Cannabinoid Formulations

Abstract

The present invention relates to a new formulation comprising a high amount of at least one cannabinoid, wherein the cannabinoid is in a non-crystalline form.

Description

1 / 66 Cannabinoid Formulations

[001] The present invention relates to a novel formulation comprising a high amount of at least one cannabinoid, wherein the cannabinoid is in a non-crystalline form.

[002] Cannabinoids are various structural classes of compounds found primarily in the cannabis plant and in most animal organisms or as synthetic compounds. At least 113 different cannabinoids have been isolated from the cannabis plant to date.

[003] There are many different cannabinoids and terpenoids present in a cannabis sample, however, only the main cannabinoids have been associated with pharmacological activity so far.

[004] The main types of cannabinoids are: cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN), cannabigerol (CBG), cannabichromene (CBC), cannabicitran (CBT), cannabinodivarin (CBV), cannabiripsol (CBR), hexahydrocannabinol (HHC), delta-9-tetrahydrocannabiphoral (THCP), tetrahydrocannabivarin (THCV), endocannabinoid (anandamide) and endocannabinoid (2-AG).

[005] Cannabinoids are known to have health benefits, which are demonstrated in medical studies, such as reducing blood pressure, reducing inflammation, preventing relapses in drug and alcohol addiction, treating anxiety disorders, treating gastrointestinal (GI) disorders, and preventing seizures.

[006] Cannabinoids can be administered in several ways, including by inhaling cannabis smoke or vapor, via Petition 870250080872, dated 09 / 09 / 2025, page 19 / 90 2 / 66 oral, for example, in tablet or capsule form, and as an aerosol spray in the cheek.

[007] Crystalline cannabinoids have been found to have low oral bioavailability. For example, it is estimated that only 6% of an orally administered dose of crystalline cannabinoid was bioavailable under fasting conditions. On the other hand, cannabinoid dissolved in lipids has been reported to exhibit approximately 4-fold increased bioavailability.

[008] One problem regarding the formulation of cannabinoids, particularly in high-dose forms, is the low solubility in water, as well as the limited solubility of cannabinoids in various oils. This makes it challenging to provide liquid or solid dosage forms containing high amounts of one or more cannabinoids, particularly in non-crystalline form, for improved bioavailability.

[009] Thus, the objective of the present invention is to provide a formulation in which at least one cannabinoid is formulated in a high quantity, and in which at least one cannabinoid is (and remains during storage) in a substantially non-crystalline form.

[010] In addition, this formulation must be usable to produce additional application forms (such as powders, tablets, capsules, etc.), which are also stable in storage.

[011] In addition, the particle size of the oil droplets containing at least one cannabinoid must be small to ensure homogeneous distribution, such as in particular in the final dosage form.

[012] Surprisingly, it was found that when using Petition 870250080872, dated 09 / 09 / 2025, page 20 / 90 3 / 66 a specific ratio of Vitamin E and at least one cannabinoid, stable emulsions with high amounts of at least one cannabinoid (in particular in a dissolved non-crystalline form) can be obtained.

[013] This liquid formulation (emulsion / dispersion) can then be used as such or transformed into a solid formulation (such as powder), in which at least one cannabinoid is contained in amounts up to approximately 45% by weight, while being in a substantially non-crystalline form, i.e., better bioavailability.

[014] Thus, the present invention relates to a liquid formulation (LF) comprising (i) 5 - 85% by weight (% by weight), based on the total weight of the liquid formulation, of at least one cannabinoid, and (ii) 2 to 25% by weight, based on the total weight of the liquid formulation, of Vitamin E, and (iii) 1 to 50% by weight, based on the total weight of the liquid formulation, of at least one emulsifier, and (iv) 12 to 55% by weight, based on the total weight of the liquid formulation, of water, wherein at least 50% by weight, based on the total weight of the cannabinoid, of the at least one cannabinoid is in a non-crystalline form and the ratio of the at least one cannabinoid to vitamin E is 2:1 to 4:1.

[015] In the context of the present invention, all percentages in a formulation always reach 100% by weight.

[016] In the context of the present invention, the preferred cannabinoids are selected from the group consisting of Petition 870250080872, dated 09 / 09 / 2025, page 21 / 90 4 / 66 cannabidiol, tetrahydrocannabinol, cannabinol, cannabigerol, cannabichromene, cannabicitran, cannabinodivarin, cannabiripsol, hexahydrocannabinol, delta-9-tetrahydrocannabiphoral, tetrahydrocannabivarin, endocannabinoid and endocannabinoid.

[017] The most preferred cannabinoids are selected from the group consisting of cannabidiol, tetrahydrocannabinol, cannabinol, cannabigerol, cannabichromene, cannabicitran, cannabinodivarine, cannabiripsol, hexahydrocannabinol and delta-9tetrahydrocannabiforal.

[018] Especially preferred cannabinoids are selected from the group consisting of cannabidiol, tetrahydrocannabinol, cannabinol and cannabigerol (the most preferred is cannabidiol).

[019] Most preferred, in all embodiments of the present invention, is the use of cannabidiol.

[020] Thus, the present invention relates to a liquid formulation (FL1), which is the liquid formulation (FL), in which at least one cannabinoid is selected from the group consisting of cannabidiol, tetrahydrocannabinol, cannabinol, cannabigerol, cannabichromene, cannabicitran, cannabinodivarin, cannabiripsol, hexahydrocannabinol, delta-9-tetrahydrocannabiforal, tetrahydrocannabivarin, endocannabinoid and endocannabinoid.

[021] Thus, the present invention relates to a liquid formulation (FL1'), which is the liquid formulation (FL), in which at least one cannabinoid is selected from the group consisting of cannabidiol, tetrahydrocannabinol, cannabinol, cannabigerol, cannabichromene, cannabicitran, cannabinodivarine, cannabiripsol, hexahydrocannabinol and delta-9-tetrahydrocannabiforal.

[022] Thus, the present invention also relates to a liquid formulation (FL1''), which is the liquid formulation (FL), in Petition 870250080872, dated 09 / 09 / 2025, page 22 / 90 5 / 66 that at least one cannabinoid is selected from the group consisting of cannabidiol, tetrahydrocannabinol, cannabinol and cannabigerol (the most preferred is cannabidiol).

[023] The amount of at least one cannabinoid in the liquid formulation according to the present invention is 5 - 85% by weight, based on the total weight of the liquid formulation.

[024] Preferably, the amount of at least one cannabinoid in the liquid formulation according to the present invention is 10–85% by weight, based on the total weight of the liquid formulation.

[025] More preferably, the amount of at least one cannabinoid in the liquid formulation according to the present invention is 10 - 80% by weight, based on the total weight of the liquid formulation.

[026] Even more preferably, the amount of at least one cannabinoid in the liquid formulation according to the present invention is 15 - 80% by weight, based on the total weight of the liquid formulation.

[027] More preferably, in all embodiments of the present invention, the amount of at least one cannabinoid in the liquid formulation according to the present invention is selected in the range of 7.5 to 50% by weight, in particular from 10 to 50% by weight, more particularly from 15 to 50% by weight. Appropriate additional ranges are selected in the range of 15 to 45% by weight, 15 to 40% by weight, 15 to 35% by weight, 15 to 30% by weight, 20 to 45% by weight, 20 to 40% by weight, 20 to 35% by weight, 20 to 30% by weight, 25 to 45% by weight, 25 to 40% by weight, 30 to 45% by weight, 30 to 40% by weight, 35 to 45% by weight, as well as 35 to 40% by weight, based on the total weight of the Petition 870250080872, dated 09 / 09 / 2025, page 23 / 90 6 / 66 liquid formulation.

[028] Thus, the present invention also relates to a liquid formulation (FL2), which is the liquid formulation (FL), (FL1), (FL1') or (FL1''), wherein the amount of at least one cannabinoid in the formulation according to the present invention is 10 - 85% by weight, based on the total weight of the liquid formulation.

[029] Thus, the present invention also relates to a liquid formulation (FL2'), which is the liquid formulation (FL), (FL1), (FL1') or (FL1,A), wherein the amount of at least one cannabinoid in the formulation according to the present invention is 10 - 80% by weight, based on the total weight of the liquid formulation.

[030] Thus, the present invention also relates to a liquid formulation (FL2''), which is the liquid formulation (FL), (FL1), (FL1') or (FL1''), wherein the amount of at least one cannabinoid in the formulation according to the present invention is 15 - 80% by weight, based on the total weight of the liquid formulation.

[031] As indicated above, at least 50% by weight, based on the total weight of the cannabinoid, of a cannabinoid is in a non-crystalline form.

[032] More preferably, in all embodiments of the present invention, at least 55% by weight, based on the total weight of the cannabinoid, of a cannabinoid is in a non-crystalline form.

[033] Even more preferably, in all embodiments of the present invention, at least 60% by weight, based on the total weight of the cannabinoid, of a cannabinoid is in a non-crystalline form.

[034] Even more preferably, in all embodiments of the present invention, at least 70% by weight, based on the total weight of the cannabinoid, of a cannabinoid is in a non-cannabinoid form. Petition 870250080872, dated 09 / 09 / 2025, p. 24 / 90 7 / 66 crystalline.

[035] Even more preferably, in all embodiments of the present invention, at least 75% by weight, based on the total weight of the cannabinoid, of a cannabinoid is in a non-crystalline form.

[036] Even more preferably, in all embodiments of the present invention, at least 80% by weight, based on the total weight of the cannabinoid, of a cannabinoid is in a non-crystalline form.

[037] Even more preferably, in all embodiments of the present invention, at least 85% by weight, based on the total weight of the cannabinoid, of a cannabinoid is in a non-crystalline form.

[038] Even more preferably, in all embodiments of the present invention, at least 90% by weight, based on the total weight of the cannabinoid, of a cannabinoid is in a non-crystalline form.

[039] Even more preferably, in all embodiments of the present invention, at least 95% by weight, based on the total weight of the cannabinoid, of a cannabinoid is in a non-crystalline form.

[040] Even more preferably, in all embodiments of the present invention, at least 98% by weight, based on the total weight of the cannabinoid, of a cannabinoid is in a non-crystalline form.

[041] Even more preferably, in all embodiments of the present invention, at least 99% by weight, based on the total weight of the cannabinoid, of a cannabinoid is in a non-crystalline form. Petition 870250080872, dated 09 / 09 / 2025, p. 25 / 90 8 / 66

[042] Even more preferably, in all embodiments of the present invention, 100% by weight, based on the total weight of the cannabinoid, of a cannabinoid is in a non-crystalline form.

[043] In all embodiments of the present invention, at least one cannabinoid is most advantageously in a substantially non-crystalline form, even more preferably dissolved in Vitamin E.

[044] In the context of the present invention, the term 'crystalline' is understood to mean a coherent or non-coherent part of one or more components having homogeneous physical properties, in particular a homogeneous melting range and a long-range order. It is well understood that crystals are solids, i.e., in a solid state of aggregation.

[045] In the context of the present invention, the term 'non-crystalline' is understood to mean a cohesive or non-cohesive part of one or more components with homogeneous physical properties, in particular without any homogeneous melting range and long-range order.

[046] In all embodiments of the present invention, most advantageously, the non-crystalline cannabinoid is liquid, that is, it is present in a liquid state of aggregation (e.g., dissolved), such as, in particular, dissolved in Vitamin E. Even more preferably, the non-crystalline cannabinoid is not, or is not substantially, amorphous, but dissolved.

[047] In the context of the present invention, the term 'long-range order' is understood to mean a regular and periodic spacing of molecules or atoms (here of at least one cannabinoid) in a crystalline solid. Consequently, the exact position of some molecules or atoms can be Petition 870250080872, dated 09 / 09 / 2025, page 26 / 90 9 / 66 is advantageously used to determine the position of all molecules or atoms in a crystalline solid.

[048] The content of the crystalline form of at least one cannabinoid in the liquid and solid formulation according to the present invention can be measured using commonly known methods, such as Differential Scanning Calorimetry (DSC).

[049] In the context of the present invention, DSC Calorimetry was used to determine the amount of crystalline form of at least one cannabinoid in the liquid, respectively solid, formulation according to the present invention, according to standard methods in the art, i.e., using the respective crystalline cannabinoid as an external standard.

[050] Thus, in all embodiments according to the present invention, preferably the degree of crystallinity (in %) is determined by DSC using the respective crystalline cannabinoid as an external standard.

[051] The DSC method as used in the present invention is carried out as follows:

[052] Liquid or powder (solid) formulations (approximately 8-10 mg) were placed in aluminum pans and hermetically sealed. Empty pans were used as reference samples. For the investigation of the crude cannabinoid material (i.e., the respective crystalline cannabinoid), approximately 1-2 mg of sample were used (external standard). Each sample was heated at 10 °C / min to 90 °C and then cooled at 10 °C / min. After heating, for the crystalline cannabinoid compound, the thermal transition peak is determined (observed), which for CBD was determined to be approximately 68 °C, which was attributed to the melting of cannabidiol crystals. Petition 870250080872, dated 09 / 09 / 2025, page 27 / 90 10 / 66 By analyzing DSC thermograms and measuring peak areas, the degree of crystallinity of a sample can then be determined, since the peak area of ​​the DSC peak corresponds to the amount of heat released during crystallization / heat consumed during melting and is proportional to the degree of crystallinity of a sample. To determine the % crystallinity, the peak areas of the samples are compared with the peak areas of the crystalline cannabinoid. The amount of crystalline cannabinoid present in the respective sample can then be calculated, which is then used to determine the degree of crystallinity (%), based on the total known amount of cannabinoid present in the sample.

