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That the Tout Untuk Ta on Mi Lova U It Aliana THATTHE TOUT UNTUK TAUS ON20170348276A1 MI LOVAU IT ALIANA (19 ) United States (12 ) Patent Application Publication ( 10) Pub . No. : US 2017/ 0348276 A1 Bryson et al . (43 ) Pub . Date : Dec . 7 , 2017 ( 54 ) NASAL CANNABIDIOL COMPOSITIONS A61K 47 /26 (2006 .01 ) A61K 47 / 02 (2006 .01 ) (71 ) Applicant: Acerus Pharmaceutical Corporation , A61K 36 / 185 ( 2006 .01 ) Mississauga (CA ) A61K 31 /05 ( 2006 .01 ) A61K 9 / 06 ( 2006 . 01 ) (72 ) Inventors : Nathan Bryson , Toronto (CA ) ; A61K 47 / 44 ( 2006 . 01) Avinash Chander Sharma, Brampton A61K 9 /00 (2006 . 01) (CA ) (52 ) U . S . CI. CPC .. .. .. A61K 31/ 352 (2013 . 01 ) ; A61K 47 /44 (21 ) Appl . No. : 15 /613 , 116 (2013 .01 ) ; A61K 47/ 38 ( 2013 .01 ) ; A61K 47/ 26 (2013 .01 ) ; A61K 9 / 0043 ( 2013 . 01 ) ; A61K ( 22 ) Filed : Jun . 2 , 2017 36 / 185 ( 2013 .01 ) ; A61K 31 /05 ( 2013 . 01 ) ; Related U . S . Application Data A61K 9 /06 (2013 . 01 ) ; A61K 47/ 02 (2013 . 01) (60 ) Provisional application No . 62 /426 ,403 , filed on Nov. (57 ) ABSTRACT 25 , 2016 , provisional application No. 62 /344 ,486 , A nasally administered cannabinoid semi- solid or viscous filed on Jun . 2 , 2016 . liquid composition ; nasal methods for administering the nasal pharmaceutical compositions ; methods for manufac Publication Classification turing the nasal pharmaceutical compositions ; and nasal ( 51 ) Int. Cl. methods of treating diseases treatable by the nasal pharma A61K 31/ 352 ( 2006 .01 ) ceutical compositions formulated with a cannabinoid or A61K 4738 ( 2006 .01 ) mixtures thereof. MULTIT - 134 . - . - - - - - - - - 130 - 102 132 c 100 me 144 N 128 140 - 150 120 - 124 Patent Application Publication Dec. 7 , 2017 Sheet 1 of 9 US 2017 / 0348276 A1 ? ??? ? . ?? ?? ?? .???? ? ?????? ???? . : 8 100 140 - ???? [1T FIG , 1 Patent Application Publication Dec . 7 , 2017 Sheet 2 of 9 US 2017 /0348276 A1 144 146 178 L Det 152 174 . 140 142 - 172 180 mm . 164 - 170 B IMME à FIG . 2 Patent Application Publication Dec . 7 , 2017 Sheet 3 of 9 US 2017 /0348276 A1 IIIIIIIII 230 200 244 228 240 250 226 280 222 . 220 . 224 FIG . 3 Patent Application Publication Dec . 7 , 2017 Sheet 4 of 9 US 2017 /0348276 A1 244 246 278 FT 274 SR 240 280 242 276 264 - 270 262 MOS 260 290 - FIG . 4 Patent Application Publication Dec . 7 , 2017 Sheet 5 of 9 US 2017 /0348276 A1 16 , 4 2 w FUT 15 ML POL ( BARREL 62,60.3 69.151055. PISTON 15 ML } PISTON FOND 15 ML ( . ) BASEose to me ( ) FIG . 5 Patent Application Publication Dec . 7 , 2017 Sheet 6 of 9 US 2017 /0348276 A1 Capoi SP 15 ) * ** OVERCAP SP 15 . MY * * 1 , 5 * 2 * 4 * * * ** * * * * * * + * - * 1 , * . " W * * * . " Poussoir Digital ( 1 ** * DIGITAL ACTUATOR ** 65,07–08 Bague SP 15 ( 1) SNAP ON SP15 Joinide com o Neck Gasket . 1 . * 6 * 2422 D- - * Mécanisme VP39 / 140 H TA 014 , 7 ( MECHANISMVP 39 / 140 H TA 014 , 7 Ø24 , 24 0 , 15 FIG . 6 Patent Application Publication Dec . 