Oral Corticosteroid Composition for Local GI Anti-Inflammation
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Solution Overview
Problem
There are no approved topically administered anti-inflammatory medications for treating conditions associated with inflammation of the upper gastrointestinal tract, and existing systemic corticosteroid treatments are associated with significant side-effects.
Innovation Solution
Development of orally administered corticosteroid compositions that disintegrate within 60 seconds in the oral cavity or simulate saliva, providing topical treatment with minimal systemic absorption, using solid or liquid formulations that include bio-gelling polymers and cyclodextrins to enhance mucosal contact.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If systemic corticosteroid administration is used to treat gastrointestinal inflammation, then anti-inflammatory effect is achieved, but significant side-effects occur including immune suppression and growth retardation in children
Solution Approach 1:
The patent applies local quality by formulating corticosteroids in orally disintegrating tablets that rapidly disintegrate in the oral cavity to provide localized treatment of the upper gastrointestinal tract. This ensures the drug acts specifically at the site of inflammation (esophagus) rather than being systemically absorbed, thereby achieving reliable anti-inflammatory effect while minimizing harmful systemic side-effects such as immune suppression and growth retardation in children
Solution Approach 2:
The patent uses an intermediary approach by employing rapidly disintegrating tablet formulations that act as intermediaries between oral administration and localized delivery. The tablet disintegrates quickly in the oral cavity to release the corticosteroid at the site of need, serving as a mediator that prevents direct systemic absorption while maintaining therapeutic effectiveness at the gastrointestinal tract
2Object-affected harmful factors
If orally disintegrating tablet formulation is used to provide topical treatment, then systemic absorption is minimized, but rapid disintegration is required to ensure effective localized delivery
Solution Approach 1:
The patent applies parameter changes by modifying the physical and chemical properties of the tablet formulation to achieve rapid disintegration. This includes adjusting disintegrant types and concentrations, tablet hardness, and moisture content to ensure the tablet disintegrates within 60 seconds in the oral cavity, thereby minimizing systemic absorption while maintaining effective localized delivery speed
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 compositions effectively treat inflammatory conditions of the gastrointestinal tract with reduced side-effects by ensuring localized delivery of corticosteroids, minimizing systemic exposure and enhancing mucosal contact.
Implementation Method 1
the solid pharmaceutical composition disintegrates within 60 seconds in simulated saliva when tested using the USP Disintegration Test, and/or which disintegrates within 60 seconds when placed in the oral cavity of a human
Implementation Method 2
the composition undergoes a change in physical properties upon contact with the gastrointestinal tract of the patient
Data Source
AI summary
The present invention is directed to orally administered corticosteroid compositions. The present invention also provides a method for treating a condition associated with inflammation of the gastrointestinal tract in an individual. The method comprises administering to an individual in need thereof a pharmaceutical composition of the present invention.