Racecadotril compositions
View Patent ↗A lipid composition comprising racecadotril, at least one surfactant and a lipid.
1. A composition comprising:
racecadotril, polyoxyl 35 castor oil USP/NF, glyceryl caprylate mono- and diglycerides USP/NF and caprylic/capric triglycerides, 70:30/C8:C10 USP/NF.
2. The composition of claim 1 , wherein the composition is stable for about 40 weeks at 40° C.
3. The composition of claim 1 , wherein the at least one surfactant is present in an amount from about 88 wt. % to about 91 wt. % in total per 100 ml of the composition.
4. The composition of claim 1 , wherein the caprylic/capric triglycerides is present in an amount of from about 1 wt. % to about 2 wt. % lipid per 100 ml of the composition.
5. The composition of claim 1 , further comprising an optional ingredient selected from the group consisting of preservatives, sweeteners, viscosity modifiers, colors, aromas, flavors, and mixtures thereof.
6. The composition of claim 1 , further comprising an optional ingredient selected from the group consisting of citric acid, sodium benzoate, sucralose, flavors and mixtures thereof.
7. A dosage form comprising the composition of claim 1 , wherein the dosage form is a soft shell dosage form, a hard shell dosage form, or a tablet dosage form.
8. The composition of claim 1 , wherein the composition has a total water content of less than about 3.5 wt. % based on the total weight of the composition.
9. The composition of claim 1 , further comprising a second active ingredient that is a digestive health active ingredient.
10. A composition comprising:
about 3.0 wt. % to about 7.0 wt. % racecadotril;
about 40 wt. % to about 53 wt. % of polyoxyl 35 castor oil USP/NF, glyceryl caprylate mono- and diglycerides USP/NF in total; and
about 40 wt. % to about 53 wt. % and caprylic/capric triglycerides, 70:30/C8:C10 USP/NF;
wherein each wt. % is based upon 100 ml of the composition.
11. A dosage form comprising the composition of claim 10 , wherein the dosage form is a soft shell dosage form, a hard shell dosage form, or a tablet dosage form.
12. A method for treating a subject experiencing diarrhea comprising the step of orally administering to the subject a composition comprising racecadotril, polyoxyl 35 castor oil USP/NF, glyceryl caprylate mono- and diglycerides USP/NF and caprylic/capric triglycerides, 70:30/C8:C10 USP/NF.
13. A composition comprising:
racecadotril, polyoxyl 35 castor oil USP/NF, glyceryl caprylate mono- and diglycerides USP/NF and caprylic/capric triglycerides, 70:30/C8:C10 USP/NF, and a digestive health active ingredient selected from the group consisting of laxatives, antacids, proton pump inhibitors, anti-gas agents, antiemetics, H2 blockers, and antidiarrheal agents.
14. The composition of claim 13 , wherein the anti-gas agent is simethicone.
15. The composition of claim 13 , wherein the antidiarrheal agent is loperamide.
16. A composition comprising:
racecadotril, polyoxyl 35 castor oil USP/NF, glyceryl caprylate mono- and diglycerides USP/NF and caprylic/capric triglycerides, 70:30/C8:C10 USP/NF,
wherein the racecadotril is present in amount from about 8% to about 10% by weight of a total weight of the composition.