Lyophilized Stool Composition with Maltodextrin and Trehalose
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Solution Overview
Problem
Current methods for faecal microbiota transplantation (FMT) lack standardization, with challenges in donor selection, preparation, and administration routes, leading to low usable donations and patient discomfort due to the lack of a standardized, stable, and acceptable preservation method for faecal microbiota.
Innovation Solution
A lyophilized stool composition using a mixture of maltodextrin and trehalose as cryoprotectants in a specific weight ratio, optimized for long-term storage and oral administration, maintaining microbiota viability and diversity for up to 7 months, and inhibiting Clostridium difficile growth.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If faecal microbiota is preserved using frozen preparations at -80°C with glycerol as cryoprotectant, then microbiota viability is maintained for up to 5 months, but storage complexity and patient discomfort increase due to dilution requirements and invasive administration routes
Solution Approach 1:
The patent changes the physical state parameter from frozen to lyophilized (freeze-dried), and modifies the cryoprotectant composition from glycerol alone to a combination of trehalose and glycerol. This parameter change enables storage at higher temperatures (4°C or room temperature) while maintaining microbiota viability, eliminating the need for -80°C freezing and complex dilution procedures.
Solution Approach 2:
The patent uses a composite cryoprotectant system combining trehalose (a disaccharide) and glycerol (a polyol) in specific concentrations. This composite material provides superior protection to the microbiota during lyophilization compared to glycerol alone, maintaining viability while enabling simplified storage and administration. The composite formulation allows the microbiota to be stored in a stable, non-frozen state.
2Reliability
If invasive administration routes (nasogastric probe, colonoscopy) are used for FMT, then microbiota delivery is effective, but patient morbidity and procedural complexity increase
Solution Approach 1:
The patent changes the physical form parameter from liquid/frozen suspension to lyophilized powder capsules. This parameter change enables oral administration without invasive procedures, as the lyophilized capsules can be taken orally and the microbiota is released in the gastrointestinal tract, maintaining delivery effectiveness while dramatically improving ease of operation and patient comfort.
Solution Approach 2:
The patent replaces the mechanical invasive administration systems (probes, colonoscopy equipment, enema devices) with a simple oral capsule delivery system. The lyophilized microbiota encapsulated in tablets or capsules is ingested by the patient, eliminating the need for complex mechanical delivery devices and invasive procedures while ensuring reliable microbiota delivery to the gastrointestinal tract.
3Reliability
If faecal microbiota is preserved using only glycerol as cryoprotectant, then freezing protection is provided, but lyophilization effectiveness and long-term stability are insufficient
Solution Approach 1:
The patent employs a composite cryoprotectant system combining trehalose and glycerol. Trehalose, a disaccharide, forms a glassy matrix during lyophilization that protects microbial structures, while glycerol provides additional cryoprotection and maintains membrane fluidity. This composite material system provides both freezing protection and long-term stability during lyophilized storage, overcoming the limitations of glycerol alone.
Solution Approach 2:
The patent changes the chemical composition parameter of the cryoprotectant system by introducing trehalose in addition to glycerol. This chemical parameter change enables effective lyophilization by forming a protective glassy matrix that maintains microbiota viability during freeze-drying and long-term storage, while the specific concentration ratios optimize both freezing protection and long-term stability.
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 method provides a standardized, stable, and acceptable form of faecal microbiota preservation, enhancing the availability and comfort of FMT by maintaining microbiota viability and diversity, and effectively inhibiting Clostridium difficile, thus improving treatment accessibility and reducing morbidity and costs.
Implementation Method 1
A lyophilized stool composition using a mixture of maltodextrin and trehalose as cryoprotectants
Implementation Method 2
Lyophilized stool composition
Implementation Method 3
lyophilized form
Data Source
AI summary
The invention relates to a lyophilized composition comprising a microbiota in its ecosystem, in particular stools, and a mixture of cryoprotectant agents comprising maltodextrin and trehalose, a capsule comprising said lyophilized composition, the use thereof, and methods for the production thereof.