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( 12 ) United States Patent US010653736B2 (12 ) United States Patent ( 10 ) Patent No.: US 10,653,736 B2 Sekura et al. (45 ) Date of Patent: May 19 , 2020 (54 ) TOPICAL TREATMENTS INCORPORATING A61K 9/06 (2013.01 ) ; A61K 9/08 ( 2013.01 ) ; CANNABIS SP . DERIVED BOTANICAL DRUG A61K 31/045 ( 2013.01) ; A61K 31/047 PRODUCT (2013.01 ) ; A61K 31/05 ( 2013.01) ; A61K 31/085 ( 2013.01 ) ; A61K 31/12 ( 2013.01) ; ( 71) Applicants :Ronald D. Sekura , Key Largo , FL A61K 31/235 ( 2013.01 ) ; A61K 31/245 (US ) ; Roscoe M.Moore , Rockville, ( 2013.01 ) ; A61K 31/352 ( 2013.01) ; A61K MD (US ) 31/573 ( 2013.01) ; A61K 31/618 ( 2013.01) ; A61K 36/00 ( 2013.01) ; A61K 36/61 ( 2013.01) ; ( 72 ) Inventors: Ronald D. Sekura , Key Largo , FL A61K 45/06 ( 2013.01) ; A61K 47/12 (2013.01 ) ; ( US ) ; Roscoe M.Moore , Rockville , A61K 47/44 ( 2013.01) ; A61P 17/06 ( 2018.01) ; MD (US ) A61Q 5/006 ( 2013.01 ) ; A61Q 5/02 (2013.01 ) ; ( * ) Notice : Subject to any disclaimer , the term of this A61Q 19/00 ( 2013.01) ; A61Q 19/001 patent is extended or adjusted under 35 ( 2013.01) U.S.C. 154 ( b ) by 0 days . (58 ) Field of Classification Search CPC A61K 36/00 ( 21) Appl. No .: 16 /257,389 USPC 424/725 See application file for complete search history. ( 22 ) Filed : Jan. 25 , 2019 (65 ) Prior Publication Data (56 ) References Cited US 2019/0175675 A1 Jun . 13 , 2019 U.S. PATENT DOCUMENTS 5,002,932 A 3/1991 Langelier et al . Related U.S. Application Data 6,355,280 B1 3/2002 Segal et al . 6,630,507 B1 10/2003 Hampson et al . (63 ) Continuation of application No. 15 / 914,064 , filed on 6,730,330 B2 5/2004 Whittle et al. Mar. 7 , 2018 , now Pat . No. 10,226,496 , which is a 6,949,582 B1 9/2005 Wallace continuation of application No. 14 /750,558 , filed on 7,026,360 B1 4/2006 Festo Jun . 25 , 2015 , now abandoned , which is a 2005/0079136 A1 4/2005 Woolfe et al. 2005/0123635 A1 6/2005 McAughey et al . continuation of application No. 14 / 498,555 , filed on 2007/0060639 A1 3/2007 Wermeling Sep. 26 , 2014 , now Pat. No. 9,095,563 . 2008/0206161 Al 8/2008 Tamarkin et al. 2008/0255224 Al 10/2008 Blum (60 ) Provisional application No. 61/ 882,990 , filed on Sep. 2011/0129463 A1 6/2011 Erez et al . 26 , 2013 . 2011/0256245 Al 10/2011 Rosenblatt et al . 2012/0264818 Al 10/2012 Newland (51 ) Int. Ci. 2013/0011484 A1 1/2013 Bevier A61K 36/00 ( 2006.01 ) 2014/0302121 Al 10/2014 Bevier A61K 36/185 (2006.01 ) A61K 31/352 ( 2006.01 ) FOREIGN PATENT DOCUMENTS A61K 31/573 ( 2006.01 ) W W 2008/127459 Al 10/2008 A61K 31/085 ( 2006.01 ) WO WO 2013/006729 A2 1/2013 A61K 31/245 (2006.01 ) WO 2015/048508 A1 4/2015 A61K 31/047 ( 2006.01) A61K 31/235 (2006.01 ) A61K 31/045 ( 2006.01 ) OTHER PUBLICATIONS A61K 36/61 ( 2006.01) Office Action dated Nov. 1 , 2019 in Australian Patent Application A61K 9/00 (2006.01 ) No. 2014324891 , pages . A61K 45/06 (2006.01 ) Chinese Office Action dated Sep. 20 , 2018 in corresponding Patent A61K 31/12 ( 2006.01) Application No. 201480064243.X (with English Translation ), 21 A61K 31/618 (2006.01 ) pages . A61K 47/12 ( 2006.01 ) A61K 9/06 (2006.01 ) ( Continued ) A61K 9/08 ( 2006.01 ) Primary Examiner — Michael V Meller A61K 47/44 ( 2017.01 ) A61K 8/49 (2006.01 ) (74 ) Attorney , Agent, or Firm Oblon , McClelland , A61Q 5700 ( 2006.01) Maier & Neustadt, L.L.P. A61Q 5/02 ( 2006.01) A61Q 19/00 ( 2006.01 ) ( 57 ) ABSTRACT A61P 17/06 ( 2006.01) A topical formulation comprising a Cannabis derived A61K 31/05 (2006.01 ) botanical drug product, wherein the concentration of tetra ( 52 ) U.S. CI. hydrocannabinol, cannabidiol, or both in the topical formu CPC A61K 36/185 (2013.01 ) ; A61K 8/498 lation is greater than 2 milligrams per kilogram . ( 2013.01) ; A61K 970014 (2013.01 ) ; A61K 9/0034 (2013.01 ) ; A61K 9/0043 ( 2013.01 ) ; 10 Claims, 1 Drawing Sheet US 10,653,736 B2 Page 2 ( 56 ) References Cited OTHER PUBLICATIONS Wei Taixing, “ Salicylic Acid ” , The Latest Clinical Drug Handbook , p . 765 and cover pages ( Aug. 31 , 2003 ) . Extended European Search Report dated Mar. 19 , 2018 in Patent Application No. 14846990.1 , 8 pages. Wilkinson , J. D. et al. , " Cannabinoids Inhibit Human Keratinocyte Proliferation Through a non -CB1 / CB2 Mechanism and have a Potential Therapeutic Value in the Treatment of Psoriasis ” Journal of Dermatological Science , Elsevier, vol . 45 , No. 2 , XP005836247 , pp . 87-92 ( Jan. 19 , 2007 ) . Office Action dated Jul. 19 , 2017 in Chinese Patent Application No. 201480064243.X (with English translation ) . Bhattacharya , et al. , Asia Pacific Journal of Pharmacology , pp . 179-188 ( 1989 ) . International Search Report and Written Opinion dated Dec. 29 , 2014 in PCT /US2014 /057801 . European Office Action dated Aug. 13 , 2019 in European Patent Application No. 14846990.1 , 6 pages . Canadian Office Action dated Sep. 30 , 2019 , in Patent Application No. 2,925,468 , 5 pages . U.S. Patent May 19 , 2020 US 10,653,736 B2 Fig . 1 . Fig . 