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Invention Title:

LYOPHILIZED COMPOSITIONS COMPRISING FECAL MICROBE-BASED THERAPEUTIC AGENTS AND METHODS FOR MAKING AND USING SAME

Publication number:

US20240131084

Publication date:
Section:

Human necessities

Class:

A61K35/74

Inventor:

Assignee:

Applicant:

Drawings (2 of 2)

Drawing 01 for LYOPHILIZED COMPOSITIONS COMPRISING FECAL MICROBE-BASED THERAPEUTIC AGENTS AND METHODS FOR MAKING AND USING SAME
Drawing 02 for LYOPHILIZED COMPOSITIONS COMPRISING FECAL MICROBE-BASED THERAPEUTIC AGENTS AND METHODS FOR MAKING AND USING SAME

Smart overview of the Invention

Compositions are developed for treating gastric, gastrointestinal, and colonic conditions, utilizing formulations that maintain microbial cell viability during freeze-thaw or freeze-drying processes. These formulations are designed to address various diseases, including autism spectrum disorder, Crohn's Disease, ulcerative colitis, irritable bowel syndrome, and recurrent C. difficile infections.

Fecal Microbiota Transplantation (FMT)

Fecal Microbiota Transplantation (FMT) involves administering human colonic microbiota to patients suffering from gut-related issues. Initially aimed at treating Clostridium difficile infections, FMT has shown high success rates and is increasingly sought after for its therapeutic benefits. However, challenges in obtaining fresh FMT material limit widespread access to this treatment.

Lyophilization Process

A significant advancement in this field is the development of lyophilized pharmaceutical compositions that utilize cryoprotectants like trehalose. This process enhances the preservation of microbial cell viability during storage and transport, enabling better access to FMT therapies without the need for fresh donor material.

Pharmaceutical Composition Details

The disclosed pharmaceutical compositions include lyophilized fecal microbe preparations with specific formulations containing trehalose and cysteine. These compositions are engineered to maintain high cell viability post-lyophilization, ensuring effective therapeutic use upon reconstitution.

Applications and Treatment Methods

The compositions can be administered to treat a wide range of disorders, particularly those related to gastrointestinal health. They offer potential solutions for conditions such as recurrent C. difficile infections, autism spectrum disorder, ulcerative colitis, and irritable bowel syndrome, providing a promising avenue for innovative therapeutic interventions.