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Hi Han at Un Ami a Hata Mai a Me HI HAN AT USUN 20180110730A1AMI A HATA MAI A ME THE ( 19) United States (12 ) Patent Application Publication ( 10) Pub . No. : US 2018 /0110730 A1 CHANGOER et al. ( 43 ) Pub . Date: Apr . 26 , 2018 ( 54 ) CHEWING GUM COMPOSITION A61K 47 / 38 (2006 .01 ) COMPRISING CANNABINOIDS AND OPIOID A61K 4736 ( 2006 .01 ) AGONISTS AND /OR ANTAGONISTS A61K 47 / 26 ( 2006 .01 ) A61K 47 / 12 (2006 .01 ) ( 71 ) Applicant: AXIM Biotechnologies, Inc ., New A61K 47 / 02 ( 2006 . 01 ) York , NY (US ) A61K 31 / 352 (2006 . 01) ( 52 ) U . S . CI. ( 72 ) Inventors : Lekhram CHANGOER , Ridderkerk CPC . .. A61K 9 /0058 (2013 . 01 ) ; A61K 31 /05 (NL ) ; George E . ANASTASSOV , New (2013 . 01 ) ; A61K 31/ 485 ( 2013 .01 ) ; A61K York , NY (US ) 4738 (2013 .01 ) ; A61K 31 / 352 ( 2013 .01 ) ; A61K 47 /26 ( 2013 .01 ) ; A61K 47 /12 (2013 .01 ) ; (21 ) Appl. No. : 15 / 787 ,498 A61K 47/ 02 ( 2013. 01 ) ; A61K 47/ 36 ( 2013 .01 ) (22 ) Filed : Oct. 18 , 2017 ( 57 ) ABSTRACT Related U . S . Application Data A chewing gum composition comprising cannabinoids or derivatives thereof and at least one opioid and optionally an (60 ) Provisional application No . 62/ 410 , 469, filed on Oct. opioid antagonist is provided . The chewing gum composi 20 , 2016 . tion is formulated to provide controlled release of cannabi noids and opioid agonists and /or opioid antagonist during Publication Classification mastication . Methods to provide opioid addiction or depen (51 ) Int. Cl. dence treatment, opioid addiction or dependence with con A61K 9 / 68 ( 2006 .01 ) current cannabis addiction or dependence treatment, or pain A6IK 31/ 05 ( 2006 .01 ) treatment using the chewing gum composition according to A61K 31/ 485 ( 2006 .01 ) this invention are also provided . US 2018 /0110730 A1 Apr. 26 , 2018 CHEWING GUM COMPOSITION [0010 ] Opioid replacement therapy is not without adverse COMPRISING CANNABINOIDS AND OPIOID effect. Methadone used long term may lead to potentially AGONISTS AND /OR ANTAGONISTS deadly slowed breathing . The analgesic effect in methadone ends long before the methadone half life , thus more metha CROSS -REFERENCE TO RELATED done is needed , causing a built up of methadone . APPLICATIONS [0011 ] The cannabis plant has many naturally occurring 0001 ] This application claims priority to U . S . Provisional substances that are of great interest in the fields of science Application No . 62 /410 , 469, filed Oct . 20 , 2016 , the content and medicine. Isolated compounds from the cannabis plant of which is hereby incorporated by reference in its entirety . include 19 - tetrahydrocannabinol ( THC ) , cannabidiol (CBD ) , cannabichromene (CBC ) , cannabigerol (CBG ) , can BACKGROUND OF THE INVENTION nabidivarin (CBDV ) , among other compounds . While THC has psychoactive effects , CBD , CBC , CBG , and CBDV do Field of the Invention not. Isolated compounds from the cannabis plant are called cannabinoids . There are a total of one hundred and forty one [ 0002 ] Opioid addiction treatment and cannabis depen ( 141) cannabinoids that have been isolated from the canna dence treatment are developing areas with many proposed bis plant. Many researchers have confirmed the medicinal techniques and remedies. This invention involves a chewing value of cannabinoids . Cannabinoids have been investigated gum composition with controlled release of cannabinoids for possible treatment of seizures , nausea , vomiting , lack of and opioid agonists and / or antagonists for opioid and can appetite , pain , arthritis , inflammation , and other conditions. nabis addiction and / or dependence treatment. This chewing [0012 ] The IUPAC nomenclature of THC is (- ) - (6aR , gum may also be used for treatment of chronic pain . 10aR ) - 6 , 6 , 9 - trimethyl - 3 - pentyl -6a , 7 , 8 , 10a - tetrahydro -6H benzo [ c ] chromen - 1 -ol . CBD ' s IUPAC nomenclature is Description of the Related Technology 2 - ( 1S , 65 ) - 3 -methyl - 6 - (prop - 1 - en - 2 - yl) cyclo - hex - 2 - enyl) 10003 ] Opioids are a group of analgesic agents commonly 5 -pentylbenzene - 1 , 3 -diol ) . CBC has the IUPAC nomencla used in clinical practice but are also commonly seen as ture of 2 -methyl - 2 - ( 4 -methylpent - 3 - enyl) -7pentyl - 5 - chrom addictive agents . Opioids bind to opioid receptors , which are enol . These are among the most prominent compounds in the found in the central and peripheral nervous system and the family of compounds extracted from the cannabis plant gastrointestinal tract. These receptors mediate both psycho referred to as cannabinoids. active and the somatic effects of opioids. [0013 ] Cannabinoidsmay be isolated by extraction or cold 10004 ) Opioids agonists include morphine , codeine , the pressing of cannabis plants . Plants in the cannabis genus baine , hydrocodone, hydromorphone , oxycodone , oxymor include Cannabis sativa , Cannabis ruderalis , and Cannabis phone, buprenorphine , fentanyl, methadone , pethidine , lev indica . These plants are the natural sources of cannabinoids. orphanol, tramadol, and dextropropoxyphene . Cannabinoids are also available in synthetic forms. Methods [0005 ] Opioids cause euphoria and thus are used illicitly . to synthesize cannabinoids in lab settings were discovered In 2011 , an estimated of 4 million people in the United and are still currently practiced . Synthetic cannabinoids are States used opioids recreationally and were dependent on more targeted , in that the synthetic compound usually comes them . Opioid dependency may start with prescription use of isolated without other cannabinoids mixed in . opioid which turns into illicit drug use . 100141 Cannabinoids from industrial hemp are marketed [0006 ] Physical dependence is the physiological adapta in the United States, such as cannabidiol. Various products tion of the body to the presence of a substance , in this case containing cannabinoids have been marketed in recent years . an opioid . It is the development of withdrawal symptoms Cannabinoids may be consumed by ingestion , by inhalation , when the substance is discontinued . Withdrawal symptoms via transmucosal, or by transdermal delivery . of opiates may include severe dysphoria , craving , irritability , [0015 ] Cannabis dependence is mainly due to 19 - THC sweating , nausea , tremor, vomiting, and myalgia . presence in cannabis . When a mammal consumes cannabis , [ 0007 ] The speed and severity of withdrawal symptoms A - THC gives the “ high ” feeling . Cannabis addiction in the occurrence depend on half - life of the opioid . Heroin and form of smoking cannabis also gives rise to lung cancer risk morphine withdrawal occur more quickly and are more similar to tobacco smoking . severe than methadone withdrawal. The acute withdrawal [0016 ] Opioid addiction treatment remains a challenge . phase is often followed by a protracted phase of depression This invention proposes a product to treat opioid addiction and insomnia that can last for months . standing alone or concurrent opioid and A9 - THC addiction / [0008 ] Addiction is marked by a change in behavior dependence . caused by the biochemical changes in the brain after con tinued substance abuse. Substance use becomes the main ABBREVIATIONS CBC : cannabichromene CBD : priority of the addict , regardless of the harm they may cause cannabidiol CBDV : cannabidivarin CBG : to themselves or others . An addiction causes people to act cannabigerol 19- THC : delta - 9 - tetrahydrocannabinol irrationally when they don ' t have the substance they are addicted to in their system . Addiction encompasses both mental and physical reliance on the substance . SUMMARY [ 0009 ] Opioid addiction therapy depends on a variety of [ 0017 ] The present invention relates to a chewing gum techniques. Among them is replacement therapy , wherein an composition comprising cannabinoids or derivatives thereof opioid is replaced with another less addictive opioid , which and at least one opioid agonist and / or antagonist . Cannabi curbs the craving feeling and reduces withdrawal symptoms, noids or derivatives thereof and opioid agonists and /or while maintains the subject ' s mental state such that the antagonists are under controlled release during mastication subject is still able to function normally . and consumption . This invention further relates to the use of US 2018 /0110730 A1 Apr. 26 , 2018 this chewing gum composition in treating opioid addiction opioid is an opioid antagonist selected from the group or dependence , concurrent cannabis and opioid addiction consisting ofNaloxone hydrochloride dehydrate and natrex and / or dependence , or pain . one hydrochloride. [0018 ] This invention provides a chewing composition [0036 ] This invention provides a chewing gum composi comprising, based on total weight of the composition : tion according to embodiments wherein the at least one 100191 0 . 1 to 5 % by weight of at least one cannabinoid ; opioid comprises both opioid agonist and opioid antagonist . [0020 ] 0 .01 to 1 % by weight of at least one opioid ; [ 0037 ] This invention provides a chewing gum composi [ 0021] 20 to 95 % by weight of a gum base ; tion according to embodiments wherein the at least one [0022 ] 5 to 35 % by weight of at least one buffering agent opioid is provided in nanoencapsulated or microencapsu selected from the group consisting of acetates , glycinates , lated form . phosphates, carbonates, glycerophosphates, citrates, and [0038 ] This invention provides a chewing gum composi borates ; tion according to embodiments wherein the preservative is [0023 ] 1 to 10 % by weight of
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