Racecadotril liquid compositions
View Patent ↗A liquid composition comprising racecadotril and cyclodextrin.
1. A liquid composition comprising racecadotril and a sulfobutyl ether derivative of β-cyclodextrin;
wherein the racecadotril is present in an amount of from about 0.10 grams to about 0.30 grams per 100 ml of the liquid composition;
wherein the cyclodextrin is present in an amount of from about 5 grams to about 50 grams per 100 ml of the liquid composition;
further comprising a buffer selected from the group consisting of a citrate, an acetate, a phosphate, and mixtures thereof;
wherein chemical degradant products of racecadotril in the liquid composition are less than about 10% when stored at 3 months and 40° C.
2. The composition of claim 1 , wherein the racecadotril is an RS racemic form or an R form.
3. The composition of claim 1 , wherein the composition comprises a sweetener selected from the group consisting of sorbitol, high fructose corn syrup, sucralose, aspartame, saccharine, sucrose, and mixtures thereof.
4. The composition of claim 1 , wherein the composition comprises a preseryatiye selected from the group consisting of sodium benzoate, potassium benzoate, propyl paraben, methyl paraben, butyl paraben, and mixtures thereof.
5. A dosage form, wherein the dosage form, comprises the composition of claim 1 delivered via a soft shell solid dosage form, a hard shell solid dosage form or a tablet dosage form.
6. The composition of claim 1 , further comprising a second active ingredient that is a digestive health active ingredient.
7. The composition of claim 1 , wherein the composition is delivered orally.
8. The composition of claim 1 , wherein the composition has a pH of from about 3 to about 5 at 25° C.
9. A dosage form, wherein the dosage form comprises the composition of claim 8 delivered via a soft shell solid dosage form, a hard shell solid dosage form or a tablet dosage form.
10. The composition of claim 8 , further comprising a second active ingredient that is a digestive health active ingredient.
11. A liquid composition comprising:
about 0.1 wt. % to about 0.3 wt. % racecadotril;
about 6 wt. % to about 8 wt. % a sulfobutyl ether derivative of β-cyclodextrin;
about 16 wt. % to about 19 wt. % sorbitol;
about 45 wt. % to about 55 wt. % high fructose corn syrup;
about 0.1 wt. % to about 0.4 wt. % sodium chloride;
about 0.1 wt. % to about 0.8 wt. % polyethylene glycol;
about 15 wt. % to about 30 wt. % water; and
about 0 wt. % to about 0.5 wt. % flavor,
wherein each wt. % is based upon 100 ml of the composition.
12. A method for treating a subject experiencing diarrhea, comprising the step of orally administering to the subject a composition comprising racecadotril and a sulfobutyl ether derivative of (β-cyclodextrin.
13. The composition of claim 6 , wherein the digestive health active ingredient is simethicone.
14. The composition of claim 10 , wherein the digestive health active ingredient is simethicone.
15. The composition of claim 6 , wherein the digestive health active ingredient is loperamide.
16. The composition of claim 10 , wherein the digestive health active ingredient is loperamide.
17. The composition of claim 1 , wherein the racecadotril is present in an amount of from about 0.25 grams per 100 ml of the composition.
18. The composition of claim 1 ,wherein the cyclodextrin is present in an amount of about 7 grams per 100 ml of the composition.