Racecadotril liquid compositions

Inactive Publication Date: 2014-09-18
JOHNSON & JOHNSON CONSUMER COPANIES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention is about a liquid medicine that contains racecadotril and cyclodextrin. The composition is made to have different concentrations of these two ingredients. The invention also includes a method for treating diarrhea by giving the medicine to a patient.

Problems solved by technology

Food intolerance caused by allergy or the consumption of foods such as fatty or spicy foods may result in diarrhea.
Food poisoning may also lead to diarrhea.
However, many of these products provide relief with some side effects.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Racecadotril Oral Liquid Formulation

[0047]The composition for an oral racecadotril liquid is shown in Table 1. Utilizing the materials in Table 1, the following mixing steps were used:

[0048]Step 1: A solution was formed by mixing purified water and hydroxypropyl beta-cyclodextrin in a suitable vessel with a laboratory mixer.

[0049]Step 2: The racecadotril was added to the solution in Step 1 and mixed in a laboratory shaker for at least 12 hours and a clear solution was formed.

[0050]Step 3: The citric acid, sorbitol solution, high fructose corn syrup, and sodium chloride was mixed to form a solution and mixed using a laboratory mixer until dissolved.

[0051]Step 4: A separate mixture was prepared by mixing the flavor into the polyethylene glycol 400 in a suitable vessel. This mixture was then mixed with the solution from Step 3 and diluted to volume with purified water.

TABLE 1Racecadotril Oral Liquid Composition (2.5 mg / g)% Weight byIngredientWeightRacecadotril0.25Hydroxypropyl beta-cyc...

example 2

Concentrated Racecadotril Aqueous Composition

[0052]Three formulations of racecadotril in an aqueous buffer of acetate were prepared and three formulations of racecadotril in an aqueous buffer of citrate were prepared. These formulations were prepared utilizing a mixture of racecadotril in the Sulfobutyl ether derivative of β-cyclodextrin (Captisol®) and are shown in Table 1.

TABLE 1Racecadotril Liquid CompositionActual CompositionSolvent SystemRacecadotrilAcetateRace-CaptisolAcetateby AssayCaptisolAcetateCaptisolBuffercadotrilLot #(w / v)Buffer (mL)(mg / mL)(g)Buffer (mL)(%)(%)(%)Formula 160%1002.6259.997254.052.4947.250.26Formula 370%1002.4170.001848.059.1840.580.24Formula 578%1002.2680.003554.659.3040.470.23ActualActual CompositionSolvent SystemRacecadotrilCitrateRace-CaptisolCitrateby AssayCaptisolCitrateCaptisolBuffercadotrilLot #(w / v)Buffer(mg / mL)(g)Buffer (mL)(%)(%)(%)Formula 260%1002.4360.012066.047.5152.250.24Formula 469%1002.3970.001662.052.9046.860.24Formula 680% 501.9239.99543...

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Abstract

A liquid composition comprising racecadotril and cyclodextrin.

Description

[0001]This application claims priority of the benefit of the filing of U.S. Provisional Application Ser. No. 61 / 787,496, filed Mar. 15, 2013, the contents of which are hereby incorporated by reference in their entirety.BACKGROUND OF THE INVENTION[0002]1. Field of the Invention[0003]The present invention relates to liquid compositions. More particularly, the present invention relates to liquid compositions containing racecadotril and the method of making said compositions.[0004]2. Related Background Art[0005]Diarrhea is an intestinal disorder that is characterized by an increase in the frequency of watery bowel movements. It may result from a variety of causes including bacteria or viral induced diarrhea. Food intolerance caused by allergy or the consumption of foods such as fatty or spicy foods may result in diarrhea. Food poisoning may also lead to diarrhea. In some instances, diarrhea may be a symptom of other conditions and diseases.[0006]Diarrhea is symptomatic of an intestinal ...

Claims

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Application Information

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IPC IPC(8): A61K47/40A61K31/197
CPCA61K31/197A61K47/40A61K31/223A61K9/0095A61K9/205A61K9/4858A61K31/451A61K31/695A61K31/265A61K31/724A61P1/12A61P43/00A61K2300/00A61K9/08
InventorLEE, DER-YANG
OwnerJOHNSON & JOHNSON CONSUMER COPANIES