Boronic Acid Esters for Stable Liposomal Formulations

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Solution Overview

Problem

Current liposomal formulations of boronic acid compounds, such as bortezomib, face challenges with low encapsulation efficacy, complex preparation methods, and poor stability, leading to high toxicity and short therapeutic use due to rapid clearance and limited shelf life.

Innovation Solution

Development of boronic acid esters that form stable liposomal formulations with improved encapsulation and release properties, using specific compounds defined by Formula I and II, which include a polyol moiety and a lipid component, enhancing stability and therapeutic efficacy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If passive entrapment methods are used to prepare liposomal formulations of boronic acid compounds, then the preparation process is simple, but the encapsulation efficacy is very low (lower than 15%)

Engineering Contradiction:
Improvepreparation process simplicityVSAvoidencapsulation efficacy
Core Design Contradiction:
Ease of manufactureVSManufacturing precision

Solution Approach 1:

The patent applies preliminary action by modifying the boronic acid compound with a lipophilic moiety before liposome formation. This pre-modification enables the compound to be incorporated into the liposomal structure during the formation process itself, achieving high encapsulation efficacy without requiring complex post-formation loading steps. The lipophilic modification allows the compound to partition into the lipid bilayer during liposome assembly, resolving the contradiction between simple preparation and high encapsulation.

Inventive Principle:
Principle #10Preliminary action

2Manufacturing precision

If remote loading methods are used to increase encapsulation efficacy, then the encapsulation can be driven by pH and chemical gradient, but the process becomes complex and requires overnight incubation

Engineering Contradiction:
Improveencapsulation efficacyVSAvoidpreparation process complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The invention performs the encapsulation action during the liposome formation process itself rather than requiring a separate loading step. By designing the boronic acid compound with a lipophilic moiety, the compound is incorporated into liposomes as they form, eliminating the need for complex remote loading procedures with overnight incubation. This preliminary incorporation during formation resolves the contradiction between high encapsulation efficacy and process simplicity.

Inventive Principle:
Principle #10Preliminary action

3Duration of action of moving object

If liposomal formulations of boronic acid compounds are prepared using conventional methods, then they can provide prolonged systemic circulation time, but the stability during lyophilization is poor leading to leakage

Engineering Contradiction:
Improvesystemic circulation timeVSAvoidlyophilization stability
Core Design Contradiction:
Duration of action of moving objectVSStability of the object's composition

Solution Approach 1:

The patent creates a composite structure by conjugating the boronic acid compound with a lipophilic moiety that integrates it into the liposomal lipid bilayer. This composite approach ensures the compound is structurally incorporated into the liposome rather than merely trapped in the aqueous core, providing stability during lyophilization while maintaining the prolonged circulation benefits of liposomal formulation. The lipophilic integration prevents leakage during dehydration and rehydration processes.

Inventive Principle:
Principle #40Composite materials

4Reliability

If free boronic acid compounds are administered clinically, then they can achieve therapeutic effects, but they exhibit high toxicity, non-specific tissue uptake, side effects, and rapid clearance

Engineering Contradiction:
Improvetherapeutic effectivenessVSAvoidtoxicity and side effects
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies the nesting principle by placing the boronic acid compound inside a liposomal carrier structure. The liposome acts as a protective container that delivers the therapeutic agent to the target site while shielding it from non-specific tissue uptake and rapid clearance. This nested structure maintains therapeutic effectiveness while reducing toxicity and side effects associated with free compound administration.

Inventive Principle:
Principle #7Nested doll (Nesting)

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 boronic acid ester formulations demonstrate enhanced stability during lyophilization and prolonged systemic circulation, reducing toxicity and increasing the shelf life of boronic acid therapeutic agents, while maintaining therapeutic effectiveness.

Implementation Method 1

Liposomes are spherical vesicles made of a lipid bilayer (e.g., a phospholipid bilayer) that are capable of encapsulating hydrophilic drugs in their aqueous core or hydrophobic drugs within their lipid bilayer.

Methodology Applied
Scientific EffectLiposomal encapsulation: Emulsion

Implementation Method 2

In order to further increase the shelf-life of liposomes, lyophilization has been utilized.

Methodology Applied
Scientific EffectLyophilization: Freeze Drying

Data Source

PatentEP3102585B1Boronic acid esters and pharmaceutical formulations thereof
Publication Date: 2021.05.19 OHIO STATE INNOVATION FOUND
  • EP3102585B1 patent drawingFigure 1~2
  • EP3102585B1 patent drawingFigure 3~4
  • EP3102585B1 patent drawingFigure 5~6

AI summary

Provided herein are boronic acid esters of boronic acid therapeutic agents, such as bortezomib. The boronic acid esters can be used to prepare liposomal formulations of boronic acid therapeutic agents with improved properties, such as enhanced stability. This disclosure, in one aspect, relates to compositions and methods of making and using the compositions.