Rifaximin Soluble Solid Dispersion for Hepatic Encephalopathy

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Solution Overview

Problem

Current therapies for managing cirrhosis and its complications, such as overt hepatic encephalopathy, have limited effectiveness, leading to poor patient outcomes with high mortality rates and a need for new treatment methodologies.

Innovation Solution

An immediate release formulation of rifaximin as a soluble solid dispersion (SSD) combined with lactulose, administered in varying dosages and frequencies, has been shown to effectively treat and prevent overt hepatic encephalopathy and complications of liver cirrhosis by reducing hospitalization and mortality rates.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If current therapies for managing cirrhosis and its complications are used, then treatment is provided, but effectiveness is limited leading to high mortality rates

Engineering Contradiction:

Improvetreatment effectivenessVSAvoidmortality rate

Core Design Contradiction:

ReliabilityVSProductivity

Solution Approach 1:

The patent changes the physical and chemical parameters of rifaximin by creating a soluble solid dispersion formulation. This transforms rifaximin from a poorly water-soluble compound into a form with enhanced solubility and absorption, thereby improving its therapeutic effectiveness in treating hepatic encephalopathy while reducing mortality rates associated with current therapies

Inventive Principle:

Principle #35Parameter changes

2Ease of operation

If traditional rifaximin formulations are used, then administration is simple, but bioavailability and clinical efficacy are insufficient

Engineering Contradiction:

Improveadministration simplicityVSAvoidclinical efficacy

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The patent creates a composite material system by formulating rifaximin as a soluble solid dispersion. This composite formulation combines rifaximin with appropriate excipients and uses specific manufacturing processes (such as hot melt extrusion or spray drying) to create a material with enhanced solubility properties, thereby improving clinical efficacy while maintaining ease of oral administration

Inventive Principle:

Principle #40Composite materials

Data Source

PatentUS20230111568A1Solid dispersions of rifaximin for the treatment of overt hepatic encephalopathy

Publication Date: 2023.04.13 BAUSCH HEALTH IRELAND LTD

AI summary

Provided herein are solid dispersions comprising rifaximin and methods of using the same for the treatment of Overt Hepatic Encephalopathy and complications associated with cirrhosis.