Faecal Microbiota Capsule with Low Cryoprotectant

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Solution Overview

Problem

Current faecal microbiota transplantation methods face challenges with high glycerol concentrations causing side effects like headaches, dizziness, and discomfort, and traditional administration methods can be invasive and uncomfortable, limiting their practicality and safety.

Innovation Solution

A faecal composition encapsulated in a capsule for oral administration, with a cryoprotectant concentration below 8% to minimize side effects and a dual-coating system for controlled release, allowing for self-administration and improved comfort.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If high concentration of glycerol (cryoprotectant) is added to the faecal composition, then microbial viability during cryopreservation is improved, but side effects like headaches, dizziness, bloating, nausea, vomiting, thirst, and diarrhoea increase

Engineering Contradiction:

Improvemicrobial viabilityVSAvoidside effects

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent changes the concentration parameter of the cryoprotectant from high (conventional) to low (below 8% v/v), demonstrating that effective cryopreservation can be achieved at lower concentrations when combined with optimized freezing protocols. This parameter change directly reduces the harmful effects while maintaining microbial viability.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent uses a composite approach by combining multiple cryoprotectants (glycerol, sucrose, and/or trehalose) in specific ratios, along with optimized freezing and thawing protocols. This composite strategy allows for reduced individual component concentrations while maintaining overall protective effectiveness, thereby reducing side effects.

Inventive Principle:

Principle #40Composite materials

2Ease of operation

If traditional administration methods (enema, probe, colonoscopy) are used for faecal microbiota transplantation, then the treatment can be administered, but the procedure becomes invasive, uncomfortable, and requires medical assistance

Engineering Contradiction:

Improveadministration easeVSAvoidinvasiveness and discomfort

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent extracts the faecal microbiota from its traditional liquid suspension form and encapsulates it in a solid capsule format. This extraction of the active ingredient into a different delivery system eliminates the need for invasive administration procedures while maintaining treatment effectiveness.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The patent replaces the mechanical/invasive administration systems (enema devices, probes, colonoscopes) with a simple oral capsule delivery system. This substitution transforms a complex medical procedure into a simple self-administered oral treatment, eliminating the harmful effects of invasive procedures.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Reliability

If fresh faecal suspension is used immediately for transplantation, then microbial viability is maintained, but the procedure requires immediate administration and lacks durability for later use

Engineering Contradiction:

Improvemicrobial viabilityVSAvoiddurability

Core Design Contradiction:

ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The patent applies preliminary cryopreservation actions to the faecal microbiota capsule, allowing it to be stored frozen for extended periods. The optimized cryoprotectant formulation and freezing protocol preserve microbial viability during long-term storage, enabling preparation in advance and storage for later administration.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent utilizes phase transitions (freezing and thawing) with optimized protocols to preserve microbial viability during long-term storage. By controlling the freezing process with specific cryoprotectant concentrations and rates, the capsule can be stored frozen indefinitely and then rapidly thawed for administration, providing both durability and viability.

Inventive Principle:

Principle #36Phase transitions

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The reduced cryoprotectant concentration minimizes adverse reactions, and the encapsulated form provides easier, more comfortable administration with enhanced microbial viability and durability, enabling effective treatment of various gastrointestinal and systemic disorders.

Implementation Method 1

the diluent comprises a cryoprotectant resulting in a final concentration of cryoprotectant in the faecal composition below 8% (v/v) cryoprotectant

Methodology Applied

Scientific EffectCryoprotection:

Data Source

PatentUS20230043598A1Capsule comprising a faecal composition

Publication Date: 2023.02.09 LAURIDSEN HENGAMEH CHLOE

AI summary

The present invention relates to a capsule comprising a faecal composition for oral administration wherein the faecal composition comprises a stool fraction and a diluent, wherein the stool fraction comprises one or more non-pathogenic microorganisms, and wherein the diluent comprises a cryoprotectant resulting in a final concentration of cryoprotectant in the faecal composition below 8% (v/v) cryoprotectant.