Stable Ready-to-Use Injectable Iron Compositions Without Dilution
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Solution Overview
Problem
Current intravenous iron compositions require time-consuming preparation and can be unstable when mixed with incorrect delivery vehicles, leading to unwanted precipitates, and they often cause adverse reactions in patients.
Innovation Solution
Development of stable, ready-to-use injectable iron compositions comprising elemental iron, a carbohydrate, and a stabilizing agent, which are pre-mixed and suitable for immediate use without dilution, minimizing preparation time and reducing adverse reactions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If intravenous iron compositions are prepared using larger volume IV bags or bottles with delivery vehicles, then the iron composition can be administered by intravenous infusion, but the preparation process becomes time-consuming and requires additional equipment and steps
Solution Approach 1:
The patent combines the iron composition with the delivery vehicle (0.9% NaCl) into a single pre-mixed ready-to-use solution. This eliminates the need for separate IV bags, delivery tubes, and infusion pumps, reducing both preparation time and equipment requirements while maintaining ease of administration through simple intravenous injection
Solution Approach 2:
The iron composition is pre-mixed with the delivery vehicle (0.9% NaCl) at the manufacturing stage to create a ready-to-use formulation. This preliminary action eliminates the need for time-consuming preparation steps in the clinical setting, where healthcare personnel would otherwise need to choose IV bags, add medication, and ensure proper dilution
2Ease of manufacture
If intravenous iron compositions are mixed with incorrect delivery vehicles, then the preparation process becomes simpler, but the composition becomes unstable and forms unwanted precipitates
Solution Approach 1:
The patent specifies precise parameters for the delivery vehicle (0.9% NaCl concentration, pH range 9.0-11.0) and iron composition to ensure compatibility and stability. By controlling these parameters, the formulation achieves both ease of preparation and reliable stability without precipitate formation
Solution Approach 2:
The patent uses 0.9% NaCl as an intermediary substance that mediates between the iron composition and the biological system. This specific delivery vehicle ensures compatibility, preventing unwanted reactions and precipitates while facilitating stable intravenous administration
3Reliability
If conventional intravenous iron compositions are used, then iron repletion can be achieved, but serious and life-threatening reactions occur most frequently with iron dextran and non-life threatening reactions also occur
Solution Approach 1:
The patent employs a higher pH range (9.0-11.0) and specific ionic composition (0.9% NaCl) to create a more stable iron formulation that reduces adverse reactions. This parameter optimization maintains iron repletion effectiveness while minimizing both serious and non-serious side effects compared to conventional formulations
Solution Approach 2:
The patent creates a composite formulation combining iron composition with 0.9% NaCl delivery vehicle, stabilizing agents, and buffering agents. This composite structure enhances safety by reducing adverse reactions while maintaining therapeutic effectiveness for iron repletion
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 stable injectable iron compositions provide a convenient and safe administration method, reducing medication errors and adverse reactions, while maintaining stability and efficacy for extended periods.
Implementation Method 1
Intravenous (IV) iron agents are colloids that contain spheroidal iron-carbohydrate nanoparticles. At the core of each particle is an iron-oxyhydroxide gel. The core is surrounded by a shell of carbohydrate that stabilizes the iron-oxyhydroxide, releases the bioactive iron in a controlled manner, and maintains the resulting particles in colloidal suspension.
Implementation Method 2
Venofer® is composed of the active pharmaceutical ingredient (API) polynuclear iron (III)-hydroxide in sucrose having a molecular weight of approximately 34,000 to 60,000 Daltons (Da) and a proposed structural formula: [Na2Fe5O8(OH)·3(H2O)]n·m(C12H22O11) where n is the degree of iron polymerization and m is the number of sucrose molecules associated with the polymerized iron (III)-hydroxide. The poly-nuclear iron (III)-hydroxide-sucrose structure is dissociated into iron and sucrose following intravenous administration, and the iron is transported as a complex with transferrin to target cells including erythroid precursor cells.
Data Source
AI summary
Injectable iron compositions comprising iron, a carbohydrate, a stabilizing agent and water are provided. These iron compositions can be prepared by mixing iron with a carbohydrate and water to form a mixture and adding a stabilizing agent to the mixture to form the stable injectable iron composition. These compositions can be considered “ready-to-use” and can treat a variety of diseases, disorders, or conditions characterized by iron deficiency or dysfunctional iron metabolism, for example, anemia.