Fatty Acid Ophthalmic Formulations for Gonococcal Eye Infection

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Solution Overview

Problem

Current prophylaxis and treatment options for Neisseria gonorrhoeae infections, particularly ophthalmia neonatorum, are inadequate due to rising antibiotic resistance, with existing treatments being either ineffective or causing adverse effects, and there is a need for alternative non-antibiotic solutions to prevent and treat eye infections in infants and adults.

Innovation Solution

The use of fatty acid compounds such as myristoleic acid, palmitoleic acid, and capric acid monoglyceride (monocaprin) in ophthalmic formulations as a prophylaxis or treatment for Neisseria gonorrhoeae infections, potentially combined with chelating agents to enhance efficacy and stability, formulated as eye drops, ointments, or hydrogels for ocular administration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If antibiotic-based prophylaxis (tetracycline or erythromycin) is used, then protection against N. gonorrhoeae infection is provided, but antibacterial resistance develops and treatment effectiveness decreases

Engineering Contradiction:
Improveprophylaxis effectivenessVSAvoidantibacterial resistance
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent changes the chemical parameter of the prophylaxis agent from antibiotic compounds to fatty acid compounds (specifically caprylic acid, capric acid, lauric acid, and myristic acid). This parameter change allows the prophylaxis to remain effective against N. gonorrhoeae while avoiding the development of antibacterial resistance that occurs with antibiotic-based treatments.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs simple fatty acid compounds that can be easily synthesized and formulated as ophthalmic preparations. These compounds act locally in the eye to prevent infection without requiring long-term systemic antibiotic therapy, thereby reducing the selection pressure that leads to resistance development.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

2Adaptability or versatility

If silver nitrate is used for prophylaxis, then historical treatment option is provided, but treatment-induced conjunctivitis and toxicity occur with high incidence

Engineering Contradiction:
Improveprophylaxis option availabilityVSAvoidconjunctivitis and toxicity
Core Design Contradiction:
Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces silver nitrate (an inorganic compound) with fatty acid compounds (organic compounds). This parameter change in chemical composition eliminates the toxic side effects and conjunctivitis associated with silver nitrate while maintaining prophylactic effectiveness against N. gonorrhoeae.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent converts the potential harm of using harsh chemical agents (like silver nitrate) into benefit by selecting fatty acid compounds that have inherent antimicrobial activity against N. gonorrhoeae but are gentle enough not to cause conjunctivitis or toxicity. The fatty acids naturally occur in breast milk and are biocompatible.

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

3Reliability

If current antibiotic treatments are used, then infection treatment is attempted, but multidrug-resistant cases require dual therapy and completely resistant cases exist

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidtherapy complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent extracts the core protective function from complex antibiotic regimens and implements it through simple fatty acid compounds applied topically to the eye. This extraction approach prevents infection before it establishes, eliminating the need for complex dual-antibiotic therapies required for multidrug-resistant cases.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent applies fatty acid compounds prophylactically to the newborn's eyes immediately after birth, before N. gonorrhoeae infection can establish. This preliminary action prevents the need for later complex treatments that would be required if resistance had already developed.

Inventive Principle:
Principle #10Preliminary action

4Loss of information

If prenatal screening is implemented, then infection risk is identified, but up to 40% of pregnant women who should be evaluated are not tested

Engineering Contradiction:
Improveinfection status detectionVSAvoidscreening compliance
Core Design Contradiction:
Loss of informationVSEase of operation

Solution Approach 1:

The patent makes prophylaxis universally applicable to all newborns regardless of maternal screening status. By applying fatty acid compounds to every newborn's eyes, the system eliminates the need for complex screening protocols and ensures no infant is left unprotected due to non-compliance with prenatal testing.

Inventive Principle:
Principle #25Self-service

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

These fatty acid compounds demonstrate bacteriostatic and bactericidal properties against Neisseria gonorrhoeae, are non-irritant to the eye, and retain antigonococcal activity for at least 9 months when stored at room temperature, offering a viable alternative to antibiotic-based treatments in the face of increasing resistance.

Implementation Method 1

These fatty acid compounds demonstrate bacteriostatic and bactericidal properties against Neisseria gonorrhoeae

Methodology Applied
Scientific EffectBacteriostatic and bactericidal properties:

Data Source

PatentEP3354264B1Prophylaxis and treatment of neisseria gonorrhoeae eye infection
Publication Date: 2021.06.02 KINGSTON UNIVERSTY HIGHER EDUCATION
  • EP3354264B1 patent drawingFigure 1~4
  • EP3354264B1 patent drawingFigure 5~7
  • EP3354264B1 patent drawingFigure 8~9

AI summary

Provided is the use of a fatty acid or fatty acid ester, or a pharmaceutically acceptable salt or solvate thereof, selected from capric acid C10:0 monoglyceride, undecanoic acid C11:0, lauric acid C12:0, tridecanoic acid C13:0, myristic acid C14:0, pentadecylic acid C15:0, myristoleic acid C14:1cΔ9, palmitoleic acid C16:1cΔ9, oleic acid C18:1cΔ9, elaidic acid C18:1tΔ9, erucic acid C22:1cΔ13, linoleic acid C18:2cΔ9,12, linolenic acid C18:3cΔ9,12,15, lauric acid C12:0 monoglyceride, myristic acid C14:0 monoglyceride, ricinoleic acid, lauric acid C12:0 sodium salt, and myristic acid C14:0 sodium salt, for the treatment or prophylaxis of an infection of the eye caused by Neisseria gonorrhoeae in a warm-blooded animal, particularly in a newborn human. Also provided is an ophthalmic formulation comprising the fatty acid or ester, for example an eye drop liquid, an ointment or a hydrogel.