GB2551987A — Oral cannabinoid formulations

USPTO Abstract

A cannabinoid containing oral solution comprising a cannabinoid, a lipid solvent, ethanol and an ultrahigh potency sweetener. Preferably the ultrahigh potency sweetener has a sweetness intensity compared to sucrose of greater than 1000, more preferably greater than 5000. The preferred sweetener is N-[N-(3,3-dimethylbutyl)-L-α-aspartyl]-L-phenylalanine 1-methyl ester (Neotame) or N-[N-3-(3-hydroxy-4-methoxyphenyl)propyl-α-L-aspartyl]-L-phenylalanine 1-methyl ester (Advantame). The cannabinoid is preferably cannabidiol (CBD). The oral solution may also comprise a flavourant. Preferably the oral solution is stable in climatic zones I and II for up to 24 months and zones III and IV for up to 18 months, without the use of a stabilising agent. Also disclosed is the use of said oral solution in the treatment of epilepsy and associated syndromes, Dravet syndrome, Lennox Gastaut syndrome, myocolonic seizures, juvenile myocolonic epilepsy, refractory epilepsy, schizophrenia, juvenile spasms, West syndrome, infantile spasms, refractory infantile spasms, tuberous sclerosis complex, brain tumours, neuropathic pain, cannabis use disorder, post-traumatic stress disorder, anxiety, early psychosis, Alzheimers disease and autism. Also disclosed is a method of treatment for said diseases/disorders comprising administering said solution. The invention provides a palatable lipid based oral formulation with low levels of ethanol that make it suitable for paediatric products aimed at young children.