Single-Unit Glucose Liquid Composition for Degradation Control

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Solution Overview

Problem

Existing parenteral liquid compositions containing glucose require mixing of separate containers due to high pH, increasing the risk of medication errors and infections, and are prone to glucose isomerization/degradation products like fructose and 5-HMF, posing safety risks.

Innovation Solution

A ready-to-administer liquid composition with a pH of 6.7 to 8.5, formulated in a single unit dosage form, that minimizes glucose isomerization/degradation by maintaining pH stability within a narrow range, allowing storage without mixing or dilution steps.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If glucose is formulated in a liquid composition with high pH (greater than 6.5), then the composition can be used in applications requiring high pH, but glucose isomerization and degradation occur, producing harmful products like fructose and 5-HMF

Engineering Contradiction:
ImprovepH range applicabilityVSAvoidglucose degradation products
Core Design Contradiction:
Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies parameter changes by precisely controlling the pH of the liquid composition to fall within the range of 6.7 to 8.5, which allows the composition to maintain high pH applicability while minimizing glucose isomerization and degradation to harmful products like fructose and 5-HMF

Inventive Principle:
Principle #35Parameter changes

2Stability of the object's composition

If separate containers are used for storage (one for glucose at low pH, another for other components at high pH), then glucose stability is maintained, but the risk of medication errors and needlestick injuries increases

Engineering Contradiction:
Improveglucose stabilityVSAvoidmedication safety
Core Design Contradiction:
Stability of the object's compositionVSReliability

Solution Approach 1:

The patent merges the previously separate storage containers into a single unified liquid composition that is ready to administer. This single container formulation maintains glucose stability through controlled pH (6.7 to 8.5) while eliminating the risks associated with mixing separate containers, such as medication errors and needlestick injuries

Inventive Principle:
Principle #5Merging (Combining)

3Adaptability or versatility

If glucose is stored in liquid composition at high pH for extended periods, then the composition can be used in applications requiring high pH, but the shelf life is limited due to glucose degradation

Engineering Contradiction:
ImprovepH range applicabilityVSAvoidshelf life
Core Design Contradiction:
Adaptability or versatilityVSDuration of action of stationary object

Solution Approach 1:

The patent extends the shelf life of the liquid composition by precisely controlling the pH within the range of 6.7 to 8.5. This parameter control minimizes glucose isomerization and degradation reactions, allowing the composition to maintain stability and efficacy for extended storage periods while still meeting the requirements of applications needing high pH

Inventive Principle:
Principle #35Parameter changes

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 retains glucose stability for extended periods, reducing impurities like fructose and 5-HMF, ensuring safety and efficacy, and extending shelf life up to 3-6 months at room temperature.

Implementation Method 1

the pH of the liquid composition is from 6.7 to 8.5

Methodology Applied
Scientific EffectpH stability:

Implementation Method 2

isomerization/degradation of glucose in liquid, aqueous compositions may be dependent on several factors, including the temperature, the pH of the liquid, the concentration of glucose

Methodology Applied
Scientific Effectisomerization/degradation:

Data Source

PatentUS20250332092A1Liquid composition comprising glucose
Publication Date: 2025.10.30 HIKMA PHARMACEUTICALS USA INC

AI summary

The present disclosure relates to an aqueous composition stored in a single unit dosage container, where the aqueous composition consists of glucose, sodium bicarbonate, water, and a pH adjusting agent if needed to adjust the pH, wherein the pH of the composition is from 6.7 to 8.1. Such composition is stable for at least 3 months at room temperature conditions.