Superoxide Dismutase Stabilization Using Deoxygenated Water

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Solution Overview

Problem

Superoxide dismutase (SOD) is prone to degradation by reactive oxygen species (ROS) during manufacturing, storage, and administration, which limits its therapeutic effectiveness due to interference with its stability and activity.

Innovation Solution

A pharmaceutical composition comprising a therapeutically effective amount of SOD combined with a stabilizing carrier, such as deoxygenated water, and a stabilizing agent to minimize exposure to ROS, including a container configuration that reduces ROS in the headspace and entry into the container.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If SOD is stored in conventional containers with oxygen present, then the container is simple and easy to manufacture, but SOD activity degrades due to ROS interference

Engineering Contradiction:

ImproveSOD activity stabilityVSAvoidcontainer configuration

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent employs an inert atmosphere by deoxygenating the aqueous carrier to less than 5 ppm oxygen and maintaining this low oxygen environment throughout storage and administration. This inert environment prevents ROS formation and protects SOD from oxidative degradation, directly resolving the contradiction between maintaining SOD stability and avoiding complex container configurations.

Inventive Principle:

Principle #39Inert atmosphere (Inert environment)

Solution Approach 2:

The patent introduces oxygen scavengers as intermediary substances that actively remove any remaining oxygen in the system. These scavengers act as mediators between the SOD and any residual oxygen, preventing direct harmful interactions while maintaining a simple container design.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If SOD is administered without stabilization measures, then the administration process is simple and fast, but SOD degrades during manufacturing, storage, and administration

Engineering Contradiction:

ImproveSOD stabilityVSAvoidmanufacturing process

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

The patent applies preliminary action by deoxygenating the aqueous carrier before SOD is added and maintaining this low oxygen state throughout the manufacturing process. This pre-established protective environment ensures SOD stability from the moment of formulation, eliminating the need for complex stabilization measures during subsequent handling and administration.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent changes the oxygen concentration parameter of the aqueous carrier from conventional levels to less than 5 ppm throughout the manufacturing and storage process. This parameter change fundamentally alters the chemical environment to protect SOD, simplifying the overall approach compared to using multiple stabilizing agents or complex processing steps.

Inventive Principle:

Principle #35Parameter changes

3Reliability

If deoxygenated water with less than 5 ppm oxygen is used as carrier, then SOD stability is improved, but the carrier preparation process becomes more complex

Engineering Contradiction:

ImproveSOD activity maintenanceVSAvoidcarrier preparation system

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent employs self-service by incorporating oxygen scavengers that automatically maintain the low oxygen environment in the carrier throughout storage and administration. This self-maintaining system eliminates the need for complex external deoxygenation equipment, allowing simple vial sealing followed by automatic oxygen removal through the scavenger action.

Inventive Principle:

Principle #25Self-service

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 composition maintains a high level of SOD activity and stability, ensuring a maximum amount of SOD reaches the treatment site, thereby enhancing its therapeutic benefits and prolonging its reactive form during storage.

Implementation Method 1

the stabilizing carrier can comprise deoxygenated water. In some examples, the deoxygenated water can have less than about 5 ppm of oxygen

Methodology Applied

Scientific EffectOxygen removal from water:

Implementation Method 2

The container can be further configured to minimize the amount of ROS in a headspace of the container and/or to minimize the entry of ROS into the container

Methodology Applied

Scientific EffectOxidation prevention:

Implementation Method 3

The stabilizing agent can encapsulate the SOD or otherwise form a stabilizing complex with the SOD

Methodology Applied

Scientific EffectEncapsulation:

Data Source

PatentUS20230193219A1Superoxide dismutase compositions and methods

Publication Date: 2023.06.22 PROFESSIONAL NUTRACEUTICAL DESIGN LLC

AI summary

The present disclosure is drawn to superoxide dismutase (SOD) compositions and methods thereof. A topical composition can comprise a combination of a therapeutically effective amount of superoxide dismutase (SOD) with a stabilizing carrier that is suitable for topical administration. A method of treating a condition in a subject that is responsive to treatment with superoxide dismutase (SOD) can comprise administering a therapeutically effective amount of the topical composition. A method of stabilizing a superoxide dismutase (SOD) composition can comprise combining an amount of SOD with deoxygenated water to form an SOD solution, and minimizing exposure of the SOD solution to reactive oxygen species (ROS).