Claims for Patent: 12,539,314

Summary for Patent: 12,539,314

Title:	Aqueous oral compositions including potassium chloride
Abstract:	The present disclosure provides an oral liquid composition comprising potassium chloride, free of alcohol, free of parabens, and with enhanced stability. The present disclosure further provides methods of using the oral liquid compositions comprising potassium chloride, and which are free of alcohol and parabens, for the treatment of hypokalemia in patients with or without metabolic alkalosis.
Inventor(s):	Shivaji Phadke, Vaishnavi Parikh
Assignee:	Genus Lifesciences Inc
Application Number:	US18/504,280
Patent Claims:	1. An aqueous oral composition consisting of: about 10% to about 20% (w/v) potassium chloride; about 1% to about 5% (w/v) glycerin; about 0.04% to about 0.16% (w/v) sucralose; about 0.1% to about 1.0% (w/v) sodium citrate dihydrate; about 0.05% to about 0.5% (w/v) citric acid; about 0.02% to about 0.2% (w/v) sodium benzoate; colorant; flavoring; buffer; and water; wherein the composition is a solution. 2. The composition of claim 1, wherein the composition has no visible formation of precipitates after being subjected to three freeze-thaw cycles, wherein each freeze-thaw cycle comprises: (i) maintaining the composition at a temperature of about −20° C. to about −10° C. for about two days; followed by (ii) maintaining the composition at a temperature of about 38° C. to about 42° C. and about 70% to about 80% relative humidity for about two days. 3. The composition of claim 1, wherein the composition has a pH of 2.0 to 4.3. 4. The composition of claim 1, wherein the composition has a pH of 2 to 4.2. 5. The composition of claim 1, wherein the citric acid content of the composition is about 0.05% to about 0.3% (w/v). 6. The composition of claim 1, wherein the citric acid content of the composition is about 0.15% to about 0.5% (w/v). 7. The composition of claim 1, wherein the colorant is FD&C Yellow No. 6. 8. The composition of claim 1, consisting of: about 10% (w/v) potassium chloride; about 1% to about 3% (w/v) glycerin; about 0.04% to about 0.16% (w/v) sucralose; about 0.1% to about 1.0% (w/v) sodium citrate dihydrate; about 0.05% to about 0.5% (w/v) citric acid; about 0.02% to about 0.1% (w/v) sodium benzoate; colorant; flavoring; buffer; and water; wherein the composition is a solution. 9. The composition of claim 8, wherein the composition has a pH of 2.0 to 4.3. 10. The composition of claim 8, wherein the composition has a pH of 2 to 4.2. 11. The composition of claim 8, wherein the colorant is FD&C Yellow No. 6. 12. The composition of claim 1, consisting of: about 20% (w/v) potassium chloride; about 3% to about 5% (w/v) glycerin; about 0.04% to about 0.16% (w/v) sucralose; about 0.1% to about 1.0% (w/v) sodium citrate dihydrate; about 0.05% to about 0.5% (w/v) citric acid; about 0.05% to about 0.2% (w/v) sodium benzoate; colorant; flavoring; buffer; and water; wherein the composition is a solution. 13. The composition of claim 12, wherein the composition has a pH of 2.0 to 4.3. 14. The composition of claim 12, wherein the composition has a pH of 2 to 4.2. 15. The composition of claim 12, wherein the colorant is FD&C Yellow No. 6. 16. An aqueous oral composition consisting of: about 10% to about 20% (w/v) potassium chloride; about 1% to about 5% (w/v) glycerin; about 0.04% to about 0.16% (w/v) sucralose; about 0.1% to about 1.0% (w/v) sodium citrate dihydrate; about 0.05% to about 0.5% (w/v) citric acid; about 0.02% to about 0.2% (w/v) sodium benzoate; colorant; flavoring; buffer; and water; wherein the composition is a solution; and wherein the composition has no visible formation of precipitates after exposure to cool white fluorescent light for about 1.2 million lux hours, followed by exposure to near ultraviolet light for 200 watt hours/square meter. 17. The composition of claim 16, wherein the composition contains an initial amount of about 10% to about 20% (w/v) potassium chloride, and after exposure of the composition to cool white fluorescent light for about 1.2 million lux hours, followed by exposure to near ultraviolet light for about 200 watt hours/square meter to obtain a light-treated composition, the light-treated composition contains potassium chloride in an amount that is no more than 3% different from the initial amount of potassium chloride. 18. The composition of claim 16, wherein the composition contains an initial amount of about 0.02% to about 0.2% (w/v) sodium benzoate, and after exposure of the composition to cool white fluorescent light for about 1.2 million lux hours, followed by exposure to near ultraviolet light for about 200 watt hours/square meter to obtain a light-treated composition, the light-treated composition contains sodium benzoate in an amount that is no more than 5% different from the initial amount of sodium benzoate. 19. The composition of claim 16, wherein the composition has a pH of 2.0 to 4.3. 20. The composition of claim 16, wherein the composition has a pH of 2 to 4.2. 21. The composition of claim 16, wherein the citric acid content of the composition is about 0.05% to about 0.3% (w/v). 22. The composition of claim 16, wherein the citric acid content of the composition is about 0.15% to about 0.5% (w/v). 23. The composition of claim 16, wherein the colorant is FD&C Yellow No. 6. 24. An aqueous oral composition consisting of: about 10% to about 20% (w/v) potassium chloride; about 1% to about 5% (w/v) glycerin; about 0.04% to about 0.16% (w/v) sucralose; about 0.1% to about 1.0% (w/v) sodium citrate dihydrate; about 0.05% to about 0.5% (w/v) citric acid; about 0.02% to about 0.2% (w/v) sodium benzoate; colorant; flavoring; buffer; and water; wherein the composition is a solution; and wherein the composition has no visible formation of precipitates after being subjected to three freeze-thaw cycles, wherein each freeze-thaw cycle comprises: (i) maintaining the composition at a temperature of about −20° C. to about −10° C. for about two days; followed by (ii) maintaining the composition at a temperature of about 23° C. to about 27° C. and about 55% to about 65% relative humidity for about two days. 25. The composition of claim 24, wherein the citric acid content of the composition is about 0.05% to about 0.3% (w/v). 26. The composition of claim 24, wherein the citric acid content of the composition is about 0.15% to about 0.5% (w/v). 27. The composition of claim 24, wherein the composition has a pH of 2.0 to 4.3. 28. The composition of claim 24, wherein the composition has a pH of 2.0 to 4.2. 29. The composition of claim 24, wherein the colorant is FD&C Yellow No. 6.