Vitamin K Microcapsules in Hydrocolloid Matrices

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Solution Overview

Problem

Vitamin K1 and K2 compounds are prone to degradation when formulated with mineral salts like calcium or magnesium, leading to significant losses during processing and storage, especially in conventional dosage forms such as tablets.

Innovation Solution

Microencapsulation of vitamin K compounds in a hydrocolloid matrix, combined with dietary minerals, to create stable microcapsules that maintain stability during processing and storage, even in the presence of calcium or magnesium salts.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If vitamin K compounds are formulated with mineral salts like calcium or magnesium in conventional dosage forms, then the product can be manufactured and administered easily, but the vitamin degrades rapidly during processing and storage

Engineering Contradiction:

Improveease of formulationVSAvoidstability

Core Design Contradiction:

Ease of manufactureVSReliability

Solution Approach 1:

The patent introduces an intermediary substance (microencapsulation material such as gelatin, albumin, or starch) that mediates between the vitamin K compound and the mineral salts. This encapsulation layer prevents direct contact between the vitamin and degrading agents (calcium/magnesium salts, moisture, light), thereby maintaining stability while allowing the formulation to proceed with conventional mineral salt inclusion.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent employs thin film encapsulation where the vitamin K compound is enclosed in a protective shell or coating made of materials like gelatin, albumin, or starch. This flexible shell protects the vitamin from degradation by mineral salts, moisture, and light during processing and storage, while still allowing the product to be formulated as conventional dosage forms.

Inventive Principle:

Principle #30Flexible shells and thin films

2Device complexity

If vitamin K compounds are exposed to light and air during processing and storage, then the manufacturing and storage process is simple, but the vitamin degrades significantly

Engineering Contradiction:

Improvecomplexity of storage conditionsVSAvoidvitamin degradation

Core Design Contradiction:

Device complexityVSLoss of substance

Solution Approach 1:

The patent uses thin film encapsulation with materials like gelatin, albumin, or starch to create a protective barrier around the vitamin K compound. This shell shields the vitamin from light and air exposure during processing and storage, preventing oxidation and photodegradation without requiring complex storage conditions.

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The patent creates an inert microenvironment within the encapsulation structure, isolating the vitamin K compound from reactive atmospheric components (oxygen, moisture, light). This effectively provides an inert atmosphere protection without requiring external inert gas environments or specialized storage facilities.

Inventive Principle:

Principle #39Inert atmosphere (Inert environment)

3Productivity

If conventional preparations containing vitamin K are used, then the formulation process is straightforward, but significant vitamin loss occurs during processing

Engineering Contradiction:

Improveprocessing efficiencyVSAvoidvitamin loss

Core Design Contradiction:

ProductivityVSLoss of substance

Solution Approach 1:

The patent applies preliminary action by pre-encapsulating the vitamin K compound in protective shells made of gelatin, albumin, or starch before the formulation process. This pre-protection ensures that the vitamin is already shielded from degradation agents during subsequent processing steps, minimizing loss while maintaining straightforward formulation procedures.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The encapsulation material serves as an intermediary that prevents direct interaction between the vitamin K compound and degrading factors during processing. This mediator layer allows conventional processing methods to be used while significantly reducing vitamin loss through the protective barrier.

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 microencapsulation process significantly improves the stability and storage properties of vitamin K compounds, preventing rapid degradation and maintaining effectiveness in formulations where light and air exposure are common, such as in tablets.

Implementation Method 1

microcapsules comprising at least one fat-soluble active substance selected from a vitamin K compound or a provitamin or a prodrug of a vitamin K compound embedded in a matrix comprising a hydrocolloid

Methodology Applied

Scientific EffectAbsorption: Absorption (physical)

Data Source

PatentUS11090276B2Formulation of fat-soluble vitamin

Publication Date: 2021.08.17 BASF SE

AI summary

The invention relates to a composition comprising A) microcapsules comprising at least one fat-soluble active substance selected from a vitamin K compound or a provitamin or a prodrug of a vitamin K compound embedded in a matrix comprising a hydrocolloid and optionally one or more other matrix components, and B) at least one dietary mineral; as well as uses and products comprising such compositions.