DEVICE FOR THE PRODUCTION OF A CANNABINOID GRANULES THAT ARE ESSENTIALLY SOLUBLE IN AQUATIC ENVIRONMENTS

Description

[0001] The invention relates to a device for producing a cannabinoid granule that is essentially soluble in an aqueous environment, wherein a matrix liquid is produced from a first liquid dissolving a cannabinoid or from a first liquid dissolving a cannabinoid and a second liquid forming an emulsion with the first liquid and a cannabinoid dissolved in the first liquid or the emulsion, wherein the matrix liquid is dried convectively to a cannabinoid granule in a fluidization apparatus (18) by spray granulation, spray agglomeration or spray encapsulation.

[0002] Devices for the production of, in particular, oral dosage forms of a cannabinoid have long been part of the state of the art.

[0003] WO 02 / 064109 A2 discloses pharmaceutical formulations for use in the administration of lipophilic drugs via mucosal surfaces. In particular, pharmaceutical formulations are provided for use in the administration of a lipophilic drug via a mucosal surface, which, upon hydration, form an emulsion containing the lipophilic drug, especially drugs containing as active ingredients certain combinations of cannabinoids in predefined ratios, wherein the drug is able to adhere to a mucosal surface and enable a controlled release of the drug.

[0004] US Patent 2016 / 0143972 A1 discloses a process for manufacturing a solid dosage form of a cannabinoid, wherein the solid dosage form of the cannabinoid is substantially soluble in an aqueous solution. The process comprises dissolving a cannabinoid and one or more emulsifiers in one or more solvents to obtain one or more combined solutions, and further comprising drying the one or more solvents from the combined solutions comprising the one or more solvents to obtain the solid dosage form of the cannabinoid.

[0005] A disadvantage is that the solid dosage forms of a cannabinoid mentioned in the prior art exhibit insufficient systemic absorption and therefore the bioavailability of the cannabinoids is low, since the particle size distributions of the solid dosage forms are not very homogeneous and, in addition, the orally administered solid dosage forms have poor flowability.

[0006] US 2019 / 022009 A1 discloses a process for producing a biopolymeric hemostatic powder, comprising adding a mixture of an organic acid, a combination of alcohols, and a bioadhesive to a reactor to obtain a binder solution, and a step for introducing a polysaccharide onto the base of the lower part of a fluidized bed reactor, driven by an airflow injected at controlled temperature and velocity; wherein the binder solution is sprayed onto this fluid and microparticles of the polysaccharide from the top of said fluidized bed reactor, and wherein the polysaccharide is chitosan, the organic acid is acetic acid, the alcohol combination consists of an alcohol and a polyalcohol, and the bioadhesive is polyvinyl alcohol.The product contains between 55% and 85% w / w of a polysaccharide; between 10% and 40% w / w of an organic acid; up to 17% w / w of a combination of alcohols and up to 3% w / w of a bioadhesive; wherein the alcohol combination consists of 95% alcohol and 5% polyalcohol and the binding liquid is sprayed onto the polymer in an amount of between 50% and 150% p / p.

[0007] DE 103 26 231 A1 relates to a process for the production of enzyme granules. The object of the invention is to provide a process for the production of enzyme granules in which the enzyme granules can be produced continuously or in batches while minimizing temperature variations during the production process and increasing the yield of enzyme activity. Simultaneously, the controllability of the granulation during production is to be improved. According to the invention, the production of enzyme granules is achieved by linking the thermal conditions in the spray zone with the temperature conditions in the remaining area of ​​the fluidized bed. In the process according to the invention, this is achieved by supplying the heated process gas for drying exclusively in the spray zone.The safe feeding of particles into the spraying area is achieved through the special geometric design of the apparatus, utilizing gravity.

[0008] DE 10 2016 121050 A1 refers to a product in tablet form or a product in capsule form, the product in each case consisting of a dried dosage form of a GcMAF-containing formulation.

[0009] The object of the invention is therefore to expand the application areas for consumers and to increase the systemic absorption of the cannabinoids, thereby improving the bioavailability of the cannabinoids and simultaneously improving the flowability of the solid dosage form of the cannabinoids by providing an improved device for carrying out a process for the production of cannabinoid granules.

