Cannabinoid oral dispersible film strip

An oral dispersible film composition comprising at least one active ingredient and a film forming agent, having a percentage relative standard deviation of potency concentration of the at least one active ingredient in a batch of said oral dispersible film composition of less than 2.5%, preferably less than 1%, more preferably less than 0.5%.

An oral dispersible film composition comprising at least one active ingredient and a film forming agent, having a dissolution time in phosphate buffered saline solution at pH 6.8 and 37 degrees C. of less than about 1 minute, preferably less than about 30 seconds, more preferably less than about 20 seconds.

The oral dispersible film composition of any preceding claim where the distribution of particle sizes have a polydispersity value of less than 1.5.

The oral dispersible film composition of any preceding claim wherein the composition contains less than 1 wt %, more preferably less than 0.5 wt %, most preferably is free of a gum resin.

The oral dispersible film composition of any preceding claim wherein the at least one active ingredient is selected from the group of cannabinoid compounds and terpenoid compounds comprised of cannabidiol, delta-9-tetrahydrocannabinol, delta-8-tetrahydrocannabinol, cannabigerol, cannabidiol acid, tetrahydrocannabinol acid, olivetol and olivetol acid or esters.

The oral dispersible film composition of any preceding claim wherein the at least one active cannabinoid compound is derived biosynthetically from Cannabis plant species, from hemp, from plant-based or animal cell microorganisms, or is obtained by chemical synthesis from non-natural starting compounds.

The oral dispersible film composition of any preceding claim comprising a second active ingredient.

The oral dispersible film composition of any preceding claim wherein the film forming agent is selected from the group consisting of pullulan, substituted and modified cellulosic polymers such as HPMC and CMC, alginate salts, starches, pectins, dextrins, gelatins, glycogen, poly(vinylalcohol) and its derivatives including polyvinylacetate, polyethyleneoxide, polyethyleneglycol, polyvinylpyrrolidone (povidone), and the oral film composition preferably contains less than 1 wt %, more preferably less than 0.5 wt %, most preferably 0 wt % of a gum resin.

An oral dispersible film composition comprising pullulan, a cannabinoid, glycerol, Tween 80, Span 80, MCT oil, peppermint oil, sucralose, maltodextrin, sorbitol, dimethyl sulfone, and optionally one or more of colourant, flavouring, limonene and menthol.

The oral dispersible film composition of any one of the preceding claims wherein the active cannabinoid ingredient is CBD (cannabidiol) or delta-9-THC (delta-9-tetrahydrocannabinol), or blends of CBD and THC, preferably present in a relative weight ratio of between 20:1 to 1:5 (CBD:THC).

An oral dispersible film composition, consisting essentially of:

• a pharmaceutical-grade or food-grade plasticizer (preferably glycerol), a cannabinoid (preferably CBD or delta-9-THC or a blend of CBD and THC in a relative weight ratio of between 20:1 to 1:5), a carrier fluid, a gum-free film forming agent (preferably pullulan), and optionally one or more of a colourant, a flavouring agent, a sweetener, one or more surfactants (preferably non-ionic surfactant), and a permeation enhancer.

The oral dispersible film composition of any one of the preceding claims wherein the cannabinoid is delta-9-THC.

The oral dispersible film composition of any one of the preceding claims wherein the cannabinoid is CBD.

The oral dispersible film composition of any one of the preceding claims wherein the composition consists of a single layer.

The oral dispersible film composition of any one of the preceding claims wherein the at least one active ingredient is CBD and the second active ingredient is vitamin B12, a biologically active metabolite thereof such as methylcobalamin, iron, any essential vitamin and essential mineral and derivative forms thereof such as a therapeutically acceptable inorganic salt, a therapeutically acceptable organic salt, a polymer-bound complex, and a protein-bound complex.

The oral dispersible film composition of any one of the preceding claims wherein the at least one active ingredient is CBD and the second active ingredient is melatonin.

Method of any one of the preceding claims wherein the first active ingredient is a cannabinoid.

The method of any one of the preceding claims, wherein the oral dispersible film comprises a second active ingredient, said method comprising combining the second active pharmaceutical ingredient with the carrier before, simultaneously with, or after, the combining of the first active pharmaceutical ingredient with the carrier.

The method of any one of the preceding claims wherein the polymer film-forming agent comprises less than 1 wt %, more preferably less than 0.5 wt % of gum resin, and even more preferably is free of gum resin.

An oral dispersible film manufactured utilizing the method of any one of the preceding claims.

An oral dispersible film manufactured utilizing the method of any one of the preceding claims, wherein the particle dispersion within the film has an average particle size of 1-20 microns, preferably 5-15 microns.

An oral dispersible film composition manufactured utilizing the method of any one of the preceding claims, having a percentage relative standard deviation of potency concentration of the at least one active ingredient in a batch of said oral dispersible film composition of less than 2.5%, preferably less than 1%, more preferably less than 0.5%.

An oral dispersible film composition manufactured utilizing the method of any one of the preceding claims, having a dissolution time in phosphate buffered saline solution at pH 6.8 and 37 degrees C. of less than about 1 minute, preferably less than about 30 seconds, more preferably less than about 20 seconds.

An oral dispersible film composition manufactured utilizing the method of any one of the preceding claims, wherein the sizes of particles dispersed in the film have a polydispersity value of less than 1.5.

Use of an oral dispersible film composition manufactured utilizing the method of any one of the preceding claims in the treatment of active inflammatory bowel disease, wherein the active ingredient is CBD and the optional second active ingredient is vitamin B12, a biologically active metabolite thereof such as methylcobalamin, iron, any essential vitamin and essential mineral and derivative forms thereof such as a therapeutically acceptable inorganic salt, a therapeutically acceptable organic salt, a polymer-bound complex, and a protein-bound complex.

Use of an oral dispersible film composition manufactured utilizing the method of any one of the preceding claims in the treatment of a sleep disorder or a sleep disturbance, wherein the active ingredient is CBD and the optional second active ingredient is melatonin.

Use of an oral dispersible film composition of any one of the preceding claims in the treatment of active inflammatory bowel disease, wherein the active ingredient is CBD and the second active ingredient is vitamin B12, a biologically active metabolite thereof such as methylcobalamin, iron, any essential vitamin and essential mineral and derivative forms thereof such as a therapeutically acceptable inorganic salt, a therapeutically acceptable organic salt, a polymer-bound complex, and a protein-bound complex.

Use of an oral dispersible film composition of any one of the preceding claims in the treatment of a sleep disorder or a sleep disturbance, wherein the active ingredient is CBD and the second active ingredient is melatonin.

An oral dispersible film composition of any one of the preceding claims, or an oral dispersible film composition manufactured utilizing the method of any one of the preceding claims, having improved bioavailability by a factor of 1.5 or more compared to oral administration directly into the GI tract.