Lactoferrin Stabilization in Infant Formula via Prebiotic Matrix

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Solution Overview

Problem

Current infant formulas lack the protective benefits of human milk, particularly in reducing the incidence of necrotizing enterocolitis, due to instability of lactoferrin during processing and insufficient oligosaccharides, which are crucial for gut health and immune system development.

Innovation Solution

A milk-based nutritional composition containing lactoferrin from a non-human source, combined with prebiotics such as polydextrose and galacto-oligosaccharides, to mimic the protective effects of human milk and promote a healthy gut microbiota.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If lactoferrin is added to commercially viable nutritional compositions, then the protective benefits against necrotizing enterocolitis are improved, but the functional capacity of lactoferrin is lost during formula processing due to temperature and pH fluctuations

Engineering Contradiction:
Improveprotective benefits against necrotizing enterocolitisVSAvoidfunctional capacity of lactoferrin
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent uses prebiotics (oligosaccharides) as an intermediary substance that protects lactoferrin from degradation during processing. The prebiotics create a protective matrix that shields lactoferrin from temperature and pH fluctuations, allowing it to maintain its functional capacity while still providing protective benefits against necrotizing enterocolitis.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent creates a composite nutritional composition where lactoferrin is combined with prebiotics in specific ratios and formulations. This composite structure allows the prebiotics to stabilize lactoferrin during processing while maintaining the biological activity needed to prevent necrotizing enterocolitis, thus resolving the contradiction between stability and functionality.

Inventive Principle:
Principle #40Composite materials

2Reliability

If human milk is used as the source of lactoferrin, then the protective effects are maximized, but the cost and availability become limiting factors for commercial nutritional compositions

Engineering Contradiction:
Improveprotective effectsVSAvoidcost and availability
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The patent uses recombinant human lactoferrin produced through genetic engineering as a copy of natural human lactoferrin. This synthetic version can be manufactured in large quantities at lower costs compared to extracting human lactoferrin from donor milk, while maintaining the same protective biological activity against necrotizing enterocolitis.

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The patent modifies the production parameters by using recombinant DNA technology to produce human lactoferrin in microbial systems or cell cultures. This parameter change from natural extraction to biotechnological production dramatically improves availability and reduces cost while preserving the protective effects.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If the concentration of lactoferrin is increased to enhance protective benefits, then the effectiveness against necrotizing enterocolitis is improved, but the cost of production and processing complexity increase

Engineering Contradiction:
Improveeffectiveness against necrotizing enterocolitisVSAvoidprocessing complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent incorporates prebiotics into the formula before lactoferrin is added, creating a protective environment in advance. This preliminary action of establishing the prebiotic matrix allows higher concentrations of lactoferrin to be added without proportionally increasing processing complexity, as the prebiotics already in place provide the necessary stabilization framework.

Inventive Principle:
Principle #10Preliminary action

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 effectively reduces the incidence of necrotizing enterocolitis by enhancing the intestinal mucus layer production and modulating the gut microbiota, thereby improving overall health and development in infants.

Implementation Method 1

It has the capacity to bind two molecules of iron in a reversible fashion and can facilitate the uptake of iron within the intestines.

Methodology Applied
Scientific EffectIron binding: Absorption (physical)

Implementation Method 2

by sequestering the environmental iron of pathogenic microorganisms, human lactoferrin effectively inhibits the growth of those microorganisms

Methodology Applied
Scientific EffectIron sequestration: Absorption (physical)

Implementation Method 3

These oligosaccharides are resistant to enzymatic digestion in the upper gastrointestinal tract and reach the colon intact, where they then serve as substrates for colonic fermentation.

Methodology Applied
Scientific EffectFermentation: Fermentation

Data Source

PatentEP2934188B1Milk-based nutritional compositions containing lactoferrin and uses thereof
Publication Date: 2018.04.11 MJN US HOLDINGS LLC
  • EP2934188B1 patent drawingFigure 1
  • EP2934188B1 patent drawingFigure 2
  • EP2934188B1 patent drawingFigure 3

AI summary

The present disclosure relates to milk-based nutritional compositions comprising lactoferrin and/or a prebiotic component, wherein, when combined, the lactoferrin and prebiotic component may exhibit additive or synergistic beneficial effects on the health and development of a pediatric subject. The disclosure further relates to methods comprising the administration of said milk-based nutritional compositions to pediatric subjects.