[0010] This problem is solved in a device of the type mentioned above by the device having a container system for producing the matrix liquid, comprising several containers that are at least partially fluidically connected to one another via pipelines, which has a cannabinoid inlet, a liquid inlet for a first liquid from the group consisting of lipids, alcohols, oils and / or any mixture thereof, a liquid inlet for a second liquid and a matrix liquid outlet, wherein the device has a first container for the first liquid, a second container for the second liquid and a container for the emulsion having an inlet, and wherein the device further has a convective drying apparatus designed as a fluidization apparatus, which is fluidically connected to the matrix liquid outlet of the container system.Preferably, the convective drying apparatus is configured as a spray dryer, a drum dryer, a vacuum dryer, or a fluidization apparatus. Surprisingly, it was found that convective drying of the cannabinoid-containing matrix fluid in a fluidization apparatus, particularly a jet or fluidized bed apparatus, through spray granulation, spray agglomeration, or spray encapsulation, results in a stable emulsion of the first and second liquids after the cannabinoid granules are redissolved in the aqueous environment. This significantly improves the absorbability of the cannabinoids and thus ensures optimal bioavailability. The improved absorbability and optimal bioavailability of the cannabinoids result from more homogeneous and smaller emulsion particles (oil droplets in water), which, for example,The cannabinoid granules are obtained by spraying and drying, particularly by film drying, the matrix liquid onto carrier particles, after re-dissolving the cannabinoid granules in an aqueous environment compared to the emulsion particles (oil droplets in water) contained in the matrix liquid prior to convective drying, preferably in a fluidization apparatus. Furthermore, a reduction in the mean diameter x and the equivalent diameter was surprisingly observed after convective drying in the fluidization apparatus. The cannabinoid granules can be readily filled into stick packs and applied directly into the oral cavity, added to a glass of liquid, compressed into tablets, or further processed into capsules.

[0011] In an advantageous embodiment of the device, the fluidization apparatus is designed as a blast bed apparatus or a fluidized bed apparatus. Compared to fluidized bed apparatuses, blast bed apparatuses, for example, allow atomization at very low fill volumes, and furthermore, the high shear forces in the atomization area promote uniform liquid film formation and minimize agglomeration tendencies.

[0012] The container for the emulsion is particularly advantageous if it corresponds to the first or second container. This ensures simple production of the matrix liquid while processing the raw materials separately.

[0013] According to a further advantageous embodiment of the preferred device, the convective drying apparatus, preferably the fluidizing apparatus, has a nozzle for atomizing the emulsion or solution. Preferably, the nozzle, preferably a two-fluid nozzle, is configured to produce droplets with a droplet size of 1 µ m to 200 µ m, preferably of 10 µ m to 100 µ m, especially preferred between 20 µ m and 60 µ to spray. The sprayed droplets particularly favor a droplet size of 25. µ m to 40 µ m, most preferred by 30 µm. By adjusting the droplet size using the nozzle and the compressed air applied to the nozzle, the shear forces occurring during spraying can be precisely controlled, resulting in a very homogeneous droplet size of the emulsion or solution being sprayed. The droplets adhere to the carrier particles, such as cellulose, lactose, or xylitol, and film evaporation preferentially occurs. This film evaporation results in very uniform evaporation of the emulsion or solution on the carrier particles.

[0014] According to an advantageous embodiment of the device, a homogenizer for homogenizing the matrix liquid is arranged between the container system and the drying apparatus, preferably the fluidization apparatus. Homogenization significantly reduces the mean diameter of the first liquid present in the emulsion, thus making the mixture of the first and second liquids, which are immiscible, more homogeneous, i.e., more uniform. Due to the homogenization, particularly high-pressure homogenization, an optimized matrix liquid is produced for convective drying, especially in the fluidization apparatus.

[0015] Furthermore, in a preferred embodiment of the device, a granulation unit, preferably a wet mixer, particularly preferably a high-shear granulator, a vertical granulator, a rotor disc granulator, or the like, is arranged between the container system and the drying apparatus for granulating the matrix liquid. According to a further embodiment of the device, an extruder for extruding the granules is arranged downstream of the granulation unit.

