Biphasic Vesicle Formulation for Intracellular Antimicrobial Delivery

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Solution Overview

Problem

Current antimicrobial treatments for pathogens like Burkholderia pseudomallei, Francisella tularensis, and VEEV face challenges due to antimicrobial resistance, inefficacy in intracellular environments, and side effects from multiple antibiotic regimens, with a lack of effective vaccines and optimized delivery systems.

Innovation Solution

A method for preparing pharmaceutical-vesicle formulations using Non-Ionic Surfactant Vesicles (NISVs) that entrap antibiotics like levofloxacin and doxycycline, modified with glucosamine and transferrin to enhance delivery across barriers and target specific tissues, using automated equipment like NanoAssemblr®, resulting in biphasic formulations for improved efficacy and reduced side effects.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If combination therapy with multiple antibiotics is used to improve efficacy against B. pseudomallei, then antimicrobial effectiveness is improved, but side effects and treatment complexity increase

Engineering Contradiction:
Improveantimicrobial effectivenessVSAvoidside effects
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent combines multiple antibiotics (levofloxacin and doxycycline) into a single vesicular formulation, allowing simultaneous delivery of both agents. This merging approach maintains the synergistic antimicrobial effectiveness of combination therapy while reducing the number of separate administrations required, thereby decreasing treatment complexity and potential side effects associated with multiple separate treatments.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The vesicular formulation acts as an intermediary delivery system that encapsulates multiple antibiotics. This intermediary structure protects the antibiotics during delivery, controls their release, and facilitates their co-administration in a single therapeutic agent, thereby maintaining efficacy while reducing the harmful effects of multiple separate administrations.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If conventional antibiotic administration is used, then treatment simplicity is maintained, but efficacy against intracellular pathogens is insufficient

Engineering Contradiction:
Improvetreatment simplicityVSAvoidefficacy against intracellular pathogens
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent modifies the physical and chemical parameters of antibiotic delivery by encapsulating them in vesicles. This changes the delivery mechanism from conventional free antibiotic administration to vesicle-mediated delivery, which enhances penetration into intracellular environments while maintaining the simplicity of oral or parenteral administration. The vesicular structure allows the antibiotics to reach intracellular pathogens effectively without complicating the treatment regimen.

Inventive Principle:
Principle #35Parameter changes

3Ease of operation

If single antibiotic dosing is used to maintain treatment simplicity, then ease of administration is improved, but antimicrobial effectiveness against B. pseudomallei is insufficient

Engineering Contradiction:
Improveease of administrationVSAvoidantimicrobial effectiveness
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent merges multiple antibiotics into a single vesicular formulation that can be administered as one dose. This combining approach allows the delivery of multiple antimicrobial agents simultaneously, maintaining the ease of single-dose administration while achieving the synergistic effectiveness that would otherwise require multiple separate antibiotics.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The vesicular formulation serves multiple functions within a single therapeutic agent: it delivers multiple antibiotics, protects them during transit, facilitates cellular uptake, and enables intracellular delivery. This multi-functionality allows single-dose administration to achieve effectiveness comparable to or exceeding that of multiple separate antibiotic treatments.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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 vesicle formulations enhance cellular uptake, target pathogens effectively, reduce side effects, and maintain antimicrobial activity, demonstrating increased survival rates and reduced weight loss in animal models.

Implementation Method 1

heating vesicle components comprising a surfactant, a hydrophobic substance and an amphiphile

Methodology Applied
Scientific EffectSelf-assembly: Self-Assembly

Implementation Method 2

processing the formulation mixture to entrap the pharmaceutical agent and carrier in a vesicle

Methodology Applied
Scientific EffectEncapsulation: Absorption (physical)

Implementation Method 3

the vesicles are modified with i) glucosamine and/or ii) transferrin... recognised by an in vivo receptor-mediated transport mechanism

Methodology Applied
Scientific EffectReceptor-mediated transport:

Data Source

PatentEP3849511B1Methods for the preparation of a pharmaceutical-vesicle formulation and associated products and uses
Publication Date: 2025.12.24 THE SEC OF STATE FOR DEFENCE IN HER BRITANNIC MAJESTYS GOVERNMENT OF THE UK OF GREAT BRITAIN & NORTHERN IRELAND
  • EP3849511B1 patent drawingFigure 1
  • EP3849511B1 patent drawingFigure 2A~2B
  • EP3849511B1 patent drawingFigure 3

AI summary

The invention relates to methods for the preparation of a pharmaceutical -vesicle formulation comprising steps of: preparing and processing vesicle components and a pharmaceutical agent to entrap the pharmaceutical agent in the vesicle and form a pharmaceutical-vesicle formulation, wherein the pharmaceutical-vesicle formulation is reconstituted in a known quantity of the pharmaceutical agent dissolved in a pharmaceutically-acceptable carrier to provide a biphasic pharmaceutical-vesicle formulation. The invention also relates to the associated pharmaceutical-vesicle formulations, pharmaceutical kits and uses as a medicament, in particular for the prevention or treatment of infection by bacteria such as Burkholderia pseudomallei and Francisella tularensis, and viruses such as Venezuelan Equine Encephalitis Virus (VEEV).