pH-Responsive Microencapsulated Probiotic Delivery for Ileum Targeting

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Solution Overview

Problem

Current probiotic delivery systems fail to specifically target and release probiotic organisms at the pH environment of the ileum and colon, leading to ineffective treatment of conditions like Clostridium difficile infection and metabolic syndrome, as most products release probiotics in the duodenum and degrade before reaching the ileum or colon.

Innovation Solution

Development of microencapsulated live probiotic organisms with a biphasic or three-phase release profile, using polymers for pH-dependent release in the ileum and colon, ensuring targeted delivery and survival through the digestive tract, incorporating strains like Lactobacillus, Bifidobacterium, and Faecalibacterium prausnitzii to restore intestinal balance.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional probiotic delivery systems are used, then probiotics are released in the duodenum, but they degrade before reaching the ileum or colon

Engineering Contradiction:
Improveprobiotic survival rateVSAvoiddelivery system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The delivery system is segmented into multiple pH-responsive coating layers, each designed to dissolve at specific pH thresholds encountered at different gastrointestinal locations. This segmentation allows probiotics to survive passage through the duodenum and be released specifically in the ileum or colon, dramatically improving survival rates without requiring complex active targeting mechanisms.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system utilizes pH parameter changes along the gastrointestinal tract as the triggering mechanism for probiotic release. By designing coatings with specific pH dissolution characteristics, the system passively responds to the natural physiological gradient, achieving targeted delivery through simple parameter-based activation rather than complex control systems.

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If probiotics are released in the duodenum, then immediate availability is achieved, but targeted delivery to ileum and colon is ineffective

Engineering Contradiction:
Improvetargeting precisionVSAvoidtransit time to target site
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The probiotics are prepared in advance with protective pH-responsive coatings that remain intact during passage through the upper gastrointestinal tract. This preliminary protection allows the probiotics to reach their target site (ileum or colon) alive and active, achieving both precise targeting and effective colonization without time loss.

Inventive Principle:
Principle #10Preliminary action

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 targeted delivery system effectively releases probiotics in the ileum and colon, enhancing colonization, improving intestinal balance, and providing therapeutic benefits for conditions such as Clostridium difficile infection and metabolic syndrome, with high viability and stability of the probiotic organisms.

Implementation Method 1

using polymers for pH-dependent release in the ileum and colon

Methodology Applied
Scientific EffectpH-dependent dissolution: Phase Change

Data Source

PatentUS11590083B2Targeted gastrointestinal tract delivery of probiotic organisms and/or therapeutic agents
Publication Date: 2023.02.28 THERABIOME LLC
  • US11590083B2 patent drawing
  • US11590083B2 patent drawing
  • US11590083B2 patent drawing

AI summary

The present invention relates to the development of a targeted delivery system for the oral delivery of probiotics or therapeutic agent for various indications, including and not limited to active and prophylaxis treatment of Clostridium difficile infection, antibiotic associated diarrhea, irritable bowel syndrome, Crohn's disease, intestinal flora replacement, supplemental flora treatments for patients taking antibiotics, and for restoration of balance and signaling between the intestinal microbiome and the intestinal cells in patients under treatment of metabolic syndrome manifestations, specifically diabetes, insulin resistance, obesity, hyperlipidemia and hypertension. The present invention restores altered probiotic organism imbalances that are characteristic of said diseases among others as well as defines a platform technology development for site specific delivery of probiotic organisms in the GI tract of a mammal, most specifically the ileum and/or right colon of a human subject.