Filled granules, their method of manufacture and their use

Abstract

The present invention relates to cannabinoid- and / or nicotine-loaded granules, comprising orodispersible sugar granules loaded with at least one cannabinoid compound and / or nicotine. The present invention relates to a method for producing cannabinoid- and / or nicotine-loaded granules, comprising the steps of: a) adding at least one cannabinoid compound and / or nicotine to orodispersible sugar granules; b) air-drying said granules; c) repeating the successive steps (a) and (b) at least 20 times; d) optionally coating the cannabinoid- and / or nicotine-loaded granules with a sugar syrup comprising a colorant or flavorant, a natural gum, a natural wax, or any combination thereof.

Description

[Technical Field]

[0001] The present invention relates to orodispersible granules containing one or more active cannabinoid compounds, to orodispersible granules containing nicotine, to a method for producing said granules and to the use of said granules as a nutritional supplement. The present invention also relates to said granules for use as a pharmaceutical. [Background technology]

[0002] The plant Cannabis Sativa L. (also known as marijuana) produces phytocannabinoids, natural biochemical compounds characterized by their ability to interact with cannabinoid receptors in brain cells.

[0003] This plant has been known for its effects on the human body for thousands of years. Cannabinoids are primarily consumed by smoking or vaporizing dried cannabis plant material. These delivery systems are unhealthy, inconvenient, and lack proper dosage control. Furthermore, the plant extracts consumed contain a combination of different phytocannabinoids, all of which are ingested.

[0004] However, it may be preferable to consume only some of these cannabinoid compounds, for example those that do not exhibit any psychotropic effects.

[0005] Approximately 110 different plant cannabinoids have been identified so far, of which the most abundant are tetrahydrocannabinol (THC), cannabidiol (CBD), and cannabinol (CBN), followed by cannabigerol (CBG), cannabichromene (CBC), and cannabinodiol (CBND).

[0006] The most notable cannabinoid is trans-delta9-tetrahydrocannabinol (Δ9-THC), a potent psychotropic compound that produces euphoric and mood-tranquilizing effects. Another important plant cannabinoid is cannabidiol (CBD), a non-psychotropic compound that exhibits many pharmacological effects, including antipsychotic, analgesic, neuroprotective, anticonvulsant, antiemetic, antitumor, antiarthritic, antioxidant, and anti-inflammatory properties.

[0007] In order to exploit the beneficial effects of each cannabinoid individually, particularly cannabidiol, which does not contain psychotropic effects, techniques have been developed for the extraction and isolation of cannabinoids.

[0008] Administration of cannabidiol has been clinically proven to have a positive effect in alleviating neuropathic pain in individuals with multiple sclerosis, as well as in cases involving psychosis, movement disorders, and anxiety behaviors, such as generalized anxiety disorder (GAD), panic disorder (PD), post-traumatic stress disorder (PTSD), social anxiety disorder (SAD), and obsessive-compulsive disorder (OCD). These anxiety-related disorders impose a significant social and economic burden (Blessing et al., 2015).

[0009] Cannabidiol administration has been well tolerated in humans over a wide range of doses up to 1500 mg / day (oral), with no reported psychomotor slowing, negative mood effects, or abnormalities in vital signs (Bergamaschi et al., 2011).

[0010] The first FDA-approved drug containing CBD is Epidiolex®, a liquid formulation of highly purified, plant-derived cannabidiol intended to treat two rare and severe childhood epilepsy syndromes.

[0011] Outside the United States, the drug Sativex®, which contains a 1:1 ratio of CBD and Δ9-THC, has been approved in many countries for the treatment of spasticity due to multiple sclerosis. The drug is offered in the form of an oromucosal spray.

[0012] Isolated plant cannabinoids can be consumed by ingestion, inhalation, or transdermal delivery.Plant cannabinoids can be extracted from plants using alcohol and then applied to the oral cavity.Plant cannabinoids can also be extracted into oil and then administered orally or through the nasal mucosa.Oil preparations can be proposed as is, or in the form of a spray contained in gelatin capsules, or can be included in transdermal compositions.

[0013] Different galenic preparations containing cannabinoids for therapeutic or non-therapeutic (recreational) use have been proposed: US Patent No. 9,095,563 describes topical compositions containing extracts of hemp seeds; International Application No. WO2017 / 189375 discloses a chewing gum composition comprising at least one isolated cannabinoid, nicotine, and at least one flavoring agent and one sweetening agent; International Application No. WO2017 / 208072 discloses a nasal cannabidiol composition comprising an oily vehicle such as a vegetable oil; International Application No. WO2017 / 180707 relates to an ingestible film containing a substance extracted from Cannabis sativa, said film consisting of a matrix and isolated cannabinoids at a concentration greater than 90%; International Application No. WO2017 / 185038 discloses an oral CBD formulation further comprising a compound intended to obtain a fast-acting physiological effect of CBD; International Application No. WO2018 / 129097 relates to a nutritional supplement comprising a synthetic cannabinoid in combination with an N-acetylated fatty amino acid, the N-acetylated fatty amino acid increasing the aqueous solubility of the cannabinoid; US Patent No. 10,434,084 describes a cannabinoid-rich powder made from tiny coated sugar particles, which can be used as a dry premix for making beverages or cooked foods; US Patent Application Publication No. 2018 / 344786 relates to an oil-based composition containing a combination of cannabinoids and terpenes.

[0014] Pharmacokinetic experiments showed that compared to transdermal application, oral formulations offered the most favorable pharmacokinetic profile ( Bartner et al., 2018 ).

[0015] However, classical oral forms can have adverse side effects, and in particular: Cannabinoid-containing compositions may induce a bad taste and / or dry mouth; Administration of tablets and capsules requires the ingestion of water, and some individuals may experience discomfort from swallowing bulky conventional dosage forms; Dry premixes for beverages or foods require water and / or ingredients that cannot be consumed as is; Oil-based formulations are likely to spill from these vials, thus complicating their transport. Furthermore, this form of administration lacks proper dose control.

[0016] Cooked preparations containing cannabinoid(s), such as cakes and candies, have been proposed, but the cooked preparations are often loaded with only small amounts of cannabinoids and are not stable over time due to the perishable nature of these foods.

[0017] It is an object of the present invention to provide an oral formulation for administering at least one cannabinoid that presents the following advantages: Oral formulations allow for easy control of the desired dose; Oral preparations are comfortable to use; Oral preparations do not produce any unpleasant taste in the mouth and do not dry out the oral mucosa; Oral formulations do not require water for administration, and more generally, do not require any preparation and can be administered directly in any situation (e.g., while traveling).