[053] Thus, the present invention also relates to a liquid formulation (FL3), which is the liquid formulation (FL), (FL1), (FL1'), (FL1''), (FL2), (FL2') or (FL2''), in which at least 55% by weight, based on the total weight of the cannabinoid, of a cannabinoid is in a non-crystalline form.

[054] Thus, the present invention also relates to a liquid formulation (FL4), which is the liquid formulation (FL), (FL1), (FL1'), (FL1''), (FL2), (FL2') or (FL2''), in which at least 60% by weight, based on the total weight of the cannabinoid, of a cannabinoid is in a non-crystalline form.

[055] Thus, the present invention also relates to a liquid formulation (FL5), which is the liquid formulation (FL), (FL1), (FL1'), (FL1''), (FL2), (FL2') or (FL2''), in which at least 65% by weight, based on the total weight of the cannabinoid, of a cannabinoid is in a non-crystalline form.

[056] Thus, the present invention also relates to a liquid formulation (FL6), which is the liquid formulation (FL), (FL1), Petition 870250080872, dated 09 / 09 / 2025, p. 28 / 90 11 / 66 (FL1'), (FL1''), (FL2), (FL2') or (FL2''), wherein at least 70% by weight, based on the total cannabinoid weight, of a cannabinoid is in a non-crystalline form.

[057] Thus, the present invention also relates to a liquid formulation (FL7), which is the liquid formulation (FL), (FL1), (FL1'), (FL1''), (FL2), (FL2') or (FL2''), in which at least 75% by weight, based on the total weight of the cannabinoid, of a cannabinoid is in a non-crystalline form.

[058] Thus, the present invention also relates to a liquid formulation (FL8), which is the liquid formulation (FL), (FL1), (FL1'), (FL1''), (FL2), (FL2') or (FL2''), in which at least 80% by weight, based on the total weight of the cannabinoid, of a cannabinoid is in a non-crystalline form.

[059] Thus, the present invention also relates to a liquid formulation (FL9), which is the liquid formulation (FL), (FL1), (FL1'), (FL1''), (FL2), (FL2') or (FL2''), in which at least 85% by weight, based on the total weight of the cannabinoid, of a cannabinoid is in a non-crystalline form.

[060] Thus, the present invention also relates to a liquid formulation (FL10), which is the liquid formulation (FL), (FL1), (FL1'), (FL1), (FL2), (FL2') or (FL2), in which at least 90% by weight, based on the total weight of the cannabinoid, of a cannabinoid is in a non-crystalline form.

[061] Thus, the present invention also relates to a liquid formulation (FL11), which is the liquid formulation (FL), (FL1), (FL1'), (FL1''), (FL2), (FL2') or (FL2), in which at least 95% by weight, based on the total weight of the cannabinoid, of a cannabinoid is in a non-crystalline form.

[062] Thus, the present invention also relates to a Petition 870250080872, dated 09 / 09 / 2025, p. 29 / 90 12 / 66 liquid formulation (FL12), which is the liquid formulation (FL), (FL1), (FL1'), (FL1), (FL2), (FL2') or (FL2), in which at least 98% by weight, based on the total cannabinoid weight, of a cannabinoid is in a non-crystalline form.

[063] Thus, the present invention also relates to a liquid formulation (FL13), which is the liquid formulation (FL), (FL1), (FL1'), (FL1''), (FL2), (FL2') or (FL2), in which 100% by weight, based on the total weight of the cannabinoid, of a cannabinoid is in a non-crystalline form.

[064] The liquid formulation according to the present invention comprises Vitamin E.

[065] Vitamin E is a group of eight fat-soluble compounds that include four tocopherols ((α)-tocopherol, (β)-tocopherol, (γ)-tocopherol and (δ)-tocopherol) and four tocotrienols ((α)-tocotrienol, (ε)-tocotrienol, (γ)-tocotrienol and (δ)-tocotrienol). Mixtures of these compounds may also be used, such as (todo-rac)-α-tocopherol. In the context of the present invention, (todo-rac)-α-tocopherol is preferred in all embodiments, which is, for example, commercially available from DSM Nutritional Products Ltd as dl-α-Tocopherol or todo-rac-α-Tocopherol.

[066] Thus, the present invention also relates to a liquid formulation (FL14), which is the liquid formulation (FL), (FL1), (FL1'), (FL1), (FL2), (FL2'), (FL2), (FL3), (FL4), (FL5), (FL6), (FL7), (FL8), (FL9), (FL10), (FL11), (FL12) or (FL13), wherein Vitamin E is (all-rac)-α-tocopherol.

[067] The liquid formulation according to the present invention comprises 2 to 25% by weight, based on the total weight of the liquid formulation, of Vitamin E.

[068] Preferably the amount of Vitamin E is Petition 870250080872, dated 09 / 09 / 2025, page 30 / 90 13 / 66 selected in the range of 3 to 20% by weight, based on the total weight of the liquid formulation.

[069] Thus, the present invention also relates to a liquid formulation (FL15), which is the liquid formulation (FL), (FL1), (FL1'), (FL1), (FL2), (FL2'), (FL2), (FL3), (FL4), (FL5), (FL6), (FL7), (FL8), (FL9), (FL10), (FL11), (FL12), (FL13) or (FL14), wherein the Vitamin E content is 3 to 20% by weight, based on the total weight of the liquid formulation.

[070] More preferably, in all embodiments of the present invention, the amount of Vitamin E in the liquid formulation according to the present invention is selected in the range of 5 to 20% by weight, such as, in particular, 5 to 15% by weight, based on the total weight of the liquid formulation.

[071] As indicated above, the ratio of at least one cannabinoid to Vitamin E is 2:1 to 4:1 in the liquid formulation according to the present invention.

[072] Preferably, the ratio of at least one cannabinoid to Vitamin E is 2:1 to 3.5:1.

[073] Most preferred, the ratio of at least one cannabinoid to Vitamin E is 2.2:1 to 3.5:1.

[074] Another preferred ratio of at least one cannabinoid to Vitamin E is 3 to 4, as most, in particular, the ratio is around 4.

[075] Thus, the present invention also relates to a liquid formulation (FL16), which is the liquid formulation (FL), (FL1), (FL1'), (FL1), (FL2), (FL2'), (FL2), (FL3), (FL4), (FL5), (FL6), (FL7), (FL8), (FL9), (FL10), (FL11), (FL12), (FL13), (FL14) or (FL15), wherein the ratio of at least one cannabinoid to Vitamin E is 2:1 to 3.5:1. Petition 870250080872, dated 09 / 09 / 2025, p. 31 / 90 14 / 66

[076] Thus, the present invention also relates to a liquid formulation (FL16'), which is the liquid formulation (FL), (FL1), (FL1'), (FL1), (FL2), (FL2'), (FL2), (FL3), (FL4), (FL5), (FL6), (FL7), (FL8), (FL9), (FL10), (FL11), (FL12), (FL13), (FL14) or (FL15), wherein the ratio of at least one cannabinoid to Vitamin E is 2.2:1 to 3.5:1.

[077] In addition, the liquid formulations according to the present invention comprise at least one emulsifier. Any commonly known and used emulsifier may be used. A single emulsifier, as well as a mixture of emulsifiers, may be used.

[078] Suitable emulsifiers are modified starches (food), Vitamin E-TPGS, ascorbyl palmitate, pectin, alginate, carrageenan, furcellaran, dextrin derivatives, celluloses and cellulose derivatives (e.g., cellulose acetate, methyl cellulose, hydroxypropyl methyl cellulose), lignosulfonate, polysaccharide gums (such as acacia gum (= gum arabic), modified acacia gum, TIC gum, linseed gum, ghatti gum, tamarind gum and arabinogalactan), gelatin (from bovine, fish, swine, poultry), vegetable proteins (such as, for example, peas, soybeans, castor beans, cottonseed, potatoes, sweet potatoes, cassava, rapeseed, sunflower, sesame, linseed, safflower, lentils, nuts, wheat, rice, maize, barley, rye, oats, lupins and sorghum), animal proteins including milk or whey proteins, lecithin, polyglycerol esters of fatty acids, monoglycerides of fatty acids, diglycerides of fatty acids,sorbitan ester and sugar ester (as well as derivatives thereof).

[079] The preferred emulsifiers in all forms Petition 870250080872, dated 09 / 09 / 2025, p. 32 / 90 15 / 66 of the present invention are modified starches (food) (OSA starch), Vitamin E-TPGS, polysaccharide gums, gelatin (from cattle, fish, pork, poultry), and vegetable proteins as well as mixtures thereof.

[080] Starches can be modified physically and chemically. Pregelatinized starches are examples of physically modified starches. Starch esters, starch ethers and cationic starches, modified, oxidized and crosslinked starches are examples of chemically modified starches. A particularly suitable starch in all embodiments of the invention is octenyl succinate starch (OSA starch) which is, for example, commercially available with Cleargum in Roquette or Capsul HS from Ingredion.

[081] Thus, the present invention also relates to a liquid formulation (FL17), which is the liquid formulation (FL), (FL1), (FL1'), (FL1), (FL2), (FL2'), (FL2), (FL3), (FL4), (FL5), (FL6), (FL7), (FL8), (FL9), (FL10), (FL11), (FL12), (FL13), (FL14), (FL15), (FL16) or (FL16'), wherein at least one emulsifier is selected from the group consisting of modified starches (food), Vitamin E-TPGS (CAS No. 900296-4), ascorbyl palmitate, pectin, alginate, carrageenan, furcellaran, dextrin derivatives, celluloses and cellulose derivatives (e.g., cellulose acetate, methyl cellulose, hydroxypropyl methyl cellulose), lignosulfonate, Polysaccharide gums (such as acacia gum (= gum arabic), modified acacia gum, TIC gum, linseed gum, ghatti gum, tamarind gum and arabinogalactan), gelatin (from cattle, fish, pigs, poultry), vegetable proteins (such as, for example, peas, soy, castor beans, cottonseed, potatoes, sweet potatoes, cassava, Petition 870250080872, dated 09 / 09 / 2025, p. 33 / 90 16 / 66 rapeseed, sunflower, sesame, flaxseed, safflower, lentils, nuts, wheat, rice, corn, barley, rye, oats, lupin and sorghum), animal proteins including milk or whey proteins, lecithin, polyglycerol esters of fatty acids, monoglycerides of fatty acids, diglycerides of fatty acids, sorbitan ester and sugar ester (as well as derivatives thereof).

[082] Thus, the present invention also relates to a liquid formulation (FL17'), which is the liquid formulation (FL), (FL1), (FL1'), (FL1), (FL2), (FL2'), (FL2), (FL3), (FL4), (FL5), (FL6), (FL7), (FL8), (FL9), (FL10), (FL11), (FL12), (FL13), (FL14), (FL15), (FL16) or (FL16'), wherein at least one emulsifier is selected from the group consisting of modified starches (food), Vitamin E-TPGS, polysaccharide gums, gelatin (from bovine, fish, porcine, poultry) and vegetable proteins. In all embodiments of the present invention, the use of gelatin is preferred.

[083] The liquid formulation according to the present invention comprises 1 to 50% by weight, based on the total weight of the liquid formulation, of at least one emulsifier.

[084] Preferably, the liquid formulation according to the present invention comprises 5 to 50% by weight, based on the total weight of the liquid formulation, of at least one emulsifier.

[085] Thus, the present invention also relates to a liquid formulation (FL18), which is the liquid formulation (FL), (FL1), (FL1'), (FL1), (FL2), (FL2'), (FL2), (FL3), (FL4), (FL5), (FL6), (FL7), (FL8), (FL9), (FL10), (FL11), (FL12), (FL13), (FL14), (FL15), (FL16), (FL16'), (FL17) or (FL17'), wherein the amount of at least one emulsifier is 5 to 50% in Petition 870250080872, dated 09 / 09 / 2025, page 34 / 90 17 / 66 weight, based on the total weight of the liquid formulation.

[086] More preferably, in all embodiments of the present invention, the amount of at least one emulsifier in the liquid formulation according to the present invention is selected in the range of 10 to 50% by weight, in particular 15 to 50% by weight, as most, in particular 20 to 50% by weight. Additional suitable ranges are selected from 15 to 45% by weight, 15 to 40% by weight, 15 to 35% by weight, 20 to 45% by weight, 20 to 40% by weight, as well as 20 to 35% by weight, based on the total weight of the liquid formulation.

[087] In all embodiments of the present invention, preferably the liquid formulation according to the present invention comprises Vitamin E-TPGS and at least one other emulsifier (different from Vitamin E-TPGS) as this further reduces the particle size of the oil droplets, which is preferred.

[088] Particular suitable emulsifiers in all embodiments according to the present invention include gelatin, a mixture of gelatin and Vitamin E-TPGS or a mixture of OSA starch and Vitamin E-TPGS, preferably in the absence of any other additional emulsifiers. Most preferably in all embodiments of the present invention is the use of gelatin, even more preferably in combination with Vitamin E-TPGS and, most preferably, in the absence of any other emulsifiers.

[089] Vitamin E-TPGS (TPGS refers to polyethylene glycol tocopherol succinate) also known as yocofersolan (INN) or tocofersolan, is a water-soluble synthetic version of Vitamin E.

