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Racecadotril lipid compositions

Active Publication Date: 2016-11-17
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 microemulsion composition that contains racecadotril, a surfactant, and a lipid. This composition can be used to treat diarrhea by administering it to a patient through an oral route. The technical effect of this invention is to provide a stable and effective treatment for diarrhea that can be easily absorbed by the body.

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

Concentrated Racecadotril Lipid Composition: For Use in Liquid Filled Gelatin Capsule

[0051]

TABLE 1Racecadotril Lipid Based Composition as a percentage of the composition:Triglyceride Type 1Formula 1Formula 3Formula 5Ingredient(% w / w)(% w / w)(% w / w)Racecadotril9.609.318.34Polyoxyl 35 Castor oil179.5552.6027.50Glyceryl Caprylate (Mono- and9.0436.2762.33Diglycerides) NF2Medium Chain Triglycerides31.811.811.83Total100100100Racecadotril Assay (mg / mL)96.0493.1483.371Commercially available from CRODA Healthcare as ETOCAS ® 35 USP / NF, EP, JP2Commercially available from CREMER as IMWITOR ® 988 USP / NF, EP, JP3Commercially available from CREMER as MIGLYOL ® 810N (Caprylic / Capric Triglycerides; 70:30 / C8:C10) USP / NF, EP, JP

TABLE 2Racecadotril Lipid Based Composition as a percentage of the composition:Triglyceride Type 2Formula 2Formula 4Formula 6Ingredient(% w / w)(% w / w)(% w / w)Racecadotril9.478.988.33Polyoxyl 35 Castor oil179.6752.7927.50Glyceryl Caprylate (Mono- and9.0536.4162.33Diglycerides) NF2...

example 2

Concentrated Racecadotril Lipid Composition: For Use in Liquid Filled Gelatin Capsule

[0058]

TABLE 4Formula 7Formula 8Ingredient(% w / w)a(% w / w)Racecadotril4.614.25Glyceryl Caprylate (Mono- and Diglycerides) NF147.9548.00Medium Chain Triglycerides247.44—Medium Chain Triglycerides3—47.75Total100100Racecadotril Assay (mg / mL)46.1142.491Commercially available from CREMER as IMWITOR 742 ® USP / NF, EP, JP2Commercially available from CREMER as MIGLYOL ® 810N (Caprylic / Capric Triglycerides; 70:30 / C8:C10) USP / NF, EP, JP3Commercially available from CREMER as MIGLYOL ® 812N (Caprylic / Capric Triglycerides; 60:40 / C8:C10) USP / NF, EP, JP

TABLE 5Formula 9Formula 10Ingredient(51.5:48.5)a(51.4:48.6)Racecadotril5.285.59Glyceryl Caprylate (Mono- and48.8348.54Diglycerides) NF1Medium Chain Triglycerides245.90—Medium Chain Triglycerides3—45.87Total100100Racecadotril Assay (mg / mL)52.7855.931Commercially available from CREMER as IMWITOR 988 ® USP / NF, EP, JP2Commercially available from CREMER as MIGLYOL ® 810N (C...

example 3

Racecadotril Lipid Composition: Droplet Size

Procedure

[0065]The droplet size was measured on a Horiba SZ-100 Nanoparticle Size Analyzer by dynamic light scattering (DLS) at a scattering angle of 90 degrees. During measurement, samples were kept in a temperature control chamber at 25° C. Immediately prior to measurement the instrument performance was checked with a nominal 100 nm polystyrene latex (PSL) size standard in 10 mM NaCl. Count rates for these measurements ranged from 1 million to 3 million counts per second. The measurements were performed for one minute each. Data were analyzed using the cumulant technique.

Solubility and Droplet Size for lipid-based formulations**Formula 1, Formula 3, Formula 5Form. 1Form. 3Form. 5Solubility (mg / mL)96.093.183.4Solubility (mg / g)92.2290.6382.14Droplet Size (nm)*18.1525.1648.37(Z-avg Diameter)1**Formula 2, Formula 4, Formula 6Form. 2Form. 4Form. 6Solubility (mg / mL)94.789.883.3Solubility (mg / g)90.7287.7382.14Droplet Size (nm)*19.4825.3947.210(...

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Abstract

A lipid composition comprising racecadotril, at least one surfactant and a lipid.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application claims the benefit of U.S. Provisional Application No. 61 / 787,597, filed on Mar. 15, 2013 and U.S. Non-Provisional application Ser. No. 13 / 929,996, filed on Jun. 28, 2013 which are incorporated by reference.BACKGROUND OF THE INVENTION[0002]1. Field of the Invention[0003]The present invention relates to lipid based microemulsion compositions. More particularly, the present invention relates to lipid based microemulsion compositions containing a pharmaceutical active ingredient 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 instanc...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/107A61K45/06A61K31/222
CPCA61K9/1075A61K45/06A61K31/222A61K9/4858A61K47/14A61K47/44A61K31/216A61P1/12Y02A50/30A61K31/265A61K9/107A61K9/48A61K31/223A61K47/00
Inventor LEE, DER-YANG
Owner JOHNSON & JOHNSON CONSUMER COPANIES
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