[0018] Interestingly, the present oral formulation is also suitable for administering nicotine, achieving the same advantages as described above for nicotine-loaded granules.

[0019] The oral preparation preferably comprises at least one terpene. Advantageously, the oral preparation according to the present invention is elegantly presented, and its administration is comfortable. As a result, the preparation is consumed in a pleasant and cheerful manner. Furthermore, the oral preparation is consumed discreetly.

[0020] [Summary of the Invention] The present invention relates to cannabinoid-loaded granules, including orodispersible sugar granules containing at least one cannabinoid compound.

[0021] The present invention also relates to nicotine-loaded granules, including orodispersible sugar granules containing nicotine.

[0022] The present invention also relates to cannabinoid and nicotine loaded granules, including orodispersible sugar granules containing at least one cannabinoid compound and nicotine.

[0023] In particular, the granules are composed of lactose, sucrose, xylitol, or a mixture thereof.

[0024] In a preferred embodiment, the cannabinoid and / or nicotine loaded granules further contain at least one terpene, preferably a combination of at least two terpenes.

[0025] In another aspect, the present invention relates to a method for producing cannabinoid and / or nicotine loaded granules, such as those described above, comprising at least the following steps: a) adding at least one cannabinoid compound and / or nicotine to orodispersible sugar granules; b) air drying the granules; c) repeating the successive steps (a) and (b) at least 20 times; d) Optionally, coating the cannabinoid and / or nicotine loaded granules with a sugar syrup containing colorants or flavorants, natural gums, natural waxes, or any combination thereof.

[0026] The present invention also relates to said cannabinoid and / or nicotine loaded granules for use as a medicament.

[0027] The present invention also relates to said cannabinoid and / or nicotine loaded granules for use in the treatment and / or prevention of chronic pain, inflammatory disorders, behavioral disorders, and anxiety disorders.

[0028] In another aspect, the present invention relates to the use of cannabinoid and / or nicotine loaded granules as a nutritional supplement.

[0029] The present invention also relates to a kit for use as a nutritional supplement, comprising in a single package at least two administration devices containing cannabinoid-loaded granules further containing at least one terpene, the at least two administration devices being distinct from one another in that the at least one terpene differs from one administration device to another.

[0030] Unless otherwise stated, the following terms and phrases are intended to have the following meanings when used herein:

[0031] The term "about" hereby indicates a range of approximately 10% of the stated amount.

[0032] In the context of the present invention, the terms "cannabinoid compounds" and "cannabinoids" are used interchangeably and both refer to a class of diverse chemical compounds that act on cannabinoid receptors within cells. This class includes endocannabinoids (naturally produced in animals), phytocannabinoids (found in cannabis and some other plants), and synthetic cannabinoids (man-made).

[0033] In the sense of the present invention, the term "cannabinoid" includes all forms derived from cannabinoids, especially those chemically derived from plant cannabinoids.

[0034] The most notable plant cannabinoid is tetrahydrocannabinol (THC), which is the primary psychoactive compound in cannabis. Its chemical name is trans-Δ9-tetrahydrocannabinol and its CAS number is 1972-08-3. THC has the following chemical structure:

[0035] [ka]

[0036] In this application, the abbreviations Δ9-THC and THC are used interchangeably and both refer to trans-Δ9-tetrahydrocannabinol.

[0037] Cannabidiol (CBD) refers to a compound referenced by CAS number 13956-29-1, which has the following chemical structure:

[0038] [ka]

[0039] It was first discovered in 1940 and isolated from the Cannabis sativa plant, where it represents up to 40% of the plant's extract.

[0040] Cannabidiol has a broad pharmacological profile that includes interactions with several receptors, more specifically, the cannabinoid type 1 receptor (CB1R), the serotonin 5-HT1A receptor, and the transient receptor potential (TRP) vanilloid type 1 (TRPV1) receptor. In addition, CBD can also directly or indirectly modulate peroxisome proliferator-activated receptor-γ, orphan G protein-coupled receptor 55, equilibrative nucleoside transporters, adenosine transporters, additional TRP channels, and glycine receptors.

[0041] Cannabidiol has very low affinity for the cannabinoid CB1 and CB2 receptors, but is said to act as an indirect antagonist of these receptors.

[0042] Synthetic cannabinoids include all chemically synthesized compounds structurally related to THC and cannabidiol, as well as non-classical cannabinoids designated as cannabinomimes.

[0043] Nicotine, also designated as 3-(N-methyl-2-pyrrolidinyl)pyridine, 1-methyl-2-(3-pyridyl)pyrrolidine, or β-pyridyl-α-N-methylpyrrolidine, CAS number 54-11-5, is a neurostimulant that is produced naturally in some plants, particularly tobacco.

[0044] Nicotine acts as a receptor agonist or antagonist at nicotinic acetylcholine receptors (nAChRs) present in the human brain. After binding to these receptors, nicotine elicits its psychotropic effects and increases the levels of several neurotransmitters in various brain structures.

[0045] Granule characteristics The present invention relates to cannabinoid and / or nicotine loaded granules comprising orodispersible sugar granules loaded with at least one cannabinoid compound and / or nicotine.

[0046] In a first aspect, the present invention relates to a cannabinoid-loaded granule comprising an orodispersible sugar granule loaded with at least one cannabinoid compound.

[0047] In the context of the present invention, the phrase "cannabinoid-loaded granules" refers to granules loaded with at least one cannabinoid compound by any technique known to those skilled in the art. Said loading techniques include: "Impregnation" includes the penetration of the cannabinoid compound into the matrix of the granules (equivalent to "loading into"); and "Sugar coating" involves agglomerating cannabinoid compounds as an outer layer around granules, and is equivalent to coating the granules with sugar syrup and then applying the cannabinoid compounds on top of the layer of sugar syrup (equivalent to "filling on top").

[0048] In a second aspect, the present invention relates to a nicotine-loaded granule comprising an orodispersible sugar granule loaded with nicotine.

[0049] In the sense of the present invention, the phrase "nicotine-loaded granules" denotes granules loaded with nicotine or any one of its derivatives exhibiting the same psychotropic properties by any technique known to those skilled in the art.

[0050] In a third aspect, the present invention relates to cannabinoid and nicotine loaded granules comprising orodispersible sugar granules loaded with at least one cannabinoid and nicotine. The cannabinoid and / or nicotine loaded granules of the present invention are granules containing cannabinoid(s) and / or nicotine using any loading technique. In other words, the term "containing" as used herein refers to granules encompassing both "loaded into" and "loaded onto" embodiments.