[090] The IUPAC name is α-hydro-ω-{[4-oxo-4-({(2R)-2,5,7,8 Petition 870250080872, dated 09 / 09 / 2025, page 35 / 90 18 / 66 tetramethyl-2-[(4R,8R)-4,8,12-trimethyltridecyl]-3,4-dihydro2H-1-benzopyran-6-yl}oxy)butanoyl]oxy}poly (oxyethylene). The CAS number is 9002-96-4.

[091] Vitamin E-TPGS is the compound with the following formula

[092] Preferably, in all embodiments of the present invention, the liquid formulation according to the present invention comprises 0.1 to 10% by weight, based on the total weight of the liquid formulation, of Vitamin E-TPGS and 0.9 to 40% by weight, based on the total weight of the liquid formulation, of at least one other emulsifier (other than Vitamin E-TPGS) such as, in particular, gelatin or OSA starch, most preferably gelatin.

[093] More preferably in all embodiments of the present invention, the liquid formulation according to the present invention comprises 0.1 to 8% by weight, based on the total weight of the liquid formulation, of Vitamin E-TPGS and 0.9 to 42% by weight, based on the total weight of the liquid formulation, of at least one other emulsifier (other than Vitamin E-TPGS) such as, in particular, gelatin or OSA starch.

[094] In all embodiments of the present invention, preferably, the ratio (w / w) of gelatin to OSA starch to Vitamin E-TPGS is selected in the range of 90: to 1:1, preferably in the range of 90: to 2.5:1, most preferably in the range of 90: to 5:1. Additional suitable ranges are 50:1 to 5:1, 25:1 to 5:1 and 10:1 to 5:1.

[095] The liquid formulation according to the present invention Petition 870250080872, dated 09 / 09 / 2025, page 36 / 90 19 / 66 comprises 12 to 55% by weight, based on the total weight of the liquid formulation, of water.

[096] Preferably, the liquid formulation according to the present invention comprises 15 to 55% by weight, based on the total weight of the liquid formulation, of water.

[097] Preferably, the liquid formulation according to the present invention comprises 20 to 55% by weight, based on the total weight of the liquid formulation, of water.

[098] Thus, the present invention also relates to a liquid formulation (FL19), which is the liquid formulation (FL), (FL1), (FL1'), (FL1), (FL2), (FL2'), (FL2), (FL3), (FL4), (FL5), (FL6), (FL7), (FL8), (FL9), (FL10), (FL11), (FL12), (FL13), (FL14), (FL15), (FL16), (FL16'), (FL17), (FL17'), (FL18), wherein the amount of water is 15 to 55% by weight, based on the total weight of the liquid formulation.

[099] Thus, the present invention also relates to a liquid formulation (FL19'), which is the liquid formulation (FL), (FL1), (FL1'), (FL1), (FL2), (FL2'), (FL2), (FL3), (FL4), (FL5), (FL6), (FL7), (FL8), (FL9), (FL10), (FL11), (FL12), (FL13), (FL14), (FL15), (FL16), (FL16'), (FL17), (FL17'), (FL18), wherein the amount of water is 20 to 55% by weight, based on the total weight of the liquid formulation.

[100] More preferably, in all embodiments of the present invention, the amount of water in the liquid formulation according to the present invention is selected in the range of 15 to 50% by weight, in particular from 15 to 45% by weight, as most, in particular from 15 to 40% by weight, based on the total weight of the liquid formulation.

[101] The liquid formulation according to the present invention Petition 870250080872, dated 09 / 09 / 2025, page 37 / 90 20 / 66 may optionally comprise at least one additional auxiliary agent. Such auxiliary agent may include colorants, thickeners (such as maltodextrin, glucose syrup), fillers, binders, flavors, antioxidants (other than Vitamin E), pH buffer.

[102] The content of these auxiliary agents may be up to 40% by weight, based on the total weight of the liquid formulation.

[103] Thus, the present invention also relates to a liquid formulation (FL20), which is the liquid formulation (FL), (FL1), (FL1'), (FL1), (FL2), (FL2'), (FL2), (FL3), (FL4), (FL5), (FL6), (FL7), (FL8), (FL9), (FL10), (FL11), (FL12), (FL13), (FL14), (FL15), (FL16), (FL16'), (FL17), (FL17'), (FL18), (FL19) or (FL19'), wherein the liquid formulation comprises at least one auxiliary agent selected from the group consisting of colorants, thickener (such as maltodextrin, glucose syrup (dehydrated), fillers, binders, flavors, antioxidants (other than Vitamin E) and pH buffer.

[104] Thus, the present invention also relates to a liquid formulation (FL20'), which is the liquid formulation (FL20), in which the amount of at least one auxiliary agent is up to 40% by weight, based on the total weight of the liquid formulation.

[105] Particularly suitable auxiliary agents present in the liquid or solid formulation according to the present invention are selected from the group of glucose syrup, an additional antioxidant (other than Vitamin E), ascorbic acid, pH buffers, flavors and / or colors, preferably from the group of glucose syrup and / or ascorbic acid. Petition 870250080872, dated 09 / 09 / 2025, p. 38 / 90 21 / 66

[106] Suitable antioxidants to be used in formulations according to the present invention are sulfites, such as (SO2 (E 220); Na2SO3 (E 221), NaHSO3 (E 222); Na2S2O5 (E 223); (K2S2O5 (E 224); CaSO3 (E 226); Ca(HSO3)2 (E 227); KHSO3 (E 228)) and ascorbic acid.

[107] Suitable glucose (dehydrated) syrup and maltodextrin to be used in accordance with the present invention are the commercially available Glucidex® products of Roquette, Glycodry dehydrated glucose syrup of Tereos, as well as Glycodry 385 of Henley Bridge, without being limited to the same.

[108] Preferably, in all embodiments of the present invention, the liquid formulation comprises glucose syrup, more preferably in an amount selected in the range of 2 to 15% by weight, most preferably 3 to 10% by weight, based on the total weight of the liquid formulation.

[109] If the liquid formulation comprises ascorbic acid, the amounts are preferably selected in the range of 0.5 to 5% by weight, more preferably in the range of 0.75 to 3% by weight, most preferably in the range of 1 to 2% by weight, based on the total weight of the liquid formulation.

[110] The liquid formulation according to the present invention can be produced using commonly known processes.

[111] Generally, the liquid formulation (emulsion / dispersion) according to the present invention is produced as follows: (i) preparation of the lipid phase, (ii) preparation of the aqueous phase, and dispersion / emulsification of the lipid phase in the aqueous phase. Petition 870250080872, dated 09 / 09 / 2025, page 39 / 90 22 / 66

[112] Thus, in a preferred embodiment, the invention also relates to a process for preparing a liquid formulation according to the present invention, said process comprising (i) preparation of the lipid phase by solubilizing at least one cannabinoid in Vitamin E, preferably at temperatures of 60 to 100°C, more preferably 65 to 90°C, most preferably 70 to 80°C, optionally followed by the addition of Vitamin E-TGPS (if present), (ii) preparation of an aqueous phase by solubilizing at least one emulsifier (other than Vitamin E-TGPS) and, if present, auxiliary agents in water, followed by (iii) emulsification of the lipid phase in the aqueous phase, preferably at temperatures of 60 to 100°C, more preferably 65 to 90°C, most preferably 70 to 85°C to form an emulsion.

[113] The preparation of the aqueous phase is carried out appropriately at elevated temperatures according to methods well known in the art. Before dispersion / emulsification it is even preferred that the aqueous phase be heated to approximately the same temperature as the lipid phase.

[114] It is also possible to convert the liquid formulation according to the present invention into a solid (dry) formulation (which may be a powder, microsphere, granules, etc.).

[115] This can be done by means of any commonly known and used technologies, such as spray drying, spray granulation, etc. Preferably, the solid formulations according to the present invention are spray-dried solid formulations or in the form of a Petition 870250080872, dated 09 / 09 / 2025, page 40 / 90 23 / 66 microspheres, which microspheres can be obtained by spraying the emulsion in a fluidized bed of solid particles, such as, in particular, corn starch, the technique of which is exemplified, for example, in EP0285682 A1. It is known to those skilled in the art that drying can occur in the presence of a carrier, which can be added to the liquid formulation before drying or used in the spray drying process of the liquid formulation in a carrier material.

[116] The particular suitable carrier materials to be used in the context of the present invention include maltodextrin (which can also be used as a thickener, i.e., having a dual role), corn starch and silica.

[117] Thus, the present invention also relates to a process for preparing a solid preparation according to the present invention, said process comprising (i) preparation of the lipid phase by solubilizing at least one cannabinoid in Vitamin E, preferably at temperatures of 60 to 100°C, more preferably 65 to 90°C, most preferably 70 to 80°C, optionally followed by the addition of Vitamin E-TGPS (if present), (ii) preparation of an aqueous phase by solubilizing at least one emulsifier (other than Vitamin E-TGPS) and, if present, auxiliary agents in water, followed by (iii) emulsification of the lipid phase in the aqueous phase, preferably at temperatures of 60 to 100°C, more preferably 65 to 90°C, most preferably 70 to 80°C to form an emulsion followed by (iv) drying of the emulsion.

[118] Solid formulations according to the present Petition 870250080872, dated 09 / 09 / 2025, p. 41 / 90 24 / 66 inventions are preferably prepared by spray drying according to standard methods in the art, preferably using maltodextrin as a carrier (auxiliary / flux) agent. Thus, step (iv) of the process preferably includes the step of drying the emulsion using maltodextrin as a carrier, even more preferably by spray drying. Preferably, maltodextrin is used in amounts of 2.5 to 15% by weight, more preferably in amounts of 3 to 10% by weight, most preferably in amounts of 5 to 10% by weight, based on the total weight of the solid formulation.

[119] It is well understood that all preferences and definitions given herein with regard to, for example, concentration ranges, also apply to processes according to the present invention.

[120] The conversion of the liquid formulation according to the present invention into a solid (dry) formulation means that the amount of water is reduced to an amount below 5% by weight, based on the total weight of the solid formulation.

[121] Preferably, in a solid formulation (such as that obtained from the liquid formulation according to the present invention), the water content is below 3% by weight, based on the total weight of the solid formulation.

[122] More preferably, in a solid formulation (such as that obtained from a liquid formulation according to), the water content is 2.5% by weight or less, based on the total weight of the solid formulation.

[123] Even more preferably, in a solid formulation (such as that obtained from a liquid formulation according to Petition 870250080872, dated 09 / 09 / 2025, page 42 / 90 25 / 66 com), the water content is below 2% by weight, based on the total weight of the solid formulation.

[124] It is well understood that the quantities (% by weight) of ingredients (i), (ii) and (iii), as well as at least one optional auxiliary agent, are changing as water is being removed.

[125] The definitions and preferences presented here for all ingredients are also applicable to solid formulations.

[126] Thus, the present invention also relates to a solid formulation, which is any one of formulations (FL), (FL1), (FL1'), (FL1), (FL2), (FL2'), (FL2), (FL3), (FL4), (FL5), (FL6), (FL7), (FL8), (FL9), (FL10), (FL11), (FL12), (FL13), (FL14), (FL15), (FL16), (FL16'), (FL17), (FL17'), (FL18), (FL19), (FL19'), (FL20) or (FL20'), wherein the water content is reduced to 0 to 5% by weight, based on the total weight of the solid formulation.

[127] Thus, the present invention also relates to a solid formulation (SF) comprising (i) 5–85% by weight, based on the total weight of the solid formulation, of at least one cannabinoid, and (ii) 2–25% by weight, based on the total weight of the solid formulation, of Vitamin E, and (iii) 1–55% by weight, based on the total weight of the solid formulation, of at least one emulsifier, and (iv) optionally up to 40% by weight, based on the total weight of the solid formulation, of at least one auxiliary agent, and (v) less than 5% by weight, based on the total weight of the solid formulation, of water, Petition 870250080872, dated 09 / 09 / 2025, page 43 / 90 26 / 66 where at least 50% by weight, based on the total cannabinoid content, of at least one cannabinoid is in a non-crystalline form and the ratio of at least one cannabinoid to Vitamin E is 2:1 to 4:1. Thus, the present invention also relates to a solid formulation (SF') comprising (i) 10–75% by weight, based on the total weight of the solid formulation, of at least one cannabinoid, and (ii) 5–20% by weight, based on the total weight of the solid formulation, of Vitamin E, and (iii) 10–50% by weight, based on the total weight of the solid formulation, of at least one emulsifier, and (iv) optionally up to 40% by weight, based on the total weight of the solid formulation, of at least one auxiliary agent, and (v) less than 5% by weight, based on the total weight of the solid formulation, of water, wherein at least 50% by weight, based on the total cannabinoid, of the at least one cannabinoid is in a non-crystalline form and the ratio of the at least one cannabinoid to Vitamin E is 2:1 to 4:1.

[128] Thus, the present invention also relates to a solid formulation (FS''), which is the solid formulation (FS) in which the water content is below 3% by weight, based on the total weight of the solid formulation.

[129] Thus, the present invention also relates to a solid formulation (FS'''), which is the solid formulation (FS) , in which the water content is equal to or 2.5% by weight, even more Petition 870250080872, dated 09 / 09 / 2025, page 44 / 90 27 / 66 preferably below 2% by weight, based on the total weight of the solid formulation.

