Phenylephrine Respiratory Compositions With pH and Aldehyde Control

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Solution Overview

Problem

Existing pharmaceutical compositions for treating respiratory illnesses face stability issues due to degradation of phenylephrine, particularly in the presence of aldehydes, acids, and metals, making it challenging to formulate stable and effective combinations of multiple actives.

Innovation Solution

Formulating compositions with a pH of 2 to 5 and being substantially free of aldehydes, using non-aldehydic aesthetic agents, and incorporating stabilizing components like metal chelators and reducing agents to enhance phenylephrine stability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If phenylephrine is formulated in liquid compositions, then it provides effective treatment of respiratory symptoms, but it degrades due to presence of oxygen, aldehydes, acids, and metals

Engineering Contradiction:
Improvestability of phenylephrineVSAvoiddegradation from oxygen, aldehydes, acids, and metals
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent removes harmful substances (aldehydes, certain acids including citric acid, and metals) from the composition to eliminate the factors causing phenylephrine degradation, thereby resolving the stability problem while maintaining therapeutic effectiveness

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent controls the pH of the composition within a specific range (pH 2-5) to prevent phenylephrine degradation. By adjusting and maintaining the pH parameter within this optimal range, the composition achieves stability while preserving the active ingredient's efficacy

Inventive Principle:
Principle #35Parameter changes

2Adaptability or versatility

If multiple pharmaceutical actives are combined in liquid compositions, then comprehensive symptom relief is achieved, but stability and effectiveness of individual actives are compromised

Engineering Contradiction:
Improvecomprehensive symptom reliefVSAvoidstability of pharmaceutical actives
Core Design Contradiction:
Adaptability or versatilityVSStability of the object's composition

Solution Approach 1:

The patent creates a localized optimal environment (pH 2-5, free from degrading substances) specifically for phenylephrine within the multi-ingredient composition. This localized control allows phenylephrine to remain stable while other ingredients perform their respective functions for comprehensive symptom relief

Inventive Principle:
Principle #3Local quality

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 compositions achieve enhanced stability and effectiveness of phenylephrine, maintaining its integrity and efficacy in treating respiratory symptoms, while avoiding degradation.

Implementation Method 1

incorporating stabilizing components like metal chelators

Methodology Applied
Scientific EffectChelation:

Implementation Method 2

incorporating stabilizing components like reducing agents to enhance phenylephrine stability

Methodology Applied
Scientific EffectReduction: Reduction

Data Source

PatentUS12403103B2Compositions and methods useful for treatment of respiratory illness
Publication Date: 2025.09.02 PROCTER & GAMBLE CO

AI summary

Disclosed are compositions including phenylephrine, its free and addition salt forms, and mixtures thereof, alone, or in combination with other pharmaceutical actives. The compositions have a pH of about 2 to about 5 and are substantially free of aldehydes. Also disclosed are methods of treating respiratory illness through administration of a composition comprising phenylephrine, its free and addition salt forms, and mixtures thereof alone, or in combination with other pharmaceutical actives.