Oxygen-Free Enema Packaging for IBD 5-ASA Stability
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Solution Overview
Problem
Current enema compositions for treating inflammatory bowel disease (IBD) using 5-aminosalicylic acid (5-ASA) suffer from bowel irritation due to stabilizing compounds like sulfites, which limits their effectiveness and safety, especially in providing long-term stability and shelf-life.
Innovation Solution
A packaged enema composition containing substantially pure 5-ASA in a substantially oxygen-free liquid carrier medium, sealed within a nitrogen atmosphere and packaged in an oxygen-free barrier with an oxygen scavenger, avoiding bowel irritant substances and preventing oxidation, thus maintaining efficacy and shelf-life.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If sulfite compounds are added to stabilize 5-ASA in enema compositions, then shelf-life and stability are improved, but bowel irritation increases
Solution Approach 1:
The patent removes sulfite compounds from the enema composition entirely, extracting the harmful stabilizing agent while maintaining stability through alternative means (inert atmosphere packaging and oxygen scavengers), thereby eliminating bowel irritation while preserving shelf-life
Solution Approach 2:
The patent introduces nitrogen atmosphere and oxygen scavengers as intermediary protective elements between the 5-ASA and oxygen, mediating the oxidation prevention function that previously required sulfite compounds, thus avoiding direct contact between 5-ASA and harmful stabilizers
2Quantity of substance
If 5-ASA is administered orally, then treatment coverage is improved, but gastric juice degradation reduces efficacy
Solution Approach 1:
The patent employs nitrogen gas (pneumatic element) to displace oxygen from the packaging environment, creating an inert atmosphere that prevents oxidation of 5-ASA during storage, thereby maintaining efficacy similar to enteric coating but in the enema delivery system
Solution Approach 2:
The patent creates an inert nitrogen atmosphere within the packaging container and uses oxygen scavengers to maintain this inert environment, protecting 5-ASA from oxidation during storage without requiring enteric coating or complex delivery systems
3Ease of operation
If foam enema is used for treatment, then ease of administration is improved, but penetration to ascending colon is insufficient
Solution Approach 1:
The patent changes the physical state parameter of the enema from foam to liquid, allowing the composition to flow more effectively and penetrate deeper into the colon including the ascending colon, while maintaining ease of administration through the flexible applicator
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 solution provides a stable and effective enema composition that avoids bowel irritation, maintains medicinal potency, and extends shelf-life by preventing oxidation, while eliminating the need for bowel irritant antioxidants like sulfites.
Implementation Method 1
stabilized against oxidation (and thus decomposition, discoloration and reduction in efficacy) of the 5-ASA active agent
Implementation Method 2
liquid enema format possesses certain advantages not present in oral treatment, suppositories, or foam enemas
Data Source
AI summary
The present invention comprises packaged enemas for the treatment of Inflammatory Bowel Disease (IBD), having substantially pure 5-ASA as the active ingredient, with a liquid carrier medium having a material avoidance of bowel irritant substances, such as anti-oxidants for the 5-ASA active ingredient, including such sulfites as potassium metabisulfite, for example, and contained within a sealed and substantially oxygen-free barrier package, which may preferably be formed of a foil/polymer laminate, and which package contains or otherwise includes an oxygen scavenger, such as a an oxygen scavenging sachet.