[130] Thus, the present invention also relates to a solid formulation (FS1), which is the solid formulation (FS), (FS'), (FS'') or (FS'''), in which at least one cannabinoid is selected from the group consisting of cannabidiol, tetrahydrocannabinol, cannabinol, cannabigerol, cannabichromene, cannabicitran, cannabinodivarin, cannabiripsol, hexahydrocannabinol, delta-9tetrahydrocannabiphoral, tetrahydrocannabivarin, endocannabinoid and endocannabinoid.

[131] Thus, the present invention also relates to a solid formulation (FS1'), which is the solid formulation (FS), (FS'), (FS'') or (FS'''), in which at least one cannabinoid is selected from the group consisting of cannabidiol, tetrahydrocannabinol, cannabinol, cannabigerol, cannabichromene, cannabicitran, cannabinodivarine, cannabiripsol, hexahydrocannabinol and delta-9tetrahydrocannabiforal.

[132] Thus, the present invention also relates to a solid formulation (FS1''), which is the solid formulation (FS), (FS'), (FS'') or (FS'''), in which at least one cannabinoid is selected from the group consisting of cannabidiol, tetrahydrocannabinol, cannabinol and cannabigerol (the most preferred is cannabidiol).

[133] Thus, the present invention also relates to a solid formulation (FS2), which is the solid formulation (FS), (FS'), (FS''), (FS'''), (FS1), (FS1') or (FS1''), wherein the amount of at least one cannabinoid in the formulation according to the present invention is 15 - 75% by weight, based on the total weight of the solid formulation.

[134] Thus, the present invention also relates to a Petition 870250080872, dated 09 / 09 / 2025, page 45 / 90 28 / 66 solid formulation (FS2'), which is the solid formulation (FS), (FS'), (FS''), (FS'''), (FS1), (FS1') or (FS1''), wherein the amount of at least one cannabinoid in the formulation according to the present invention is 15 - 70% by weight, based on the total weight of the solid formulation.

[135] Thus, the present invention also relates to a solid formulation (FS2''), which is the solid formulation (FS), (FS'), (FS''), (FS'''), (FS1), (FS1') or (FS1''), wherein the amount of at least one cannabinoid in the formulation according to the present invention is 20 - 65% by weight, based on the total weight of the solid formulation.

[136] Thus, the present invention also relates to a solid formulation (FS3), which is the solid formulation (FS), (FS'), (FS''), (FS'''), (FS1), (FS1'), (FS1''), (FS2), (FS2') or (FS2''), in which at least 55% by weight, based on the total weight of the cannabinoid, of a cannabinoid is in a non-crystalline form.

[137] Thus, the present invention also relates to a solid formulation (FS4), which is the solid formulation (FS), (FS'), (FS''), (FS'''), (FS1), (FS1'), (FS1''), (FS2), (FS2') or (FS2''), in which at least 60% by weight, based on the total weight of the cannabinoid, of a cannabinoid is in a non-crystalline form.

[138] Thus, the present invention also relates to a solid formulation (FS5), which is the solid formulation (FS), (FS'), (FS''), (FS'''), (FS1), (FS1'), (FS1''), (FS2), (FS2') or (FS2''), in which at least 65% by weight, based on the total weight of the cannabinoid, of a cannabinoid is in a non-crystalline form. Petition 870250080872, dated 09 / 09 / 2025, p. 46 / 90 29 / 66

[139] Thus, the present invention also relates to a solid formulation (FS6), which is the solid formulation (FS), (FS'), (FS''), (FS'), (FS1), (FS1'), (FS1''), (FS2), (FS2') or (FS2''), in which at least 70% by weight, based on the total weight of the cannabinoid, of a cannabinoid is in a non-crystalline form.

[140] Thus, the present invention also relates to a solid formulation (FS7), which is the solid formulation (FS), (FS'), (FS''), (FS'''), (FS1), (FS1'), (FS1''), (FS2), (FS2') or (FS2''), in which at least 75% by weight, based on the total weight of the cannabinoid, of a cannabinoid is in a non-crystalline form.

[141] Thus, the present invention also relates to a solid formulation (FS8), which is the solid formulation (FS), (FS'), (FS''), (FS'''), (FS1), (FS1'), (FS1''), (FS2), (FS2') or (FS2''), in which at least 80% by weight, based on the total cannabinoid, of a cannabinoid is in a non-crystalline form.

[142] Thus, the present invention also relates to a solid formulation (FS9), which is the solid formulation (FS), (FS'), (FS''), (FS'''), (FS1), (FS1'), (FS1''), (FS2), (FS2') or (FS2''), in which at least 85% by weight, based on the total cannabinoid weight, of a cannabinoid is in a non-crystalline form.

[143] Thus, the present invention also relates to a solid formulation (FS10), which is the solid formulation (FS), (FS'), (FS''), (FS'''), (FS1), (FS1'), (FS1''), (FS2), (FS2') or (FS2''), in which at least 90% by weight, based on the total cannabinoid weight, of a cannabinoid is in a non-crystalline form. Petition 870250080872, dated 09 / 09 / 2025, p. 47 / 90 30 / 66

[144] Thus, the present invention also relates to a solid formulation (FS11), which is the solid formulation (FS), (FS'), (FS''), (FS'''), (FS1), (FS1'), (FS 1), (FS2), (FS2') or (FS2''), in which at least 95% by weight, based on the total cannabinoid weight, of a cannabinoid is in a non-crystalline form.

[145] Thus, the present invention also relates to a solid formulation (FS12), which is the solid formulation (FS), (FS'), (FS''), (FS'''), (FS1), (FS1'), (FS1''), (FS2), (FS2') or (FS2''), in which at least 98% by weight, based on the total cannabinoid weight, of a cannabinoid is in a non-crystalline form.

[146] Thus, the present invention also relates to a solid formulation (FS13), which is the solid formulation (FS), (FS'), (FS''), (FS'''), (FS1), (FS1'), (FS1''), (FS2), (FS2') or (FS2''), in which 100% by weight, based on the total cannabinoid weight, of a cannabinoid is in a non-crystalline form.

[147] Thus, the present invention also relates to a solid formulation (FS14), which is the solid formulation (FS), (FS'), (FS''), (FS'''), (FS1), (FS1'), (FS1''), (FS2), (FS2'), (FS2''), (FS3), (FS4), (FS5), (FS6), (FS7), (FS8), (FS9), (FS10), (FS11), (FS12) or (FS13), where Vitamin E is (all-rac)-α-tocopherol.

[148] Thus, the present invention also relates to a solid formulation (FS15), which is the solid formulation (FS), (FS'), (FS''), (FS'''), (FS1), (FS1'), (FS1''), (FS2), (FS2'), (FS2''), (FS3), (FS4), (FS5), (FS6), (FS7), (FS8), (FS9), (FS10), (FS11), (FS12), (FS13) or (FS14), wherein the Vitamin E content is 8 to 18% by weight, based on the total weight of the solid formulation.

[149] Thus, the present invention also relates to a Petition 870250080872, dated 09 / 09 / 2025, page 48 / 90 31 / 66 solid formulation (FS16), which is the solid formulation (FS), (FS'), (FS''), (FS'), (FS1), (FS1'), (FS1''), (FS2), (FS2'), (FS2''), (FS3), (FS4), (FS5), (FS6), (FS7), (FS8), (FS9), (FS10), (FS11), (FS12), (FS13), (FS14), (FS15) or (FS15'), in which the ratio of at least one cannabinoid to Vitamin E is 2:1 to 3.5:1.

[150] Thus, the present invention also relates to a solid formulation (FS16'), which is the solid formulation (FS), (FS'), (FS''), (FS'''), (FS1), (FS1'), (FS1''), (FS2), (FS2'), (FS2''), (FS3), (FS4), (FS5), (FS6), (FS7), (FS8), (FS9), (FS10), (FS11), (FS12), (FS13), (FS14), (FS15) or (FS15'), wherein the ratio of at least one cannabinoid to Vitamin E is 2.2:1 to 3.5:1.

[151] Thus, the present invention also relates to a solid formulation (FS17), which is the solid formulation (FS), (FS'), (FS''), (FS'''), (FS1), (FS1'), (FS1''), (FS2), (FS2'), (FS2''), (FS3), (FS4), (FS5), (FS6), (FS7), (FS8), (FS9), (FS10), (FS11), (FS12), (FS13), (FS14), (FS15), (FS15'), (FS16) or (FS16'), wherein at least one emulsifier is selected from the group consisting of modified starches (food), Vitamin E-TPGS (CAS no. 9002-96-4), ascorbyl palmitate, pectin, alginate, carrageenan, furcellaran, dextrin derivatives, celluloses and cellulose derivatives (e.g., acetate of cellulose, methyl cellulose, hydroxypropyl methylcellulose), lignosulfonate, polysaccharide gums (such as acacia gum (= gum arabic), modified acacia gum, TIC gum, linseed gum, ghatti gum, tamarind gum and arabinogalactan), gelatin (from cattle, fish, pigs, poultry), vegetable proteins (such as, for example, peas, soy, castor beans, cottonseed, potatoes, sweet potatoes,cassava, rapeseed, sunflower, sesame, flaxseed, safflower, lentils, walnuts, wheat, rice, corn, barley, rye, oats, Petition 870250080872, dated 09 / 09 / 2025, p. 49 / 90 32 / 66 lupin and sorghum), animal proteins including milk or whey proteins, lecithin, polyglycerol esters of fatty acids, monoglycerides of fatty acids, diglycerides of fatty acids, sorbitan ester and sugar ester (as well as derivatives thereof).

[152] Thus, the present invention also relates to a solid formulation (FS17'), which is the solid formulation (FS), (FS'), (FS''), (FS'''), (FS1), (FS1'), (FS1''), (FS2), (FS2'), (FS2''), (FS3), (FS4), (FS5), (FS6), (FS7), (FS8), (FS9), (FS10), (FS11), (FS12), (FS13), (FS14), (FS15), (FS15'), (FS16) or (FS16'), wherein at least one emulsifier is selected from the group consisting of modified starches (food), Vitamin E-TPGS, polysaccharide gums, gelatin (from bovine, fish, porcine, poultry) and vegetable proteins.

[153] Thus, the present invention also relates to a solid formulation (FS18), which is the solid formulation (FS), (FS'), (FS''), (FS'''), (FS1), (FS1'), (FS1''), (FS2), (FS2'), (FS2''), (FS3), (FS4), (FS5), (FS6), (FS7), (FS8), (FS9), (FS10), (FS11), (FS12), (FS13), (FS14), (FS15), (FS15'), (FS16), (FS16'), (FS17) or (FS17'), wherein the amount of at least one emulsifier is 15 to 50% by weight, based on the total weight of the solid formulation.

[154] Thus, the present invention also relates to a solid formulation (FS19), which is the solid formulation (FS), (FS'), (FS''), (FS'''), (FS1), (FS1'), (FS1''), (FS2), (FS2'), (FS2''), (FS3), (FS4), (FS5), (FS6), (FS7), (FS8), (FS9), (FS10), (FS11), (FS12), (FS13), (FS14), (FS15), (FS15'), (FS16), (FS16'), (FS17), (FS17') or (FS18), wherein the solid formulation comprises at least one auxiliary agent selected from the group consisting of colorants, thickeners (such as maltodextrin, Petition 870250080872, dated 09 / 09 / 2025, pages 50 / 90 33 / 66 glucose syrup), fillers, binders, flavorings, antioxidants (other than Vitamin E) and pH buffer.

[155] Thus, the present invention also relates to a solid formulation (FS19'), which is the solid formulation (FS19), in which the amount of at least one auxiliary agent is up to 35% by weight, based on the total weight of the solid formulation.

[156] Particularly suitable auxiliary agents present in the solid formulation according to the present invention are selected from the group of glucose syrup (dehydrated), maltodextrin, ascorbic acid, pH buffers, flavors and / or colors, preferably from the group of glucose syrup (dehydrated), maltodextrin and / or ascorbic acid.

[157] In all embodiments of the present invention, it is particularly preferred that the liquid and / or solid formulation comprise, as an emulsifier, Vitamin E-TPGS and at least one other emulsifier (different from Vitamin E-TPGS) such as, in particular, gelatin.

[158] In all embodiments of the present invention, the use of gelatin having a Bloom level of less than 200, such as in the range of 100 to 200, is particularly preferred.

[159] In all embodiments of the present invention, it is particularly preferred if the liquid and solid formulations according to the present invention do not contain additional oil near Vitamin E, i.e., Vitamin E is the only oil, which is used in the preparation process to solubilize at least one cannabinoid present in the formulations according to the present invention.

[160] Thus, particularly preferred formulations according to the present invention are as follows. Petition 870250080872, dated 09 / 09 / 2025, p. 51 / 90 34 / 66

[161] · A liquid formulation (A) consisting essentially of (i) 7.5 to 50% by weight, preferably 10 to 40% by weight, most preferably 15 to 30% by weight, based on the total weight of the liquid formulation, of at least one cannabinoid, and (ii) 3 to 20% by weight, preferably 3 to 15% by weight, most preferably 3 to 10% by weight, based on the total weight of the liquid formulation, of Vitamin E, and (iii) 0 to 5% by weight, preferably 0 to 4% by weight, most preferably 0 to 3.5% by weight of Vitamin E-TPGS, (iv) 15 to 50% by weight, preferably 20 to 40% by weight, most preferably 20 to 35% by weight, based on the total weight of the liquid formulation, of at least one emulsifier, and (v) 1 to 15% by weight, preferably 2.5 to 12% by weight, most preferably 4 to 10% by weight of glucose syrup, and (vi) 0 to 5% by weight, preferably 0 to 4% by weight, most preferably 0 to 3% by weight of at least one auxiliary agent chosen from the group of antioxidants (other than Vitamin E),pH buffers, flavor and / or colorants, and (vii) 12 to 55% by weight, preferably 15 to 50% by weight, most preferably 15 to 45% by weight, based on the total weight of the liquid formulation, of water, wherein at least 50% by weight, based on the total weight of the cannabinoid, of at least one cannabinoid is in a non-crystalline form, and wherein the ratio of at least one cannabinoid to Vitamin E is 2:1 to 4:1.

