1,4-Dihydropyridine Compositions for Chelation-Based Oxidation Control

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Solution Overview

Problem

Calcium channel blockers, particularly 1,4-dihydropyridines, are susceptible to oxidation, forming pyridine analogues with lower calcium channel blocking activity and increased toxicological effects, leading to product recalls and decreased therapeutic efficacy.

Innovation Solution

The inclusion of a chelating agent in pharmaceutical compositions comprising 1,4-dihydropyridines stabilizes the compounds, reducing the formation of pyridine analogues and maintaining therapeutic effectiveness by forming stable, ready-to-use injectable formulations.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If 1,4-dihydropyridine compounds are used as calcium channel blockers, then therapeutic efficacy is achieved, but oxidation occurs forming pyridine analogues with lower activity and increased toxicity

Engineering Contradiction:
Improvetherapeutic efficacyVSAvoidoxidation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

A chelating agent is introduced as an intermediary substance that binds to metal ions, preventing them from catalyzing the oxidation of the 1,4-dihydropyridine compound. This mediator approach directly addresses the oxidation problem while preserving the therapeutic efficacy of the DHP.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The invention creates a chemically inert environment by incorporating a chelating agent that sequesters metal ions, effectively removing the catalytic metals that would otherwise promote oxidation. This inerting approach protects the DHP compound from oxidation without affecting its biological activity.

Inventive Principle:
Principle #39Inert atmosphere (Inert environment)

2Stability of the object's composition

If chelating agent is added to stabilize the 1,4-dihydropyridine compound, then oxidation is prevented, but composition complexity increases

Engineering Contradiction:
Improvecompound stabilityVSAvoidcomposition complexity
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The invention optimizes the concentration parameter of the chelating agent to a specific range (0.01-10% w/v) where sufficient stabilization occurs without excessive complexity. This parameter optimization balances stability improvement with compositional simplicity.

Inventive Principle:
Principle #35Parameter changes

3Ease of operation

If pharmaceutical compositions are made ready-to-use without dilution, then ease of operation is improved, but stability over time deteriorates

Engineering Contradiction:
Improveease of useVSAvoidshelf life
Core Design Contradiction:
Ease of operationVSDuration of action of stationary object

Solution Approach 1:

The chelating agent is pre-added to the formulation during manufacturing, creating a stable foundation before use. This preliminary stabilization allows the product to maintain its integrity and activity throughout storage and administration without requiring dilution or special handling.

Inventive Principle:
Principle #10Preliminary action

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 compositions demonstrate improved stability and reduced impurities, ensuring prolonged efficacy and safety for treating cardiovascular disorders without the need for dilution before use.

Implementation Method 1

The inclusion of a chelating agent in pharmaceutical compositions comprising 1,4-dihydropyridines stabilizes the compounds, reducing the formation of pyridine analogues

Methodology Applied
Scientific EffectChelation:

Implementation Method 2

a class of calcium channel blockers, namely 1,4-dihydropyridines ('DHPs'), are susceptible to oxidation of the dihydropyridine ring to the pyridine ring

Methodology Applied
Scientific EffectOxidation prevention: Oxidation

Data Source

PatentUS12440482B21,4-dihydropyridine compositions, methods of making and use
Publication Date: 2025.10.14 AMERICAN REGENT INC

AI summary

Provided herein are pharmaceutical compositions comprising a class of calcium channel blockers and at least one chelating agent. More specifically, the pharmaceutical compositions comprise at least one 1,4-dihydropyridine (DHP) compound and at least one chelating agent. The chelating agents used in this disclosure can decrease the degradation of the constituent DHPs of the DHP compositions. The DHP compositions can be used to treat cardiovascular disorders and are more stable for prolonged periods of time.