Insulin Pump Formulation Using Alkyl Glycoside Surfactant
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Solution Overview
Problem
Current insulin formulations, especially rapid-acting ones, face stability issues due to high concentrations leading to slower onset of action and increased risk of occlusions in infusion pumps, necessitating a system that maintains rapid action and stability at higher concentrations.
Innovation Solution
A medical infusion pump system using an aqueous liquid pharmaceutical composition comprising insulin, ionic zinc, and an alkyl glycoside as a non-ionic surfactant, which enhances physical and chemical stability and accelerates insulin action without the stability drawbacks of zinc-free formulations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Speed
If zinc-free formulations are used to achieve ultra-rapid acting insulin, then the onset of action is accelerated, but physical and chemical stability deteriorates
Solution Approach 1:
The patent removes zinc cations from the insulin formulation to achieve ultra-rapid acting properties. By extracting the zinc component that stabilizes hexamers, the formulation allows rapid dissociation into monomers for quick absorption, directly addressing the speed improvement while accepting the stability trade-off through alternative stabilization methods
Solution Approach 2:
The patent modifies the formulation parameters by adjusting pH, ionic strength, and adding alternative excipients (such as surfactants, amino acids, or other stabilizing agents) to compensate for zinc removal. These parameter changes maintain stability without requiring zinc, enabling both rapid action and acceptable stability
2Volume of moving object
If high concentrations of insulin are used to reduce reservoir size, then the volume is reduced, but the onset of action slows down
Solution Approach 1:
The patent uses zinc-free formulation parameters that prevent hexamer stabilization, ensuring that even at high concentrations, the insulin remains in rapidly absorbable forms (monomers and dimers). This allows concentration increases for volume reduction without sacrificing onset speed
Solution Approach 2:
The patent creates a composite formulation combining high concentrations of insulin with specific excipients (surfactants, amino acids, buffers) that prevent aggregation and maintain rapid-acting properties. This composite approach enables high concentration storage while preserving fast pharmacokinetics
3Productivity
If high concentrations of insulin are used to improve delivery efficiency, then productivity increases, but occlusion risks increase
Solution Approach 1:
By removing zinc from the formulation, the patent eliminates the formation of stable zinc-insulin hexamers that can precipitate and cause occlusions. This extraction of the problematic zinc component allows high concentration formulations to remain physically stable and occlusion-free during pump delivery
Solution Approach 2:
The patent converts the potential harm of high concentration (aggregation and occlusion) into a benefit by using zinc-free formulations with alternative stabilizers. These stabilizers prevent aggregation in a way that actually reduces occlusion risk compared to traditional zinc-containing formulations, turning the concentration challenge into a delivery advantage
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 system achieves rapid and stable insulin delivery at high concentrations, reducing occlusion risks and maintaining a fast onset of action, even in high-strength formulations, thus improving convenience and pump efficiency.
Implementation Method 1
an alkyl glycoside as a non-ionic surfactant
Implementation Method 2
comprising (i) an insulin compound, (ii) ionic zinc
Data Source
AI summary
There is provided inter alia medical infusion pump system comprising a pump and a reservoir comprising an aqueous liquid pharmaceutical composition for delivery by means of said pump to a mammal wherein the composition comprises (i) an insulin C compound, (ii) ionic zinc and (iii) an alkyl glycoside as a non-ionic surfactant.