WO2021078999A1 - Composition de gomme à mâcher ou de pastille comprenant du cbd - Google Patents

Composition de gomme à mâcher ou de pastille comprenant du cbd Download PDF

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Publication number
WO2021078999A1
WO2021078999A1 PCT/EP2020/080047 EP2020080047W WO2021078999A1 WO 2021078999 A1 WO2021078999 A1 WO 2021078999A1 EP 2020080047 W EP2020080047 W EP 2020080047W WO 2021078999 A1 WO2021078999 A1 WO 2021078999A1
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WO
WIPO (PCT)
Prior art keywords
chewing gum
cbd
lozenge
gum
composition according
Prior art date
Application number
PCT/EP2020/080047
Other languages
English (en)
Inventor
Frank Barone
Kirill Chumenko
Vitaly FARGESEN
Igor PALATNIK
Original Assignee
Newmark Biotech, Llc
De Lang, R.J.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Newmark Biotech, Llc, De Lang, R.J. filed Critical Newmark Biotech, Llc
Publication of WO2021078999A1 publication Critical patent/WO2021078999A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G4/00—Chewing gum
    • A23G4/06—Chewing gum characterised by the composition containing organic or inorganic compounds
    • A23G4/068—Chewing gum characterised by the composition containing organic or inorganic compounds containing plants or parts thereof, e.g. fruits, seeds, extracts
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
    • A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
    • A23G3/36—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
    • A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
    • A23G3/36—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds
    • A23G3/364—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds containing microorganisms or enzymes; containing paramedical or dietetical agents, e.g. vitamins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
    • A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
    • A23G3/36—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds
    • A23G3/48—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds containing plants or parts thereof, e.g. fruits, seeds, extracts
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
    • A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
    • A23G3/50—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by shape, structure or physical form, e.g. products with supported structure
    • A23G3/54—Composite products, e.g. layered, coated, filled
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G4/00—Chewing gum
    • A23G4/06—Chewing gum characterised by the composition containing organic or inorganic compounds
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G4/00—Chewing gum
    • A23G4/06—Chewing gum characterised by the composition containing organic or inorganic compounds
    • A23G4/12—Chewing gum characterised by the composition containing organic or inorganic compounds containing microorganisms or enzymes; containing paramedical or dietetical agents, e.g. vitamins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G4/00—Chewing gum
    • A23G4/18—Chewing gum characterised by shape, structure or physical form, e.g. aerated products
    • A23G4/20—Composite products, e.g. centre-filled, multi-layer, laminated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/05—Phenols
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A61K9/0058—Chewing gums

Definitions

  • the present invention pertains to a chewing gum or lozenge composition comprising CBD (cannabidiol). More in particular, to a liquid filled chewing gum or lozenge composition comprising hemp oil and it’s applications as a delivery vehicle for CBD.
  • CBD canbidiol
  • Cannabis is a family of plants with two primary classes: Indica and Sativa.
  • THC Tetrahydrocannabinol
  • CBD Cannabidiol
  • CBD is a non-psychoactive component (no “high”) of the cannabis plant. CBD actually counters the psychoactive properties of THC.
  • Numerous research studies have shown CBD to be effective in various degrees in relieving chronic pain headaches and migraines, insomnia, anxiety disorder, loss of appetite, depression, diabetes, nausea, alzheimer’s, ALS, arthritis, bone health, cancer, epilepsy and seizures. In contrast to the many positive benefits of CBD, there have been almost no credible studies that have shown even mild ill-effects from consuming even high doses of CBD, to the point that many detractors have had to resort to searching for side effects from extreme dosages.
  • ECS Endocannabinoid System
  • the ECS is a widely-recognized neuromodulatory system located in the central and peripheral nervous system that regulates a wide range of homeostasis (healthy balance) in key body functions such as mood, sleep cycles, appetite, immune response, metabolism, pain response, cell repair and more.
  • the ECS is a network of neurons, located throughout the brain, most organs and throughout the body, whose neurotransmitters depend on certain cannabinoids to send signals from one neuron to the next.
  • Cannabinoids that are found in hemp, marijuana and other plants are found in the human nervous system, specifically the ECS.
  • Cannabinoids that are found in the human body are referred to as endocannabinoids, while those same cannabinoids found in plants are referred to phytocannabinoids.
