Digestible Polymer Shell for Lag Time Release
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Solution Overview
Problem
Current delivery vehicles that release active ingredients in the gastrointestinal tract after a predetermined lag time either provide intermittent or restricted delivery, which is not suitable for conditions like Crohn's disease or ulcerative colitis, and face challenges with enteric coatings dissolving at high pH, limiting their application to the duodenum.
Innovation Solution
A delivery vehicle comprising a core with a lipid or lipophilic active ingredient dispersed in a continuous polymer matrix surrounded by a digestible polymer shell with a melting or softening point above human body temperature, allowing for tailored lag time release by varying the shell's chemical and physical properties, enabling continuous and rapid release at specific locations within the GI tract.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Speed
If an enteric coating is used to achieve rapid and continuous release, then the release speed is improved, but the coating dissolves at high pH limiting delivery location control
Solution Approach 1:
The patent changes the key parameter from pH-dependent dissolution (enteric coating) to temperature-dependent melting (shellac-based coating). The shellac coating has a melting point above body temperature, allowing it to remain intact in the stomach and release the active ingredient continuously and rapidly in the intestine, achieving both fast release and precise location control.
Solution Approach 2:
The patent replaces the chemical dissolution mechanism of enteric coatings with a physical melting mechanism of the shellac-based coating. This substitution allows the coating to maintain structural integrity until it reaches the target location, where body temperature causes it to melt and release the active ingredient continuously.
2Loss of time
If a matrix material is used for delayed release, then the lag time control is improved, but the release becomes intermittent and slow
Solution Approach 1:
The patent utilizes the phase transition of the shellac-based coating from solid to liquid at body temperature. The coating remains solid in the stomach, providing delayed release, then melts in the intestine, enabling continuous and rapid release of the active ingredient, thus resolving the contradiction between lag time control and release speed.
Solution Approach 2:
The patent uses a composite structure consisting of a core containing the active ingredient dispersed in a continuous matrix, surrounded by a shellac-based coating. This composite design allows the core matrix to provide structural support while the shellac coating controls the release profile, achieving both delayed onset and rapid continuous release.
3Loss of time
If the digestible polymer shell thickness is increased to extend lag time, then the lag time is improved, but the device complexity increases
Solution Approach 1:
The patent changes the approach from varying shell thickness to varying shell composition (different digestible polymers with different digestion rates). This allows precise control of lag time through chemical composition rather than physical dimensions, simplifying the device structure while maintaining functionality.
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
This solution allows for controlled and efficient release of active ingredients at desired locations and times within the GI tract, minimizing metabolic modification and improving bioavailability, particularly effective for conditions like ulcerative colitis, Crohn's disease, and obesity management.
Implementation Method 1
a digestible polymer shell (4) having a melting and/or softening point above the body temperature of an animal or human
Implementation Method 2
digestible polymer shell (4) to be compromised e.g. by dissolution, erosion, digestion and/or degradation
Data Source
AI summary
A delivery vehicle comprising a core (1) surrounded by a digestible polymer shell (4) having a melting and/or softening point above the body temperature of an animal or human, wherein said core comprises a lipid and/or lipophilic active ingredient (2) dispersed in a continuous polymer matrix (3). The delivery vehicle can be used to release lipid and/or lipophilic active ingredients, such as pharmaceuticals, nutraceuticals, supplements, traditional/herbal medicine, or combinations thereof, after a predetermined lag time following ingestion.