2 . US 10,653,736 B2 1 2 TOPICAL TREATMENTS INCORPORATING products . To a large extent major focus has been directed at CANNABIS SP . DERIVED BOTANICAL DRUG systemically administered formulations and formulations PRODUCT taking advantage of psychotropic activities or use of can nabinoids as antioxidants and neuroprotectants . CROSS -REFERENCE TO RELATED 5 U.S. Pat . No. 6,630,507, incorporated herein by reference , APPLICATIONS discloses pharmaceutical compounds and compositions that are useful as tissue protectants , such as neuroprotectants and This application is a continuation of U.S. application Ser. cardioprotectants . The compounds and compositions are No. 15 /914,064 , filed on Mar. 7 , 2018 , which is a continu disclosed to be used in the treatment of acute ischemic ation of U.S. application Ser. No. 14 / 750,558, filed on Jun . 10 neurological insults or chronic neurodegenerative diseases . 25 , 2015 , which is a continuation of U.S. application Ser. The disclosed compositions include cannabidiol and other No. 14 /498,555 (now U.S. Pat . No. 9,095,563 ) , filed on Sep. cannabinoids, and the compositions are disclosed to include 26 , 14 , which claims the benefit of U.S. Provisional THC in amounts that do not promote psychoactive or Application No. 61/ 882,990 , filed on Sep. 26 , 2013 , which psychotoxic effects . Accordingly , there is no disclosure of is herein incorporated by reference in its entirety . 15 topical compositions that include THC in amounts that exceed the detection limit of THC . FIELD OF THE INVENTION In view of the foregoing , there is a need for topical This invention relates to topical formulations that com formulations that comprise a Cannabis derived botanical prise a Cannabis derived botanical drug product , methods of 20 drug product that take advantage of diverse pharmacologic making the topical formulations, and methods of using the activities, that are beyond and unforeseen from those topical formulations in treating dermatological diseases. described in U.S. Pat . No. 6,630,507 B1, in treatment of dermatologic and other diseases. We also define that the BACKGROUND OF THE INVENTION major cannabinoids are present in our products at concen 25 trations exceeding the commmonly applied maximum levels The botanical genus Cannabis includes the species indica that define cannabis derived products , such as hemp oil, and sativia . Within these species multiple distinct varieties legal for non -drug use can provide unexpected and highly and strains have been and continue to be developed . The genus known produce more than 480 different chemical beneficial treatments for a wide variety of diseases. substances . Among these chemicals approximately 80 dis- 30 BRIEF SUMMARY OF THE INVENTION tinct entities exist which are classified as cannabinoids. The two species differ in the amount of tetrahydrocannabinol One object of the invention is to provide a topical prepa ( THC ) produced. Cannabis sativia produces higher levels of ration comprising a Cannabis derived botanical drug prod THC . The psychotropic affects associated with THC have uct such that the concentration of tetrahydrocannabinol in made the sativia species preferred as a recreational sub- 35 the final product is greater than 2 milligrams per kilogram . stance and for medicinal use where the psychotropic effect Other objects of the invention include methods of making is desired . Not -with - standing THC and other chemical enti the topical preparations and methods of using the topical ties produced by the sativia species have significant and preparations to treat dermatological diseases. diverse pharmacological action . The indica species is cultivable in cooler climates and 40 BRIEF DESCRIPTION OF THE DRAWINGS produce more cannabidiol ( CBD ) than THC . This allows production of extracts with low THC . The seeds from FIG . 1 shows an area of skin affected by plaque psoriasis . Cannabis species are used to produce hemp oil which is used FIG . 2 shows the results of treating psoriasis affected area industrially and also as a nutritional supplement. by application of topical formulation comprising a Cannabis Cannabis derived materials which may contain THC and 45 derived botanical drug product according to the present CBD in addition to numerous natural substances produced invention . by the plants have been reported to have diverse pharma cological activities that include analgesic , anti- inflamma EMBODIMENTS OF THE PRESENT tory, anti - cancer , antibiotic , and anti- oxidant activity . INVENTION In most jurisdictions throughout the world , including the 50 United States , cannabinoids (which include THC , structur One embodiment of the present invention is [ 1 ] a topical ally related compounds, and in some instances CBD ) are formulation comprising a Cannabis derived botanical drug controlled substances and use for medical purposes has been product, wherein the concentration of tetrahydrocannabinol discouraged .
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