[162] It is well understood that all preferences and definitions as given here also apply to the liquid formulation (A) such Petition 870250080872, dated 09 / 09 / 2025, p. 52 / 90 35 / 66 such as, in particular: (a) the emulsifier is selected from gelatin or OSA starch, more preferably the emulsifier is gelatin or a mixture of gelatin and Vitamin E-TPGS, and / or (b) the Vitamin E is (all-rac)-α-tocopherol, and / or (c) the gelatin is a gelatin having a Bloom index selected in the range of 100-200, and / or (d) at least 75% by weight of the at least cannabinoid is in a non-crystalline form, and / or (e) the at least one cannabinoid is CBD, and / or (f) the additional antioxidant (other than Vitamin E) is ascorbic acid.

[163] · A liquid formulation (B) consisting essentially of: (i) 10 to 40% by weight, preferably 15 to 35% by weight, most preferably 20 to 30% by weight, based on the total weight of the liquid formulation, of at least one cannabinoid, and (ii) 3 to 20% by weight, preferably 4 to 15% by weight, most preferably 5 to 15% by weight, based on the total weight of the liquid formulation, of Vitamin E, and (iii) 0 to 5% by weight, preferably 0 to 4% by weight, most preferably 0 to 3.5% by weight of Vitamin E-TPGS, (iv) 15 to 50% by weight, preferably 20 to 40% by weight, most preferably 20 to 35% by weight, based on the total weight of the liquid formulation, of gelatin, and (v) 1 to 15% by weight, preferably 2.5 to 12% by weight, most preferably 4 to 10% by weight of glucose syrup, and (vi) 0 to 5% by weight, preferably 0 to 4% by weight, most preferably 0 to 3% by weight of at least one auxiliary agent. Petition 870250080872, dated 09 / 09 / 2025, page 53 / 90 36 / 66 chosen from the group of antioxidants (other than Vitamin E), pH buffers, flavor and / or colors, and (vii) 12 to 45% by weight, preferably 15 to 40% by weight, most preferably 15 to 35% by weight, based on the total weight of the liquid formulation, of water, wherein at least 50% by weight, based on the total weight of the cannabinoid, of at least one cannabinoid is in a non-crystalline form, and wherein the ratio of at least one cannabinoid to Vitamin E is 2:1 to 4:1.

[164] It is again understood that all preferences and definitions as given here also apply to the liquid formulation (B) such as, in particular: (g) the emulsifier is a mixture of gelatin and Vitamin E- TPGS, and / or (h) at least 75% by weight, preferably at least 85% by weight, most preferably at least 95% by weight, such that at least 99% by weight of the at least cannabinoid is in a non-crystalline form, and / or (i) the Vitamin E is (all-rac)-α-tocopherol, and / or (j) the gelatin is a gelatin having a Bloom index selected in the range of 100-200, and / or (k) the at least one cannabinoid is CBD and / or (l) the additional antioxidant (other than Vitamin E) is ascorbic acid.

[165] · A solid formulation (C) consisting essentially of (i) 10 to 50% by weight, preferably 20 to 45% by weight, most preferably 30-40% by weight, based on the total weight of Petition 870250080872, dated 09 / 09 / 2025, page 54 / 90 37 / 66 solid formulation, of at least one cannabinoid, and (ii) 3 to 20% by weight, preferably 3 to 15% by weight, most preferably 5 to 15% by weight, based on the total weight of the solid formulation, of Vitamin E, and (iii) 0 to 7.5% by weight, preferably 0 to 7% by weight, most preferably 0 to 5.5% by weight, based on the total weight of the solid formulation, of Vitamin E-TPGS, (iv) 15 to 50% by weight, preferably 20 to 40% by weight, most preferably 20 to 35% by weight, based on the total weight of the solid formulation, of at least one emulsifier (other than Vitamin E-TPGS), and (v) 1 to 20% by weight, preferably 5 to 20% by weight, most preferably 5 to 15% by weight, based on the total weight of the solid formulation, of glucose syrup, and (vi) 0 to 5% by weight, preferably 0 to 4% by weight, most preferably 0 to 3% by weight, based on the total weight of the solid formulation, of at least one auxiliary agent chosen from the group of antioxidants (other than Vitamin E), pH buffers,flavor and / or colorings, and (vii) 0 to 15% by weight, preferably 2.5 to 10% by weight, most preferably 5 to 10% by weight, based on the total weight of the solid formulation, of a carrier, and (viii) less than 5% by weight, preferably 0 to 3.5% by weight, based on the total weight of the solid formulation, of water. wherein at least 50% by weight, based on the total weight of the cannabinoid, of at least one cannabinoid is in a non-crystalline form, and wherein the ratio of at least one cannabinoid to Vitamin E is 2:1 to 4:1. Petition 870250080872, dated 09 / 09 / 2025, p. 55 / 90 38 / 66

[166] It is well understood that all preferences and definitions as given here also apply to the solid formulation (C) as in particular: (a) the emulsifier is selected from gelatin or OSA starch, more preferably the emulsifier is gelatin or a mixture of gelatin and Vitamin E-TPGS, and / or (b) the Vitamin E is (all-rac)-α-tocopherol, and / or (c) the gelatin is a gelatin having a Bloom index selected in the range of 100-200, and / or (d) the carrier is maltodextrin, corn starch or silica, and / or (e) at least 75% by weight of the at least cannabinoid is in a non-crystalline form, and / or (f) the at least cannabinoid is CBD, and / or (g) the additional antioxidant (other than Vitamin E) is ascorbic acid, and / or (h) the solid formulation is a spray-dried solid formulation.

[167] · A solid formulation (D) consisting essentially of (i) 10 to 50% by weight, preferably 20 to 45% by weight, most preferably 30-40% by weight, based on the total weight of the solid formulation, of at least one cannabinoid, and (ii) 3 to 20% by weight, preferably 4 to 15% by weight, most preferably 5 to 15% by weight, based on the total weight of the solid formulation, of Vitamin E, and (iii) 0 to 5.5% by weight, preferably 1 to 5.5% by weight, most preferably 2.5 to 5.5% by weight, based on the total weight of the solid formulation, of Vitamin E-TPGS, and Petition 870250080872, dated 09 / 09 / 2025, page 56 / 90 39 / 66 (iv) 15 to 50% by weight, preferably 20 to 40% by weight, most preferably 20 to 35% by weight, based on the total weight of the solid formulation, of gelatin, and (v) 1 to 15% by weight, preferably 2.5 to 12% by weight, most preferably 4 to 10% by weight, based on the total weight of the solid formulation, of glucose syrup, and (vi) 0 to 5% by weight, preferably 0 to 4% by weight, most preferably 0 to 3% by weight, based on the total weight of the solid formulation, of at least one auxiliary agent chosen from the group of antioxidants (other than Vitamin E), pH buffers, flavor and / or colorants, and (vii) 0 to 15% by weight, preferably 3 to 10% by weight, most preferably 5 to 10% by weight, based on the total weight of the solid formulation, of a vehicle, and (viii) less than 5% by weight, preferably 0 to 3.5% by weight, based on the total weight of the solid formulation, of water. wherein at least 50% by weight, based on the total weight of the cannabinoid, of at least one cannabinoid is in a non-crystalline form, and wherein the ratio of at least one cannabinoid to Vitamin E is 2:1 to 4:1.

[168] It is again well understood that all preferences and definitions as given here also apply to the solid formulation (D) as, in particular: (a) the emulsifier is a mixture of gelatin and Vitamin ETPGS, and / or (b) at least 75% by weight, preferably at least 85% by weight, most preferably at least 95% by weight, such that at least 99% by weight of the cannabinoid is in a Petition 870250080872, dated 09 / 09 / 2025, p. 57 / 90 40 / 66 non-crystalline form, and / or (c) Vitamin E is (all-rac)-α-tocopherol, and / or (d) the gelatin is a gelatin having a Bloom value in the range of 100-200, and / or (e) the vehicle is maltodextrin, corn starch or silica, and / or (f) at least one cannabinoid is CBD, and / or (g) the additional antioxidant (other than Vitamin E) is ascorbic acid and / or (h) the solid formulation is a spray-dried solid formulation.

[169] Even more advantageous, in all embodiments of the present invention, a solid formulation (E) is obtained consisting essentially of (i) 30-45% by weight, based on the total weight of the solid formulation, of CBD, and (ii) 5 to 15% by weight, based on the total weight of the solid formulation, of Vitamin E, and (iii) 0 to 5.5% by weight, based on the total weight of the solid formulation, of Vitamin E-TPGS, and (iv) 20 to 35% by weight, based on the total weight of the solid formulation, of gelatin, and (v) 4 to 10% by weight, based on the total weight of the solid formulation, of glucose syrup, and (vi) 0 to 3% by weight, based on the total weight of the solid formulation, of an additional antioxidant (other than Vitamin E), preferably ascorbic acid, and (vii) 0 to 10% by weight, based on the total weight of the solid formulation, of maltodextrin, Petition 870250080872, dated 09 / 09 / 2025, pp. 58 / 90 41 / 66 (viii) less than 5% by weight, based on the total weight of the solid formulation, of water.

[170] The most preferred embodiment of all embodiments of the present invention is a solid formulation (F) consisting essentially of (i) 35-42% by weight, based on the total weight of the solid formulation, of CBD, and (ii) 5 to 15% by weight, based on the total weight of the solid formulation, of Vitamin E, and (iii) 2.5 to 5.5% by weight, based on the total weight of the solid formulation, of Vitamin E-TPGS, and (iv) 25 to 35% by weight, based on the total weight of the solid formulation, of gelatin, and (v) 4 to 10% by weight, based on the total weight of the solid formulation, of glucose syrup, and (vi) 0 to 3% by weight, based on the total weight of the solid formulation, of an additional antioxidant (other than Vitamin E), preferably ascorbic acid, and (vii) 0 to 10% by weight, based on the total weight of the solid formulation, of maltodextrin, (viii) less than 5% by weight, based on the total weight of the solid formulation, of water.

[171] Another advantageous solid formulation according to the present invention is a solid formulation (G), consisting essentially of (i) 35-42% by weight, based on the total weight of the solid formulation, of CBD, and (ii) 5 to 15% by weight, based on the total weight of the solid formulation, of Vitamin E, and Petition 870250080872, dated 09 / 09 / 2025, pp. 59 / 90 42 / 66 (iii) 2.5 to 5.5% by weight, based on the total weight of the solid formulation, of Vitamin E-TPGS, and (iv) 25 to 35% by weight, based on the total weight of the solid formulation, of gelatin, and (v) 4 to 10% by weight, based on the total weight of the solid formulation, of glucose syrup, and (vi) 1 to 3% by weight, based on the total weight of the solid formulation, of an additional antioxidant (other than Vitamin E), preferably ascorbic acid, and (vii) 0 to 10% by weight, based on the total weight of the solid formulation, of maltodextrin, (viii) less than 5% by weight, based on the total weight of the solid formulation, of water.

[172] The term 'consisting essentially of' as used in the context of the invention means that the addition of the % by weight of the listed ingredients amounts to up to 100% by weight. However, it cannot be excluded that small amounts of impurities may be present, such as, for example, in amounts of less than 5% by weight, preferably less than 3% by weight, which are introduced via the respective processes or raw materials used.

[173] The term 'less than 5% by weight of water' refers to any amount selected in the range of 0 to < 5% by weight, such as 0 to 4.999% by weight, based on the total weight of the solid formulation. Particular advantageous formulations according to the present invention comprise 1 to < 5% by weight, 2 to < 5% by weight or 2.5 to < 5% by weight of water, based on the total weight of the solid formulation.

[174] Solid formulations according to the present Petition 870250080872, dated 09 / 09 / 2025, pp. 60 / 90 43 / 66 inventions are preferably in the form of particles having a preferred particle size of less than 1.5 mm, even more preferably less than 1 mm. Said particle size of the solid formulations can, for example, be determined by screening, according to standardized methods in the art.

[175] In another preferred embodiment, the solid formulations according to the present invention are incorporated into dosage forms suitable for oral application, such as a tablet (orally dispersible tablet, chewable tablet, film-coated tablet, immediate-release tablet, prolonged-release or sustained-release tablet and the like), a capsule, an orally dispersible film or a gum.

[176] The amount of the solid formulation of the present invention to be incorporated into such an oral dosage form is preferably selected in the range of 10 mg to 500 mg.

