Antioxidant Osmotic Dispenser Composition for Gamma Sterilization

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Solution Overview

Problem

Existing osmotic dispensers face issues with aldehyde formation due to gamma radiation, which can contaminate the active agent, and there is a need for improved radiation stability and compatibility with active agents.

Innovation Solution

Incorporation of antioxidants such as butylated hydroxytoluene (BHT) in the solute composition, along with polymers like polyethylene oxide and polyethylene glycol, to minimize aldehyde formation and enhance radiation stability, while using a semipermeable membrane to control fluid release.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If gamma radiation is used to sterilize the osmotic dispenser, then sterilization is achieved, but aldehyde formation occurs which contaminates the active agent

Engineering Contradiction:

ImprovesterilizationVSAvoidaldehyde formation

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent converts the harmful effect of gamma radiation (aldehyde formation) into a beneficial outcome by adding antioxidants to the solute composition. The antioxidants scavenge free radicals generated during irradiation, preventing aldehyde formation while maintaining the sterilization benefit. This transforms the harmful radiation effect into a controlled process that achieves both sterilization and prevents contamination.

Inventive Principle:

Principle #22Blessing in disguise (Convert harm into benefit)

Solution Approach 2:

The antioxidant acts as an intermediary substance between the gamma radiation and the active agent. It intercepts the harmful free radicals and reactive oxygen species generated by radiation before they can contaminate the active agent with aldehydes, thus protecting the active agent while allowing sterilization to proceed.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If antioxidants are added to the solute composition, then radiation stability and prevention of aldehyde formation are improved, but device complexity increases

Engineering Contradiction:

Improveradiation stabilityVSAvoidcomposition complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent modifies the chemical composition parameters of the solute by incorporating antioxidants at specific concentrations (0.1-10% w/w). This parameter change enhances radiation stability and prevents aldehyde formation without fundamentally altering the device structure or operation, thus improving reliability with minimal impact on overall device complexity.

Inventive Principle:

Principle #35Parameter changes

3Stability of the object's composition

If the osmotic dispenser is made from materials compatible with active agents, then agent integrity is maintained, but manufacturing constraints increase

Engineering Contradiction:

Improveactive agent integrityVSAvoidmanufacturing constraints

Core Design Contradiction:

Stability of the object's compositionVSEase of manufacture

Solution Approach 1:

The patent employs composite material strategies by combining antioxidants with the solute composition matrix. This composite approach creates a chemically inert environment that protects the active agent from degradation while maintaining ease of manufacture through standardized formulation techniques and compatible material selections.

Inventive Principle:

Principle #40Composite materials

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 inclusion of antioxidants in the solute composition prevents aldehyde formation, maintaining the integrity and efficacy of the active agent, ensuring stable and controlled delivery.

Implementation Method 1

the antioxidant comprises at least one member selected from butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA), thioethers, histidine, cysteine, tryptophan, tyrosine, ascorbic acid, vitamin E, ascorbyl palmitate, erythorbic acid, potassium metabisulfite, propyl gallate, sodium ascorbate, sodium bisulfate, sodium metabisulfite, sodium sulfite, sodium formaldehyde sulfoxylate, and thymol

Methodology Applied

Scientific EffectOxidation: Oxidation

Implementation Method 2

a semipermeable membrane encapsulating the osmotically-effective solute composition

Methodology Applied

Scientific EffectOsmosis: Osmosis

Implementation Method 3

an osmotically-effective solute composition encapsulating at least a portion of the container

Methodology Applied

Scientific EffectOsmotic pressure: Osmotic Pressure

Data Source

PatentEP3076946B1Compositions comprising antioxidant, fluid dispensers, and methods involving the same

Publication Date: 2026.01.07 ALZET LLC

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Figure 6~7

AI summary

A composition includes a salt; a polymer; and an antioxidant. A dispenser includes a flexible container having a closed end and an opposed open end; an osmotically-effective solute composition encapsulating at least a portion of the container, the solute composition including antioxidant in an amount of at least 0.5 wt%, based on weight of the solute composition; a semipermeable membrane encapsulating the osmotically-effective solute composition; a cap having a sealing surface adapted for sealing engagement with the open end of the container; and a port extending from an interior of the container and through the cap. Also disclosed are methods of making and using the composition and osmotic pumps.