Enteric Coated Multiparticulate Peppermint Oil Composition
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Solution Overview
Problem
Single-unit enteric coated peppermint oil capsules are unpredictable in dose absorption, have unreliable onset of action, and are prone to volatility issues, making them unsuitable for acute gastrointestinal flare-ups and stable storage.
Innovation Solution
Development of enteric coated multiparticulate compositions with a hydrophobic phase containing peppermint oil dispersed in a microcrystalline cellulose-based gel and a hydrophilic phase, using a proteinaceous subcoating to enhance stability and prevent volatility, allowing for controlled release and processing at room temperature.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If single-unit enteric coated peppermint oil capsules are used, then the peppermint oil is protected from stomach absorption, but the dose absorption becomes unpredictable and the onset of action becomes unreliable
Solution Approach 1:
The invention divides a single-unit capsule into multiple smaller enteric-coated particles or granules containing peppermint oil. This segmentation allows the peppermint oil to be distributed across multiple particles that dissolve at different locations and times in the intestine, providing more predictable and reliable dose absorption while maintaining simplicity in the overall formulation approach.
2Speed
If peppermint oil is released quickly when the capsule dissolves, then the onset of action is rapid, but the dose dumping effect occurs and absorption becomes unpredictable
Solution Approach 1:
By segmenting the peppermint oil dose into multiple smaller enteric-coated particles, the invention ensures that the oil is released gradually as particles dissolve at different rates and locations in the intestine. This prevents dose dumping while still achieving relatively rapid onset of action, and improves absorption predictability through distributed release.
Solution Approach 2:
The invention creates local variations in dissolution characteristics among different particles through differences in coating thickness, composition, or particle size. This local quality variation ensures that not all peppermint oil is released simultaneously, preventing dose dumping while maintaining reliable and predictable absorption patterns.
3Stability of the object's composition
If the capsules are stored or shipped at temperatures much above room temperature, then the peppermint oil remains stable in the capsule, but the volatile components evaporate and permeate the capsule
Solution Approach 1:
Segmenting the peppermint oil into multiple small particles increases the total surface area to volume ratio, which can actually worsen volatility. However, the enteric coating on each particle provides a protective barrier that reduces volatile loss during storage and shipping, while the segmented structure allows for better heat distribution and reduced hot spot formation that could accelerate degradation.
Solution Approach 2:
The invention uses composite enteric coating materials with appropriate glass transition temperatures and permeability characteristics to create a barrier that prevents peppermint oil evaporation and permeation during elevated temperature storage, while maintaining the desired release properties in the intestine.
4Reliability
If conventional enteric coated formulations are used, then the peppermint oil is protected from stomach acid, but the onset of action is delayed by several hours due to stomach residence time
Solution Approach 1:
The segmented multiparticulate structure allows for faster transit through the stomach compared to a single large capsule, as the smaller particles can move more freely and are less likely to be retained. This reduces the stomach residence time delay while still maintaining protection from stomach acid through the enteric coating, enabling faster onset of action when needed for acute gastrointestinal flare-ups.
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 multiparticulate composition provides a stable and controlled release of peppermint oil, reducing dose dumping and volatility, ensuring reliable absorption and onset of action, and maintaining stability during storage and processing.
Implementation Method 1
a hydrophobic phase containing peppermint oil dispersed in a microcrystalline cellulose-based gel
Implementation Method 2
a hydrophobic phase containing peppermint oil dispersed in a microcrystalline cellulose-based gel
Implementation Method 3
The enteric coating prevents the capsule from dissolving in the stomach, but allows the capsule to dissolve in the intestines and release the peppermint oil
Implementation Method 4
a hydrophilic phase containing a hydrogel
Implementation Method 5
using a proteinaceous subcoating to enhance stability and prevent volatility
Data Source
AI summary
A multiparticulate composition is formed from a plurality of individual cores including a hydrophobic phase containing peppermint oil dispersed in a microcrystalline cellulose-based gel and a hydrophilic phase containing a hydrogel. An enteric coating is over the individual cores. The multiparticulate composition can be used to treat gastrointestinal disorders.