[0016] Preferably, the homogenizer and / or the grating unit and / or the extruder are fluidically connected to each other.

[0017] According to a further advantageous embodiment of the device, the inlet and the matrix fluid outlet are designed as a single opening in the container system. The advantage of such a design for the inlet and matrix fluid outlet lies in the simpler construction and the easier sealing.

[0018] The device is used to carry out a process in which the matrix liquid is dried convectively. Preferably, the matrix liquid is spray-dried or convectively dried in a fluidization apparatus by spray granulation, spray agglomeration, or spray encapsulation to form cannabinoid granules. Surprisingly, it was found that convective drying of the cannabinoid-containing matrix liquid in a fluidization apparatus, particularly a jet or fluidized bed apparatus, by spray granulation, spray agglomeration, or spray encapsulation, after re-dissolving the cannabinoid granules in an aqueous environment, results in a stable emulsion of the first and second liquids. This significantly improves the absorbability of the cannabinoids and thus ensures optimal bioavailability.The improved absorbability and optimal bioavailability of the cannabinoids result from more homogeneous and smaller emulsion particles (oil droplets in water) after the cannabinoid granules are re-dissolved in an aqueous environment, compared to the emulsion particles (oil droplets in water) contained in the matrix liquid before convective drying in the fluidization apparatus. The dissolution behavior of the granules in the aqueous environment is also improved compared to conventional products, such as tablets. Furthermore, a surprising reduction in the mean diameter x and the equivalent diameter was observed after convective drying in the fluidization apparatus. The cannabinoid granules can be readily filled into stick packs, compressed into tablets, or further processed into capsules.

[0019] Cannabinoids are transformation products and synthetic analogs of some terpene phenols. The term also encompasses endogenous substances with similar pharmacological properties to cannabinoids, known as endocannabinoids, and substances from plants other than hemp that have similar or identical effects to cannabinoids, known as phytocannabinoids. For example, a cannabinoid may contain one or more of cannabidiol (CBD), cannabinol (CBN), Δ9-tetrahydrocannabinol (THC), or other compounds.

[0020] According to a further development of the procedure, a cannabinoid is first dissolved in the first liquid, then the first liquid is mixed with the second liquid to form the emulsion.

[0021] Furthermore, in one particular embodiment of the process, the first liquid is first mixed with the second liquid to form the emulsion, and then a cannabinoid is dissolved in the emulsion.

[0022] Preferably, the first liquid consists of lipids, alcohols, oils, and / or any mixture thereof. The choice of the first liquid is of great importance, for example, for the absorption of cannabinoids in the human gastrointestinal tract. At the same time, the choice of the first liquid is also significant with regard to potential flavor masking. Oils, such as orange oil, are particularly suitable for this purpose.

[0023] The second liquid is preferably an aqueous solution or water.

[0024] In a very advantageous embodiment of the process, the first liquid is an oil or a mixture of different oils, in particular rapeseed, orange or coconut oil, and / or an alcohol or a mixture of different alcohols, in particular ethanol, preferably with a purity of > 80%, and the second liquid is water and thus an oil-in-water emulsion or an alcoholic solution.

[0025] Emulsifiers are auxiliary substances used to produce and stabilize emulsions. These are preferably surfactants that serve to mix two immiscible liquids, such as oil and water, into a finely dispersed mixture, the so-called emulsion, and to stabilize it.

[0026] According to an advantageous further development of the process, an emulsifier is added to the second liquid before mixing it with the first liquid.

[0027] Following a further advantageous development of the process, an emulsifier is added to the emulsion before convective drying.

[0028] In addition, an emulsifier is preferably added to the matrix liquid before convective drying.

[0029] The addition of one or more emulsifiers has the advantage that the first and second liquids are more finely dispersed in the emulsion, thus producing a matrix liquid better suited for convective drying in a convective drying apparatus, e.g., a drum dryer, a vacuum dryer, or, in particular, in a fluidization apparatus, preferably a jet or fluidized bed apparatus. The addition of one or more emulsifiers, such as Hi-Cap 100 (modified starch) or the like, is preferably carried out with stirring, preferably by means of a stirring device or the like, and / or the application of temperature, i.e., the supply or removal of heat.

