Cyclodextrin-Stabilized Insulin Formulation for Preterm Infant Feeds
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Solution Overview
Problem
Preterm infants experience feeding difficulties and disorders such as late-onset sepsis and necrotizing enterocolitis due to underdeveloped digestive systems, and existing insulin formulations in infant feeds tend to polymerize and agglomerate, reducing insulin availability.
Innovation Solution
A solubilized insulin formulation is developed, incorporating insulin with cyclodextrin, sodium chloride, and maltodextrin, combined with an oil-in-water nanodroplet emulsion containing DHA and Coenzyme Q10, and lyophilized to form an amorphous powder that remains stable in infant feeds.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If insulin is added to preterm infant feeds, then intestinal maturation is accelerated and growth is improved, but insulin polymerizes and agglomerates reducing availability
Solution Approach 1:
The patent uses cyclodextrin as an intermediary substance that forms inclusion complexes with insulin. The cyclodextrin molecules act as mediators between insulin and the aqueous environment of infant feed, preventing insulin polymerization and agglomeration while maintaining insulin's biological activity and availability.
Solution Approach 2:
The patent creates a composite formulation combining insulin with cyclodextrin, sodium chloride, and maltodextrin. This composite material approach allows insulin to be stabilized in the infant feed environment through interactions with multiple components, particularly cyclodextrin inclusion complexes, preventing degradation while maintaining efficacy.
2Reliability
If insulin formulation is prepared with multiple components, then stability and solubility are improved, but formulation complexity increases
Solution Approach 1:
The patent merges multiple functional components into a single integrated formulation: cyclodextrin for stabilization, sodium chloride for solubility enhancement, and maltodextrin as a carrier. This combining of functions into one formulation simplifies the overall process of preparing stable insulin-containing infant feed while achieving multiple objectives simultaneously.
3Quantity of substance
If insulin is solubilized in hydrochloric acid and pH adjusted, then solubility is improved, but processing steps increase
Solution Approach 1:
The patent utilizes pH adjustment as a parameter change to optimize insulin solubility. By controlling the pH of the formulation to a specific range, the patent enhances insulin solubility and stability without requiring complex processing steps, leveraging the pH-dependent solubility characteristics of insulin.
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 formulation effectively prevents or reduces the severity of late-onset sepsis and necrotizing enterocolitis by promoting intestinal maturation and reducing adverse events in preterm infants, allowing for faster weaning off parenteral nutrition and earlier discharge.
Implementation Method 1
adding cyclodextrin to solution (b) to thereby encapsulate the insulin in cyclodextrin cavities
Implementation Method 2
lyophilizing a filtrate to obtain an amorphous powder
Implementation Method 3
combined with an oil-in-water nanodroplet emulsion containing DHA and Coenzyme Q10
Data Source
AI summary
An insulin formulation and a method of preparing and using same. The insulin preparation includes insulin, oligosaccharide and sodium chloride at a ratio of 1:A:B (w:w:w respectively) with ranges of A and B are 1000-5000 and 10-50, respectively.