  • the ECS maintains the body’s homeostasis by keeping a narrow range in blood sugar levels, internal temperature, blood pH, and the retention of water and certain minerals.
  • bodies must constantly produce their own endocannabinoids. If not enough amounts are created, it is thought that clinical endocannabinoid deficiency may occur, which throughout history humans have treated by ingesting phytocannabinoids.
  • Chewing gum and lozenges are well known in the art. Examples can be found in US9253991, US2019/2244117.
  • the present invention now pertains to a chewing gum and/or lozenge composition that delivers CBD and CBD-related compounds.
  • the composition is suitable for oral administration and provides a pre-set dose to the user of a CBD containing composition.
  • the invention also pertains to a method of making a chewing gum and/or lozenge composition.
  • the invention further relates to the use of the chewing gum and/or lozenge composition as a medicament or for the treatment of a variety of ailments.
  • the term “approximately” and “about” generally indicate a variability of about 5% of the number(s) or range. Typically, “approximately” and “about”, indicate a variability from between 0.001 to 10% from the number(s) or range.
  • the verb "to comprise” as is used in this description and in the claims and its conjugations are used in its non-limiting sense to mean that items following the word are included, but items not specifically mentioned are not excluded.
  • reference to an element by the indefinite article “a” or “an” does not exclude the possibility that more than one of the elements are present, unless the context clearly requires that there is one and only one of the elements.
  • the indefinite article “a” or “an” thus usually means “at least one”.
  • the words “a” and “an” when used in the present document in concert with the word comprising or containing denote “one or more.”
  • the chewing gum composition comprising the CBD or the extract containing CBD comprises a gum base as is commonly used in chewing gum formulations that are commercially available and accepted by the consumer.
  • the CBD or the extract containing CBD may be comprised by a solid material, for instance composed of a cellulose which comprises a well- defined amount of the cannabinoid or the derivative thereof, e.g. in and/or onto voids or pores within the solid material.
  • the chewing gum composition according to the present invention has a high initial release rate of the CBD thereof to provide a rapid adsorption of the CBD. Accordingly, it is preferred that the chewing gum composition according to the present invention releases at least 1 % by weight to not more than 30 % by weight, based on the total weight content of the CBD in the chewing gum composition according to the present invention within five minutes after ingestion. It is also preferred that the onset of the release starts within three minutes after ingestion.
  • a center fill gum in which the CBD is largely incorporated in the liquid fill is an advantageous formulation thereof.
  • a chewing gum generally refers to a chewable rubber or plastic that provides the structural integrity of the chewing gum. It may comprise natural materials (chicle) or synthetic materials (like paraffin wax and related polymers). Typically, the chewing gum composition is non-disintegrating, i.e. it does not disintegrate during chewing, and it does not crumble. It is currently contemplated that use of a particular gum base in combination with a suitable selection of additives has a significant impact on the non-disintegrating properties of chewing gum compositions. Examples of suitable gum bases having suitable properties and leading to non- disintegrating chewing gum compositions are e.g.
  • the gum base is normally present in the chewing gum composition according to the present invention in an amount of about 25 to about 85 % by weight, preferably about 30 to about 80 % by weight, more preferably about 40% to about 80 % by weight and in particular about 50 to about 80% w/w, based on the total weight of the chewing gum composition.
  • the chewing gum composition comprises one or more further ingredients, e.g. fats, waxes, emulsifiers, plasticizers, oils, flavouring agents and the like as desirable to modify the texture of the chewing gum.
  • a lozenge is a solid dosage form (porous or non-porous) that may comprise or consist of ingredients that are typically provided in a matrix and often covered by a coating, usually a soluble coating.
  • the inside of a lozenge may comprise or consist of compressed powers, microcapsules, microencapsulated particles or liquids. Lozenge can be hard or chewable and dissolve complete in the oral cavity.
  • hemp oil refers to a concentrated, optionally purified liquid form of CBD, which has been extracted from the cannabis plant.
  • the cannabis extract may take the form of a concentrated oil, which may be readily poured or added dropwise to the other gum ingredients during the mixing process.
  • the purity of the hemp oil may range from 50-99%, and is typically 90% pure.
  • the hemp oil is CBD oil.
