Racecadotril lipid compositions

Patent metadata

Field	Value
Publication number	US-10039712-B2
Application number	US-201313929996-A
Country	US
Kind code	B2
Filing date	Jun 28, 2013
Priority date	Jun 28, 2012
Publication date	Aug 7, 2018
Grant date	Aug 7, 2018

Abstract

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.

First claim

What is claimed:

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%.

Assignees

• Johnson & Johnson Consumer Inc

Inventors

• Lee Der-Yang

Classifications

• A61P1/12

  Antidiarrhoeals · CPC title

• A61K47/44

  Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin (synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14) · CPC title

• A61K47/00

  Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient · CPC title

• A61K31/265

  of carbonic, thiocarbonic, or thiocarboxylic acids, e.g. thioacetic acid, xanthogenic acid, trithiocarbonic acid · CPC title

• A61K31/223 Primary

  of alpha-aminoacids · CPC title