THC Composition Stability Using Acid and Sealed Storage
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Solution Overview
Problem
Cannabinoid compounds, particularly (-)-Δ9-trans-tetrahydrocannabinol (THC), are prone to degradation due to sensitivity to light, heat, and acid-catalyzed isomerization, making them challenging to synthesize, purify, and store stably for extended periods in pharmaceutical forms.
Innovation Solution
Incorporating an acid, such as citric acid, and a pharmaceutically-acceptable solvent like ethanol into the THC composition, with the acid being sufficiently soluble to enhance stability, and storing the composition in a sealed container under controlled conditions, such as refrigeration or encapsulation in a capsule, to maintain stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If cannabinoid compositions are stored under ambient conditions, then convenience is improved, but degradation occurs due to sensitivity to light, heat, and air
Solution Approach 1:
The patent removes harmful elements (oxygen and moisture) from the storage environment by using sealed containers and desiccants, thereby extracting the degradation-causing factors while maintaining convenient ambient storage conditions
Solution Approach 2:
The patent creates an inert storage environment by sealing cannabinoid compositions in containers with desiccants and protective atmospheres, preventing contact with reactive elements (oxygen, moisture) that cause degradation, thus enabling stable ambient storage without refrigeration
2Stability of the object's composition
If refrigeration is used to store cannabinoid compositions, then stability is improved, but device complexity and storage requirements increase
Solution Approach 1:
The patent employs disposable sealed containers with integrated desiccants that provide stable storage conditions without requiring refrigeration infrastructure, eliminating the need for complex cooling systems while maintaining cannabinoid stability
Solution Approach 2:
By creating inert sealed storage environments with desiccants, the patent eliminates the need for refrigeration while maintaining stability, thereby reducing device complexity and infrastructure requirements
3Stability of the object's composition
If bases (e.g., amines) are included in the formulation to improve stability, then cannabinoid degradation is reduced, but unwanted side reactions may occur
Solution Approach 1:
The patent converts the potential harm of reactive environments into benefit by using sealed containers with desiccants that actively prevent moisture and oxygen contact, transforming what would be degradation conditions into protective storage conditions without requiring chemical additives
Solution Approach 2:
The patent creates an inert physical environment through sealed containers and desiccants that prevents degradation without introducing reactive chemical bases, thereby avoiding side reactions while maintaining stability
4Stability of the object's composition
If hard gelatin capsules are used instead of soft gelatin capsules, then stability is improved by eliminating glycerol, but manufacturing precision requirements increase
Solution Approach 1:
The patent removes glycerol from the formulation by using hard gelatin capsules instead of soft capsules, extracting the instability-causing component while accepting increased manufacturing precision requirements for capsule filling and sealing
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 approach significantly reduces THC degradation during storage, maintaining high purity and stability under various conditions, including room temperature, ambient, and elevated temperatures, ensuring the composition remains effective for extended periods.
Implementation Method 1
Cannabinoid compounds, particularly (-)-Δ9-trans-tetrahydrocannabinol (THC), are prone to degradation due to sensitivity to light, heat, and acid-catalyzed isomerization
Implementation Method 2
CBN is the primary product of THC degradation; thus, its concentration increases during storage as well as with exposure to light, heat, and air
Data Source
AI summary
A composition comprising a high purity cannabinoid, an acid, and a pharmaceutically-acceptable solvent achieves room temperature stability for over 24 months. The acid improves the stability of the composition and the solvent enhances the solubility of the acid, thereby allowing the acid to have an improved stabilizing effect on the highly pure cannabinoid. Preferably, the solvent is an alcohol and, more preferably, the composition contains an oil. A method for making the composition includes combining the cannabinoid and the solvent and evaporating a portion of the solvent, along with adding an acid to the composition, before, during, or after the evaporating step. A method for making and storing the composition includes storing the composition in a manner adapted to maintain its stability. Pharmaceutical dosage forms include a formulated composition, such as having the oil. A method of treating a subject comprises administering to the subject the dosage form.