Alkylammonium EDTA Salt Chelation in Lipid Formulations
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Solution Overview
Problem
Lipid-based formulations are prone to oxidation, especially due to trace metal ions, which reduces the efficacy and shelf life of bioactive agents, and existing antioxidants are not effective in non-aqueous environments.
Innovation Solution
Incorporation of alkylammonium EDTA salts, which are soluble in non-aqueous lipid environments, to chelate metal ions and prevent oxidative degradation of lipids and bioactive agents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional antioxidants are used in lipid-based formulations, then oxidation resistance is expected to improve, but these antioxidants are not effective in non-aqueous lipid environments
Solution Approach 1:
The patent changes the chemical parameters of the antioxidant by selecting alkylammonium EDTA salts with specific properties. These salts have altered solubility characteristics compared to conventional antioxidants, enabling them to dissolve and function effectively in non-aqueous lipid environments while maintaining their metal-chelating and oxidation-preventing capabilities.
Solution Approach 2:
The alkylammonium EDTA salt acts as an intermediary substance that bridges the gap between the non-aqueous lipid environment and the oxidation protection function. The salt's unique structure allows it to mediate between the hydrophobic lipid phase and the hydrophilic metal ions, enabling effective chelation and oxidation prevention in the non-aqueous medium.
2Ease of manufacture
If trace metal ions are present in lipid formulations, then formulation simplicity is maintained, but oxidative degradation increases reducing shelf life
Solution Approach 1:
The patent applies preliminary action by incorporating the alkylammonium EDTA salt into the formulation during the manufacturing process. This preemptive measure ensures that metal ions are chelated and oxidation is prevented from the outset, rather than attempting to remove metal ions after they have caused degradation. The antioxidant is present before any oxidative damage can occur.
Solution Approach 2:
The patent converts the potentially harmful presence of trace metal ions into a benefit by using them as targets for the chelating action of the EDTA salt. Rather than attempting complete elimination of metal ions, the formulation embraces their presence and uses the chelation mechanism to neutralize their harmful oxidative effects, transforming a liability into a controlled interaction.
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
Significantly reduces oxidative degradation, extending the shelf life and stability of lipid-based formulations by effectively chelating metal ions and preventing chemical degradation reactions.
Implementation Method 1
Incorporation of alkylammonium EDTA salts, which are soluble in non-aqueous lipid environments, to chelate metal ions and prevent oxidative degradation of lipids and bioactive agents
Implementation Method 2
Significantly reduces oxidative degradation, extending the shelf life and stability of lipid-based formulations by effectively chelating metal ions and preventing chemical degradation reactions
Data Source
AI summary
The present invention relates to mixtures comprising:i) at least one lipid and/or at least one oil; andii) an alkyl ammonium EDTA salt;wherein the mixture has a water content in the range of 0 to 1.0 wt %.The invention further relates to mixtures which are pre-formulations, methods of treatment comprising administration of such pre-formulations, to pre-filled administration devices and kits containing the formulations, to the use of an alkylammonium EDTA salt to reduce the decomposition of the lipid components and/or any active agent contained within the pre-formulation, and to alkyl ammonium EDTA salts as described herein.