Racecadotril lipid compositions
View Patent ↗The present invention is drawn to a pharmaceutical composition comprising racecadotril, at least one surfactant and a lipid. The pharmaceutical composition is useful in treating diarrhea.
1. A liquid composition comprising:
about 4.0 wt. % to about 10.0 wt. % racecadotril;
about 90 wt. % of surfactant in total, wherein the surfacant is a combination of polyoxyl 35 castor oil and glyceryl caprylate mono- and diglyceride; and
about 1% about 2 wt. % lipid, wherein the lipid is medium-chain triglycerides;
wherein each wt. % is based upon 100 ml of the composition;
wherein the liquid composition is stable for about 3 months at 40° C.
2. The liquid composition of claim 1 , wherein the surfactant is present in an amount from 88 wt. % to 91 wt. % in total per 100 ml of the composition.
3. The liquid 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.
4. The liquid composition of claim 1 , further comprising an optional ingredient selected from the group consisting of citric acid, sodium benzoate, sucralose, flavors and mixtures thereof.
5. A dosage form comprising the liquid composition of claim 1 , wherein the dosage form is a soft shell dosage form, a hard shell dosage form, or a tablet dosage form.
6. The liquid 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 liquid composition.
7. The liquid composition of claim 1 , further comprising a second active ingredient that is a digestive health active ingredient.
8. A method for treating a subject experiencing diarrhea comprising the step of orally administering to the subject a composition comprising a composition as recited in claim 1 .
9. The dosage form of claim 7 , wherein the digestive health active ingredient is selected from the group consisting of laxatives, antacids, proton pump inhibitors, anti-gas agents, antiemetics, H2 blockers, and antidiarrheal agents.
10. The dosage form of claim 9 , wherein the anti-gas agent is simethicone.
11. The dosage form of claim 9 , wherein the antidiarrheal agent is loperamide.
12. The dosage form of claim 1 , wherein the racecadotril is present in amount from 8% to 10%.