[0051] In the context of the present invention, the phrase "cannabinoid and / or nicotine loaded granules" denotes granules filled by any technique known to those skilled in the art with: (i) at least one cannabinoid, or (ii) nicotine or any one of its derivatives exhibiting the same psychotropic properties; or (iii) at least one of cannabidiol and nicotine.

[0052] Orally dispersible sugar granules, also called pellets or beads, are commonly used as carriers for homeopathic medicines. Homeopathic pills are actually made from granules made of an inert substance such as sugar, onto which a small amount of liquid homeopathic preparation is placed and allowed to evaporate.

[0053] Neutral orodispersible sugar granules (i.e., without any active compounds) are commercially available and known to those skilled in the art. In the context of the present invention, the phrase "neutral granules" refers to granules prior to any step of filling.

[0054] In a particular embodiment of the invention, the orodispersible sugar neutral granules are composed of lactose, sucrose, xylitol, or a mix thereof.

[0055] Preferentially, the neutral granules are composed 100% of xylitol, a sugar alcohol with CAS number 87-99-0, which is industrially prepared from lignocellulose derived from wood and agricultural waste.

[0056] These granules are orally dispersible (also defined as orodispersible, dissolvable in the mouth, melt-in-the-mouth or porous granules), which means that the granules are designed so that when they come into contact with saliva, they disperse or break down without the aid of water, and then release the active compound(s) they contain.

[0057] These granules are intended for sublingual administration of the active compound they contain.

[0058] These granules are advantageously useful in situations where water is not available or is prohibited, such as pre-operatively.

[0059] The optimal time for orodispersible granules to disintegrate in the mouth is considered to be less than one minute. Most disintegration times vary from 5 to 30 seconds.

[0060] The neutral granules used to prepare the cannabinoid-loaded granules preferably have an annular shape, for example small beads or balls or spheres.

[0061] Preferably, the neutral and filled granules of the present invention have a diameter greater than 1 millimeter.

[0062] In a preferred aspect of the invention, each neutral granule has a diameter of about 2 to 10 millimeters, preferably about 3 to 4 millimeters. In a specific embodiment of the invention, each granule has a diameter of about 3 to 4 millimeters, particularly 3.7 millimeters.

[0063] In a preferred embodiment of the present invention, each neutral granule weighs about 30 to 300 milligrams, preferably about 30 to 150 milligrams. Typically, these neutral granules are commercially available in "8 per gram" batches (i.e., each granule weighs about 125 mg), "10 per gram" batches (each granule weighs about 100 mg), "20 per gram" batches (each granule weighs about 50 mg), and "25 per gram" batches (each granule weighs about 40 mg).

[0064] cannabinoid compounds In certain embodiments of the present invention, the cannabinoids used to fill the neutral granules are cannabidiol (CBD), cannabigerol (CBG), trans-Δ9-tetrahydrocannabinol (TACNA), Binol (THC), and mixtures thereof.

[0065] According to a first embodiment, the granules contain cannabidiol (CBD). These granules are particularly intended for individuals who wish to consume only cannabidiol via a sublingual administration method.

[0066] In particular, the granules contain products such as pure CBD, which is an isolate of cannabidiol.

[0067] According to a second embodiment, the granules contain trans-Δ9-tetrahydrocannabinol. Binol Contains (THC).

[0068] According to a third embodiment, the granules contain cannabidiol (CBD) and trans-Δ9-tetrahydrocannabinol. Binol (THC) in any ratio of each component, such as 50% CBD and 50% THC, or 20% CBD and 80% THC, or vice versa, or 90% CBD and 10% THC, or vice versa.

[0069] In certain embodiments, CBD and THC can be combined in specific ratios between 99:1 CBD / THC and 1:99 CBD / THC, including the inclusive limits of this range.

[0070] Although CBD and THC act through different mechanisms of action, many of their physiological effects overlap. When combined, CBD and THC can enhance each other's benefits while reducing the undesirable effects, including the psychotropic or impairing effects, of THC.

[0071] According to a fourth embodiment, the granules contain cannabidiol (CBD), trans-Δ9-tetrahydrocannabinol (TAC), Binol (THC), or a mixture of these, and possibly other cannabinoid compounds.

[0072] According to a fifth embodiment, the granules contain cannabidiol (CBD) in combination with cannabigerol (CBG).

[0073] The at least one cannabinoid used to fill the neutral granules may be of natural origin or synthetic.

[0074] Preferably, the at least one cannabinoid is a naturally occurring phytocannabinoid, in particular the at least one cannabinoid may be a phytocannabinoid extracted from the plant Cannabis sativa.

[0075] Preferably, the at least one cannabinoid is in a purified form comprising at least 90% of said cannabinoid, which purified form may in particular be an isolate of said cannabinoid.

[0076] The extract from the plant Cannabis sativa may be in different forms, for example, an emulsion, oil, paste, liquid, resin, crystal, powder, or pulp.

[0077] These different forms of cannabinoid extracts fall into two main categories: "full spectrum" or "isolate." "Full spectrum" extracts contain primarily one cannabinoid, but also contain small amounts of other cannabinoids derived from the plant.

[0078] "Isolate" includes purified cannabinoids that have been extracted from the plant and isolated from other cannabinoids.

[0079] According to a preferred embodiment of the invention, the isolate contains at least 95%, preferably at least 99%, and more preferably about 99.9% by weight of the target cannabinoid, based on the total weight of the isolate.

[0080] Cannabidiol isolates with over 99% CBD are commercially available, for example, from SPECTRUMS Europe or FOLIUM BIOSCIENCES (US).

[0081] These isolates, obtained from the refining of oil-based full-spectrum extracts, are usually in the form of a crystalline powder. This powder dissolves in oil but not in water. Interestingly, these isolates do not exhibit any taste or flavor. Advantageously, the CBD isolates contain only trace amounts of THC, or even better, no THC at all.

[0082] Sugar coating of granules In a preferred embodiment of the present invention, the granules are sugar coated with a sugar syrup and an extract containing at least one cannabinoid compound and / or nicotine.

[0083] This technique, called "sugar coating" of the granules, is a routine procedure for those skilled in the art of homeopathic granules, as well as those skilled in the art of confectionery manufacturing. This technique is advantageous because it allows for a uniform distribution of the at least one cannabinoid compound and / or nicotine in an outer layer of sugar created around the granule.

