Self-emulsifiing systems for cananinoids

Description

1 / 116 Self-emulsifying systems for cannabinoids. Field of the invention.

[001] The invention relates to the field of cannabinoids. In particular, the present invention relates to self-emulsifying systems for cannabinoids, such as self-emulsifying systems including surfactants with a polyethylene glycol moiety. BACKGROUND OF THE INVENTION

[002] Cannabinoids are a group of chemical materials found in Cannabis sativa, Cannabis indica, Cannabis ruderalis, the marijuana plant, and related plant species. They are known to activate cannabinoid receptors (CB1 and CB2). These chemical materials are well-produced endogenously in humans and other animals. Cannabinoids are cyclic molecules that exhibit particular properties, such as being lipophilic, having the ability to easily cross the blood-brain barrier, and having low toxicity.

[003] Cannabis sativa contains more than 400 chemical materials and approximately 120 cannabinoids, the active constituents of cannabis, including tetrahydrocannabinol (THC), cannabidinol (CBD), cannabinol (CBN), tetrahydrocannabivarin (THCV), and cannabigerol (CBG). Pharmacologically, the main psychoactive constituent of cannabis is tetrahydrocannabinol (THC), which is used to treat a wide range of medical conditions, including glaucoma, AIDS waste, neuropathic pain, treatment of spasticity associated with multiple sclerosis, fibromyalgia, and chemotherapy-induced nausea. THC is also effective in treating allergies, inflammation, infection, depression, migraine, bipolar disorder, anxiety disorders, drug dependence, and drug withdrawal syndromes.

[004] Gastrointestinal release of cannabinoids may provide some advantages compared to oral mucosal absorption of Petition 870260085113, dated 08 / 21 / 2026, page 6 / 314 2 / 116 cannabinoids, particularly regarding the absorption of cannabinoids in the small intestine or colon of the gastrointestinal tract, which involves absorption on a short timescale but also on a long timescale. However, certain challenges arise if cannabinoids have to be released into the oral cavity as part of a powder formulation, such as a chewable tablet powder formulation, but must be released to the mucosal surfaces in the gastrointestinal tract for improved absorption. Considerations such as the ability to withstand a low pH in the stomach, or various chemical and physical challenges, may imply that powder formulations may be problematic to apply as a delivery platform for cannabinoids intended for gastrointestinal absorption. Furthermore, achieving adequate absorption in the gastrointestinal tract may be problematic under these circumstances.

[005] Specifically, certain systems for gastrointestinal release of cannabinoids would be expected to be degraded to a high degree and, consequently, to result in less absorption in the gastrointestinal tract, such as the colon. Other systems for gastrointestinal release of cannabinoids would be expected to result in less cellular absorption due to steric hindrance and, thus, less absorption in the gastrointestinal tract, such as the small intestine.

[006] Although oral administration of cannabinoids is a common routine administration, less attention has been given in the prior art to realized systems that allow a high amount of cannabinoids to be administered to patients in need thereof. In particular, less attention has been given to realized cannabinoid systems that allow a high loading of cannabinoids and, at the same time, provide convenience during oral administration. Typically, vehicle systems can be expected to provide an inconvenient sensation in the mouth in formulations Petition 870260085113, dated 08 / 21 / 2026, page 7 / 314 3 / 116 oral tablets that must be dissolved or disintegrated in the oral cavity.

[007] A special challenge applies in the case of systems being released into the oral cavity, such as when the oral application form is partially dissolved or partially disintegrated in the oral cavity, but the vehicle systems containing the cannabinoids must be released into the gastrointestinal tract for absorption of the cannabinoids. Under these circumstances, it may be critical to provide a special vehicle system that can allow the cannabinoids to be contained in the vehicle for a relatively long time so that the vehicle system is released into the gastrointestinal tract with a high cannabinoid load.

[008] Furthermore, less attention has been given to the administration of high doses of cannabinoids and the associated mouthfeel during or after partial dissolution or partial disintegration in the oral cavity of the application form. Typically, when systems are present, it can be expected that vehicle systems as such will accommodate an inappropriate mouthfeel, such as a gritty sensation or even a grinding sound when chewing the application form with a vehicle system content.

[009] The challenges of vehicle systems can particularly arise if a high load of cannabinoids has to be present and, consequently, a high load of vehicle systems is present in the formulation. At the same time, the homogeneity and / or release of the cannabinoid in the application form is important, which in some cases can be a challenge if cannabinoids are applied in a vehicle system.

[0010] In addition, it is preferable that a formulation be provided that can also help in obtaining improved sensory properties of oral cannabinoid release. Here, important sensory properties include texture, perception of Petition 870260085113, dated 08 / 21 / 2026, page 8 / 314 4 / 116 taste, perception of sweetness, and unpleasant notes associated with cannabinoids. These properties are both relevant from a convenient perspective in solid dosage forms, but certainly also to support proper release of cannabinoids from tablets and adverse side effects of cannabinoids.

[0011] Consequently, there is a need in the prior art for powders and formulations that solve the aforementioned challenges and problems of the prior art. In particular, there is a need in the prior art for powders to be applied in various forms of administration, such as tablets, sachets, chewing gums and lozenges, which are both associated with adequate uniformity of cannabinoid content and adequate sensory properties.

[0012] More specifically, it is desired that these formulations also be acceptable or improved with respect to taste masking and provide a desired release of the vehicle systems into the oral cavity and a desired release of cannabinoids for gastrointestinal absorption.

[0013] Finally, there is a need in the prior art for systems that can accommodate increased absorption of cannabinoids in the gastrointestinal tract, such as the small intestine or colon. At the same time, there is a need for systems that provide adequate stability of cannabinoids when, for example, absorption of cannabinoids is to occur in the small intestine or colon. SUMMARY OF THE INVENTION

[0014] Consequently, an orally dissolvable or chewable tablet powder formulation is provided, comprising one or more carrier systems comprising one or more liquid or solid self-emulsifying systems loaded with cannabinoids. Petition 870260085113, dated 08 / 21 / 2026, page 9 / 314 5 / 116 in an amount of at least 10% by weight of the compressed powder formulation, wherein one or more self-emulsifying systems include i) at least one or more surfactants, one or more lipids and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a liquid self-emulsifying system, and ii) at least one or more surfactants, one or more waxes and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a solid self-emulsifying system, and wherein the powder formulation also comprises one or more water-soluble agents in an amount of 20 to 80% by weight of the compressed powder formulation; and one or more flavorings.

[0015] In addition, an orally dissolvable or chewable tablet powder formulation is provided, comprising one or more carrier systems comprising one or more liquid or solid self-emulsifying systems loaded with cannabinoids in an amount of at least 10% by weight of the tablet powder formulation, wherein one or more self-emulsifying systems include i) at least one or more surfactants, one or more lipids and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a liquid self-emulsifying system, and ii) at least one or more surfactants, one or more waxes and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a solid self-emulsifying system, and wherein the powder formulation also comprises one or more water-soluble agents in an amount of 20 to 80% by weight of the tablet powder formulation;and one or more flavorings, characterized in that said one or more self-emulsifying systems are stable at a pH of about 1 to 4 and are operable for release from the gastrointestinal tract of one or more cannabinoids upon release from one or more vehicle systems in the oral cavity. Petition 870260085113, dated 08 / 21 / 2026, page 10 / 314 6 / 116

[0016] In some embodiments of the invention, one or more self-emulsifying systems are stable at a pH of about 1 to 4.

[0017] In some embodiments of the invention, one or more self-emulsifying systems are operable for the release from the gastrointestinal tract of one or more cannabinoids upon release from one or more vehicle systems into the oral cavity.

[0018] In some embodiments of the invention, one or more self-emulsifying systems are stable at a pH of about 1 to 4 and are operable for the release of one or more cannabinoids from the gastrointestinal tract upon release of one or more vehicle systems into the oral cavity.

[0019] One of the advantages according to the invention is that a vehicle system allows the cannabinoids to be contained in the vehicle for a relatively long time so that the vehicle system can release them into the gastrointestinal tract at a relatively high load.

[0020] Furthermore, it was observed that the vehicle system can withstand conditions in the stomach, such as a low pH value, without being critically affected by such conditions and allow effective release of cannabinoids in the gastrointestinal tract, such as in the intestines.

[0021] According to the invention, it was not expected that a high load of cannabinoids would be obtained while the compressed powder formulation would serve to release the cannabinoids to the gastrointestinal target without the challenges described in the prior art. The challenge of the carrier systems arises particularly if a high load of cannabinoids has to be present and, consequently, a high load of the carrier system is present in the formulation.

[0022] A special advantage of the present invention is that the system is particularly suitable for vehicle system release. Petition 870260085113, dated 08 / 21 / 2026, page 11 / 314 7 / 116 in the oral cavity, such as when the oral application form is partially dissolved or partially disintegrated in the oral cavity, and subsequent release of the vehicle system into the gastrointestinal tract for absorption of the cannabinoids. Under these circumstances, it has been observed that the vehicle system may allow the cannabinoids to be contained in the vehicle for a relatively long time for the vehicle system to be released into the gastrointestinal tract with a high cannabinoid load.

[0023] At the same time, the homogeneity of the cannabinoid in the application form is important, which in some cases can be a challenge if the cannabinoids are applied in a vehicle system. These challenges can also be overcome by the present invention. Consequently, variations can be avoided and a safe and convenient release can be achieved.

[0024] In addition, a formulation is provided that can also help in achieving improved sensory properties of oral cannabinoid release. Here, important sensory properties include texture, taste perception, sweetness perception, and unpleasant notes associated with cannabinoids. These properties are both relevant from a convenience perspective in solid dosage forms, but certainly also to support proper release of cannabinoids from the tablets and avoid adverse cannabinoid side effects.

[0025] Another challenge is that cannabinoids tend to be associated with unpleasant aftertastes when released into the oral cavity due to the physicochemical properties of the compounds. Since cannabinoids can be contained in vehicles according to the invention, these unpleasant aftertastes are less prevalent during administration according to the invention.

[0026] In some embodiments of the invention, one or more ten Petition 870260085113, dated 08 / 21 / 2026, page 12 / 314 8 / 116 surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety. In the present context, the term “moiety” is given the common understanding within organic chemistry, that is, the polyethylene glycol moiety is part of a molecule and can be identified as such within the molecule. This may be a surfactant tail, a surfactant side group, part of a chain within the surfactant, etc. In the present context, a “polyethylene glycol moiety” is specifically non-free polyethylene glycol.

[0027] One of the advantages of including one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety as part of self-emulsifying systems according to the invention is that the in vivo absorption of cannabinoids was seen to be surprisingly increased. This was highly unexpected, since a high PEG content in the surfactant was theoretically expected to result in less cellular absorption due to the high steric hindrance expected of a surfactant with a PEG moiety for cellular absorption. However, the exact opposite was seen, which was a great surprise to the inventors.

[0028] Specifically, it was observed that the in vivo absorption of cannabinoids in rats including a surfactant with a polyethylene glycol (PEG) moiety as part of self-emulsifying systems according to the invention was particularly pronounced on a short timescale, as the plasma concentration of cannabinoid was initially very high as a function of time compared to self-emulsifying systems containing other surfactants, such as surfactants without the PEG moiety, when applied in an in vivo test setting with rats. Furthermore, the plasma concentration was initially very high compared to the reference, Epidiolex®, whose system contains a high content of sesame oil, which, incidentally, is Petition 870260085113, dated 08 / 21 / 2026, page 13 / 314 9 / 116 problematic due to adverse laxative properties.

[0029] As used herein, the term “long timescales” indicates more than 240 minutes after in vivo administration of cannabinoids in rats and “short timescales” indicates less than 240 minutes after in vivo administration of cannabinoids in rats. Without being linked by theory, it is believed that “short timescales” may indicate absorption in the small intestine of rats, while “long timescales” may indicate absorption in the colon of rats. However, not only was a surprisingly high initial absorption observed with the inclusion of one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety as part of self-emulsifying systems according to the invention, but also an overall absorption of cannabinoids was seen to be high over time, including a relatively high absorption over a long timescale as indicated by the elevated plasma concentration of cannabinoids over time. Compared to the reference, Epidiolex®, the overall absorption of cannabinoids, including absorption over both short and long timescales, was on average at the same level and even higher.

[0030] Furthermore, the stability of self-emulsifying systems with surfactants having a PEG moiety was observed to stabilize cannabinoids to a surprisingly high degree, whereby degradation in the hostile environment of the gastrointestinal tract was limited.

[0031] In some embodiments of the invention, one or more surfactants having a chemical structure that includes a PEG moiety is present in an amount of at least 20% by weight of one or more liquid or solid self-emulsifying systems.

[0032] In some embodiments of the invention, one or more surfactants having a chemical structure that includes a PEG moiety are present in an amount of at least 25% by weight of a Petition 870260085113, dated 08 / 21 / 2026, p. 14 / 314 10 / 116 or more liquid or solid self-emulsifying systems.

[0033] In some embodiments of the invention, one or more surfactants having a chemical structure that includes a PEG moiety is present in an amount of at least 30% by weight of one or more liquid or solid self-emulsifying systems.

[0034] In some embodiments of the invention, one or more surfactants having a chemical structure that includes a PEG moiety is present in an amount of at least 35% by weight of one or more liquid or solid self-emulsifying systems.

[0035] In some embodiments of the invention, one or more surfactants having a chemical structure that includes a PEG moiety is present in an amount of at least 40% by weight of one or more liquid or solid self-emulsifying systems.

[0036] In some embodiments of the invention, one or more surfactants having a chemical structure that includes a PEG moiety is present in an amount of at least 50% by weight of one or more liquid or solid self-emulsifying systems.

[0037] In some embodiments of the invention, one or more surfactants having a chemical structure that includes a PEG moiety is present in an amount of at least 60% by weight of one or more liquid or solid self-emulsifying systems.

[0038] In some embodiments of the invention, one or more surfactants having a chemical structure that includes a PEG moiety is present in an amount of 20 to 80% by weight of one or more liquid or solid self-emulsifying systems.

[0039] In some embodiments of the invention, one or more surfactants having a chemical structure that includes a PEG moiety is present in an amount of 25 to 75% by weight of one or more liquid or solid self-emulsifying systems.

[0040] In some embodiments of the invention, one or more ten Petition 870260085113, dated 08 / 21 / 2026, p. 15 / 314 11 / 116 actives having a chemical structure that includes a PEG moiety is present in an amount of 30 to 75% by weight of one or more liquid or solid self-emulsifying systems.

[0041] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in a relatively high weight amount in one or more liquid or solid autoemulsifying systems. This relatively high amount has been observed to be preferable to balance high absorption in terms of plasma concentration and the need for the autoemulsifying systems to work optimally. Furthermore, a relatively high presence of cannabinoids, such as CBD, in the SEDDS may be important to limit the SEDDS content in the oral formulation.

[0042] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in an amount of at least 15% by weight of one or more liquid or solid self-emulsifying systems.

[0043] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in an amount of at least 20% by weight of one or more liquid or solid self-emulsifying systems.

[0044] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in an amount of at least 25% by weight of one or more liquid or solid self-emulsifying systems.

[0045] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in an amount of at least 30% by weight of one or more liquid or solid self-emulsifying systems.

[0046] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in a Petition 870260085113, dated 08 / 21 / 2026, p. 16 / 314 12 / 116 quantity of at least 35% by weight of one or more liquid or solid self-emulsifying systems.

[0047] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in an amount of at least 40% by weight of one or more liquid or solid self-emulsifying systems.

[0048] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in an amount of 15 to 50% by weight of one or more liquid or solid self-emulsifying systems.

[0049] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in an amount of 20 to 40% by weight of one or more liquid or solid self-emulsifying systems.

[0050] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in an amount of 25 to 35% by weight of one or more liquid or solid self-emulsifying systems.

[0051] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in an amount of 10 to 30% by weight of the compressed powder formulation.

[0052] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in an amount of 10 to 20% by weight of the compressed powder formulation.

[0053] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in an amount of at least 5% by weight of the compressed powder formulation.

[0054] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in a Petition 870260085113, dated 08 / 21 / 2026, p. 17 / 314 13 / 116 quantity of at least 10% by weight of the compressed powder formulation.

[0055] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in an amount of at least 15% by weight of the compressed powder formulation.

[0056] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in an amount of at least 20% by weight of the compressed powder formulation.

[0057] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in an amount of at least 25% by weight of the compressed powder formulation.

[0058] In some embodiments of the invention, one or more carrier systems are released from the orally dissolvable or chewable compressed powder formulation in the oral cavity.

[0059] In some embodiments of the invention, at least 90% of one or more vehicle systems is released from the orally dissolvable or chewable tablet powder formulation into the oral cavity within 5 minutes of oral administration.

[0060] In some embodiments of the invention, at least 50% of one or more isolated or synthetic cannabinoids are released from one or more vehicle systems 10 minutes after oral administration.

[0061] In some embodiments of the invention, at least 20% of one or more isolated or synthetic cannabinoids are released from one or more vehicle systems 10 minutes after oral administration.

[0062] In some embodiments of the invention, the self-emulsification system in hydration forms an emulsion for the release of one or more cannabinoids to mucosal surfaces in the gastrointestinal tract. Petition 870260085113, dated 08 / 21 / 2026, page 18 / 314 14 / 116 testinal.

[0063] In some embodiments of the invention, the self-emulsification system in hydration forms an emulsion for the release of one or more cannabinoids to mucosal surfaces in the small intestines of the gastrointestinal tract.

[0064] In some embodiments of the invention, the self-emulsification system in hydration forms an emulsion for the release of one or more cannabinoids to mucosal surfaces in the colon of the gastrointestinal tract.

[0065] In some embodiments of the invention, one or more carrier systems provide stable conditions for the release of one or more cannabinoids to mucosal surfaces in the gastrointestinal tract. In some embodiments of the invention, one or more carrier systems provide stable conditions for the release of one or more cannabinoids to mucosal surfaces in the stomach of the gastrointestinal tract.

[0066] In some embodiments of the invention, one or more self-emulsifying systems comprise one or more liquid self-emulsifying systems.

[0067] In some embodiments of the invention, one or more lipids comprise one or more oils.

[0068] In some embodiments of the invention, one or more lipids comprise one or more oils comprising orange oil.

[0069] In some embodiments of the invention, one or more lipids comprise one or more triglycerides.

[0070] In some embodiments of the invention, one or more lipids comprise one or more triglycerides of vegetable origin.

[0071] In some embodiments of the invention, one or more lipids comprise one or more oils selected from the group consisting of almond oil, castor oil, coconut oil, corn oil, Petition 870260085113, dated 08 / 21 / 2026, page 19 / 314 15 / 116 Cottonseed oil, linseed oil, olive oil, palm oil, peanut oil, rapeseed oil, safflower oil, sesame oil, soybean oil, sunflower oil, and combinations thereof.

[0072] In some embodiments of the invention, one or more lipids comprise one or more triglycerides selected from one or more C4 to C14 triglycerides.

[0073] In some embodiments of the invention, one or more lipids comprise one or more triglycerides comprising a partially hydrogenated vegetable oil.

[0074] In some embodiments of the invention, one or more lipids comprise one or more triglycerides comprising a fully hydrogenated vegetable oil.

[0075] In some embodiments of the invention, one or more lipids comprise one or more triglycerides comprising caprylic acid in an amount of 50 to 80% by weight.

[0076] In some embodiments of the invention, one or more lipids comprise one or more triglycerides comprising capric acid in an amount of 20 to 45% by weight.

[0077] In some embodiments of the invention, one or more lipids do not comprise an aromatic oil.

[0078] In some embodiments of the invention, one or more lipids comprise one or more lipophilic compounds selected from the group consisting of glyceryl caprylate, glyceryl caprate, glyceryl monocaprylate, glyceryl monooleate, glyceryl monostearate, glyceryl monolinoleate, polyglyceryl-3 dioleate, propylene glycol dicaprylocaprate, propylene glycol dilaurate, benzyl alcohol, alpha-tocopherol, isopropyl myristate, glycerol monocaprylocaprate, and combinations thereof.

[0079] In some embodiments of the invention, one or more lipids comprise one or more lipophilic compounds selected from Petition 870260085113, dated 08 / 21 / 2026, p. 20 / 314 16 / 116 group consisting of glyceryl caprylate mixed with glyceryl caprate (Type I), glyceryl caprylate mixed with glyceryl caprate (Type II), glyceryl monocaprylate (Type I), glyceryl monooleate (Type 40), glyceryl monooleate (Type 60), glyceryl monooleate (Type 90), glyceryl monostearate, glyceryl monolinoleate, polyglyceryl-3 dioleate, propylene glycol dicaprylocaprate, propylene glycol dilaurate, benzyl alcohol, alpha-tocopherol, isopropyl myristate, glycerol monocaprylocaprate, and combinations thereof.

[0080] In some embodiments of the invention, one or more lipids comprise one or more lipophilic compounds having an HLB value of less than 6.

[0081] In some embodiments of the invention, one or more lipids comprise one or more lipophilic compounds that are not triglycerides.

[0082] In some embodiments of the invention, one or more lipids are present in an amount of 1 to 30% by weight of the orally dissolvable or chewable powder tablet formulation.

[0083] In some embodiments of the invention, one or more lipids are present in an amount of 5 to 30% by weight of the orally dissolvable or chewable powder tablet formulation.

[0084] In some embodiments of the invention, one or more lipids are present in an amount of 10 to 30% by weight of the orally dissolvable or chewable powder tablet formulation.

[0085] In some embodiments of the invention, one or more lipids are present in an amount of 5 to 40% by weight of one or more self-emulsifying systems.

[0086] In some embodiments of the invention, one or more lipids are present in an amount of 10 to 40% by weight of one or more self-emulsifying systems.

[0087] In some embodiments of the invention, one or more lipids Petition 870260085113, dated 08 / 21 / 2026, p. 21 / 314 17 / 116 improves the homogeneity of one or more cannabinoids in the orally dissolvable or chewable tablet powder formulation.

[0088] In some embodiments of the invention, one or more lipids are present in an amount of 10 to 300 mg in the orally dissolvable or chewable tablet powder formulation.

[0089] In some embodiments of the invention, one or more lipids are present in an amount of 50 to 300 mg in the orally dissolvable or chewable tablet powder formulation.

[0090] In some embodiments of the invention, one or more self-emulsifying systems comprise one or more solid self-emulsifying systems.

[0091] In some embodiments of the invention, one or more waxes comprise a solid and / or a semi-solid material at 25 degrees Celsius. In some embodiments, one or more waxes comprise a solid and / or a semi-solid lipid.

[0092] Generally, the expression “solid self-emulsifying system” is intended to mean self-emulsifying systems that are solid and / or a semi-solid at 25 degrees Celsius, and the expression “liquid self-emulsifying system” is intended to mean self-emulsifying systems that are liquid and / or a semi-liquid at 25 degrees Celsius.

[0093] In some embodiments of the invention, one or more waxes is present in an amount of 1 to 30% by weight of the orally dissolvable or chewable powder tablet formulation.

[0094] In some embodiments of the invention, one or more waxes improves the homogeneity of one or more cannabinoids in the orally dissolvable or chewable compressed powder formulation.

[0095] In some embodiments of the invention, one or more waxes is present in an amount of 10 to 300 mg in the orally dissolvable or chewable tablet powder formulation.

[0096] In some embodiments of the invention, one or more ce Petition 870260085113, dated 08 / 21 / 2026, page 22 / 314 18 / 116 ras is present in a quantity of 50 to 300 mg in the orally dissolvable or chewable tablet powder formulation.

[0097] In some embodiments of the invention, one or more surfactants have an HLB value greater than 6.

[0098] In some embodiments of the invention, one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety being selected from the group consisting of sugar- and lipid-based surfactants with PEG modification, PEG-containing polymer-based surfactants containing PEG, PEGylated emulsifiers, and combinations thereof.

[0099] In some embodiments of the invention, one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety, being sugar and lipid-based surfactants with PEG modification selected from the group consisting of polyoxyethylene sorbitan monolaurate (20), polyoxyethylene sorbitan monooleate (20), polyoxyethylene sorbitan monopalmitate (20), polyoxyethylene sorbitan monostearate (20), polyoxyethylene sorbitan trioleate (20), and combinations thereof.

[00100] In some embodiments of the invention, one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety, the PEG-containing surfactants being PEG-containing polymer-based surfactants selected from the group consisting of poloxamer 124, poloxamer 188, poloxamer 338, poloxamer 407, and combinations thereof. All being triple-block copolymers of polyoxyethylene and polyoxypropylene glycol.

