Composition and method for proton pump inhibitor suspension

1. An oral liquid suspension of a proton pump inhibitor (PPI), comprising:

a PPI, wherein the PPI is omeprazole and is present at 2 mg/ml in the suspension;

0.4%-0.6% (w/v) benzyl alcohol;

1.0%-6.0% (w/v) a copolymer of ethylene oxide and propylene oxide;

0.1%-0.3% (w/v) simethicone emulsion (30%);

8.0%-8.8% (w/v) sodium bicarbonate;

0.5%-1.5% (w/v) sodium citrate (dihydrate);

a sweetener that comprises ammonium glycyrrhizate and sucralose;

a thickening agent that is xanthan gum or hydroxyethylcellulose; and

water,

wherein the pH of the suspension is at least pH 8.0, and wherein the formulation retains homogeneity of less than +/−5% of variation for the omeprazole by assay after at least 30 days stored at 5° C.

2. The suspension of claim 1 , wherein the copolymer of ethylene oxide and propylene oxide is Poloxamer 188.

3. The suspension of claim 1 , wherein the sweetener further comprises sorbitol.

4. The suspension of claim 1 , further comprising propylene glycol.

5. The suspension of claim 1 , further comprising FD&C Red No. 40, or strawberry flavor.

6. The suspension of claim 1 , wherein the dynamic viscosity is greater than or equal to 50 and less than or equal to 1000 centipoise (cP) when determined at 6 rpm and 25° C.

7. The suspension of claim 1 , wherein the dynamic viscosity is greater than or equal to 40 and less than or equal to 50 centipoise (cP) when determined at 6 rpm and 25° C.

8. The suspension of claim 1 , wherein the dynamic viscosity is greater than or equal to 200 and less than or equal to 300 centipoise (cP) when determined at 6 rpm and 25° C.

9. The suspension of claim 1 , wherein the suspension includes the following:

a. 0.5% (w/v) benzyl alcohol;

b. 0.003% (w/v) FD&C Red No. 40;

c. 0.15% (w/v) strawberry flavor;

d. 0.35% (w/v) hydroxyethylcellulose;

e. 2.00-4.00% (w/v) Poloxamer 188;

f. 5.0% (w/v) propylene glycol;

g. 0.2% (w/v) simethicone emulsion (30%);

h. 8.4% (w/v) sodium bicarbonate;

i. 1.0% (w/v) sodium citrate (dihydrate);

j. ammonium glycyrrhizate and 0.45% (w/v) sucralose;

k. 0.4% (w/v) xanthan gum; and

l. purified water.

10. The suspension of claim 1 , wherein the suspension includes the following:

a. 0.5% (w/v) benzyl alcohol;

b. 0.003% (w/v) FD&C Red No. 40;

c. 0.15% (w/v) strawberry flavor;

d. 0.07% (w/v) ammonium glycyrrhizate;

e. 0.25% (w/v) hydroxyethylcellulose;

f. 2.0% (w/v) Poloxamer 188;

g. 0.08% (w/v) saccharin sodium;

h. 0.2% (w/v) simethicone emulsion (30%);

i. 8.4% (w/v) sodium bicarbonate;

j. 1.0% (w/v) sodium citrate (dihydrate);

k. 2.5% (w/v) sorbitol solution (70%);

l. 0.4% (w/v) sucralose; and

m. purified water.

11. The suspension of claim 1 , wherein the suspension is stable for at least 30 days when stored at 2-8 degrees Celsius.

12. The suspension of claim 1 , wherein the suspension comprises the following:

omeprazole that is present at 2 mg/ml in the suspension;

0.4%-0.6% (w/v) benzyl alcohol;

0.2%-0.5% (w/v) hydroxyethylcellulose;

1.0%-6.0% (w/v) Poloxamer 188;

0.1%-0.3% (w/v) simethicone emulsion (30%);

8.0%-8.8% (w/v) sodium bicarbonate;

0.5%-1.5% (w/v) sodium citrate (dihydrate);

ammonium glycyrrhizate and 0.35%-0.5% (w/v) sucralose;

1.5%-4% (w/v) sorbitol solution; and

8%-12% (w/v) glycerin 99.7%.

