Claims for Patent: 10,632,150

Summary for Patent: 10,632,150

Title:	Potassium phosphates composition for injection
Abstract:	Disclosed herein is a sterile composition for injection comprised of potassium phosphates having no visible particulate. Also disclosed herein is a manufacturing process for the sterile composition and its use.
Inventor(s):	Thomas; H. Greg (Flowery Branch, GA), LeVasseur; Richard (Flowery Branch, GA), Kiel; Jeffrey S. (Flowery Branch, GA), Pipho; Anthony Reid (Winterville, NC)
Assignee:	CMP Development LLC (Farmville, NC)
Application Number:	16/389,181
Patent Claims:	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.degree. C. for 24-months or (ii) storage at 25.degree. 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.degree. 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.degree. C. or at 25.degree. 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.degree. C. for 24-months or (ii) storage at 25.degree. 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.degree. C. for 24-months or (b) storage at 25.degree. 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.degree. 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.degree. C. or at 25.degree. 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 .mu.m; (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.degree. 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.