Polymer Nanoaggregate Pharmaceutical Composition for Poorly Water Soluble Agents

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Solution Overview

Problem

Current pharmaceutical formulations struggle to effectively deliver water insoluble or poorly water soluble bioactive agents, often requiring multiple surfactants and complex emulsification processes, which are costly and challenging to scale up.

Innovation Solution

A pharmaceutical composition comprising a nanoaggregate formed from a water-soluble polymer and a water insoluble or poorly water soluble bioactive agent, where the polymer has terminal groups modified with hydrophobic and hydrophilic moieties, allowing for solubility in aqueous solutions and effective drug delivery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If multiple surfactants and complex emulsification processes are used to deliver water insoluble bioactive agents, then the delivery effectiveness is improved, but the manufacturing complexity and cost increase

Engineering Contradiction:
Improvedelivery effectivenessVSAvoidmanufacturing complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent extracts and eliminates the need for multiple surfactants and complex emulsification processes by using a single polymer conjugate that inherently provides solubility enhancement through its amphiphilic structure, thereby reducing manufacturing complexity while maintaining delivery effectiveness

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The polymer conjugate serves multiple functions simultaneously: it acts as a solubility enhancer, a delivery vehicle, and a stabilizing agent for water insoluble bioactive agents, replacing the need for multiple separate surfactants and emulsification steps

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

2Reliability

If multiple surfactants and complex emulsification processes are used, then the delivery effectiveness is improved, but the scalability and cost-effectiveness deteriorate

Engineering Contradiction:
Improvedelivery effectivenessVSAvoidscalability and cost
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The invention removes the requirement for costly and difficult-to-scale emulsification processes by employing a polymer conjugate system that achieves effective delivery through simple conjugation chemistry, enabling easier manufacturing and better scalability

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent changes the chemical parameters of the bioactive agent by conjugating it with amphiphilic polymer chains, transforming it from water insoluble to water soluble, thereby achieving effective delivery without requiring complex emulsification processes

Inventive Principle:
Principle #35Parameter changes

3Quantity of substance

If conventional formulation methods are used for water insoluble bioactive agents, then the solubility remains poor, but the manufacturing process becomes complex

Engineering Contradiction:
ImprovesolubilityVSAvoidmanufacturing process complexity
Core Design Contradiction:
Quantity of substanceVSDevice complexity

Solution Approach 1:

The patent fundamentally changes the solubility parameter of water insoluble bioactive agents by chemically conjugating them with amphiphilic polymer chains, transforming their physical-chemical properties to achieve high solubility in aqueous solutions

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention creates a composite material system where the bioactive agent is chemically bonded to amphiphilic polymer chains, combining the therapeutic properties of the drug with the solubility-enhancing properties of the polymer

Inventive Principle:
Principle #40Composite materials

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 composition achieves enhanced solubility and bioavailability of poorly water soluble bioactive agents, simplifying manufacturing processes and reducing costs by eliminating the need for complex surfactant systems.

Implementation Method 1

a water-soluble polymer and a water insoluble or poorly water soluble bioactive agent, where the polymer has terminal groups modified with hydrophobic and hydrophilic moieties

Methodology Applied
Scientific EffectAmphiphilic interaction: Amphiphiles

Implementation Method 2

A pharmaceutical composition comprising a nanoaggregate formed from a water-soluble polymer and a water insoluble or poorly water soluble bioactive agent

Methodology Applied
Scientific EffectSelf-assembly: Self-Assembly

Data Source

PatentUS20250195443A1Polymer Nanoaggregate Pharmaceutical Composition and Use Thereof
Publication Date: 2025.06.19 FULGENT GENETICS INC
  • US20250195443A1 patent drawing
  • US20250195443A1 patent drawing
  • US20250195443A1 patent drawing

AI summary

This disclosure is directed to a pharmaceutical composition for treating or preventing a disease. The pharmaceutical composition can comprise a polymer-drug nanoaggregate having a polymer and at least one bioactive agent that is water insoluble or poorly water soluble. The polymer is water soluble and comprises at least one first terminal group modified with H or a hydrophobic moiety and a second terminal group modified with a hydrophilic moiety and can be a modified symmetrically or asymmetrically branched polymers. This disclosure is also directed to a method for treating or preventing a disease including one or more immune disorders, infectious diseases and cancers using the pharmaceutical composition disclosed herein. The pharmaceutical composition can be a vaccine or an adjuvant for a vaccine.