[0084] Sugar coating is usually carried out using a coating turbine. Coating turbines useful for this step are in particular those of the DRIAM, GLATT or MANESTY type.

[0085] The sugar coating process involves three steps: coating the granules with sugar syrup, then applying an extract containing at least one cannabinoid compound (full range or isolate, preferentially isolate) and / or nicotine to the granules, and finally air-drying the coated granules.

[0086] The sugar syrup comprises water and at least one sugar, such as a polyol, a monosaccharide, a disaccharide, or any combination thereof. Preferably, the sugar is selected from lactose, sucrose, a polyol, or a mixture thereof. In particular, the sugar is a polyol, preferably xylitol.

[0087] In a preferred embodiment of the present invention, the sugar syrup has a concentration of about "60 BRIX", which corresponds to 60 grams of sugar dissolved in 100 ml of water. The sugar syrup can also be a solution at 40, 50, 65, 70, 80 or 90 BRIX.

[0088] Advantageously, the extract containing at least one cannabinoid compound is derived from the plant Cannabis sativa L.

[0089] Preferably it is an isolate containing only one cannabinoid compound.

[0090] In a preferred embodiment, the isolate comprises at least 95% by weight of said one cannabinoid compound.

[0091] Loaded cannabinoid dose Dosage is an important factor in achieving maximum benefit and minimum adverse effects of Cannabis sativa extract. The optimal average daily dose of cannabinoids for adults (i.e., the amount that is safe without side effects) varies from individual to individual, but is established by a physician and is as follows: 25-30 milligrams per day for CBD, and For THC, 20-30 milligrams per day.

[0092] Preferably, each single dose administered should not exceed 10 mg.

[0093] In certain embodiments, the cannabinoid-loaded granules are prepared to contain a specific amount of at least one cannabinoid or a mix thereof.

[0094] For example, each granule contains 5, 10, 15, 20, 25 or 30 mg of cannabinoid, ie a single cannabinoid or a mix of at least two cannabinoid compounds.

[0095] Preferably, each granule contains one cannabinoid in a dose of between about 2 mg and about 8 mg, preferentially between about 4 mg and about 6 mg, more preferably in a dose equal to about 5 mg.

[0096] In a particular embodiment of the invention, a cannabinoid-loaded granule weighs approximately 130 mg and comprises 125 mg of sugar granules and 5 mg of at least one cannabinoid, in this embodiment the at least one cannabinoid represents 3.85% of the total dry weight of the loaded granule.

[0097] In another particular embodiment of the invention, the cannabinoid-loaded granule weighs approximately 45 mg and comprises 40 mg of sugar granules and 5 mg of the at least one cannabinoid, in this embodiment the at least one cannabinoid represents 11.11% of the total dry weight of the loaded granule.

[0098] In a preferred embodiment of the present invention, the at least one cannabinoid represents about 2% to 15% by weight of the total dry weight of the cannabinoid-loaded granules.

[0099] Nicotine dosage Dosage is an important factor in achieving the maximum benefits and minimum adverse effects of nicotine. Although it varies from individual to individual, physicians have established that for temporary interruption or cessation of smoking, approximately 1 mg of nicotine should be administered for each cigarette consumed daily by an individual.

[0100] Preferably, each single dose administered will not exceed 30 mg of nicotine.

[0101] In certain embodiments, the nicotine-loaded granules are prepared to contain a particular amount of nicotine, for example, each granule can contain 5, 10, 15, 20, 25, or 30 mg of nicotine.

[0102] According to certain embodiments, the present invention relates to: The fill granules contain cannabidiol (CBD) in combination with nicotine; The filling granules are trans-Δ9-tetrahydrocannabinol Binol (THC) in combination with nicotine; The filled granules contain cannabidiol (CBD) and trans-Δ9-tetrahydrocannabinol. Binol Contains a mix of both THC and nicotine; The fill granules contain cannabidiol (CBD) in combination with cannabigerol (CBG) and nicotine.

[0103] Cannabinoid and / or nicotine loaded granules further containing terpenes In certain embodiments of the present invention, the cannabinoid and / or nicotine loaded granules further contain at least one terpene, preferably a combination of at least two terpenes.

[0104] More specifically, the present invention relates to: cannabinoid-loaded granules further containing at least one terpene, preferably a combination of at least two terpenes; nicotine-loaded granules further containing at least one terpene, preferably a combination of at least two terpenes; and A cannabinoid and nicotine loaded granule further comprising at least one terpene, preferably a combination of at least two terpenes.

[0105] Advantageously, the cannabinoid and / or nicotine loaded granules of the present invention are impregnated with a solution comprising a combination of at least two terpenes.

[0106] Terpenes are a class of organic hydrocarbons produced by various plants, especially conifers, and some insects. Terpenes and their derivatives, terpenoids, are the major components of essential oils. Terpenes are also the major components of the Cannabis sativa plant, which contains at least 120 identified compounds.

[0107] Terpenes have desirable properties for use in the food and pharmaceutical industries. Terpenes and terpenoids occur in a wide range, but their extraction from natural sources is often problematic. As a result, they are often supplied as synthetic products derived from chemical synthesis.

[0108] In a preferred embodiment of the present invention, the granules are impregnated with a solution comprising at least one terpene selected from the group consisting of myrcene, d-limonene, α-pinenene, linalool, borneol, caryophyllene, terpinolene, menthol, geraniol, bisabolol, β-caryophyllene, humulene, linalool, farnesene, α-phellandrene, and any combination thereof.

[0109] Impregnation of granules is a routine procedure for those skilled in the art of homeopathic granules. The procedure has been extensively described in the literature, for example in U.S. Pat. No. 4,703,717. This technique involves the use of: a liquid comprising an active compound (at least one terpene); Porous sugar granules of desired size / weight, and An impregnation device having a control means.

[0110] Impregnated devices are commercially available at any homeopathic device store, for example http: / / www.vanda-france.fr / .

[0111] Advantageously, the granules of the invention are impregnated with terpene(s) at an impregnation rate of between 0.2% and 2%, preferably at an impregnation rate of 0.5%.

[0112] As presented in the Examples section, a typical dosage corresponding to a 0.5% pick-up is approximately 25 grams of terpene per 5000 grams of xylitol granules.

[0113] In a particular implementation of the method for making cannabinoid and / or nicotine loaded granules, the granules are first impregnated with a dynamized solution containing at least one terpene and then loaded with the cannabinoid(s) and / or nicotine.