  • the THC content is below 0.3 wt%.
  • the hemp oil may also be provided as a powder, microcapsules etc.
  • the chewing gum and/or lozenge composition may be a center or liquid-filled chewing gum and/or lozenge of the type as described in US9253991.
  • a center filled chewing gum or lozenge composition is typically composed of a center that has a composition that is substantially different from the surrounding composition (typically a gum).
  • the center can have having distinct functional characteristics.
  • the center can be liquid or semisolid.
  • Various components can be provided in the interior of a gum or lozenge in a liquid or semi-liquid form while the gum or lozenge itself can be of a traditional composition and/or may incorporate various other (or the same) desirable components to supplement and/or co-act with the components contained in the center.
  • the center filled chewing gum or lozenge of the invention may contain CBD in the center in liquid or semisolid form surrounded by a gum base or lozenge base. In one embodiment, the base itself may also contain CBD.
  • a time-release effect is provided as the contents of the center are almost instantly released while masticating, while the CBD in the base is released during prolonged mastication or consumption.
  • delayed release capsules may be provided suspended or encapsulated in the center of the base gum.
  • the CBD may be present in the chewing gum or lozenge in an amount of up to 30% by weight, drawn on the total weight of the chewing gum or lozenge.
  • Another embodiment of the present disclosure relates to a (liquid-filled) chewing gum or lozenge including a chewing gum base shell and a liquid filling, wherein the amount of CBD in the (liquid-filled) chewing gum or lozenge is from about 0.1 wt% to about 30 wt %, about 0.2 wt% to about 20 wt % or about 0.5 wt% to about 10 wt%.
  • the liquid filling of the lozenge or chewing gum may contain CBD in an amount of about 0.1 wt% to about 30 wt %, about 0.2 wt% to about 20 wt % or about 0.5 wt% to about 10 wt%.
  • the liquid filling may further comprise additives as exemplified herein elsewhere.
  • the chewing gum or lozenge of the present invention may be provided in the form of a unit dosage form.
  • a unit dosage formulations of the present invention may be contain about 1 mg to about 100 mg, about 2 mg to about 90 mg, about 3 mg to about 80 mg, about 5 mg to about 70 mg, about 10 mg to about 60 mg or about 50 mg of CBD, preferably in the form of an extract.
  • Unit dosage formulations of the embodiments of the present disclosure can include CBD in the amount about 1 mg to about 100 mg, about 2 mg to about 90 mg, about 3 mg to about 80 mg, about 5 mg to about 70 mg, about 10 mg to about 60 mg or about 50 mg of CBD, preferably in the form of an extract.
  • the chewing gum or lozenge composition is a unit dose and contains hemp oil ( a preferred CBD extract) in an amount of from about 1 mg to about 100 mg. with an average content of 20% CBD in hemp oil, the amount of CBD in a unit dose is preferably from about 0.2 mg to about 20 mg.
  • a particular chewing gum or lozenge composition according to the invention is one, wherein the chewing gum composition contains: CBD , preferably in the form of an extract, in an amount of from about 0.1 to about 20 wt%; gum base in an amount of from about 25 to about 90 wt%; sweetening, flavouring and/ or additive agents in an amount from about 0.0001 to about 50.wt%; wherein the sum of all ingredients adds up to 100 wt%.
  • CBD preferably in the form of an extract, in an amount of from about 0.1 to about 20 wt%
  • gum base in an amount of from about 25 to about 90 wt%
  • sweetening, flavouring and/ or additive agents in an amount from about 0.0001 to about 50.wt%
  • the sum of all ingredients adds up to 100 wt%.
  • Another particular chewing gum or lozenge composition according to the invention is one, wherein the chewing gum composition contains hemp oil in an amount of approximately about 0.1 to about 20 wt%; gum base in an amount of approximately 25 to about 90 wt%; sweetening, flavouring and/ or additive agents in an amount about 0.0001 to about 50.wt%; wherein the sum of all ingredients adds up to 100 wt%.
  • the CBD is provided in the liquid filling and/or in the gum base.
  • CBD is provided in both the liquid fill and the gumbase.