[0030] Furthermore, according to an additional advantageous embodiment of the process, the matrix liquid is homogenized before convective drying. Preferably, the emulsion is homogenized under high pressure, particularly preferably at pressures between 50 bar and 250 bar, very preferably at pressures between 100 bar and 200 bar, and most preferably at pressures between 125 bar and 175 bar. Homogenization significantly reduces the mean diameter of the droplets of the first liquid present in the emulsion, so that the mixture of the first and second liquids, which are immiscible, becomes more homogeneous, i.e., more uniform. Due to the homogenization, especially high-pressure homogenization, an optimized matrix liquid is produced for convective drying, particularly in the fluidizing apparatus.

[0031] Advantageously, the matrix liquid is applied to one or more carrier materials before convective drying, particularly in a fluidization apparatus. Applying the matrix liquid to one or more carrier materials prior to convective drying preferably produces a wet granulate containing the cannabinoid while simultaneously compacting the carrier materials. Preferably, the matrix liquid is extruded after application to one or more carrier materials, or it is pelletized after application to one or more carrier materials.

[0032] In a further advantageous embodiment of the process, carrier particles are placed in the fluidization apparatus. These carrier particles, in particular, for example, maltodextrin, mannitol, cellulose, lactose, xylitol, or a mixture thereof, serve as nuclei for the formation of the cannabinoid granules. Part of the matrix liquid evaporates, and spray-dried granule nuclei are formed from the matrix liquid itself.

[0033] Advantageously, additives are added to the solution, emulsion, or matrix liquid before convective drying. The addition of additives, such as carbohydrates (e.g., maltodextrin), starch, sugars (e.g., fructose or sucrose), salts (e.g., magnesium stearate), flavorings, or similar substances, can mask the odor and taste of the cannabinoid granules. Additives can also be used, for example, to adjust the compressibility of the cannabinoid granules during tablet production or to modify the release profile of the cannabinoids.

[0034] Depending on a preferred further development of the process, the process is carried out batchwise or continuously. By varying the plant and process parameters, the desired end product properties, such as particle size distribution, dissolution rate, bulk density, or residual moisture, can be individually and optimally adjusted.

[0035] The invention will now be explained in more detail with reference to the accompanying drawing, which shows Figure 1 schematic representation of a first embodiment of a preferred device for producing a cannabinoid granule that is substantially soluble in aqueous media, Figure 2 schematic representation of a second embodiment of a preferred device for producing a cannabinoid granule that is substantially soluble in aqueous media, Figure 3 a cumulative distribution curve and a density distribution curve of oil droplets of an oil-in-water emulsion (with rapeseed oil) before drying in the jet bed apparatus, Figure 4 a cumulative distribution curve and a density distribution curve of oil droplets of an oil-in-water emulsion (with rapeseed oil) after dissolution of the cannabinoid granules dried in the jet bed apparatus in water,Figure 5 shows a cumulative distribution curve and a density distribution curve of oil droplets of an oil-in-water emulsion (with coconut oil) before drying in a jet bed apparatus, and Figure 6 shows a cumulative distribution curve and a density distribution curve of oil droplets of an oil-in-water emulsion (with coconut oil) after dissolving the cannabinoid granules dried in the jet bed apparatus in water.

[0036] Fig. 1 Figure 1 shows a schematic representation of a first embodiment of a preferred device 1 for producing a cannabinoid granule that is essentially soluble in aqueous media.

[0037] The device 1 comprises a container system 2 for producing the matrix fluid. In the exemplary embodiment according to Fig. 1 The container system 2 comprises three containers 3, which are fluidically connected to each other. This fluidic connection between the containers 3 is achieved by means of pipes 4.

[0038] The first container 3a of the container system 2, which is designed with double walls for heating or cooling, has a cannabinoid inlet 5 and a liquid inlet 6 for a first liquid consisting of the group consisting of lipids, alcohols, oils and / or any mixture thereof, but preferably of rapeseed, orange or coconut oil.

