Alcohol-Free Potassium Chloride Oral Solution With Clear Stability

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Solution Overview

Problem

Existing oral potassium chloride solutions face issues with bacterial contamination due to the use of alcohol preservatives, which are unsafe for children, and parabens, which have poor aqueous stability, leading to cloudy formulations and potential misinterpretation as defective.

Innovation Solution

Aqueous oral compositions comprising potassium chloride, glycerin, and sodium benzoate, with optional sweeteners, buffers, and flavorings, that are free of alcohol and parabens, maintaining stability under temperature cycling and light exposure without visible precipitates.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If alcohol is used as a preservative in oral potassium chloride solutions, then bacterial contamination is prevented, but safety concerns arise for children

Engineering Contradiction:

Improvemicrobial stabilityVSAvoidalcohol safety for children

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent changes the chemical composition parameters by replacing alcohol with a combination of parabens (methylparaben, ethylparaben, propylparaben) at specific concentrations (0.05-0.5% each) to achieve microbial stability without using harmful alcohol, thus resolving the contradiction between reliability and safety

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent uses a composite preservative system combining multiple paraben esters with potassium sorbate and edetate disodium to create an effective antimicrobial formulation that eliminates the need for alcohol while maintaining microbial stability in the oral solution

Inventive Principle:

Principle #40Composite materials

2Reliability

If parabens are used as preservatives in oral potassium chloride solutions, then bacterial growth is controlled, but poor water solubility leads to cloudy formulations

Engineering Contradiction:

Improvemicrobial stabilityVSAvoidformulation clarity

Core Design Contradiction:

ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent introduces glycerin (1-10% w/v) as a solubilizing intermediary that enhances the water solubility of paraben preservatives, allowing them to remain dissolved and prevent cloudy appearance while maintaining their antimicrobial effectiveness

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent optimizes the concentration parameters of parabens (0.05-0.5% for each type) and adjusts pH (3.0-5.0) to maximize solubility and maintain clear formulation appearance while ensuring adequate preservative activity

Inventive Principle:

Principle #35Parameter changes

3Quantity of substance

If high concentrations of potassium chloride are used in oral solutions, then treatment effectiveness is improved, but solubility and stability challenges arise

Engineering Contradiction:

Improvepotassium chloride concentrationVSAvoidsolution stability

Core Design Contradiction:

Quantity of substanceVSStability of the object's composition

Solution Approach 1:

The patent achieves high potassium chloride concentrations (10-40% w/v) by adjusting multiple parameters including pH (3.0-5.0), ionic strength, and the presence of complexing agents like edetate disodium, which enhance potassium chloride solubility and prevent precipitation during storage

Inventive Principle:

Principle #35Parameter changes

Data Source

PatentUS12539314B1Aqueous oral compositions including potassium chloride

Publication Date: 2026.02.03 GENUS LIFESCIENCES INC

AI summary

The present disclosure provides an oral liquid composition comprising potassium chloride, free of alcohol, free of parabens, and with enhanced stability. The present disclosure further provides methods of using the oral liquid compositions comprising potassium chloride, and which are free of alcohol and parabens, for the treatment of hypokalemia in patients with or without metabolic alkalosis.