Back to results
US 2021/0069167 A1Published application
Compositions and kits for omeprazole suspension
AssigneeAzurity Pharmaceuticals, Inc.
InventorsZeus Pendon, Steven Dinh
Life of this patent
Estimating the term…
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.
Claims30
A liquid diluent for reconstituting omeprazole, 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.
8 more elements
A suspension of omeprazole consisting essentially of:
- omeprazole;
- poloxamer;
- a suspending agent, wherein the suspending agent is (i) sodium carboxymethylcellulose (CMC) or (ii) a combination of sodium CMC and microcrystalline cellulose;
- an acid neutralizing agent;
- a defoamer;
- 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;
- wherein the suspension is homogenous and stable for at least 30 days at ambient conditions and at refrigerated temperature conditions.
8 more elements
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,
- a suspending agent, wherein the suspending agent is (i) sodium carboxymethylcellulose (CMC) or (ii) a combination of sodium CMC and microcrystalline cellulose,
- an acid neutralizing agent,
- a defoamer,
- 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;
- 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,
- 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;
- and
- wherein the reconstituted omeprazole suspension is homogenous and stable for at least 30 days at ambient and refrigerated temperature conditions.
10 more elements
Dependencies are inferred from the claim text.