7 , 2017 Sheet 7 of 9 US 2017 /0348276 A1 STEP 1 STEP 4 STEP 7 BLOW YOUR NOSE AM THE TIP OF THE REPEAT THE PROCESS TO CLEAR YOUR ACTUATOR TO THE INNER FOR THE RIGHT NOSTRIL NOSTRLS CORNER OF YOUR LEFT EYE . THE OPENING ON THE TIP OF THE ACTUATOR MUST FACE THE NASAL MUCOSA STEP STEP 5 STEP 8 REMOVE THE CAP DEPRESS THE PUMP PLACE YOUR FINGER UNTIL IT STOPS ON THE PUMP OF THE ACTUATOR AND , IN FRONT OF A MIRROR , ADVANCE THE TIP OF THE ACTUATOR INTO YOUR RIGHT NOSTRIL UNTIL THE FINGER ON THE PUMP REACHES THE BASE OF THE NOSE STEP 3 STEP 6 STEP 9 mi PLACE YOUR FINGER SLOWLY REMOVE AIM THE TIP OF THE ON THE PUMP OF THE THE ACTUATOR FROM ACTUATOR TO THE ACTUATOR AND , IN FRONT YOUR NOSE INNER CORNER OF OF A MIRROR . ADVANCE CONTINUE ON YOUR RIGHT EYE THE TIP OF THE ACTUATOR REVERSE SIDE THE OPENING ON INTO YOUR LEFT NOSTRIL THE TIP OF THE UNTIL THE FINGER ON ACTUATOR MUST THE PUMP REACHES FACE THE NASAL THE BASE OF THE NOSE MUCOSA FIG . 7A Patent Application Publication Dec . 7 , 2017 Sheet 8 of 9 US 2017 /0348276 A1 STEP 10 ch DEPRESS THE PUMP UNTIL IT STOPS SLOWLY REMOVE THE ACTUATOR FROM YOUR NOSE STEP 11 AS AVA GEL THAT REMAINS ON THE TIP OF THE ACTUATOR USING A CLEAN , DRY SWAB STEP 12 PRESS THE NOSTRILS NEAR THE BRIDGE OF THE NOSE LIGHTLY TOGETHER AND MASSAGE FOR ONE SECOND DO NOT BLOW YOUR NOSE OR SNIFF FOR ONE HOUR AFTER ADMNISTRATION OF THE MEDICATION FIG . 7B Patent Application Publication Dec . 7 , 2017 Sheet 9 of 9 US 2017 /0348276 A1 Pharmacokinetic analysis of 10 % and 20 % CBD in Castor Oil after administration to 4 subjects . .*. 1 . 5 . 4 . 5. 6 . many thinnan Sobje *. Onvon . + . Modw . Subja 1 - Subj3 * * V :'(Y w . Sooj4 -, . * .4 A IN 100UNAS00 . ? . * * * * * * ** * wwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwMMWWMN .. 10 . 00 15 . 00 20 . 00 25 . 00 3000 FIG . 8 US 2017 /0348276 A1 Dec . 7 , 2017 NASAL CANNABIDIOL COMPOSITIONS rons. The CB , receptor is also expressed in many other organs and tissues including adipocytes, leukocytes , spleen , RELATED APPLICATIONS heart , lung , the gastrointestinal tract ( liver , pancreas , stom [ 0001 ] This application for U . S patent claims the benefit ach , and the small and large intestine ) , kidney , bladder , of and priority to U . S . Provisional Application Ser . No . reproductive organs, skeletalmuscle , bone, joints , and skin . 62/ 426 , 403 , filed Nov. 25 , 2016 and entitled “ Cannabidiol CB , receptor expression appears to be relatively sparse in Nasal Formulations” , and U . S . Provisional Application Ser. the brainstem region . CB2 receptors are most highly con No . 62 /344 ,486 , filed Jun . 2 , 2016 and entitled “ Cannabidiol centrated in the tissues and cells of the immune system such Nasal Formulations ” . Each of the foregoing U . S . Provisional as the leukocytes and the spleen , but can also be found in Applications and their content are incorporated herein by bone and to a lesser degree in liver and in nerve cells reference in their entireties . including astrocytes , oligodendrocytes and microglia , and even some neuronal sub - populations. FIELD OF THE INVENTION [ 0006 ] Dysregulation of the endocannabinoid system [0002 ] The present invention is directed to cannabinoid appears to be connected to a number of pathological con pharmaceutical compositions for topical application into the ditions , with the changes in the functioning of the system nasal cavity of a subject, nasal methods of use thereof and being either protective or maladaptive. Modulation of the methods of manufacture . In accordance with the present endocannabinoid system either through the targeted inhibi invention , the nasal cannabinoid compositions of the present tion of specific metabolic pathways, and /or directed agonism invention can be used as medical cannabis to treat disorders or antagonism of its receptors may hold therapeutic promise . or disease states or alleviate or mitigate symptoms thereof