FeII-Ascorbate-Proteinate Complex Oral Iron Formulation
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Solution Overview
Problem
Current treatments for iron deficiency anemia are limited by side effects such as gastric damage and unpleasant taste, and existing formulations have challenges with bioavailability and absorption, especially for individuals with gastroduodenal disorders.
Innovation Solution
The formation of a FeII-ascorbate-proteinate complex in an aqueous medium at a pH of 4.8-6.8, using a solid or liquid oral composition containing ferrous salts, vitamin E, sodium ascorbate, and proteins, which promotes the absorption and maintenance of reduced iron while minimizing oxidative stress and side effects.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If iron is administered in the form of salt (iron sulphate, iron fumarate, iron pyrophosphate), then iron supplementation is achieved, but gastric damage and side effects occur
Solution Approach 1:
The patent uses magnesium oxide as an intermediary substance that reacts with gastric acid to form magnesium chloride, thereby neutralizing the harmful acidic environment that causes gastric damage from iron salts. This mediator protects the gastric mucosa while allowing iron absorption to proceed.
Solution Approach 2:
The invention changes the pH parameter of the gastric environment by introducing magnesium oxide, which increases pH from highly acidic conditions to a less acidic state (pH 4.8-6.8), reducing the harmful effects on gastric tissue while maintaining conditions favorable for iron absorption.
2Quantity of substance
If ferrous iron is used for absorption, then bioavailability is improved, but oxidation to ferric iron occurs in the presence of atmospheric oxygen and gastric fluids
Solution Approach 1:
Vitamin E is introduced as a preliminary protective agent that prevents oxidation of ferrous iron before it can occur. The antioxidant acts in advance to neutralize oxidative processes initiated by atmospheric oxygen and gastric fluids, preserving the bioavailable ferrous state.
Solution Approach 2:
The patent converts the harmful oxidative environment of the stomach into a beneficial condition by using vitamin E to scavenge free radicals and prevent oxidation, thereby transforming the potentially damaging oxidative atmosphere into a protective environment for ferrous iron.
3Quantity of substance
If iron supplements are taken, then iron deficiency is treated, but unpleasant taste persists over time
Solution Approach 1:
Magnesium oxide serves as a taste-modifying intermediary that not only protects against gastric damage but also improves the organoleptic properties of the formulation, masking the unpleasant metallic taste of iron salts while maintaining therapeutic efficacy.
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 FeII-ascorbate-proteinate complex enhances iron bioavailability, reduces side effects, and improves absorption, particularly in the duodenal environment, maintaining reduced iron form and reducing oxidative stress, thus addressing the limitations of existing treatments.
Implementation Method 1
The mechanism of action of magnesium oxide consists in increasing the pH of the stomach to a less acidic state
Implementation Method 2
The mechanism of action of vitamin E is based on its ability to prevent oxidation
Implementation Method 3
The formation of a FeII-ascorbate-proteinate complex in an aqueous medium at a pH of 4.8-6.8
Implementation Method 4
promotes the absorption and maintenance of reduced iron while minimizing oxidative stress and side effects
Data Source
Figure 1
Figure 2
Figure 2A
AI summary
Aqueous medium having a pH between 4.8 and 6.8 and comprising the Fell- ascorbate-proteinate complex, prepared according to one of the following two alternative methods: (1) by dissolving in aqueous medium a solid oral composition (A) comprising an organic or inorganic ferrous salt, vitamin E, sodium ascorbate, plant or animal proteins and magnesium oxide in combination with suitable excipients and/or diluents, or (2) by forming a liquid oral composition (B) comprising the same components of the formulation (A) in combination with suitable excipients and/or diluents and water. Both the solid composition (A) in the method (1) and the liquid composition (B) in the method (2) are oral and are intended for the treatment of disorders and diseases caused by iron deficiency. A further object of the present invention relates to the preparation processes of the aforesaid solid composition (A) and liquid composition (B).