  • the chewing gum or lozenge composition according to the invention at least 50% of the CBD, drawn on the whole amount of CBD is provided in the liquid filing and the remainder in the gum base. In a preferred embodiment of the chewing gum or lozenge composition according to the invention, at least 50% of the CBD, drawn on the whole amount of CBD is provided in the gum base and the remainder in the liquid filling. In another preferred embodiment, the liquid filling contains from 30-70 % of the CBD drawn on the whole amount of CBD and the gumbase contains from 70-30% of the CBD drawn on the whole amount of CBD in the unit formulation.
  • Hemp oil is one of the main sources for the CBD extract used in the present invention.
  • Hemp oil can contain other active ingredients, such as cannabichromene (CBC); tetrahydrocannabinol; THC, cannabigerol (CBG ); cannabicyclol (CBL ); (8) cannabinodiol (CBND); (9) (10) cannabitriol (CBT) and others.
  • CBC cannabichromene
  • THC cannabigerol
  • CBL cannabicyclol
  • CBND cannabinodiol
  • CBT cannabitriol
  • the chewing gum or lozenge composition may further contain components that that have a positive effect on the dental status on the teeth in the oral cavity.
  • a preferred example is sodium bicarbonate that can be present in an amount of 0.1 to 10 wt%.
  • Sodium bicarbonate in chewing gums or lozenge can typically exert an additional and often synergetic teeth whitening and cleaning effect.
  • the chewing gum and lozenge compositions of the invention can be used as a medicament or a therapeutic agent.
  • the chewing gum and lozenge compositions of the invention can be used to relieve or alleviate local and/or systemic pain, used as an analgesic and/or to relieve and/or alleviate inflammation.
  • the chewing gum and lozenge compositions of the invention can be orally administered (e.g., placed in the mouth).
  • the chewing gum and lozenge compositions of the invention can include or contain pharmaceutical compositions, including analgesic and/or anti-inflammatory pharmaceutical compositions for the treatment of pain and/or inflammation.
  • the chewing gum and lozenge compositions of the invention typically contain a pharmaceutically effective amount of a pharmaceutically acceptable and effective cannabinoid such as CBD, preferably in the form of an CBD extract, preferably hemp oil.
  • a pharmaceutically acceptable carrier may be present in for example, the liquid fill of the chewing gum or lozenge.
  • the chewing gum and lozenge compositions (e.g. chewing gum and lozenges that may be liquid-filled ) may also include oral care compositions for the treatment of oral or dental pain. This also comprises oral care analgesic and/or anti inflammatory compositions that can play a role in the treatment of oral or dental pain and/or inflammation.
  • buccal adsorption enhancers such as short (C6-C10) and medium chain fatty acids (C12-C14 fatty acids) and salts thereof, preferably sodium and calcium salts.
  • Other suitable components that may be used as buccal adorption enhancers are for instance cetearyl glucosides, glyceryl stearate, cetearyl alcohol, sodium stearoyl lactylate, cetearyl olivate, sorbitan olivate, sodium cholate, sodium glycocholate, sodium glycodeoxycholate, taurodeoxycholate, sodium deoxycholate, sodium lithocholate chenocholate, chenodeoxycholate, ursocholate, ursodeoxy-cholate, hyodeoxycholate, dehydrocholate, glycochenocholate, taurochenocholate, and taurochenodeoxycholate.
  • SDS sodium dodecyl sulfate
  • SLS sodium lauryl sulfate
  • salts and other derivatives of saturated and unsaturated fatty acids surfactants, bile salt analogs, derivatives of bile salts, can be used, alone or in combination.
  • the buccal adsorption enhancers can be added to the gum compositions in an mount of 0.1-2 wt%, drawn on the gum formulation and can be added to the gum base and/or to the liquid filling.
  • a fixing agent generally refers to a polyol that allows the gum to have a hard outer coating.
  • the polyol may be sorbitol, maltitol/isomalt, mannitol, starch, and the like.
  • the chewing gum composition preferably comprises a flavouring agent, in an amount of about 0.5 to about 12 % by weight, more preferably about 1 to about 10 % by weight, even more preferably about 1.5 to about 9 % by weight, yet even more preferably about 2 to about 8 % by weight, based on the total weight of the chewing gum composition.
  • Flavouring agents can be e.g., menthol flavour, eucalyptus, mint flavour and/or L-menthol.
