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 liquid diluent for reconstituting proton pump inhibitor (PPI), consisting essentially of:
1.0%-4.0% w/v poloxamer;
1.0%-5.0% w/v of a suspending agent, wherein the suspending agent is (i) sodium carboxymethylcellulose (CMC) or (ii) a combination of sodium CMC and microcrystalline cellulose;
8.0%-8.8% w/v of an acid neutralizing agent;
0.1%-0.3% w/v of a defoamer;
0.2%-1.2% w/v of a preservative;
water;
optionally a buffer that maintains a pH of 8 to 9.5; and
optionally one or more selected from a sweetener, a coloring agent, and a flavoring agent; and
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 liquid diluent of claim 1 , wherein the poloxamer has a number average molecular weight of about 7000 to about 10,000 Da.
3. The liquid diluent of claim 1 , wherein the poloxamer has an ethylene glycol content of about 80 wt % to about 85 wt %.
4. The liquid diluent of claim 1 , wherein the poloxamer is poloxamer 188 and is present in the liquid diluent at 1% w/v, 2% w/v, or 4% w/v.
5. The liquid diluent of claim 1 , wherein the suspending agent is sodium CMC and wherein the sodium CMC is present in the liquid diluent at 1.0% to 2.0% w/v.
6. The liquid diluent of claim 1 , wherein the suspending agent is a combination of sodium CMC and microcrystalline cellulose.
7. The liquid diluent of claim 6 , wherein the combination of sodium CMC and microcrystalline cellulose is present in the liquid diluent at about 4.0% w/v.
8. The liquid diluent of claim 1 , wherein the liquid diluent comprises a coloring agent and a flavoring agent.
9. The liquid diluent of claim 1 , wherein the acid neutralizing agent is sodium bicarbonate.
10. The liquid diluent of claim 1 , wherein the buffer is present in the liquid diluent.
11. The liquid diluent of claim 10 , wherein the buffer is selected from sodium citrate, sodium bicarbonate, or a combination thereof.
12. The liquid diluent of claim 10 , wherein the buffer is one or more of a citrate, tartrate, acetate, carbonate, phosphate, metaphosphate, glycerophosphate, polyphosphate, and pyrophosphate.
13. The liquid diluent of claim 1 , wherein the defoamer is simethicone emulsion.
14. The liquid diluent of claim 1 , wherein the sweetener is present in the liquid diluent.
15. The liquid diluent of claim 14 , wherein the sweetener is glucose, fructose, sucrose, xylitol, maltodextrin, polydextrose, glycerin, inulin, maltol, salts of acesulfame, alitame, aspartame, neotame, cyclamate salts, sucralose, sorbitol, saccharin and its salts, or a combination thereof.
16. The liquid diluent of claim 1 , wherein the preservative is benzyl alcohol and is present at about 0.4% to about 0.6% w/v in the liquid diluent.
17. The liquid diluent of claim 1 , wherein the preservative is one or more of the group consisting of: benzyl alcohol, ascorbic acid, ascorbyl palmitate or other pharmaceutically acceptable ascorbate salts, BHA, BHT, citric acid or other citrate salts, sodium benzoate, benzoic acid or other pharmaceutically acceptable benzoate salts, sodium bisulfate, sodium metabisulfite, sodium sulfite, parabens, potassium sorbate or other pharmaceutically acceptable sorbate salts, and vanillin.
18. The liquid diluent of claim 1 , wherein the PPI is omeprazole.
19. The liquid diluent of claim 1 , wherein the PPI is lansoprazole.