Claims for Patent: 11,925,661

Summary for Patent: 11,925,661

Title:	Ready-to-use potassium phosphates in sodium chloride solutions
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.
Inventor(s):	Brijeshkumar B. Pandya, Govind R. Jagadale, Dasaradhi Lakkaraju, Bala Tripura Sundari Chodavarapu, Anand Shukla, Jwalant Shukla
Assignee:	Nivagen Pharmaceuticals Inc
Application Number:	US18/460,941
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,925,661
Patent Claims:	1. A sterile ready-to-use aqueous potassium solution, comprising potassium phosphates and sodium chloride, wherein the solution comprises between 1.5 mmol/100 mL and 15 mmol/100 ml phosphorous and equal or less than 50 mcg/L aluminum, and wherein the solution has a pH of between 2 and 6. 2. The solution of claim 1, wherein the potassium phosphates comprise potassium dihydrogen phosphate and potassium hydrogen phosphate at a molar ratio of about 0.7 to 1.3. 3. The solution of claim 2, wherein the potassium dihydrogen phosphate is present in the solution an amount of between about 112 mg/100 ml and about 1,120 mg/100 ml and wherein the potassium hydrogen phosphate is present in the solution in an amount of between about 118 mg/100 ml and about 1,180 mg/100 ml. 4. The solution of claim 1, wherein the potassium is present in the solution in an amount of no more than 22 mEq/100 mL. 5. The solution of claim 1, wherein the sodium chloride is present in the solution in an amount of up to 900 mg/100 ml. 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 total liquid particle count of no more than 360 and no more than 30 for particles having a size of equal to or greater than 15 and equal to or greater 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 between 100 mL and 1,000 mL, and optionally wherein the flexible polyolefin container is a flexible multilayer bag. 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) between about 1.5 mmol 100 ml and 15 mmol/100 ml phosphorus, and (c) no more than 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 at a molar ratio of about 0.7 to 1.3, and/or wherein the potassium dihydrogen phosphate is present in the solution an amount of between about 112 mg/100 ml and about 1,120 mg/100 ml and wherein the potassium hydrogen phosphate is present in the solution in an amount of between about 118 mg/100 ml and about 1,180 mg/100 ml. 13. The pharmaceutical product of claim 12, wherein the sodium chloride is present in the aqueous solution in an amount of up to 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 between 100 mL and 1,000 mL. 15. The pharmaceutical product of claim 14, wherein the flexible polyolefin container is a flexible multilayer bag. 16. The pharmaceutical product of claim 11, wherein the flexible polymeric container is enclosed in a secondary metallized overwrap. 17. 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 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. 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 or peripheral 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.