PDE5 Inhibitor and NO-Releasing Compound Combination for Pulmonary Hypertension

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Solution Overview

Problem

Current treatments for pulmonary hypertension are inadequate, leading to short life expectancy and fatal complications due to elevated pulmonary arterial pressure and associated conditions such as pulmonary edema and heart failure, with limited effective therapies available, especially for idiopathic and neonatal cases.

Innovation Solution

Administering a therapeutically effective amount of a PDE5 inhibitor, such as vardenafil, in combination with an NO-releasing compound like sodium nitrite, to induce vasodilation and reduce pulmonary arterial pressure through inhalation, either simultaneously or sequentially, to extend the half-life of the NO-releasing compound and enhance bioavailability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If current treatments for pulmonary hypertension are used, then pulmonary arterial pressure is reduced, but life expectancy remains short and fatal complications occur due to inadequate treatment effectiveness

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidlife expectancy
Core Design Contradiction:
ReliabilityVSDuration of action of moving object

Solution Approach 1:

The patent combines a PDE5 inhibitor and an NO-releasing compound into a single therapeutic regimen for pulmonary hypertension. This combination therapy addresses the inadequacy of current monotherapies by simultaneously targeting two different mechanisms: PDE5 inhibition prevents cGMP breakdown while NO release promotes vasodilation, creating a synergistic effect that improves treatment reliability and potentially extends life expectancy in patients with inadequate response to existing therapies

Inventive Principle:
Principle #5Merging (Combining)

2Productivity

If pulmonary arterial pressure is reduced through current therapies, then blood flow improves, but pulmonary edema and heart failure complications still occur

Engineering Contradiction:
Improveblood flowVSAvoidpulmonary edema and heart failure
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent changes the pharmacological parameters of pulmonary hypertension treatment by introducing a dual-mechanism approach. The PDE5 inhibitor increases cGMP levels to promote smooth muscle relaxation, while the NO-releasing compound directly donates nitric oxide to enhance vasodilation. This parameter change in therapeutic strategy aims to achieve more complete pressure reduction and blood flow improvement without the harmful complications of pulmonary edema and heart failure that occur with current therapies

Inventive Principle:
Principle #35Parameter changes

3Duration of action of moving object

If NO-releasing compounds are administered alone, then vasodilation occurs, but the half-life is short and bioavailability is limited

Engineering Contradiction:
Improvehalf-life of NO-releasing compoundVSAvoidbioavailability of NO-releasing compound
Core Design Contradiction:
Duration of action of moving objectVSQuantity of substance

Solution Approach 1:

The patent uses the PDE5 inhibitor as an intermediary to protect and extend the action of the NO-releasing compound. By inhibiting PDE5, the enzyme that breaks down cGMP, the inhibitor creates a protective effect that prolongs the half-life of the NO-releasing compound and enhances its bioavailability. This intermediary mechanism allows the NO compound to remain active longer and at higher effective concentrations, overcoming the limitations of short half-life and limited bioavailability when administered alone

Inventive Principle:
Principle #24Intermediary (Mediator)

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 combination of PDE5 inhibitors and NO-releasing compounds effectively decreases blood pressure, increases blood flow, and induces vasodilation, thereby treating pulmonary hypertension by maintaining normal pulmonary pressures and improving lung function, potentially extending life expectancy and reducing fatal complications.

Implementation Method 1

phosphodiesterase type-5 (PDE5) inhibitor

Methodology Applied
Scientific EffectPhosphodiesterase inhibition: Enzyme

Implementation Method 2

nitric oxide (NO)-releasing compound

Methodology Applied
Scientific EffectNitric oxide release: Chemical Bonding

Data Source

PatentUS20200222412A1Methods and compositions for treating pulmonary hypertension
Publication Date: 2020.07.16 UNITED THERAPEUTICS CORP

AI summary

The present disclosure provides compositions and methods for treating pulmonary hypertension. The compositions and methods are based on administering a NO-releasing compound, such as nitrite, to a subject in need thereof in an amount sufficient to increase the level of circulating nitric oxide (NO), a potent vasodilator, thereby reducing the subject's blood pressure and increasing blood flow.