# US 11,439,602 B2 · Composition and method for transdermal delivery of cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC) > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,439,602 B2 - Document ID: US11439602B2 - Status: Granted - Kind: B2 - Application number: 17/170,231 - Filed: 2021-02-08 - Published: 2021-08-19 - Granted: 2022-09-13 - Earliest claimed: 2020-02-18 - Assignees: Ovation Science Inc. - Applicants: Ovation Science Inc. - Inventors: James A. Roszell - Web page: https://patentgrep.com/patent/US11439602B2 ## CPC - A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)} - A61K 9/7053: {obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene} - A61K 9/7007: {Drug-containing films, membranes or sheets (A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence)} - A61K 31/658: {o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol} - A61K 47/32: Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers {, poly(meth)acrylates, or polyvinyl pyrrolidone} - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) ## Abstract A transdermal delivery composition for the delivery to skin and the penetration of the skin includes: (a) a therapeutic effective amount of a cannabinoid mixture, wherein the cannabinoid mixture comprises cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC) at a weight ratio of about 1:20 to about 20:1; (b) a hydrophilic polymer/hydrophobic polymer adduct in an amount sufficient to hold the cannabinoid composition and provide a sustain release of the cannabinoid mixture after application to skin tissue over a time period of at least 6 hours; (c) a penetrant component in an amount sufficient to assist with a transdermal penetration of the cannabinoid mixture through skin tissue once the composition has been applied to skin tissue; (d) a surfactant component in an amount sufficient to stabilize the polymer adduct and release the cannabinoid mixture from the transdermal delivery composition upon application to skin tissue; and (e) at least about 70 wt. % water. A method of application of a transdermal delivery composition to skin tissue includes applying the transdermal delivery composition to skin tissue and spreading the composition to form a film on the skin tissue. A method for formulating a transdermal delivery composition based on a desired penetration weight ratio of CBD to THC through skin tissue includes selecting a formulation weight ratio of CBD to THC for formulating the composition, wherein the weight ratio is determined by multiplying the desired penetration weight ratio of CBD to THC by a CBD/TCH delivery factor, wherein the CBD/THC delivery factor. ## Claims ### Claim 1 A transdermal delivery composition comprising: (a) at least 0.05 wt. % of a cannabinoid mixture, wherein the cannabinoid mixture comprises cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC) at a weight ratio of about 20:1 to about 1:20; (b) a hydrophilic polymer/hydrophobic polymer adduct in an amount sufficient to hold the cannabinoid mixture and provide a sustained release of the cannabinoid mixture after application to skin tissue, wherein the hydrophobic polymer/hydrophilic polymer adduct comprises at least two different poly(vinylpyrrolidone/alkylene) polymers, wherein the alkylene group of each polymer contains at least 10 carbon atoms, and wherein the hydrophilic polymer/hydrophobic polymer adduct comprises poly(maleic acid/methylvinylether) copolymer having a weight average molecular weight of about 50,000 to 4,000,000; (c) 3.5 wt. % to 5 wt. % of penetrant component comprising a mixture of oleic acid and limonene to assist with a transdermal penetration of the cannabinoid mixture through skin tissue once the composition has been applied to skin tissue; (d) about 3 wt. % to about 9 wt. % of a surfactant component to release the cannabinoid mixture from the transdermal delivery composition upon application to skin tissue; and (e) at least about 70 wt. % water. ### Claim 2 (depends on 1) A transdermal delivery composition according to claim 1, wherein the at least two different poly(vinylpyrrolidone/alkylene) polymers comprise poly(vinylpyrrolidone/1-eicosene) and poly(vinylpyrrolidone/hexadecene). ### Claim 3 (depends on 1) A transdermal delivery composition according to claim 1, wherein the cannabinoid mixture comprises the CBD and THC at a weight ratio of about 10:1 to about 1:10. ### Claim 4 (depends on 1) A transdermal delivery composition according to claim 1, wherein the composition further comprises an emollient in an amount of about 1 wt. % to about 5 wt. %. ### Claim 5 (depends on 1) A transdermal delivery composition according to claim 1, wherein the composition further comprises an antioxidant in an amount of about 0.1 wt. % to about 1 wt. %. ### Claim 6 (depends on 1) A transdermal delivery composition according to claim 1, wherein the composition further comprises a pH neutralizing agent in an amount sufficient to provide a pH of about 6-7.5. ### Claim 7 (depends on 1) A transdermal delivery composition according to claim 1, wherein the transdermal delivery composition provides a sustained release of the cannabinoid mixture after application to skin tissue over a time period of at least 4 hours. ### Claim 8 (depends on 1) A transdermal delivery composition according to claim 1, wherein the transdermal delivery composition provides a sustained release of the cannabinoid mixture after application to skin tissue over a time period of at least 6 hours. ### Claim 9 (depends on 1) A transdermal delivery composition according to claim 1, wherein the transdermal delivery composition comprises 0.05 wt. % to 2 wt. % of the cannabinoid mixture. ### Claim 10 (depends on 1) A transdermal delivery composition according to claim 1, wherein the transdermal delivery composition comprises 0.1 wt. % to 1.5 wt. % of the cannabinoid mixture.