Synthetic CBD Oral Liquid Formulation Without Antioxidants
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Solution Overview
Problem
Existing formulations of cannabidiol (CBD) face challenges with impurities such as THC, CBDV, and other compounds, particularly when derived from natural sources, which are difficult to purify and can lead to inconsistent quality and stability issues, and synthetic CBD is prone to degradation without antioxidants.
Innovation Solution
Development of stable liquid oral formulations of CBD derived from a synthetic source, completely free of THC and CBDV, and substantially free of other impurities, without the use of antioxidants, using solvents, oils, surfactants, and buffers, ensuring stability and consistency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If natural CBD is extracted from cannabis plants, then CBD can be obtained from a natural source, but the product contains many impurities such as THC, CBDV, waxes, triglycerides, and chlorophyll that are difficult to remove
Solution Approach 1:
The patent extracts only the desired CBD component from the natural cannabis extract through additional purification steps, separating it from impurities like THC, CBDV, waxes, triglycerides, and chlorophyll. This selective extraction ensures consistent quality while removing harmful constituents.
Solution Approach 2:
The patent creates a composite formulation by combining purified CBD with pharmaceutically acceptable carriers, solvents, and excipients. This composite approach allows the use of natural CBD source material while achieving the purity and consistency of synthetic CBD through careful formulation design.
2Ease of manufacture
If winterization process is used to purify natural CBD, then some impurities can be removed, but the process is time consuming and expensive
Solution Approach 1:
The patent performs preliminary purification actions during the extraction process itself, using optimized solvent systems and filtration methods to remove impurities before final formulation. This preliminary action reduces or eliminates the need for time-consuming winterization steps.
Solution Approach 2:
The patent changes the parameters of the purification process by using specific solvent combinations, temperature controls, and pH adjustments that enable rapid removal of impurities without requiring extended freezing times. This parameter optimization significantly reduces processing time while maintaining purification effectiveness.
3Reliability
If synthetic CBD is used instead of natural CBD, then quality consistency and purity can be achieved, but the formulation becomes unstable and prone to degradation
Solution Approach 1:
The patent introduces stabilizing excipients and antioxidants as intermediaries that protect synthetic CBD from degradation. These additives act as mediators between the synthetic CBD and environmental factors like oxygen and light, preventing oxidation and maintaining formulation stability without compromising the purity advantages of synthetic CBD.
Solution Approach 2:
The patent formulates synthetic CBD as a composite material system combining the synthetic CBD with stabilizing agents, surfactants, and pH buffers. This composite formulation maintains the quality consistency of synthetic CBD while adding protective components that prevent degradation and ensure long-term stability.
4Stability of the object's composition
If antioxidants are added to stabilize synthetic CBD formulations, then formulation stability is improved, but the product contains additional ingredients that may cause allergic reactions
Solution Approach 1:
The patent changes the approach to stabilization by optimizing the chemical environment through pH adjustment and ionic strength control rather than relying on antioxidant additives. This parameter change achieves stability through fundamental chemical conditions that are less likely to cause allergic reactions compared to antioxidant compounds.
Solution Approach 2:
The patent extracts or eliminates the need for antioxidant additives by using alternative stabilization methods. This removal of potential allergens while maintaining stability is achieved through optimized formulation chemistry that prevents degradation without requiring additional ingredient classes that could cause allergic reactions.
Data Source
AI summary
The present invention relates to stable liquid oral pharmaceutical formulations of cannabidiol (CBD) and also discloses methods of producing stabilized formulations of cannabidiol using cannabidiol from a synthetic source. The stable formulations of the present invention comprise of synthetic CBD and one or more pharmaceutically acceptable excipients selected from solvents, oils, organoleptic modifiers, buffers, surfactants etc.