[00101] In some embodiments of the invention, one or more surfactants comprise one or more surfactants having a structure Petition 870260085113, dated 08 / 21 / 2026, page 23 / 314 19 / 116 chemical composition including a portion of polyethylene glycol (PEG) being PEGylated emulsifiers selected from the group consisting of d-alpha-tocopheryl polyethylene glycol succinate, d-alpha-tocopheryl succinate, PEG-1000 castor oil, PEG-15 hydroxystearate, PEG-30, PEG-32 lauryl glycerides, PEG-32 stearyl glycerides, PEG-35 castor oil, PEG-40 hydrogenated castor oil, PEG-6 lauryl glycerides, PEG-6 linoleoyl glycerides, PEG-6 oleoyl glycerides, PEG-8 caprylic / capric glycerides, polyoxyl 20 cetostearyl ether, polyoxyethylene lauryl ether, Polyoxyethylene-23-lauryl ether, and combinations thereof. In this context, the abbreviation “PEG-15” is intended to signify that 15 PEG units are present. The same numbering applies to the other abbreviations, where the number after PEG indicates the number of “PEG” units in the molecule when the number is 100 or less.If the number after PEG is greater than 100, the number indicates the average molecular weight of the "PEG" chain in the molecule.

[00102] In some embodiments of the invention, one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety comprising d-alpha-tocopheryl polyethylene glycol succinate.

[00103] In some embodiments of the invention, one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety comprising polyoxyethylene lauryl ether.

[00104] In some embodiments of the invention, one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety comprising polyoxyethylene-23-lauryl ether.

[00105] In some embodiments of the invention, one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) portion. Petition 870260085113, dated 08 / 21 / 2026, page 24 / 314 20 / 116 dendo poloxamer 188.

[00106] In some embodiments of the invention, one or more surfactants have an average HLB value greater than 6.

[00107] In some embodiments of the invention, one or more surfactants have an average HLB value greater than 9.

[00108] In some embodiments of the invention, one or more surfactants is selected from the group consisting of PEG-35 castor oil, PEG-6 oleoyl glycerides, PEG-6 linoleoyl glycerides, PEG-8 caprylic / capric glyceride, sorbitan monolaurate, sorbitan monooleate, polyoxyethylene sorbitan monolaurate (20), polyoxyethylene sorbitan monostearate (60), polyoxyethylene sorbitan monooleate (80), lauroyl polyoxyl-32 glycerides, stearoyl polyoxyl-32 glycerides, polyoxyl-32 stearate, propylene glycol monolaurate, propylene glycol dilaurate, and mixtures and combinations thereof.

[00109] In some embodiments of the invention, one or more self-emulsifying systems also comprise one or more co-solvents.

[00110] In some embodiments of the invention, one or more self-emulsifying systems also comprise one or more co-solvents selected from the group consisting of polyglyceryl-3-dioleate, 1,2-propandiol, polyethylene glycol 300, polyethylene glycol 400, diethylene glycol monoethyl ether, and mixtures and combinations thereof.

[00111] In some embodiments of the invention, one or more self-emulsifying systems also comprise one or more hydrophilic solvents.

[00112] In some embodiments of the invention, one or more self-emulsifying systems also comprise one or more hydrophilic solvents in an amount of at least 5% by weight of one or more liquid or solid self-emulsifying systems. Petition 870260085113, dated 08 / 21 / 2026, page 25 / 314 21 / 116

[00113] In some embodiments of the invention, one or more self-emulsifying systems also comprise one or more hydrophilic solvents in an amount of at least 10% by weight of one or more liquid or solid self-emulsifying systems.

[00114] In some embodiments of the invention, one or more self-emulsifying systems also comprise one or more hydrophilic solvents in an amount of at least 20% by weight of one or more liquid or solid self-emulsifying systems.

[00115] In some embodiments of the invention, one or more self-emulsifying systems also comprise one or more hydrophilic solvents in an amount of 10 to 50% by weight of one or more liquid or solid self-emulsifying systems.

[00116] In some embodiments of the invention, one or more self-emulsifying systems also comprise one or more hydrophilic solvents in an amount of 10 to 40% by weight of one or more liquid or solid self-emulsifying systems.

[00117] In some embodiments of the invention, one or more self-emulsifying systems also comprise one or more hydrophilic solvents in an amount of 10 to 30% by weight of one or more liquid or solid self-emulsifying systems.

[00118] In some embodiments of the invention, one or more self-emulsifying systems also comprise one or more hydrophilic solvents selected from the group consisting of propylene glycol, acetyl tributyl citrate, triethyl acetyl citrate, dimethyl sulfoxide, ethanol, ethyl oleate, glycerol triacetate (a preferred highly purified version), diethylene glycol monoethyl ether, polyethylene glycol 200, polyethylene glycol 300, polyethylene glycol 400, polyethylene glycol 600, propan-2-ol, glycerol, triethyl citrate, and combinations thereof.

[00119] In some embodiments of the invention, one or more self-emulsifying systems also comprise one or more solvents. Petition 870260085113, dated 08 / 21 / 2026, page 26 / 314 22 / 116 hydrophilic materials comprising propylene glycol.

[00120] In some embodiments of the invention, one or more emulsifying systems also comprise one or more stabilizers.

[00121] In some embodiments of the invention, one or more self-emulsifying systems also comprise one or more stabilizers selected from the group consisting of lauroylpolyxyl-32 glycerides; stearoyl polyoxyl-32 glycerides; polyoxyl-32 stearate; synthetic copolymer of ethylene oxide (80) and propylene oxide (27); polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer; alpha-, beta- or gamma cyclodextrins and derivatives thereof; pea proteins (globulin proteins, albumins, glutelins); and mixtures and combinations thereof.

[00122] In some embodiments of the invention, the orally dissolvable or chewable compressed powder formulation also comprises one or more permeation enhancers.

[00123] In some embodiments of the invention, the orally dissolvable or chewable compressed powder formulation also comprises antioxidants.

[00124] In some embodiments of the invention, the orally dissolvable or chewable compressed powder formulation also comprises preservatives.

[00125] In some embodiments of the invention, one or more surfactants comprise one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) moiety. These may also be referred to as “non-PEG surfactants”.

[00126] In the present context, the “portion” is provided as the common understanding within organic chemistry, that is, the polyethylene glycol portion is part of a molecule and can be identified as such within the molecule. This can be like a surfactant tail, Petition 870260085113, dated 08 / 21 / 2026, page 27 / 314 23 / 116 being a surfactant side group, being part of a chain within the surfactant, etc. In the present context, the expression “one or more surfactants” comprises one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) moiety, specifically implying that a “PEG” moiety is not present in the molecule.

[00127] One of the advantages of including one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) moiety as part of self-emulsifying systems according to the invention is that in vivo absorption of cannabinoids was seen to be surprisingly increased, particularly over long timescales, such as more than 240 minutes after in vivo administration in rats. This was highly unexpected, since a low PEG content in the surfactant was theoretically expected to result in pronounced surfactant degradation, which was expected to result in low cellular absorption due to a lower surfactant content after degradation. In fact, degradation was observed to be increased as expected. Despite this, in vivo absorption was very high over long timescales as observed for high-level plasma concentrations of cannabinoids in rats at a relatively long time after absorption.

[00128] Specifically, it was observed that the in vivo absorption of cannabinoids including a surfactant without a polyethylene glycol (PEG) moiety as part of self-emulsifying systems was especially pronounced over long timescales, as plasma cannabinoid concentration remained at a very high level as a function of time compared to other surfactants, such as surfactants that include a PEG moiety, when applied in an in vivo test setting with rats. Furthermore, the plasma concentration was at the same level as in the reference, Epidi Petition 870260085113, dated 08 / 21 / 2026, page 28 / 314 24 / 116 olex®, in terms of cannabinoid absorption over long timescales.

[00129] However, not only was a surprising increase observed over long timescales. In addition, a high initial absorption was observed over short timescales, much greater than Epidiolex®.

[00130] Furthermore, overall cannabinoid uptake was found to be very high over time when including a surfactant without a polyethylene glycol (PEG) moiety as part of self-emulsifying systems. Compared to the reference, Epidiolex®, overall cannabinoid uptake, including uptake over both short and long timescales, was on average much higher. Moreover, compared to PEG-containing surfactants, including a surfactant without a polyethylene glycol (PEG) moiety (i.e., a “non-PEG surfactant”) as part of a self-emulsifying system, the overall uptake level was much higher, including uptake over both short and long timescales. This was highly surprising.

[00131] In some embodiments of the invention, one or more surfactants comprise one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) moiety, the one or more surfactants having a chemical structure that does not include a PEG moiety being present in an amount of 0.1 to 20% by weight of one or more liquid or solid self-emulsifying systems.

[00132] In some embodiments of the invention, one or more surfactants comprise one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) moiety, the one or more surfactants having a chemical structure that does not include a PEG moiety being present in an amount of 0.1 to 10% by weight of one or more liquid or solid self-emulsifying systems. Petition 870260085113, dated 08 / 21 / 2026, page 29 / 314 25 / 116

[00133] In some embodiments of the invention, one or more surfactants comprise one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) moiety, the one or more surfactants having a chemical structure that does not include a PEG moiety being present in an amount less than 10% by weight of one or more liquid or solid self-emulsifying systems.

[00134] In some embodiments of the invention, one or more surfactants comprise one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) moiety, the one or more surfactants having a chemical structure that does not include a PEG moiety being present in an amount less than 5% by weight of one or more liquid or solid self-emulsifying systems.

[00135] In some embodiments of the invention, one or more surfactants comprise one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) moiety, the one or more surfactants having a chemical structure that does not include a PEG moiety being present in an amount less than 2% by weight of one or more liquid or solid self-emulsifying systems.

[00136] In some embodiments of the invention, one or more surfactants comprise one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) moiety, the one or more surfactants having a chemical structure that does not include a PEG moiety being present in an amount less than 1% by weight of one or more liquid or solid self-emulsifying systems.

[00137] In some embodiments of the invention, one or more surfactants comprise one or more surfactants having a structure Petition 870260085113, dated 08 / 21 / 2026, p. 30 / 314 26 / 116 chemical that does not include a polyethylene glycol (PEG) portion being selected from the group consisting of monoglycerides, sugar- and lipid-based surfactants, and combinations thereof.

[00138] In some embodiments of the invention, one or more surfactants comprise one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) moiety, being selected from the group consisting of decaglycerol mono- and dioleate, hexaglycerol octastearate, polyglycerol esters of oleic acid, propylene glycol monocaprylate, propylene glycol monolaurate, triglycerol monooleate, polyglyceryl-4 oleyl ether olivate, polyglyceryl-4 laurate / sebacate, polyglyceryl-4 caprylate / caprate, and combinations thereof.

[00139] In some embodiments of the invention, one or more surfactants comprise one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) moiety, being selected from the group consisting of decaglycerol mono- and dioleate, hexaglycerol octastearate, polyglycerol esters of oleic acid, propylene glycol monocaprylate (Type I), propylene glycol monocaprylate (Type II), propylene glycol monolaurate (Type I), propylene glycol monolaurate triglyceride monooleate (Type II), polyglyceryl-4 oleyl ether olivate, polyglyceryl-4 laurate / sebacate, polyglyceryl-4 caprylate / caprate, and combinations thereof.

[00140] In some embodiments of the invention, one or more surfactants comprise one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) moiety, selected from the group consisting of sorbitan monolaurate, sorbitan monooleate, sorbitan monopalmitate, sorbitan monostearate, sorbitan trioleate, sucrose palmitate, sucrose stearate, and combinations thereof.

[00141] In some embodiments of the invention, one or more ten Petition 870260085113, dated 08 / 21 / 2026, page 31 / 314 27 / 116 surfactants comprise one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) moiety comprising polyglyceryl-4 laurate / sebacate and / or polyglyceryl-4 caprylate / caprate. In some embodiments, polyglyceryl-4 laurate / sebacate and / or polyglyceryl-4 caprylate / caprate may contain water.

[00142] In some embodiments of the invention, one or more surfactants comprise one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) portion comprising ascorbic acid palmitate.

[00143] In some embodiments of the invention, one or more surfactants comprise one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) portion comprising sodium lauryl sulfate.

[00144] In some embodiments of the invention, one or more surfactants comprise one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) moiety comprising soy phosphatidylcholine.

[00145] In some embodiments of the invention, one or more surfactants substantially do not comprise one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) moiety.

[00146] In some embodiments of the invention, one or more surfactants do not comprise one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) moiety.

[00147] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are selected from the group consisting of cannabidiol (CBD), cannabidiolic acid (CBDA), cannabidivarin (CBDV), and combinations thereof.

[00148] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are selected from the group Petition 870260085113, dated 08 / 21 / 2026, p. 32 / 314 28 / 116 which consists of tetrahydrocannabinol (THC), tetrahydrocannabinolic acid (THCA), tetrahydrocannabivarin (THCV), and combinations thereof. In some embodiments of the invention, one or more isolated or synthetic cannabinoids comprise cannabidiol (CBD).

[00149] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are selected from the group consisting of cannabidinol (CBD), cannabidiolic acid (CBDA), tetrahydrocannabinol (THC), tetrahydrocannabidolic acid (THCA), cannabigerol (CBG), cannabichromene (CBC), cannabinol (CBN), cannabielsoin (CBE), iso-tetrahydrocannabinol (iso-THC), cannabicyclol (CBL), cannabicitran (CBT), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), and combinations thereof.

[00150] In some embodiments of the invention, one or more isolated synthetic cannabinoids or synthetic cannabinoids is an isolated cannabinoid.

[00151] In some embodiments of the invention, one or more isolated or synthetic cannabinoids is a synthetic cannabinoid.

[00152] In some embodiments of the invention, one or more isolated or synthetic cannabinoids is not a cannabinoid distillate with a cannabinoid purity greater than 80%.

[00153] In some embodiments of the invention, the purity of isolated cannabinoids is greater than 95%. In some embodiments of the invention, the purity of isolated cannabinoids is greater than 98%. In some embodiments of the invention, the purity of isolated cannabinoids is greater than 99%.

[00154] In some embodiments of the invention, one or more isolated or synthetic cannabinoids is not a cannabinoid extract with a cannabinoid purity of less than 80%. Petition 870260085113, dated 08 / 21 / 2026, pp. 33 / 314 29 / 116

[00155] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in an amount of at least 10 mg in the orally dissolvable or chewable tablet powder formulation.

[00156] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in an amount of at least 20 mg in the orally dissolvable or chewable tablet powder formulation.

[00157] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in an amount of at least 30 mg in the orally dissolvable or chewable tablet powder formulation.

[00158] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in an amount of at least 40 mg in the orally dissolvable or chewable tablet powder formulation.

[00159] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in an amount of at least 60 mg in the orally dissolvable or chewable tablet powder formulation.

[00160] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in an amount of at least 75 mg in the orally dissolvable or chewable tablet powder formulation.

[00161] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in an amount of at least 100 mg in the orally dissolvable or chewable tablet powder formulation.

[00162] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in a Petition 870260085113, dated 08 / 21 / 2026, pp. 34 / 314 30 / 116 quantity of at least 150 mg in the powder formulation, orally dissolvable or chewable tablet.

[00163] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in an amount of at least 200 mg in the orally dissolvable or chewable tablet powder formulation.

[00164] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in an amount of at least 250 mg in the orally dissolvable or chewable tablet powder formulation.

[00165] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in an amount of at least 300 mg in the orally dissolvable or chewable tablet powder formulation.

[00166] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in an amount of at least 400 mg in the orally dissolvable or chewable tablet powder formulation.

[00167] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in an amount of at least 500 mg in the orally dissolvable or chewable tablet powder formulation.

[00168] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in an amount of at least 600 mg in the orally dissolvable or chewable tablet powder formulation.

[00169] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are present in an amount of at least 300 mg in the orally dissolvable or chewable tablet powder formulation. Petition 870260085113, dated 08 / 21 / 2026, p. 35 / 314 31 / 116

[00170] In some embodiments of the invention, one or more carrier systems comprise one or more solid carriers selected from the group consisting of silica, microcrystalline cellulose, cellulose, silicified microcrystalline cellulose, clay, talc, starch, pregelatinized starch, calcium carbonate, dicalcium phosphate, modified calcium carbonate, magnesium carbonate, magnesium aluminometasilicate, hyperporous silica, and mixtures thereof.

[00171] In some embodiments of the invention, one or more vehicle systems comprise one or more microcrystalline cellulose vehicles.

[00172] In some embodiments of the invention, one or more vehicle systems comprise one or more modified calcium carbonate vehicles.

[00173] In some embodiments of the invention, one or more vehicle systems comprise one or more silica vehicles.

[00174] In some embodiments of the invention, one or more vehicle systems comprise one or more mesoporous silica vehicles.

[00175] In some embodiments of the invention, one or more vehicle systems comprise one or more mesoporous silica vehicles comprising magnesium aluminometasilicate.

[00176] In some embodiments of the invention, one or more carrier systems comprise one or more mesoporous silica carriers comprising dicalcium phosphate.

[00177] In some embodiments of the invention, one or more vehicle systems comprise one or more solid vehicles having an average particle size of 20 to 200 microns.

[00178] In some embodiments of the invention, one or more vehicle systems comprise one or more solid vehicles having an average particle size of 30 to 150 microns. Petition 870260085113, dated 08 / 21 / 2026, page 36 / 314 32 / 116

[00179] In some embodiments of the invention, one or more carrier systems are present in an amount exceeding 10% by weight of the orally dissolvable or chewable powder tablet formulation.

[00180] In some embodiments of the invention, one or more carrier systems are present in an amount exceeding 20% ​​by weight of the orally dissolvable or chewable powder tablet formulation.

[00181] In some embodiments of the invention, one or more carrier systems are present in an amount of 30 to 1500 mg in the orally dissolvable or chewable tablet powder formulation.

[00182] In some embodiments of the invention, one or more vehicle systems comprise one or more solid vehicles having an average pore volume above 1.0 cm3 / g.

[00183] In some embodiments of the invention, one or more vehicle systems comprise one or more solid vehicles having an average pore volume above 1.5 cm3 / g.

[00184] In some embodiments of the invention, one or more vehicle systems comprise one or more solid vehicles having an average density above 50 g / L.

[00185] In some embodiments of the invention, one or more vehicle systems comprise one or more solid vehicles having an average density of 50 to 400 g / L.

[00186] In some embodiments of the invention, one or more vehicle systems comprise one or more solid vehicles having an average density of 150 to 400 g / L.

[00187] In some embodiments of the invention, one or more vehicle systems comprise one or more solid vehicles that are not characterized as a powder flow promoter.

[00188] In some embodiments of the invention, one or more systems Petition 870260085113, dated 08 / 21 / 2026, page 37 / 314 33 / 116 self-emulsifying liquid or solid ingredients are present in amounts of 30 to 800 mg in the orally dissolvable or chewable tablet powder formulation.

[00189] In some embodiments of the invention, one or more liquid or solid self-emulsifying systems are present in an amount of 30 to 300 mg in the orally dissolvable or chewable tablet powder formulation.

[00190] In some embodiments of the invention, one or more isolated or synthetic cannabinoids are fully contained within one or more liquid or solid self-emulsifying systems.

[00191] In some embodiments of the invention, the orally dissolvable or chewable compressed powder formulation comprises one or more cannabinoids separated from one or more liquid or solid self-emulsifying systems.

[00192] In some embodiments of the invention, one or more water-soluble agents are present in an amount of 30 to 80% by weight of the compressed powder formulation.

[00193] In some embodiments of the invention, one or more water-soluble agents are present in an amount of 40 to 80% by weight of the compressed powder formulation.

[00194] In some embodiments of the invention, one or more water-soluble agents comprise one or more sugar alcohol particles.

[00195] In some embodiments of the invention, one or more water-soluble agents comprise one or more sugar alcohol particles selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, isomalt, and combinations thereof.

[00196] In some embodiments of the invention, one or more water-soluble agents comprise one or more sugar alcohol particles comprising sugar alcohol particles not directly Petition 870260085113, dated 08 / 21 / 2026, pages 38 / 314 34 / 116 compressible (non-DC) and directly compressible (DC) sugar alcohol particles.

[00197] In some embodiments of the invention, one or more water-soluble agents comprise one or more sugar alcohol particles comprising non-directly compressible (non-DC) sugar alcohol particles and directly compressible (DC) sugar alcohol particles in a non-DC to DC ratio between 0.2 and 1.2.

[00198] In some embodiments of the invention, one or more water-soluble agents comprise one or more sugar alcohol particles comprising non-directly compressible (non-DC) sugar alcohol particles and directly compressible (DC) sugar alcohol particles in a non-DC to DC ratio between 0.3 and 0.7.

[00199] In some embodiments of the invention, the orally dissolvable or chewable compressed powder formulation is associated with an improved mouthfeel.

[00200] In some embodiments of the invention, the orally dissolvable or chewable compressed powder formulation is associated with an improved mouthfeel comprising a less gritty mouthfeel.

[00201] In some embodiments of the invention, the orally dissolvable or chewable powder tablet formulation is associated with an improved mouthfeel comprising a less strident sound when chewing the orally dissolvable or chewable powder tablet formulation.

[00202] In some embodiments of the invention, the orally dissolvable or chewable compressed powder formulation is associated with an improved mouthfeel due to one or more carrier systems compared with separately added carriers not comprising one or more liquid or solid self-emulsifying systems. Petition 870260085113, dated 08 / 21 / 2026, pp. 39 / 314 35 / 116

[00203] In some embodiments of the invention, the orally dissolvable or chewable compressed powder formulation is associated with an improved mouthfeel due to the presence of one or more water-soluble agents.

[00204] In some embodiments of the invention, the orally dissolvable or chewable compressed powder formulation also comprises one or more disintegrants.

[00205] In some embodiments of the invention, the orally dissolvable or chewable compressed powder formulation also comprises one or more disintegrants selected from the group consisting of croscarmellose sodium, crospovidone, sodium starch glycolate, and combinations thereof.

[00206] In some embodiments of the invention, the orally dissolvable or chewable compressed powder formulation also comprises at least one dissolution modifier selected from the group consisting of acacia, agar, alginic acid or a salt thereof, carbomer, carboxymethylcellulose, carrageenan, cellulose, chitosan, copovidone, cyclodextrins, ethylcellulose, gelatin, guar gum, hydroxyethyl cellulose, hydroxyethyl methylcellulose, hydroxypropyl cellulose, hypromellose, insulin, methylcellulose, pectin, polycarbophil or a salt thereof, polyvinyl alcohol, pullulan, starch, tragacanth, trehalose, xanthan gum and mixtures thereof.

[00207] In some embodiments of the invention, the orally dissolvable or chewable powder tablet formulation also comprises at least one dissolution modifier in an amount of 3 to 20% by weight of the orally dissolvable or chewable powder tablet formulation.

[00208] In some embodiments of the invention, the orally dissolvable or chewable compressed powder formulation also comprises one or more organic acids. Petition 870260085113, dated 08 / 21 / 2026, p. 40 / 314 36 / 116

[00209] In some embodiments of the invention, the powder formulation also comprises one or more organic fruit acids. The organic fruit acids according to the invention can support the fruit flavor. The organic fruit acids according to the invention can also support the sweet flavor.

[00210] In some embodiments of the invention, one or more flavorings are present in an amount of 0.1 to 10% by weight of the orally dissolvable or chewable powder tablet formulation.

[00211] In some embodiments of the invention, one or more self-emulsifying systems comprise one or more isolated or synthetic cannabinoids and one or more lipids in a cannabinoid to lipid weight ratio of 10:1 to 1:10.

[00212] In some embodiments of the invention, one or more self-emulsifying systems comprise one or more isolated or synthetic cannabinoids and one or more lipids in a cannabinoid to lipid weight ratio of 10:1 to 1:5.

[00213] In some embodiments of the invention, one or more self-emulsifying systems comprise one or more isolated or synthetic cannabinoids and one or more lipids in a cannabinoid to lipid weight ratio of 8:1 to 1:2.

[00214] In some embodiments of the invention, one or more self-emulsifying systems comprise one or more isolated or synthetic cannabinoids and one or more lipids in a cannabinoid to lipid weight ratio of 4:1 to 1:2.

[00215] In some embodiments of the invention, one or more self-emulsifying systems comprise one or more isolated or synthetic cannabinoids and one or more lipids in a cannabinoid to lipid weight ratio of 3:1 to 1:1.

[00216] In some embodiments of the invention, one or more systems Petition 870260085113, dated 08 / 21 / 2026, p. 41 / 314 37 / 116 self-emulsifying themes comprise one or more isolated or synthetic cannabinoids and one or more waxes in a cannabinoid to wax weight ratio of 10:1 to 1:10.

