for 24-months.

16. The composition of claim 12 , wherein the vial is comprised of plastic and wherein the sterile composition for injection has an aluminum content of not more than 5 ppm after storage for 48-months either at 4-8° C. or at 25° C. and 60% relative humidity.

17. The composition of claim 12 , wherein a volume of the sterile composition ranges from 15 mL to 16 mL.

18. A method for treating hypophosphatemia in a patient in need thereof, which comprises:

(a) diluting the sterile composition for injection of claim 7 with a pharmaceutically acceptable diluent to obtain a diluted composition and

(b) intravenously administering the diluted composition to the patient;

wherein the patient exposure to aluminum is less than 5 mcg/kg/day.

19. A process for preparing the composition of claim 1 , which comprises:

(a) dissolving an amount of potassium dibasic phosphate in a vessel containing a first amount of sterile water that represents 25% of the total amount of water;

(b) adding a second amount of sterile water that represents 60% of the total amount of water to the composition of step (a);

(c) dissolving an amount of potassium monobasic phosphate in the composition of step (b);

(d) adding a third amount of water to the composition of step (c); and

(e) filtering the composition of step (d) through a membrane having a plurality of pores each with a pore diameter of 0.2 μm;

(f) dispensing a volume of the composition of step (e) into a vial;

(g) sealing the vial of step (f); and

(h) heating the vial of step (g) at a temperature of 121° C. for 15 to 30 minutes.

20. A method for treating hypophosphatemia in a patient in need thereof, which comprises:

(a) diluting the sterile composition for injection of claim 11 with a pharmaceutically acceptable diluent to obtain a diluted composition and

(b) intravenously administering the diluted composition to the patient;

wherein the patient exposure to aluminum is less than 5 mcg/kg/day.

21. A method for treating hypophosphatemia in a patient in need thereof, which comprises:

(a) diluting the sterile composition for injection of claim 17 with a pharmaceutically acceptable diluent to obtain a diluted composition and

(b) intravenously administering the diluted composition to the patient;

wherein the patient exposure to aluminum is less than 5 mcg/kg/day.