Iron-Encapsulating Denatured Protein Matrix for Gastrointestinal Tolerability
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Solution Overview
Problem
Current oral iron supplements, particularly ferrous sulfate, have poor bioavailability and tolerability issues, leading to inadequate iron absorption and gastrointestinal discomfort, which contributes to the high prevalence of iron deficiency worldwide.
Innovation Solution
A composition comprising iron and a denatured protein carrier, where the iron is encapsulated within a denatured protein matrix, releasing ferrous iron slowly in the gastrointestinal tract, enhancing bioavailability and tolerability by controlling the release of iron in simulated gastric and intestinal fluids.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If ferrous sulfate is used as oral iron supplement, then iron supplementation is provided, but bioavailability is poor and gastrointestinal tolerability is poor
Solution Approach 1:
A protein-based carrier acts as an intermediary between the iron compound and the gastrointestinal environment. The carrier protects the iron from direct contact with gastric acid and intestinal enzymes, enabling controlled release and improving both bioavailability and tolerability by mediating the interaction between iron and the biological system.
Solution Approach 2:
The invention changes the physical and chemical parameters of iron delivery by using a protein carrier system that modifies release kinetics. The carrier controls the rate and timing of iron release, transforming the immediate release characteristic of ferrous sulfate into a sustained, controlled release profile that improves absorption while reducing gastrointestinal irritation.
2Reliability
If ferrous sulfate is used as oral iron supplement, then iron supplementation is provided, but gastrointestinal tolerability is poor
Solution Approach 1:
The protein carrier serves as a protective intermediary that shields the gastrointestinal tract from the harsh effects of direct iron exposure. This mediator allows iron supplementation to proceed effectively while buffering the harmful gastrointestinal effects, thereby maintaining efficacy while improving tolerability.
Solution Approach 2:
The iron compound is pre-encapsulated in a protein carrier before administration, providing beforehand cushioning against gastrointestinal irritation. This prior protection prevents direct contact between the iron and sensitive gastrointestinal tissues, cushioning against discomfort before it occurs.
3Object-affected harmful factors
If delayed release formulations are used, then gastrointestinal tolerability is improved, but bioavailability is reduced
Solution Approach 1:
The invention optimizes the release parameters by using a protein carrier with specific structural and functional properties. Unlike conventional delayed-release formulations that may release iron too late or too slowly, this carrier system is designed to release iron at optimal points in the gastrointestinal tract, changing the release parameters to simultaneously improve tolerability and maintain bioavailability.
Solution Approach 2:
The protein carrier provides different functional qualities at different stages of gastrointestinal transit. It offers protection in the stomach to improve tolerability, then transitions to facilitate iron release in the intestine to ensure bioavailability. This local differentiation of protective and release functions resolves the contradiction between delayed release benefits and bioavailability requirements.
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 composition achieves a relative bioavailability of at least 120% compared to ferrous sulfate, with improved gastrointestinal tolerability and palatability, effectively addressing the limitations of existing oral iron supplements.
Implementation Method 1
the composition releases less than 70% or less than 50 wt % of the total iron content as ferrous iron over the course of one hour in simulated gastric fluid at pH 1.6
Implementation Method 2
the composition releases more than 10 wt %, 20 wt %, 30 wt % or 40 wt % of the total iron content over the course of one hour in simulated intestinal fluid at pH 6.6
Implementation Method 3
a carrier comprising denatured protein, wherein the composition releases less than 70% or less than 50 wt % of the total iron content as ferrous iron
Data Source
AI summary
Compositions containing iron and denatured protein have been prepared that are capable of increasing serum iron and other divalent metal cations in a subject. For example, edible microbeads have been prepared containing iron entrapped within a protein matrix that provides a gastroprotective effect and improves iron bioavailability relative to previously known vehicles for delivering iron to a subject.