Compositions and kits for omeprazole suspension
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.
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.