Claims for Patent: 11,813,291

Summary for Patent: 11,813,291

Title:	Ready-to-use potassium phosphates in sodium chloride solutions
Abstract:	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.
Inventor(s):	Brijeshkumar B. Pandya, Govind R. Jagadale, Dasaradhi Lakkaraju, Bala Tripura Sundari Chodavarapu, Anand Shukla, Jwalant Shukla
Assignee:	Nivagen Pharmaceuticals Inc
Application Number:	US17/499,001
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,813,291
Patent Claims:	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.