Soft Capsule Composition Homogenization via Colloidal Milling

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Solution Overview

Problem

Existing compositions fail to provide a stable, non-aqueous, homogeneous dispersion of hydroxytyrosol, monacolin K, and crocin for encapsulation in soft capsules, leading to issues with aggregate formation and inconsistent delivery of active ingredients.

Innovation Solution

A method involving sieving of dried extracts to achieve uniform particle sizes, followed by dispersion in edible oil with an emulsifier, and subsequent homogenization using a colloidal mill, ensures a stable non-aqueous composition with standardized hydroxytyrosol, monacolin K, and crocin, maintaining the active ingredient percentages and stability over time.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If dried extracts are dispersed directly in edible oil, then the composition can be prepared, but aggregate formation occurs and homogeneity is poor

Engineering Contradiction:
Improvestability of dispersionVSAvoidhomogeneity of active ingredients
Core Design Contradiction:
Stability of the object's compositionVSManufacturing precision

Solution Approach 1:

The dried extracts are sieved through a 60 mesh sieve before dispersion to pre-establish uniform particle sizes. This preliminary size reduction prevents aggregate formation during subsequent mixing and ensures homogeneous distribution of active ingredients throughout the edible oil matrix.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

A colloidal mill is introduced as an intermediary device between simple mixing and final product formation. The colloidal mill's high-shear mixing action breaks down any forming aggregates and distributes extract particles uniformly throughout the oil, achieving both stability and homogeneity that simple mixing cannot provide.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of manufacture

If particle sizes are not standardized, then preparation is simpler, but active ingredient delivery is inconsistent

Engineering Contradiction:
Improvesimplicity of preparationVSAvoidconsistency of active ingredient delivery
Core Design Contradiction:
Ease of manufactureVSManufacturing precision

Solution Approach 1:

Sieving the dried extracts through a 60 mesh sieve before dispersion pre-establishes uniform particle sizes. This preliminary size control ensures that all extract particles are within a consistent size range, which promotes uniform distribution and consistent active ingredient delivery while maintaining a relatively simple preparation process.

Inventive Principle:
Principle #10Preliminary action

3Ease of manufacture

If aqueous extraction method is used, then active ingredients are easily extracted, but the composition becomes aqueous and is unsuitable for soft capsule encapsulation

Engineering Contradiction:
Improveease of extractionVSAvoidsuitability for encapsulation
Core Design Contradiction:
Ease of manufactureVSAdaptability or versatility

Solution Approach 1:

The extraction parameter is changed from aqueous to non-aqueous (using supercritical carbon dioxide). This parameter change maintains extraction effectiveness for the active ingredients while producing a non-aqueous extract that is compatible with soft capsule encapsulation requirements, eliminating the need for subsequent drying or concentration steps.

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 method results in a homogeneous, stable non-aqueous composition that retains the active ingredients' percentages, ensuring effective encapsulation and prolonged stability, providing a synergistic effect in maintaining blood cholesterol levels and protecting blood lipids from oxidative stress.

Implementation Method 1

subsequent homogenization using a colloidal mill, ensures a stable non-aqueous composition

Methodology Applied
Scientific EffectHomogenization:

Implementation Method 2

dispersion in edible oil with an emulsifier

Methodology Applied
Scientific EffectEmulsification: Emulsion

Data Source

PatentEP3773514B1Composition, in the form of a soft capsule, comprising a combination of extracts from olive fruit, red yeast rice and crocus sativus l. and method of preparing the same
Publication Date: 2022.05.04 TSETI IOULIA
  • EP3773514B1 patent drawing
  • EP3773514B1 patent drawing

AI summary

A stable non-aqueous composition comprising the unique combination of hydroxytyrosol, monacolin K and crocin, contained in standardized extracts of olive fruits, Red Yeast Rice and, Crocus Sativus L. respectively and a method for preparing the same. This composition is suitable for the preparation of a nutritional supplement in the form of a soft capsule for the protection of blood lipids from oxidative stress.