Compositions and methods for treating epilepsy

Abstract

[Solution] Disclosed herein are compositions and methods for delivering compositions to a subject in need of treatment for epilepsy. The disclosed compositions are delivered orally. Additionally, disclosed are kits containing the disclosed compositions as part of a method for delivering cannabidiol- and CBD-containing compositions to a subject in need of treatment for epilepsy.

Description

[Technical Field]

[0001] Disclosed herein are compositions and methods for delivering compositions to a subject in need of treatment for epilepsy. The disclosed compositions are delivered orally. Additionally, disclosed are kits containing the disclosed compositions as part of a method for delivering cannabidiol- and CBD-containing compositions to a subject in need of treatment for epilepsy. [Brief explanation of the drawings]

[0002] [Figure 1] FIG. 1 compares the results of a cannabidiol steady-state study performed by Devinsky (see Devinsky, O. et al., "Randomized, dose-ranging safety trial of cannabidiol in Dravet syndrome," Neurology 2018, Vol. 90, pp. e1204-e1211) to the disclosed steady-state study of the disclosed compositions in humans at two time points. The black line connects the two steady-state points obtained in this study. The dotted black line extrapolates the results of this data to Devinsky's point at approximately 5 mg / kg / day, demonstrating the achievement of pre-dose steady-state cannabidiol plasma levels of greater than 60 ng / mL versus the approximately 22 ng / mL achieved by Devinsky. [Figure 2] Figure 2 shows plasma alanine transaminase concentrations for CBD and placebo. Figure 2 indicates that plasma alanine transaminase concentrations remained effectively unchanged over time. [Figure 3] FIG. 3 shows plasma alkaline phosphatase concentrations for CBD and placebo. [Figure 4]Figure 4 indicates that plasma alkaline phosphatase remained effectively unchanged over time. Figure 4 shows plasma total bilirubin concentrations for CBD and placebo. Figure 4 indicates that plasma total bilirubin concentrations remained effectively unchanged over time. [Figure 5] Figure 5 shows plasma gamma-glutamyltransferase levels for CBD and placebo, indicating that plasma gamma-glutamyltransferase levels remained effectively unchanged over time. [Figure 6] Figure 6 shows plasma aspartate transaminase concentrations for CBD and placebo. Figure 6 indicates that plasma aspartate transaminase concentrations remained effectively unchanged over time. DETAILED DESCRIPTION OF THE INVENTION

[0003] The materials, compounds, compositions, articles, and methods described herein may be more readily understood by reference to the following detailed description of specific embodiments of the disclosed subject matter and the examples included therein.

[0004] Also, various publications are referenced throughout this specification. The disclosures of these publications in their entireties are hereby incorporated by reference into this application in order to more fully describe the state of the art to which the disclosed subject matter pertains. The references disclosed are also individually and specifically incorporated by reference into this application for the material contained in them that is discussed in the sentence in which the reference is relied upon.

[0005] General definition In this specification and in the claims that follow, reference will be made to a number of terms, which shall be defined to have the following meanings.

[0006] All percentages, ratios, and proportions herein are by weight unless otherwise specified. All temperatures are in degrees Celsius (°C) unless otherwise specified.

[0007] Unless this disclosure expressly requires otherwise, the terms "a" and "an" are defined as one or more.

[0008] Ranges may be expressed herein as from "about" one particular value and / or to "about" another particular value. When such a range is expressed, another embodiment includes from the one particular value and / or to the other particular value. Similarly, when values ​​are expressed as approximations, by use of "about," the particular value will be understood to form another embodiment. Further, it will be understood that each of the endpoints of a range is significant both in relation to the other endpoint, and independently of the other endpoint.

[0009] The terms "comprise" (and any form of "comprise," e.g., "comprises" and "comprising"), "have" (and any form of "have," e.g., "has" and "having"), "include" (and any form of "include," e.g., "includes" and "including"), and "contain" (and any form of "contain," e.g., "contains" and "containing") are open linking verbs. Consequently, an apparatus that "comprises," "has," "includes," or "contains" one or more elements includes, but is not limited to, including only, those one or more elements. Similarly, a method that "comprises," "has," "includes," or "contains" one or more steps includes, but is not limited to, including only those one or more steps.

[0010] Any embodiment of any of the disclosed methods or compositions may consist of or consist essentially of any of the recited steps, elements, and / or features, rather than comprising / comprising / containing / having. Thus, in any of the claims, the terms "consisting of" or "consisting essentially of" may be substituted for any of the open linking verbs listed above to modify the scope of a given claim from what it would otherwise be using the open linking verb.

[0011] The term "subject" as used herein refers to a human or animal that would benefit from being administered the disclosed compositions described herein, for example, without limitation, those suffering from one or more forms of epilepsy.

