Claims for Patent: 11,771,686

Summary for Patent: 11,771,686

Title:	Compositions and kits for omeprazole suspension
Abstract:	Disclosed herein are liquid diluents, formulations, and kits for preparing reconstituted suspensions of a proton pump inhibitor (e.g., omeprazole). The present disclosure also provides formulations for liquid diluents that do not have a tendency for gel formation following exposure to freeze-thaw cycles.
Inventor(s):	Zeus Pendon, Steven Dinh
Assignee:	Azurity Pharmaceuticals Inc
Application Number:	US16/998,731
Patent Claims:	1. A method of ameliorating a gastrointestinal disorder in a subject in need thereof, wherein the gastrointestinal disorder relates to a production of excess stomach acid, and wherein the subject has a gastric ulcer, the method comprising: administering a reconstituted omeprazole to the subject, wherein the reconstituted omeprazole is reconstituted in a liquid diluent, and wherein the liquid diluent consists essentially of: 1.0% -4.0% w/v poloxamer 188; 1.0% -2.0% w/v sodium carboxymethylcellulose (CMC); 8.0% -8.8% w/v sodium bicarbonate; 0.5% -1.5% w/v sodium citrate; 0.1% -0.3% w/v simethicone emulsion; 0.35% -3.5% w/v sweetener; 0.4% -0.6% w/v preservative, wherein the preservative is benzyl alcohol; and water; wherein the liquid diluent is stable for at least 30 days at 5±3° C. and is resistant to gel formation for at least one freeze-thaw cycle. 2. The method of claim 1, wherein the poloxamer 188 is present in the liquid diluent at 1% w/v, 2% w/v, or 4% w/v. 3. The method of claim 1, wherein the sodium CMC is present in the liquid diluent at 1.2% w/v. 4. The method of claim 1, wherein the liquid diluent further comprises a coloring agent and a flavoring agent, wherein the coloring agent is 0.002%-0.005% w/v FD&C Red No. 40, and wherein the flavoring agent is 0.1% -0.2% w/v Strawberry Flavor CW08. 5. The method of claim 1, wherein the sodium bicarbonate is present in the liquid diluent at 8.4% w/v. 6. The method of claim 1, wherein the sodium citrate is present in the liquid diluent at 1% w/v. 7. The method of claim 1, wherein the simethicone emulsion is present in the liquid diluent at 0.15% w/v. 8. The method of claim 1, wherein the sweetener comprises 70% sorbitol solution and sucralose. 9. The method of claim 8, wherein the 70% sorbitol solution is present in the liquid diluent at 2.5% w/v. 10. The method of claim 8, wherein the sucralose is present in the liquid diluent at 0.4 w/v. 11. The method of claim 1, wherein the benzyl alcohol is present in the liquid diluent at 0.5% w/v. 12. The method of claim 1, wherein the subject is a child or an elderly. 13. A method of ameliorating a gastrointestinal disorder in a subject in need thereof, wherein the gastrointestinal disorder relates to a production of excess stomach acid, and wherein the subject has a gastric ulcer, the method comprising providing a kit consisting essentially of: a first container having a 100% w/w omeprazole powder; a second container having a liquid diluent consisting essentially of: 1.0% -4.0% w/v poloxamer 188; 1.0% -2.0% w/v sodium carboxymethylcellulose (CMC); 8.0% -8.8% w/v sodium bicarbonate; 0.5% -1.5% w/v sodium citrate; 0.1% -0.3% w/v simethicone emulsion; 0.4% -0.6% w/v benzyl alcohol; 0.35% -3.5% w/v a sweetener; and water; wherein the liquid diluent is stable for at least 30 days and is resistant to gel formation for at least one freeze-thaw cycle; wherein the first and second containers are of a size such that the omeprazole powder and liquid diluent can be combined in either the first or second container to produce a reconstituted omeprazole suspension; wherein the reconstituted omeprazole suspension is homogenous and stable for at least 30 days at ambient and refrigerated temperature conditions. 14. The method of claim 13, wherein the percent of omeprazole powder dissolved to make the reconstituted omeprazole suspension is >80% by dissolution assay after 5 minutes of mixing. 15. The method of claim 13, wherein the subject is a child or an elderly. 16. A method of ameliorating a gastrointestinal disorder in a subject in need thereof, wherein the gastrointestinal disorder relates to a production of excess stomach acid, and wherein the subject has a gastric ulcer, the method comprising: (i) reconstituting omeprazole in a liquid diluent, wherein the liquid diluent consists essentially of: 1.0% -4.0% w/v poloxamer 188; 1.0% -2.0% w/v sodium carboxymethylcellulose (CMC); 8.0% -8.8% w/v sodium bicarbonate; 0.5% -1.5% w/v sodium citrate; 0.1% -0.3% w/v simethicone emulsion; 0.35% -3.5% w/v sweetener; 0.4% -0.6% w/v preservative, wherein the preservative is benzyl alcohol; and water; wherein the liquid diluent is stable for at least 30 days at 5±3° C. and is resistant to gel formation for at least one freeze-thaw cycle; and (ii) administering the reconstituted omeprazole to the subject. 17. The method of claim 13, wherein the poloxamer 188 is present in the liquid diluent at 1% w/v, 2% w/v, or 4% w/v. 18. The method of claim 16, wherein the poloxamer 188 is present in the liquid diluent at 1% w/v, 2% w/v, or 4% w/v. 19. The method of claim 13, wherein the sodium CMC is present in the liquid diluent at 1.2% w/v. 20. The method of claim 16, wherein the sodium CMC is present in the liquid diluent at 1.2% w/v. 21. The method of claim 13, wherein the sodium bicarbonate is present in the liquid diluent at 8.4% w/v. 22. The method of claim 16, wherein the sodium bicarbonate is present in the liquid diluent at 8.4% w/v. 23. The method of claim 13, wherein the sodium citrate is present in the liquid diluent at 1% w/v. 24. The method of claim 16, wherein the sodium citrate is present in the liquid diluent at 1% w/v. 25. The method of claim 13, wherein the sweetener comprises 70% sorbitol solution and sucralose. 26. The method of claim 16, wherein the sweetener comprises 70% sorbitol solution and sucralose.