Nanosuspensions of cannabidiol for developing water-dispersible formulations
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Publication Number
US-11975098-B2
Publication Date
2024-05-07
Expiration Date
Abstract
Aqueous nanosuspensions of cannabidiol (CBD) having improved stability, shelf life, and/or CBD content are provided, as are methods of making such nanosuspensions. The nanosuspensions include ethyl maltol as an emulsifying agent and may be manufactured by either a melt emulsification process or a solvent evaporation process. The nanosuspensions may also have an improved taste and are thus suitable for use as, e.g., beverage additives.
Core Innovation
The invention relates to aqueous nanosuspensions of cannabidiol (CBD) that use ethyl maltol as an additive. The purpose is to provide water-dispersible CBD nanosuspensions with improved chemical and physical stability and improved shelf life. The disclosed formulations are also directed to taste/flavor masking and improved CBD loading.
The problem being solved is that prior micronization/nanosuspension approaches face limitations in achieving stable, biocompatible, and palatable CBD formulations. The background describes challenges associated with melt emulsification in producing stable CBD nanosuspensions suitable for storage, with a need to maintain nanoscale particle size and stable quality over time.
The invention provides an aqueous nanosuspension comprising between about 0.25 wt % and about 0.75 wt % CBD, between about 0.125 wt % and about 0.75 wt % ethyl maltol, at least about 8 wt % non-ionic surfactant, and an aqueous solvent. The nanosuspension is stable at room temperature for at least about one month and has CBD particle size less than about 100 nanometers.
In the disclosed scope, the formulations can include poloxamer as the non-ionic surfactant and can optionally be lyophilized. Stability characterization includes particle size and polydispersity index (PDI), with the nanosuspensions described as maintaining favorable particle size and PDI after lyophilization and rehydration.
Claims Coverage
The independent claim defines an aqueous nanosuspension composition with specified wt % ranges and stability/particle-size requirements. Dependent claims refine the independent claim by specifying the non-ionic surfactant as poloxamer, adding a polydispersity index threshold, and specifying a minimum CBD content on a dry weight basis.
Ethyl maltol-enabled stable aqueous CBD nanosuspension
An aqueous nanosuspension of cannabidiol (CBD) comprising between about 0.25 wt % and about 0.75 wt % CBD and between about 0.125 wt % and about 0.75 wt % ethyl maltol, together with an aqueous solvent, where the nanosuspension is stable at room temperature for at least about one month.
Sub-100 nm CBD particle aqueous formulation with non-ionic surfactant
The aqueous nanosuspension further comprises at least about 8 wt % non-ionic surfactant and the CBD particle size is less than about 100 nanometers.
Poloxamer as the non-ionic surfactant
The non-ionic surfactant is poloxamer.
Low polydispersity index nanosuspension quality
The aqueous nanosuspension has a polydispersity index of no more than about 0.3.
Minimum CBD content on a dry weight basis
The aqueous nanosuspension comprises at least about 2% CBD on a dry weight basis.
Across the independent claim and its dependent refinements, the claimed invention centers on an ethyl maltol-containing aqueous nanosuspension of CBD with defined wt % ranges, at least about 8 wt % non-ionic surfactant, sub-100 nm CBD particle size, and room-temperature stability for at least about one month; dependent claims further require poloxamer, limit PDI to no more than about 0.3, and define a minimum CBD level on a dry weight basis.
Stated Advantages
Improved chemical and physical stability.
Improved shelf life.
Taste/flavor masking.
Improved CBD loading.
Documented Applications
Use as a beverage additive, assessed by stability upon 5x dilution for beverage/additive use.
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