[00217] In some embodiments of the invention, one or more self-emulsifying systems comprise one or more isolated or synthetic cannabinoids and one or more waxes in a cannabinoid to wax weight ratio of 10:1 to 1:5.

[00218] In some embodiments of the invention, one or more self-emulsifying systems comprise one or more isolated or synthetic cannabinoids and one or more waxes in a cannabinoid to wax weight ratio of 8:1 to 1:2.

[00219] In some embodiments of the invention, one or more self-emulsifying systems comprise one or more isolated or synthetic cannabinoids and one or more waxes in a cannabinoid to wax weight ratio of 4:1 to 1:2.

[00220] In some embodiments of the invention, one or more self-emulsifying systems comprise one or more isolated or synthetic cannabinoids and one or more waxes in a cannabinoid to wax weight ratio of 3:1 to 1:1.

[00221] In some embodiments of the invention, one or more vehicle systems comprise one or more solid vehicles and one or more vehicle systems comprise one or more liquid or solid self-emulsifying systems in a solid vehicle to liquid weight ratio or solid self-emulsifying system of 2:8 to 8:2.

[00222] In some embodiments of the invention, one or more vehicle systems comprise one or more solid vehicles and one or more vehicle systems comprise one or more liquid or solid self-emulsifying systems in a solid vehicle to liquid weight ratio or solid self-emulsifying system of 4:6 to Petition 870260085113, dated 08 / 21 / 2026, page 42 / 314 38 / 116 6:4.

[00223] In some embodiments of the invention, one or more liquid or solid self-emulsifying systems loaded with cannabinoids in an amount of at least 10% by weight of the powder tablet formulation comprises at least two separate liquid or solid self-emulsifying systems.

[00224] In some embodiments of the invention, a first liquid or solid self-emulsifying system comprises one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety, and a second liquid or solid self-emulsifying system comprises one or more surfactants having a chemical structure that does not have a polyethylene glycol (PEG) moiety.

[00225] In some embodiments of the invention, one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety in the first liquid or solid self-emulsifying system is present in an amount of at least 20% by weight of the first liquid or solid self-emulsifying system.

[00226] In some embodiments of the invention, one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) moiety in the second liquid or solid self-emulsifying system is present in an amount of at least 5% by weight of the second liquid or solid self-emulsifying system.

[00227] In some embodiments of the invention, the first liquid or solid self-emulsifying system is located in a first compartment or module of the orally dissolvable or chewable powder tablet formulation, and a second compartment or module of the orally dissolvable or chewable powder tablet formulation comprises the second liquid or solid self-emulsifying system.

[00228] In some embodiments of the invention, the powder formulation Petition 870260085113, dated 08 / 21 / 2026, page 43 / 314 39 / 116 orally dissolvable or chewable tablet is an orally dissolvable tablet.

[00229] In some embodiments of the invention, the orally dissolvable or chewable powder tablet formulation is an orally dissolvable tablet that disintegrates in the oral cavity within 2 minutes of oral administration.

[00230] In some embodiments of the invention, the orally dissolvable or chewable compressed powder formulation is a chewable tablet.

[00231] In some embodiments of the invention, the orally dissolvable or chewable compressed powder formulation is a lozenge comprising particulate ingredients.

[00232] In some embodiments of the invention, the orally dissolvable or chewable compressed powder formulation comprises a gum base.

[00233] In some embodiments of the invention, the orally dissolvable or chewable compressed powder formulation is a chewable compressed gum tablet.

[00234] In some embodiments of the invention, the unit weight of the orally dissolvable or chewable powder tablet formulation is from 400 to 2000 mg.

[00235] In another aspect of the invention, an orally dissolvable or chewable powder formulation is provided comprising: one or more carrier systems comprising one or more liquid or solid self-emulsifying systems loaded with cannabinoids in an amount of at least 10% by weight of the powder formulation; or one or more self-emulsifying systems including: i) at least one or more surfactants, one or more lipids and one or more isolated or synthetic cannabinoids when the system Petition 870260085113, dated 08 / 21 / 2026, page 44 / 314 40 / 116 self-emulsifying is a liquid self-emulsifying system, and ii) at least one or more surfactants, one or more waxes and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a solid self-emulsifying system; one or more water-soluble agents in an amount of 20 to 80% by weight of the powder formulation; and one or more flavorings, wherein one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety.

[00236] In another aspect of the invention, an orally dissolvable or chewable powder formulation is provided comprising: one or more carrier systems comprising one or more liquid or solid self-emulsifying systems loaded with cannabinoids in an amount of at least 10% by weight of the powder formulation; or one or more self-emulsifying systems including: i) at least one or more surfactants, one or more lipids and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a liquid self-emulsifying system, and ii) at least one or more surfactants, one or more waxes and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a solid self-emulsifying system; one or more water-soluble agents in an amount of 20 to 80% by weight of the powder formulation; and one or more flavorings, wherein said one or more self-emulsifying systems are stable at a pH of about 1 to 4 and operable for release from the gastrointestinal tract of one or more cannabinoids upon release from one or more vehicle systems in the oral cavity. Petition 870260085113, dated 08 / 21 / 2026, page 45 / 314 41 / 116

[00237] In this aspect of the invention, the orally dissolvable or chewable powder formulation can also be defined, according to any of the previous embodiments.

[00238] In another aspect of the invention, a toothpick packet is provided comprising an orally dissolvable or chewable powder formulation comprising: one or more carrier systems comprising one or more liquid or solid self-emulsifying systems loaded with cannabinoids in an amount of at least 10% by weight of the powder formulation; or one or more self-emulsifying systems including: i) at least one or more surfactants, one or more lipids and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a liquid self-emulsifying system, and ii) at least one or more surfactants, one or more waxes and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a solid self-emulsifying system; one or more water-soluble agents in an amount of 20 to 80% by weight of the powder formulation; and one or more flavorings, wherein one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety.

[00239] In another aspect of the invention, a toothpick packet is provided comprising an orally dissolvable or chewable powder formulation comprising: one or more vehicle systems comprising one or more liquid or solid self-emulsifying systems loaded with cannabinoids in an amount of at least 10% by weight of the powder formulation; the one or more self-emulsifying systems including Petition 870260085113, dated 08 / 21 / 2026, page 46 / 314 42 / 116 of: i) at least one or more surfactants, one or more lipids and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a liquid self-emulsifying system, and ii) at least one or more surfactants, one or more waxes and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a solid self-emulsifying system; one or more water-soluble agents in an amount of 20 to 80% by weight of the powder formulation; and one or more flavorings, wherein said one or more self-emulsifying systems are stable at a pH of about 1 to 4 and operable for release from the gastrointestinal tract of one or more cannabinoids upon release from one or more vehicle systems in the oral cavity.

[00240] In this aspect of the invention, the unit weight of the orally dissolvable or chewable powder formulation is from 400 to 2000 mg.

[00241] Furthermore, in this aspect of the invention, the toothpick package can also be defined according to any of the previous embodiments.

[00242] In another aspect of the invention, a sachet is provided comprising an orally dissolvable or chewable powder formulation comprising: one or more carrier systems comprising one or more liquid or solid self-emulsifying systems loaded with cannabinoids in an amount of at least 10% by weight of the powder formulation; or one or more self-emulsifying systems including: i) at least one or more surfactants, one or more lipids and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a liquid self-emulsifying system, and Petition 870260085113, dated 08 / 21 / 2026, page 47 / 314 43 / 116 ii) at least one or more surfactants, one or more waxes and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a solid self-emulsifying system; one or more water-soluble agents in an amount of 20 to 80% by weight of the powder formulation; and one or more flavorings, wherein one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety.

[00243] In another aspect of the invention, a sachet is provided comprising an orally dissolvable or chewable powder formulation comprising: one or more carrier systems comprising one or more liquid or solid self-emulsifying systems loaded with cannabinoids in an amount of at least 10% by weight of the powder formulation; or one or more self-emulsifying systems including: i) at least one or more surfactants, one or more lipids and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a liquid self-emulsifying system, and ii) at least one or more surfactants, one or more waxes and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a solid self-emulsifying system; one or more water-soluble agents in an amount of 20 to 80% by weight of the powder formulation; and one or more flavorings, wherein said one or more self-emulsifying systems are stable at a pH of about 1 to 4 and operable for release from the gastrointestinal tract of one or more cannabinoids upon release from one or more vehicle systems in the oral cavity. Petition 870260085113, dated 08 / 21 / 2026, page 48 / 314 44 / 116

[00244] In this aspect of the invention, the unit weight of the orally dissolvable or chewable powder formulation is from 400 to 2000 mg.

[00245] Furthermore, in this aspect of the invention, the sachet can also be defined according to any of the previous embodiments.

[00246] In another aspect of the invention, a pouch is provided comprising an orally dissolvable or chewable powder formulation comprising: one or more carrier systems comprising one or more liquid or solid self-emulsifying systems loaded with cannabinoids in an amount of at least 10% by weight of the powder formulation; or one or more self-emulsifying systems including: i) at least one or more surfactants, one or more lipids and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a liquid self-emulsifying system, and ii) at least one or more surfactants, one or more waxes and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a solid self-emulsifying system; one or more water-soluble agents in an amount of 20 to 80% by weight of the powder formulation; and one or more flavorings, wherein one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety.

[00247] In another aspect of the invention, a pouch is provided comprising an orally dissolvable or chewable powder formulation comprising: one or more vehicle systems comprising one or more liquid or solid self-emulsifying systems loaded with Petition 870260085113, dated 08 / 21 / 2026, page 49 / 314 45 / 116 cannabinoids in an amount of at least 10% by weight of the powder formulation; or one or more self-emulsifying systems including: i) at least one or more surfactants, one or more lipids and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a liquid self-emulsifying system, and ii) at least one or more surfactants, one or more waxes and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a solid self-emulsifying system; one or more water-soluble agents in an amount of 20 to 80% by weight of the powder formulation; and one or more flavorings, wherein said one or more self-emulsifying systems are stable at a pH of about 1 to 4 and operable for release from the gastrointestinal tract of one or more cannabinoids upon release from one or more vehicle systems in the oral cavity.

[00248] In this aspect of the invention, the unit weight of the orally dissolvable or chewable powder formulation is from 400 to 2000 mg.

[00249] Furthermore, in this aspect of the invention, the bag can also be defined according to any of the previous embodiments.

[00250] In another aspect of the invention, a capsule formulation is provided comprising: one or more carrier systems comprising one or more liquid or solid self-emulsifying systems loaded with cannabinoids in an amount of at least 10% by weight of the formulation; or one or more self-emulsifying systems including: i) at least one or more surfactants, one or more lipids and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a liquid self-emulsifying system, and Petition 870260085113, dated 08 / 21 / 2026, page 50 / 314 46 / 116 ii) at least one or more surfactants, one or more waxes and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a solid self-emulsifying system; one or more water-soluble agents in an amount of 20 to 80% by weight of the formulation; and one or more flavorings, wherein one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety.

[00251] In another aspect of the invention, a capsule formulation is provided comprising: one or more carrier systems comprising one or more liquid or solid self-emulsifying systems loaded with cannabinoids in an amount of at least 10% by weight of the formulation; or one or more self-emulsifying systems including: i) at least one or more surfactants, one or more lipids and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a liquid self-emulsifying system, and ii) at least one or more surfactants, one or more waxes and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a solid self-emulsifying system; one or more water-soluble agents in an amount of 20 to 80% by weight of the formulation; and one or more flavorings, wherein said one or more self-emulsifying systems are stable at a pH of about 1 to 4 and operable for release from the gastrointestinal tract of one or more cannabinoids upon release from one or more vehicle systems in the oral cavity.

[00252] In some embodiments of the invention, the capsule comprises an orally dissolvable or chewable powder formulation. Petition 870260085113, dated 08 / 21 / 2026, page 51 / 314 47 / 116 DETAILED DESCRIPTION OF THE INVENTION

[00253] The verb "to understand" as used in this description and the accompanying claims and its conjugations are used in their non-limiting sense to mean that items following the expression are included, but items not specifically mentioned are not excluded. Furthermore, reference to an element by the indefinite article "a" or "an" does not exclude the possibility that more than one of the elements are present, unless the context clearly requires that there be one and only one of the elements. The indefinite article "a" or "an" thus generally means at least one. Additionally, the expressions "a" and "an" when used in this document in connection with the expression "to understand" or "to contain" indicate one or more. The expression "one or more" is intended to mean one, two, three, or more.

[00254] As used herein, the term approximately or about in reference to a number is generally considered to include numbers that fall within a range of 5%, 10%, 15%, or 20% toward (greater than or less than) the number, unless otherwise stated or otherwise evident from the context (except where such a number would be less than 0% or above 100% of a possible value).

[00255] As used herein, the term “%” and “percent” refers to percentage by weight, unless otherwise stated.

[00256] The term particle size refers to the ability of particles to move through or be retained by sieve holes of a specific size. As used herein, the term “particle size” refers to the average particle size as determined in accordance with the European Pharmacopoeia 9.1 when using the particle size distribution estimate 2.9.38 of the method. Petition 870260085113, dated 08 / 21 / 2026, page 52 / 314 48 / 116 analytical sieve test, unless otherwise specifically mentioned.

[00257] The term “particle” or similar expression is understood to indicate a discrete, unique composition of solid material, such as a granule or individual powdered elements, having a particle size that may deviate considerably.

[00258] In the present context, the term “release” refers to the released substance being released from the solid dosage form or the released vehicle system being released from the solid dosage form. In some embodiments, the release process of a substance corresponds to the substance being dissolved in saliva or mucosa. The term “release,” in the present context, is intended to mean tested under “in vivo” conditions, unless otherwise stated. In the present context, when the solid dosage form is chewed, “in vivo” conditions is intended to mean that a sample is chewed with a chewing frequency of 60 chews per minute for a certain period of time in a test panel of 8 test subjects, unless otherwise stated. These test subjects abstain from eating and drinking for at least 30 minutes before the start of any test.The test subjects are healthy individuals selected on an objective basis according to specified requirements.

[00259] The term “texture” refers to a qualitative measurement of the properties of the solid dosage form and the overall mouthfeel experienced by the user during use. Thus, the term “texture” encompasses measurable quantities such as hardness as well as more subjective parameters related to the sensation experienced by a user, such as a gritty feeling during or after chewing the product.

[00260] The term “sustained release” or “extended release” is Petition 870260085113, dated 08 / 21 / 2026, page 53 / 314 49 / 116 herein understood to mean prolonged release over time. The term “rapid release” or “quick release” or “high release” is herein understood to mean a higher concentration released over a given period of time. The term “controlled release” is intended to mean a release of a substance or the carrier system of a solid dosage form by the aid of active use of the dosage form in the individual’s oral cavity, whereby active use is the control of the amount of substance or carrier system released.

[00261] A “self-emulsifying agent” is an agent that will form an emulsion when presented with an alternating expression with a minimum energy requirement. In contrast, an emulsifying agent, as opposed to a self-emulsifying agent, is an additional energy requirement to form an emulsion.

[00262] Due to the poor solubility of certain active ingredients in physiological fluids, there is an unmet need to solubilize cannabinoids in the mixture with the body's physiological fluids to facilitate bioabsorption. To overcome low bioavailability, several lipid-based drug delivery systems and autoemulsifying systems have been developed. Lipid-based delivery systems and particularly autoemulsifying drug delivery systems (SEDDS) have been shown to increase the solubility, dissolution, and bioavailability of many insoluble active ingredients.

[00263] The particular challenges are considered to originate in the formulation of solid dosage forms with SEDDS. For example, challenges may arise in obtaining a homogeneous mixture, where variations are avoided and a safe and convenient release can be achieved. Furthermore, the overall formulation of solid dosage forms that provide convenience to the user does not Petition 870260085113, dated 08 / 21 / 2026, page 54 / 314 The 50 / 116 ratio needs to be compromised, which is often the case if precaution is not taken, such as in cases where a high load of active ingredients is required.

[00264] Particularly with respect to SEDDS, the formulation of the present invention can provide some clear benefits, both allowing a higher load of active ingredients and, at the same time, providing improved sensory properties of the formulation during use. Other advantages are also present.

[00265] Importantly, the presence of SEDDS or at least one self-emulsifying agent was observed to act synergistically with the formulation of the present invention. The presence of SEDDS or at least one self-emulsifying agent was also observed to increase the absorption of the active ingredients through mucosal surfaces, such as the gastrointestinal tract. In this respect, the gastrointestinal tract is not considered to include the oral cavity.

[00266] The administration routine, in the present context, is considered to be as follows. First, the vehicle system is at least partially or totally released into the oral cavity, whereby the saliva generated causes the vehicle system containing a substantial amount of cannabinoids to expand for release into the gastrointestinal tract. Without being linked by theory, it is believed that the relatively more responsive or faster release of the vehicle system containing the cannabinoid into the oral cavity and the relatively prolonged release of cannabinoids from the vehicle into the oral cavity contribute to the cannabinoids being released more accurately into the gastrointestinal tract. Consequently, the system of the present invention provides a surgical approach with respect to several advantages for the release of cannabinoids into the gastrointestinal tract.

[00267] Consequently, surgery between the presence of SEDDS or at least one autoemulsifying agent and cannabinoids was a Petition 870260085113, dated 08 / 21 / 2026, p. 55 / 314 51 / 116 surprise to the inventors. In particular, the potential for SEDDS to have a high load of active ingredients, as in the vehicle system according to the invention, also contributes to the synergy of the solid dosage form according to the invention.

[00268] In the present context, SEDDS is a solid or liquid dosage form comprising at least one surfactant and optionally a co-surfactant, characterized primarily by the fact that said dosage form can spontaneously form an oil-in-water emulsion in the oral cavity or at room temperature (generally referring to body temperature, i.e., 37°C). When SEDDS enters the gastrointestinal tract, it is initially self-emulsifying as emulsion droplets and rapidly disperses. The resulting microparticulate matter at the micrometer or nanometer level can penetrate the mucous membrane of the gastrointestinal tract, and the absorbable oil droplets enter the bloodstream, thereby significantly improving the bioavailability of the active ingredient.

[00269] The term “non-DC sugar alcohol particles” refers to non-directly compressible (non-DC) sugar alcohol particles. Note that the terms “non-DC sugar alcohol particles” and “non-DC particles” are used interchangeably. In the present context, non-DC sugar alcohol particles refer to particles that have not been processed by granulation with, for example, other sugar alcohols or binders for the purpose of obtaining so-called direct compressible (DC) particles. In the present context, non-DC sugar alcohol particles include particles obtained by crystallization followed by milling that does not involve other sugar alcohols or binders. Thus, non-DC sugar alcohol particles are considered to be particles consisting of non-DC sugar alcohol.

[00270] The term “DC sugar alcohol particles” refers to Petition 870260085113, dated 08 / 21 / 2026, page 56 / 314 52 / 116 Direct compressible sugar alcohol (DC) particles. Note that the terms “DC sugar alcohol particles” and “DC particles” are used interchangeably. DC sugar alcohol particles can be obtained, for example, as sugar alcohol particles having DC grade by nature, for example, sorbitol, or by granulation of non-DC sugar alcohol with, for example, other sugar alcohols or binders for the purpose of obtaining so-called direct compressible (DC) particles. Furthermore, granulation of non-DC sugar alcohol with water as a binder is considered to result in “DC sugar alcohol particles” in the present context.

[00271] The term “tableted” or “pressed” is intended to mean that the tablet composition is pressed in a tablet apparatus and primarily being composed of particulate material. Although the terms imply a step in the method, in the present context, the terms are intended for the tablet resulting from tablet formation from a portion of particles. It is noted that a tablet composition or tableted composition that is mentioned as comprising particles should eventually be understood as particles that have been pressed together in a tablet-forming step.

[00272] The following description explains how the tablet of the invention can be produced and provides further details about what can be added to the composition of the invention.

[00273] Typically, the tablet manufacturing process of the invention can be carried out in a single tablet press, such as a rotary tablet press. However, it may be beneficial, under some circumstances, to use a separate tablet press. Petition 870260085113, dated 08 / 21 / 2026, p. 57 / 314 53 / 116

[00274] Preferably, the upper punch is convex, which provides the upper face of the pressed tablet with a concave shape.

[00275] It should clearly be noted that the shape of the punctures may vary depending on the desired tablet shape.

[00276] In some embodiments of the invention, the pressing of the tablets is carried out with a force of 20 to 50 kN.

[00277] In one embodiment of the invention, the “tablet” is a “rapid disintegrating tablet” (“RDT”), such as an “orally disintegrated tablet” (“ODT”). In some embodiments, if such a tablet is made as one module, as opposed to two or more modules, then the tablet is intended to be an RDT tablet. If, on the other hand, the tablet is made larger than one module, such as two modules, such an additional module may be a “diamond” module, which provides a longer disintegration time compared to an RDT module. The composition of an “RDT” module and a “diamond” module contributes to another embodiment of the invention. A “diamond” module may also comprise elements of the “RDT” modules, but is generally different in composition, providing an extended disintegration time.

[00278] The term “diamond” is intended to encompass a “diamond-shaped composition” that has been “compressed” into a “diamond module.” In the present context, a “diamond module” or similar expression is intended to mean that the module, during use in the oral cavity, is intended to be sucked or licked. The term “diamond” is given the common meaning in the art of diamonds. The intention is that the diamond module cannot be chewed. The intention is also that the FDT module cannot be chewable. Generally, the “diamond module” of the present invention can disintegrate when sucked or licked in minutes, as opposed to seconds, for disinfectant tablets. Petition 870260085113, dated 08 / 21 / 2026, p. 58 / 314 54 / 116 oral administration (ODT) or fast-disintegrating tablets (FDT). Consequently, the intention is that the “diamond module” will release one or more cannabinoids over a longer period of time than the FDT module, if the tablet is made as a combination of the two molecules.

[00279] The term “module” is generally intended to be composed of a composition of matter with substantially identical characteristics throughout the module. Consequently, if two modules are present, then the two modules are different in composition and generally have two different characteristics along each module. In the present context, if two modules are present, then the tablet is composed of two molecules fused together. The term “fused” is intended to mean that the tablet is joined together by means of compression force. The tablet may be composed of more than two molecules. A module may, in certain embodiments, be a gum-based module. In the present context, the invention provides an attractive biphasic masking release, even if the cannabinoid release is “single phase”.

[00280] In the context of the present invention, a “chewable tablet” is intended to mean an oral tablet that is chewed upon oral administration, having a characteristic that allows convenient chewing without adverse side effects associated with the texture of the oral tablet.

[00281] In particular, less attention is given to the benefits of chewable tablet formulations that help achieve a cannabinoid release characteristic that provides increased convenience and effectiveness. One such release characteristic is increased saliva generation upon chewing. Increased saliva generation, and particularly an experience of increased saliva generation upon administration, may have some pronounced benefits. Petition 870260085113, dated 08 / 21 / 2026, page 59 / 314 55 / 116 for the release of cannabinoids on mucosal surfaces.

[00282] One advantage of a chewable tablet with a non-DC sugar alcohol particle content is a surprisingly strong saliva generation compared to conventional chewable tablets and lozenges. In particular, the non-DC particles can surprisingly induce a remarkable saliva generation. The increased saliva generation can have a surprisingly high impact on the delivery of cannabinoid mucosal delivery systems in the gastrointestinal tract. Specifically, the increased saliva generation can allow for increased delivery of the oral formulation from the vehicle systems, whereby the vehicle systems can be more rapidly and easily dilated. More specifically, this allows the vehicle systems to access the gastrointestinal tract with a higher load of cannabinoids and thus provides greater absorption of one or more cannabinoids to mucosal surfaces in the gastrointestinal tract.Consequently, a synergy between the absorption of cannabinoids in the gastrointestinal tract and the increased generation of saliva can be seen according to the invention.

[00283] Having a combination of non-DC particles and DC particles can also facilitate sufficient mechanical strength combined with tablet stability, tablet disintegrability on chewing, and saliva generation induced by chewing.

[00284] An unexpected advantage over the previous technique is that saliva generation is surprisingly sustained after a user has swallowed most of the non-DC sugar alcohols. This sustained saliva generation can be advantageous in relation to many applications of an oral tablet varying in mouthfeel, taste, flavor perception, etc. Petition 870260085113, dated 08 / 21 / 2026, page 60 / 314 56 / 116

[00285] In the present context, non-DC sugar alcohol particles are understood and defined by the person skilled in the art with reference to their typical commercial grade.