[177] To prepare a solid dosage form according to the present invention, the solid formulations according to the present invention can be mixed with excipients known in the art, such as • diluents, such as lactose, starch, microcrystalline cellulose, sorbitol, mannitol, dibasic calcium phosphate dihydrate, calcium sulfate dihydrate, sucrose-based diluents and mixtures thereof; • binders, such as acacia, cellulose derivatives, gelatin, glucose, polyvinylpyrrolidone, starch, sucrose, sorbitol, tragacanth, sodium alginate and mixtures thereof; • disintegrants, such as microcrystalline cellulose and cellulose derivatives, starch and its derivatives, alginic acid and Petition 870250080872, dated 09 / 09 / 2025, pp. 61 / 90 44 / 66 its derivatives, ion exchange resins, cross-linked sodium carboxymethyl cellulose, sodium starch glycolate, cross-linked polyvinylpyrrolidone and formaldehyde-casein; • Lubricants, anti-adherents and slip agents, such as magnesium, calcium and sodium stearates, stearic acid, hydrogenated castor oil, talc, water, polyethylene glycol, sodium lauryl sulfate, magnesium lauryl sulfate and silica.

[178] The liquid formulation according to the present invention, such as the liquid formulations [(FL), (FL1), (FL1'), (FL1''), (FL2), (FL2'), (FL2), (FL3), (FL4), (FL5), (FL6), (FL7), (FL8), (FL9), (FL10), (FL11), (FL12), (FL13), (FL14), (FL15), (FL16), (FL16'), (FL17), (FL17'), (FL18), (FL19), (FL19'), (FL20) or (FL20')] as well as the solid formulation [(FS), (FS'), (FS''), (FS'), (FS1), (FS1'), (FS1''), (FS2), (FS2'), (FS2), (FS3), (FS4), (FS5), (FS6), (FS7), (FS8), (FS9), (FS10), (FS11), (FS12), (FS13), (FS14), (FS15), (FS15'), (FS16), (FS16'), (FS17), (FS17'), (FS18), (FS19) or (FS19')] according to the present invention, can be used in a variety of fields of application, such as food, feed, dietary supplements, pharmaceuticals, and personal care products.

[179] These products can be in any form (such as solid, liquid or gel-like).

[180] Preferred are foods, dietary supplements, pharmaceuticals and personal care products comprising at least one liquid formulation according to the present invention, such as the liquid formulations [(FL), (FL1), (FL1'), (FL1''), (FL2), (FL2'), (FL2''), (FL3), (FL4), (FL5), (FL6), (FL7), (FL8), (FL9), (FL10), (FL11), (FL12), (FL13), (FL14), (FL15), (FL16), (FL16'), (FL17), (FL17'), Petition 870250080872, dated 09 / 09 / 2025, pp. 62 / 90 45 / 66 (FL18), (FL19), (FL19'), (FL20) or (FL20')] and / or at least one solid formulation [(FS), (FS'), (FS''), (FS'''), (FS1), (FS1'), (FS1''), (FS2), (FS2'), (FS2''), (FS3), (FS4), (FS5), (FS6), (FS7), (FS8), (FS9), (FS10), (FS11), (FS12), (FS13), (FS14), (FS15), (FS15'), (FS16), (FS16'), (FS17), (FS17'), (FS18), (FS19) or (FS19')] according to the present invention.

[181] The invention also relates to the following embodiments:

[182] 1. A solid formulation comprising (i) 10 to 50% by weight, based on the total weight of the solid formulation, of at least one cannabinoid, and (ii) 3 to 20% by weight, based on the total weight of the solid formulation, of Vitamin E, and (iii) 0 to 7.5% by weight, based on the total weight of the solid formulation, of Vitamin E-TPGS, and (iv) 15 to 50% by weight, based on the total weight of the solid formulation, of at least one emulsifier (other than Vitamin E-TPGS), and (v) 1 to 40% by weight, based on the total weight of the solid formulation, of at least one auxiliary agent, and (vi) less than 5% by weight, based on the total weight of the solid formulation, of water, wherein at least 50% by weight, based on the total weight of the cannabinoid, of at least one cannabinoid is in a non-crystalline form, and wherein the ratio of at least one cannabinoid to Vitamin E ratio is 2:1 to 10:1, preferably 2:1 to 4:1. 2. The solid formulation according to embodiment 1, comprising (i) 10 to 50% by weight, based on the total weight of the formulation Petition 870250080872, dated 09 / 09 / 2025, pp. 63 / 90 46 / 66 solid, of at least one cannabinoid, and (ii) 3 to 20% by weight, based on the total weight of the solid formulation, of Vitamin E, and (iii) 0 to 7.5% by weight, based on the total weight of the solid formulation, of Vitamin E-TPGS, and (iv) 15 to 50% by weight, based on the total weight of the solid formulation, of at least one emulsifier (other than Vitamin E-TPGS), and (v) 1 to 40% by weight, based on the total weight of the solid formulation, of at least one auxiliary agent, and (vi) less than 5% by weight, based on the total weight of the solid formulation, of water, wherein at least 50% by weight, based on the total weight of the cannabinoid, of the at least one cannabinoid is in a non-crystalline form, and wherein the ratio of the at least one cannabinoid to Vitamin E is 2:1 to 10:1, preferably 2:1 to 4:1.

[183] ​​3. The solid formulation according to embodiment 2, in which the formulation consists essentially of ingredients (i) to (vi).

[184] 4. The solid formulation according to any of embodiments 1 to 3, wherein the amount of at least one cannabinoid is selected in the range of 20 to 45% by weight, preferably in the range of 30 to 45% by weight, most preferably in the range of 35 to 40% by weight, based on the total weight of the solid formulation.

[185] 5. The solid formulation according to any of the embodiments 1 to 3, wherein the amount of Vitamin E is selected in the range of 3 to 15% by weight, preferably in the range Petition 870250080872, dated 09 / 09 / 2025, pp. 64 / 90 47 / 66 from 5 to 15% by weight, based on the total weight of the solid formulation.

[186] 6. The solid formulation according to any of embodiments 1 to 5, wherein the amount of Vitamin E-TPGS is selected in the range of 0 to 7% by weight, preferably in the range of 0 to 5.5% by weight, even more preferably in the range of 2 to 5.5% by weight, based on the total weight of the solid formulation.

[187] 7. The solid formulation according to any of embodiments 1 to 6, wherein the amount of the emulsifier is selected in the range of 20 to 40% by weight, preferably in the range of 20 to 35% by weight, based on the total weight of the solid formulation.

[188] 8. The solid formulation according to any of embodiments 1 to 6, wherein the amount of at least one auxiliary agent is selected in the range of 5 to 34% by weight, preferably in the range of 5 to 28% by weight, based on the total weight of the solid formulation.

[189] 9. The solid formulation according to any of the embodiments 1 to 8, wherein the amount of water is selected in the range of 0 to less than 5% by weight, based on the total weight of the solid formulation.

[190] 10. The solid formulation according to any of embodiments 1 to 9, wherein at least one cannabinoid is selected from the group of cannabidiol, tetrahydrocannabinol, cannabinol, cannabigerol, cannabichromene, cannabicitran, cannabinodivarin, cannabiripsol, hexahydrocannabinol, delta-9tetrahydrocannabiforal, tetrahydrocannabivarin, endocannabinoid and endocannabinoid.

[191] 11. The solid formulation according to any of the embodiments 1 to 10, in which at least one cannabinoid is Petition 870250080872, dated 09 / 09 / 2025, pages 65 / 90 48 / 66 cannabidiol.

[192] 12. The solid formulation according to any of the embodiments 1 to 11, wherein Vitamin E is (all-rac)-α-tocopherol.

[193] 13. The solid formulation according to any of embodiments 1 to 12, wherein the emulsifier is gelatin (from bovine, fish, swine, poultry, preferably from swine) or modified starch (OSA).

[194] 14. The solid formulation according to embodiment 13, wherein the gelatin has a Bloom value of less than 200, preferably selected in the range of 100 to 200.

[195] 15. The solid formulation according to any of embodiments 1 to 14, wherein at least one auxiliary agent is selected from the group of colorants, thickeners, carriers, fillers, binders, flavors, antioxidants (other than Vitamin E) and pH buffers.

[196] 16. The solid formulation according to any of embodiments 1 to 15, in which at least one auxiliary agent is selected from the group of thickeners, carriers and antioxidants (other than Vitamin E).

[197] 17. The solid formulation according to embodiment 16, in which the thickener is selected from the group of glucose syrup (dehydrated), maltodextrin, as well as mixtures thereof.

[198] 18. The solid formulation according to embodiment 16 or 17, in which the vehicle is selected from the group of maltodextrin, corn starch and / or silica.

[199] 19. The solid formulation according to embodiment 17, 18 or 19, in which the additional antioxidant is selected from the sulfite and / or ascorbic acid group, preferably the Petition 870250080872, dated 09 / 09 / 2025, pages 66 / 90 49 / 66 additional antioxidant is ascorbic acid.

[200] 20. The solid formulation according to any of embodiments 1 to 19, wherein at least one auxiliary agent includes at least one thickener and at least one antioxidant (other than Vitamin E), more preferably at least one thickener, at least one carrier and at least one antioxidant (other than Vitamin E).

[201] 21. The solid formulation according to any of the embodiments 17 to 20, wherein the amount of glucose syrup in the solid formulation is selected in the range of 1 to 20% by weight, preferably 5 to 20% by weight, most preferably 5 to 15% by weight, based on the total weight of the solid formulation.

[202] 22. The solid formulation according to any of the embodiments 17 to 21, wherein the amount of maltodextrin in the solid formulation is selected in the range of 2.5 to 15% by weight, preferably 3 to 10% by weight, most preferably 5 to 10% by weight, based on the total weight of the solid formulation.

[203] 23. The solid formulation according to any of the embodiments 17 to 22, wherein the amount of the additional antioxidant, preferably ascorbic acid in the solid formulation, is selected in the range of 1 to 3% by weight, based on the total weight of the solid formulation.

[204] 24. The solid formulation according to any of embodiments 1 to 23, wherein the solid formulation is a spray-dried solid formulation.

[205] 25. The solid formulation according to any of embodiments 1 to 24, wherein at least 75% by weight of the at least cannabinoid is in a non-crystalline form.

[206] 26. Use of a solid formulation according to any Petition 870250080872, dated 09 / 09 / 2025, pp. 67 / 90 50 / 66 one of categories 1 to 25 in food products, feed products, dietary supplements, pharmaceutical compositions and personal care products.

[207] 27. Use of a formulation according to any one of embodiments 1 to 25 in pharmaceutical products.

[208] 28. A food product, feed product, dietary supplement, pharmaceutical product and personal care product comprising a formulation according to any one of embodiments 1 to 27.

[209] 29. The pharmaceutical product according to embodiment 28, wherein the pharmaceutical product is in the form of a tablet, a capsule, an orally dispersible film or a gum, preferably a tablet or a capsule.

[210] 30. Use of Vitamin E, preferably (all-rac)-atocopherol to enhance the bioavailability of at least one cannabinoid, preferably cannabidiol, most preferably in the form of a solid formulation according to any of embodiments 1 to 25.

[211] 31. Use of Vitamin E to reduce or inhibit the formation of crystals of at least one cannabinoid, preferably cannabidiol, most preferably in the form of a solid formulation such as the solid formulations according to any of embodiments 1 to 25.

[212] 32. A process for preparing a solid formulation according to any one of embodiments 1 to 25, said process encompassing the steps of (i) solubilizing at least one cannabinoid in Vitamin E, optionally followed by the addition of Vitamin E-TGPS to form a lipid phase, Petition 870250080872, dated 09 / 09 / 2025, pp. 68 / 90 51 / 66 (ii) solubilization of at least one emulsifier (other than Vitamin E-TGPS) and optionally one or more of the auxiliary agents in water to form an aqueous phase, followed by (iii) emulsification of the lipid phase in the aqueous phase, followed by (iv) drying of the emulsion.

[213] 33. The process according to embodiment 32, in which step (i) is carried out at a temperature selected in the range of 60 to 100°C, preferably 65 to 90°C, most preferably 70 to 80°C.

[214] 34. The process according to embodiment 32 or 33, in which the emulsification is carried out at a temperature selected in the range of 60 to 100°C, more preferably 65 to 90°C, most preferably 70 to 80°C.

[215] 35. The process according to any one of embodiments 32 to 34, wherein the drying is spray drying, preferably using maltodextrin as an auxiliary agent (carrier).

[216] 36. The solid formulation according to any of the preceding claims, wherein the degree of crystallinity (in %) is determined by DSC using the respective crystalline cannabinoid as an external standard.

[217] It is well understood that all definitions and preferences as outlined here also apply to modalities 1 to 35.

[218] Additional preferred modes are as follows.

[219] 1a. A liquid formulation comprising (i) 5–85% by weight, based on the total weight of the liquid formulation, of at least one cannabinoid, and (ii) 2–25% by weight, based on the total weight of the formulation Petition 870250080872, dated 09 / 09 / 2025, pages 69 / 90 52 / 66 liquid, of Vitamin E, and (iii) 1 to 50% by weight, based on the total weight of the liquid formulation, of at least one emulsifier, and (iv) 12 to 55% by weight, based on the total weight of the liquid formulation, of water, wherein at least 50% by weight, based on the total weight of the cannabinoid, of at least one cannabinoid is in a non-crystalline form and the ratio of at least one cannabinoid to Vitamin E is 2:1 to 4:1.

[220] 2a. Liquid formulation according to embodiment 1a, wherein at least one cannabinoid is selected from the group consisting of cannabidiol, tetrahydrocannabinol, cannabinol, cannabigerol, cannabichromene, cannabicitran, cannabinodivarin, cannabiripsol, hexahydrocannabinol, delta-9-tetrahydrocannabiforal, tetrahydrocannabivarin, endocannabinoid and endocannabinoid.