[0039] The first container 3a can be temperature-controlled by means of a heating medium flowing through the container jacket space 9, which is located between the inner wall 7 and the outer wall 8 of the container. Preferably, the container 3a is heated to improve the solubility of a cannabinoid that may not be readily soluble in the first liquid. The temperature control device is not strictly necessary.

[0040] Furthermore, the first container 3a has a motor-driven stirring device 10 for stirring the first liquid. The stirring device is not strictly necessary.

[0041] For a second liquid, in particular an aqueous solution or water, the container system 2 comprises a second container 3b having a liquid inlet 11.

[0042] The first and second containers 3a and 3b are each connected via a pipe 4 to inlets 12 of a third container 3c. The first liquid containing the cannabinoid and the second liquid are conveyed via pipes 4 into the third container 3c, e.g. by means of pumps.

[0043] In the third container 3c, the matrix liquid is produced by mixing the first liquid containing the cannabinoid with the second liquid, whereby the first and second liquids form an emulsion. Preferably, this is produced in the third container 3c while stirring by means of a motor-driven stirring device 13. The produced matrix liquid leaves the container system 2 for the production of the matrix liquid via a matrix liquid outlet 14.

[0044] The matrix fluid can also be produced through other partial steps. For example, by simply mixing all components together in a single container.

[0045] The matrix fluid is conveyed via a pipe 15 into a homogenizer 16, preferably a high-pressure homogenizer, for homogenization, e.g. by means of a pump. The homogenized matrix fluid is then conveyed from the homogenizer 16 via the pipe 17 into the fluidization apparatus 18, e.g. by means of a pump.

[0046] In the exemplary embodiment of the Fig. 1 The drying apparatus is designed as a fluidization apparatus 18 for the production of a cannabinoid granule that is essentially soluble in aqueous media, wherein the fluidization apparatus 18 is designed here as a jet bed apparatus 19. The structure of the jet bed apparatus 19 comprises, from bottom to top, a distribution chamber 20, a process chamber 21, an expansion zone 22, and an exhaust air section 23.

[0047] The process gas 24 required for drying the cannabinoid granules to be produced is supplied to the distribution chamber 20, where the process gas 24 is distributed and enters a process chamber 21 preferably as a kind of free jet via a slot opening 25 and a process gas deflection part 26.

[0048] Furthermore, the cross-sectional area of ​​the apparatus can optionally increase in the expansion zone 22, so that the velocity of the process gas flow decreases steadily upwards. The process gas 24 leaves the jet bed apparatus 19 preferably as exhaust gas 28 cleaned by a dust removal system 27, in particular filter cartridges or textile filter elements.

[0049] Process chamber 21 contains carrier particles, referred to as starter material, such as mannitol, cellulose, xylitol, or the like, which are carried upwards by the process gas 24 towards the dust removal system 27. In the upper region of process chamber 21 and in the expansion zone 22 above it, the process gas velocity decreases, causing the upward-flowing carrier particles to exit the process gas stream laterally and fall back into process chamber 21. The lower region of process chamber 21 is bounded by inclined side surfaces 28. Due to the inclined side surfaces 28, the carrier particles are transported by gravity across the return zone 29 towards the slot opening 25, where they are subsequently carried back into process chamber 21 by the process gas 24.

[0050] This mechanism creates a very uniform solids circulation 30 of the carrier particles. In the lower region of the process chamber 21, one or more spray devices 31, preferably a spray nozzle or the like, are arranged, which spray upwards in the same direction as the process gas 24 and serve to introduce the matrix liquid. Such introduction of the matrix liquid in the lower region of the process chamber 21 is referred to as bottom spraying.

[0051] The nozzle, preferably a two-fluid nozzle, is configured to produce droplets with a droplet size of 1 µ m to 200 µ m, preferably of 10 µ m to 100 µ m, particularly preferably between 20µm and 60 µ to spray. The sprayed droplets particularly favor a droplet size of 25. µ m to 40 µ m, most preferred by 30 µm. By adjusting the droplet size using the nozzle and the compressed air applied to the nozzle, the shear forces occurring during spraying can be precisely controlled, thus achieving a very homogeneous droplet size of the emulsion or solution to be sprayed. The droplets adhere to the carrier particles, such as cellulose, lactose, or xylitol, and film evaporation preferentially occurs.

