(12) United States Patent (10) Patent No.: US 9,095,563 B2 Sekura Et Al
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US009095563B2 (12) United States Patent (10) Patent No.: US 9,095,563 B2 Sekura et al. (45) Date of Patent: Aug. 4, 2015 (54) TOPICAL TREATMENTS INCORPORATING A61E36/6 (2006.01) CANNABSSP. DERVED BOTANCAL DRUG A61E36/00 (2006.01) PRODUCT (52) U.S. Cl. CPC ............. A6 IK3I/352 (2013.01); A61 K3I/045 (71) Applicants: Ronald D. Sekura, Key Largo, FL (US); (2013.01); A61 K3I/047 (2013.01); A61 K Roscoe M. Moore, Jr., Rockville, MD 31/085 (2013.01); A61 K3I/235 (2013.01); (US) A6 IK3I/245 (2013.01); A61 K3I/573 (2013.01); A61 K36/00 (2013.01); A61 K (72) Inventors: Ronald D. Sekura, Key Largo, FL (US); 36/85 (2013.01); A6 IK36/6 (2013.01) Roscoe M. Moore, Jr., Rockville, MD (58) Field of Classification Search (US) CPC ...................................................... A61K 36/00 (*) Notice: Subject to any disclaimer, the term of this S. licati - - - - - file? - - - - - - - - - - - - -let - - - - - - - - - - -h hist 424f725 patent is extended or adjusted under 35 ee appl1cauon Ille Ior complete searcn n1Story. U.S.C. 154(b) by 0 days. (56) References Cited (21) Appl. No.: 14/498,555 U.S. PATENT DOCUMENTS (22) Filed: Sep. 26, 2014 6,630,507 B1 10/2003 Hampson et al. 7,026,360 B1 4/2006 Festo (65) Prior Publication Data 2008/0206161 A1 8/2008 Tamarkin et al. 2008, 0255224 A1 10, 2008 Blum US 2015/OO86494 A1 Mar. 26, 2015 OTHER PUBLICATIONS Related U.S. Application Data International Search Report and Written Opinion issued Dec. 29. (60) Provisional application No. 61/882,990, filed on Sep. 2014 in PCT/US2014/057801. 26, 2013. Primary Examiner — Michael Meller (51) Int. Cl. (74) Attorney, Agent, or Firm - Oblon, McClelland, Maier AOIN 65/00 (2009.01) & Neustadt, L.L.P. A6 IK3I/352 (2006.01) A 6LX3/573 (2006.01) (57) ABSTRACT A6 IK3I/085 (2006.01) A topical formulation comprising a Cannabis derived botani A6 IK3I/245 (2006.01) cal drug product, wherein the concentration of tetrahydrocan A6 IK3 L/047 (2006.01) nabinol, cannabidiol, or both in the topical formulation is A6 IK3I/235 (2006.01) greater than 2 milligrams per kilogram. A6 IK3I/045 (2006.01) A6 IK36/85 (2006.01) 30 Claims, 1 Drawing Sheet U.S. Patent Aug. 4, 2015 US 9,095,563 B2 US 9,095,563 B2 1. 2 TOPCAL TREATMENTS INCORPORATING are useful as tissue protectants, such as neuroprotectants and CANNABSSP DERVED BOTANCAL DRUG cardioprotectants. The compounds and compositions are dis PRODUCT closed to be used in the treatment of acute ischemic neuro logical insults or chronic neurodegenerative diseases. The CROSS-REFERENCE TO RELATED disclosed compositions include cannabidiol and other can APPLICATIONS nabinoids, and the compositions are disclosed to include THC in amounts that do not promote psychoactive or psychotoxic This application claims the benefit of U.S. Provisional effects. Accordingly, there is no disclosure of topical compo Application No. 61/882,990, filed on Sep. 26, 2013, which is sitions that include THC in amounts that exceed the detection herein incorporated by reference in its entirety. 10 limit of THC. In view of the foregoing, there is a need for topical formu FIELD OF THE INVENTION lations that comprise a Cannabis derived botanical drug prod This invention relates to topical formulations that comprise uct that take advantage of diverse pharmacologic activities, a Cannabis derived botanical drug product, methods of mak 15 that are beyond and unforeseen from those described in U.S. ing the topical formulations, and methods of using the topical Pat. No. 6,630.507 B1, in treatment of dermatologic and other formulations in treating dermatological diseases. diseases. We also define that the major cannabinoids are present in our products at concentrations exceeding the com BACKGROUND OF THE INVENTION monly applied maximum levels that define cannabis derived products, such as hemp oil, legal for non-drug use can provide The botanical genus Cannabis includes the species indica unexpected and highly beneficial treatments for a wide vari and sativia. Within these species multiple distinct varieties ety of diseases. and strains have been and continue to be developed. The genus known produce more than 480 different chemical sub BRIEF SUMMARY OF THE INVENTION stances. Among these chemicals approximately 80 distinct 25 entities exist which are classified as cannabinoids. The two One object of the invention is to provide a topical prepara species differ in the amount of tetrahydrocannabinol (THC) tion comprising a Cannabis derived botanical drug product produced. Cannabis sativia produces higher levels of THC. such that the concentration of tetrahydrocannabinol in the The psychotropic affects associated with THC have made the final product is greater than 2 milligrams per kilogram. Other sativia species preferred as a recreational Substance and for 30 objects of the invention include methods of making the topi medicinal use where the psychotropic effect is desired. Not cal preparations and methods of using the topical prepara