Multiparticulate Insulin Granulate for Uniform, Rapid Dissolution
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Solution Overview
Problem
Preterm and short bowel syndrome infants face challenges with insulin administration due to poor solubility in aqueous solvents, difficulty in providing accurate low-dose insulin content, and insulin degradation during processing and storage, which complicates the design of insulin-containing drug products.
Innovation Solution
A multiparticulate granulate comprising insulin and infant nutritional excipient, free of layered structures, that rapidly dissolves in aqueous solvents, maintains stability during storage, and minimizes insulin loss during nasogastric administration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If insulin is administered in traditional formulations, then insulin delivery is possible, but solubility in aqueous solvents is poor and content uniformity is difficult to achieve
Solution Approach 1:
The insulin formulation is segmented into multiple discrete particles or droplets within the enteral nutrition product. This segmentation increases the total surface area for dissolution and allows for better distribution of insulin throughout the aqueous matrix, improving both solubility and content uniformity across different doses.
Solution Approach 2:
The formulation creates local zones of high insulin concentration within individual particles or micro-droplets, while the overall bulk remains soluble. This local quality approach allows insulin to be delivered in controlled, uniform amounts at specific locations where it can effectively act on intestinal tissue.
2Ease of manufacture
If insulin is processed and stored in traditional formulations, then manufacturing is possible, but insulin degradation occurs during processing and storage
Solution Approach 1:
Insulin is incorporated into the enteral nutrition product during the manufacturing process itself, rather than being added separately after production. This preliminary action allows insulin to be protected within the product matrix from the outset, preventing degradation during subsequent storage and handling while maintaining ease of manufacture.
Solution Approach 2:
The enteral nutrition product acts as an intermediary carrier that protects insulin from degrading conditions. The food matrix serves as a protective environment that maintains insulin stability during processing and storage, while still allowing the insulin to remain bioavailable when administered.
3Reliability
If insulin is administered during nasogastric feeding, then therapeutic effect is possible, but insulin loss occurs during administration
Solution Approach 1:
The insulin is merged with the enteral nutrition product in a unified formulation, eliminating the need for separate administration through the nasogastric tube. This combination ensures that insulin is delivered simultaneously with nutrition, preventing loss during transfer while maintaining therapeutic effectiveness.
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 multiparticulate granulate ensures consistent content uniformity, rapid dissolution, and stability, reducing insulin loss and adverse effects, facilitating early enteral nutrition transition in preterm and SBS infants.
Implementation Method 1
rapidly dissolves in aqueous solvents
Data Source
AI summary
The present invention is directed to multiparticulate granulate compositions comprising particles of insulin and particles of an infant nutritional excipient, wherein the multiparticulate granulate is substantially free of layers of insulin and excipient, methods of making thereof, and methods of use thereof.