[0052] Due to the highly efficient heat and mass transfer, as well as the high carrier particle circulation in the spray zone 32 of the process chamber 21 of the spray bed apparatus 19, the matrix liquid is largely deposited on the carrier particles, thus ensuring uniform wetting of the particle surfaces. This uniform wetting, combined with the high particle circulation between the spray zone 32 and the return zone 29, results in the formation of a very uniform liquid film on the carrier particles. During the drying process, the matrix liquid evaporates and exits the spray bed apparatus 19 with the exhaust gas 28. The cannabinoid contained in the matrix liquid remains on the particle surface of the carrier particles, resulting in very uniform and homogeneous growth of the cannabinoid granules.

[0053] The discharge 33 of the cannabinoid granules can be realized, for example, by an overflow or by a volumetric discharge device, in particular a rotary valve, or also by a gravity classifier, preferably a zigzag classifier supplied with screening gas or a riser tube classifier.

[0054] Mechanical units 34, such as crushers, shredders, etc., can be arranged as required in the process chamber 21, preferably in the return zone 29, in order to produce sufficiently fine particles as granule nuclei for the granule formation process by crushing.

[0055] Optionally, one or more spray devices 35, preferably spraying downwards, can be arranged in the process chamber 21 or in the apparatus components above it, the expansion zone 22 and the exhaust air section 23. The liquid matrix fluid can also be injected into the process chamber 21 of the spray bed apparatus 19 via the spray device 35. Alternatively, additives 36 or other components 37 in liquid form can be sprayed via some of the spray devices 31, 35 and thus homogeneously embedded in the granule structure.

[0056] In the preferred device 1, a granulation unit (not shown) for granulating the matrix liquid can be arranged between the container system 2 and the fluidization apparatus 18, which is designed as a jet bed apparatus 19. Furthermore, an extruder for extruding the granules can be arranged downstream of the granulation unit. Preferably, the homogenizer 16 and / or the granulation unit and / or the extruder are fluidically connected to each other.

[0057] In the Fig. 2 A schematic representation of a second embodiment of a preferred device 1 for the production of a cannabinoid granule that is essentially soluble in aqueous media is shown.

[0058] The device 1 comprises a container system 2 for producing the matrix fluid. In the second embodiment according to Fig. 2 Container system 2 has a single container 3.

[0059] The double-walled container 3 of the container system 2, designed for heating or cooling, has a cannabinoid inlet 5 and a liquid inlet 6 for a first liquid consisting of lipids, alcohols, oils and / or any mixture thereof, but particularly preferably of rapeseed, orange or coconut oil, and a liquid inlet 11 for a second liquid, in particular an aqueous solution or water.

[0060] The first container 3a can be temperature-controlled by means of a heating medium flowing through the container jacket space 9, which is located between the inner wall 7 and the outer wall 8 of the container. Preferably, the container 3a is heated to improve the solubility of a cannabinoid that may not be readily soluble in the first liquid. The temperature control device is not strictly necessary.

[0061] Furthermore, the first container 3a has a motor-driven stirring device 10 for stirring the first liquid. The stirring device is not strictly necessary.

[0062] In container 3, the matrix liquid is produced by mixing the first liquid containing the cannabinoid with the second liquid, whereby the first and second liquids form an emulsion. Preferably, this is produced in container 3 while stirring using a motor-driven stirring device 13. The produced matrix liquid leaves the container system 2 for the production of the matrix liquid via a matrix liquid outlet 14. In the exemplary embodiment, the inlet 5, 6, 11 and the matrix liquid outlet 14 are designed as a container system opening 38.

[0063] The matrix fluid is conveyed via a pipe 15 into a homogenizer 16, preferably a high-pressure homogenizer, for homogenization, e.g. by means of a pump. The homogenized matrix fluid is then conveyed from the homogenizer 16 via the pipe 17 into the fluidization apparatus 18, e.g. by means of a pump.

[0064] The further convective drying process using a fluidization apparatus is carried out in accordance with the first process described in Fig. 1 described example.