with-standing THC and other chemical entities produced by tions to treat dermatological diseases. the sativia species have significant and diverse pharmacologi cal action. BRIEF DESCRIPTION OF THE DRAWINGS The indica species is cultivable in cooler climates and 35 produce more cannabidiol (CBD) than THC. This allows FIG. 1 shows an area of skin affected by plaque psoriasis. production of extracts with low THC. The seeds from Can FIG. 2 shows the results of treating psoriasis affected area nabis species are used to produce hemp oil which is used by application of topical formulation comprising a Cannabis industrially and also as a nutritional Supplement. derived botanical drug product according to the present Cannabis derived materials which may contain THC and 40 invention. CBD in addition to numerous natural substances produced by the plants have been reported to have diverse pharmacologi EMBODIMENTS OF THE PRESENT cal activities that include analgesic, anti-inflammatory, anti INVENTION cancer, antibiotic, and anti-oxidant activity. In most jurisdictions throughout the world, including the 45 One embodiment of the present invention is 1 a topical United States, cannabinoids (which include THC, structur formulation comprising a Cannabis derived botanical drug ally related compounds, and in Some instances CBD) are product, wherein the concentration of tetrahydrocannabinol controlled Substances and use for medical purposes has been in the topical formulation is greater than 2 milligrams per discouraged. Since some products derived from cannabis kilogram. species are economically important (e.g. hemp oil) maximum 50 Another embodiment of the present invention is 2 a topi levels for cannabinoids in products have been set. In Cana cal formulation comprising a Cannabis derived botanical dian hemp seed oil THC levels are usually below detection drug product, wherein the concentration of cannabidiol in the limit of 4 ppm (parts per million, or 4 mg/kg). Legal limit for topical formulation is greater than 2 milligrams per kilogram. THC content in foodstuffs in Canada is 10 ppm. Some Euro Another embodiment of the present invention is 3 a topi pean countries have limits of 5 ppm or none-detected, some 55 cal formulation comprising a Cannabis derived botanical EU countries do not have such limits at all. drug product, wherein the concentration of each, cannabidiol Relaxation of laws limiting the use of marijuana and thus and tetrahydrocannabinol, in the topical formulation is cannabinoid containing products, in some jurisdictions (e.g. greater than 2 milligrams per kilogram. as of 2013 medical marijuana is considered legal in 20 states Another embodiment of the present invention is 4 a topi and the District of Columbia) has opened the door to encour 60 cal formulation according to 1, 2, or 3, which further age development of new cannabinoid containing products. To comprises hydrocortisone or any steroid within Groups I to a large extent major focus has been directed at Systemically VII in the US classification system in a therapeutically effec administered formulations and formulations taking advan tive amount. tage of psychotropic activities or use of cannabinoids as anti Another embodiment of the present invention is 5 a topi oxidants and neuroprotectants. 65 cal formulation according to 1, 2, or 3, which further U.S. Pat. No. 6,630,507, incorporated herein by reference, comprises an antibiotic compound in a therapeutically effec discloses pharmaceutical compounds and compositions that tive amount. US 9,095,563 B2 3 4 Another embodiment of the present invention is 6 a topi DETAILED DESCRIPTION OF THE INVENTION cal formulation according to 1, 2, or 3, which further comprises an antiseptic compound in a therapeutically effec Unless indicated otherwise, the indefinite articles “a” and tive amount. “an are synonymous with “at least one' or “one or more.” Another embodiment of the present invention is 7 a topi Unless indicated otherwise, definite articles used herein, such cal formulation according to 1, 2, or 3, which further as “the also include the plural of the noun. Terms used herein comprises an antifungal compound in a therapeutically effec Such as "comprising.” “consisting essentially of” and “con tive amount. sisting of have their ordinary and customary meaning under Another embodiment of the present invention is 8a topi U.S. patent law. Unless otherwise indicated, the transitional cal formulation according to 1, 2, or 3, which further 10 comprises an anti-acne agent in a therapeutically effective term "comprising is synonymous with “including.” “con amount. taining,” or “characterized by and is inclusive or open-ended Another embodiment of the present invention is 9 a topi and does not exclude additional, unrecited elements or cal formulation according to 1, 2, or 3, which further method stages. Unless otherwise indicated, the transitional comprises a soothing, Smoothing, moisturizing or protective 15 term “consisting essentially of limits the scope of the claim agent in a therapeutically effective amount.