Transdermal delivery of tetrahydrocannabinol
Inventors
Plakogiannis, Fotios M. • Lather, Tamanna • Modi, Nisarg • Borovinskaya, Marina
Assignees
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Publication Number
US-12268699-B2
Publication Date
2025-04-08
Expiration Date
Abstract
Provided is a transdermal drug delivery system comprising tetrahydrocannabinol (THC). Transdermal delivery can provide a drug plasma concentration at predetermined rate for a predetermined period of time with a simplified therapeutic regimen by decreasing dosing frequency for the treatment and/or prevention of pain and/or inflammation.
Core Innovation
The invention relates to a THC transdermal delivery pharmaceutical composition and, in particular, a transdermal matrix patch formulation. The composition includes tetrahydrocannabinol (THC) and is formulated to provide a constant rate of delivery of active components. The patch is intended to deliver THC in a therapeutic range over a period of time, including over 7 days.
The composition is defined by specific formulation components and concentration ranges, including a solvent comprising propylene glycol, a penetration enhancer comprising oleic acid, an antioxidant comprising butylated hydroxytoluene, suspending agent(s) comprising silicon dioxide, and polyvinylpyrrolidone, together with a silicone pressure sensitive adhesive. The pH of the composition is maintained at approximately 4.0 to 8.0, and the patch is characterized as a transdermal matrix patch.
The described system addresses delivery performance goals by avoiding dosing variability and by aiming to maintain steady systemic exposure rather than oral first-pass metabolism and plasma peak/trough behavior. In the described context, the constant delivery supports treating and/or preventing pain and inflammation, including neuropathic pain, and is also described for Parkinson’s disease. The document further supports formulation scope that may include transdermal liquid/semisolid/matrix patch variants and optional microneedles.
Claims Coverage
The independent claim identified in the provided material is clm-00001. It sets out one central inventive concept: a THC-containing transdermal matrix patch composition with specified component concentration ranges, maintained pH, and constant-rate delivery over 7 days in a therapeutic range. Dependent claims further narrow the delivery performance outcomes and medical use contexts (e.g., Parkinson’s disease and dosing intervals) but are not separately independent claims in the provided excerpt.
THC transdermal matrix patch with defined solvent, enhancer, antioxidant, suspending agent, and adhesive
A pharmaceutical composition comprising tetrahydrocannabinol (THC) in a dosage form for transdermal delivery in the form of a transdermal matrix patch, wherein the pharmaceutical composition comprises a concentration of THC selected from specified w/w percentages; about 5% to about 20% w/w propylene glycol; about 1% to about 20% w/w oleic acid; about 0.1% to about 0.7% w/w butylated hydroxytoluene; about 2% to about 15% w/w silicon dioxide; about 0.1% to about 20% w/w polyvinylpyrrolidone; and about 50% to about 80% w/w of a silicone pressure sensitive adhesive.
Maintained pH of approximately 4.0 to 8.0 for the transdermal composition
The pH of the composition is maintained at approximately 4.0 to 8.0.
Constant rate of delivery in a therapeutic range over 7 days
The pharmaceutical composition provides a constant rate of delivery of the active components of the transdermal matrix patch in a therapeutic range in a patient over 7 days.
Across the independent claim and its dependent refinements, the coverage centers on a THC transdermal matrix patch with specified formulation components, maintained pH of approximately 4.0 to 8.0, and constant-rate delivery that provides active components in a therapeutic range over 7 days. The dependent claims further specify delivery-performance outcomes such as plasma concentration within a therapeutic range and reduced variability, and narrow medical treatment contexts including pain and inflammation and Parkinson’s disease.
Stated Advantages
Provides a constant rate of delivery of the active components in a therapeutic range in a patient over 7 days.
Maintains plasma concentrations of active components within a therapeutic range over time.
Reduces variability in the dosage of active components delivered over a time period.
Documented Applications
Treating and/or preventing pain and inflammation, including neuropathic pain.
Treating Parkinson’s disease by selecting a patient and topically applying a transdermal-delivery dosage-form pharmaceutical composition.
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