Enteric-Coated Iron-Copper Oral Supplement for GI Tolerability

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Solution Overview

Problem

Existing oral iron supplements cause gastrointestinal side effects and poor absorption due to the irritative nature of divalent iron, leading to ineffective long-term treatment and potential harm to the intestinal flora, while copper deficiency affects iron absorption and antioxidant activities.

Innovation Solution

An oral administration form comprising a solid association of Fe(II) and Cu(II) salts coated with an enteric and hydrophilic polymer layer, which protects iron from gastric contact and releases it in the small intestine, ensuring bioavailability and stability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If oral iron supplementation is administered to treat iron deficiency, then iron levels are improved, but gastrointestinal side effects occur

Engineering Contradiction:

Improveiron levelsVSAvoidgastrointestinal side effects

Core Design Contradiction:

Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

Copper acts as an intermediary substance that facilitates iron absorption through the copper-iron interaction mechanism. The patent describes how copper supplementation enhances iron absorption and reduces gastrointestinal side effects by modulating the absorption pathway and reducing oxidative stress in the intestinal mucosa.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The invention uses a composite formulation combining both iron and copper salts in specific ratios. This composite approach leverages the synergistic interaction between copper and iron, where copper enhances iron absorption while mitigating the harmful oxidative effects of iron on the gastrointestinal tract.

Inventive Principle:

Principle #40Composite materials

2Quantity of substance

If high doses of iron are administered to ensure adequate supplementation, then iron deficiency treatment is improved, but absorption efficiency decreases due to saturable transport mechanisms

Engineering Contradiction:

Improveiron supplementationVSAvoidabsorption efficiency

Core Design Contradiction:

Quantity of substanceVSProductivity

Solution Approach 1:

The patent changes the chemical parameters by using specific iron salts (ferrous sulfate, ferrous fumarate, ferrous gluconate) and copper salts in optimized ratios. This parameter optimization ensures that iron remains in the divalent state for optimal absorption while copper enhances the transport efficiency through physiological pathways.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

Copper serves as a mediator that facilitates iron transport across the intestinal barrier. The copper-iron interaction enhances the efficiency of iron absorption, allowing for better utilization of supplemented iron without requiring excessively high doses that would saturate transport mechanisms.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Ease of operation

If iron is released in the stomach for absorption, then availability is improved, but mucosal damage occurs due to oxidizing properties

Engineering Contradiction:

Improveiron availabilityVSAvoidmucosal damage

Core Design Contradiction:

Ease of operationVSObject-generated harmful factors

Solution Approach 1:

Copper acts as a protective intermediary that reduces the direct oxidative contact between iron and intestinal mucosa. The patent describes how copper supplementation modifies the iron absorption pathway to reduce oxidative stress and protect the mucosal barrier while maintaining iron availability.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The invention converts the potentially harmful oxidizing properties of iron into a beneficial process by utilizing copper-mediated absorption pathways. The oxidative properties of iron are harnessed for absorption enhancement while copper simultaneously protects the mucosa from damage, transforming a harmful effect into a controlled beneficial mechanism.

Inventive Principle:

Principle #22Blessing in disguise (Convert harm into benefit)

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 formulation effectively supplements iron without gastrointestinal side effects, enhances absorption, and maintains stability over time, promoting optimal tolerability and absorption, as evidenced by increased intracellular ferritin levels.

Implementation Method 1

an oral administration form comprising a solid association of Fe(II) and Cu(II) salts coated with an enteric and hydrophilic polymer layer, which protects iron from gastric contact and releases it in the small intestine

Methodology Applied

Scientific EffectEnteric coating protection: Physical Containment

Implementation Method 2

coated with an enteric and hydrophilic polymer layer, which protects iron from gastric contact and releases it in the small intestine, ensuring bioavailability and stability

Methodology Applied

Scientific EffectHydrophilic polymer absorption enhancement: Absorption (physical)

Data Source

PatentEP3709994B1Oral administration form comprising an iron-copper mixture and its use as a food supplement

Publication Date: 2025.09.10 PIZETA PHARMA SPA

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AI summary

The present invention discloses an oral administration form comprising an association of Fe(II) and Cu(II). The oral administration form finds advantageous application as a food supplement for the supplementation of iron and copper, without side effects for the stomach and intestine.