Needleless Liquid Pharmaceutical Composition Using Osmotic Pressure

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Solution Overview

Problem

Existing needleless injectors using combustion energy for drug delivery face challenges such as side effects from viral vectors and lipid nanoparticles, and complex machinery issues with electroporation, necessitating a technique that achieves high physiological activity without injection needles.

Innovation Solution

A liquid pharmaceutical composition with an osmotic pressure between 400 mOsmol/kg and 1000 mOsmol/kg, injected using an injector without needles, containing biofunctional substances like nucleic acids or proteins, utilizing osmotic pressure to enhance delivery efficacy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If viral vectors or lipid nanoparticles are used for drug delivery, then delivery efficiency to cell cytosol is improved, but side effects such as anaphylaxis occur

Engineering Contradiction:
Improvedelivery efficiencyVSAvoidside effects
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent extracts and eliminates the harmful components (viral vectors and lipid nanoparticles) from the drug delivery system while retaining the core function of delivering nucleic acids to the cell cytosol. This is achieved by using a needleless injector that directly injects the pharmaceutical composition without requiring these problematic carriers.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent employs a disposable needleless injector system that replaces complex, potentially harmful delivery vehicles with a simple, single-use injection device. This eliminates the need for viral vectors or lipid nanoparticles that cause immune reactions, while maintaining effective drug delivery through controlled injection parameters including osmotic pressure optimization.

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

2Productivity

If electroporation is used for nucleic acid delivery, then delivery to cell cytosol is achieved, but local toxicity and complex machinery are required

Engineering Contradiction:
Improvedelivery efficiencyVSAvoidmachinery complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The patent replaces the complex electroporation machinery with a simpler mechanical needleless injection system. Instead of using electrical fields to facilitate nucleic acid entry into cells, the invention uses a mechanically actuated injector that delivers the pharmaceutical composition directly through the skin and into the target tissue, eliminating the need for complex electrical equipment.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent extracts and removes the complex electroporation apparatus from the drug delivery system, retaining only the essential function of nucleic acid delivery to the cell cytosol through a simplified injection mechanism that uses optimized osmotic pressure and needleless injection technology.

Inventive Principle:
Principle #2Taking out (Extraction)

3Productivity

If osmotic pressure is increased to improve substance permeability, then delivery efficacy is improved, but risk of tissue damage increases

Engineering Contradiction:
Improvedelivery efficacyVSAvoidtissue damage
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent optimizes the osmotic pressure parameter of the pharmaceutical composition to a specific range (400-1000 mOsmol/kg) that balances delivery efficacy with tissue safety. This parameter optimization allows the composition to effectively penetrate tissue and reach the cell cytosol while minimizing the risk of osmotic shock or tissue damage that would occur with higher pressures.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent incorporates buffering agents and osmotic regulators in the pharmaceutical composition before injection to cushion and mitigate potential tissue damage from pressure changes. These pre-formulated protective components ensure that even under increased osmotic pressure conditions, the surrounding tissues are protected from adverse effects while maintaining effective drug delivery.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

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 solution achieves higher physiological activity in the injection target by optimizing osmotic pressure, improving substance permeability and retention, and reducing adverse effects.

Implementation Method 1

the liquid pharmaceutical composition has an osmotic pressure of more than 400 mOsmol/kg and 1000 mOsmol/kg or less

Methodology Applied
Scientific EffectOsmotic pressure: Osmotic Pressure

Data Source

PatentUS20250339364A1Liquid pharmaceutical composition
Publication Date: 2025.11.06 DAICEL CORP
  • US20250339364A1 patent drawing
  • US20250339364A1 patent drawing
  • US20250339364A1 patent drawing

AI summary

The present disclosure provides a liquid pharmaceutical composition containing a biofunctional substance, an injector to inject the same, and a method of injecting the same.