  • Other flavors used may be natural or synthetic and may be menthol, peppermint, spearmint, or a sour acid, such as citric, tartaric, malic, lactic, adipic, and fumaric.
  • the chewing gum composition preferably comprises a pharmaceutically acceptable sweetener, e.g. sugar alcohols including xylitol, sorbitol and/or isomalt, artificial sweeteners such as e.g. aspartame, sucralose, acesulfame potassium or saccharin.
  • a pharmaceutically acceptable sweetener e.g. sugar alcohols including xylitol, sorbitol and/or isomalt
  • artificial sweeteners such as e.g. aspartame, sucralose, acesulfame potassium or saccharin.
  • the amount of the pharmaceutically acceptable sweetener is normally preferably at least about 0.05 % by weight, more preferably about 0.075 to about 5 % by weight, even more preferably about 5 to about 35 % by weight, yet even more preferably about 10 to about 35 % by weight, even yet more preferably about 15 to about 35 % by weight and in particular about 20 to about 30 % by weight, based on the total weight of the chewing gum composition. It is highly preferred that the pharmaceutically acceptable sweetener is non-cariogenic as well as non- carcinogenic.
  • Sweeteners used may include: sugar, dextrose, glucose or corn syrup, erythritol, isomalt, maltitol, mannitol, sorbitol, lactitol, aspartame, acesulfame-K, saccharine, sucralose, neohesperidine, dihydrichalcone.
  • Additives in the present invention typically refers to non-structural or flavor- related compounds that are added to the cannabis extract chewing gum to impart other desirable properties. These may include various vitamins for imparting healthful effects to the user. Caffeine and gingerol are two additives that might be used.
  • the chewing gum composition according to the present invention preferably comprises a buffering agent. Suitable buffering agents are typically those selected from the group consisting of acetates, glycinates, phosphates, glycerophosphates, citrates such as citrates of alkaline metals, carbonates, hydrogen carbonates, and borates, and mixtures thereof.
  • the chewing gum composition preferably comprises a buffering agent in an amount of about 0.5 to about 5 % by weight, more preferably about 0.75% to about 4 % by weight, even more preferably about 0.75 to about 3 % by weight, yet even more preferably about 1 to about 2% by weight, based on the total weight of the chewing gum composition.
  • the chewing gum composition according to the present invention preferably further comprises an anti-oxidant, e.g., ascorbyl palmitate and sodium ascorbate, in an amount of about 0.05 to about 0.3 % by weight, more preferably about 0.1 to about 0.25 % by weight, yet even more preferably about 0.15 to about 0.2 % by weight, based on the total weight of the chewing gum composition.
  • an anti-oxidant e.g., ascorbyl palmitate and sodium ascorbate
  • the pharmaceutically acceptable excipients used in the chewing composition according to the present invention are preferably selected from the group of excipients normally used within the pharmaceutical industry for the preparation of tablets, i.e. excipients like fillers, desintegrants, binders, lubricants and the like.
  • Suitable fillers include celluloses and cellulose derivatives including micro crystalline cellulose, hydroxypropylcellulose and sodium carboxymethylcellulose, lactose, starches including potato starch and maize starch (in the US known as corn starch).
  • Suitable lubricants include stearates including magnesium stearate, talc and colloidal silica dioxide.
  • the chewing gum of the invention may advantageously also contain softeners or plasticizers.
  • softeners or plasticizers examples thereof are lecithin, hydrogenated vegetable oils, glycerol ester, lanolin, methyl ester, pentaerythritol ester, rice bran wax, stearic acid, sodium potassium stearates, and the like.
  • the chewing gum may further comprise gingerol, caffeine, flavourings, and sweeteners, preferably artificial sweeteners.
  • the user masticating the CBD extract chewing gum receives CBD from the chewing gum.
  • the artificial sweeteners may be based on a preference of the user.
  • the chewing gum may also comprise vitamins, antibiotics, colorants, etc.
  • the cannabis extract chewing gum ensures delivery of CBD extract to the user who chews it.
  • the addition of vitamins or antibiotics may provide added benefits to users.
  • the absorption may happen through the lining of the mouth and/or by swallowing.
  • CBD active CBD
  • it may be prefreed to administer CBD through the buccal mucosa of the cheek pouch or by sublingual administration.