[0114] Optionally, the filled granules can be coated with a natural gum, such as gum arabic, immediately after the terpene impregnation step. This optional step is useful for immobilizing and isolating at least one terpene and also aids in solidification of the granules.

[0115] Additional compounds The cannabinoid and / or nicotine loaded granules according to the present invention may also comprise at least one additional active compound.

[0116] These active compounds may be chosen in particular from mushroom extracts, caffeine, flavonoids, and combinations thereof.

[0117] Mushroom extracts are in particular extracts from the following mushrooms: Hydnum repandum, commonly known as sweettooth, wood hedgehog or hedgehog mushroom, a Basidiomycete fungus of the Basidiomycete family, Yamabushitake (Hericium erinaceus), also known as Lion's Mane Mushroom, Monkey Head Mushroom, Bearded Tooth Mushroom, Satyr Beard, Bearded Hedgehog Mushroom, Pom Pom Mushroom, or Bearded Tooth Fungus, belongs to the group of dental fungi. Chaga, or Inonotus obliquus, family Hymenochaetaceae, A polypore fungus belonging to the genus Ganoderma, also known as Reishi, Lingzhi, or Ganoderma lindsii, Trametes versicolor, also known as Coriolus versicolor or Polyporus versicolor, polypore mushroom.

[0118] In certain embodiments, the cannabinoid and / or nicotine loaded granules according to the present invention further comprise at least one mushroom extract.

[0119] In certain embodiments, the cannabinoid and / or nicotine loaded granules according to the present invention further comprise caffeine.

[0120] In certain embodiments, the cannabinoid and / or nicotine loaded granules according to the present invention further comprise at least one flavonoid.

[0121] The cannabinoid and / or nicotine loaded granules may further contain additional compounds selected from the group of solubilizers, thickeners, surfactants, colorants (especially for whitening the granules), flavoring agents, effervescent agents, antioxidants, bioadhesives, pH modifiers, vitamins, minerals, penetration enhancers or transdermal absorption enhancers, absorption enhancers, serotonin, caffeine, amino acids, and mixtures thereof.

[0122] Penetration or permeation enhancers and absorption enhancers, if present, are added to improve the absorption of the cannabinoid by the mucosal tissues of an individual.

[0123] The vitamins are in particular selected from the group consisting of thiamine, riboflavin, nicotinic acid, pantothenic acid, pyridoxine, biotin, folic acid, vitamin B12, lipoic acid, ascorbic acid, vitamin A, vitamin D, vitamin E, and vitamin K.

[0124] These additional compounds can be added to the granules by impregnation or as part of the sugar coating of the granules.

[0125] Final coating of cannabinoid and / or nicotine loaded granules The final coating of the fill granules allows for aesthetic appeal while improving the stability of the granules, and in particular if traces of crystalline powder of cannabinoid isolate are still present around the fill granules, the final coating can allow said traces to be fixed onto the granules.

[0126] In certain embodiments of the present invention, the cannabinoid and / or nicotine loaded granules are coated with a sugar syrup containing colorants or flavorants, natural gums, natural waxes, or any combination thereof.

[0127] This optional step makes it possible to obtain shiny granules. In addition, this final coating protects the granules from breakage.

[0128] The techniques for obtaining this coating are described above.

[0129] This final coating is an outer layer on all surfaces of the granule and has a thickness of less than 10 microns. The final coating may include, among others: natural gums, such as gum arabic or xanthan gum, or natural waxes, such as carnauba wax or beeswax, or For sugar coating: a polyol, such as xylitol, or a monosaccharide, such as glucose or fructose, or a disaccharide, such as saccharose, lactose, or sucrose, or Any combination of these.

[0130] Optionally, the final coating layer may include colorants and / or flavorants.

[0131] The final coating layer may contain a colorant selected from suitable synthetic or natural colorants known to those skilled in the art.

[0132] The final coating layer may also contain flavoring agents selected from synthetic flavor oils and flavoring aromatics and / or natural oils, such flavoring agents being selected from among those having one of the following flavors: mint, ginger, anise, cinnamon, peppermint, licorice, honey, vanilla, citrus oils including lemon, orange, grape, lime and grapefruit, and fruit essences including apple, pear, peach, strawberry, raspberry, cherry, plum, pineapple, apricot, etc.

[0133] Method for producing cannabinoid and / or nicotine loaded granules The present invention also relates to a method for producing cannabinoid and / or nicotine loaded granules, such as those described above, comprising at least the following steps: a) adding at least one cannabinoid compound and / or nicotine to orodispersible sugar granules; b) air drying the granules; c) repeating the successive steps (a) and (b) at least 20 times; d) Optionally, coating the cannabinoid and / or nicotine loaded granules with a sugar syrup containing colorants or flavorants, natural gums, natural waxes, or any combination thereof.

[0134] The step of "adding to the orodispersible sugar granules" can be carried out by any technique known to those skilled in the art. In particular, this step of adding at least one cannabidiol compound and / or nicotine can be the following step: applying an extract containing at least one cannabinoid compound and / or nicotine to orodispersible sugar granules; or Incorporating at least one cannabinoid compound and / or nicotine into orodispersible sugar granules.

[0135] Optional steps can be added at any point in the methods described above: for example, a terpene(s) impregnation step followed by a scrubbing step can be introduced before or after the cannabinoid and / or nicotine loading step (a).

[0136] In certain embodiments of the present invention, a method for producing cannabinoid and / or nicotine loaded granules, such as those described above, comprises at least the following steps: a1) coating orodispersible sugar granules with sugar syrup, in particular xylitol syrup; a2) applying an extract containing at least one cannabinoid compound and / or nicotine to the xylitol coated granules; b) air drying the granules; c) repeating the successive steps (a1), (a2) and (b) at least 20 times; d) Optionally, further coating the cannabinoid and / or nicotine loaded granules with a sugar syrup containing colorants or flavorants, natural gums, natural waxes, or any combination thereof.

[0137] In step (a1), orodispersible sugar granules are sprayed with a sugar syrup, for example xylitol syrup, which may also be pre-impregnated with a solution comprising at least one terpene, preferably a combination of at least two terpenes.

[0138] Steps (a1), (a2) and (b) are carried out in a coating turbine, and are realized sequentially and repeated at least 20 times, preferably at least 30 times, more preferably at least 40 times, and in a preferred manner about 50 times.

