Stable High Lipid Ketogenic Formula via Casein Stabilization

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Solution Overview

Problem

Current ketogenic diet formulations for tube feeding are unstable, prone to phase separation, and have limited viscosity, making them unsuitable for long-term storage and administration, especially in small tubes, which can lead to clogging and incomplete nutrition.

Innovation Solution

A sterile liquid composition with a high lipid content (>80% of total calories) stabilized by a protein-fibre blend of casein, resistant starch, soy fibre, and inulin, which prevents precipitation and phase separation, maintaining stability for over 6 months and suitable for tube feeding.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If high lipid content (>80% of total calories) is used in ketogenic diet formulation, then therapeutic effectiveness for refractory epilepsy is improved, but phase separation and instability occur

Engineering Contradiction:
Improvetherapeutic effectivenessVSAvoidphase separation
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent uses casein as an intermediary substance to stabilize the high-lipid emulsion. Casein forms a protective film around lipid droplets, preventing phase separation while maintaining the required >80% lipid content for therapeutic effectiveness in refractory epilepsy treatment.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The invention creates a composite emulsion system combining lipid, casein, and dietary fibre. This composite structure leverages the emulsifying properties of casein and the stabilizing effects of fibre to maintain homogeneity in high-lipid formulations, resolving the contradiction between high lipid content and stability.

Inventive Principle:
Principle #40Composite materials

2Stability of the object's composition

If thickeners are added to prevent sedimentation of insoluble ingredients, then stability is improved, but viscosity increases beyond acceptable range for tube feeding

Engineering Contradiction:
Improvesedimentation preventionVSAvoidviscosity
Core Design Contradiction:
Stability of the object's compositionVSEase of operation

Solution Approach 1:

The patent replaces conventional thickeners with a natural stabilizing system using casein and dietary fibre. This approach achieves sedimentation prevention without the excessive viscosity increase associated with traditional thickening agents, maintaining ease of administration through small-bore tubes.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

3Stability of the object's composition

If powder compositions are used instead of ready-to-use liquid, then storage stability is improved, but preparation complexity and potential for errors increase

Engineering Contradiction:
Improvestorage stabilityVSAvoidpreparation complexity
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The patent applies preliminary stabilization actions during manufacturing by incorporating casein and dietary fibre into the liquid formulation. This pre-stabilization allows the product to maintain stability in ready-to-use liquid form without requiring complex preparation procedures, eliminating both storage and preparation complexity issues.

Inventive Principle:
Principle #10Preliminary action

4Reliability

If high lipid content is used to achieve ketogenic effect, then therapeutic benefit is improved, but risk of tube clogging increases

Engineering Contradiction:
Improvetherapeutic benefitVSAvoidtube clogging risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

Casein acts as an intermediary that prevents lipid aggregation and sediment formation. The casein-coated lipid emulsion maintains fluidity and homogeneity, preventing tube clogging while preserving the high lipid content necessary for ketogenic therapeutic benefit.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The composite emulsion system combining lipid, casein, and dietary fibre creates a stable homogeneous mixture that resists phase separation and sedimentation. This composite structure prevents tube clogging while maintaining >80% lipid content for effective ketogenic therapy.

Inventive Principle:
Principle #40Composite materials

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 composition provides a stable, shelf-stable, and convenient form of ketogenic diet for patients, reducing the risk of clogging and ensuring balanced nutrition, while also addressing gastrointestinal issues associated with traditional ketogenic diets.

Implementation Method 1

a stable emulsion of a ketogenic diet

Methodology Applied
Scientific EffectEmulsion: Emulsion

Implementation Method 2

prevents precipitation and phase separation

Methodology Applied
Scientific EffectSuspension: Suspension

Data Source

PatentUS8975222B2Stable high lipid liquid formula
Publication Date: 2015.03.10 NV NUTRICIA

AI summary

The present invention provides a ketogenic diet in the form of a sterile shelf stable ready to use formula, in particular a tube feed, comprising casein and dietary fiber.