[221] 3a. Liquid formulation according to embodiment 1a or embodiment 2a, wherein the amount of at least one cannabinoid in the formulation according to the present invention is 10 - 85% by weight, based on the total weight of the liquid formulation.

[222] 4a. Liquid formulation according to any of the preceding embodiments (1a to 3a), wherein at least 55% by weight, based on the total weight of the cannabinoid, of a cannabinoid is in a non-crystalline form.

[223] 5a. Liquid formulation according to any of the preceding embodiments (1a to 4a), wherein Vitamin E is (todorac)-α-tocopherol.

[224] 6a. Liquid formulation according to any of the Petition 870250080872, dated 09 / 09 / 2025, pp. 70 / 90 53 / 66 preceding modalities (1a to 5a), in which the Vitamin E content is 3 to 20% by weight, based on the total weight of the liquid formulation.

[225] 7a. Liquid formulation according to any of the preceding embodiments (1a to 6a), wherein at least one emulsifier is selected from the group consisting of modified starches (food), Vitamin E-TPGS, ascorbyl palmitate, pectin, alginate, carrageenan, furcellaran, dextrin derivatives, celluloses and cellulose derivatives (e.g., cellulose acetate, methyl cellulose, hydroxypropyl methylcellulose), lignosulfonate, polysaccharide gums (such as acacia gum (= gum arabic), modified acacia gum, TIC gum, linseed gum, ghatti gum, tamarind gum and arabinogalactan), gelatin (from cattle, fish, pigs, poultry), vegetable proteins (such as, for example, peas, soybeans, castor beans, cottonseed, potatoes, sweet potatoes, cassava, rapeseed, sunflower, sesame, seed of flaxseed, safflower, lentils, nuts, wheat, rice, corn, barley, rye, oats, lupins and sorghum), animal proteins including milk or whey proteins, lecithin,Polyglycerol fatty acid esters, monoglycerides of fatty acids, diglycerides of fatty acids, sorbitan esters and sugar esters (as well as derivatives thereof).

[226] 8a. Liquid formulation according to any of the preceding embodiments (1a-7a), wherein the liquid formulation comprises at least one auxiliary agent selected from the group consisting of colorants, thickeners, fillers, binders, flavors, antioxidants and pH buffer.

[227] 9a. Liquid formulation according to embodiment 8a, in which the quantity of at least one auxiliary agent is up to 40% Petition 870250080872, dated 09 / 09 / 2025, pp. 71 / 90 54 / 66 by weight, based on the total weight of the liquid formulation.

[228] 10a. A solid formulation comprising (i) 5–85% by weight, based on the total weight of the solid formulation, of at least one cannabinoid, and (ii) 2–25% by weight, based on the total weight of the solid formulation, of Vitamin E, and (iii) 1–50% by weight, based on the total weight of the solid formulation, of at least one emulsifier, and (iv) optionally up to 40% by weight, based on the total weight of the solid formulation, of at least one auxiliary agent, and (v) less than 5% by weight, based on the total weight of the solid formulation, of water, wherein at least 50% by weight, based on the total weight of the cannabinoid, of the at least one cannabinoid is in a non-crystalline form and the ratio of the at least one cannabinoid to Vitamin E is 2:1 to 4:1.

[229] 11a. Solid formulation according to embodiment 10a, wherein the water content is below 3% by weight, based on the total weight of the solid formulation.

[230] 12a. Solid formulation according to embodiment 10a or embodiment 11a, wherein at least one cannabinoid is selected from the group consisting of cannabidiol, tetrahydrocannabinol, cannabinol, cannabigerol, cannabichromene, cannabicitran, cannabinodivarine, cannabiripsol, hexahydrocannabinol and delta-9tetrahydrocannabiforal.

[231] 13a. Use of a formulation according to any of the preceding embodiments in food products, feed products, dietary supplements, pharmaceutical compositions and Petition 870250080872, dated 09 / 09 / 2025, pp. 72 / 90 55 / 66 personal care products.

[232] 14a. Use of a formulation according to any of the preceding embodiments 1a - 12a in pharmaceutical compositions.

[233] 15a. A food product, feed product, dietary supplement, pharmaceutical product and personal care product comprising a formulation according to any of the preceding embodiments 1a - 12a.

[234] 16a. A pharmaceutical composition comprising a formulation according to any of the preceding embodiments 1a - 12a.

[235] The following examples are presented to better illustrate the compositions and effects of the present invention. These examples are for illustrative purposes only and are not intended to limit the scope of the invention in any way.

[236] All parts and percentages in the Examples are related to weight (unless otherwise indicated) and temperature is given in °C (unless otherwise indicated). Examples General Methods

[237] The degree of crystallinity of the solid formulations was measured using Differential Scanning Calorimetry (DSC) as described below:

[238] External standard: Crystalline CBD (1-2 mg) was placed in an aluminum pan which was then hermetically sealed (external standard). An empty pan was used as a reference. The respective samples were heated from 10°C at 10°C / min to 90°C and then cooled at 10°C at 10°C / min. The crystalline CBD exhibited a thermal transition peak (melting point) at approximately 68°C. Petition 870250080872, dated 09 / 09 / 2025, pp. 73 / 90 56 / 66

[239] The respective powder (solid) formulations were also measured using approximately 8-10 mg of the respective sample.

[240] Then, the peak area of ​​the respective sample is referenced against the peak area of ​​the external standard to calculate the amount of crystals and, respectively, the percentage of crystallinity in the respective samples.

[241] All particle sizes were determined using a Beckmann Coulter, Delsa Nano S (dynamic light scattering).

[242] Bioavailability was tested using a Caco2 model as further detailed below. Figure 1: DSC thermogram of the solid formulation of example 2 (y-axis: heat flux (normalized) (W / g); x-axis Temperature (°C)) solid line: t=0 (directly after production) dashed line: after storage for 12 months at 5°C dotted line: after storage for 12 months at 25°C dashed-dotted line: after storage for 12 months at 40°C.

[243] DSC analysis showed no crystallization peaks after storage, even at low temperatures, illustrating the excellent stability of a solid formulation according to the present invention. Example 1

[244] (i) For the preparation of the lipid phase, a total of 95 g of CBD were dispersed in 40.5 g of (all-rac)-α-tocopherol a Petition 870250080872, dated 09 / 09 / 2025, pp. 74 / 90 57 / 66 75°C while stirring until completely dissolved.

[245] The lipid phase was kept warm until complete dispersion in the aqueous phase.

[246] (ii) For preparation of the aqueous phase, a total of 123 g of porcine gelatin, bloom 140, was hydrated and dissolved in 167.5 g of hot water (40°C). Subsequently, 23.5 g of dehydrated glucose syrup, DE2023, were added and the solution was heated to the process temperature of 75°C.

[247] (iii) The hot liquid phase was stirred, and the hot lipid phase was added slowly and homogenized at elevated temperature (about 75°C) to form a liquid formulation. No crystals were observed in the liquid formulation (visual assessment).

[248] After adjusting the viscosity with water (approximately 440 g), the emulsion was spray-dried at approximately 180°C inlet temperature, 80°C outlet temperature using maltodextrin as carrier (approximately 6%).

[249] A fine-flowing powder was obtained, containing approximately 2.5% residual water and 32.8% CBD with >99% of the CBD in non-crystalline form as determined by DSC (i.e., no detectable crystals). Example 2

[250] (i) For the preparation of the lipid phase, a total of 95 g of CBD were dispersed in 40.5 g of (todo-rac)-α-tocopherol at 75°C under stirring until complete dissolution. Subsequently, 1.51 g of Vitamin E-TPGS was added to the hot (75°C) CBD / (todo-rac)-α-tocopherol mixture and homogenized.

[251] The lipid phase was kept warm until complete dispersion in the aqueous phase. Petition 870250080872, dated 09 / 09 / 2025, pp. 75 / 90 58 / 66

[252] (ii) For the preparation of the aqueous phase, a total of 123 g of porcine gelatin, bloom 140, was hydrated and dissolved in hot water (40°C). Subsequently, 31.5% dehydrated glucose syrup, DE2023, was added and the solution was heated to the process temperature of 75°C.

[253] (iii) The hot aqueous phase was stirred, and the hot lipid phase was slowly added and homogenized for 40 min at an elevated temperature of about 75°C to form a liquid formulation. No crystals were observed in the liquid formulation (visual assessment).

[254] After adjusting the viscosity with water, the emulsion was spray-dried at approximately 180°C inlet temperature, 80°C outlet temperature, using maltodextrin as a carrier (approximately 6%).

[255] A fine-flowing powder was obtained, containing approximately 2.5% residual water and 3.6% CBD with >99% of the CBD in non-crystalline form, as determined by DSC (i.e., below the limit of detection (abbreviation bld)). The sample remained stable, i.e., it did not show crystal formation even when stored at various temperatures, as determined by DSC measurements after 12 months of storage at 5°C, 25°C and 40°C, as shown in Figure 1. Table 1 Ingredients Example 1 Example 2 % by weight % by weight CBD 26.5 26.4 (all-rac)-α-tocopherol (Vit. E) 11.3 11.2 Vitamin E-TPGS - 0.4 Pork gelatin 34.3 34.2 Glucose syrup 8.8 8.7 Water 19.1 19.0 CBD / Vit. E ratio 2.35 2.35 Petition 870250080872, dated 09 / 09 / 2025, pp. 76 / 90 59 / 66 Particle size [nm] 260 225 CBD content in liquid formulation [%] 26.5 26.4 CBD content in solid formulation [%] 32.8 32.6 Residual water in solid formulation [%] 2.5 2.5 Solid crystals (DSC) [%] bld* bld* • below the detection threshold

[256] As can be seen in Table 1, the addition of Vitamin E-TPGS surprisingly reduced the particle size. Furthermore, no crystal formation was observed, either in liquid or solid form. Example 3

[257] A 40% CBD powder (solid) formulation was prepared analogously to Example 2 with the ingredients as shown in Table 2. Again, no crystal formation was observed in the liquid formulation (visual assessment). The fine-flowing powder obtained contained approximately 2.5% residual water and 40.7% CBD with >99% of the CBD in non-crystalline form, as determined by DSC. The solid powder remained stable in open storage. Table 2a Ingredients Example 3b g % by weight CBD 150 27.6 (all-rac)-α-tocopherol (Vit. E) 37.58 6.9 Vitamin E-TPGS 18.79 3.5 Pork gelatin 122.7 22.6 Glucose syrup 25 4.6 Ascorbic acid 9.5 1.7 α 180 33.1 CBD / Vit. E ratio 4 CBD content in liquid formulation [%] 27.6 CBD content in solid formulation [%] 40.7 Residual water in solid formulation [%] <2% Crystals in solid formulation (DSC) [%] bld* Sensory Non-sticky • below the detection threshold Petition 870250080872, dated 09 / 09 / 2025, pp. 77 / 90 60 / 66 Table 2b Ingredients Example 3b g % by weight CBD 107.92 28.6 (all-rac)-α-tocopherol (Vit. E) 26.98 7.1 Vitamin E-TPGS 26.98 7.1 Pork gelatin 78.49 20.8 Glucose syrup 15.99 4.2 Ascorbic acid 6.08 1.6 Water 115.14 30.5 CBD / Vit. E ratio 4 CBD content in liquid formulation [%] 28.6 CBD content in solid formulation [%] 40.3 Residual water in solid formulation [%] <2.0 Crystals in solid formulation (DSC) [%] bld* Sensory Non-sticky • below the detection threshold Table 2c Ingredients Example 3b g % by weight CBD 107.9 28.6 (all-rac)-α-tocopherol (Vit. E) 15.4 3.4 Vitamin E-TPGS 13.4 3.3 Pork gelatin 98.2 24.2 Glucose syrup 20 4.9 Ascorbic acid 7.6 1.9 Water 144 35.4 CBD / Vit. E ratio 7 CBD content in liquid formulation [%] 26.5 CBD content in solid formulation [%] 40.3 Residual water in solid formulation [%] <2.0 Crystals in solid formulation (DSC) [%] 2.7% Sensory Non-sticky

[258] As can be seen from table 2b, increasing the amounts of Vitamin E-TPGS to > 7% by weight results in an increase in the stickiness of the formulation, which is less desirable as it impacts handling properties. Petition 870250080872, dated 09 / 09 / 2025, pp. 78 / 90 61 / 66

[259] As can be recovered from table 2c, the increase in the ratio to 7:1 leads to the formation of crystals compared with the solid formulations having a ratio of 4:1, which do not exhibit any crystal formation. Example 4

[260] Liquid and powder (solid) CBD formulations using OSA starch instead of gelatin were prepared in analogy to Example 1 with the ingredients as shown in Table 3. Again, no crystal formation was observed in the liquid formulations (visual assessment). Table 3 Ingredients Example 4 Example 5 [g] [%] [g] [%] CBD 51 14.5 101 25.7 (all-rac)-α-tocopherol (Vit. E) 12.93 3.7 25.29 6.4 OSA starch (Cleargum COA1) 104 29.6 109 27.8 Glucose syrup 26 7.4 15.6 4.0 Water 157 44.7 141.4 36.0 CBD / Vit. E ratio 4 4 CBD content in liquid formulation [%] 14.7 25.8 CBD content in solid formulation [%] 21.3 32.8 Crystals in solid formulation (DSC) [%] 6.3 23.3

