PEG Alkyl Ether Acylamide Carrier for Stable Topical Emulsions

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Solution Overview

Problem

Acylamides are difficult to incorporate and solubilize within emulsions, leading to instability and reduced trans-cutaneous absorption, which affects their biological activity and application in topical formulations.

Innovation Solution

A carrier composition comprising an acylamide and a polyethylene glycol alkyl ether dispersing agent, prepared by heating and cooling to form an amorphous mixture, facilitating dispersion and incorporation into emulsions without recrystallization.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If acylamides are solubilized within the fatty phase of an emulsion using very high temperatures (above 90°C), then the solubility of acylamides is improved, but the thermal stability of active substances and lipophilic excipients is compromised, leading to degradation

Engineering Contradiction:
Improvesolubility of acylamidesVSAvoidthermal stability of active substances and excipients
Core Design Contradiction:
Quantity of substanceVSReliability

Solution Approach 1:

The invention changes the temperature parameter from very high temperatures (above 90°C) to moderate temperatures (60-80°C), and introduces a specific weight ratio parameter (1:3 to 1:10 of acylamide to fatty acid amide) to achieve solubilization under milder conditions that preserve thermal stability of other components

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention introduces fatty acid amides as an intermediary substance that facilitates the solubilization of acylamides in the fatty phase. The fatty acid amide acts as a mediator that enables acylamide incorporation at lower temperatures, preventing direct thermal exposure of other heat-sensitive active substances and excipients

Inventive Principle:
Principle #24Intermediary (Mediator)

2Adaptability or versatility

If acylamides are incorporated into emulsions, then the topical application potential is improved, but recrystallization occurs after cooling, impairing physico-chemical stability

Engineering Contradiction:
Improvetopical application potentialVSAvoidphysico-chemical stability of emulsion
Core Design Contradiction:
Adaptability or versatilityVSStability of the object's composition

Solution Approach 1:

The invention optimizes the weight ratio parameter of acylamide to fatty acid amide (1:3 to 1:10), which prevents recrystallization by maintaining acylamides in a solubilized state within the fatty phase even after cooling, thus preserving emulsion stability

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention creates a composite system combining acylamides with fatty acid amides in specific proportions, forming a stable mixed fatty phase that prevents phase separation and recrystallization, enhancing overall emulsion stability

Inventive Principle:
Principle #40Composite materials

3Adaptability or versatility

If acylamides are incorporated into emulsions, then topical application is enabled, but trans-cutaneous absorption is reduced due to partial recrystallization

Engineering Contradiction:
Improvetopical application capabilityVSAvoidtrans-cutaneous absorption
Core Design Contradiction:
Adaptability or versatilityVSEase of operation

Solution Approach 1:

The invention optimizes the concentration ratio of acylamide to fatty acid amide (1:3 to 1:10), ensuring complete solubilization that prevents recrystallization and maintains acylamides in an absorbable state for effective trans-cutaneous delivery

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

Fatty acid amides serve as a mediator that keeps acylamides in solution within the fatty phase, preventing crystallization that would block absorption pathways and enabling sustained trans-cutaneous penetration

Inventive Principle:
Principle #24Intermediary (Mediator)

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 carrier composition enhances the stability and biological activity of acylamides by promoting trans-cutaneous absorption and ease of use in topical formulations, improving their effectiveness in treating skin conditions.

Implementation Method 1

a dispersing agent consisting of a polyethylene glycol alkyl ether of formula II wherein R1 is a linear or branched, saturated alkyl, characterized by a number of carbon atoms comprised between C1 and C4, wherein one of the carbons may or may not be bonded to a hydroxyl, m is comprised between 16 and 18, n is comprised between 7 and 10, z is comprised between 9 and 14, the first solid active and the dispersing agent are in a weight ratio comprised between 1:1.5 and 1:23, so that the first solid active is dispersed in the dispersing agent

Methodology Applied
Scientific EffectDispersion: Dispersion (of waves)

Implementation Method 2

heating the dispersing agent at a temperature ≥ 25°C

Methodology Applied
Scientific EffectHeating: Heating

Data Source

PatentEP4647065A1Vehicle for acylamides based on alkyl ether derivatives of polyethylene glycol
Publication Date: 2025.11.12 LAB DELLA FARMACIA SPA
  • EP4647065A1 patent drawingFigure 1~3
  • EP4647065A1 patent drawingFigure 4
  • EP4647065A1 patent drawingFigure 5~6

AI summary

The present patent application relates to a carrier composition comprising a first solid active consisting of an acylamide of formula I, a dispersing agent consisting of a polyethylene glycol alkyl ether of formula II, wherein: R1 is a linear or branched, saturated alkyl, characterized by a number of carbon atoms comprised between C1 and C4, wherein one of the carbons may or may not be bonded to a hydroxyl, m is comprised between 16 and 18, n is comprised between 7 and 10, z is comprised between 9 and 14, the first solid active and the dispersing agent are in a weight ratio comprised between 1:1.5 and 1:23, so that the first solid active is dispersed in the dispersing agent.