IV Microparticle Formulation for Stable Suspension and Anti-Clumping

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Existing intravenous therapy formulations face challenges in maintaining therapeutic microparticles in suspension for extended periods without aggregation, which can lead to blood clotting, blockages, and other serious health issues.

Innovation Solution

A formulation comprising sodium carboxymethyl cellulose, poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol) polymer, and mannitol, along with therapeutic microparticles, is developed to stabilize microparticles for at least 90 minutes, using FDA-approved ingredients.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Speed

If therapeutic microparticles are administered via intravenous therapy, then the drug can be delivered directly into the circulatory system for fast and controlled administration, but the microparticles may settle or form clumps before or during injection, leading to blood clotting, blockages, strokes, and heart failure

Engineering Contradiction:

Improveadministration speedVSAvoidsuspension stability

Core Design Contradiction:

SpeedVSReliability

Solution Approach 1:

The patent introduces a formulation system comprising multiple components (surfactants, viscosity-modifying agents, buffers, and stabilizers) that act as intermediaries between the microparticles and the intravenous administration system. These components collectively prevent microparticle aggregation and settling while maintaining compatibility with blood circulation, thereby enabling fast IV administration without the risk of clumping or blockages

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The invention employs a composite formulation system that combines multiple functional components: surfactants (e.g., polysorbate 80, poloxamer 188) for surface stabilization, viscosity-modifying agents (e.g., hydroxypropyl methylcellulose, carboxymethyl cellulose) for suspension maintenance, and buffers (e.g., phosphate buffer, citrate buffer) for pH control. This composite approach allows the formulation to simultaneously achieve fast administration, long-term suspension stability (≥30 minutes), and biocompatibility

Inventive Principle:

Principle #40Composite materials

2Ease of manufacture

If the intravenous formulation is prepared in advance under practical hospital or pharmacy conditions, then the formulation can be ready for administration, but the microparticles must remain suspended for at least 30 minutes under these working conditions

Engineering Contradiction:

Improveformulation preparationVSAvoidsuspension duration

Core Design Contradiction:

Ease of manufactureVSDuration of action of moving object

Solution Approach 1:

The patent optimizes multiple formulation parameters to achieve both ease of preparation and extended suspension duration. Key parameter adjustments include: surfactant concentrations (0.01-5% w/v) to prevent aggregation, viscosity modifiers at specific concentrations (0.1-5% w/v) to maintain suspension without requiring complex preparation equipment, and pH buffering (pH 6.0-8.0) to ensure stability under hospital storage conditions. These parameter optimizations enable simple mixing procedures while guaranteeing ≥30 minutes of stable suspension

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The formulation components serve multiple functions simultaneously: surfactants provide both surface stabilization and solubility enhancement, viscosity-modifying agents contribute to suspension stability and formulation viscosity control, and buffers maintain pH while also acting as stabilizers. This multi-functionality simplifies the overall formulation preparation process while ensuring prolonged suspension stability under practical hospital or pharmacy conditions

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 formulation effectively suspends therapeutic microparticles for up to 2.5 hours, ensuring safe and stable intravenous administration, reducing the risk of clumping and associated health risks.

Implementation Method 1

The present disclosure provides formulations for suspending therapeutic microparticles and methods of making and using the same

Methodology Applied

Scientific EffectSuspension: Suspension

Implementation Method 2

Methodology Applied

Scientific EffectStabilization:

Implementation Method 3

The formulation effectively suspends therapeutic microparticles for up to 2.5 hours, ensuring safe and stable intravenous administration, reducing the risk of clumping and associated health risks

Methodology Applied

Scientific EffectSuspension: Suspension

Data Source

PatentUS12465569B2Microparticle formulations for intravenous therapy and methods for their manufacture and use

Publication Date: 2025.11.11 THE METHODIST HOSPITAL

AI summary

The present disclosure provides methods and formulations for therapeutic microparticles, wherein formulations are used for administering therapeutic microparticles to subjects by way of intravenous injection. Also, provided are methods of administering therapeutic microparticles to subjects in need thereof. The formulations provide stability and prevent settling and clumping of therapeutic microparticles in solution up to 3 hours.