[261] As can be seen from Table 3, the use of OSA starch, in contrast to the use of gelatin, resulted in some crystal formation. Example 4: Bioavailability

[262] CBD powder formulations (solids) (microspheres) comprising approximately 12-16% by weight of CBD and a particle size distribution of approximately 200 nm using different oils, as described below, were prepared to compare the influence of the oil on CBD bioavailability. Liquid formulations were prepared analogously to Petition 870250080872, dated 09 / 09 / 2025, pp. 79 / 90 62 / 66 example 1 above. Then, the respective microparticles were prepared by spraying the liquid formulation onto a fluidized bed using native corn starch. The amount of the respective oil was chosen to ensure complete dissolution of the CBD in the oil. Table 4 Ingredient Ex. 6 Ref. 1 Ref. 2 Ref. 3 Ref. 4 [g] CBD 25 30.7 30.8 29.6 33 (all-rac)-α-tocopherol (Vit. E) 6.3 MCT 14.32 Monoolein 57.22 Monolinolein 57.2 Corn oil 61.2 OSA starch (Cleargum COA1) 120 102 120 96 OSA starch (HS Capsule) 104.5 Glucose syrup 30 55 25.5 30 10.2 Water 181.2 198 154 181.2 61.2 CBD content in liquid formulation* [%] 7 8 8 7 13 CBD content in solid formulation* [%] 14 15 14 12 16 Crystals in solid formulation (DSC) [%] <1 <1 <1 <1 <1

[263] Bioavailability was tested using the Caco-2 Bioavailability test as shown below: • Cell culture preparation

[264] Caco-2 ECACC 86010202 (European Collection of Cell Cultures, Salisbury, United Kingdom) were cultured at 37°C in a 5% CO2 atmosphere in DMEM medium supplemented with 4.5 g / L D-Glucose, 4 mM L-Glutamine, 1 mM Sodium Pyruvate, 1% MEM Non-essential Amino Acids, 50 μg / mL Gentamicin (Life Technologies Europe BV, Zug, Switzerland) and 10% heat-inactivated FBS (Sigma-Aldrich, Buchs, Switzerland). Sub-confluent cells were tryptinized using 0.25% Trypsin / EDTA (Life Petition 870250080872, dated 09 / 09 / 2025, pages 80 / 90 63 / 66 Technologies Europe BV, Zug, Switzerland. • Caco-2 Bioavailability Test

[265] Cells were seeded at a density of 70,000 cells / well in a 12-well cellQART® cell culture insert, PET membrane, 0.4 μM pore size, cell growth area of ​​1.1 cm2 / well (SABEU, Northeim, Germany). The medium was changed every two or three days. After 21 days of culture, the barrier integrity of the differentiated cell monolayers cultured in insert plates was confirmed by measuring the transepithelial electrical resistance (TEER) using an EVOM2 voltameter (World Precision Instruments, Berlin) equipped with STX2-PLUS electrodes. TEER values ​​correlate with the tightness of the confluent monolayer.

[266] After 21 days, the insert plates were washed twice with HBSS solution (HBSS pH 7.4 with Ca2+ and Mg2+, containing 5.5 mM D-(+)-glucose, sodium bicarbonate, and supplemented with 4 mM L-glutamine and 20 mM HEPES, Life Technologies Europe BV, Zug, Switzerland) and incubated for 1 ha at 37 °C in a CO2 incubator. CBD treatment solutions were prepared in HBSS solution at a concentration of 15 μM. The treatment solution was applied to the apical chamber (200 μL) and 1.5 mL of BSA solution was added. 4% HBSS was added to the basolateral chamber. The plate was then incubated for 3 hours at 37 °C in a CO2 incubator on an orbital shaker (80 rpm).

[267] After incubation, buffer solutions from the basolateral (BL) and apical (API) compartments were collected and diluted in acetonitrile for analysis. Cell layers (CL) were washed once with HBSS solution, then 500 μL of acetonitrile were added to the apical portion. The cells were Petition 870250080872, dated 09 / 09 / 2025, pages 81 / 90 64 / 66 scrapings were taken from the membrane with the tip of a pipette and then collected for analysis.

[268] Cannabidiol was quantified by a stable isotope dilution LC-MS method using an Agilent 1290 Infinity II UHPLC connected to a Bruker Impact II Q-TOF mass spectrometer. Eight cannabidiol calibration solutions covering a concentration range from 2.5 ng / ml to 2000 ng / ml were prepared in acetonitrile. A 500 ng / ml solution of deuterium-labeled d3-Cannabidiol (CAS No. 1435783-16—6) in acetonitrile served as an internal standard. Before injection, 250 ml of the calibration solution were mixed with 25 ml of the internal standard. Similarly, 250 ml of the centrifuged CaCO2 compartment samples were combined with 25 ml of the internal standard. The analytical column was a Raptor ARC C18 column (2.1 x 150 mm). The mobile phase was water / acetonitrile 24:76 (v / v) containing 5 mM ammonium formate and 0.1% v / v formic acid. The chromatogram was developed isocratically at a flow rate of 0.4 ml / min and a column temperature of 30 °C. The injection volume was 1.5 ml. The column effluent was introduced into a VIP-HESI source (Bruker Daltonik GmbH) operating in positive ionization mode. The mass spectrometer was operating in full scan mode, scanning the m / z range 100-1000 with a spectrum rate of 4 Hz. High-resolution chromatograms extracted at m / z 315.2319 and m / z 318.2507 with a width of 5 mDa were used for quantification. A calibration curve was established by least squares regression, plotting the ratios of peak area (analyte area versus internal standard area) against added concentrations. Regression and computation of quantitative data were performed using TASQ 1.4 software. Petition 870250080872, dated 09 / 09 / 2025, pages 82 / 90 65 / 66 (Bruker Daltonik). The amounts of CBD measured as a percentage of the original CBD content of the apical compartment (API), basolateral compartment (BL), and cell layer (CL) are shown in Table 5. Cell permeability (reflecting bioavailability) of CBD is determined by the sum of the amounts measured in the basolateral compartment and the cell layer (BL + CL). A higher recovery indicates greater cell permeability of CBD. Table 5: Bioavailability test results CBD oil in BL and CL* [%] (all-rac)-α-tocopherol (Vit. E) 45.8% MCT 41.4% Monoolein 23.8% Monolinolein 16.2% Corn oil 23.2%

[269] Total amount of CBD in API, BL and CL was set to 100%.

[270] As can be seen from Table 5, the product form with Vit. E exhibited the best bioavailability as the highest amount of CBD was detectable in the cell lysate (CL) and basolateral portion (BL). Example 5: Pharmaceutical compositions comprising solid formulations according to the present invention.

[271] Tablets and capsules using the ingredients as shown in Tables 6, 7 and 8 are prepared using the solid formulations of examples 1, 2, 3a, 3b, 3c, 4, 5 and 6, respectively, according to standard methods in the art. Table 6 Example 5a: Tablets 1 2 3 Weight (mg) Microcrystalline cellulose (e.g., Vivapur 102) 186 680 670 Cross-linked polyvinylpyrrolidone (e.g., Kollidon CL) 2 8 12 Magnesium stearate 1 8 12 Silica 1 4 6 Petition 870250080872, dated 09 / 09 / 2025, pages 83 / 90 66 / 66 Solid formulation according to examples 1, 2, 3a, 3b, 4, 5 respectively: 6, 10, 100, 500. Total: 200, 800, 1200. Table 7 Example 5b: Orally dispersible tablets 1 2 3 Weight (mg) Mannitol (e.g., Pearlitol Flash) 325 322 430 Sorbitol (e.g., Neosorb P 200 SD) 75 90 120 Solid formulation according to examples 1, 2, 3a, 3b, 4, 5 respectively 6 100 188 250 Total 500 600 800 Table 8 Example 5c. Capsule filling 1 2 3 4 5 Weight (mg) Microcrystalline cellulose (e.g., Vivapur 102) 54 / / / 34 Sorbitol 5 17.5 / / / Mannitol / 17.5 / / Sodium starch glycolate / / / 26.25 12.5 Silica 1 3.5 3.5 / 3.5 Solid formulation according to examples 1, 2, 3a, 3b, 4, 5 respectively 6 40 329 329 323.75 200 Total 100 350 350 350 250 Petition 870250080872, dated 09 / 09 / 2025, pages 84 / 90

Claims

1 / 4 CLAIMS 1. Solid formulation, characterized in that it comprises (i) 5 - 85% by weight, based on the total weight of the solid formulation, of at least one cannabinoid, and (ii) 2 to 25% by weight, based on the total weight of the solid formulation, of Vitamin E, and (iii) 1 to 50% by weight, based on the total weight of the solid formulation, of at least one emulsifier, and (iv) optionally up to 40% by weight, based on the total weight of the solid formulation, of at least one auxiliary agent, and (v) less than 5% by weight, based on the total weight of the solid formulation, of water, wherein at least 50% by weight, based on the total weight of the cannabinoid, of the at least one cannabinoid is in a non-crystalline form and the ratio of the at least one cannabinoid to Vitamin E is 2:1 to 10:1, preferably 2:1 to 4:

1.

2. Solid formulation, according to claim 1, characterized in that the formulation comprises (i) 10 to 50% by weight, based on the total weight of the solid formulation, of at least one cannabinoid, and (ii) 3 to 20% by weight, based on the total weight of the solid formulation, of Vitamin E, and (iii) 0 to 7.5% by weight, based on the total weight of the solid formulation, of Vitamin E-TPGS, and (iv) 15 to 50% by weight, based on the total weight of the solid formulation, of at least one emulsifier (other than Vitamin E-TPGS), and Petition 870250080872, dated 09 / 09 / 2025, p. 85 / 90 2 / 4 (v) 1 to 40% by weight, based on the total weight of the solid formulation, of at least one auxiliary agent, and (vi) less than 5% by weight, based on the total weight of the solid formulation, of water, wherein at least 50% by weight, based on the total weight of the cannabinoid, of at least one cannabinoid is in a non-crystalline form, and wherein the ratio of at least one cannabinoid to Vitamin E is 2:1 to 10:1, preferably 2:1 to 4:

1.

3. Solid formulation according to claim 2, characterized in that the formulation consists essentially of ingredients (i) to (vi).

4. Solid formulation, according to any of the preceding claims, characterized in that the amount of at least one cannabinoid is selected in the range of 20 to 45% by weight, preferably in the range of 30 to 45% by weight, most preferably in the range of 35 to 40% by weight, based on the total weight of the solid formulation.

5. Solid formulation, according to any of the preceding claims, characterized in that the amount of Vitamin E is selected in the range of 3 to 15% by weight, preferably in the range of 5 to 15% by weight, based on the total weight of the solid formulation.

6. Solid formulation, according to any of the preceding claims, characterized in that at least one cannabinoid is selected from the group consisting of cannabidiol, tetrahydrocannabinol, cannabinol, cannabigerol, cannabichromene, cannabicitran, cannabinodivarin, cannabiripsol, hexahydrocannabinol, delta-9-tetrahydrocannabiforal, tetrahydrocannabivarin, endocannabinoid and endocannabinoid, preferably at least one cannabinoid is cannabidiol.

7. Solid formulation, according to any of the preceding claims, characterized in that Vitamin E is (all-rac)-α-tocopherol.

8. Solid formulation, according to any of the preceding claims, characterized in that at least one emulsifier is selected from the group consisting of modified starches (food), gelatin and a mixture of gelatin and Vitamin E-TPGS, preferably the emulsifier consists of a mixture of gelatin and Vitamin E-TPGS.

9. Solid formulation, according to any of the preceding claims, characterized in that at least one auxiliary agent is chosen from the group of colorants, thickeners, carriers, fillers, binders, flavors, antioxidants and pH buffer, preferably from the group of thickeners, carriers and antioxidants, most preferably from the group of glucose syrup, maltodextrin, corn starch and / or ascorbic acid.

10. Solid formulation, according to any of the preceding claims, characterized in that the solid formulation is a spray-dried solid formulation.

11. Use of a formulation, as defined in any of the preceding claims, characterized by being in food products, feed products, dietary supplements, pharmaceutical products and personal care products.

12. Food product, feed product, dietary supplement, pharmaceutical product and personal care product, characterized in that they comprise a formulation, as defined in any of the preceding claims 1 to 10.

13. Pharmaceutical product according to claim 12, characterized in that the pharmaceutical product is in the form of a tablet, a capsule, an orally dispersible film or a gum.

14. Use of Vitamin E, preferably (all-rac)-atocopherol, characterized in that it enhances the bioavailability of at least one cannabinoid, preferably cannabidiol, most preferably in the form of a solid formulation, as defined in any of embodiments 1 to 13.

15. Process for the preparation of a solid formulation, as defined in any one of claims 1 to 10, the process characterized in that it includes the steps of (i) solubilizing at least one cannabinoid in Vitamin E, optionally followed by the addition of Vitamin E-TGPS to form a lipid phase, (ii) solubilizing at least one emulsifier (other than Vitamin E-TGPS) and optionally one or more of the auxiliary agents in water to form an aqueous phase, followed by (iii) emulsifying the lipid phase in the aqueous phase, followed by (iv) drying the emulsion, preferably by spray drying, even more preferably using maltodextrin as an auxiliary agent (carrier). Petition 870250080872, dated 09 / 09 / 2025, pp. 88 / 90

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