Corticosteroid Foam Stability via Buffer Extraction

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Solution Overview

Problem

Conventional methods for manufacturing corticosteroid foams face issues such as degradation and inactivation of the active ingredient during production and storage, leading to reduced efficacy and short shelf life.

Innovation Solution

A method for manufacturing stable foamable compositions that involves forming a homogenous solution with an aliphatic alcohol, a can corrosion inhibitor, a polyol, and a foam structuring agent, without a traditional buffer system, which is then cooled and filled into canisters before being charged with a propellant, maintaining stability and efficacy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional methods are used to manufacture corticosteroid foams, then the foam composition can be produced, but the corticosteroid degrades and inactivates during manufacture and storage, reducing efficacy and shelf life

Engineering Contradiction:
Improvestability of corticosteroidVSAvoidshelf life of composition
Core Design Contradiction:
ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The patent removes the traditional buffer system from the foam composition formulation. By extracting this component that causes corticosteroid degradation, the invention eliminates the harmful chemical environment while maintaining foam stability through alternative means (propellant-based foaming mechanism).

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention changes the pH parameters and chemical composition parameters of the foam base by eliminating buffers and using specific alcohol/surfactant/propellant combinations. This parameter change creates a chemically inert environment that prevents corticosteroid degradation while maintaining therapeutic efficacy.

Inventive Principle:
Principle #35Parameter changes

2Stability of the object's composition

If a traditional buffer system is used in foam composition, then pH stability can be maintained, but manufacturing complexity increases and corticosteroid stability decreases

Engineering Contradiction:
ImprovepH stabilityVSAvoidmanufacturing complexity
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The patent extracts and removes the buffer system from the formulation entirely. Instead of managing buffer-related manufacturing complexity, the invention uses a simplified alcohol-based foam base with propellant that inherently provides stability without requiring buffer management during manufacturing.

Inventive Principle:
Principle #2Taking out (Extraction)

3Productivity

If corticosteroid is added to foam composition at high temperature, then mixing efficiency improves, but corticosteroid degradation increases

Engineering Contradiction:
Improvemixing efficiencyVSAvoidcorticosteroid stability
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The invention changes the temperature parameter at which corticosteroid is incorporated into the foam base. By using lower temperatures during mixing and relying on the propellant-based foaming mechanism, the patent achieves adequate mixing efficiency while preventing thermal degradation of the corticosteroid.

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 method produces a stable, long-term corticosteroid foam with enhanced clinical efficacy and prolonged shelf life, maintaining skin hydration levels and avoiding increased transepidermal water loss, while ensuring the corticosteroid remains effective for treating skin disorders.

Implementation Method 1

charged with a propellant thereby forming a single-phase foamable composition

Methodology Applied
Scientific EffectPressure differential: Pressure Gradient

Implementation Method 2

at least one foam structuring agent comprising one or more fatty alcohols, non-ionic surfactants, or combinations thereof

Methodology Applied
Scientific EffectSurface tension: Surface Tension

Data Source

PatentUS11020407B2Corticosteroid containing foam compositions and method of manufacture thereof
Publication Date: 2021.06.01 MAYNE PHARMA LLC
  • US11020407B2 patent drawing
  • US11020407B2 patent drawing
  • US11020407B2 patent drawing

AI summary

The present invention provides a method for treating various skin diseases by topically administering to a subject a composition formulated as a foamable composition which includes a corticosteroid, such as halobetasol. The composition may include a corticosteroid, ethyl alcohol, emulsifying wax, cetostearyl alcohol, polyoxyl 20 cetostearyl ether, water, benzoic acid and propellant.