Semi-Viscous Ear Canal Formulation for Dryness and Inflammation

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Solution Overview

Problem

Current treatments for inflammation associated with 'dry ear' or asteatosis, such as otitis externa, lack effectiveness in prevention and often cause irritation due to the use of drying solvents and pH imbalanced solutions, leading to complications in managing symptoms and infections.

Innovation Solution

A semi-viscous, lipid-based formulation containing hydrocortisone, combined with a polyhydroxy solvent base of diglycerin and 1,3-butylene glycol, along with surfactants and natural anti-inflammatory and wound-healing agents, is applied topically to address inflammation and prevent dryness in the ear canal.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If drying solvents and pH imbalanced solutions are used to treat ear inflammation, then microbial growth is controlled, but irritation and dryness of the ear canal skin worsen

Engineering Contradiction:
Improveeffectiveness in controlling microbial growthVSAvoidirritation and dryness of ear canal skin
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent changes the pH parameter of the treatment solution to match the natural pH of healthy ear canal skin (slightly acidic), and modifies the solvent composition by using mild solvents like glycerin and propylene glycol instead of harsh drying solvents. This resolves the contradiction by maintaining microbial control effectiveness while eliminating skin irritation and dryness caused by pH imbalance and excessive drying.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent uses a composite solvent system combining multiple mild solvents (glycerin, propylene glycol, water) rather than a single harsh solvent. This composite approach provides both antimicrobial effectiveness and skin moisturizing properties, resolving the contradiction between controlling microbial growth and preventing skin dryness.

Inventive Principle:
Principle #40Composite materials

2Reliability

If cortisone is applied to treat inflammation in the ear canal, then inflammation is reduced, but absorption is insufficient due to the anatomy of the ear canal

Engineering Contradiction:
Improveanti-inflammatory effectivenessVSAvoidamount of cortisone absorbed
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The patent introduces permeation enhancers as intermediary substances that facilitate the transport of cortisone through the ear canal skin barrier. These mediators temporarily modify the skin permeability or form channels that allow deeper penetration of the cortisone, resolving the contradiction between reducing inflammation and achieving sufficient absorption despite ear canal anatomy.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent modifies the physical-chemical parameters of the cortisone formulation, including using smaller molecular weight cortisone derivatives, adjusting the pH to enhance penetration, and optimizing the solvent composition to improve skin permeation. These parameter changes enable sufficient absorption of anti-inflammatory agents despite the anatomical constraints of the ear canal.

Inventive Principle:
Principle #35Parameter changes

3Ease of operation

If the ear canal skin is stripped of protective earwax coating, then discomfort is alleviated, but susceptibility to infection and desiccation increases

Engineering Contradiction:
Improverelief from discomfortVSAvoidprotection against infection and desiccation
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent formulates a treatment that restores and maintains the natural protective functions of the ear canal skin, enabling it to protect itself. The treatment includes components that replenish lipids, maintain pH balance, and promote healthy skin barrier function, allowing the ear canal to maintain its own protective coating without requiring repeated mechanical removal of earwax.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent uses a composite formulation containing multiple protective components including lipid-replenishing agents, pH-balancing buffers, and mild antimicrobials. This composite approach simultaneously provides comfort relief and restores protective functions, resolving the contradiction between alleviating discomfort and maintaining protection against infection and desiccation.

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 effectively reduces inflammation, prevents dryness, and promotes wound healing while minimizing irritation, making it suitable for individuals with hypersensitivities to antibiotics or cream-based formulations, with improved delivery and permeation of anti-inflammatory agents.

Implementation Method 1

The first component of the base liquid formulation, diglycerin (diglycerol) is a semi-viscous, sticky or glutinous, and hygroscopic lipid which is adsorbed on the skin surface and penetrates the skin.

Methodology Applied
Scientific EffectPermeation: Permeation

Implementation Method 2

In the present invention formulation, a combination of the cationic and nonionic surfactants is used for effective dispersion and delivery of anti-inflammatory hydrocortisone and for higher permeation of lipophilic ingredients

Methodology Applied
Scientific EffectSurfactant: Surfactant

Implementation Method 3

The lubricative properties of cerumen arise from the high content of the sebum produced by the sebaceous glands.

Methodology Applied
Scientific EffectLubrication: Lubrication

Data Source

PatentUS8758836B2Method and formulation for treating dry ear inflammation with cortisone
Publication Date: 2014.06.24 YOSHPE NINA S

AI summary

The present invention provides a method and formulation for treating and preventing asteatosis or “dry ear” symptoms and inflammation. The method of the present invention comprises topically applying to the ear canal a semi-viscous diglycerin and butylene glycol polyhydroxy liquid formulation including hydrocortisone, a natural product anti-irritant, a wound healing agent, and an anti-inflammatory agent, stabilized with a cationic surfactant and a nonionic surfactant.