Berberine Ursodeoxycholate Composition for Primary Sclerosing Cholangitis Treatment

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Solution Overview

Problem

Current treatments for primary sclerosing cholangitis (PSC) are ineffective in slowing or stopping disease progression, leading to serious liver damage and increased risk of malignancy, with no FDA-approved therapeutic agents available.

Innovation Solution

The use of berberine ursodeoxycholate (BUDCA) as a pharmaceutical composition, either alone or in combination with other agents, to treat PSC by reducing serum alkaline phosphatase, cholestasis, and hepatocellular inflammation, administered orally in various dosage forms.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional treatments are used for PSC, then current standard of care is maintained, but disease progression is not slowed or stopped leading to serious liver damage

Engineering Contradiction:

Improveeffectiveness of treatmentVSAvoidliver damage and disease progression

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies the composite materials principle by combining berberine and ursodeoxycholic acid into a single pharmaceutical composition (BUDCA). This composite approach leverages the synergistic effects of both compounds: berberine provides anti-inflammatory and antimicrobial properties while ursodeoxycholic acid offers cholestatic benefits. The combination formulation addresses the limitations of conventional monotherapies by integrating multiple mechanisms of action into one treatment, thereby improving reliability in slowing disease progression while reducing harmful liver damage.

Inventive Principle:

Principle #40Composite materials

2Adaptability or versatility

If no FDA-approved therapeutic agents are available, then current treatment options are limited, but patients continue to suffer from disease progression and complications

Engineering Contradiction:

Improveavailability of treatment optionsVSAvoiddisease management effectiveness

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

The patent applies segmentation by dividing the treatment approach into distinct therapeutic components that can be evaluated and combined. The BUDCA composition segments the therapeutic needs into: (1) berberine for its anti-inflammatory and gut dysbiosis correction effects, and (2) ursodeoxycholic acid for its cholestatic benefits. This segmented approach allows for targeted treatment of different pathogenic mechanisms in PSC, thereby expanding treatment options and improving disease management effectiveness where no FDA-approved agents previously existed.

Inventive Principle:

Principle #1Segmentation

3Manufacturing precision

If BUDCA is administered to reduce serum alkaline phosphatase and inflammation markers, then liver enzyme levels decrease, but the dosage and administration protocol must be optimized

Engineering Contradiction:

Improvereduction in liver enzymes and inflammation markersVSAvoiddosage formulation and administration protocol

Core Design Contradiction:

Manufacturing precisionVSDevice complexity

Solution Approach 1:

The patent applies the merging principle by consolidating two separate therapeutic agents (berberine and ursodeoxycholic acid) into a single combined pharmaceutical composition. This merging simplifies the administration protocol compared to giving two separate medications, while maintaining the precision needed to reduce liver enzymes and inflammation markers. The fixed-ratio combination ensures consistent delivery of both active components, optimizing therapeutic effect while reducing complexity in dosage management.

Inventive Principle:

Principle #5Merging (Combining)

Data Source

PatentUS20230346803A1Compositions of berberine ursodeoxycholate and methods thereof for treating primary sclerosing cholangitis

Publication Date: 2023.11.02 SHENZHEN HIGHTIDE BIOPHARM

AI summary

The invention provides pharmaceutical compositions of berberine ursodeoxycholate (BUDCA) and methods of use thereof for the treatment primary sclerosing cholangitis, and related diseases and conditions.