Insulin Composition with Anti-inflammatory Agents for CSII Wear-Time Extension
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Solution Overview
Problem
Current continuous subcutaneous insulin infusion (CSII) systems have limited wear-time at a single site, typically lasting only 2-3 days due to impaired infusion site efficacy, leading to frequent changes and increased waste, necessitating a solution to extend usage time for patient convenience and consistent efficacy.
Innovation Solution
A pharmaceutical composition comprising insulin, a preservative, and at least one agent selected from meloxicam, bromfenac sodium, acetylsalicylic acid, paracetamol, salicylic acid, heparin, or dexamethasone, which is designed for use with a pump and infusion set to enhance the duration of CSII therapy by maintaining stability and efficacy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If commercially available insulin infusion sets are used for CSII, then the device can be used for 2-3 days, but the infusion site efficacy is impaired after 3-5 days, requiring frequent changes
Solution Approach 1:
The patent applies preliminary action by incorporating anti-inflammatory agents (meloxicam, bromfenac sodium, acetylsalicylic acid, salicylic acid, or dexamethasone) and anticoagulant agents (heparin) into the insulin composition before infusion. These agents prevent inflammation and foreign body response in advance, thereby extending the functional duration of the infusion set while maintaining consistent insulin efficacy at the infusion site for up to 21 days
Solution Approach 2:
The patent changes the chemical composition parameters of the insulin formulation by adding specific concentrations of anti-inflammatory and anticoagulant agents. This parameter modification transforms the insulin solution from a standard formulation into an enhanced composition that actively prevents infusion site complications, thereby extending the reliable operational duration from 3-5 days to 7-21 days
2Reliability
If the infusion set is changed frequently every 2-3 days, then infusion site efficacy is maintained, but patient convenience is reduced and waste increases
Solution Approach 1:
By pre-formulating insulin with anti-inflammatory and anticoagulant agents, the system proactively prevents infusion site inflammation and foreign body response. This preliminary protective action eliminates the need for frequent infusions, allowing single-site use for 7-21 days and significantly improving patient convenience while maintaining consistent efficacy
Solution Approach 2:
The enhanced insulin composition enables continuous, uninterrupted insulin delivery at a single infusion site for extended periods (7-21 days). The anti-inflammatory and anticoagulant agents ensure continuous prevention of site complications, maintaining reliable insulin absorption and therapeutic effect throughout the extended wear period without requiring site changes
3Ease of operation
If the infusion set is used for extended periods beyond 3-5 days, then patient convenience improves, but infusion site efficacy deteriorates due to foreign body response
Solution Approach 1:
The patent converts the harmful foreign body response and inflammation that normally limit infusion set duration into a benefit by using anti-inflammatory agents (meloxicam, bromfenac sodium, acetylsalicylic acid, salicylic acid, dexamethasone) and anticoagulant agents (heparin). These agents transform the pathological inflammatory process into a controlled therapeutic effect that protects the infusion site, enabling extended wear-time of 7-21 days while maintaining consistent insulin efficacy
Data Source
AI summary
The present invention relates to pharmaceutical insulin compositions comprising insulin, a preservative, and at least one selected from the group consisting of aspirin, acetaminophen, dexamethasone, heparin, meloxicam, bromfenac sodium, salicylic acid; and the use of the compositions to treat diabetes.