Clobetasol Propionate Formulation Stability and Application

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Solution Overview

Problem

Current topical formulations for clobetasol propionate face challenges in delivery efficiency, stability, tolerability, and adherence due to greasiness, leading to side effects and poor treatment compliance, especially for long-term use in treating psoriasis and other dermatitis conditions.

Innovation Solution

An aqueous vehicle based on propylene glycol as a solvent and macrogol-glycerol hydroxystearate as a non-ionic emulsifier, capable of holding low concentrations of clobetasol propionate, providing a stable and easy-to-apply formulation in the form of a spray, cream, or ointment, with additional ingredients like hyaluronic acid and glycyrrhetinic acid for enhanced skin penetration and anti-inflammatory effects.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional topical formulations of clobetasol propionate are used, then therapeutic efficacy is achieved, but greasiness and poor tolerability occur leading to reduced adherence

Engineering Contradiction:
Improvetherapeutic efficacyVSAvoidease of application
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent changes the physical-chemical parameters of the formulation by using an aqueous vehicle with propylene glycol and macrogol-glycerol hydroxystearate emulsifier, allowing the formulation to achieve both therapeutic efficacy and ease of application without greasiness

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent creates a composite formulation system combining water, propylene glycol, and macrogol-glycerol hydroxystearate emulsifier to achieve a non-greasy, easily applicable topical preparation that maintains therapeutic effectiveness

Inventive Principle:
Principle #40Composite materials

2Duration of action of moving object

If long-term topical treatment is performed, then chronic skin conditions are managed, but side effects such as skin thinning and adrenal suppression occur

Engineering Contradiction:
Improveduration of treatmentVSAvoidside effects
Core Design Contradiction:
Duration of action of moving objectVSObject-affected harmful factors

Solution Approach 1:

The patent modifies the formulation parameters to enable long-term treatment by improving stability and reducing local side effects, allowing extended duration of action without proportionally increasing harmful effects

Inventive Principle:
Principle #35Parameter changes

3Productivity

If conventional formulations are used, then treatment is provided, but chemical instability occurs leading to reduced durability

Engineering Contradiction:
Improvetreatment provisionVSAvoidchemical stability
Core Design Contradiction:
ProductivityVSStability of the object's composition

Solution Approach 1:

The patent changes the chemical parameters of the formulation by selecting specific compatible ingredients (aqueous vehicle, propylene glycol, macrogol-glycerol hydroxystearate) that prevent degradation and maintain chemical stability over time

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent develops a stable composite formulation system where the selected ingredients work together to maintain chemical integrity and durability of the clobetasol propionate preparation throughout the product shelf life

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 formulation achieves high chemical stability and ease of application, reducing side effects and improving treatment compliance by delivering effective, low-dose clobetasol propionate to the skin with prolonged durability and enhanced therapeutic effects.

Implementation Method 1

an aqueous vehicle based on propylene glycol as a solvent

Methodology Applied
Scientific EffectSolvation: Solvation

Implementation Method 2

propylene glycol as a solvent and moisture-retaining agent

Methodology Applied
Scientific EffectHumidity retention:

Implementation Method 3

macrogol-glycerol hydroxystearate as a non-ionic emulsifier

Methodology Applied
Scientific EffectEmulsification: Emulsion

Implementation Method 4

additional ingredients like hyaluronic acid and glycyrrhetinic acid for enhanced skin penetration

Methodology Applied
Scientific EffectSkin penetration: Permeation

Data Source

PatentEP2398457B1A topical formulation of low level clobetasol propionate for treating disorders of the skin and mucous membranes
Publication Date: 2016.08.10 ABIGO MEDICAL AB

AI summary

A new topical formulation is provided, with a high chemical stability, of for example a low dose clobetasol propionate, suitable for the topical treatment of skin and mucous membrane conditions associated with disorders including psoriasis, eczema, and other forms of dermatitis and also topical use associated with he mouth, such as lichen planus. The formulation includes an aqueous vehicle of based on propylene glycol as a solvent and moisture-retaining agent, and macrogol-glycerol hydroxystearate as a non-ionic emulsifier, being capable of holding surprisingly low concentrations of clobetasol. The vehicle holds concentrations about 0.005 % to about 0.05 % by weight of 17-clobetasol propionate, more preferably about 0.02 to 0.025 %, even more preferably 0.025 % by weight of 17-clobetasol propionate. The formulation has a good chemical stability, resulting in a long durability.