  • Such administration through the mucosal tissues of the mouth, pharynx, and esophagus of therapeutic drugs possesses a distinct usefulness.
  • Administration of CBD by this route does not expose the drug to the gastric and intestinal digestive juices.
  • the drugs largely bypass the liver on the first pass through the body, thereby avoiding additional metabolism and/or inactivation of the drug.
  • the CBD extract, sucg as hemp oil
  • the CBD may have an unpleasant taste.
  • the final gum product may contain the drug uniformly distributed throughout in the gum base, the liquid fill or both in order to ensure uniform levels of medication.
  • varying concentrations in the gum base or fill within known and controlled ranges may be desired to vary the rate of CBD administration.
  • the CBD may have varying solubility in the various compounds of the gum and/or the liquid fill components, it may be that difficulties are encountered in attempting to blend solid drugs in a uniform or otherwise carefully controlled manner. This may lead to the resultant gum product is often found to in need of improvement of the more uniform or controlled distribution of the drug.
  • pH conditions within the mouth may tend to adversely affect the administration of certain lipophilic drugs by the mucosal administration route. It has been found in the art that administration of drugs through the mucosal tissues generally occurs best when the drug is in the unionized form. Variations in pH affect the percentage of the drug which is unionized at a particular point in time. As a result, the pH conditions within the mouth often limit the effectiveness of certain drugs administered buccally or sublingually in that those conditions cause the drug to exist in the ionized form which is largely unavailable for transfer across the mucosal tissues.
  • a related advancement in the art would be to provide such methods and compositions that avoid the disadvantages of overdosing, underdosing, and the immediate metabolism encountered in the "first pass effect".
  • CBD may profit from enhanced diffusione across mucosal membranes if the mucosal membrane is treated with a permeation enhancer. It has also been found that certain permeability enhancers can significantly enhance the permeability of lipophilic and nonlipophilic drugs.
  • Typical permeation enhancers include bile salts such as sodium cholate, sodium glycocholate, sodium glycodeoxycholate, taurodeoxycholate, sodium deoxycholate, sodium lithocholate chenocholate, chenodeoxycholate, ursocholate, ursodeoxy-cholate, hyodeoxycholate, dehydrocholate, glycochenocholate, taurochenocholate, and taurochenodeoxycholate.
  • bile salts such as sodium cholate, sodium glycocholate, sodium glycodeoxycholate, taurodeoxycholate, sodium deoxycholate, sodium lithocholate chenocholate, chenodeoxycholate, ursocholate, ursodeoxy-cholate, hyodeoxycholate, dehydrocholate, glycochenocholate, taurochenocholate, and taurochenodeoxycholate.
  • permeation enhancers such as sodium dodecyl sulfate (“SDS”), dimethyl sulfoxide (“DMSO”), sodium lauryl sulfate, salts and other derivatives of saturated and unsaturated fatty acids, surfactants, bile salt analogs, derivatives of bile salts, or such synthetic permeation enhancers as described in United States Patent No. 4,746,508 may also be used.
  • SDS sodium dodecyl sulfate
  • DMSO dimethyl sulfoxide
  • sodium lauryl sulfate sodium lauryl sulfate
  • salts and other derivatives of saturated and unsaturated fatty acids such as sodium dodecyl sulfate (“SDS”), dimethyl sulfoxide (“DMSO”), sodium lauryl sulfate, salts and other derivatives of saturated and unsaturated fatty acids, surfactants, bile salt analogs, derivatives of bile salts, or such synthetic perme
  • bile salts are good enhancers for hydrophilic drugs and long chain fatty acids, their salts, derivatives, and analogs are more suitable for lipophilic drugs.
  • DMSO, SDS, and medium chain fatty acids (C-8 to about C-14) their salts, derivatives, and analogs may work for both hydrophilic and lipophilic drugs.
  • the permeation enhancer concentration within the dissolvable matrix material may be varied depending on the potency of the enhancer and rate of dissolution of the dissolvable matrix. Other criteria for determining the enhancer concentration include the desired lag time. The upper limit for enhancer concentration is set by toxic effect to or irritation limits of the mucosal membrane.
