Granted Patent B2

US 9,636,300 · App. 14/205,565 · Granted May 2, 2017

Abstract

Claims (19)

1. A composition for oral administration, comprising:

about 4% to about 10% racecadotril, about 90% of at least one surfactant and about 1% to about 2% lipid,

wherein the at least one surfactant is a glyceride selected from the group consisting of Distearoylphosphatidylglycerol (DSPG), L-α-dimyristoylphosphatidylcholine (DMPC), L-α-dimyristoylphosphatidylglycerol (DMPG), Polyoxyl 35 castor oil, Polyoxyl 40 hydrogenated castor oil, Polyoxyl 60 hydrogenated castor oil, PEG 300 capryliecapric glycerides, PEG 400 caprylic/capric glycerides, PEG 300 oleic glycerides, PEG 300 linoleic glycerides, Glyceryl Caprylate, Glyceryl Caprylate Diglyceride medium chain partial glycerides, and mixtures thereof,

wherein the lipid is a triglyceride selected from the group consisting of Long-chain triglycerides, Medium-chain triglycerides, Caprylic/capric triglycerides and mixtures thereof;

wherein the composition is stable for about 3 months at 40° C.

2. The composition of claim 1 , wherein the at least one surfactant is present in an amount of from about 88 wt. % to about 91 wt. % in total per 100 ml of the composition.

3. The composition of claim 1 , further comprising an optional ingredient selected from the group consisting of buffers, preservatives, sweeteners, viscosity modifiers, colors, aromas, flavors, and mixtures thereof.

4. The composition of claim 1 , further comprising an optional ingredient selected from the group consisting of xanthan gum, citric acid, sodium benzoate, sucralose, flavors and mixtures thereof.

5. 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.

6. The composition of claim 1 , wherein the at least one surfactant is castor oil.

7. The composition of claim 1 , wherein the at least one surfactant is selected from a monoglyceride and a diglyceride.

8. The composition of claim 1 , further comprising a digestive health active ingredient.

9. The composition of claim 8 , 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 composition of claim 8 , wherein the anti-gas agent is simethicone.

11. The composition of claim 8 , wherein the antidiarrheal agent is loperamide.

12. A soft shell dosage form comprising the composition of claim 1 .

13. A hard shell dosage form containing the composition of claim 1 .

14. A tablet dosage form containing the composition of claim 1 .

15. A method for treating a subject experiencing diarrhea comprising the step of orally administering to the subject the composition of claim 1 .

Assignments (8)