Claims for Patent: 12,551,466

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Summary for Patent: 12,551,466

Title:	Ready-to-use oral liquid formulation of clonidine
Abstract:	The present disclosure relates generally to a ready-to-use oral liquid formulation of clonidine or pharmaceutically acceptable salt thereof, as well as methods of manufacture and use.
Inventor(s):	Manish Umrethia, Ronak Patel
Assignee:	Liqmeds Worldwide Ltd
Application Number:	US19/307,340
Patent Claims:	1. A ready-to-use (RTU) oral liquid formulation, comprising: clonidine or pharmaceutically acceptable salt thereof; propylene glycol; one or more buffering agents; one or more pharmaceutically acceptable excipients; and purified water. 2. The RTU oral liquid formulation of claim 1, wherein the amount of clonidine or pharmaceutically acceptable salt thereof ranges from 0.01 mg/mL to 10 mg/mL. 3. The RTU oral liquid formulation of claim 1, wherein the clonidine or pharmaceutically acceptable salt thereof is present in an amount of about 0.05 mg/mL. 4. The RTU oral liquid formulation of claim 1, wherein the amount of propylene glycol ranges from 50 mg/mL to 300 mg/mL. 5. The RTU oral liquid formulation of claim 1, wherein the amount of propylene glycol ranges from 50 mg/mL to 200 mg/mL. 6. The RTU oral liquid formulation of claim 1, wherein the propylene glycol is present in an amount of about 100 mg/mL. 7. The RTU oral liquid formulation of claim 1, wherein the one or more buffering agents is selected from citrate, sulfamate, acetate, aconitate, formate, glutarate, succinate, glutamate, malate, tartrate, carbonate, tris, borate, glycinate, and phosphate. 8. The RTU oral liquid formulation of claim 1, wherein the one or more buffering agent comprises a phosphate buffer. 9. The RTU oral liquid formulation of claim 1, wherein the one or more buffering agent comprises sodium dihydrogen phosphate, disodium hydrogen phosphate, or a combination thereof. 10. The RTU oral liquid formulation of claim 1, wherein the amount of buffering agent ranges from 1 mg/mL to 50 mg/mL. 11. The RTU oral liquid formulation of claim 1, wherein the amount of buffering agent ranges from 1 mg/mL to 10 mg/mL. 12. The RTU oral liquid formulation of claim 1, wherein the one or more pharmaceutically acceptable excipients comprises a sweetener, a preservative, a flavour, or a combination thereof. 13. The RTU oral liquid formulation of claim 1, wherein the amount of one or more pharmaceutically acceptable excipients comprises a sweetener, a preservative, a flavour, or a combination thereof ranges from 0.01 mg/mL to 10 mg/mL. 14. The RTU oral liquid formulation of claim 1, wherein the formulation has a pH of from about 6 to about 8. 15. The RTU oral liquid formulation of claim 1, wherein the formulation has a pH of from about 6.5 to about 7.5. 16. The RTU oral liquid formulation of claim 1, wherein the formulation is substantially free of a carrier agent or vehicle selected from glycerin; a stabilizer selected from sodium chloride, histidine, meglumine, arginine, and tromethamine; a preservative selected from potassium sorbate, sorbic acid, sodium propionate, and benzoic acid; and a sugar alcohol selected from xylitol. 17. The RTU oral liquid formulation of claim 1, wherein the formulation has less than 0.5% clonidine related substance individual impurities after storage at 25° C./60% RH for 9 months and 40° C./NMT 25% RH for 6 months. 18. The RTU oral liquid formulation of claim 1, wherein the formulation has less than 1% clonidine related substance total impurities after storage at 25° C./60% RH for 9 months and 40° C./NMT 25% RH for 6 months. 19. The RTU oral liquid formulation of claim 1, wherein the weight ratio of propylene glycol to purified water in the oral liquid formulation disclosed herein is ranges from 0.8:8 to 1:11. 20. The RTU oral liquid formulation of claim 1, wherein the amount of purified water ranges from 60% w/w to 95% w/w. 21. The RTU oral liquid formulation of claim 1, wherein the amount of purified water ranges from 85% w/w to 95% w/w. 22. The RTU oral liquid formulation of claim 1, wherein the formulation, comprising: clonidine or pharmaceutically acceptable salt thereof in an amount of about 0.05 mg/mL; propylene glycol as a solvent in an amount of about 100 mg/mL; sodium dihydrogen phosphate in an amount of about 3.98 mg/mL, and disodium hydrogen phosphate in an amount of about 4.28 mg/mL as a buffering agent; a sweetener in an amount of from 0.01 mg/mL to 10 mg/mL; a preservative in an amount of from 0.01 mg/mL to 10 mg/mL; a flavour in an amount of from 0.01 mg/mL to 10 mg/mL; and purified water. 23. A method for the treatment of hypertension, which comprises administering to a patient in need thereof a therapeutically effective amount of the ready-to-use oral liquid formulation of claim 1.