[0065] Subsequently, the produced cannabinoid granules can be coated, for example, in a drum coater. This has the advantage that the cannabinoid granules can, for example, receive an enteric coating or a flavor masking.

[0066] The following are examples of the production of a matrix fluid and its further processing in the fluidization apparatus.

[0067] Example 1: The production of the cannabinoid granules in the fluidization apparatus designed as a jet bed apparatus was carried out in batch operation as a bottom spray.

[0068] 500 g of mannitol was used as starting material in the fluidization apparatus.

[0069] The matrix liquid contains 200 g Hi-Cap 100, 200 g maltodextrin, 1365 g water, 5 g cannabidiol (CBD), and 50 g rapeseed oil. The cannabidiol (CBD) was dissolved in rapeseed oil as the first liquid, and the maltodextrin and Hi-Cap 100 were dissolved in water as the second liquid. The CBD-containing rapeseed oil and the water containing the maltodextrin and Hi-Cap 100 were then mixed together to form an emulsion, thus creating the matrix liquid. The maltodextrin and Hi-Cap 100 act as additives to form a matrix structure within the matrix liquid.

[0070] Spray rates were set between 10 and 15 g / min. The produced cannabinoid granules dissolved well in water, forming a stable oil-in-water emulsion. The residual moisture content of the cannabinoid granules was 1.8%.

[0071] Following its preparation, the matrix fluid was analyzed using a Cilas 1190 LD (Quantachrome) laser diffraction system. The particle size of the CBD-containing oil droplets present in the matrix fluid emulsion was determined in Fig. 3 The cumulative distribution curve, with equivalent diameters x₁₀ = 1.17 µm, x₅₀ = 7.97 µm, and x₅₀ = 18.37 µm, exhibits a mean diameter of x = 8.87 µm. Furthermore, the density distribution curve, with its two maxima, shows a bimodal distribution.

[0072] After the production of the cannabinoid granules and subsequent dissolution of the cannabinoid granules in water, a stable oil-in-water emulsion has formed in the aqueous environment.

[0073] The cannabinoid granules dissolved in the aqueous environment were dissolved in water and the particle size of the CBD-containing oil droplets was analyzed again using the Cilas 1190 LD (Quantachrome) laser diffraction system. Fig. 4 The analysis shows that the cumulative distribution curve with equivalent diameters x 10 = 0.82 µ m, x 50 = 2.33 µm and x 90 = 6.26 µ m has a mean diameter of x = 3.01 µ Furthermore, the density distribution curve shows a monomodal distribution. The oil droplets exhibit a very homogeneous density distribution with significantly smaller diameters. This leads to a significantly improved absorbability of CBD and thus to more optimal bioavailability. This improved absorbability of the cannabinoids results from more homogeneous and smaller emulsion particles.

[0074] Example 2: The production of the cannabinoid granules in the fluidization apparatus designed as a jet bed apparatus was carried out in batch operation as a bottom spray.

[0075] The starting material in the fluidization apparatus consisted of 250 g mannitol and 250 g maltrodextrin, i.e. in a 1:1 ratio.

[0076] The matrix liquid contains 200 g Hi-Cap 100, 200 g maltodextrin, 1417 g water, 5.5 g cannabidiol (CBD), and 51 g coconut oil. The cannabidiol (CBD) was dissolved in coconut oil as the first liquid, and the maltodextrin and Hi-Cap 100 were dissolved in water as the second liquid. The CBD-containing coconut oil and the water containing the maltodextrin and Hi-Cap 100 were then mixed together to form an emulsion, thus creating the matrix liquid. The maltodextrin and Hi-Cap 100 act as additives to form a matrix structure within the matrix liquid.

[0077] The spray rates were increased compared to example 1. Additionally, the process air flow rate was reduced to minimize product loss at the filters. The produced cannabinoid granules dissolved well in water, forming a stable oil-in-water emulsion. The residual moisture content of the cannabinoid granules was 3.4%.