[0139] Step (d) consists of final sugar coating the cannabinoid and / or nicotine loaded granules with a thin outer layer on all surfaces of the granules, comprising: natural gums, such as gum arabic or xanthan gum, or natural waxes, such as carnauba wax or beeswax, or Sugar coating containing water and: a polyol, such as xylitol, or a monosaccharide, such as glucose or fructose, or Disaccharides, such as saccharose, lactose, or sucrose, and Optionally, flavoring and / or coloring agents, or Any combination of these.

[0140] This step (d) can be repeated at least twice, for example: A first sugar coating step is carried out to coat the granules with flavoring agents, A second coating step is achieved with wax to obtain a shiny appearance of the cannabinoid and / or nicotine loaded granules.

[0141] The first sugar coating step to coat the granules with flavoring can be repeated at least 2 times, at least 5 times, at least 10 times, 20 times, or more times before the second coating step.

[0142] The coating is carried out using a coating turbine. Coating turbines useful for this step are in particular those of the DRIAM, GLATT or MANESTY type.

[0143] Another implementation of the method according to the present invention is presented in Example 4. This particular method comprises the following steps: 1) impregnating orodispersible sugar granules with at least one terpene; 2) scrubbing with natural gum; 3) loading the granules with at least one cannabinoid compound and / or nicotine; 4) coating the granules with a sugar syrup, optionally containing flavoring agents; 5) Final coating of wax on the granules for protection and shine.

[0144] The present invention also relates to a method of making cannabinoid-loaded granules, comprising at least the following steps: a) freeze-drying a solution comprising at least one cannabinoid compound and one sugar; b) forming granules from the freeze-dried powder, for example using a tablet press; c) Optionally, coating the cannabinoid-loaded granules with a sugar syrup containing colorants or flavorants, natural gums, natural waxes, or any combination thereof.

[0145] This method is particularly useful when the at least one cannabinoid compound is THC. This method is exemplified in Example 5.

[0146] Uses of the cannabinoid and / or nicotine loaded granules of the present invention The present invention also relates to cannabinoid and / or nicotine loaded granules as described above or as obtainable by any one of the methods as described above, for use as a medicament.

[0147] It is contemplated that the cannabinoid and / or nicotine loaded granules are administered sublingually. Interestingly, this route of delivery of the cannabinoid(s) allows for a rapid onset of the cannabinoid(s) across the oral mucosa.

[0148] In another aspect, the present invention relates to said cannabinoid and / or nicotine loaded granules for use in the treatment and / or prevention of chronic pain, inflammatory disorders, behavioral disorders, and anxiety disorders.

[0149] As used herein, the terms "treat," "treating," or "treatment" refer to administering therapy to an individual with the goal of reducing the frequency and / or severity of symptoms of a disease, defect, disorder, or adverse condition in said individual.

[0150] As used herein, the terms "prevent," "preventing," or "prevention" refer to the administration of a therapeutic compound to an individual with the goal of reducing the likelihood that the individual will develop a particular disease.

[0151] In a particular embodiment, the present invention relates to nicotine-loaded granules for use in the treatment of tobacco addiction on an occasional or regular basis.

[0152] Nutritional supplements and kits containing the same The present invention also relates to the use of cannabinoid and / or nicotine loaded granules as described above or as obtainable by any one of the methods as described above, as a nutritional supplement.

[0153] As used herein, the term "nutritional supplement" refers to any food supplement served in addition to a normal dietary regimen that is intended to provide a substance not normally consumed.

[0154] The individual consuming the nutritional supplement may be: "recreational users" of cannabinoids, and / or Individuals who wish to consume a dose of nicotine on an occasional or regular basis.

[0155] The present invention also relates to a kit for use as a nutritional supplement, comprising in a single package at least two administration devices containing cannabinoid-loaded granules further containing at least one terpene, the at least two administration devices being distinct from one another in that the at least one terpene differs from one administration device to another.

[0156] In certain embodiments, the kit further comprises a means for conveying information or instructions for use of the kit.

[0157] In certain embodiments, the kit comprises cannabidiol-loaded granules.

[0158] As previously mentioned, the optimal daily dose of a cannabinoid, e.g., cannabidiol (CBD), is about 25 mg per day, and consequently, in certain embodiments, the optimal daily dose is 5 granules containing 5 mg of CBD each.

[0159] According to this last embodiment, the user of the kit chooses to consume 5 granules over the course of the day depending on the user's particular needs: concentration, drowsiness, fatigue, pre-workout energy boost, etc.

[0160] If the kit contains three administration devices, the user may choose to consume two granules from one administration device in the morning, one granule from another administration device in the afternoon, and two granules from the final administration device in the evening before going to sleep.

[0161] Advantageously, the kits of the invention contain enough granules for one week of administration (35 granules of cannabinoid-loaded granules), for two weeks of administration (70 granules of cannabinoid-loaded granules) or even for one month of administration (more than 140 granules of cannabinoid-loaded granules), the number of granules being based on an optimal daily dose of five granules per day.

[0162] These granules are distributed over at least two administration devices, preferably three, four, five, six or seven administration devices.

[0163] Each administration device contains approximately 5, 10, 15, 20, 25 or 30 granules of cannabinoid-loaded granules. [Example]

[0164] Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that many changes can be made to the exemplary embodiments and other arrangements can be devised without departing from the spirit and scope of the present invention as defined in the appended claims.

[0165] Example 1. Method of Preparation of Cannabinoid-Loaded Granules In this experiment, xylitol granules were loaded with 5 mg of CBD per granule. The xylitol beads used were approximately 3.7 mm in diameter and weighed 0.04 g.

[0166] A - Impregnation of granules with terpene combinations. A solution containing a combination of pure terpenes (myrcene type), e.g., limonene, A-pinene, linalool, caryophyllene, was used in the following proportions: 1 kg of xylitol beads, and 5g of terpene solution.

[0167] The dynamization of the solution was repeated three times: 20 seconds, 300 shakes. As is well known to those skilled in the art, liquids containing active ingredients are preferentially "dynamized" before impregnation. In homeopathy, "dynamization" refers to the vigorous shaking of an alcoholic solution containing the active compound in a process called "shaking."

[0168] Impregnation is achieved using either a liquid injector or a coating turbine. By injector: Delivery of terpene solution by adding to beads Mixing: 30 minutes Drying time: 20-30 minutes By turbine: Delivery of terpene solution by spraying (atomization using an automatic spray gun) onto beads; Mixing: 30 minutes, Drying time: 20-30 minutes (using small central air treatment), ambient temperature below 40°C.

[0169] At the end of this process, the xylitol beads are impregnated with a combination of at least two terpenes (in this case 5 g of terpene per kg of beads, ie 0.5% by weight terpene per bead).