[00286] In one embodiment of the invention, the non-DC sugar alcohol particles are not granulated prior to tablet production. Thus, the non-DC sugar alcohol particles are supplied as ungranulated particles. These are typically available in a non-DC form of the relevant sugar alcohol as particles that have been pre-processed by granulation with other sugar alcohols or binders for the purpose of obtaining so-called direct compressible (DC) particles based on sugar alcohol particles that are, by themselves, not suitable for direct compression. Such non-DC sugar alcohol particles may typically consist of sugar alcohol. Consequently, the non-DC sugar alcohol particles may typically be particles consisting of sugar alcohol, which is not directly compressible in its pure form.

[00287] The weight ratio between non-DC sugar alcohol particles and DC sugar alcohol particles has proven to be significant according to an embodiment of the invention in that a relatively high quantity of non-DC sugar alcohol particles must be present to obtain the mouthfeel and taste obtained through the invention. However, this taste and mouthfeel also reside in the DC sugar alcohol particles. An example of such a DC sugar alcohol particle is DC grade xylitol, which, together with the non-DC sugar alcohol particles, can provide a mouthfeel that is unique and very attractive to forehead panels.

[00288] The weight ratio between non-DC sugar alcohol particles and DC sugar alcohol particles is important for the Petition 870260085113, dated 08 / 21 / 2026, page 61 / 314 57 / 116 purpose of obtaining an advantageous taste and mouthfeel. By having an upper limit of this weight ratio, chewing will also bring a desirable crunchy sensation experience when chewing the tablet, the crunchiness being obtained through the use of substantial amounts of DC sugar alcohol particles and non-DC sugar alcohol particles.

[00289] In one embodiment of the invention, the non-DC sugar alcohol particles are selected from non-DC particles of erythritol, maltitol, xylitol, isomalt, lactitol, mannitol, and combinations thereof. An advantage of the above embodiment may be that a desirable induced saliva generation is obtained. According to one embodiment of the invention, the non-DC sugar alcohol particles consist of sugar alcohols selected from erythritol, maltitol, xylitol, isomalt, lactitol, mannitol, and combinations thereof.

[00290] In one embodiment of the invention, the non-DC sugar alcohol particles are selected from non-DC particles of erythritol, maltitol, xylitol, isomalt, and combinations thereof. An advantage of the above embodiment may be that a desirable induced saliva generation is obtained.

[00291] In one embodiment of the invention, the non-DC sugar alcohol particles are selected from non-DC particles of erythritol, maltitol, xylitol, and combinations thereof. In another embodiment of the invention, the non-DC sugar alcohol particles are non-DC erythritol particles. An advantage of the above embodiment may be that a desirable saliva-induced generation is obtained, along with a cooling sensation. In another embodiment of the invention, the non-DC sugar alcohol particles are non-DC xylitol particles. An advantage of the above embodiment may be that a desirable saliva-induced generation is obtained, along with a cooling sensation. Petition 870260085113, dated 08 / 21 / 2026, page 62 / 314 58 / 116

[00292] In one embodiment of the invention, said DC sugar alcohol particles comprise sugar alcohols selected from DC particles of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, isomalt, and combinations thereof.

[00293] Sorbitol is an example of a sugar alcohol, which is considered DC grade when supplied as particles consisting of sorbitol, i.e., in its pure form. On the other hand, several other sugar alcohols are considered non-DC grade if supplied as particles consisting of the specific sugar alcohol. Consequently, such non-DC sugar alcohols are conventionally processed into DC grade sugar alcohols, for example, by granulating them with, for example, a binder.

[00294] Examples of commercial grades of DC sugar alcohols include sorbitol particles supplied as, for example, Neosorb® P 300 SD from Roquette, mannitol particles supplied as, for example, Pearlitol® 300DC or Pearlitol 200 SD from Roquette, maltitol supplied as, for example, SweetPearl® P 300 DC, xylitol supplied as, for example, Xylisorb® XTAB 400 DC or Xylitab 200 from Dupont.

[00295] In one embodiment of the invention, the oral tablet comprises at least two molecules. The module can typically be assembled from several compressed particles and has a weight that is greater than 0.1 grams and less than 10 grams. In one embodiment of the invention, a module is defined as several particles being pressed together to form a particle assembly module.

[00296] In one embodiment of the invention, the oral tablet comprises several oral tablet modules. In the present context, the application of, for example, two molecules is particularly advantageous when non-DC sugar alcohol particles are primarily present in one module, thereby optimizing salivation. Petition 870260085113, dated 08 / 21 / 2026, page 63 / 314 59 / 116 desired salivation and sensory experience of the module and the tablet as such, while another module may primarily comprise DC sugar alcohol particles that serve as a support ensuring that the desired stability and friability of the complete tablet is achieved.

[00297] The term “cannabinoid composition” is intended to mean a volume of material comprising one or more cannabinoids. The cannabinoid composition may contain components other than cannabinoids. The cannabinoid composition may consist of cannabinoids. The cannabinoid composition may consist of one type of cannabinoid. The cannabinoid composition may consist of two types of cannabinoids. The cannabinoid composition may consist of two or more types of cannabinoids.

[00298] The terms “water-insoluble gum base” or “gum base” or “gum base matrix” or similar expression refers primarily to water-insoluble ingredients and hydrophobic gum-based ingredients. The “gum base” may contain gum-based polymers, natural resins, elastomeric plasticizers, greases, emulsifiers, fats and / or fillers.

[00299] The term “natural resin”, as used herein, means resin compounds being polyterpenes derived from terpenes of natural origin or resin compounds derived from gum resin, wood resin or high oil resin.

[00300] Elastomers provide the rubbery, elastomeric, and elastic nature to the gum, which varies depending on the chemical structure of the ingredient and how it may be combined with other ingredients. Elastomers suitable for use in the gum base and gum of the present invention may include both natural and synthetic types. Polyvinyl acetate elastomeric plasticizers are not considered according to the invention. Petition 870260085113, dated 08 / 21 / 2026, page 64 / 314 60 / 116

[00301] Elastomers may be selected from the group consisting of styrene-butadiene copolymers, polyisobutylene copolymers, isobutylene-isoprene copolymers, polyethylene, polyurethane or any combination thereof. Preferred elastomers are styrene-butylene copolymers (SBR), polyisobutylene and isobutyleneisoprene copolymers (BR).

[00302] Styrene-butadiene elastomers, or SBRs as they may be called, are typically copolymers of approximately 20:80 to 60:40 styrene:butadiene monomers. The ratio of these monomers affects the elasticity of the SBR as assessed by Mooney viscosity. As the styrene:butadiene ratio decreases, the Mooney viscosity decreases.

[00303] The SBR structure typically consists of linear chain 1,3-butadiene copolymerized with phenylethylene (styrene). The average molecular weight of SBR is <600,000 g / mol.

[00304] Isobutylene-isoprene type elastomers, or butyl as they may be called, have molar percentage levels of isoprene ranging from 0.2 to 4.0. Similar to SBR, as the isoprene:isobutylene ratio decreases, so does the elasticity, as measured by Mooney viscosity.

[00305] The structure of butyl rubber typically consists of branched 2-methyl-1,3-butadiene (isoprene) copolymerized with branched 2-methylpropene (isobutylene). The average molecular weight of BR is in the range of 150,000 g / mol to 1,000,000 g / mol.

[00306] Polyisobutyrene, or PIB as it may be called, is a type of elastomer that is a polymer of 2-methylpropene. Low molecular weight elastomers provide soft chewing characteristics to gum-based materials while still providing elastic qualities like other elastomers. Average molecular weights can range from about 30,000 to 120,000 g / mol and penetration can range from about 4 mi Petition 870260085113, dated 08 / 21 / 2026, p. 65 / 314 61 / 116 liters to 20 millimeters. The greater the penetration, the softer the PIB. Similar to SBR and butyl, high molecular weight elastomers provide elasticity to the gum. The average molecular weight ranges from 120,000 to 1,000,000 g / mol.

[00307] Polybutene varies in average molecular weight from about 5,000 g / mol to about 30,000 g / mol.

[00308] Useful natural elastomers include natural rubber such as smoked or liquid latex or guayule, natural gums such as jelutong, lechi caspi, perillo, sorva, massaranduba balata, massaranduba chocolate, nispero, rosidinha, chicle, gutta percha, gutta kataiu, niger gutta, tunu, chilte, chiquibul, gutta hang kang. Natural elastomers can also be applied in aspects of the invention.

[00309] Elastomeric plasticizers vary the firmness of the gum base. Their specificity regarding the breaking of the elastomer's intermolecular chain (plasticization) along with their various softening points causes varying degrees of firmness in the finished gum and compatibility when used in the base. Polyvinyl acetate elastomer plasticizers are examples of elastomeric plasticizers of the present invention.

[00310] Natural resins can be selected from ester gums which include, as examples, glycerol esters of partially hydrogenated resins, glycerol esters of polymerized resins, glycerol esters of partially dimerized resins, glycerol esters of high-oil resins, pentaerythritol esters of partially hydrogenated resins, methyl esters of resins, partially hydrogenated methyl esters of resins, pentaerythritol ethers of resins, synthetic resins such as terpene resins derived from alpha-pinene, beta-pinene, and / or d-limonene, and natural terpene resins.

[00311] In one embodiment of the invention, the dosage form only Petition 870260085113, dated 08 / 21 / 2026, p. 66 / 314 62 / 116 includes other selected ingredients from the group consisting of flavorings, dry binders, tablet production aids, anti-masking agents, emulsifiers, antioxidants, enhancers, mucoadhesives, absorption enhancers, high-intensity sweetness, softeners, colors, active ingredients, water-soluble indigestible polysaccharides, water-insoluble polysaccharides, or any combination thereof.

[00312] The solid dosage form according to the invention is manufactured by applying pressure to a particle content by suitable compression means. The particles or powder are then pressed into a coherent, compact tablet. The particles may, for example, comprise so-called primary particles or aggregated primary particles. When these are pressed, bonds are established between the particles or granules, thereby imparting a certain mechanical strength to the pressed tablet.

[00313] It should be noted that the terms introduced above: powder, primary particles and aggregated primary particles may be somewhat misleading in that the difference between primary particles and aggregated primary particles may often be viewed differently depending on the user's background. Some may, for example, be considered a sweetener, such as sorbitol, as a primary particle, despite the fact that sorbitol, due to the processing typically performed on sorbitol when released to the customer, should instead be considered as some type of aggregated primary particles. The definition adopted in this invention is that aggregated primary particles refer to macroparticles comprising more or less preprocessed primary particles.

[00314] When pressure is applied to particles, the mass volume is reduced, and the amount of air is decreased. During this Petition 870260085113, dated 08 / 21 / 2026, p. 67 / 314 63 / 116 process energy is consumed. As particles approach each other during the volume reduction process, both can be stabilized between the particles or granules. The formation of bonds is associated with a reduction in the system's energy as system energy is released. Volume reduction occurs through different mechanisms, and different types of bonds can be established between particles or granules depending on the applied pressure and the properties of the particles or granules. The first thing that happens is that when a powder is pressed, the particles are rearranged under relatively low pressures to form a closer packing structure. Particles with a regular shape seem to undergo rearrangement more easily than those with an irregular shape.As pressure increases, further rearrangement is prevented, and subsequent volume reduction is achieved by plastic and elastic deformation and / or fragmentation of the tablet particles. Brittle particles are likely to undergo fragmentation, i.e., breaking of the original particles into smaller units. Plastic deformation is an irreversible process that results in a permanent change in particle shape, while particles resume their original shape after elastic deformation. Evidently, both plastic and elastic deformation can occur when compressing a solid dosage form.

[00315] Several studies of the types of binding in pressed tablets have been carried out over the years, typically in the context of pharmaceutical materials, and various techniques for obtaining pressed tablets from available powders have been provided. Such studies have been largely focused on what happens when volume reduction is performed and how the final product can be optimized for a given purpose. Several refinements with respect to pressed tablets have been made, for example, by adding, for instance, Petition 870260085113, dated 08 / 21 / 2026, page 68 / 314 64 / 116 plo, binders in raw tablet materials for the purpose of obtaining sufficient strength in the final pressed tablet while maintaining acceptable properties, for example, with respect to release.

[00316] Unlike compressed chewing gum, conventional chewing gum can be manufactured by sequentially adding the chewing gum ingredients to a commercially available mixture known in the art where the finished gum base is already present. After the initial ingredients have been thoroughly mixed, the gum mass is discharged from the mixer and shaped into the desired form such as by rolling into sheets and cutting into sticks, extruding into pieces or molding into pellets. Generally, the ingredients of conventional chewing gum can be mixed by melting the gum base and adding it to the running mixer. Colors, active agents and / or emulsifiers can also be added at this time. A softener such as glycerin can also be added here, along with syrup and a portion of the bulking / sweetening agent. Other portions of the bulking / sweetening agent can then be added to the mixer.A flavoring agent is typically added with the final portion of the bulking / sweetening agent. A high-intensity sweetener is preferably added after the final portion of bulking and flavoring agent has been added. The mixing procedure typically takes thirty to forty minutes, although longer mixing times may sometimes be required. Those skilled in the art will recognize that many variations of the procedure described above can be followed.

[00317] In some embodiments of the invention, the solid dosage form does not include conventional chewing gum, that is, so-called extruded chewing gum.

[00318] According to the invention, the solid dosage form Petition 870260085113, dated 08 / 21 / 2026, p. 69 / 314 65 / 116 compressed according to the invention may comprise from about 0.1 to about 75% by weight of an outer coating over the center of the solid dosage form. Thus, suitable coating types include hard coatings, film coatings, and soft coatings of any composition, including those currently used in coating compressed solid dosage forms.

[00319] A currently preferred type of external coating is a hard coating, the term being used in the conventional sense that the term includes sugar coatings and sugar-free coatings and combinations thereof. The aim of the hard coating is to obtain a sweet and crisp layer, which is appreciated by the consumer and can protect the solid dosage form centers for various reasons. In a typical production process of solid dosage form centers with a protective sugar coating, the solid dosage form centers are successively treated in suitable coating equipment with aqueous solutions of crystallizable sugars such as sucrose or dextrose, which, depending on the achievable coating stage, may contain other functional ingredients, for example, fillers, binding agents, colorants, etc.In the present context, the sugar coating may contain functional or active compounds, including flavor compounds and / or active compounds.

[00320] In a typical hard coating process as will be described and detailed below, a sugar and / or crystallizable polyol containing a suspension containing sugar and / or crystallizable polyol is applied to the centers in solid form and the water contained therein is evaporated by water blowing. This cycle must be repeated several times, typically 3 to 80 times, to achieve the required swelling. The term “swelling” refers to the increase in weight or thickness of the Petition 870260085113, dated 08 / 21 / 2026, p. 70 / 314 66 / 116 products, as considered at the end of the coating operation by comparison with the beginning, and in relation to the final weight or thickness of the coated products. According to the present invention, the coating layer constitutes about 0.1 to about 75% by weight of the solid dosage form element, such as about 10 to about 60% by weight, including about 15 to about 50% by weight.

[00321] In one embodiment of the invention, the product is a bag.

[00322] In one aspect of the invention, the particle population used for tablet formation may also be present in a bag as a powder. Consequently, this aspect of the invention includes the particle population in a bag without tablet formation, but as a powder or part of a powder with other words or powdered ingredients. It follows that the directly compressible (DC) and non-directly compressible (non-DC) sugar alcohol particles of the invention may be included in the bag according to the invention. Additional embodiments pertaining to the particle population of the invention may also be applicable when included in a bag. It is noted that additional ingredients may be present in the bag, such as water-soluble fibers or water-insoluble fibers, including microcrystalline cellulose.

[00323] According to an advantageous embodiment of the invention, the bag comprises a water-permeable membrane, such as a woven or non-woven fabric.

[00324] The sachets according to the invention comprise openings, wherein the characteristic opening dimension is adapted to a characteristic dimension of the particle population in order to retain the matrix composition within the bag before use and / or to retain a portion of the contents within the bag during use.

[00325] In other words, according to the various modalities, Petition 870260085113, dated 08 / 21 / 2026, page 71 / 314 67 / 116 The pouch forms a membrane that allows the passage of saliva and prevents or inhibits the passage of at least part of the contents. The pouch membrane can be made of any suitable material, for example, woven or non-woven (e.g., cotton, wool, etc.), heat-sealable non-woven cellulose, or other polymeric materials such as a synthetic, semi-synthetic, or natural polymeric material. An example of a suitable pouch material is paper made from pulp and a small amount of moisture-resistant agent. A suitable material for use should provide a semi-permeable membrane layer to prevent dust or the contents from carrying into the bag or pouch during use. Suitable materials are also those that do not have a significant impact on the release of the active ingredients from the pouch.

[00326] The powder is loaded into sachets and is held in the bag and is kept in the bag by a seal. An ideal bag is chemically and physically stable, is pharmaceutically acceptable, is insoluble in water, is easy to load with powder and seal, and provides a semi-permeable membrane layer that prevents the powder from escaping the bag, but allows saliva and the dissolved or sufficiently small suspended components of the powder in the bag to pass through said bag.

[00327] The pouch can be placed in the oral cavity by the user. Saliva then enters the pouch, and the active ingredient and other components, which are soluble in saliva, begin to dissolve and are transported with the saliva from the pouch to the oral cavity. In some embodiments of the invention, the pouch can be chewed in a manner similar to chewing gum. This is particularly advantageous when the particle population comprises a gum base. Consequently, the pouch can be chewed into a coherent residue containing water-insoluble components.

[00328] According to embodiments of the invention, aromati Petition 870260085113, dated 08 / 21 / 2026, p. 72 / 314 68 / 116 aromas can be selected from the group consisting of coconut, coffee, chocolate, vanilla, grapefruit, orange, lemon, methanol, licorice, caramel aroma, honey aroma, peanut, walnut, cashew, hazelnut, almond, pineapple, strawberry, raspberry, tropical fruits, cherries, cinnamon, peppermint, wintergreen, spearmint, eucalyptus, spearmint, fruit essences such as apple, pear, peach, strawberry, apricot, raspberry, cherry, pineapple and plum essence. Essential oils include peppermint, spearmint, menthol, eucalyptus, clove oil, bay leaf oil, anise, thyme, cedar leaf oil, nutmeg, and the fruit oils mentioned above.

[00329] Suitable antioxidants for use include butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), beta-carotene, tocopherols, acidulants such as Vitamin C (ascorbic acid or corresponding salts (ascorbates)), propyl gallate, catechins, green tea extract, other synthetic and natural types or mixtures thereof.

[00330] High-intensity sweetening agents may also be used according to preferred embodiments of the invention. Preferred high-intensity sweeteners include, but are not limited to, sucralose, aspartame, acesulfame salts, alitame, neotame, saccharin and its salts, cyclamic acid and its salts, glycyrrhizin, dihydrochalcones, thaumatin, mannylene, monk fruit extract, advantame, stevioside and the like, alone or in combination.

[00331] To provide longer-lasting sweetness and flavor perception, it may be desirable to encapsulate or otherwise control the release of at least a portion of the high-intensity sweeteners.

[00332] Techniques such as wet granulation, grease granulation, spray drying, spray cooling, fluidized bed coating, preservation, yeast cell encapsulation, and fiber extrusion can be used to obtain desired release characteristics. Encapsulations of Petition 870260085113, dated 08 / 21 / 2026, page 73 / 314 69 / 116 sweetening agents can also be supplied using another formulation component such as a resin compound.

[00333] The level of use of high-intensity sweetener will vary considerably and will depend on factors such as sweetener potency, release rate, desired product sweetener, level and type of flavor used, and cost considerations. Thus, the active level of artificial sweetener may vary from about 0.001 to about 8% by weight (preferably from about 0.02 to about 8% by weight). When vehicles used for encapsulation are included, the level of use of the encapsulated high-intensity sweetener will be proportionally higher.

[00334] The invention, if desired, may include one or more fillers / texturizers which include, as examples, magnesium and calcium carbonate, sodium sulfate, ground limestone, silicate compounds such as magnesium and aluminum silicate, kaolin and clay, aluminum oxide, silicon dioxide, talc, titanium oxide, mono-, di- and tricalcium phosphates, cellulose polymers such as wood, and combinations thereof. According to one embodiment of the invention, a preferred filler texturizer is calcium carbonate.

[00335] According to the invention, one or more cannabinoids can be selected from several cannabinoids.

[00336] Cannabinoids are a group of compounds that include endocannabinoids, phytocannabinoids, and those that are either endocannabinoids or phytocannabinoids, hereinafter referred to as phytocannabinoids.

[00337] Endocannabinoids are endogenous cannabinoids, which may have high-affinity ligands for CB1 and CB2 receptors.

[00338] Phytocannabinoids are cannabinoids that originate in nature and can be found in the cannabis plant. Phytocannabinoids may be present in an extract that includes a botanical drug substance, isolated, or reproduced synthetically. Petition 870260085113, dated 08 / 21 / 2026, p. 74 / 314 70 / 116

[00339] Syntocannabinoids are compounds capable of interfering with cannabinoid receptors (CB1 and / or CB2), but are not found endogenously or in the cannabis plant. Examples include WIN 55212 and rimonabant.

[00340] An isolated phytocannabinoid or “isolated cannabinoid” is one that has been extracted from the cannabis plant and purified to such an extent that additional components, such as secondary and minor cannabinoids and the non-cannabinoid fraction, have been substantially removed.

[00341] A synthetic cannabinoid is one produced by chemical synthesis. This term includes modification of an isolated phytocannabinoid, for example, forming a pharmaceutically acceptable salt thereof.

[00342] A substantially pure cannabinoid is defined as a cannabinoid that is present with more than 95% (volume / volume) purity. More preferably greater than 96% (volume / volume) through 97% (volume / volume) complete to 98% (volume / volume) to 99% (volume / volume) and greater.

[00343] In some applications, a purity above 80% (volume / volume) may be applied.

[00344] A highly purified cannabinoid is defined as a cannabinoid that has been extracted from the cannabis plant and purified to the extent that other cannabinoids and non-cannabinoid components that are co-extracted with the cannabinoids have been substantially removed, such that the highly purified cannabinoid is greater than or equal to 95% (volume / volume) pure.

[00345] “Plant material” is defined as a plant or part of a plant (e.g., bark, wood, leaves, stems, roots, flowers, fruits, seeds, berries, or parts thereof) as well as exudates, and includes material that falls within the definition of “botanical raw material” in the Guidance for Industry Botanical Drug Products Draft Gui Petition 870260085113, dated 08 / 21 / 2026, p. 75 / 314 71 / 116 dance, August 2000, U.S. Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research.

[00346] In the context of this application, the terms cannabis extract or cannabinoid extract, which are used interchangeably, encompass Botanical Drug Substances derived from cannabis plant material. A Botanical Drug Substance is defined in the Guidance for Industry Botanical Drug Products Draft Guidance, August 2000, U.S. Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research as: a drug substance derived from one or more macroscopic plants, algae, or fungi. It is prepared from botanical raw materials by one or more of the following processes: pulverization, decoction, expression, aqueous extraction, ethanolic extraction, or other similar processes. A botanical drug substance does not include a highly or chemically modified substance derived from natural sources. Thus, in the case of cannabis, botanical drug substances derived from the cannabis plant do not include highly purified, Pharmacopoeia-grade cannabinoids.

[00347] The term “cannabis plant(s)” encompasses Cannabis sativa type and also variants thereof, including cannabis chemovars that naturally contain different amounts of the individual cannabinoids, Cannabis sativa indica subspecies including the variants var. indica and var. kafiristanica, Cannabis indica, Cannabis ruderalis, and also plants that are the result of genetic crossing, self-crossing or hybrids thereof. The term “Cannabis plant material” should consequently be interpreted as encompassing plant material derived from one or more cannabis plants. For the avoidance of doubt, it is hereby established that “cannabis plant material” includes dried cannabis biomass. Petition 870260085113, dated 08 / 21 / 2026, p. 76 / 314 72 / 116

[00348] Preferably, one or more cannabinoids are selected from: cannabichromene (CBC), cannabichromenic acid (CBCV), cannabidinol (CBD), cannabidiolic acid (CBDA), cannabidivarin (CBDV), cannabigerol (CBG), propyl variant of cannabigerol (CBGV), cannabicyclol (CBL), cannabinol (CBN), propyl variant of cannabinol (CBNV), cannabitriol (CBO), tetrahydrocannabinol (THC), tetrahydrocannabidolic acid (THCA), tetrahydrocannabivarin (THCV), and tetrahydrocannabivarinic acid (THCV A). More preferably, one or more cannabinoids is CBD or THC. This list is not exhaustive and merely details the cannabinoids that are identified in this application by reference.

[00349] To date, more than 120 different phytocannabinoids have been identified, which are within the scope of the present invention.

