Water-Soluble Iron-Maltodextrin Complexes for Parenteral Stability
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Solution Overview
Problem
Existing parenteral iron preparations, such as those based on sucrose and dextran, are unstable at high temperatures, making sterilization difficult, and can induce anaphylactic shocks, with limited stability and dosage capabilities.
Innovation Solution
The development of water-soluble iron (III) carbohydrate complexes using oxidation products of maltodextrins, which are easily obtainable and produce complexes that are stable at high temperatures, reducing toxicity and avoiding anaphylactic reactions, by reacting iron (III) salts with oxidized maltodextrins in an alkaline hypochlorite solution.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If iron sucrose or iron dextran complexes are used for parenteral application, then iron deficiency anaemia can be treated, but the preparations are unstable at temperatures above 100°C making sterilization difficult
Solution Approach 1:
The patent changes the chemical parameters of the carbohydrate ligand by using oxidation products of maltodextrins instead of sucrose or dextran. This parameter change results in a new iron complex that maintains stability while enabling sterilization at temperatures of 120-121°C, thus resolving the contradiction between stability and sterilization capability.
2Reliability
If iron dextran complexes are used for parenteral application, then iron deficiency anaemia can be treated, but they can induce dangerous anaphylactic shocks
Solution Approach 1:
The patent extracts the harmful component by replacing the dextran ligand with oxidation products of maltodextrins. This extraction of the problematic dextran structure while retaining the essential iron-carbohydrate complex functionality eliminates the anaphylactic shock risk while maintaining therapeutic efficacy.
3Reliability
If pullulan-based iron complexes are used, then parenteral application is possible, but they are difficult to obtain and require complex production processes with high temperatures and pressure
Solution Approach 1:
The patent adopts a disposable approach by using readily available maltodextrins as starting materials instead of requiring the complex production of pullulan. The simple oxidation process converts these inexpensive, easily obtainable maltodextrins into the required ligands, dramatically reducing production complexity and cost while maintaining parenteral applicability.
4Productivity
If the stability of iron complexes is increased to enable high dosage and application rate, then treatment efficiency improves, but the complexity of the preparation increases
Solution Approach 1:
The patent achieves high stability for increased application rates through a parameter change in the ligand structure - using oxidation products of maltodextrins with specific dextrose equivalents (5-20). This targeted parameter change provides the required stability without increasing overall preparation complexity, as the oxidation process is straightforward and the starting materials are simple.
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 iron (III) carbohydrate complexes are stable at high temperatures, allowing for effective sterilization, reduced toxicity, and increased dosage and application rates, with the ability to be produced from commercially available starting products, enhancing their suitability for parenteral use.
Implementation Method 1
the maltodextrins are oxidized in an aqueous solution with a hypochlorite solution
Implementation Method 2
reacting the obtained solution with an aqueous solution of an iron (III) salt
Data Source
AI summary
Water soluble iron carbohydrate complex obtainable from an aqueous solution of iron (III) salt and an aqueous solution of the oxidation product of one or more maltrodextrins using an aqueous hypochlorite solution at a pH-value within the alkaline range, where, when one maltodextrin is applied, its dextrose equivalent lies between 5 and 20, and when a mixture of several maltodextrins is applied, the dextrose equivalent of the mixture lies between 5 and 20 and the dextrose equivalent of each individual maltodextrin contained in the mixture lies between 2 and 40, process for its production and medicament for the treatment and prophylaxis of iron deficiency conditions.