Transdermal delivery of cannabidiol
Inventors
Plakogiannis, Fotios M. • Lather, Tamanna • Modi, Nisarg • Borovinskaya, Marina
Assignees
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Publication Number
US-12097293-B2
Publication Date
2024-09-24
Expiration Date
Abstract
Provided is a transdermal drug delivery system comprising cannabidiol, or a cannabidiol salt alone or in combinations thereof. 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 disclosure describes a pharmaceutical composition comprising cannabidiol (CBD) in a dosage form for transdermal delivery, particularly in the form of a transdermal matrix patch. The composition includes a CBD concentration selected from specified percentage w/w options, a solvent comprising propylene glycol, a penetration enhancer comprising oleic acid, a suspending agent comprising silicon dioxide, and a silicone pressure sensitive adhesive. The pH of the composition is maintained at approximately 4.0 to 8.0.
The transdermal matrix patch provides a constant rate of delivery of the active components in a therapeutic range in a patient over 7 days, including delivery over a period of time for pain and/or inflammation. The disclosed transdermal delivery system is presented as addressing limitations of prior regimens, including reducing dosing frequency and dosing variability compared with oral regimens while maintaining therapeutic plasma levels.
The method coverage includes selecting a patient in need of treatment of pain and/or inflammation and topically applying a pharmaceutical composition comprising cannabidiol and specified cannabidiol forms, derivatives, and active metabolites in a dosage form for transdermal delivery. Dependent aspects further describe maintaining constant blood serum levels and maintaining plasma concentration of the active components within a therapeutic range over time, with delivery at a constant rate and steady absorption.
Claims Coverage
The document includes two independent claims. The first independent claim specifies a transdermal matrix patch composition with tightly defined CBD formulation components and pH, and a defined constant delivery performance over 7 days. The second independent claim specifies a topical transdermal treatment method for pain and/or inflammation using a CBD-containing pharmaceutical composition that includes a broad set of cannabidiol forms and active metabolites.
CBD transdermal matrix patch with defined solvent, penetration enhancer, suspending agent, and silicone adhesive
A pharmaceutical composition comprising cannabidiol (CBD) in a dosage form for transdermal delivery, wherein the composition comprises a concentration of CBD selected from about 1% to about 15% w/w; about 5% to about 20% w/w of a solvent comprising propylene glycol; about 1% to about 20% w/w of a penetration enhancer comprising oleic acid; about 2% to about 15% w/w of at least one suspending agent comprising silicon dioxide; about 50% to about 80% w/w of a silicone pressure sensitive adhesive; and wherein the pH of the composition is maintained at approximately 4.0 to 8.0.
Constant rate transdermal delivery in therapeutic range over 7 days
The pharmaceutical composition is in the form of a transdermal matrix patch, further wherein 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.
Topical transdermal treatment method for pain and/or inflammation using CBD-containing pharmaceutical composition
A method for the treatment of pain and/or inflammation comprising selecting a patient in need of treatment of pain and/or inflammation; topically applying a pharmaceutical composition comprising cannabidiol and selected cannabidiol forms including the free base, salts, isomers, amorphous forms, crystalline forms, co-crystalline forms, prodrugs, analogs, derivatives, synthetic forms, biosynthetic forms, and active metabolites, alone or in combinations thereof, in a dosage form for transdermal delivery.
Overall, the claim coverage centers on a specified transdermal matrix patch formulation maintaining pH approximately 4.0 to 8.0 with defined CBD, propylene glycol, oleic acid, silicon dioxide, and silicone pressure sensitive adhesive, and a topical method of treating pain and/or inflammation by applying the CBD-containing transdermal dosage form.
Stated Advantages
Reduces dosing frequency versus oral regimens.
Reduces dosing variability and supports therapeutic plasma levels via constant rate delivery over the stated period.
Documented Applications
Treatment of pain and/or inflammation using a topical transdermal delivery system comprising cannabidiol and specified cannabidiol forms and derivatives in a transdermal dosage form.
Delivery for pain and/or inflammation indications including headaches, migraine, tension headaches, cluster headaches, neuropathic pain, nociceptive pain, fibromyalgia, arthritis and rheumatism, and other specified pain categories and patient populations listed in the method coverage.
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