Claims for Patent: 10,751,333

Summary for Patent: 10,751,333

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:	US16/513,604
Patent Claims:	1. A liquid diluent for reconstituting omeprazole, 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; 0.35%-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 and is resistant to gel formation for at least one freeze-thaw cycle. 2. The liquid diluent of claim 1, wherein the poloxamer 188 is present in the liquid diluent at 1% w/v. 3. The liquid diluent of claim 1, wherein the poloxamer 188 is present in the liquid diluent at 2% w/v. 4. The liquid diluent of claim 1, wherein the poloxamer 188 is present in the liquid diluent at 4% w/v. 5. The liquid diluent of claim 1, wherein the sodium CMC is present in the liquid diluent at 1.2% w/v. 6. The liquid diluent of claim 1, wherein the liquid diluent comprises a coloring agent, and wherein the coloring agent is 0.002%-0.005% w/v FD&C Red No. 40. 7. The liquid diluent of claim 6, wherein the FD&C Red No. 40 is 0.003% w/v. 8. The liquid diluent of claim 1, wherein the liquid diluent comprises a flavoring agent, and wherein the flavoring agent is 0.1%-0.2% w/v Strawberry Flavor CW08. 9. The liquid diluent of claim 8, wherein the Strawberry Flavor CW08 is 0.15% w/v. 10. The liquid diluent of claim 1, wherein the sodium bicarbonate is present in the liquid diluent at 8.4% w/v. 11. The liquid diluent of claim 1, wherein the sodium citrate is present in the liquid diluent at 1% w/v. 12. The liquid diluent of claim 1, wherein the simethicone emulsion is present in the liquid diluent at 0.15% w/v. 13. The liquid diluent of claim 1, wherein the sweetener comprises 70% sorbitol solution and sucralose. 14. The liquid diluent of claim 13, wherein the 70% sorbitol solution is present in the liquid diluent at 2.5% w/v. 15. The liquid diluent of claim 13, wherein the sucralose is present in the liquid diluent at 0.4 w/v. 16. The liquid diluent of claim 1, wherein the benzyl alcohol is present in the liquid diluent at 0.5% w/v. 17. A suspension of omeprazole consisting essentially of: omeprazole, poloxamer 188, sodium carboxymethylcellulose (CMC), sodium bicarbonate, sodium citrate, simethicone emulsion, benzyl alcohol, a sweetener, and water; wherein the suspension is homogenous and stable for at least 30 days at ambient conditions and at refrigerated temperature conditions. 18. The suspension of claim 17, wherein the poloxamer 188 is present in the suspension at 1.0%-4.0% w/v. 19. The suspension of claim 17, wherein the poloxamer 188 is present in the suspension at 1.0% w/v. 20. The suspension of claim 17, wherein the sodium CMC is present in the suspension at 1.0%-2.0% w/v. 21. The suspension of claim 17, wherein the sodium CMC is 1.2% w/v. 22. The suspension of claim 17, wherein the poloxamer 188 is 1.0%-4.0% w/v and the Sodium CMC is 1.0%-2.0% w/v. 23. The suspension of claim 17, consisting essentially of: omeprazole; 1.0%-4.0% w/v poloxamer 188; 1.0%-2.0% w/v sodium 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 benzyl alcohol; and water. 24. 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 poloxamer 188, sodium carboxymethylcellulose (CMC), sodium bicarbonate, sodium citrate, simethicone emulsion, benzyl alcohol, 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. 25. The kit of claim 24, wherein the percent of omeprazole powder dissolved to make the reconstituted omeprazole suspension is >80% by dissolution assay after 5 minutes of mixing. 26. The kit of claim 24, wherein the poloxamer 188 is present in the reconstituted omeprazole suspension at 1.0%-4.0% w/v and the sodium CMC is present in the reconstituted omeprazole suspension at 1.0%-2.0% w/v. 27. The kit of claim 24, wherein the diluent consists essentially of: 1.0% w/v of poloxamer 188; 1.2% w/v sodium CMC; 8.4% w/v sodium bicarbonate; 1.0% w/v sodium citrate; 0.5% w/v benzyl alcohol; and 0.15% w/v simethicone emulsion. 28. The kit of claim 24, wherein the sweetener comprises 2.5% w/v sorbitol solution (70%) and 0.4% w/v sucralose.