Cannabidiol Oral Formulations for Purity, Stability, and Bioavailability
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Solution Overview
Problem
Commercially available cannabidiol is often contaminated with delta-9-tetrahydrocannabinol, a Schedule I drug, posing regulatory challenges and undesirable side effects, and there is a need for stable, substantially pure synthetically synthesized cannabidiol formulations.
Innovation Solution
Oral pharmaceutical formulations comprising cannabidiol with specific vehicles and additives that enhance bioavailability and stability, including lipids, antioxidants, and preservatives, providing increased cannabidiol and metabolite concentrations when administered in a fed condition compared to a fasted condition.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If commercially available cannabidiol is used, then availability is improved, but purity deteriorates due to delta-9-tetrahydrocannabinol contamination
Solution Approach 1:
The patent extracts and removes delta-9-tetrahydrocannabinol contaminant from commercially available cannabidiol through chromatographic purification processes, isolating the desired cannabidiol compound while eliminating the harmful Schedule I drug contaminant
Solution Approach 2:
The patent creates composite pharmaceutical formulations combining purified cannabidiol with specific excipients, lipids, and delivery vehicles to enhance stability and bioavailability while maintaining high purity levels
2Speed
If cannabidiol is administered in fasted condition, then absorption speed is improved, but bioavailability deteriorates
Solution Approach 1:
The patent modifies the physical and chemical parameters of cannabidiol through formulation with lipids and excipients, changing its solubility and absorption characteristics to achieve enhanced bioavailability in fed states while maintaining controlled absorption kinetics
Solution Approach 2:
The patent introduces lipid vehicles and excipients as intermediary substances that facilitate cannabidiol absorption and transport, acting as mediators between the drug and biological systems to enhance bioavailability without requiring fasted conditions
3Stability of the object's composition
If cannabidiol is formulated with lipids and excipients, then stability is improved, but formulation complexity increases
Solution Approach 1:
The patent develops composite pharmaceutical formulations integrating cannabidiol with stabilizing excipients, lipids, and preservatives in optimized ratios that enhance compositional stability while maintaining manageable formulation complexity through systematic design
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 formulations achieve significantly higher cannabidiol and metabolite concentrations, offering improved therapeutic efficacy for various medical conditions, including epilepsy and neuropathic pain, while minimizing delta-9-tetrahydrocannabinol presence.
Implementation Method 1
a vehicle consisting of a lipid or selected from the group consisting of water, ethanol, glycerin, propylene glycol, polyethylene glycol 400 and a combination thereof
Implementation Method 2
the oral pharmaceutical formulations of the present invention further comprise an antioxidant or preservative selected from the group consisting of alpha-tocopherol, ascorbyl palmitate, methyl paraben, propyl paraben and a combination thereof
Data Source
AI summary
The present invention is generally directed to substantially pure cannabidiol, stable cannabinoid pharmaceutical formulations, and methods of their use.