Lipid Nanoparticle Formulations for Nucleic Acid Delivery

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Solution Overview

Problem

The delivery of nucleic acids, such as siRNA and oligonucleotides, faces challenges including enzymatic degradation, immune activation, off-target cytotoxicity, and inefficient endosomal release, limiting their clinical translation due to instability and poor targeting.

Innovation Solution

Lipid nanoparticles comprising a combination of cationic lipids with tertiary and quaternary amine headgroups, peptides like gramicidin, and RNase-degrading agents like proteinase K, which enhance transfection efficiency and stability, while maintaining colloidal stability and targeted delivery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If cationic lipids with high positive charge are used to enhance nucleic acid binding and cellular uptake, then transfection efficiency is improved, but cytotoxicity increases

Engineering Contradiction:
Improvetransfection efficiencyVSAvoidcytotoxicity
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent adjusts the charge density parameter of cationic lipids by using mixtures with different headgroup charges (quaternary vs tertiary amines) and controlling the lipid-to-nucleic acid ratio. This optimization allows achieving sufficient transfection efficiency while reducing excessive positive charge that causes cytotoxicity.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs composite lipid formulations combining multiple cationic lipid types (quaternary and tertiary amines) with different properties. This composite approach balances the high charge density needed for transfection with reduced cytotoxicity through the complementary characteristics of different lipid components.

Inventive Principle:
Principle #40Composite materials

2Adaptability or versatility

If nucleic acids are delivered systemically to reach target cells, then therapeutic coverage is improved, but enzymatic degradation by nucleases increases

Engineering Contradiction:
Improvesystemic delivery capabilityVSAvoidnucleic acid stability
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The patent uses cationic lipids as intermediary carriers that form stable complexes with nucleic acids. These lipid-nucleic acid complexes protect the nucleic acids from nuclease degradation while enabling systemic circulation and delivery to target cells.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The lipid formulation creates a protective shell around the nucleic acid payload. This flexible lipid layer shields the vulnerable nucleic acid from enzymatic degradation in the bloodstream while allowing cellular uptake and endosomal release.

Inventive Principle:
Principle #30Flexible shells and thin films

3Ease of operation

If LNs are taken up by endocytosis to enter cells, then cellular delivery is improved, but endosomal degradation of encapsulated drug occurs

Engineering Contradiction:
Improvecellular uptake efficiencyVSAvoiddrug release efficiency
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent utilizes pH-dependent parameter changes of tertiary amine-cationic lipids. These lipids remain neutral at extracellular pH but become positively charged in the acidic endosomal environment, triggering membrane disruption and drug release while maintaining cellular uptake efficiency.

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 lipid nanoparticle formulations achieve high transfection efficiency, reduce cytotoxicity, and provide stable, targeted delivery of therapeutic agents, including nucleic acids, with improved serum stability and pH-dependent release mechanisms.

Implementation Method 1

Lipid nanoparticles comprising a combination of cationic lipids with tertiary and quaternary amine headgroups

Methodology Applied
Scientific EffectElectrostatic interaction: Electrostatics

Implementation Method 2

peptides like gramicidin

Methodology Applied
Scientific EffectIon channel formation:

Implementation Method 3

RNase-degrading agents like proteinase K

Methodology Applied
Scientific EffectProteolytic degradation: Enzyme

Implementation Method 4

pH-dependent release mechanisms

Methodology Applied
Scientific EffectpH-dependent phase transition: Phase Change

Data Source

PatentEP2852381B1Lipid nanoparticle compositions and methods of making and methods of using the same
Publication Date: 2020.10.07 THE OHIO STATES UNIV
  • EP2852381B1 patent drawingFigure 1
  • EP2852381B1 patent drawingFigure 2
  • EP2852381B1 patent drawingFigure 3

AI summary

Lipid nanoparticle formulations, methods of making, and methods of using same are disclosed.