Glycerol-Free Liquid Lactase Formulation for Infant Formula
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Solution Overview
Problem
Current lactase formulations contain glycerol, which is prohibited in infant and toddler formulas, making them unsuitable for production, and there is a need for stable, glycerol-free liquid lactase formulations for these applications.
Innovation Solution
Development of stable aqueous liquid lactase formulations using at least 20 wt % sodium, calcium, or potassium-L-lactate, with optional components like sugars and sodium or potassium chloride, to achieve microbial and enzymatic stability without glycerol, allowing their use in infant and toddler formulas.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If glycerol is used as stabilizer in liquid lactase formulations, then microbial and enzymatic stability is improved, but the formulation becomes unsuitable for infant and toddler formulas due to regulatory prohibition
Solution Approach 1:
The patent replaces glycerol with alternative stabilizing agents (sugars, polyols, buffers, proteins) and adjusts formulation parameters such as water activity (Aw ≤ 0.82), pH (6.0-8.0), and component concentrations to achieve stability without glycerol, making the formulation suitable for infant and toddler formulas
Solution Approach 2:
The patent employs composite stabilization systems combining multiple components (e.g., sugars with buffers, polyols with proteins) to achieve both microbial and enzymatic stability without relying on prohibited glycerol, thereby maintaining reliability while ensuring adaptability to infant formula requirements
2Reliability
If water activity is reduced to prevent microbial growth, then microbial stability is improved, but enzymatic activity may be reduced
Solution Approach 1:
The patent optimizes water activity to a specific range (Aw ≤ 0.82) and adjusts pH (6.0-8.0) and temperature parameters to simultaneously achieve microbial stability and preserve enzymatic activity, balancing both requirements through controlled parameter changes
Solution Approach 2:
The patent introduces intermediary substances such as buffers, proteins, and specific sugar-phosphate compounds that mediate between water activity reduction and enzymatic activity preservation, allowing low water activity to maintain microbial stability while intermediaries protect and maintain enzyme function
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 formulations provide enzymatic and microbial stability, enabling their use in infant and toddler formulas, with residual enzymatic activity above 80% after 2 months and low microbial growth, meeting the requirements for shelf-stability and safety.
Implementation Method 1
Lactase or β-galactosidase (E.C: 3.2.1.23) is an enzyme which catalyses the hydrolysis of lactose (a disaccharide) into its component monosaccharides glucose and galactose
Implementation Method 2
In juveniles and people that are lactose tolerant, lactose is hydrolyzed into galactose and glucose by the 'lactase-phlorizin hydrolase' (LPH) in the small intestinal brush border of the jejunum
Data Source
AI summary
A stable aqueous liquid lactase formulation is provided, comprising lactase and further comprising sodium, calcium or potassium-L-lactate or a combination thereof and optionally a sugar, and/or optionally comprising sodium or potassium chloride or a combination thereof, preferably wherein the concentration of each of the components is such that the water activity Aw is at most 0.82. The formulation is particularly suitable when using invertase-free lactase, allowing the use of sucrose as stabilizer. Also provided is a process to produce the liquid lactase formulation, an infant formula (e.g. as powder of granulate) comprising the liquid lactase formulation, a method to produce said infant formula, and the use of the formulation in the production of infant formula.