DA-DKP Extraction for Respiratory Inflammation Treatment

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Solution Overview

Problem

Current treatments for viral respiratory diseases, such as COVID-19, are inadequate in addressing severe inflammation and respiratory distress, leading to prolonged symptoms and complications like ARDS, with no approved treatments for ARDS and limited effectiveness in managing post-COVID symptoms.

Innovation Solution

A pharmaceutical composition comprising DA-DKP, prepared by removing albumin from a human serum albumin composition, is administered to reduce lung inflammation, vascular permeability, and inflammatory signaling proteins, and increase lung prostaglandins, either nebulized or intravenously, to treat viral respiratory diseases and associated inflammation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If current treatments for viral respiratory diseases are used, then general symptom management is provided, but severe inflammation and respiratory distress are not adequately addressed

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidsevere inflammation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent extracts and isolates specific bioactive components ( diketopiperazines, particularly Asp-Ala-DKP) from human serum albumin through a multi-step purification process involving acidification, ultrafiltration, and chromatography. This extraction enables the use of the therapeutic agent without the bulk albumin protein, concentrating the anti-inflammatory active ingredients for targeted treatment of severe respiratory inflammation.

Inventive Principle:
Principle #2Taking out (Extraction)

2Reliability

If no specific treatment for ARDS is available, then standard care is provided, but mortality and prolonged symptoms persist

Engineering Contradiction:
Improvemortality reductionVSAvoidprolonged symptoms
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent employs preliminary action by administering the DA-DKP composition early in the disease course to prevent the development of severe ARDS and its associated complications. The treatment is designed to be given before irreversible lung damage occurs, thereby reducing mortality and preventing prolonged symptoms rather than treating established severe disease.

Inventive Principle:
Principle #10Preliminary action

3Quantity of substance

If albumin-containing solutions are used, then protein delivery is achieved, but the active therapeutic components are diluted and less effective

Engineering Contradiction:
Improveactive component concentrationVSAvoidpurification process
Core Design Contradiction:
Quantity of substanceVSDevice complexity

Solution Approach 1:

The patent applies extraction by removing the bulk albumin protein while retaining and concentrating the smaller diketopiperazine molecules through acidification followed by ultrafiltration using membranes with specific molecular weight cutoffs. This separates the active therapeutic components from the inactive bulk protein, achieving high concentration of the therapeutic agent.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent applies local quality by creating different functional zones in the purification process: the acidification step precipitates albumin while leaving diketopiperazines in solution, ultrafiltration membranes with specific pore sizes selectively retain or pass different molecular sizes, and chromatography columns provide final purification. Each step creates local conditions optimized for separating specific components.

Inventive Principle:
Principle #3Local quality

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 reduces ventilator time, mortality, and improves oxygenation parameters, with significant clinical improvements in respiratory symptoms and pulmonary function, as demonstrated by improved World Health Organization ordinal scale scores and reduced inflammatory markers.

Implementation Method 1

The composition effectively reduces ventilator time, mortality, and improves oxygenation parameters, with significant clinical improvements in respiratory symptoms and pulmonary function, as demonstrated by improved World Health Organization ordinal scale scores and reduced inflammatory markers.

Methodology Applied
Scientific EffectAnti-inflammatory effect:

Data Source

PatentUS11278598B2Methods for treating diseases associated with respiratory viruses
Publication Date: 2022.03.22 AMPIO PHARMACEUTICALS INC

AI summary

The present disclosure provides a method of treating a disease associated with a respiratory virus. The method comprises administering an effective amount of a pharmaceutical composition prepared by removing albumin from a solution of a human serum albumin composition and/or comprising a diketopiperazine with amino acid side chains of aspartic acid and alanine (DA-DKP), such as a low molecular weight fraction of human serum albumin. The present disclosure also provides a pharmaceutical product as well as a kit comprising DA-DKP.