Cannabidiol Formulation Purity and Stability Without THC
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Solution Overview
Problem
Existing cannabinoid formulations, particularly those containing cannabidiol, are often contaminated with delta-9-tetrahydrocannabinol, which is a regulated Schedule I drug, posing challenges in patient access and desirability due to its hallucinogenic effects, and there is a need for stable, substantially pure synthetically synthesized cannabidiol formulations.
Innovation Solution
The development of stable pharmaceutical formulations comprising specific ratios of cannabidiol, caprylic/capric triglyceride, and alpha-tocopherol, with optional additives like antioxidants, polyethylene glycol, and flavorings, to create formulations suitable for oral administration, ensuring high purity and stability of cannabidiol.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If commercially available cannabidiol is used, then treatment availability is improved, but purity is worsened due to delta-9-tetrahydrocannabinol contamination
Solution Approach 1:
The patent extracts and removes the harmful delta-9-tetrahydrocannabinol contaminant from commercially available cannabidiol through chromatographic purification processes, isolating the pure cannabidiol component while discarding the unwanted THC fraction
Solution Approach 2:
The patent changes the chemical composition parameters by establishing specific ratios of cannabidiol (28-32%), caprylic/capric triglyceride (66-74%), and alpha-tocopherol (0.1-1.0%), transforming the formulation from a contaminated state to a purified, stabilized state with defined compositional parameters
2Ease of manufacture
If delta-9-tetrahydrocannabinol is present in cannabidiol formulations, then commercial availability is improved, but patient desirability is worsened due to hallucinogenic effects and regulatory restrictions
Solution Approach 1:
The patent converts the harmful presence of delta-9-tetrahydrocannabinol into a benefit by using it as a marker for purification - the removal of THC becomes the defining characteristic of the invention, transforming a contaminant problem into a purity solution that simultaneously achieves commercial viability and eliminates hallucinogenic effects
3Device complexity
If cannabidiol is stored without stabilization, then formulation simplicity is improved, but stability is worsened leading to degradation
Solution Approach 1:
The patent introduces caprylic/capric triglyceride as an intermediary carrier medium and alpha-tocopherol as an intermediary protective agent that mediates between the cannabidiol and degrading environmental factors, creating a protective microenvironment that prevents oxidation and degradation while maintaining formulation stability
Solution Approach 2:
The patent creates a composite pharmaceutical formulation by combining cannabidiol with caprylic/capric triglyceride and alpha-tocopherol in specific ratios, forming a stable composite system where each component contributes unique properties that collectively enhance overall stability while maintaining simplicity of administration
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 provide stable, substantially pure cannabidiol with reduced delta-9-tetrahydrocannabinol content, enhancing treatment efficacy for conditions such as neuropathic pain, epilepsy, and glioblastoma multiforme, while being suitable for various administration routes and patient conditions.
Implementation Method 1
0.1 to 1.0 % of alpha-tocopherol
Implementation Method 2
from about 66 to about 74 % of caprylic/capric triglyceride
Data Source
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AI summary
The present invention is generally directed to substantially pure cannabidiol, stable cannabinoid pharmaceutical formulations, and methods of their use.