Vitamin K2 Nanoparticle Formulation for Solubility and Absorption

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Solution Overview

Problem

Existing formulations of vitamin K2, particularly MK-7, face challenges with solubility and stability, leading to poor absorption and efficacy in treating conditions associated with vitamin K deficiency, such as osteoporosis and cardiovascular diseases, especially in patients with chronic kidney disease (CKD) due to low concentrations and oxidative stress during hemodialysis.

Innovation Solution

Development of nano-sized particles of vitamin K2, specifically MK-7, stabilized for storage and administration, with sizes ranging from 0.1 nm to 1,000 nm, using homogenizers and emulsifiers to enhance solubility and bioavailability, and administered in formulations that increase serum levels and carboxylation of vitamin K-dependent proteins.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If conventional formulations of vitamin K2 (MK-7) are used, then the treatment approach is simple, but solubility and bioavailability are poor

Engineering Contradiction:

Improveformulation simplicityVSAvoidsolubility and bioavailability

Core Design Contradiction:

Ease of manufactureVSReliability

Solution Approach 1:

The patent transforms conventional vitamin K2 formulations into nanoparticle formulations with particle sizes ranging from 1 nm to 1000 nm. This parameter change in particle size dramatically improves solubility and bioavailability while maintaining formulation feasibility through established nanoparticle preparation methods

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent creates composite nanoparticle systems combining vitamin K2 with appropriate carriers or stabilizers to enhance solubility. The nanoparticle formulation acts as a composite material that improves the physical and biological properties of vitamin K2 while preserving its therapeutic function

Inventive Principle:

Principle #40Composite materials

2Stability of the object's composition

If conventional formulations of vitamin K2 (MK-7) are used, then the formulation is stable for storage, but absorption and efficacy are poor

Engineering Contradiction:

Improvestorage stabilityVSAvoidabsorption and efficacy

Core Design Contradiction:

Stability of the object's compositionVSReliability

Solution Approach 1:

The patent changes the physical state of vitamin K2 from conventional bulk form to nanoparticle form (1-1000 nm size range). This parameter change enables the formulation to maintain storage stability while dramatically improving absorption and efficacy through enhanced surface area and cellular uptake

Inventive Principle:

Principle #35Parameter changes

3Ease of operation

If standard doses of vitamin K2 are administered, then the dosage is easy to control, but serum levels and carboxylation of vitamin K-dependent proteins are insufficient

Engineering Contradiction:

Improvedosage controlVSAvoidserum levels and carboxylation efficacy

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The patent changes the delivery form to nanoparticles, which improves bioavailability and serum levels of vitamin K2. This allows for more effective carboxylation of vitamin K-dependent proteins at controlled dosages, as the nanoparticle form enhances absorption and systemic availability

Inventive Principle:

Principle #35Parameter changes

4Reliability

If vitamin K2 is administered to CKD patients undergoing hemodialysis, then the treatment addresses the condition, but oxidative stress during dialysis reduces effectiveness

Engineering Contradiction:

Improvetreatment effectivenessVSAvoidoxidative stress during hemodialysis

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The nanoparticle formulation protects vitamin K2 from oxidative degradation during hemodialysis. The nanoparticle structure serves as a protective carrier that reduces the impact of oxidative stress, maintaining the integrity and effectiveness of vitamin K2 in CKD patients undergoing dialysis

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 nano-particle formulations significantly enhance the solubility and bioavailability of vitamin K2, improving treatment outcomes for conditions like osteoporosis, vascular calcification, and CKD-related bone and cardiovascular diseases by increasing serum levels and carboxylation of proteins, thereby reducing calcification and enhancing bone mineral density.

Implementation Method 1

using homogenizers and emulsifiers to enhance solubility and bioavailability

Methodology Applied

Scientific EffectHomogenization:

Implementation Method 2

using homogenizers and emulsifiers to enhance solubility and bioavailability

Methodology Applied

Scientific EffectEmulsification: Emulsion

Implementation Method 3

improving treatment outcomes for conditions like osteoporosis, vascular calcification, and CKD-related bone and cardiovascular diseases by increasing serum levels

Methodology Applied

Scientific EffectAbsorption: Absorption (physical)