Ready-to-Infuse Oxytocin Composition for Room-Temperature Stability
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Solution Overview
Problem
Current oxytocin formulations are unstable at room temperature, leading to reduced efficacy and increased risk of human error during dilution and administration, which is particularly problematic in resource-scarce settings where refrigeration is unavailable, contributing to maternal deaths during childbirth.
Innovation Solution
Aqueous, ready-to-infuse oxytocin injection compositions stabilized with chelating agents and amino acids, maintaining at least 90% oxytocin assay after storage for 3 months under refrigerated and controlled room temperature conditions, eliminating the need for dilution and reducing administration errors.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If oxytocin is formulated as an aqueous solution for injection, then it can be administered effectively for inducing labor and treating postpartum hemorrhage, but it rapidly degrades at room temperature reducing efficacy
Solution Approach 1:
The patent changes the concentration parameter by providing ready-to-infuse solutions at multiple fixed concentrations (10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 mU/mL), eliminating the need for manual dilution and ensuring consistent efficacy while maintaining stability through controlled formulation parameters
Solution Approach 2:
The oxytocin is pre-diluted and pre-mixed with stabilizing agents and preservatives during manufacturing, so that when it reaches the patient, it is already in the correct concentration and stable formulation, eliminating degradation issues that would occur with manual dilution
2Adaptability or versatility
If manual dilution is required to prepare oxytocin infusion, then flexibility in dosing is achieved, but human error and administration errors increase
Solution Approach 1:
The patent provides ready-to-infuse solutions at multiple fixed concentrations (10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 mU/mL), allowing dosing flexibility through selection of appropriate concentration rather than manual dilution, thereby eliminating human error in calculation and mixing
Solution Approach 2:
The formulation is designed to be self-dosing through fixed concentration options, where the healthcare provider simply selects the appropriate pre-prepared solution rather than performing complex manual dilution calculations and mixing procedures
3Adaptability or versatility
If refrigeration is unavailable in resource-scarce settings, then basic medical services can be provided, but oxytocin degradation occurs leading to reduced efficacy
Solution Approach 1:
The patent formulates oxytocin at higher concentrations (10-100 mU/mL) with optimized stabilizing agents and preservatives, creating a formulation that maintains efficacy at room temperature for extended periods, enabling use in settings without reliable refrigeration
Solution Approach 2:
The ready-to-infuse solutions are provided as single-use, pre-stabilized formulations that maintain efficacy throughout their shelf-life at room temperature, eliminating the need for continuous refrigeration and ensuring reliable efficacy in resource-scarce settings
4Stability of the object's composition
If concentrated oxytocin solutions are used, then storage stability is improved, but dilution errors and administration complexity increase
Solution Approach 1:
The patent provides ready-to-infuse solutions at multiple fixed concentrations (10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 mU/mL), eliminating the need for manual dilution of concentrated solutions, thereby reducing administration complexity while maintaining storage stability through optimized formulation
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 compositions provide stable oxytocin solutions that maintain efficacy and reduce human error, ensuring consistent treatment outcomes in resource-limited settings.
Implementation Method 1
aqueous, ready-to-infuse oxytocin injection compositions stabilized with chelating agents and amino acids
Implementation Method 2
aqueous, ready-to-infuse oxytocin injection compositions stabilized with chelating agents and amino acids
Data Source
AI summary
The present disclosure provides aqueous, ready-to-infuse oxytocin injection compositions comprising from about 0.01 IU/mL to about 0.1 IU/mL oxytocin, chelating agent, buffer, and aspartic acid, wherein the composition is free of any preservative, and comprises an oxytocin: aspartic acid wt/vol ratio of from about 1:50 to about 1:2000.