pH-Dependent Microencapsulation for Ileum Probiotic Delivery
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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 fail to survive transit to the ileum or right-sided colon.
Innovation Solution
Development of microencapsulated live probiotic organisms with a biphasic or triphasic release profile, using polymers for pH-dependent release in the ileum and colon, ensuring targeted delivery and protection from stomach and duodenum digestive actions, and incorporating specific bacterial strains like Lactobacillus, Bifidobacterium, and Faecalibacterium prausnitzii.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional probiotic delivery systems are used, then probiotics are released in the duodenum, but they fail to survive transit to the ileum or right-sided colon
Solution Approach 1:
The delivery system is segmented into multiple protective layers (enteric coating, microencapsulation) that release probiotics at different pH levels along the GI tract, ensuring survival through the duodenum and targeted release in the ileum and colon
Solution Approach 2:
pH-sensitive polymers and enteric coatings act as intermediaries that protect probiotics from the harsh duodenal environment and control their release at the target site (ileum/colon) based on pH differential
2Productivity
If probiotics are released in the duodenum, then immediate availability is achieved, but ineffective treatment of ileum and colon conditions occurs
Solution Approach 1:
The probiotics are pre-protected with enteric coatings and microencapsulation designed to withstand the duodenum and release only when reaching the ileum/colon, ensuring they arrive at the target site alive and active
Solution Approach 2:
The delivery system exploits pH parameter changes along the GI tract (acidic stomach → neutral duodenum → slightly alkaline ileum/colon) to trigger controlled release at the target site, transforming the transit journey into a controlled delivery mechanism
3Manufacturing precision
If non-targeted probiotic release is used, then simple formulation is maintained, but specific bacterial strains fail to reach required locations
Solution Approach 1:
Different regions of the GI tract receive different probiotic strains through pH-dependent release characteristics, with each strain targeted to its optimal location (ileum or colon) based on its specific pH sensitivity profile
Solution Approach 2:
The formulation uses composite protective structures combining enteric coatings, microencapsulation materials, and pH-sensitive polymers to achieve precise targeted delivery while maintaining manufacturability
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 microbial balance, alleviating conditions such as Clostridium difficile infection and metabolic syndrome, with high viability and specificity, improving treatment efficacy and safety.
Implementation Method 1
a first enteric coating that is substantially insoluble at a pH of less than about 7.0 and soluble at a pH of about 7.0 to about 8.0
Implementation Method 2
a core comprising a probiotic formulation; a first enteric coating encapsulating the core
Data Source
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.