  • various techniques may be employed, such as spray drying or freeze drying of the CBD, preferably in combination with a wall material selected from the group consisting of maltodextrin, gum arabic, chitosan, citrus fruit fiber, colloidal silicon dioxide, sodium caseinate-soy lecithin, skimmed milk powder, whey protein concentrate, gelatin, alginates.
  • Jeyakumari et al. describes various ways of microencapsulation of bioactive food ingredients,, but do not suggest this for the formulation of CBD in gum formulations (Jeyakumari A, Zynudheen AA, Parvathy U. Microencapsulation of bioactive food ingredients and controlled release-a review. MOJ Food Process Technol. 2016;2(6):214-224. DOI: 10.15406/mojfpt.2016.02.00059).
  • the chewing gum composition of example 3 is rolled to a slab.
  • a layer of the encapsulated hemp oil of example 1 is laid on top of the slab and a second slab of the chewing gum composition is laid on top.
  • the slabs are rolled together and subsequently divided into center-filled pieces
  • Example 8 center-fill chewing gum
  • the chewing gum composition of example 3 is rolled to a slab and placed on a gum press to form the bottom cavity.
  • the bottom cavity is filled with the encapsulated hemp oil and sodium bicarbonate of example 2.
  • a second slab is rolled and placed on top to form the top piece.
  • the gum is punched by a gum press to form the center-filled gum.

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Abstract

L'invention concerne une composition de gomme à mâcher ou de pastille qui peut être fourrée de liquide et qui contient un extrait de CBD, de préférence de l'huile de chanvre. L'extrait de CBD peut être présent dans la gomme ou la pastille et/ou dans son fourrage liquide en une quantité allant jusqu'à 100 mg par dose unitaire. La gomme ou la pastille peuvent être utilisées à des fins pharmaceutiques et/ou pour des soins dentaires.
PCT/EP2020/080047 2019-10-25 2020-10-26 Composition de gomme à mâcher ou de pastille comprenant du cbd WO2021078999A1 (fr)

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US20110097283A1 (en) 2008-03-26 2011-04-28 Mareda Holding Bv Chewing gum compositions comprising cannabinoids
US9253991B2 (en) 1999-09-20 2016-02-09 Jack Barreca Chewing gum with B vitamins
US20160158298A1 (en) 2013-12-11 2016-06-09 Jeffrey A. Kolsky Medical cannabis lozenges and compositions thereof
US20170312261A1 (en) 2016-04-27 2017-11-02 Axim Biotechnologies, Inc. Chewing gum composition comprising cannabinoids and nicotine
US20180110730A1 (en) 2016-10-20 2018-04-26 Axim Biotechnologies, Inc. Chewing gum composition comprising cannabinoids and opioid agonists and/or antagonists
US20190244117A1 (en) 2018-02-08 2019-08-08 Cavium, Llc Streaming engine for machine learning architecture

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US4746508A (en) 1983-06-06 1988-05-24 Beth Israel Hospital Assn. Drug administration
US9253991B2 (en) 1999-09-20 2016-02-09 Jack Barreca Chewing gum with B vitamins
US20110097283A1 (en) 2008-03-26 2011-04-28 Mareda Holding Bv Chewing gum compositions comprising cannabinoids
US20160158298A1 (en) 2013-12-11 2016-06-09 Jeffrey A. Kolsky Medical cannabis lozenges and compositions thereof
US20170312261A1 (en) 2016-04-27 2017-11-02 Axim Biotechnologies, Inc. Chewing gum composition comprising cannabinoids and nicotine
US20180110730A1 (en) 2016-10-20 2018-04-26 Axim Biotechnologies, Inc. Chewing gum composition comprising cannabinoids and opioid agonists and/or antagonists
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Title
ANONYMOUS: "What is Full-Spectrum Hemp Oil and Why is it Important? - ECHO Connection", 5 May 2017 (2017-05-05), XP055712326, Retrieved from the Internet <URL:https://echoconnection.org/full-spectrum-hemp-oil-important/> [retrieved on 20200707] *
JEYAKUMARI AZYNUDHEEN AAPARVATHY U: "Microencapsulation of bioactive food ingredients and controlled release-a review", MOJ FOOD PROCESS TECHNOL, vol. 2, no. 6, 2016, pages 214 - 224, XP055610882, DOI: 10.15406/mojfpt.2016.02.00059

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