Claims for Patent: 12,343,338

Summary for Patent: 12,343,338

Title:	Ramipril solution for oral dosage
Abstract:	This disclosure relates to pharmaceutical compositions in the form of a solution for oral delivery. Particularly, the pharmaceutical compositions comprise an active pharmaceutical ingredient, a buffering agent, and water. In some embodiments, the pH of the composition is from about pH 5 to about pH 8. In some embodiments, the active pharmaceutical ingredient is selected from ramipril, solifenacin, vigabatrin, losartan potassium, warfarin, and melatonin.
Inventor(s):	Sandip Mehta, Manish Kumar Umrethia, Jayanta Mandal
Assignee:	Liqmeds Worldwide Ltd
Application Number:	US18/652,993
Patent Claims:	1. A liquid pharmaceutical solution, consisting of: an active pharmaceutical ingredient consisting of ramipril or a pharmaceutically acceptable salt thereof in an amount of about 0.1% wt; an antimicrobial preservative selected from the group consisting of methylparaben, ethylparaben, and a combination thereof in an amount of from about 0.1% wt to about 1% wt; a buffering agent selected from the group consisting of citric acid, citric acid monohydrate, and a combination thereof; a sweetener; a flavoring agent; and water; wherein the liquid pharmaceutical solution has a pH of from about 3 to about 4; and wherein the liquid pharmaceutical solution does not contain a polyhydric alcohol having 2 to 6 carbon atoms. 2. The liquid pharmaceutical solution of claim 1, wherein the ramipril or a pharmaceutically acceptable salt thereof is present in an amount of about 1 mg/mL. 3. The liquid pharmaceutical solution of claim 1, wherein the buffering agent is citric acid. 4. The liquid pharmaceutical solution of claim 1, wherein the buffering agent is citric acid monohydrate. 5. The liquid pharmaceutical solution of claim 1, wherein the sweetener is selected from the group consisting of glucose, sucralose, maltitol, trehalose, fructose, xylose, dextrose, galactose, tagatose, maltose, sucrose, lactitol, saccharin or a salt thereof, cyclamate or a salt thereof, aspartame, acesulfame or a salt thereof, dulcin, ammonium glycyrrhizinate, alitame, inulin, isomalt, neohesperidin dihydrochalcone, thaumatin, or a combination thereof in an amount of from about 0.01% wt to about 15% wt. 6. The liquid pharmaceutical solution of claim 1, wherein the sweetener is sucralose. 7. The liquid pharmaceutical solution of claim 1, wherein the liquid pharmaceutical solution has a total ramipril impurity content of about 0.92% after storage at 5° C.±3° C. for six-months. 8. The liquid pharmaceutical solution of claim 1, wherein the preservative is present in an amount of from about 0.1% wt to about 0.5% wt. 9. The liquid pharmaceutical solution of claim 1, wherein the buffering agent is present in an amount of from about 0.01% wt to about 0.5% wt. 10. The liquid pharmaceutical solution of claim 1, wherein the buffering agent is citric acid and is present in an amount of from about 0.01% wt to about 0.5% wt. 11. The liquid pharmaceutical solution of claim 1, wherein the buffering agent is citric acid monohydrate and is present in an amount of from about 0.01% wt to about 0.5% wt. 12. The liquid pharmaceutical solution of claim 1, wherein the sweetener is sucralose and is present in an amount of from about 0.01% wt. to about 1% wt. 13. The liquid pharmaceutical solution of claim 1, wherein the flavoring agent is present in an amount of from about 0.001% wt. to about 1% wt. 14. The liquid pharmaceutical solution of claim 1, wherein the sweetener is sucralose and is present in an amount of about 0.05% wt. 15. The liquid pharmaceutical solution of claim 1, wherein the preservative consists of methylparaben in an amount of about 0.18% wt and ethylparaben in an amount of about 0.012% wt. 16. A method for the treatment of hypertension, which comprises administering a therapeutically effective amount of the liquid pharmaceutical solution of claim 1 to a patient in need thereof.