Statin and Omega-3 Composition for Plaque Stabilization

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Solution Overview

Problem

Current treatments for cardiovascular disease (CVD) often fail to effectively reduce multiple risk factors associated with the condition, particularly in patients with omega-3 fatty acid deficiencies, leading to unstable plaques and increased risk of acute coronary syndrome (ACS) and stroke, due to limitations in existing lipid-regulating medications and dietary modifications.

Innovation Solution

A novel composition combining statins with a specific ratio of highly purified omega-3 fatty acids, primarily EPA and DHA, designed to stabilize vulnerable plaques and reduce CVD risk factors by enhancing lipid profiles and providing a sustained vasodilatory effect.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If statins are used to lower cholesterol levels, then LDL cholesterol is reduced, but vulnerable plaques remain unstable and CVD risk factors are not fully addressed

Engineering Contradiction:
Improveplaque stabilityVSAvoidCVD risk factors
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent combines statins with omega-3 fatty acids (EPA and DHA) in a single composition to achieve synergistic effects. The statin component addresses cholesterol reduction while the omega-3 component stabilizes vulnerable plaques and reduces triglycerides, thereby merging multiple therapeutic functions into one formulation that comprehensively addresses CVD risk factors.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The invention creates a composite pharmaceutical composition containing both statins and omega-3 fatty acids. This composite formulation allows the combination of drugs with different mechanisms of action to work together, providing comprehensive protection against CVD by simultaneously lowering LDL cholesterol, stabilizing plaques, and reducing triglycerides.

Inventive Principle:
Principle #40Composite materials

2Quantity of substance

If dietary modifications are recommended to increase omega-3 intake, then omega-3 levels should improve, but patient compliance is poor and optimal care is not achieved

Engineering Contradiction:
Improveomega-3 fatty acid levelsVSAvoidpatient compliance
Core Design Contradiction:
Quantity of substanceVSEase of operation

Solution Approach 1:

The patent provides a pharmaceutical composition that automatically supplies the necessary omega-3 fatty acids (EPA and DHA) to patients, eliminating the need for them to independently modify their diets. The formulation self-provides the therapeutic nutrients, ensuring consistent omega-3 levels without relying on patient compliance with dietary changes.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The pharmaceutical composition acts as an intermediary between the recommended dietary intake and actual patient consumption. Instead of relying on patients to voluntarily increase omega-3 intake through diet, the medication serves as a mediator that delivers the necessary nutrients reliably, bridging the gap between medical advice and patient behavior.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Adaptability or versatility

If existing lipid-regulating medications are used, then cholesterol levels are managed, but multiple CVD risk factors cannot be effectively reduced simultaneously

Engineering Contradiction:
Improverisk factor reduction capabilityVSAvoideffectiveness in reducing risk factors
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The patent creates a multi-functional pharmaceutical composition that simultaneously addresses multiple CVD risk factors: LDL cholesterol reduction (via statin), triglyceride reduction (via omega-3), and plaque stabilization (via omega-3). This universal formulation can manage multiple risk factors concurrently, making it adaptable to patients with complex profiles requiring comprehensive cardiovascular protection.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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 therapy effectively increases omega-3 levels, stabilizes vulnerable plaques, reduces triglycerides, and improves lipid profiles, thereby lowering the risk of ACS and stroke, with a sustained vasodilatory effect lasting at least 6 hours, as demonstrated by increased EPA, DHA, and DPA levels and improved clinical outcomes in clinical studies.

Implementation Method 1

The combination is effective for correcting omega-3 deficiencies in patients in need thereof, thereby providing a mechanism for stabilizing vulnerable plaques, and thereby reducing the incidence of ACS and stroke

Methodology Applied
Scientific EffectAnti-inflammatory mechanism:

Implementation Method 2

higher levels of lipid oxidation products creating plaques and streaks which cause blockages of coronary arteries

Methodology Applied
Scientific EffectAntioxidant mechanism:

Implementation Method 3

one or more statins (or HMG-CoA reductase inhibitors), a class of drug used to lower cholesterol levels by inhibiting the enzyme HMG-CoA reductase

Methodology Applied
Scientific EffectEnzyme inhibition: Enzyme

Implementation Method 4

a composition having an EPA:DHA:DPA ratio and level of omega-3 purity which enable them to be effective in stabilizing vulnerable plaque while providing a sustained vasodilatory effect, defined as a vasodilatory effect lasting at least 6 hours

Methodology Applied
Scientific EffectVasodilation:

Data Source

PatentUS9248138B2Process and composition for stabilization of vulnerable plaque utilizing a combination of a statin and omega 3 fatty acids
Publication Date: 2016.02.02 PIVOTAL THERAPEUTICS

AI summary

A composition and a method of treatment utilizing a combination of statins (or HMG-CoA reductase inhibitors), a class of drug used to lower cholesterol levels by inhibiting the enzyme HMG-CoA reductase, with mixtures of an omega-3 fatty acid formulation containing about 90% or more omega 3 fatty acids by weight including a combination of Eicosapentaenoic acid (EPA), Docosapentaenoic acid (DPA) and Docosahexaenoic acid (DHA) in a weight ratio of EPA:DHA of from 5.7 to 6.3, wherein the sum of the EPA, DHA and DPA represent about 82% by weight of the total formulation and about 92% of the total omega 3 fatty acid content of the composition, the compositions and method designed to stabilize vulnerable plaque while mediating omega-3 deficiencies in individuals in need thereof.