Tranexamic Acid and Chitosan Spray for Hemostasis

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Solution Overview

Problem

There is a need for a pharmaceutical composition that can effectively treat wounds or injuries, particularly for use as a topical hemostatic composition or for surgical intervention, which current hemostatic agents do not adequately address.

Innovation Solution

A topical spray composition comprising a therapeutically effective amount of tranexamic acid and chitosan, along with excipients such as polyethylene glycol, polysorbate 80, polyvinyl pyrrolidone, and glacial acetic acid, which facilitates local administration and enhances hemostatic effects.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If conventional hemostatic agents (powdered gelatin, thrombin patches) are used, then hemostatic effect is achieved, but ease of administration and application is poor requiring manual handling and precise placement

Engineering Contradiction:

Improveease of administrationVSAvoidhemostatic effect

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The invention uses a pressurized spray canister to deliver the hemostatic composition as an aerosol mist. The pressurized gas propels the liquid composition through a nozzle, creating a fine spray that can be easily applied to wound surfaces without manual handling of powders or patches. This hydraulic/pneumatic delivery system resolves the contradiction by making administration easy while maintaining reliable hemostatic effect through controlled delivery of the active ingredients.

Inventive Principle:

Principle #29Pneumatics and hydraulics

Solution Approach 2:

The invention changes the physical state and delivery parameters of the hemostatic composition by formulating it as a sprayable aerosol rather than powder or patch. The composition is delivered as fine droplets with specific particle size distribution, creating a mist that can be evenly distributed over wound surfaces. This parameter change in delivery form resolves the contradiction between ease of administration and hemostatic reliability.

Inventive Principle:

Principle #35Parameter changes

2Reliability

If tranexamic acid is administered systemically (intravenously), then hemostatic effect is achieved, but systemic side effects occur including thrombotic risk and renal issues

Engineering Contradiction:

Improvehemostatic effectVSAvoidsystemic side effects

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention applies tranexamic acid locally at the wound site through topical spray administration rather than systemic intravenous injection. The concentrated hemostatic agent is delivered directly to the bleeding area, achieving high local concentration where needed while minimizing systemic absorption. This local quality approach resolves the contradiction by maintaining reliable hemostatic effect at the target site while reducing systemic side effects and thrombotic risk.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The spray formulation acts as an intermediary delivery system that enables local administration of tranexamic acid. The aerosol delivery mechanism serves as a mediator between the drug and the wound site, allowing controlled local application without requiring systemic circulation. This intermediary approach resolves the contradiction by achieving reliable local hemostasis while avoiding the harmful systemic effects associated with intravenous administration.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Reliability

If topical tranexamic acid is applied in high concentration, then hemostatic effect is enhanced, but stability and formulation challenges increase

Engineering Contradiction:

Improvehemostatic effectVSAvoidformulation stability

Core Design Contradiction:

ReliabilityVSStability of the object's composition

Solution Approach 1:

The invention uses a composite formulation containing tranexamic acid combined with chitosan and other excipients in a sprayable vehicle. The chitosan component provides stabilizing properties and enhances the hemostatic effect through synergistic action. This composite material approach resolves the contradiction by enabling high concentration of tranexamic acid to be formulated in a stable sprayable composition that maintains both efficacy and formulation stability.

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 effectively treats bleeding in wounds and surgical sites by promoting hemostasis, reducing bleeding time, and providing a stable and effective delivery system for tranexamic acid and chitosan.

Implementation Method 1

The sprayable composition comprises tranexamic acid and chitosan

Methodology Applied

Scientific EffectAbsorption: Absorption (physical)

Implementation Method 2

Tranexamic acid is a competitive inhibitor of plasminogen activation, and at much higher concentrations, a noncompetitive inhibitor of plasmin

Methodology Applied

Scientific EffectCompetitive inhibition: Enzyme

Data Source

PatentUS20250064720A1Tranexamic acid spray for knee arthroplasty

Publication Date: 2025.02.27 SHILPA MEDICARE LTD

AI summary

The present invention relates to novel formulations comprising a sprayable composition comprising tranexamic acid and chitosan for use in the treatment of wounds or injuries, in particular for use as a topical hemostatic composition or for surgical intervention and the process for preparation thereof.