[0170] B - Coating of terpene-impregnated xylitol beads with xylitol syrup, followed by application of CBD or any other cannabinoid compound. In this example, 2 kg of terpene-impregnated xylitol beads (i.e., approximately 50,000 beads) were used with 250 g of cannabidiol (CBD), distributing approximately 5 mg of CBD to each bead.

[0171] First, a xylitol syrup at 60 BRIX was prepared using 450 g of xylitol and 300 g of water and heated to 80° C. The temperature of the syrup was then reduced to between 50° C. and 60° C., and the concentration of xylitol was adjusted to 60 BRIX.

[0172] Once a syrup of 60 BRIX is obtained, xylitol beads are introduced into the turbine for coating.

[0173] Each CBD coating and application cycle includes the following substeps: Using an automatic spray gun, spray the beads with xylitol syrup and then mix for about 30 seconds; Applying CBD isolate to the beads; and Dry the beads in an air treatment for 3-4 minutes using "cold" air at a temperature of approximately 25°C.

[0174] These successive steps are repeated approximately 64 times.

[0175] The number of sprays depends on the cycle: The first 10 cycles consist of eight sprays of xylitol syrup / CBD isolate, during which 4.5g of xylitol syrup (0.04 liters) and 2.25g of cannabidiol are loaded into the beads. During cycles no. 11-20, 12 sprays of xylitol syrup / CBD isolate are carried out. The beads are filled with 6.75g of xylitol syrup and 3.375g of cannabidiol. Cycle no. 21 involves 16 sprays of 1 xylitol syrup / CBD isolate, during which 4.5 g of cannabidiol is dispensed.

[0176] Using this process, 250 g of cannabidiol is gradually introduced into 50,000 beads.

[0177] Example 2: Further coating of cannabinoid-loaded granules for flavor, color and / or brightness Advantageously, two steps of "final sugar coating" are carried out: 1. Coating xylitol syrup with vanilla flavoring (or any other flavor): Spray the xylitol syrup onto the beads using an automatic spray gun and mix for approximately 4 minutes. Dry the beads in air for about 3 minutes. During the final spray, add vanilla flavoring (2g / kg) to the beads with minimal air. Allow the beads to dry. Repeat this step approximately 25 times.

[0178] 2. Without air, mix the carnauba wax with the CBD-filled granules in the following proportions: 500 mg of wax for every 1 kg of filled granules.

[0179] Example 3. Kit Preparation The kit includes eight administration devices containing xylitol granules loaded with 5 mg CBD per granule, as well as other active compounds.

[0180] Each administration device contains CBD-loaded granules that further contain a mix of terpenes, and the administration devices are distinct from one another in that the mix of terpenes varies from one administration device to another, in this example each granule contains 0.5% by weight of the terpene mix.

[0181] Each one of the eight dosing devices is designed for a specific use: 1) Brain Focus - "Focus" The CBD-loaded granules further comprise a combination of at least two terpenes selected from the following: alpha-pinenene, d-limonene, borneol, and myrcene. 2) Sports Booster - "Sports" The CBD-loaded granules further comprise a combination of at least two terpenes selected from the following: alpha-pinenene, d-limonene, terpinolene, menthol, geraniol, and bisabolol. 3) Sleep The CBD-loaded granules further comprise a combination of at least two terpenes selected from the following: alpha-pinenene, beta-caryophyllene, humulene, linalool, and myrcene. 4) Pain relief The CBD-loaded granules further comprise a combination of at least two terpenes selected from the following: alpha-pinenene, d-limonene, geraniol, humulene, farnesene, linalool, and myrcene. 5) Safeguard (Immune System Booster) – “Immunity” The CBD-loaded granules further comprise a combination of at least two terpenes selected from the following: α-pinenene, d-limonene, β-caryophyllene, α-phellandrene, linalool, and myrcene. 6) Aphrodisiac Stimulant (Sensitivity) - "Intimacy" The CBD-loaded granules further comprise a combination of at least two terpenes selected from the following: α-pinenene, d-limonene, terpinolene, β-caryophyllene, humulene, farnesene, linalool, and myrcene. 7) Relax The CBD-loaded granules further comprise a combination of at least two terpenes selected from the following: farnesene, beta-caryophyllene, and myrcene. 8) “Pure CBD” CBD-loaded granules with a combination of at least two terpenes. The CBD is said to be "pure" because these granules do not contain any cannabigerol (CBG).

[0182] Example 4. Illustration of an industrial process for the preparation of filled granules Phase 1: Impregnation Step 1 - Control Ambient temperature: between 20° and 30° Humidity measurement: Between 20% and 35% Step 2 - Start the device Granules made of xylitol (5000 g) are deposited in a coating device. Switch on the device. The mixing speed is comprised between 30 and 40 rpm (revolutions per minute). Step 3 - Dynamization of the Terpene / Alcohol Solution The following compounds are mixed: Natural terpenes (approx. 25g) Ethyl alcohol (approximately 75g) Mix terpenes and alcohols by dynamization: 2-6 hours / 300-500 shakes. The dynamized solution is integrated into the coating equipment in four steps, then: Mix for 10 to 30 minutes Dry at a temperature between 40°C and 60°C for 30 to 60 minutes.

[0183] Phase 2: Scrubbing Step 1 - Preparation of the main compound (dilution between 2% and 5%) Xylitol powder: approx. 100g Distilled water: 25g-30g Gum arabic: 25g-30g Step 2 - Preparation of the Gum For approximately 100g of dry powder: Gum arabic: 20g to 30g Xylitol powder: 70g-80g Blend xylitol powder and gum arabic. For approximately 50 ml of solution: Gum arabic: 5g Xylitol powder: 20g Distilled water: 25g Blend xylitol powder and gum arabic Heat the water to 30-45°C. Mix the powder with water and maintain the temperature Pour mix into coating equipment; stir for 1-5 minutes. Pour 100g of dry powder into the coating device Blend for approximately 1 to 5 minutes. Dry at 20℃ to 30℃ for about an hour.

[0184] Phase 3: CBD-CBG Coating Step 1 - Prepare the ingredients Xylitol powder: between 2700g and 3500g Distilled water: between 1000g and 1700g CBD-CBG: Approximately 1400g Step 2 - Preparing Xylitol Syrup Pour distilled water into the hot beverage machine Adjust the temperature between 65℃ and 85℃ Pour in the xylitol powder Check the syrup's Brix: between 60 and 90 Step 3 - CBD-CBG Coating The coating process involves 40 to 70 steps, each of which includes: Pour approximately 100ml of xylitol syrup and 20g of CBD-CBG into the coating device. Mix for approximately 1 to 5 minutes. Dry at between 20°C and 30°C.

