Dopamine Injectable Solution With Low Oxygen for 7-Day Stability
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Solution Overview
Problem
Existing treatments for Parkinson's disease, such as continuous dopaminergic administration, face issues with stability, oxidation, and neurotoxicity, leading to ineffective neuroprotection and motor complications, while current pharmaceutical solutions are not stable for prolonged use with pumps in contact with the skin.
Innovation Solution
A pharmaceutical injectable solution of dopamine hydrochloride in water for injection, maintained at a pH between 3.0 and 5.5 and with an oxygen content of 0.008% or less, ensuring stability for at least 7 days at 37°C, suitable for use with an anaerobic pump.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If dopamine is administered continuously to treat Parkinson's disease, then motor complications are reduced, but oxidation and neurotoxicity occur leading to instability
Solution Approach 1:
The patent applies the inert atmosphere principle by formulating dopamine in an oxygen-free environment using oxygen-free water for injection and maintaining anaerobic conditions throughout storage and administration. This eliminates oxygen contact that causes oxidation, thereby preventing neurotoxicity while maintaining continuous dopamine delivery for treating Parkinson's disease motor complications
2Duration of action of moving object
If dopamine solution is stored at physiological temperature for prolonged use with pumps, then continuous delivery is enabled, but stability is compromised leading to degradation
Solution Approach 1:
The patent maintains anaerobic conditions in the pump system using oxygen-free water for injection and seals that prevent oxygen ingress. This allows the dopamine solution to remain stable at physiological temperature (37°C) for prolonged periods (at least 7 days) enabling continuous delivery through implanted pumps without degradation
Solution Approach 2:
The patent modifies the chemical parameters of the dopamine solution by adjusting pH to between 3.0 and 5.5 and eliminating oxygen content. These parameter changes enhance the chemical stability of dopamine at physiological storage temperatures, enabling prolonged continuous delivery without decomposition
3Quantity of substance
If L-dopa is administered orally to increase dopamine levels, then dopamine deficiency is attenuated, but pulsatile stimulation causes motor complications
Solution Approach 1:
The patent implements continuous dopaminergic administration through implanted pumps that deliver dopamine at a constant rate directly to the brain. This continuous delivery eliminates the pulsatile stimulation caused by oral L-dopa administration, maintaining stable dopamine levels in the striatum and preventing motor complications while effectively treating dopamine deficiency
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 solution provides stable, continuous dopamine delivery, reducing motor complications and neurotoxicity, effectively treating conditions linked to low dopamine levels without the drawbacks of previous treatments.
Implementation Method 1
The solution is adapted to be delivered with an anaerobic pump
Implementation Method 2
wherein the solution has a pH between 3.0 and 5.5
Data Source
AI summary
The present disclosure relates to a pharmaceutical injectable solution comprising dopamine or a pharmaceutically acceptable salt thereof, preferably dopamine hydrochloride, dissolved in water for injection, wherein the solution has a pH between 3.0 and 5.5, and has an oxygen content equal to or lower than 0.008% (8 ppm), and uses thereof.