[00350] Cannabinoids can be divided into different groups as follows: Phytocannabinoids; Endocannabinoids; and synthetic cannabinoids.

[00351] Cannabinoid receptors can be activated by three main groups of agonist ligands, for the purposes of the present invention, whether or not referred to as such herein, lipophilic in nature and classified respectively as: endocannabinoids (produced endogenously by mammalian cells); phytocannabinoids (such as cannabidiol, produced by the cannabis plant); and synthetic cannabinoids (such as HU-210).

[00352] Phytocannabinoids can be found as the neutral carboxylic acid form or the decarboxylated form depending on the method used to extract the cannabinoids. For example, heating the carboxylic acid form is known to cause most of the carboxylic acid to be decarboxylated.

[00353] Phytocannabinoids can also occur as the pentyl (5 carbon atoms) or propyl (3 carbon atoms) variant. Petition 870260085113, dated 08 / 21 / 2026, p. 77 / 314 73 / 116 For example, the phytocannabinoid THC is known to be a CB1 receptor agonist, while the propyl variant THCV has been found to be a CB1 receptor antagonist, meaning it has almost opposite effects.

[00354] According to the invention, examples of phytocannabinoids may be cannabichromene (CBC), cannabichromenic acid (CBCV), cannabidinol (CBD), cannabidiolic acid (CBDA), cannabidivarin (CBDV), cannabigerol (CBG), propyl variant of cannabigerol (CBGV), cannabicyclol (CBL), cannabinol (CBN), propyl variant of cannabinol (CBNV), cannabitriol (CBO), tetrahydrocannabinol (THC), tetrahydrocannabidolic acid (THCA), tetrahydrocannabivarin (THCV), and tetrahydrocannabivarinic acid (THCV A). More preferably, one or more cannabinoids is CBD or THC.

[00355] The formulation according to the present invention may also comprise at least one cannabinoid selected from those described in A. Douglas Kinghorn et al., Phytocannabinoids, Vol. 103, Chapter 1, pages 1 to 30.

[00356] Examples of endocannabinoids are molecules that activate cannabinoid receptors within the body. Examples include 2-arachidonoylglycerol (2AG), 2-arachidonoylglyceryl ether (2AGE), arachidonoyl dopamine, and arachidonoylethanolamide (anandamide). Structurally related endogenous molecules have been identified that share similar structural aspects but exhibit weak or no activity for cannabinoid receptors, yet are also termed endocannabinoids. Examples of these endocannabinoid lipids include 2-acylglycerols, alkyl or alkenyl glyceryl ethers, acyl dopamines, and N-acylethanolamides containing alternative fatty acid or alcohol moieties, as well as other fatty acid amides containing different head groups. These include N-acylserines as well as many or Petition 870260085113, dated 08 / 21 / 2026, p. 78 / 314 74 / 116 N-acylated amino acids. Examples of cannabinoid receptor agonists are neuromodulators and affect short-term memory, appetite, stress response, anxiety, immune function, and analgesia.

[00357] In one embodiment, the cannabinoid is palmitoylethanolamide (PEA), which is an endogenous fatty acid amide belonging to the class of nuclear factor agonists.

[00358] Synthetic cannabinoids encompass a variety of distinct chemical classes: cannabinoids structurally related to THC, cannabinoids unrelated to THC, such as (cannabimimetics) including aminoalkylindoles, 1,5-diarylpyrazoles, quinolines, and arylsulfonamides, and eicosanoids related to endocannabinoids. Any or all of these cannabinoids may be used in the present invention.

[00359] It is preferred that the formulation comprise one or two primary cannabinoids, which are preferably selected from the group consisting of cannabidinol (CBD) or cannabidivarin (CBDV), tetrahydrocannabinol (THC), tetrahydrocannabivarin (THCV), tetrahydrocannabinolic acid (THCA), cannabigerol (CBG) and cannabidiolic acid (CBDA) or a combination thereof. It is preferred that the formulation comprise cannabidinol and / or tetrahydrocannabinol.

[00360] Preferably, the solid dosage form of the present invention can be used for the treatment or relief of pain, epilepsy, cancer, nausea, inflammation, congenital disorders, neurological disorders, oral infections, dental pain, apnea, psychiatric disorders, gastrointestinal disorders, inflammatory bowel disease, loss of appetite, diabetes and fibromyalgia.

[00361] In another aspect of the present invention, the oral cannabinoid formulation is suitable for use in the treatment of conditions requiring the administration of a neuroprotective or anti-inflammatory medication. Petition 870260085113, dated 08 / 21 / 2026, page 79 / 314 75 / 116 anticonvulsant.

[00362] Oral cannabinoid formulations may be used in the treatment of seizures.

[00363] Oral cannabinoid formulations may be used in the treatment of Dravet syndrome, Lennox-Gastaut syndrome, myoclonic seizures, juvenile myoclonic epilepsy, refractory epilepsy, schizophrenia, juvenile spasms, West syndrome, infantile spasms, infantile refractory spasms, tuberous sclerosis complex, brain tumors, neuropathic pain, cannabis use disorder, post-traumatic stress disorder, anxiety, early psychosis, Alzheimer's disease, and autism.

[00364] The following non-limiting examples illustrate different variations of the present invention. The examples are intended to indicate the inventive concept; consequently, the examples mentioned should not be understood as exhaustive for the present invention. In particular, CBD is used as an exemplary compound, but it could also be another cannabinoid. EXAMPLES Example 1 Premix: Hydrogenated Vegetable Oil (HVO) added to a blend of CBD carriers and isolated mesoporous extracts.

[00365] A mesoporous silica carrier (Syloid XDP 3050) supplied by Grace in an amount of approximately 1000 g was added to a Lodige high-shear mixer. Following this, a cannabinoid powder composition comprising CBD isolate from cannabis plant tissues (phytocannabinoid) with a CBD content of 99% supplied by Medicinal Hemp (lot number MH B18592) in an amount of approximately 500 g was sieved through a 600 micron sieve and added to the silica carrier composition. This mixture was mixed in the mixer at a speed of approximately 80 rpm. Petition 870260085113, dated 08 / 21 / 2026, page 80 / 314 76 / 116 for approximately 5 minutes. After activating the helicopter (approximately 600 rpm) of the Lodige mixer, the HVO supplied by AAK under the trade name Akocrem NT 76-33, with a melting point of 30-35 degrees Celsius, was melted at a temperature of approximately 55 degrees Celsius and added to the mixture in a quantity of approximately 500 g. After adding the lipid composition, the temperature in the mixer was approximately 49 degrees Celsius, and the mixture was also mixed for approximately 10 minutes. After 10 minutes, the temperature of the final mixture was approximately 51 degrees Celsius. A total of 2 kg of powdered premix was made, with a CBD content of approximately 250 mg / g.

[00366] For all examples, [%] indicates “% by weight”, also referred to as “% by weight”, unless specifically stated otherwise. Premix Number 100 101 102 103 104 105 106 Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Content [%] Content [%] Syloid XDP 3050 20.0 30.0 40.0 50.0 60.0 70.0 80.0 CBD Isolate (99% purity) 40.0 35.0 30.0 25.0 20.0 15.0 10.0 HVO 40.0 35.0 30.0 25.0 20.0 15.0 10.0 Total 100 100 100 100 100 100 100 Table 1: Hydrogenated Vegetable Oil (HVO) preheated to a temperature of approximately 55 degrees Celsius. Variation in CBD isolate content (99% purity). Sample 103 corresponds to the above procedure; the other samples are adjusted for variations in content. Premix Number 110 111 112 113 114 Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Syloid XDP 3050 50.0 50.0 50.0 50.0 50.0 CBD Isolate (99% purity) 45.0 40.0 20.0 10.0 5.0 HVO 5.0 10.0 30.0 40.0 45.0 Total 100 100 100 100 100 Petition 870260085113, dated 08 / 21 / 2026, page 81 / 314 77 / 116 Table 2: Hydrogenated Vegetable Oil (HVO) preheated to a temperature of approximately 55 degrees Celsius. Variation in HVO content. Samples are prepared according to the above procedure, but adjusted for variations in content. Premix Number 120 121 122 123 124 Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Syloid XDP 3150 (by Grace) 50.0 Aeroperl 300 (by Evonik) 50.0 Prosolv 730 (by JRS Pharma) 50.0 Omyanutra (by Omya) 50.0 VivaPur 105 (by JRS Pharma) 50.0 CBD Isolate (99% purity) 25.0 25.0 25.0 25.0 25.0 HVO 25.0 25.0 25.0 25.0 25.0 Total 100 100 100 100 100 Table 3: Hydrogenated Vegetable Oil (HVO) preheated to a temperature of approximately 55 degrees Celsius. Variation in vehicle type. Here, Syloid XDP 3050 was replaced by other vehicles. Samples are prepared according to the above procedure, but adjusted for variations in content. Example 2 Premix: Migliol added to a mixture of isolated CBD and mesoporous vehicles.

[00367] A mesoporous silica carrier (Syloid XDP 3050) supplied by Grace in an amount of approximately 1000 g was added to a Lõdige high-shear mixer. Following this, a cannabinoid powder composition comprising CBD isolate from cannabis plant tissues (phytocannabinoid) with a CBD content of 99% supplied by Medicinal Hemp (lot number MH B18592) in an amount of approximately 500 g was sieved through a 600-micron sieve and added to the silica carrier composition. This mixture was placed in the mixer at a speed of Petition 870260085113, dated 08 / 21 / 2026, page 82 / 314 78 / 116 approximately 80 rpm for about 5 minutes. After activating the Lodige mixer's helicopter (approximately 600 rpm), Single Chain Triglyceride (MCT), Migliol 812, supplied by Sasol, was added to the mixture over a period of about 3 minutes in an amount of approximately 500 g. After adding Migliol 812, the mixture was heated and mixed for about 10 minutes. After 10 minutes, the temperature of the final mixture was approximately 51 degrees Celsius. A total of 2 kg of powdered premix was made, with a CBD content of approximately 250 mg / g. Premix Number 200 201 202 203 204 205 206 Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Content [%] Content [%] Syloid XDP 3050 20.0 30.0 40.0 50.0 60.0 70.0 80.0 CDB Isolate (99% purity) 40.0 35.0 30.0 25.0 20.0 15.0 10.0 Migliol 812 40.0 35.0 30.0 25.0 20.0 15.0 10.0 Total 100 100 100 100 100 100 100 Table 4: Migliol 812 not preheated. Variation in CBD isolate content (99% purity). Sample 203 corresponds to the above procedure; the other samples are adjusted for variations in content. Premix Number 210 211 212 213 214 Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Syloid XDP 3050 50.0 50.0 50.0 50.0 50.0 CDB Isolate (99% purity) 45.0 40.0 20.0 10.0 5.0 Migliol 812 5.0 10.0 30.0 40.0 45.0 Total 100 100 100 100 100 Table 5: Migliol 812 not preheated. Variation in Migliol 812 content. Samples are prepared according to the procedure above, but adjusted for variations in content. Petition 870260085113, dated 08 / 21 / 2026, page 83 / 314 79 / 116 Premix Number 220 221 222 223 224 Raw material name Content [%] Content [%] Content [%] Content [%] Content [%] Syloid 25.0 25.0 25.0 Migliol 812 25.0 Migliol 810 25.0 Migliol 818 25.0 Migliol 829 25.0 Migliol 840 25.0 Total 100 100 100 100 100 Table 6: Migliol not having been preheated, unless specifically noted. Variation in the type of Migliol. Sample 222 corresponds to the above procedure. Migliol 829 in Premix Number 223 in Powder is heated to approximately 50°C to work. Premix Number 230 231 232 233 234 235 Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Content [%] Syloid XDP 3150 (from Grace) 50.0 Aeroperl 300 (from Evonik) 50.0 Prosolv 730 (by JRS Pharma) 50.0 Omyanutra (by Omya) 50.0 VivaPur 105 (by JRS Pharma) 50.0 Neusilin® US2 50.0 CBD Isolate (99% purity) 25.0 25.0 25.0 25.0 25.0 25.0 Migliol 812 25.0 25.0 25.0 25.0 25.0 25.0 Total 100 100 100 100 100 100 Table 7: Migliol 812 not preheated. Variation in vehicle type. Here, Xyloid XDP 3050 was replaced by other vehicles. Samples are prepared according to the above procedure, but adjusted for variations in levels. Petition 870260085113, dated 08 / 21 / 2026, page 84 / 314 80 / 116 Example 3 Premix: High load - Hydrogenated Vegetable Oil (HVO) added to a mixture of isolated CBD and mesoporous carriers.

[00368] A mesoporous silica carrier (Syloid XDP 3050) supplied by Grace in an amount of approximately 1000 g was added to a Lodige high-shear mixer and heated to a temperature of approximately 55 degrees Celsius. Following this, a cannabinoid powder composition comprising CBD isolate from cannabis plant tissues (phytocannabinoid) with a CBD content of 99% supplied by Medicinal Hemp (lot number MH B18592) in an amount of approximately 750 g was sieved through a 600 micron sieve and added to the silica carrier composition. This mixture was placed in the mixer at a speed of approximately 80 rpm for approximately 5 minutes.After activating the helicopter (approximately 600 rpm) of the Lodige mixer, HVO supplied by AAK under the trade name Akocrem NT 76-33 with a melting point of 30 to 35 degrees Celsius was melted at a temperature of approximately 55 degrees Celsius and added to the mixture in a quantity of approximately 250 g. After adding the lipid composition, the temperature in the mixer was approximately 49 degrees Celsius, and the mixture was also mixed for approximately 10 minutes. After 10 minutes, the temperature of the final mixture was approximately 51 degrees Celsius. A total of 2 kg of powdered premix was made, with a CBD content of approximately 375 mg / g. Premix Number 300 301 302 303 304 Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Syloid XDP 3050 62.5 57.5 50.0 37.5 27.5 CBD Isolate (99% purity) 25.0 30.0 37.5 50.0 60.0 HVO 12.5 12.5 12.5 12.5 12.5 Total 100 100 100 100 100 Petition 870260085113, dated 08 / 21 / 2026, page 85 / 314 81 / 116 Table 8: Hydrogenated Vegetable Oil (HVO) preheated to a temperature of approximately 55 degrees Celsius. Variation in CBD Isolate content (99% purity). Sample 302 corresponds to the above procedure; the other samples are adjusted for variations in content. Premix Number 310 311 312 313 314 Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Xyloid XDP 3050 58.5 56.5 52.5 42.5 32.5 CBD Isolate (99% purity) 37.5 37.5 37.5 37.5 37.5 HVO 4.0 6.0 10.0 20.0 30.0 Total 100 100 100 100 100 Table 9: Hydrogenated Vegetable Oil (HVO) preheated to a temperature of approximately 55 degrees Celsius. Variation in HVO content. Samples are prepared according to the above procedure, but adjusted for variations in content. Premix Number 320 321 322 323 324 325 Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Content [%] Syloid XDP 3150 (from Grace) 50.0 Aeroperl 300 (from Evonik) 50.0 Prosolv 730 (by J RS Pharma) 50.0 Omyanutra (by Omya) 50.0 VivaPur 105 (by J RS Pharma) 50.0 Neusilin® US2 50.0 CBD Isolate (99% purity) 37.5 37.5 37.5 37.5 37.5 37.5 HVO 12.5 12.5 12.5 12.5 12.5 12.5 Total 100 100 100 100 100 100 Table 10: Hydrogenated Vegetable Oil (HVO) having been preheated to a temperature of approximately 55 degrees Celsius. Variation in vehicle type. Here, Syloid XDP 3050 has been replaced by other vehicles. Petition 870260085113, dated 08 / 21 / 2026, page 86 / 314 82 / 116 The samples are prepared according to the procedure above, but adjusted for variations in content. Example 4 Premix: Mixture of Hydrogenated Vegetable Oil (HVO) with isolated CBD added to porous vehicles.

[00369] A mesoporous silica carrier (Syloid XDP 3050) supplied by Grace in an amount of approximately 1000 g was added to a Lodige high-shear mixer. Following this, a cannabinoid powder composition comprising CBD isolate from cannabis plant tissues (phytocannabinoid) with a CBD content of 99% supplied by Medicinal Hemp (lot number MH B18592) in an amount of approximately 500 g was mixed with HVO supplied by AAK under the trade name Akocrem NT 76-33 with a melting point of 30 to 35 degrees Celsius in an amount of approximately 500 g. While stirring, the CBD-HVO mixture was heated to a temperature of approximately 60 degrees Celsius to form a liquid solution of CBD in HVO. The CBD and HVO mixture was then added to the silica carrier. After adding the lipid composition, the mixture was stirred for approximately 10 minutes. A total of 2000 g of powdered premix was made. Premix Number 400 401 402 403 404 405 406 Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Content [%] Content [%] Syloid XDP 3050 20.0 30.0 40.0 50.0 60.0 70.0 80.0 CBD Isolate (50% CBD Mix) 80.0 70.0 60.0 50.0 40.0 30.0 20.0 Total 100.0 100 100 100 100 100 100.0 Table 11: Hydrogenated Vegetable Oil (HVO) heated to a temperature of approximately 60 degrees Celsius after mixing with 99% pure CBD (50% CBD mixture). Sample 403 corresponds to Petition 870260085113, dated 08 / 21 / 2026, page 87 / 314 83 / 116 In accordance with the above procedure, the other samples are adjusted for variations in levels. Premix Number 410 411 412 413 414 Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Syloid XDP 3050 50.0 50.0 50.0 50.0 50.0 CBD Isolate (X% CBD Mixture) 50.0 (10%)* 50.0 (30%)* 50.0 (50%)* 50.0 (80%)* 50.0 (90%)* Total 100 100 100 100 100 Table 12: Hydrogenated Vegetable Oil (HVO) heated to a temperature of approximately 60 degrees Celsius after mixing with 99% pure CBD (X% CBD mixture). Variation in CBD content in mixture with HVO. *indicates the percentage X of CBD in “X% CBD mixture”. Sample 412 corresponds to the above procedure; the other samples are adjusted for variations in content. Premix Number 420 421 422 423 424 425 Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Content [%] Syloid XDP 3150 (by Grace) 50.0 Aeroperl 300 (by Evonik) 50.0 Prosolv 730 (from JRS Pharma) 50.0 Omyanutra (by Omya) 50.0 VivaPur 105 (by JRS Pharma) 50.0 Neusilin® US2 50.0 CBD Isolate (50% CBD blend) 50.0 50.0 50.0 50.0 50.0 50.0 Total 100 100 100 100 100 100 Table 13: Hydrogenated Vegetable Oil (HVO) heated to a temperature of approximately 60 degrees Celsius after mixing with 99% CBD (75% CBD mixture). Variation in carrier type. Here, Syloid XDP 3050 was substituted for other carriers. Samples are prepared according to the above procedure, but adjusted to Petition 870260085113, dated 08 / 21 / 2026, page 88 / 314 84 / 116 variation in levels. Example 5 Premix: Mixture of Migliol with isolated CBD added to porous vehicles.

[00370] A mesoporous silica carrier (Syloid XDP 3050) supplied by Grace in an amount of approximately 1000 g was added to a Lodige high shear mixer. Following this, a cannabinoid powder composition comprising CBD isolate from cannabis plant tissues (phytocannabinoid) with a CBD content of 99% supplied by Medicinal Hemp (lot number MH B18592) in an amount of approximately 500 g was mixed with Single Chain Triglyceride (MCT), Migliol 812, supplied by Sasol in an amount of approximately 500 g. While stirring, the CBDMCT mixture was heated to a temperature of approximately 70 degrees Celsius to form a liquid solution of CBD in MCT. The CBD and Migliol 812 mixture was then added to the silica carrier powder composition in an amount of approximately 1000 g. After the addition of the lipid composition, the mixture was mixed for about 10 minutes. A total of 2000 g of powder premix of the mixture was made. Premix Number 500 501 502 503 504 505 506 Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Content [%] Content [%] Syloid XDP 3050 20.0 30.0 40.0 50.0 60.0 70.0 80.0 CBD Isolate (50% CBD Mix) 80.0 70.0 60.0 50.0 40.0 30.0 20.0 Total 100 100 100 100 100 100 100 Table 14: Migliol 812 mixed with 99% pure CBD followed by heating (50% CBD mixture). Variation in CBD content (50% CBD mixture). Sample 503 corresponds to the above procedure; the other samples are adjusted for variations in content. Petition 870260085113, dated 08 / 21 / 2026, page 89 / 314 85 / 116 Premix Number 510 511 512 513 514 Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Syloid XDP 3050 50.0 50.0 50.0 50.0 50.0 CBD Isolate (X% CBD Mixture) 50.0 (10%)* 50.0 (30%)* 50.0 (50%)* 50.0 (80%)* 50.0 (90%)* Total 100 100 100 100 100 Table 15: Migliol 812 mixed with 99% CBD followed by heating (X% CBD mixture). Variation in CBD content in mixture with Migliol 812. Indicates the percentage X of CBD in “X% CBD mixture”. Sample 512 corresponds to the above procedure; the other samples are adjusted for variations in content. Premix Number 520 521 522 523 524 525 Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Content [%] Syloid XDP 3150 (by Grace) 50.0 Aeroperl 300 (by Evonik) 50.0 Prosolv 730 (from JRS Pharma) 50.0 Omyanutra (by Omya) 50.0 VivaPur 105 (by JRS Pharma) 50.0 Neusilin® US2 50.0 CBD Isolate (50% CBD blend) 50.0 50.0 50.0 50.0 50.0 50.0 Total 100 100 100 100 100 100 Table 16: Migliol 812 mixed with 99% CBD followed by heating (50% CBD mixture). Variation in vehicle type. Here, Syloid XDP 3050 was replaced by other vehicles. Samples are prepared according to the above procedure, but adjusted for variations in levels. Petition 870260085113, dated 08 / 21 / 2026, page 90 / 314 86 / 116 Example 6 Premix: Comparative samples - without non-volatile solvent

[00371] A mesoporous silica carrier (Syloid XDP 3050) supplied by Grace was added to a Lodige high-shear mixer. Following this, a cannabinoid powder composition comprising CBD isolate from cannabis plant tissues (phytocannabinoid) with a purity of approximately 99% CBD supplied by Medicinal Hemp (lot number MH18592) or Valens (lot number BVA032013) was sieved through a 600-micron sieve and added to the silica powder carrier composition. This mixture was mixed at a speed of approximately 80 rpm for about 10 minutes. No solvent was present. Premix Number 600 601 602 603 604 Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Syloid XDP 3050 65.0 70.0 75.0 80.0 85.0 CDB Isolate (MH18592) 35.0 30.0 25.0 20.0 15.0 Total 100 100 100 100 100 Table 17: Variation in the content of CBD isolate. Example 7 Premixing: Liquid self-emulsifying systems with isolated CBD and mesoporous carriers.

[00372] A mesoporous silica carrier (Syloid XDP 3050) supplied by Grace in an amount of approximately 1000 g was added to a Lodige high shear mixer. Following this, a cannabinoid powder composition comprising CBD isolate from cannabis plant tissues (phytocannabinoid) with a CBD content of 99% supplied by Medicinal Hemp (lot number MH B18592) in an amount of approximately 500 g was sieved through a 600 micron sieve. The CBD was added to approximately 500 g of a composition comprising lipid and surfactant (Composition of Petition 870260085113, dated 08 / 21 / 2026, page 91 / 314 87 / 116 (SEDDS). After activating the helicopter (approximately 600 rpm) of the Lõdige mixer, the SEDDS composition containing CBD was added to the mixture. A total of 2 kg of powdered premix was made, with a CBD content of approximately 250 mg / g. A co-solvent and / or permeation enhancer would optionally be added. In addition, one or more hydrophilic solvents would optionally be added. Premix Number 700 701 702 703 704 705 706 Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Content [%] Content [%] Syloid XDP 3050 20.0 30.0 40.0 50.0 60.0 70.0 80.0 CDB Isolate (99% purity) 40.0 35.0 30.0 25.0 20.0 15.0 10.0 SEDDS Composition 40.0 35.0 30.0 25.0 20.0 15.0 10.0 Total 100 100 100 100 100 100 100 Table 18: Variation in CBD Isolate content (99% purity). Sample 703 corresponds to the procedure above; the other samples are adjusted for variations in content. Premix Number 710 711 712 713 714 Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Syloid XDP 3050 50.0 50.0 50.0 50.0 50.0 CDB Isolate (99% purity) 45.0 40.0 20.0 10.0 5.0 SEDDS Composition 5.0 10.0 30.0 40.0 45.0 Total 100 100 100 100 100 Table 19: Variation in SEDDS content. Samples are adjusted for variations in content. Premix Number 720 721 722 723 724 725 Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Content [%] Syloid XDP 3150 (by Grace) 50.0 Aeroperl 300 (by Evonik) 50.0 Prosolv 730 (by JRS Pharma) 50.0 Petition 870260085113, dated 08 / 21 / 2026, page 92 / 314 88 / 116 Premix Number 720 721 722 723 724 725 Omyanutra (by Omya) 50.0 VivaPur 105 (by JRS Pharma) 50.0 Neusilin® US2 50.0 CBD Isolate (99% purity) 25.0 25.0 25.0 25.0 25.0 25.0 SEDDS Composition 25.0 25.0 25.0 25.0 25.0 25.0 Total 100 100 100 100 100 100 Table 20: Variation in vehicle type. Here, Syloid XDP 3050 was replaced by other vehicles. Samples are prepared according to the procedure above, but adjusted for variations in levels. Example 8 Premixing: Solid self-emulsifying systems with isolated CBD and mesoporous carriers.