[0078] Following its preparation, the matrix fluid was analyzed using a Cilas 1190 LD (Quantachrome) laser diffraction system. The particle size of the CBD-containing oil droplets present in the matrix fluid emulsion was determined in Fig. 5 The cumulative distribution curve shows an equivalent diameter of x 10 = 1.18. µ m, x 50 = 6.99 µ m and x 90 = 15.17 µ m has a mean diameter of x = 7.58 µ m up.

[0079] Furthermore, the density distribution curve with its two maxima shows a bimodal distribution.

[0080] After the production of the cannabinoid granules and subsequent dissolution of the cannabinoid granules in water, a stable oil-in-water emulsion has formed in the aqueous environment.

[0081] The cannabinoid granules dissolved in the aqueous environment were dissolved in water and the particle size of the CBD-containing oil droplets was analyzed again using the Cilas 1190 LD (Quantachrome) laser diffraction system. Fig. 6 The analysis shows that the cumulative distribution curve with equivalent diameters x 10 = 0.90 µ m, x 50 = 2.48 µ m and x 90 = 6.24 µ m has a mean diameter of x = 3.08 µFurthermore, the density distribution curve shows a monomodal distribution. The oil droplets exhibit a very homogeneous density distribution with significantly smaller diameters. This leads to a significantly improved absorbability of CBD and thus to more optimal bioavailability. This improved absorbability of the cannabinoids results from more homogeneous and smaller emulsion particles.

Claims

1. Apparatus (1) for carrying out a method for producing a cannabinoid granulate which is substantially soluble in an aqueous environment, wherein a matrix liquid is produced from a first liquid dissolving a cannabinoid or from a first liquid dissolving a cannabinoid and a second liquid forming an emulsion with the first liquid and a cannabinoid dissolved in the first liquid or the emulsion, wherein the matrix liquid is convectively dried to a cannabinoid granulate in a fluidization apparatus (18) by a spray granulation, spray agglomeration or spray encapsulation, characterized in that the apparatus (1) has a container system (2) for producing the matrix liquid, said container system having a plurality of containers (3a, 3b, 3c) which are at least partially fluidically connected to one another via pipelines (4), which [container system] has a cannabinoid inlet (5), a liquid inlet (6) for a first liquid from the group of lipids, alcohols, oils and / or any mixture thereof, a liquid inlet (11) for a second liquid and a matrix liquid outlet (14), wherein the apparatus has a first container (3a) for the first liquid, a second container (3b) for the second liquid and a container (3c) having an inlet (12) for the emulsion, and wherein the apparatus further has a convective drying apparatus which is fluidically connected to the matrix liquid outlet (14) of the container system (2) and is designed as a fluidization apparatus (18).

2. Apparatus (1) according to claim 1, characterized in that the fluidization apparatus (18) is designed as a spouted bed apparatus (19) or as a fluidized bed apparatus.

3. Apparatus (1) according to claim 1, characterized in that the container (3c) for the emulsion corresponds to the first or second container (3a, 3b).

4. Apparatus (1) according to one of claims 1 to 3, characterized in that the fluidization apparatus (18) has a nozzle for atomizing the emulsion or solution.

5. Apparatus (1) according to claim 4, characterized in that the nozzle, preferably a two-fluid nozzle, is configured to spray droplets with a droplet size of 1 µm to 200 µm, preferably of 10 µm to 100 µm, particularly preferably between 20 µm and 60 µm.

6. Apparatus (1) according to one of claims 1 to 5, characterized in that a homogenizer (16) for homogenizing the matrix liquid is arranged between the container system (2) and the fluidization apparatus (18).

7. Apparatus (1) according to one of claims 1 to 6, characterized in that a granulation unit, preferably a high shear granulator, a vertical granulator or a rotor disk granulator, for granulating the matrix liquid is arranged between the container system (2) and the drying apparatus (18).

8. Apparatus (1) according to claim 7, characterized in that an extruder for extruding the granulate is arranged after the granulation unit.

9. Apparatus (1) according to one of claims 6 to 8, characterized in that the homogenizer (16) and / or the granulation unit and / or the extruder are fluidically connected to one another.

10. Apparatus (1) according to one of claims 1 to 9, characterized in that the inlet (5, 6, 11, 12) and the matrix liquid outlet (14) are formed as one container system opening (38).