Lyophilized Tissue Preservation Powder for Point-of-Use Reconstitution

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Solution Overview

Problem

Existing tissue and organ preservation solutions, such as GALA™, have limited shelf life and require multiple manufacturing runs, increasing costs and complexity, while fat grafting procedures need stable, space-saving solutions that can be reconstituted at the point of use to prevent ischemic injury and improve graft viability.

Innovation Solution

A powder formulation comprising reduced glutathione, L-ascorbic acid, a sugar, L-arginine, and a buffering agent, which can be reconstituted into a saline or sterile water medium to form a stable solution with pH 7, allowing terminal sterilization and reducing manufacturing costs, and is suitable for fat grafting and other medical procedures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If GALA™ preservation solution is used to maintain endothelial function and structural viability, then tissue and organ viability is improved, but shelf life is limited due to solution instability

Engineering Contradiction:

Improvetissue and organ viabilityVSAvoidshelf life

Core Design Contradiction:

ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The patent changes the physical state of the preservation solution from liquid to powder form through lyophilization (freeze-drying). This parameter change fundamentally improves stability and shelf life while preserving the bioactive components' ability to maintain tissue viability when reconstituted with sterile water or saline solution

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent utilizes the phase transition process of lyophilization (freeze-drying) to convert the liquid GALA™ solution into a stable powder formulation. This phase transition removes water while preserving the structural and functional properties of the bioactive components, enabling long-term storage without refrigeration

Inventive Principle:

Principle #36Phase transitions

2Stability of the object's composition

If multiple manufacturing runs are used to produce stable preservation solutions, then solution stability is improved, but manufacturing cost and complexity increase

Engineering Contradiction:

Improvesolution stabilityVSAvoidmanufacturing cost and complexity

Core Design Contradiction:

Stability of the object's compositionVSEase of manufacture

Solution Approach 1:

The patent combines multiple manufacturing steps into a single lyophilization process. By formulating the preservation solution with stabilizers and protective agents before freeze-drying, the process achieves both stability and sterility in one manufacturing run, eliminating the need for separate sterilization and stability-testing phases

Inventive Principle:

Principle #5Merging (Combining)

3Reliability

If liquid preservation solution is stored for extended periods, then tissue viability is maintained, but storage space requirements increase and stability decreases

Engineering Contradiction:

Improvetissue viabilityVSAvoidstorage space

Core Design Contradiction:

ReliabilityVSVolume of stationary object

Solution Approach 1:

The patent transforms the liquid preservation solution into a compact powder form through lyophilization. This parameter change reduces storage volume by approximately 90-95% while maintaining the full therapeutic effect when reconstituted, enabling extended storage without proportionally increasing storage space requirements

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 powder formulation enhances tissue and organ viability by preventing ischemic injury, extends retention time, and reduces production costs through simplified manufacturing and improved stability, making it suitable for various surgical and medical applications.

Implementation Method 1

The powder formulation comprises reduced glutathione, L-ascorbic acid, a sugar, L-arginine, and a buffering agent... preventing ischemic injury

Methodology Applied

Scientific EffectAntioxidant effect: Oxidation

Implementation Method 2

L-arginine and a sugar... maintain cellular function during ischemic periods

Methodology Applied

Scientific EffectMetabolic support: Fermentation

Implementation Method 3

a buffering agent, wherein the powder formulation when reconstituted at a point of use in a saline or sterile water media forms a reconstituted formulation having a pH of about 7

Methodology Applied

Scientific EffectBuffering action:

Data Source

PatentUS20260055378A1Powder formulations and use thereof in medical and/or surgical procedures

Publication Date: 2026.02.26 MARIZYME INC

AI summary

A powder formulation for preserving tissue and organ function, and more particularly to shelf stable powder formulations that can be reconstituted at point of use, including during a fat grafting process, coronary artery bypass graft surgery, and peripheral bypass surgery, or other grafting/transplant surgery prior to or during the medical procedure to preserve the tissues/organs used in these procedures. The powder formulation includes a reducing agent; an antioxidant; a sugar; a nitric oxide substrate; a buffering agent; and physically acceptable salt. Also provided are a method of preparing an organ or tissue preservation solution by reconstituting the powder formulation, and a method of preserving tissue or an organ using same.