[00373] A mesoporous silica carrier (Syloid XDP 3050) supplied by Grace in an amount of approximately 1000 g was added to a Lõdige high-shear mixer. Following this, a cannabinoid powder composition comprising CBD isolate from cannabis plant tissues (phytocannabinoid) with a CBD content of 99% supplied by Medicinal Hemp (lot number MH B18592) in an amount of approximately 500 g was sieved through a 600 micron sieve. The CBD was added to approximately 500 g of a composition comprising wax and surfactant (SEDDS Composition). After activating the helicopter (approximately 600 rpm) of the Lõdige mixer, the SEDDS composition containing the CBD was added to the mixture. A total of 2 kg of powder premix was made, the CBD content of which was approximately 250 mg / g. A co-solvent and / or permeation enhancer would optionally be added. Premix Number 800 801 802 803 804 805 806 Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Content [%] Content [%] Syloid XDP 3050 20.0 30.0 40.0 50.0 60.0 70.0 80.0 Petition 870260085113, dated 08 / 21 / 2026, page 93 / 314 89 / 116 Premix Number 800 801 802 803 804 805 806 CBD Isolate (99% purity) 40.0 35.0 30.0 25.0 20.0 15.0 10.0 SEDDS Composition 40.0 35.0 30.0 25.0 20.0 15.0 10.0 Total 100 100 100 100 100 100 100 Table 21: Variation in CBD Isolate content (99% purity). Sample 80 corresponds to the procedure above; the other samples are adjusted for variations in content. Premix Number 810 811 812 813 814 Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Syloid XDP 3050 50.0 50.0 50.0 50.0 50.0 CDB Isolate (99% purity) 45.0 40.0 20.0 10.0 5.0 SEDDS Composition 5.0 10.0 30.0 40.0 45.0 Total 100 100 100 100 100 Table 22: Variation in SEDDS content. Samples are adjusted for variations in content. Premix Number 820 821 822 823 824 825 Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Content [%] Syloid XDP 3150 (by Grace) 50.0 Aeroperl 300 (by Evonik) 50.0 Prosolv 730 (from JRS Pharma) 50.0 Omyanutra (by Omya) 50.0 VivaPur 105 (by JRS Pharma) 50.0 Neusilin® US2 50.0 CBD Isolate (99% purity) 25.0 25.0 25.0 25.0 25.0 25.0 SEDDS Composition 25.0 25.0 25.0 25.0 25.0 25.0 Total 100 100 100 100 100 100 Table 23: Variation in vehicle type. Here, Syloid XDP 3050 was replaced by other vehicles. Samples are prepared according to the procedure above, but adjusted for variations in levels. Petition 870260085113, dated 08 / 21 / 2026, page 94 / 314 90 / 116 Example 9 Premix: Solid self-emulsifying systems with isolated CBD.

[00374] A cannabinoid powder composition comprising CBD isolate from cannabis plant tissues (phytocannabinoid) with a CBD content of 99% supplied by Medicinal Hemp (batch number MH B18592) in an amount of approximately 400 g was sieved through a 600 micron sieve. The CBD was added to approximately 400 g of a composition comprising wax and surfactant (SEDDS Composition). A total of 800 g of mixture was made, the CBD content of which was approximately 500 mg / g. A co-solvent and / or permeation enhancer would optionally be added. Premix Number 900 901 902 903 904 905 906 Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Content [%] Content [%] CDB Isolate (99% purity) 20.0 30.0 40.0 50.0 60.0 70.0 80.0 SEDDS Composition 80.0 70.0 60.0 50.0 40.0 30.0 20.0 Total 100 100 100 100 100 100 100 Table 24: Variation in CBD Isolate content (99% purity). Sample 903 corresponds to the procedure above; the other samples are adjusted for variations in content. Example 10 Premix: Solid self-emulsifying systems with isolated CBD and permeation enhancer.

[00375] A cannabinoid powder composition comprising CBD isolate from cannabis plant tissues (phytocannabinoid) with a CBD content of 99% supplied by Medicinal Hemp (batch number MH B18592) in an amount of approximately 400 g was sieved through a 600 micron sieve. The CBD was added to approximately 400 g of a composition comprising wax, ten Petition 870260085113, dated 08 / 21 / 2026, page 95 / 314 91 / 116 active ingredient, and a permeation enhancer (SEDDS composition). A total of 800 g of mixture was made, with a CBD content of approximately 500 mg / g. Premix Number 1000 1001 1002 1003 1004 1005 1006 Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Content [%] Content [%] CDB Isolate (99% purity) 20.0 30.0 40.0 50.0 60.0 70.0 80.0 SEDDS Composition 30.0 70.0 60.0 50.0 40.0 30.0 20.0 Total 100 100 100 100 100 100 100 Table 25: Variation in CBD Isolate content (99% purity). Sample 1003 corresponds to the procedure above; the other samples are adjusted for variations in content. Example 11 Premix: Liquid self-emulsifying systems with isolated CBD and permeation enhancer.

[00376] A cannabinoid powder composition comprising CBD isolate from cannabis plant tissues (phytocannabinoid) with a CBD content of 99% supplied by Medicinal Hemp (batch number MH B18592) in an amount of approximately 400 g was sieved through a 600 micron sieve. The CBD was added to approximately 400 g of a composition comprising lipid, surfactant, and a permeation enhancer (SEDDS Composition). A total of 800 g of mixture was made, the CBD content of which was approximately 500 mg / g. Premix Number 1100 1101 1102 1103 1104 1105 1106 Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Content [%] Content [%] CDB Isolate (99% purity) 20.0 30.0 40.0 50.0 60.0 70.0 80.0 SEDDS Composition 80.0 70.0 60.0 50.0 40.0 30.0 20.0 Total 100 100 100 100 100 100 100 Petition 870260085113, dated 08 / 21 / 2026, page 96 / 314 92 / 116 Table 26: Variation in CBD Isolate content (99% purity). Sample 1103 corresponds to the procedure above; the other samples are adjusted for variations in content. Example 11A Premixing: Liquid self-emulsifying systems with isolated CBD and PEG and non-PEG surfactants.

[00377] A cannabinoid powder composition comprising CBD isolate from cannabis plant tissues (phytocannabinoid) with a CBD content of 99% supplied by Medicinal Hemp (lot number MH B18592) in an amount of approximately 300 g was sieved through a 600 micron sieve. The CBD was added to approximately 700 g of a composition comprising lipid, surfactant, and hydrophilic solvent (SEDDSs AZ composition). For each SEDDS composition, a total of 1000 g of mixture was made to produce loaded SEDDS A30-Z30 in which the CBD content was approximately 300 mg / g.

[00378] The above procedure was repeated with the addition of CBD to the composition of AZ SEDDSs to produce loaded A25-Z25 SEDDSs in which the CBD content was approximately 250 mg / g.

[00379] The above procedure was also repeated with the addition of CBD to the composition of AZ SEDDSs to produce loaded A20-Z20 SEDDS in which the CBD content was approximately 200 mg / g. SEDDS ABCDE Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Benzyl alcohol 14 - - - - Propylene glycol 10 - 31 - 30 Alpha-tocopherol 9 - - - - Polyglyceryl-4 laurate / sebacate mixed with polyglyceryl-4 caprylate / caprate and water 67 - - - - Petition 870260085113, dated 08 / 21 / 2026, p. 97 / 314 93 / 116 SEDDS ABCDE Ascorbic acid palmitate - - 2 - 2 Sodium lauryl sulfate - - 6 - 10 Soy phosphatidylcholine - - 5 - 6 Single-chain triglyceride (C8-C10) - - 20 - 22 Glyceryl monocaprylocaprate - - 26 - 30 Poloxamer 188 - - 10 - - Isopropyl myristate - 30 - 30 - Orange oil - 20 - 40 - Polyethylene lauryl ether - 50 - 30 - Total 100 100 100 100 100 Table 26A: Unloaded SEDDS formulations. Crude material content indicated as weight % (% by weight). SEDDS FGHIJ Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Benzyl alcohol - 15 - - - Propylene glycol - - - 40 - Alpha-tocopherol - 9 - - - Polyglyceryl-4 laurate / sebacate mixed with polyglyceryl-4 caprylate / caprate and water 61 - 61 - 61 Ascorbic acid palmitate - - - 2 - Glycerol monocaprylocaprate - - - - Poloxamer 188 - - - 39 - PEG-1000 d-alpha-tocopheryl succinate - 11 - - - Polyoxyethylene-23-lauryl ether - 65 - - - Polyglyceryl-3 dioleate - - - 19 - Oil 22 - 22 - 22 Caprylic acid 6 - - - - Caprylic acid - - 6 - - Oleyl alcohol - - - - 6 Ethanol 11 - 11 - 11 Total 100 100 100 100 100 Petition 870260085113, dated 08 / 21 / 2026, page 98 / 314 94 / 116 Table 26B: Unloaded SEDDS formulations. Crude material content indicated as weight % (% by weight). SEDDS KLMNO Crude Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Propylene glycol - - 40 - - Ascorbic acid palmitate - - 2 - - Soybean phosphatidylcholine 20 20 - 30 - Glyceryl monocaprylocaprate - - 19 - - Poloxamer 188 - - 39 - - PEG-1000 d-alpha-tocopheryl succinate 20 20 - 20 20 Polyoxyethylene ether lauryl - 10 - - - Isopropyl myristate 30 30 - 30 30 Orange oil 20 20 - 20 40 Polyoxyethylene sorbitan monooleate (80) 10 - - - 10 Total 100 100 100 100 100 Table 26C: Unloaded SEDDS formulations. Crude material content indicated as weight % (% by weight). SEDDS PQRST Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Benzyl alcohol 10 - 21 - - Propylene glycol - - 35 41 31 Alpha-tocopherol 9 - - - - Sodium dodecyl sulfate - - 6 - 10 Ascorbic acid palmitate - - - - 2 Soy phosphatidylcholine 5 - 9 - 8 Single Chain Triglyceride (C8-C10) - - - 18 - Glyceryl monocaprylocaprate - - 29 - 10 Poloxamer 188 - - - 41 20 PEG-1000 d-alpha-tocopheryl succinate 10 20 - - - Polyoxyethylene lauryl ether 53 10 - - - Petition 870260085113, dated 08 / 21 / 2026, page 99 / 314 95 / 116 SEDDS PQRST Isopropyl myristate 13 30 - - - Orange oil - 40 - - - Caprylic acid - - - - 19 Total 100 100 100 100 100 Table 26D: Unloaded SEDDS formulations. Crude material content indicated as weight % (% by weight). SEDDS UVXYZ Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Ethanol 7 23 - - - Propylene glycol - - 30 30 - Propylene glycol dicaprylocaprate 10 - - - - Sodium dodecyl sulfate - - 10 6 - Polyglyceryl-4 laurate / sebacate mixed with polyglyceryl-4 caprylate / caprate and water 30 - - - - Soy phosphatidylcholine 3 7 6 6 - Single Chain Triglyceride (C8-C10) - - 22 20 - Glycerol monocaprylocaprate - - 30 26 - Poloxamer 188 - - - 10 - d-alpha-tocopheryl PEG-1000 succinate - - - - 20 Polyoxyethylene lauryl Ether - 20 - - - Orange oil 20 20 - - 20 Polyglyceryl-3 diolate 10 - - - - Polyglyceryl-4 oleyl ether olivate 20 - - - - Isopropyl myristate - 30 - - 30 Polyoxyethylene sorbitan monooleate (80) - - - - 30 Ascorbic acid palmitate - - 2 2 - Total 100 100 100 100 100 Petition 870260085113, dated 08 / 21 / 2026, page 100 / 314 96 / 116 Table 26E: Unloaded SEDDS formulations. Crude material content indicated as weight % (% by weight). Premix Number 1140 1141 1142 1143 1144 1145 1146 Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Content [%] Content [%] CDB Isolate (99% purity) 15.0 20.0 25.0 30.0 35.0 40.0 50.0 SEDDS Composition 85.0 80.0 75.0 70.0 65.0 60.0 50.0 Total 100 100 100 100 100 100 100 Table 26F: Variation in CBD Isolate content (99% purity). Sample 1143 corresponds to the above procedure, producing SEDDS with a 30% CBD load; the other samples are adjusted for variations in content. Example 11B Characterization of SEDDS

[00380] In the table below, characteristic properties of the SEDDS of Example 11A (in premix 1141 of Table 26F corresponding to a CBD loading of 20%) are outlined in terms of the droplet size of the SEDDS and the zeta potential of the SEDDS, i.e., SEDDS preloaded with CBD. Both properties affect the SEDDS' properties for mucosal penetration.

[00381] Tablet size was measured for SEDDS preloaded with 1:100 CBD emulsified (v / v) in deionized water and incubated for 4 hours at 37 degrees Celsius at 300 rpm. Values ​​are averages (n=4). Values ​​are measured after 4 hours.

[00382] Zeta potential was measured for SEDDS pre-loaded with 1:100 emulsified CBD (v / v) in deionized water and incubated for 4 hours at 37 degrees Celsius at 300 rpm. Values ​​are averages (n=4). Values ​​are measured after 4 hours. Petition 870260085113, dated 08 / 21 / 2026, page 101 / 314 97 / 116 SEDDS Droplet Size Zeta Potential Samples Nm mV A20 199 -33 B20 nana C30 187 -1 D20 230 -2 E30 187 -1 F20 80 0 G20 150 -2 H20 78 -3 I30 132 -4 J20 200 -10 K20 250 -4 L20 nana M30 182 -1 N20 250 -1 O20 210 -5 P20 230 -2 Q20 nana R30 220 na S30 102 na T30 271 -24 U20 nana V20 nana X30 139 -2 Y30 136 -41 Z20 600 -1 Table 26G: Measurements after 4 hours. R and S measured after 72 hours. G and P measured after 24 hours. Petition 870260085113, dated 08 / 21 / 2026, page 102 / 314 98 / 116 Example 12 Premix: self-emulsifying systems with isolated CBD.

[00383] A cannabinoid powder composition comprising CBD isolate from cannabis plant tissues (phytocannabinoid) with a CBD content of 99% supplied by Medicinal Hemp (lot number MH B18592) in an amount of approximately 400 g was sieved through a 600 micron sieve. The CBD was added to approximately 400 g of a SEDDS composition according to Table 27. A total of 800 g of mixture was made, the CBD content of which was approximately 500 mg / g. Raw Material Name Content [vol. %] % [vol. %] % [vol. %] % [vol. %] % [vol. %] % Kolliphor EL (by BASF) 33 27 50 - - Labrafil M 1944 CS (by Gattefossé) 34 26 20 - - Oleic Acid (by Acme Synthetic Chemicals) - - - 50 40 Maisine CC (by Gattefossé) 33 27 30 50 40 Transcutol (by Gattefossé) - 20 - - 20 Total 100 100 100 100 100 Table 27: SEDDS formulations. Crude material content indicated by % by volume (vol. %). Premix Number 1200 1201 1202 1203 1204 1205 1206 Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Content [%] Content [%] CDB Isolate (99% purity) 20.0 30.0 40.0 50.0 60.0 70.0 80.0 SEDDS Composition (Table 27) 80.0 70.0 60.0 50.0 40.0 30.0 20.0 Total 100 100 100 100 100 100 100 Table 28: Variation in the content of CBD isolate (99% purity). Sample 1203 corresponds to the procedure above, the other samples... Petition 870260085113, dated 08 / 21 / 2026, page 103 / 314 99 / 116 trans are adjusted for variations in levels. Example 13 Premixing: self-emulsifying systems with isolated CBD and carriers.

[00384] A mesoporous silica carrier (Syloid XDP 3050) supplied by Grace in an amount of approximately 1000 g was added to a Lodige high-shear mixer. Following this, a cannabinoid powder composition comprising CBD isolate from cannabis plant tissues (phytocannabinoid) with a CBD content of 99% supplied by Medicinal Hemp (lot number MH B18592) in an amount of approximately 500 g was sieved through a 600 micron sieve. The CBD was added to approximately 500 g of a SEDDS composition according to Example 12, Table 27, as well as Example 11A, Tables 26A-26F. After activating the helicopter (approximately 600 rpm) of the Lodige mixer, the SEDDS composition containing the CBD was added to the mixture. A total of 2 kg of powdered premix was made, with a CBD content of approximately 250 mg / g, and a permeation enhancer was optionally added. Premix Number 1300 1301 1302 1303 1304 1305 1306 Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Content [%] Content [%] Syloid XDP 3050 20.0 30.0 40.0 50.0 60.0 70.0 80.0 CDB Isolate (99% purity) 40.0 35.0 30.0 25.0 20.0 15.0 10.0 SEDDS Composition 40.0 35.0 30.0 25.0 20.0 15.0 10.0 Total 100 100 100 100 100 100 100 Table 29: Variation in CBD Isolate content (99% purity). Sample 1303 corresponds to the procedure above; the other samples are adjusted for variations in content. Premix Number 1310 1311 1312 1313 1314 Raw Material Name Content Content Content Content Content Petition 870260085113, dated 08 / 21 / 2026, page 104 / 314 100 / 116 [%] [%] [%] [%] [%] Syloid XDP 3050 50.0 50.0 50.0 50.0 50.0 CBD Isolate (99% purity) 45.0 40.0 20.0 10.0 5.0 SEDDS Composition 5.0 10.0 30.0 40.0 45.0 Total 100 100 100 100 100 Table 30: Variation in SEDDS and CBD content. Samples are adjusted for variations in content. Premix Number 1320 1321 1322 1323 1324 Raw Material Name Content [%] Content [%] Content [%] Content [%] Content [%] Syloid XDP 3150 (by Grace) 50.0 Aeroperl 300 (by Evonik) 50.0 Prosolv 730 (by JRS Pharma) 50.0 Omyanutra (by Omya) 50.0 VivaPur 105 (by JRS Pharma) 50.0 CBD Isolate (99% purity) 25.0 25.0 25.0 25.0 25.0 SEDDS Composition 25.0 25.0 25.0 25.0 25.0 Total 100 100 100 100 100 Table 31: Variation in vehicle type. Here, Syloid XDP 3050 was replaced by other vehicles. Samples are prepared according to the procedure above, but adjusted for variations in levels. Example 14 Preparation of two-layer chewable tablets based on Examples 1 to 8 and 13

[00385] The tablets were made as in the CBD-containing mixtures of Examples 1 to 8 and 13, with each layer having a weight of approximately 50% of the total tablet. The total weight of the tablets was 1800 mg. The tablets were made using a standard tablet compression machine (3090i, available from Fette GmbH) comprising a dosing apparatus (P 3200 C, available from Fette GmbH, Germany). Punch used: 16.00 mm round punches. A Petition 870260085113, dated 08 / 21 / 2026, page 105 / 314 The rotor speed used for the 101 / 116 rotor was 11 rpm.

[00386] A first layer (layer indicated 1) comprising the CBD-containing mixture made in examples 1 to 8 and 13 and the additional ingredients was prepared and compressed before the tablet formation of the layer comprising gum base (layer indicated 2). Layer 1, weighing approximately 900 mg, was compressed at a compression force of approximately 5 kN. Hereinafter, layer 2, weighing approximately 900 mg and comprising gum base and additional ingredients, was pressed on top of layer 1 at a compression force of 40 kN. The tablet machine was commissioned by adjusting the loading depth and compression force. In this way, the weight and hardness of tablets share the acceptance criteria. A pre-compression force may be included to avoid the limitation included to prevent encapsulation. Content [%] Layer 1 - 900 mg Content [%] Layer 2 - 900 mg Raw material name Sample of premix from one of examples 1 to 8 and 13 16.1 Flavorings 1.2 1.8 High-intensity sweeteners 0.1 0.3 Lubricant 3.0 3.0 Mannitol 29.6 Xylitol 12.7 Gum base 31.5 Other components 0.7 Total 50 50 Table 32: In all tablet examples, the quantity of the various ingredients is given as a % by weight of the tablet. Name of raw material Content [%] Layer 1 - 900 mg Content [%] Layer 2 - 900 mg Sample of premix from one of examples 1 to 8 and 13 24.2 Petition 870260085113, dated 08 / 21 / 2026, page 106 / 314 102 / 116 Name of raw material Content [%] Layer 1 - 900 mg Content [%] Layer 2 - 900 mg Flavorings 1.2 1.8 High-intensity sweeteners 0.1 0.3 Lubricant 3.0 3.0 Mannitol 21.5 Xylitol 12.7 Gum base 31.5 Other components 0.7 Total 50 50 Tablet 33: In all tablet examples, the quantity of the various ingredients is given as a percentage by weight of the tablet. Raw Material Name Content [%] Layer 1 - 900 mg Content [%] Layer 2 - 900 mg Sample of premix from one of examples 1 to 8 and 13 24.2 16.1 Flavorings 1.2 1.8 High-intensity sweeteners 0.1 0.3 Lubricant 3.0 3.0 Mannitol 21.5 Xylitol 28.1 Other components 0.7 Total 50 50 Table 34: In all tablet examples, the quantity of the various ingredients is given as a % by weight of the tablet. Example 15 Preparation of two-layer chewable tablets based on examples 9-12 and 11A.

[00387] The tablets were made as in the CBD-containing mixtures of Examples 9-12, as well as Example 11A, Tables 26A-26F, with each layer having a weight of approximately 50% of the total tablet. The total weight of the tablets was 1800 mg. The tablets were made using a standard tablet compression machine. Petition 870260085113, dated 08 / 21 / 2026, page 107 / 314 103 / 116 (3090i, available from Fette GmbH) comprising dosing apparatus (P 3200 C, available from Fette GmbH, Germany). Punch used: 16.00 mm round punches. Rotor speed used was 11 rpm.

[00388] A first layer (layer indicated 1) comprising the CBD-containing mixture made in Examples 9-12, as well as Example 11 A, Tables 26A-26F, and the additional ingredients were prepared and compressed prior to tablet formation of the layer comprising gum base (if present) (layer indicated 2). Layer 1, weighing approximately 900 mg, was compressed at a compression force of approximately 5 kN. Hereinafter, layer 2, weighing approximately 900 mg and comprising gum base and additional ingredients, was pressed on top of layer 1 at a compression force of 40 kN. The tablet machine was commissioned by adjusting the loading depth and compression force so that the tablet weight and hardness met acceptable criteria. A pre-compression force may be included to prevent encapsulation. Content [%] Layer 1 - 900 mg Content [%] Layer 2 - 900 mg Raw material name Sample of premix from one of examples 9 to 12 and 11A 20.0 Flavorings 1.2 1.8 High-intensity sweeteners 0.1 0.3 Lubricant 3.0 3.0 Mannitol 25.7 Xylitol DC 12.7 Gum base 31.5 Other components 0.7 Total 50 50 Table 35: In all tablet examples, the quantity of the various ingredients is given as a % by weight of the tablet. Petition 870260085113, dated 08 / 21 / 2026, page 108 / 314 104 / 116 Raw Material Name Content [%] Layer 1 - 900 mg Content [%] Layer 2 - 900 mg Sample of premix from one of examples 9 to 12 and 11A 20 10 Flavorings 1.2 1.8 High-intensity sweeteners 0.1 0.3 Lubricant 3.0 3.0 Mannitol 21.5 Xylitol DC 34.2 Other components 0.7 Total 50 50 Table 36: In all tablet examples, the quantity of the various ingredients is given as a % by weight of the tablet. Raw Material Name Content [%] Layer 1 - 900 mg Content [%] Layer 2 - 900 mg Sample of premix from one of examples 9 to 12 and 11A 24.2 16.1 Flavorings 1.2 1.8 High-intensity sweeteners 0.1 0.3 Lubricant 3.0 3.0 Mannitol 21.5 Xylitol DC 28.1 Other components 0.7 Total 50 50 Table 37: In all tablet examples, the quantity of the various ingredients is given as a % by weight of the tablet. Example 16 Test method for content uniformity in mixtures and powdered mixtures

[00389] The Uniformity of Content (CU), that is, the homogeneity of the active substance of CBD in mixtures (Pre-Mix Samples) as well as powder mixtures which are mixtures that contain ingredients Petition 870260085113, dated 08 / 21 / 2026, page 109 / 314 The uniformity of dosage units of 105 / 116 active ingredients to be processed in oral dosage form (Powder Mixtures) is determined in accordance with European Pharmacopoeia 10.8 using a test method 2.9.40.