However , a major and consistent therapeutic challenge con where it is useful to administer cannabinoid , such as schizo fronting the routine use of psychoactive cannabinoids ( e . g . phrenia , epilepsy, pain , anxiety , spasticity and migraine . The THC ) in the clinic has remained that of achieving selective nasal cannabinoid compositions of the present invention are targeting of the site of disease and the sparing of other bodily semi- solid or viscous liquid pharmaceutical compositions , regions such as the mood and cognitive centers of the brain . namely, creams, gels and emulsions, preferably thixotropic creams, gels and emulsions, that are formulated with thera [0007 ] Cannabis peutically effective amounts of cannabinoid and are nasally [ 0008 ] Marihuana (Marijuana ) is the common name for administered to treat disorders or disease states or alleviate Cannabis sativa ( i . e . cannabis ), a hemp plant that grows or mitigate symptoms thereof that are treatable with can throughout temperate and tropical climates . The leaves and nabinoid . flowering tops of Cannabis plants contain at least 489 distinct compounds distributed among 18 different chemical BACKGROUND classes , and harbor more than 70 different phytocannabi [ 0003] Endocannabinoid System noids. The principal cannabinoids appear to be delta - 9 [ 0004 ] The endocannabinoid system is an ancient, evolu tetrahydrocannabinol (i .e . 19- THC , THC ) , cannabinol tionarily conserved , and ubiquitous lipid signaling system ( CBN ) , and cannabidiol (CBD ) , although the relative abun found in all vertebrates , and which appears to have impor dance of these and other cannabinoids can vary depending tant regulatory functions throughout the human body . The on a number of factors such as the Cannabis strain , the soil endocannabinoid system has been implicated in a very broad and climate conditions , and the cultivation techniques . Other number of physiological as well as pathophysiological pro cannabinoids found in cannabis include cannabigerol cesses including neural development, immune function , (CBG ) , cannabichromene (CBC ) , tetrahydrocannabivarin inflammation , appetite , metabolism and energy homeostasis , ( THCV ) and many others . In the living plant, these phyto cardiovascular function , digestion , bone development and cannabinoids exist as both inactive monocarboxylic acids bone density , synaptic plasticity and learning , pain , repro ( e . g . THCA ) and as active decarboxylated forms ( e . g . THC ) ; duction , psychiatric disease , psychomotor behaviour, however , heating ( at temperatures above 120° C . ) promotes memory , wake / sleep cycles , and the regulation of stress and decarboxylation ( e . g . THCA to THC ) and results in biologi emotional state . The system consists of the cannabinoid 1 cal activation . Furthermore , pyrolysis transforms each of the and 2 (CB1 and CB2 ) receptors, the CB receptor ligands hundreds of compounds in cannabis into a number of other N - arachidonoylethanolamine ( i . e . anandamide or AEA ) and compounds, many of which remain to be characterized both 2 -arachidonoylglycerol ( 2 - AG ) as well as the endocannabi chemically and pharmacologically . Therefore , marihuana noid -synthesizing and degrading enzymes fatty acid amide ( cannabis ) can be considered a very crude drug containing a hydrolase (FAAH ) and monoacylglycerol lipase (MAGL ) .
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