[0185] Phase 4: Xylitol syrup coating Step 1 - Separate the ingredients Xylitol powder: between 1250 and 1900g Distilled water: between 500 and 850g Vanilla flavoring: between 5g and 12g Step 2 - Preparing Xylitol Syrup Pour distilled water into the hot beverage machine Adjust the temperature between 65℃ and 85℃ Pour in the xylitol powder Check the syrup's Brix: between 60 and 90 Step 3 - Xylitol Syrup Coating Reloading the granules into the coating equipment The coating process involves 10 to 30 steps, each of which includes the following substeps: Pour approximately 50ml of xylitol syrup into the coating device. Mix for approximately 1 to 5 minutes. Dry between 20℃ and 30℃ Incorporate vanilla flavoring between steps 15 and 25.

[0186] Phase 5: Protect-Shine Step 1 - Prepare the ingredients Carnauba wax: 0.9g to 2.5g (per 5000g of granules) Step 2 - Protect - Shine Reloading the granules into the coating equipment Pour carnauba wax into the coating device Mix for approximately 30 to 60 minutes. Dry at a temperature of 20°C to 30°C for approximately 30 minutes.

[0187] Example 5. Illustration of an alternative industrial process for the preparation of THC-loaded granules The process includes the following steps: 1. Preparation of solution (1), comprising: THC (80% concentrated hemp oil) Food-grade ethyl alcohol terpenes Incorporating THC oil into ethanol, Incorporating terpenes into a THC and ethanol solution, The solution is then homogenized by dynamization.

[0188] 2. Preparation of Sugar and Water Solution (2) diluting the polyol and lecithin in water; Heat the water to between 70-75 degrees Celsius. Incorporating xylitol into water Incorporating lecithin into water The solution is homogenized by dynamization.

[0189] 3. Incorporation of Solution 2 into Solution 1: The final solution is homogenized by ultrasonic homogenization. The procedure is repeated until particles between 100 and 200 microns in size are obtained.

[0190] 4. Freeze-drying the solution: The solution is freeze-dried to produce a powder by the following technique: Dispense the solution into the tray Incubation in a freezer: Freeze for 9-12 hours Freeze-dry for 24-28 hours

[0191] 5. Preparation and homogenization of powder for incorporation into tablet press. The lyophilized powder is mixed with excipients (mannitol, xylitol...) in the following proportions: 43% lyophilized powder 57% excipients Powder homogenization is carried out in a dry granulator, hammer granulator or wheel granulator. Particles with a size between 100 and 200 microns are obtained.

[0192] 6. Powder molding A tablet press is used to form granules with diameters comprised between 3 and 4 mm.

[0193] 7. First coating of granules The coating process involves 10 to 30 steps. Each step includes the following substeps: Add approximately 50 ml of xylitol syrup (69% xylitol to 31% water) to the coating equipment; Stir for 1 to 5 minutes; Dry between 20° and 30° Celsius.

[0194] 8. Second coating of granules for protection and gloss Reloading the granules into the coating equipment; Add carnauba wax to the granules; Blend for 30 minutes to 1 hour. References patents US 9,095,563 WO 2017 / 189375 WO 2017 / 208072 WO 2017 / 180707 WO 2017 / 185038 WO 2018 / 129097 US 10,434,084 US 2018 / 344786 Bibliographic references Blessing EM, Steenkamp MM, Manzanares J,Marmar CR. Cannabidiol as a Potential Treatment for Anxiety Disorders.Neurotherapeutics. 2015 Oct;12(4):825-36. Bergamaschi MM, Queiroz RH, Zuardi AW, Crippa JA. Safety and side effects of cannabidiol, a Cannabis sativaconstituent. Curr Drug Saf. 2011 Sep 1;6(4):237-49. Bartner LR, McGrath S, Rao S, Hyatt LK,Wittenburg LA. Pharmacokinetics of cannabidiol administered by 3 deliverymethods at 2 different dosages to healthy dogs. Can J Vet Res. 2018Jul;82(3):178-183.

Claims

1. A method for producing cannabinoid-loaded granules, comprising: The cannabinoid-loaded granules comprising sugar granules loaded with at least one cannabinoid compound, the sugar granules have a diameter of 2 to 10 millimeters; decomposes upon contact with saliva to release said at least one cannabinoid compound; The method comprises at least the following steps: a) adding at least one cannabinoid compound to sugar granules having a diameter of between 2 and 10 millimeters; b) air-drying the granules; and c) repeating said successive steps (a) and (b) at least 20 times.

2. 10. The method of claim 1, wherein the sugar granules are composed of lactose, sucrose, xylitol, or a mix thereof.

3. 3. The method of claim 1 or 2, wherein each sugar granule is 3 to 4 millimeters in diameter and / or weighs 30 to 150 milligrams.

4. 4. The method of any one of claims 1 to 3, wherein the at least one cannabinoid compound is selected from the group consisting of cannabidiol (CBD), cannabigerol, trans-Δ9-tetrahydrocannabinol (THC), and mixtures thereof.

5. 5. The method of any one of claims 1 to 4, wherein the at least one cannabinoid compound is natural or synthetic.

6. 6. The method of any one of claims 1 to 5, wherein the cannabinoid-loaded granules are sugar-coated with a sugar syrup and an extract containing at least one cannabinoid compound.

7. 7. The method of claim 6, wherein the extract containing at least one cannabinoid compound is derived from the plant Cannabis sativa L. and comprises at least 95% by weight of said cannabinoid compound.

8. 8. The method of any one of claims 1 to 7, wherein each cannabinoid-loaded granule contains a dose of from 2 mg to 8 mg of at least one cannabinoid compound.

9. 9. The method of any one of claims 1 to 8, wherein each cannabinoid-loaded granule contains a dose of at least one cannabinoid compound equal to 5 mg.

10. The method of any one of claims 1 to 9, further comprising coating the cannabinoid-loaded granules with a sugar syrup containing a colorant or flavoring agent, a natural gum, a natural wax, or any combination thereof.

11. A method according to any one of claims 1 to 10, wherein the cannabinoid-loaded granules are used as a medicine or nutritional supplement.

12. A method according to any one of claims 1 to 11, wherein the cannabinoid-loaded granules are used in the treatment and / or prevention of chronic pain, inflammatory disorders, behavioral disorders, and anxiety disorders.

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