[00390] At least 5 samples, each having the same fixed weight in the range of 0.25-2 grams, are collected from the powder mixture for analysis. For each sample, the CBD active content is analyzed using standard HPLC techniques. Content Uniformity is then calculated as the relative standard deviation (RSD) of the individual results.

[00391] These tests were performed on powders for bags, sachets, and stick packs. In addition, this test was done for other cannabinoids, including THC. Example 17 Test method for content uniformity in solid dosage forms

[00392] The Uniformity of Content (UC), that is, the homogeneity of the active substances of CBD in solid dosage forms, is determined in accordance with European Pharmacopoeia 10.8 using the Uniformity of Dosage Units test method 2.9.40.

[00393] At least 10 samples are collected from solid dosage forms, e.g., tablets, for analysis. For each sample, the CBD active content is analyzed using standard HPLC techniques. Content Uniformity is then calculated as the relative standard deviation (RSD) of the individual results.

[00394] This test included tests on chewable tablets, chewable gum tablets, and lozenges comprising particulate ingredients. In addition, this test was performed for other cannabinoids, including THC. Petition 870260085113, dated 08 / 21 / 2026, page 110 / 314 106 / 116 Example 18 In vivo release test in solid dosage forms

[00395] The sample dosage form was tested on a test panel of 8 test subjects. Test subjects abstained from eating and drinking for at least 30 minutes prior to the initiation of any test. The test subject was a healthy individual attached on an objective basis according to specified requirements. After specific time intervals of use, e.g., 0, 0.5, 1, 2, 3, 5, and 10 minutes, the CBD content was measured in the remaining solid dosage form residue. The solid dosage form was subjected to triple measurements for each of the 8 test subjects, providing a total of 24 measurements for each sample. An average of the 24 measurements was calculated, and the % weight release was calculated based on the original CBD content in the sample. The CBD content was measured in the remaining dosage form residue, if still present.

[00396] The solid dosage form was weighed and placed in the mouth, and test subjects were instructed to place and use the solid dosage form as understood. For chewable gum, test subjects were instructed to chew the sample at a rate of 60 chews per minute. For lozenges, test subjects were instructed to place the sample between the tongue and palate, and then the solid dosage form was sucked and rotated every 0.5 minutes. Since the desired test time was objective (0.5, 1, 2, 3, 5, and 10 min.), the solid dosage form was taken out and weighed directly into a glass measuring container to be used for CBD content analysis. An in vivo dissolution profile was obtained by analyzing the CBD content in the solid dosage form at different dissolution times.

[00397] This test was performed on chewable tablets, chewing gum, and lozenges containing particulate ingredients. Additionally, this test was performed on other cannabinoids, including THC. Petition 870260085113, dated 08 / 21 / 2026, page 111 / 314 107 / 116 Example 19 In vitro release test in solid dosage forms

[00398] The sample dosage form was tested. After specific usage time intervals, e.g., 0, 0.5, 1, 2, 3, 5, and 10 minutes, the CBD content was measured in the remaining solid dosage form residue. The solid dosage form was subjected to triple measurements. An average of the measurements was calculated, and the % weight release was calculated based on the original CBD content in the sample. The CBD content was measured in the remaining solid dosage form residue, if still present.

[00399] The solid dosage form was weighed. Then, 25 ml of phosphate buffer was added to a 50 ml measuring tube with a screw cap. The solid dosage form was added to the tube. The tube was fixed horizontally on a shaker table. After shaking, the solid dosage form was analyzed for CBD content. An in vitro profile was obtained by analyzing the CBD content in the solid dosage at different dissolution times.

[00400] This test was performed on tablets, chewable gum, and lozenges comprising particulate ingredients. In addition, this test was performed on other cannabinoids, including THC. Example 20 In vitro release test of premixes

[00401] The corresponding tests were performed on premixes of examples 1 to 8 and 13 according to the procedure outlined in Example 19. Example 21 In vitro release test of powder mixtures

[00402] The corresponding tests were performed on powder mixtures comprising premixes of Examples 1 to 8 and 13 according to the procedure outlined in Example 19. Petition 870260085113, dated 08 / 21 / 2026, page 112 / 314 108 / 116

[00403] The powder mixtures included tests on powders for bags, sachets, and stick packaging. Example 22 Sensory evaluation test setup for solid dosage forms

[00404] In addition to in vivo or in vitro release measurements, sensory tests were performed to reveal very important characteristics and properties of the solid dosage form and powder mixtures. Sensory parameters are important as indicators of the structure of the solid dosage form composition. Structure is the underlying orientation of how the solid dosage form resembles the structure of a comparative solid dosage form, which is fixed as the standard in the test series, i.e., the solid dosage forms are compared with each other in the test series of preferably 5 samples. The test setup consisted of 8 people in a test panel. All test subjects were healthy individuals appointed on an objective basis according to specified requirements. Sensory analysis was performed according to ISO 4121-2003 under test conditions following ISO 8589. The result is an average of the results of the 8 individuals.

[00405] Test characters provide a rating from “+” to “+++++”, where “+” is poor and “+++++” is excellent, that is, “+++++” means the solid dosage form was excellent compared to the standard, “+++” means the solid dosage form was comparable to the standard, and “+” means the solid dosage form was far from comparable to the standard. “0” indicated that it was not tested.

[00406] Four different parameters were tested on a test panel: Sandy texture. Aroma. Sweetness. Unpleasant notes. Squeaking sound. Table 38: Parameters Petition 870260085113, dated 08 / 21 / 2026, page 113 / 314 109 / 116

[00407] “Sandy Texture” - the overall impression of the solid dosage form when placed in the mouth with respect to the impression of particle roughness, i.e., a sensation of sand in the mouth during administration.

[00408] “Taste” - the overall impression of the solid dosage form during its intended use with respect to taste. For example, a very low aroma experience results in a very low rating, and a very high taste experience that was not comparable to the standard also results in a very low rating.

[00409] “Sweetness” - the overall impression of the taste of the solid dosage form during its intended use with respect to sweetness. For example, if the sweetness diminishes rapidly, a very low rating will be given, and if the sweetness is too high, giving an uncomfortable sensation, a very low rating will also be given.

[00410] “Unpleasant notes” - the overall impression of unpleasant notes from one or more cannabinoids in the composition during intended use. For example, if unpleasant notes (grassy, ​​bitter notes, throat irritation) are experienced in the throat, a low rating was given, and if other uncomfortable sensations are experienced, a low rating will also be given.

[00411] “Grinding sound” - the overall impression when chewing a solid chewable dosage form in relation to causing a grinding sensation upon contact with the teeth. For example, if a grinding sound is experienced, a low rating will be given. Example 23 Results of Content Uniformity in Premixes

[00412] The procedures of Example 16 were used for the premixes (Premix Samples) above and the results revealed a good degree of uniformity of the inventive samples. The result Petition 870260085113, dated 08 / 21 / 2026, page 114 / 314 110 / 116 of the content uniformity for the sample was revealed as a single value obtained as the relative standard deviation (RSD) of the CBD content of the multiple samples collected at the end of the premix preparation procedures. Example 24 Results in content uniformity in powder mixtures and solid dosage forms.

[00413] The procedures of Example 16 were used for powder mixtures (Powder Mixture) that are powder premixes (Sample of Powder Premixes) with active ingredients as outlined in the formulations of the oral dosage forms. The powder mixtures included tests on powders for pouches, sachets, and stick packs as well as powder mixtures for use in solid dosage forms, including chewable tablets, chewing gums, and lozenges comprising particulate ingredients according to the previous examples. The procedure of Example 17 was used for the dosage forms.

[00414] The Content Uniformity (CU) result for the sample is provided as a single value obtained as the relative standard deviation (RSD) of CBD content from multiple samples collected at the end of the preparation procedures. If the individual samples were collected at different stages of a tablet production process (e.g., beginning, middle, and end), then Content Uniformity is determined by analyzing mixed samples from the different process stages. The results revealed a surprisingly good content uniformity of the inventive samples. Example 25 Results regarding the release of solid dosage forms

[00415] The procedures of Example 19 were performed on solid dosage forms according to the previous examples. The results Petition 870260085113, dated 08 / 21 / 2026, page 115 / 314 111 / 116 revealed a surprisingly good release of the inventive samples. Similar good results were seen for the gum-free tablets, FDT tablets, compressed chewing gums, and lozenges. Example 26 Results regarding the release of premixes

[00416] The procedures of Example 20 were performed on the premixes according to the previous examples. The results revealed a surprisingly good release of the inventive samples. Example 27 Results on the release of powder mixtures

[00417] The procedures of Example 21 were performed on the powder mixtures according to the previous examples. The results revealed a surprisingly good release of the inventive samples. Good results were observed for the powders according to the previous examples for use in bags, sachets, stick packaging, and flow packs. Example 28 Results on the sensory evaluation test setup for solid dosage forms.

[00418] The procedures in Example 22 were performed to establish the benefits of the sensory properties of solid samples from instant application. Surprisingly, good results were observed for chewable tablets with or without a gum base, FDT tablets, compressed chewing gums, and lozenges. Example 29 Degradability of selected SEDDS

[00419] Effect studies were performed to stabilize the effect of degradability on selected SEDDS from Example 11A, Tables 26A-26F. For SEDDS A, G, P, the CDB variation in SEDDS was Petition 870260085113, dated 08 / 21 / 2026, page 116 / 314 112 / 116 20% by weight of SEDDS (as outlined in Table 26F in Example 11A). For SEDDS C, E, I, M, the CBD loading in SEDDS was 30% by weight of SEDDS (as outlined in Table 26F in Example 11A).

[00420] Studies were conducted in vitro based on the release of fatty acids (in mol) from SEDDS formulations after lipase treatment for 60 min (incubation time). The amount of fatty acids released was an indication of degradability. A blank sample was prepared for evaluation of the results. SEDDS 0 min 5 min 10 min 20 min 30 min 40 min 50 min 60 min A20 0.00 0.04 0.07 0.10 0.15 0.18 0.27 0.32 C30 0.00 0.05 0.08 0.10 0.13 0.14 0.15 0.16 E30 0.00 0.06 0.09 0.13 0.15 0.16 0.17 0.18 G20 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 I30 0.00 0.00 0.00 0.00 0.01 0.01 0.01 0.01 M30 0.00 0.04 0.05 0.06 0.07 0.08 0.08 0.09 P20 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 Table 39: Fatty acid release measured in millimoles as a function of time.

[00421] The results revealed that certain SEDDS with a relatively low amount of PEG-containing surfactants degraded relatively quickly, such as samples A20, C30, and E30. On the other hand, SEDDS with a relatively high amount of PEG-containing surfactants degraded to a lesser degree. This trend was as expected, since the PEG portion in the surfactants was expected to protect the SEDDS from degradation. Example 30 Effect studies

[00422] Effective studies were conducted to stabilize the plasma pharmacokinetic (PK) profile in Sprague Dawley rats from selected SEDDS from Example 11A, Tables 26A-26F. The CBD loading in the SEDDS was approximately 20% by weight of the SEDDS (as outlined in Petition 870260085113, dated 08 / 21 / 2026, pp. 117 / 314 113 / 116 Table 26F in Example 11A).

[00423] Samples with SEDDS pre-loaded with CBD (in deionized water) were administered to rats by oral standard galvanic techniques, i.e., by means of a tube that releases the SEDDS into the rats' stomachs.

[00424] The studies were conducted by orally administering 6,643 mg / kg of CBD to rats, equivalent to a human (70 kg) consuming 75 mg of CBD. Plasma CBD concentration (mg / mL) was measured after certain time intervals that reveal in vivo absorption of CBD. The values ​​are averages (n=7). An Epidiolex® reference was applied.

[00425] The area under the curve (AUC) was stabilized during periods of 0 to 240 minutes, as well as 0 to 1440 minutes, corresponding to the total test period. The values ​​were applied to establish absorption in rats on short time scales (0 to 240 minutes) and absorption in rats on long time scales (240 to 1440 minutes) as well as to measure the total absorption of CBD from rats during the entire time period.

[00426] In addition, the maximum plasma concentration (Cmax) was determined. SEDDS AUC 0-240 AUC 0-1440 AUC 0-240 AUC 0-1440 - AUC 0-240 No. min*ng / mL min*ng / mL % of AUC 0-1440 min*ng / mL A20 4152 10337 40.2 6185 P20 3706 8575 43.2 4869 G20 4535 8482 53.5 3947 Epidiolex® 1988 8428 23.6 6440 Table 39A: The area under the curve (AUC) was established over the periods (indicated in minutes from time 0 to various time points) as the average values ​​(n=7). The values ​​are indicated in minutes multiplied by nanogram CBD per milliliter. Furthermore, a Petition 870260085113, dated 21 / 08 / 2026, page 118 / 314 114 / 116 percent was calculated.

[00427] As can be seen from the AUC results, it is evident that G20 (having a high content of PEG-containing surfactants) provides a much faster absorption of 53.5% within 240 minutes of total absorption after 1440 minutes compared to A20 (having a lower content of PEG-containing surfactants) with a value of 40.2%, and a faster absorption than P20 (having a lower content of PEG-containing surfactants than G20) with a value of 43.2% within 240 minutes of oral absorption after 1440 minutes. This was highly surprising, since it was theoretically expected that PEG-containing surfactants could be proposed for steric hindrance in terms of cellular absorption. However, the direct opposite occurred compared to SEDDS having less or no PEG-containing surfactants.

[00428] Furthermore, compared with Epidiolex®, the results were more pronounced, where the absorption of Epidiolex® within 240 minutes was 23.6% of the total oral absorption after 1440 minutes. Consequently, also for the SEDDS containing no surfactant containing PEG (here A20 with a value of 40.2%), absorption on short time scales was greater than that of the reference, Epidiolex®.

[00429] Given that absorption on short time scales (0 to 240 minutes) was considerably greater for SEDDS with PEG-containing surfactants, one prospect is to apply these SEDDS for faster absorption of cannabinoids, such as CBD, for example, in combination with SEDDS systems providing prolonged absorption.

[00430] As can also be seen from the AUC results, total absorption (0 to 1440 minutes) was significantly higher for A20 than all other SEDDS and Epidiolex®, i.e., a value of 10337 min* ng / mL was observed for SEDDS A20 with surfactants that do not include PEG portions, which was considerably higher than SEDDS having a high content of surfactants with PEG. Petition 870260085113, dated 08 / 21 / 2026, pp. 119 / 314 115 / 116 (8482 for G20 and 8575 for P20), and even in comparison with Epidiolex®. This was highly unexpected and surprising, since studies revealed in Example 29 showed that these SEDDS (with surfactants that did not include PEG moieties) were degraded. Conversely, despite this degradation, absorption was very high and much greater than SEDDS that do not degrade as revealed in Example 29. Consequently, total absorption (on both short and long timescales) was unexpectedly higher for SEDDS with surfactants that do not include a PEG moiety.

[00431] Furthermore, as can be seen from the AUC results, absorption over long timescales (within 240 to 1440 minutes) was also significantly higher for SEDDS having surfactants that do not include PEG moieties with a value of 6185 min*ng / mL compared to SEDDS having surfactants with PEG-containing moieties with values ​​of 4869 and 3947 min*ng / mL. This is evident from a higher absorption of those SEDDS over long timescales compared to the other SEDDS in the test. This was also highly surprising, given that the degradability tests in Example 29 revealed the degradation of these SEDDS. Highly unexpectedly, the absorption was higher over long timescales despite this fact and comparable to the reference, Epidiolex®. One perspective is to apply these SEDDS for more prolonged absorption of cannabinoids, such as CBD, for example, in combination with SEDDS systems providing faster absorption. SEDDS Cmax No. ng / mL A20 34.8 P20 30.6 G20 35.8 Epidiolex® 25.0 Petition 870260085113, dated 08 / 21 / 2026, pp. 120 / 314 116 / 116 Table 40: The maximum concentration Cmax in nanograms per milliliter indicated for selected samples and an Epidiolex® reference.

[00432] As can be seen from the Cmax results, the maximum concentration of A20, G20, and P20 was much higher than the reference, Epidiolex®. Consequently, these SEDDS performed better in terms of peak concentration than the reference, i.e., the maximum achievable concentration level is higher. This was highly surprising, since, for SEDDS having surfactants with PEG moieties (G20 and P20), it was expected that steric hindrance due to the PEG moieties could negatively affect absorption. However, the results show that this was not the case. As for SEDDS having surfactants without any PEG moiety (A20), this was also unexpected in view of the degradability studies revealed in Example 29, where it was shown that those SEDDS degraded significantly. Petition 870260085113, dated 08 / 21 / 2026, pp. 121 / 314

Claims

1 / 34 CLAIMS 1. An orally dissolvable or chewable tablet powder formulation, characterized in that it comprises: one or more carrier systems comprising one or more liquid or solid self-emulsifying systems loaded with cannabinoids in an amount of at least 10% by weight of the tablet powder formulation; or one or more self-emulsifying systems including: i) at least one or more surfactants, one or more lipids and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a liquid self-emulsifying system, and ii) at least one or more surfactants, one or more waxes and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a solid self-emulsifying system; one or more water-soluble agents in an amount of 20 to 80% by weight of the tablet powder formulation;And one or more flavorings, wherein one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety.

2. Orally dissolvable or chewable compressed powder formulation according to claim 1, characterized in that said one or more self-emulsifying systems are stable at a pH of about 1 to 4.

3. Orally dissolvable or chewable powder-compressed formulation according to claim 1 or 2, characterized in that said one or more self-emulsifying systems are stable at a pH of about 1 to 4 and operable for release from the gastrointestinal tract of one or more cannabinoids upon release from one or more vehicle systems in the oral cavity. Petition 870260085113, dated 08 / 21 / 2026, p. 122 / 314 2 / 34 4. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety, the one or more surfactants having a chemical structure that includes a PEG moiety being present in an amount of at least 20% by weight of one or more liquid or solid self-emulsifying systems.

5. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety, the one or more surfactants having a chemical structure that includes a PEG moiety being present in an amount of at least 25% by weight of one or more liquid or solid self-emulsifying systems.

6. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety, the one or more surfactants having a chemical structure that includes a PEG moiety being present in an amount of at least 30% by weight of one or more liquid or solid self-emulsifying systems.

7. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety, the one or more surfactants having a chemical structure that includes a PEG moiety being present in an amount of at least 35% by weight of one or more liquid or solid self-emulsifying systems.

8. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety, the one or more surfactants having a chemical structure that includes a PEG moiety being present in an amount of at least 40% by weight of one or more liquid or solid self-emulsifying systems.

9. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety, the one or more surfactants having a chemical structure that includes a PEG moiety being present in an amount of at least 50% by weight of one or more liquid or solid self-emulsifying systems.

10. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more isolated or synthetic cannabinoids are present in an amount of at least 20% by weight of one or more liquid or solid self-emulsifying systems.

11. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more isolated or synthetic cannabinoids are present in an amount of at least 30% by weight of one or more liquid or solid self-emulsifying systems. Petition 870260085113, dated 08 / 21 / 2026, p. 124 / 314 4 / 34 12. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more isolated or synthetic cannabinoids are present in an amount of 10 to 30% by weight of the compressed powder formulation.

13. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more isolated or synthetic cannabinoids are present in an amount of 10 to 20% by weight of the compressed powder formulation.

14. Orally dissolvable or chewable powdered tablet formulation, according to any of the preceding claims, characterized in that one or more isolated or synthetic cannabinoids are present in an amount of at least 15% by weight of the powdered tablet formulation.

15. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more carrier systems are released from the orally dissolvable or chewable compressed powder formulation in the oral cavity.

16. Orally dissolvable or chewable powder-compressed formulation, according to any of the preceding claims, characterized in that at least 90% of one or more vehicle systems is released from the orally dissolvable or chewable powder-compressed formulation into the oral cavity within 5 minutes of oral administration.

17. Orally dissolvable or chewable powder tablet formulation, according to any of the preceding claims, characterized in that at least 50% of one or more isolated or synthetic cannabinoids are released from one or more vehicle systems 10 minutes after oral administration.

18. Orally dissolvable or chewable powder tablet formulation, according to any of the preceding claims, characterized in that at least 20% of one or more isolated or synthetic cannabinoids are released from one or more vehicle systems 10 minutes after oral administration.

19. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that the self-emulsification system upon hydration forms an emulsion for the release of one or more cannabinoids to mucosal surfaces in the gastrointestinal tract.

20. Orally dissolvable or chewable powder-compressed formulation, according to any of the preceding claims, characterized in that the self-emulsification system upon hydration forms an emulsion for the release of one or more cannabinoids to mucosal surfaces in the small intestines of the gastrointestinal tract.

21. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that the self-emulsification system upon hydration forms an emulsion for the release of one or more cannabinoids to mucosal surfaces in the colon of the gastrointestinal tract.

22. Orally dissolvable or chewable powder-compressed formulation, according to any of the preceding claims, characterized in that one or more carrier systems provide stable conditions for the release of one or more cannabinoids to mucosal surfaces in the stomach of the gastrointestinal tract.

23. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more autoemulsifying systems comprise one or more liquid autoemulsifying systems. Petition 870260085113, dated 08 / 21 / 2026, page 126 / 314 6 / 34 24. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more lipids comprise one or more oils.

25. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more lipids comprise one or more triglycerides.

26. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more lipids comprise one or more triglycerides of vegetable origin.

27. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more lipids comprise one or more oils selected from the group consisting of almond oil, castor oil, coconut oil, corn oil, cottonseed oil, linseed oil, olive oil, palm oil, peanut oil, rapeseed oil, safflower oil, sesame oil, soybean oil, sunflower oil, and combinations thereof.

28. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more lipids comprise one or more triglycerides selected from one or more C4 to C14 triglycerides.

29. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more lipids comprise one or more triglycerides comprising a partially hydrogenated vegetable oil. Petition 870260085113, dated 08 / 21 / 2026, page 127 / 314 7 / 34 30. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more lipids comprise one or more triglycerides comprising a fully hydrogenated vegetable oil.

31. Orally dissolvable or chewable powder tablet formulation, according to any of the preceding claims, characterized in that one or more lipids comprise one or more triglycerides comprising caprylic acid in an amount of 50 to 80% by weight.

32. Orally dissolvable or chewable powder tablet formulation, according to any of the preceding claims, characterized in that one or more lipids comprise one or more triglycerides comprising capric acid in an amount of 20 to 45% by weight.

33. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more lipids comprise one or more lipophilic compounds selected from the group consisting of glyceryl caprylate, glyceryl caprate, glyceryl monocaprylate, glyceryl monooleate, glyceryl monostearate, glyceryl monolinoleate, polyglyceryl-3 dioleate, propylene glycol dicaprylocaprate, propylene glycol dilaurate, benzyl alcohol, alpha-tocopherol, isopropyl myristate, glycerol monocaprylocaprate, and combinations thereof.

34. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more lipids do not comprise an aromatic oil. Petition 870260085113, dated 08 / 21 / 2026, p. 128 / 314 8 / 34 35. Orally dissolvable or chewable powder tablet formulation, according to any of the preceding claims, characterized in that one or more lipids are present in an amount of 1 to 30% by weight of the orally dissolvable or chewable powder tablet formulation.

36. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more lipids are present in an amount of 5 to 40% by weight of one or more self-emulsifying systems.

37. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more lipids improves the homogeneity of one or more cannabinoids in the orally dissolvable or chewable compressed powder formulation.

38. Orally dissolvable or chewable powder-compressed formulation, according to any of the preceding claims, characterized in that one or more lipids are present in an amount of 10 to 300 mg in the orally dissolvable or chewable powder-compressed formulation.

39. Orally dissolvable or chewable powder-compressed formulation, according to any of the preceding claims, characterized in that one or more lipids are present in an amount of 50 to 300 mg in the orally dissolvable or chewable powder-compressed formulation.

40. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more self-emulsifying systems comprise one or more solid self-emulsifying systems.

41. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more waxes comprise a solid and / or a semi-solid material at 25 degrees Celsius. Petition 870260085113, dated 08 / 21 / 2026, page 129 / 314 9 / 34 42. Orally dissolvable or chewable powder tablet formulation, according to any of the preceding claims, characterized in that one or more waxes are present in an amount of 1 to 30% by weight of the orally dissolvable or chewable powder tablet formulation.

43. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more waxes improves the homogeneity of one or more cannabinoids in the orally dissolvable or chewable compressed powder formulation.

44. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more waxes is present in an amount of 10 to 300 mg in the orally dissolvable or chewable compressed powder formulation.

45. Orally dissolvable or chewable powder-compressed formulation, according to any of the preceding claims, characterized in that one or more waxes is present in an amount of 50 to 300 mg in the orally dissolvable or chewable powder-compressed formulation.

46. ​​Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety being selected from the group consisting of sugar- and lipid-based surfactants with PEG modification, PEG-containing polymer-based surfactants, PEG-containing emulsifiers, and combinations thereof.

47. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety, being sugar and lipid-based surfactants with PEG modification selected from the group consisting of polyoxyethylene sorbitan monolaurate (20), polyoxyethylene sorbitan monooleate (20), polyoxyethylene sorbitan monopalmitate (20), polyoxyethylene sorbitan monostearate (20), polyoxyethylene sorbitan trioleate (20), and combinations thereof.

48. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety, being PEG-containing polymer-based surfactants selected from the group consisting of poloxamer 124, poloxamer 188, poloxamer 338, poloxamer 407, and combinations thereof.

49. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety, being PEGylated emulsifiers selected from the group consisting of d-alpha-tocopheryl polyethylene glycol succinate, d-alpha-tocopheryl succinate, PEG-1000, PEG15 hydroxystearate, PEG-30 castor oil, PEG-32 lauryl glycerides, PEG-32 stearyl glycerides, PEG-35 castor oil, PEG-40 castor oil. Petition 870260085113, dated 08 / 21 / 2026, page 1. 131 / 314 11 / 34 hydrogenated castor oil, PEG-6 lauryl glycerides, PEG-6 linoleoyl glycerides, PEG-6 oleoyl glycerides, PEG-8 caprylic / capric glycerides, polyoxyl 20 cetostearyl ether, polyoxyethylene lauryl ether, polyoxyethylene 23 lauryl ether, and combinations thereof.

50. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety comprising d-alpha-tocopheryl polyethylene glycol succinate.

51. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety comprising polyoxyethylene lauryl ether.

52. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety comprising polyoxyethylene 23-lauryl ether.

53. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety comprising poloxamer 188.

54. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims Petition 870260085113, dated 08 / 21 / 2026, page 132 / 314 12 / 34, characterized in that one or more surfactants have an average HLB value greater than 6.

55. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more self-emulsifying systems also comprise one or more hydrophilic solvents.

56. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more self-emulsifying systems also comprise one or more hydrophilic solvents in an amount of at least 5% by weight of the one or more liquid or solid self-emulsifying systems.

57. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more self-emulsifying systems also comprise one or more hydrophilic solvents in an amount of at least 10% by weight of the one or more liquid or solid self-emulsifying systems.

58. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more self-emulsifying systems also comprise one or more hydrophilic solvents in an amount of at least 20% by weight of the one or more liquid or solid self-emulsifying systems.

59. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more self-emulsifying systems also comprise one or more hydrophilic solvents selected from the group consisting of propylene glycol, acetyl tributyl citrate, triethyl acetyl citrate, dimethyl sulfoxide, ethanol, ethyl oleate, glycerol triacetate, diethylene glycol monoethyl ether, polyethylene glycol 200, polyethylene glycol 300, polyethylene glycol 400, polyethylene glycol 600, propan-2-ol, glycerol, triethyl citrate, and combinations thereof.

60. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more self-emulsifying systems also comprise one or more hydrophilic solvents comprising propylene glycol.

61. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more surfactants comprise one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) moiety.

62. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more surfactants comprise one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) moiety, the one or more surfactants having a chemical structure that does not include a PEG moiety being present in an amount of 0.1 to 20% by weight of one or more liquid or solid self-emulsifying systems.

63. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more surfactants comprise one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) moiety, the one or more surfactants having a chemical structure that does not include a PEG moiety being present in an amount of 0.1 to 10% by weight of one or more liquid or solid self-emulsifying systems. Petition 870260085113, dated 08 / 21 / 2026, p. 134 / 314 14 / 34 64. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more surfactants comprise one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) moiety, the one or more surfactants having a chemical structure that does not include a PEG moiety being present in an amount less than 5% by weight of one or more liquid or solid self-emulsifying systems.

65. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more surfactants comprise one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) moiety, being selected from the group consisting of monoglycerides, sugar-based and lipid-based surfactants, and combinations thereof.

66. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more surfactants comprise one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) moiety comprising polyglycerol esters of fatty acids.

67. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more surfactants comprise one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) moiety, being selected from the group consisting of decaglycerol mono- and dioleate, hexaglycerol octastearate, polyglycerol esters of oleic acid, propylene glycol monocaprylate, propylene glycol monolaurate, triglycerol monooleate, polyglyceryl-4 oleyl ether olivate, polyglyceryl-4 laurate / sebacate, polyglyceryl-4 caprylate / caprate, and combinations thereof.

68. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more surfactants comprise one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) moiety, being selected from the group consisting of sorbitan monolaurate, sorbitan monooleate, sorbitan monopalmitate, sorbitan monostearate, sorbitan trioleate, sucrose palmitate, sucrose stearate, and combinations thereof.

69. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more surfactants comprise one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) moiety comprising polyglyceryl-4 laurate / sebacate and / or polyglyceryl-4 caprylate / caprate.

70. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more surfactants comprise one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) moiety comprising ascorbic acid palmitate.

71. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more surfactants comprise one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) moiety comprising sodium lauryl sulfate.

72. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more surfactants comprise one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) moiety comprising soy phosphatidylcholine.

73. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more surfactants do not comprise one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) moiety.

74. Orally dissolvable or chewable powder tablet formulation, according to any of the preceding claims, characterized in that one or more isolated or synthetic cannabinoids are selected from the group consisting of cannabidiol (CBD), cannabidiolic acid (CBDA), cannabidivarin (CBDV), and combinations thereof.

75. Orally dissolvable or chewable powder tablet formulation, according to any of the preceding claims, characterized in that one or more isolated or synthetic cannabinoids are selected from the group consisting of tetrahydrocannabinol (THC), tetrahydrocannabinolic acid (THCA), tetrahydrocannabivarin (THCV), and combinations thereof.

76. Orally dissolvable or chewable powder tablet formulation, according to any of the preceding claims, characterized in that one or more isolated or synthetic cannabinoids comprise cannabidiol (CBD).

77. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more isolated or synthetic cannabinoids is selected from the group consisting of ca Petition 870260085113, dated 08 / 21 / 2026, page 1. 137 / 314 17 / 34 nabidinol (CBD), cannabidiolic acid (CBDA), tetrahydrocannabinol (THC), tetrahydrocannabidolic acid (THCA), cannabigerol (CBG), cannabichromene (CBC), cannabinol (CBN), cannabielsoin (CBE), isotetrahydrocannabinol (iso-THC), cannabicyclol (CBL), cannabicitran (CBT), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), and combinations thereof.

78. Orally dissolvable or chewable powdered tablet formulation, according to any of the preceding claims, characterized in that one or more isolated or synthetic cannabinoids is an isolated cannabinoid.

79. Orally dissolvable or chewable powdered tablet formulation, according to any of the preceding claims, characterized in that one or more isolated or synthetic cannabinoids is a synthetic cannabinoid.

80. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more isolated or synthetic cannabinoids are not a cannabinoid distillate with a cannabinoid purity greater than 80%.

81. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more isolated or synthetic cannabinoids are not a cannabinoid extract with a cannabinoid purity of less than 80%.

82. Orally dissolvable or chewable powdered tablet formulation, according to any of the preceding claims, characterized in that one or more isolated or synthetic cannabinoids are present in an amount of at least 40 mg in the orally dissolvable or chewable powdered tablet formulation. Petition 870260085113, dated 08 / 21 / 2026, page 138 / 314 18 / 34 83. Orally dissolvable or chewable powdered tablet formulation, according to any of the preceding claims, characterized in that one or more isolated or synthetic cannabinoids are present in an amount of at least 75 mg in the orally dissolvable or chewable powdered tablet formulation.

84. Orally dissolvable or chewable powdered tablet formulation, according to any of the preceding claims, characterized in that one or more isolated or synthetic cannabinoids are present in an amount of at least 150 mg in the orally dissolvable or chewable powdered tablet formulation.

85. Orally dissolvable or chewable powdered tablet formulation, according to any of the preceding claims, characterized in that one or more isolated or synthetic cannabinoids are present in an amount of at least 300 mg in the orally dissolvable or chewable powdered tablet formulation.

86. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more carrier systems comprise one or more solid carriers selected from the group consisting of silica, microcrystalline cellulose, cellulose, silicified microcrystalline cellulose, clay, talc, starch, pregelatinized starch, calcium carbonate, dicalcium phosphate, modified calcium carbonate, magnesium carbonate, magnesium aluminometasilicate, hyperporous silica, and mixtures thereof.

87. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims Petition 870260085113, dated 08 / 21 / 2026, pp. 139 / 314 19 / 34, characterized in that one or more carrier systems comprise one or more microcrystalline cellulose carriers.

88. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more carrier systems comprise one or more modified calcium carbonate carriers.

89. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more carrier systems comprise one or more silica carriers.

90. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more carrier systems comprise one or more mesoporous silica carriers.

91. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more carrier systems comprise one or more mesoporous silica carriers comprising magnesium aluminometasilicate.

92. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more carrier systems comprise one or more mesoporous silica carriers comprising dicalcium phosphate.

93. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more carrier systems comprise one or more solid carriers having an average particle size of 20 to 200 microns.

94. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more carrier systems comprise one or more solid carriers having an average particle size of 30 to 150 microns. Petition 870260085113, dated 08 / 21 / 2026, page 140 / 314 20 / 34 95. Orally dissolvable or chewable powder tablet formulation, according to any of the preceding claims, characterized in that one or more carrier systems are present in an amount exceeding 10% by weight of the orally dissolvable or chewable powder tablet formulation.

96. Orally dissolvable or chewable powder tablet formulation, according to any of the preceding claims, characterized in that one or more carrier systems are present in an amount exceeding 20% ​​by weight of the orally dissolvable or chewable powder tablet formulation.

97. Orally dissolvable or chewable powder-compressed formulation, according to any of the preceding claims, characterized in that one or more carrier systems are present in an amount of 30 to 1500 mg in the orally dissolvable or chewable powder-compressed formulation.

98. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more carrier systems comprise one or more solid carriers having an average pore volume above 1.0 cm3 / g.

99. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more carrier systems comprise one or more solid carriers having an average pore volume above 1.5 cm3 / g.

100. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more carrier systems comprise one or more solid carriers having an average density above 50 g / L. Petition 870260085113, dated 08 / 21 / 2026, page 141 / 314 21 / 34 101. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more carrier systems comprise one or more solid carriers having an average density of 50 to 400 g / L.

102. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more carrier systems comprise one or more solid carriers having an average density of 150 to 400 g / L.

103. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, wherein one or more carrier systems comprise one or more solid carriers that are not characterized as a powder flow promoter.

104. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more liquid or solid self-emulsifying systems are present in an amount of 30 to 800 mg in the orally dissolvable or chewable compressed powder formulation.

105. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more liquid or solid self-emulsifying systems are present in an amount of 30 to 300 mg in the orally dissolvable or chewable compressed powder formulation. Petition 870260085113, dated 08 / 21 / 2026, page 142 / 314 22 / 34 106. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more isolated or synthetic cannabinoids are wholly contained within one or more liquid or solid self-emulsifying systems.

107. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that the orally dissolvable or chewable compressed powder formulation comprises one or more cannabinoids separated from one or more liquid or solid self-emulsifying systems.

108. Orally dissolvable or chewable powder-compressed formulation, according to any of the preceding claims, characterized in that one or more water-soluble agents are present in an amount of 30 to 80% by weight of the powder-compressed formulation.

109. Orally dissolvable or chewable powder-compressed formulation, according to any of the preceding claims, characterized in that one or more water-soluble agents are present in an amount of 40 to 80% by weight of the powder-compressed formulation.

110. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more water-soluble agents comprise one or more sugar alcohol particles.

111. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more water-soluble agents comprise one or more sugar alcohol particles from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, isomalt, and combinations thereof.

112. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more water-soluble agents comprise one or more sugar alcohol particles comprising non-directly compressible (non-DC) sugar alcohol particles and directly compressible (DC) sugar alcohol particles.

113. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more water-soluble agents comprise one or more sugar alcohol particles comprising non-directly compressible (non-DC) sugar alcohol particles and directly compressible (DC) sugar alcohol particles in a non-DC to DC ratio between 0.2 and 1.

2.

114. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that the orally dissolvable or chewable compressed powder formulation is associated with an improved mouthfeel.

115. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that the orally dissolvable or chewable compressed powder formulation is associated with an improved mouthfeel comprising a less gritty mouthfeel.

116. Orally dissolvable or chewable powder tablet formulation, according to any of the preceding claims, characterized in that the orally dissolvable or chewable powder tablet formulation is associated with an improved mouth sensation comprising a less strident sound when chewing the orally dissolvable or chewable powder tablet formulation.

117. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that the orally dissolvable or chewable compressed powder formulation is associated with an improved mouthfeel due to one or more vehicle systems compared with separately added vehicles not comprising one or more liquid or solid self-emulsifying systems.

118. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that the orally dissolvable or chewable compressed powder formulation is associated with an improved mouthfeel due to the presence of one or more water-soluble agents.

119. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that it also comprises one or more disintegrants.

120. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that it also comprises one or more disintegrants selected from the group consisting of croscarmellose sodium, crospovidone, sodium starch glycolate, and combinations thereof.

121. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that it also comprises at least one dissolution modifier selected from the group consisting of acacia, agar, alginic acid or a salt thereof, carbomer, carboxymethylcellulose, carrageenan, cellulose, chitosan, copovidone, cyclodextrins, ethylcellulose, gelatin, guar gum, hydroxyethyl cellulose, hydroxyethyl methylcellulose, hydroxypropyl cellulose, hypromellose, insulin, methylcellulose, pectin, polycarbophil or a salt thereof, polyvinyl alcohol, pullulan, starch, tragacanth, trehalose, xanthan gum and mixtures thereof.

122. Orally dissolvable or chewable powder tablet formulation, according to any of the preceding claims, characterized in that it also comprises at least one dissolution modifier in an amount of 3 to 20% by weight of the orally dissolvable or chewable powder tablet formulation.

123. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that it comprises one or more organic acids.

124. Orally dissolvable or chewable powder tablet formulation, according to any of the preceding claims, characterized in that one or more flavorings are present in an amount of 0.1 to 10% by weight of the orally dissolvable or chewable powder tablet formulation.

125. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more self-emulsifying systems comprise one or more isolated or synthetic cannabinoids and one or more lipids in a cannabinoid to lipid weight ratio of 10:1 to 1:

10.

126. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims. Petition 870260085113, dated 08 / 21 / 2026, page 146 / 314 26 / 34, characterized in that one or more self-emulsifying systems comprise one or more isolated or synthetic cannabinoids and one or more lipids in a cannabinoid to lipid weight ratio of 10:1 to 1:

5.

127. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more self-emulsifying systems comprise one or more isolated or synthetic cannabinoids and one or more lipids in a cannabinoid to lipid weight ratio of 8:1 to 1:

2.

128. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more self-emulsifying systems comprise one or more isolated or synthetic cannabinoids and one or more lipids in a cannabinoid to lipid weight ratio of 4:1 to 1:

2.

129. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more self-emulsifying systems comprise one or more isolated or synthetic cannabinoids and one or more lipids in a cannabinoid to lipid weight ratio of 3:1 to 1:

1.

130. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more self-emulsifying systems comprise one or more isolated or synthetic cannabinoids and one or more waxes in a cannabinoid to wax weight ratio of 10:1 to 1:

10.

131. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims. Petition 870260085113, dated 08 / 21 / 2026, p. 147 / 314 27 / 34, characterized in that one or more self-emulsifying systems comprise one or more isolated or synthetic cannabinoids and one or more waxes in a cannabinoid to wax weight ratio of 10:1 to 1:

5.

132. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more self-emulsifying systems comprise one or more isolated or synthetic cannabinoids and one or more waxes in a cannabinoid to wax weight ratio of 8:1 to 1:

2.

133. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more self-emulsifying systems comprise one or more isolated or synthetic cannabinoids and one or more waxes in a cannabinoid to wax weight ratio of 4:1 to 1:

2.

134. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more self-emulsifying systems comprise one or more isolated or synthetic cannabinoids and one or more waxes in a cannabinoid to wax weight ratio of 3:1 to 1:

1.

135. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that one or more carrier systems comprise one or more solid carriers and the one or more carrier systems comprise one or more liquid or solid self-emulsifying systems in a solid carrier to liquid or solid self-emulsifying system weight ratio of 2:8 to 8:

2.

136. Orally dissolvable or chewable compressed powder formulation Petition 870260085113, dated 08 / 21 / 2026, page 148 / 314 28 / 34, according to any of the preceding claims, characterized in that one or more carrier systems comprise one or more solid carriers and one or more carrier systems comprise one or more liquid or solid self-emulsifying systems in a solid to liquid carrier or solid self-emulsifying system weight ratio of 4:6 to 6:

4.

137. Orally dissolvable or chewable tablet powder formulation, according to any of the preceding claims, characterized in that one or more liquid or solid self-emulsifying systems loaded with cannabinoids in an amount of at least 10% by weight of the tablet powder formulation comprises at least two separate liquid or solid self-emulsifying systems.

138. Orally dissolvable or chewable compressed powder formulation according to claim 137, characterized in that a first liquid or solid self-emulsifying system comprises one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety, and a second liquid or solid self-emulsifying system comprises one or more surfactants having a chemical structure that does not have a polyethylene glycol (PEG) moiety.

139. Orally dissolvable or chewable compressed powder formulation according to claim 138, characterized in that one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety in the first liquid or solid self-emulsifying system is present in an amount of at least 20% by weight of the first liquid or solid self-emulsifying system.

140. Orally dissolvable or chewable compressed powder formulation according to claim 138 or 139, characterized by the fact that one or more surfactants having a chemical structure that does not include a polyethylene glycol (PEG) moiety in the second liquid or solid self-emulsifying system is present in an amount of at least 5% by weight of the second liquid or solid self-emulsifying system.

141. Orally dissolvable or chewable powder tablet formulation according to any one of claims 138 to 140, characterized in that the first liquid or solid self-emulsifying system is located in a first compartment or module of the orally dissolvable or chewable powder tablet formulation, and a second compartment or module of the orally dissolvable or chewable powder tablet formulation comprises the second liquid or solid self-emulsifying system.

142. Orally dissolvable or chewable powder-compressed formulation, according to any of the preceding claims, characterized in that the orally dissolvable or chewable powder-compressed formulation is an orally dissolvable tablet.

143. Orally dissolvable or chewable powder-compressed formulation, according to any of the preceding claims, characterized in that the orally dissolvable or chewable powder-compressed formulation is an orally dissolvable tablet that disintegrates in the oral cavity within 2 minutes of oral administration.

144. Orally dissolvable or chewable powder-compressed formulation, according to any of the preceding claims, characterized in that the orally dissolvable or chewable powder-compressed formulation is a chewable tablet.

145. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims. Petition 870260085113, dated 08 / 21 / 2026, page 150 / 314 30 / 34, characterized in that the orally dissolvable or chewable compressed powder formulation is a lozenge comprising particulate ingredients.

146. Orally dissolvable or chewable compressed powder formulation, according to any of the preceding claims, characterized in that the orally dissolvable or chewable compressed powder formulation comprises a gum base.

147. Orally dissolvable or chewable powder-compressed formulation, according to any of the preceding claims, characterized in that the orally dissolvable or chewable powder-compressed formulation is a chewable gum tablet.

148. Orally dissolvable or chewable powder tablet formulation, according to any of the preceding claims, characterized in that the unit weight of the orally dissolvable or chewable powder tablet formulation is from 400 to 2000 mg.

149. An orally dissolvable or chewable powder formulation characterized in that it comprises: one or more carrier systems comprising one or more liquid or solid self-emulsifying systems loaded with cannabinoids in an amount of at least 10% by weight of the powder formulation; or one or more self-emulsifying systems including: i) at least one or more surfactants, one or more lipids and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a liquid self-emulsifying system, and ii) at least one or more surfactants, one or more waxes and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a solid self-emulsifying system; Petition 870260085113, dated 08 / 21 / 2026, p.151 / 314 31 / 34 one or more water-soluble agents in an amount of 20 to 80% by weight of the powder formulation; and one or more flavorings, wherein one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety.

150. Orally dissolvable or chewable powder formulation according to claim 149, characterized in that it is also as defined in any one of claims 2 to 141.

151. Stick pack, characterized in that it comprises an orally dissolvable or chewable powder formulation comprising: one or more carrier systems comprising one or more liquid or solid self-emulsifying systems loaded with cannabinoids in an amount of at least 10% by weight of the powder formulation; or one or more self-emulsifying systems including: i) at least one or more surfactants, one or more lipids and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a liquid self-emulsifying system, and ii) at least one or more surfactants, one or more waxes and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a solid self-emulsifying system; one or more water-soluble agents in an amount of 20 to 80% by weight of the powder formulation;and one or more flavorings, wherein one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety.

152. Toothpick package, according to claim 151, Petition 870260085113, dated 08 / 21 / 2026, pp. 152 / 314 32 / 34, characterized in that the unit weight of the orally dissolvable or chewable powder formulation is 400 to 2000 mg.

153. Toothpick package, according to claim 151 or 152, characterized in that it is as defined in any one of claims 2 to 141.

154. Sachet, characterized in that it comprises an orally dissolvable or chewable powder formulation comprising: one or more carrier systems comprising one or more liquid or solid self-emulsifying systems loaded with cannabinoids in an amount of at least 10% by weight of the powder formulation; or one or more self-emulsifying systems including: i) at least one or more surfactants, one or more lipids and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a liquid self-emulsifying system, and ii) at least one or more surfactants, one or more waxes and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a solid self-emulsifying system; one or more water-soluble agents in an amount of 20 to 80% by weight of the powder formulation;and one or more flavorings, wherein one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety.

155. Sachet, according to claim 154, characterized in that the unit weight of the orally dissolvable or chewable powder formulation is from 400 to 2000 mg.

156. Sachet, according to claim 154 or 155, characterized in that it is as defined in any of claims 2 to 141. Petition 870260085113, dated 08 / 21 / 2026, pp. 153 / 314 33 / 34 157. Pouch, characterized in that it comprises an orally dissolvable or chewable powder formulation comprising: one or more carrier systems comprising one or more liquid or solid self-emulsifying systems loaded with cannabinoids in an amount of at least 10% by weight of the powder formulation; or one or more self-emulsifying systems including: i) at least one or more surfactants, one or more lipids and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a liquid self-emulsifying system, and ii) at least one or more surfactants, one or more waxes and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a solid self-emulsifying system; one or more water-soluble agents in an amount of 20 to 80% by weight of the powder formulation;and one or more flavorings, wherein one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety.

158. Pouch, according to claim 157, characterized in that the unit weight of the orally dissolvable or chewable powder formulation is from 400 to 2000 mg.

159. Bag, according to claim 157 or 158, characterized in that it is as defined in any of claims 2 to 141.

160. Capsule formulation, characterized in that it comprises: one or more carrier systems comprising one or more liquid or solid self-emulsifying systems loaded with cannabinoids in an amount of at least 10% by weight of the formulation; or one or more self-emulsifying systems including: i) at least one or more surfactants, one or more lipids and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a liquid self-emulsifying system, and ii) at least one or more surfactants, one or more waxes and one or more isolated or synthetic cannabinoids when the self-emulsifying system is a solid self-emulsifying system; one or more water-soluble agents in an amount of 20 to 80% by weight of the formulation; and one or more flavorings, wherein one or more surfactants comprise one or more surfactants having a chemical structure that includes a polyethylene glycol (PEG) moiety.

161. Capsule, according to claim 160, characterized in that the unit weight of the formulation is from 400 to 2000 mg.

162. Capsule, according to claim 160 or 161, characterized in that it comprises an orally dissolvable or chewable powder formulation.

163. Capsule, according to any one of claims 160 to 162, characterized in that it is as defined in any one of claims 2 to 141. Petition 870260085113, dated 21 / 08 / 2026, pp. 155 / 314