PKU Nutritional Formula Using Caseino-Glycomacropeptide

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Solution Overview

Problem

Individuals with phenylketonuria (PKU) face challenges with compliance due to the unpleasant taste and high osmolality of traditional amino acid diets, leading to poor dietary adherence and nutritional challenges.

Innovation Solution

A ready-to-drink, shelf-stable nutritional formula with a balanced amino acid profile, including caseino-glycomacropeptide and complementary essential amino acids, is developed, which is low in phenylalanine and has an acceptable taste, using aseptic production methods and modified starch to stabilize the formula and prevent precipitation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If purified amino acids are provided in lieu of protein, then complete nutrition is achieved, but the taste becomes unpleasant due to potent gustatory stimulation

Engineering Contradiction:
Improvenutrition completenessVSAvoidtaste acceptability
Core Design Contradiction:
Quantity of substanceVSEase of operation

Solution Approach 1:

The patent changes the chemical form of amino acids from free amino acids to peptide-bonded amino acids in caseino-glycomacropeptide. This parameter change transforms the gustatory properties while maintaining nutritional completeness, as peptides do not provide the same potent taste stimulation as free amino acids.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent uses caseino-glycomacropeptide, which is a composite structure containing amino acids bonded in peptide sequences within a glycomacropeptide matrix. This composite form provides complete amino acid nutrition while the peptide bonds mask the unpleasant tastes associated with free amino acids.

Inventive Principle:
Principle #40Composite materials

2Quantity of substance

If traditional amino acid diets are used, then nutritional requirements are met, but compliance deteriorates due to unpleasant taste and high osmolality

Engineering Contradiction:
Improvenutritional adequacyVSAvoiddietary compliance
Core Design Contradiction:
Quantity of substanceVSReliability

Solution Approach 1:

The patent changes the osmolality parameter by using peptide-bonded amino acids instead of free amino acids. Peptides have lower osmolality than free amino acids, which directly addresses the high osmolality issue that reduces compliance. The taste parameter is also improved through the peptide structure.

Inventive Principle:
Principle #35Parameter changes

3Quantity of substance

If tyrosine is added to the formula, then amino acid balance is improved, but precipitation occurs reducing stability

Engineering Contradiction:
Improveamino acid balanceVSAvoidformula stability
Core Design Contradiction:
Quantity of substanceVSStability of the object's composition

Solution Approach 1:

The patent uses modified starch as an intermediary substance that interacts with tyrosine to prevent precipitation. The modified starch acts as a stabilizing agent that keeps tyrosine in solution at the concentrations needed for proper amino acid balance, thereby maintaining both nutritional adequacy and formula stability.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Object-affected harmful factors

If protein is restricted in the diet, then phenylalanine intake is reduced, but nutritional completeness deteriorates

Engineering Contradiction:
Improvephenylalanine restrictionVSAvoidnutrition completeness
Core Design Contradiction:
Object-affected harmful factorsVSQuantity of substance

Solution Approach 1:

The patent extracts the phenylalanine component from protein sources while retaining the beneficial amino acids. By using caseino-glycomacropeptide and supplementary amino acids, the formula provides complete nutrition without phenylalanine, effectively separating the harmful component from the nutritional benefits.

Inventive Principle:
Principle #2Taking out (Extraction)

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 formula provides complete nutrition with improved taste and stability, enhancing compliance and nutritional outcomes for PKU patients by maintaining the solubility of tyrosine and preventing precipitation, thus ensuring a stable and palatable dietary solution.

Implementation Method 1

the formula is produced under aseptic conditions

Methodology Applied
Scientific EffectAseptic processing:

Implementation Method 2

the formula is canned (placed in containers that are hermetically sealed and sterilized, such as by heat)

Methodology Applied
Scientific EffectHeat sterilization: Heating

Implementation Method 3

modified starch to stabilize the formula and prevent precipitation

Methodology Applied
Scientific EffectStabilization:

Data Source

PatentUS9414619B2Liquid nutritional formula for phenylketonuria patients
Publication Date: 2016.08.16 CAMBROOKE THERAPEUTICS
  • US9414619B2 patent drawing
  • US9414619B2 patent drawing
  • US9414619B2 patent drawing

AI summary

This is a process to make a shelf-stable, liquid, ready-to-drink, aseptic nutritional formula for the treatment of PKU, tyrosinemia or other errors of metabolism. The liquid nutritional formula has caseino-glyco-macropeptide as the primary protein source and complementary essential amino acids to complete the requirement profile. The beverage also includes vitamins and minerals sufficient to meet daily requirements. When used as a complete diet, the nutritional formula includes a carbohydrate source and a fat source. The nutritional formula has a pleasant taste.