13. The suspension of claim 12 , wherein the suspension consists essentially of the following:

omeprazole that is present at 2 mg/ml in the suspension;

0.4%-0.6% (w/v) benzyl alcohol;

0.002%-0.005% (w/v) FD&C Red No. 40;

0.1%-0.2% (w/v) strawberry flavor;

0.2%-0.5% (w/v) hydroxyethylcellulose;

1.0%-6.0% (w/v) Poloxamer 188;

0.1%-0.3% (w/v) simethicone emulsion (30%);

8.0%-8.8% (w/v) sodium bicarbonate;

0.5%-1.5% (w/v) sodium citrate (dihydrate);

ammonium glycyrrhizate and 0.35%-0.5% (w/v) sucralose;

purified water;

1.5%-4% (w/v) sorbitol solution; and

8%-12% (w/v) glycerin 99.7%.

14. The suspension of claim 12 , wherein the suspension consists essentially of the following:

omeprazole that is present at 2 mg/ml in the suspension;

0.5% (w/v) benzyl alcohol;

0.003% (w/v) FD&C Red No. 40;

0.15% (w/v) strawberry flavor;

0.35% (w/v) hydroxyethylcellulose;

2.0% (w/v) Poloxamer 188;

0.15% (w/v) simethicone emulsion (30%);

8.4% (w/v) sodium bicarbonate;

1.0% (w/v) sodium citrate (dihydrate);

ammonium glycyrrhizate and 0.4% (w/v) sucralose;

purified water;

2.5% (w/v) sorbitol solution; and

10% (w/v) glycerin 99.7%.

15. The suspension of claim 12 , wherein the suspension consists essentially of the following:

omeprazole that is present at 2 mg/ml in the suspension;

0.5% (w/v) benzyl alcohol;

0.003% (w/v) FD&C Red No. 40;

0.15% (w/v) strawberry flavor;

0.35% (w/v) hydroxyethylcellulose;

4.0% (w/v) Poloxamer 188;

0.15% (w/v) simethicone emulsion (30%);

8.4% (w/v) sodium bicarbonate;

1.0% (w/v) sodium citrate (dihydrate);

ammonium glycyrrhizate and 0.4% (w/v) sucralose;

purified water;

2.5% (w/v) sorbitol solution; and

10% (w/v) glycerin 99.7%.

16. The suspension of claim 1 , wherein the suspension consists essentially of the following:

omeprazole that is present at 2 mg/ml in the suspension;

0.4-0.6% (w/v) benzyl alcohol;

0.002-0.005% (w/v) dye;

0.1-0.2% (w/v) flavoring;

0.06-0.08% (w/v) ammonium glycyrrhizate;

1.00-3.00% (w/v) Poloxamer 188;

4.0-6.0% (w/v) propylene glycol;

0.1-0.3% (w/v) simethicone emulsion;

8.0-8.8% (w/v) sodium bicarbonate;

0.5-1.5% (w/v) sodium citrate (dihydrate);

0.4-0.45% (w/v) sucralose;

0.3-0.5% (w/v) xanthan gum; and

purified water.

17. The suspension of claim 1 , wherein the suspension consists essentially of the following:

omeprazole that is present at 2 mg/ml in the suspension;

0.5% (w/v) benzyl alcohol;

0.003% (w/v) FD&C Red No. 40;

0.15% (w/v) strawberry flavor;

0.07% (w/v) ammonium glycyrrhizate;

2.00% (w/v) Poloxamer 188;

5.0% (w/v) propylene glycol;

0.2% (w/v) simethicone emulsion (30%);

8.4% (w/v) sodium bicarbonate;

1.0% (w/v) sodium citrate (dihydrate);

0.45% (w/v) sucralose;

0.4% (w/v) xanthan gum; and

purified water.