Injectable Cannabidiol Solvent Composition for THC-Stable Delivery
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Solution Overview
Problem
Cannabidiol formulations are unstable due to degradation into THC and insoluble in water, requiring stable and soluble formulations for parenteral administration.
Innovation Solution
A solvent system comprising triglyceride oil and C1-C3 alkyl esters of C6-C22 fatty acids is used to solubilize and stabilize cannabidiol, maintaining low viscosity and high concentration for non-IV parenteral administration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If cannabidiol is formulated in traditional solvents, then solubility is achieved, but chemical stability deteriorates due to degradation into THC
Solution Approach 1:
The patent changes the chemical parameters of the solvent system by using specific triglyceride oils with defined fatty acid compositions (C6-C22) and controlled chain lengths. This parameter change creates a chemically stable environment that prevents oxidation and degradation of cannabidiol into THC, while maintaining solubility through the lipophilic properties of the triglyceride-based solvent system.
2Ease of operation
If cannabidiol concentration is increased to reduce injection volume, then practicality improves, but viscosity increases making administration difficult
Solution Approach 1:
The patent optimizes the physical parameters of the formulation by selecting triglyceride oils with specific viscosity characteristics and fatty acid chain lengths (C6-C22). This creates a balance where high cannabidiol concentrations (up to 500 mg/mL) can be achieved while maintaining viscosity below 35 cP, ensuring ease of administration through subcutaneous, intramuscular, or intrathecal routes.
Solution Approach 2:
The patent uses a composite solvent system combining multiple triglyceride oils with different fatty acid compositions. This composite approach allows the formulation to achieve both high cannabidiol solubility and low viscosity by leveraging the complementary properties of different triglyceride components, creating a synergistic effect that neither single component could achieve alone.
3Quantity of substance
If water is used as solvent, then solubility of polar compounds improves, but cannabidiol remains insoluble
Solution Approach 1:
The patent changes the polarity parameter of the solvent system by using lipophilic triglyceride oils with specific fatty acid compositions (C6-C22). This parameter change creates a non-aqueous solvent environment that is chemically compatible with cannabidiol's lipophilic nature, enabling complete solubility and stable formulation without water, thereby preventing hydrolysis and other water-related degradation pathways.
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 formulation achieves phase and chemical stability, allowing for effective, low-viscosity, high-concentration cannabidiol delivery via subcutaneous, intramuscular, and intrathecal routes without THC conversion.
Implementation Method 1
certain alkyl esters of fatty acids are effective, in combination with a triglyceride oil, to solubilize and stabilize cannabidiol
Implementation Method 2
cannabidiol stability, meaning that the cannabidiol does not break down or convert into other compounds (such as THC) to maintain efficacy and function over time
Implementation Method 3
provide a formulation that has a low enough viscosity and high enough cannabidiol concentration to provide a cannabidiol formulation suitable for parenteral administration
Data Source
AI summary
An injectable cannabidiol formulation for non-IV parenteral administration comprising, consisting essentially of, or consisting of: (a) a solvent system consisting of (i) an effective amount of at least one triglyceride oil; and (ii) an effective amount of at least one C1-C3 alkyl ester of a C6-C22 fatty acid; and (b) an effective amount of cannabidiol; wherein the formulation is free of water and ethanol, has a viscosity less than about 35 cP, and is phase stable and chemically stable. The formulation can further comprise at least one additional pharmaceutically acceptable excipient. Kits containing the formulation are also described.