Racecadotril liquid compositions
View Patent ↗A liquid composition comprising racecadotril and cyclodextrin.
1. A liquid composition comprising racecadotril and hydroxypropyl-beta-cyclodextrin with a buffer, wherein the racecadotril is present in an amount from about 0.10 grams to about 0.30 grams per 100 mL of the liquid composition, wherein the hydroxypropyl-beta-cyclodextrin is present in an amount of from about 5 grams to about 50 grams per 100 mL of the liquid composition, and wherein the buffer is a citrate, an acetate, a phosphate or mixtures thereof.
2. The liquid composition of claim 1 , wherein the racecadotril is an RS racemic form or R form.
3. The liquid composition of claim 1 , further comprising an ingredient selected from the group consisting of buffers, preservatives, sweeteners, viscosity modifiers, colors, aromas, flavors, and mixtures thereof.
4. The liquid composition of claim 3 , wherein the sweetener is sorbitol, high fructose corn syrup, sucralose, aspartame, saccharine, sucrose, or mixtures thereof.
5. The liquid composition of claim 3 , wherein the preservative is sodium benzoate, potassium benzoate, propyl paraben, methyl paraben, butyl paraben, or mixtures thereof.
6. A dosage form, wherein the dosage form comprises the liquid composition of claim 1 delivered via a soft shell solid dosage form, a hard shell solid dosage form or a tablet dosage form.
7. The liquid composition of claim 1 , further comprising a second active ingredient that is a digestive health active ingredient.
8. The liquid composition of claim 1 , wherein the composition is delivered orally.
9. The liquid composition of claim 1 , wherein the composition has a pH of from about 3 to about 5 at 25° C.
10. A dosage form, wherein the dosage form comprises the liquid composition of claim 9 delivered via a soft shell solid dosage form, a hard shell solid dosage form or a tablet dosage form.
11. The liquid composition of claim 9 , further comprising a second active ingredient that is a digestive health active ingredient.
12. A liquid composition comprising:
about 0.1 wt. % to about 0.3 wt. % racecadotril;
about 6 wt. % to about 8 wt. % hydroxypropyl-beta-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.
13. A method for treating a subject experiencing diarrhea, comprising the step or orally administering to the subject a liquid composition comprising racecadotril and hydroxypropyl-beta-cyclodextrin with a buffer, wherein the racecadotril is present in an amount from about 0.10 grams to about 0.30 grams per 100 mL of the liquid composition, wherein the hydroxypropyl-beta-cyclodextrin is present in an amount ef from about 5 grams to about 50 grams per 100 mL of the liquid composition, and wherein the buffer is a citrate, an acetate, a phosphate or mixtures thereof.
14. The liquid composition of claim 7 , wherein the digestive health active ingredient is simethicone.
15. The liquid composition of claim 11 , wherein the digestive health active ingredient is simethicone.
16. The liquid composition of claim 7 , wherein the digestive health active ingredient is loperamide.
17. The liquid composition of claim 11 , wherein the digestive health active ingredient is loperamide.