[0012] As used herein, the terms "treat," "treating," "treatment," and the like refer to reducing or ameliorating a disorder and / or its associated symptoms. It will be understood, although not excluded, that treating epilepsy does not require that epilepsy or any condition or symptom associated with epilepsy be completely eliminated.

[0013] As used herein, the terms "prevent," "preventing," "prevention," "prophylaxis," and the like are subsumed within the term "treating" and refer to reducing the probability of developing a disorder or condition in a subject who does not have the disorder or condition but is at risk or predisposed to developing it.

[0014] As used herein, "pharmaceutically acceptable" means physiologically tolerable for either human or veterinary medical use. In addition, "pharmaceutically acceptable" refers to a material that is not biologically or otherwise undesirable. That is, the material can be administered to a subject without causing any adverse biological effects or interacting in a deleterious manner with any of the other components of the pharmaceutical composition in which it is contained. Essentially, a pharmaceutically acceptable material is non-toxic to the recipient. The carrier would naturally be selected to minimize any degradation of the active ingredient and to minimize any adverse side effects in the subject, as would be well known to one of skill in the art. For a discussion of pharmaceutically acceptable carriers and other components of pharmaceutical compositions, see, e.g., Remington's Pharmaceutical Sciences, 18th ed., Mack Publishing Company, 1990.

[0015] The term "pharmaceutical composition" is defined herein as a composition approved by a regulatory agency, such as the Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Pharmaceutical and Food Safety Bureau of Japan (PFSB), and the like.

[0016] The term "over the counter" or "OTC" or "non-pharmaceutical" is defined herein as the disclosed compositions that can be purchased and sold without a prescription.

[0017] Unless expressly prohibited by the nature of the disclosure or the embodiments, feature(s) of one embodiment may be applied to other embodiments without being described or illustrated.

[0018] Unless defined otherwise, all scientific and technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the described invention, the preferred methods and materials are described herein. All publications mentioned in this application are incorporated by reference herein to disclose and describe the methods and / or materials in connection with which the publications are cited.

[0019] Cannabidiol Cannabidiol (CBD) is a non-psychoactive component of Cannabis sativa. It is one of the main components of cannabis plant extracts. CBD oil is a commercial term, but the amount of cannabidiol present in CBD oil varies depending on the method of extraction.

[0020] In general, CBD oil (an extract of Cannabis sativa) is defined in part by the following, which are currently accepted guidelines for the content and quality of CBD oil:

[0021] Full-spectrum CBD products generally contain the full range of terpenes and cannabinoids present in the source plant (including any trace amounts of THC), which boosts the so-called entourage effect when consumed. This is the crudest form of CBD oil.

[0022] Broad-spectrum CBD products generally contain all or most of the terpenes present in the source plant and several other cannabinoids in addition to CBD, but most or all of the THC has been removed. Typically, the amount of THC is less than about 0.5%. However, extracted cannabidiol, either in the form of CBD and / or cannabis oil, contains less than about 0.15% THC by weight. This form is typically used for over-the-counter applications and is frequently known as a CBD "tincture." This tincture is typically sold in an eyedropper for sublingual use.

[0023] Isolates are pure CBD with substantially all other compounds removed. While isolate CBD products have their own unique benefits, they do not offer the same entourage effect that full- or broad-spectrum CBD products can. This is near-chemically pure cannabidiol (generally at least about 98%-99% cannabidiol) in powder form rather than liquid oil, which is suitable for many applications, including in pharmaceutical preparations when manufactured according to pharmaceutical standards and in pre-drug "proof-of-concept" testing. For purposes of this disclosure, cannabidiol refers to an isolate having greater than about 98% by weight of 2-[(1R,6R)-6-isopropenyl-3-methylcyclohex-2-en-1-yl]-5-pentylbenzene-1,3-diol. Additionally, the cannabidiol used to formulate the disclosed pharmaceutical compositions contains less than about 0.15% Δ 9 -Contains tetrahydrocannabinol (THC).

[0024] The term "full-spectrum CBD" is defined above. The term "CBD" or "CBD oil" refers to "broad-spectrum CBD" as defined above. Those skilled in the art of formulating cannabidiol will recognize that pharmaceutical compositions require cannabidiol to be present in a pure form. Therefore, CBD, CBD oil, etc., may be suitable only for non-prescription or over-the-counter formulations.

[0025] According to the present disclosure, the base composition may include CBD oil. As used herein, the term "CBD oil" refers to a cannabidiol-containing extract from the cannabis plant Cannabis sativa. The CBD oil useful for preparing the disclosed compositions may be a crude extract containing less than about 80% cannabidiol by weight. CBD oil used herein containing less than about 80% cannabidiol by weight is referred to as "crude CBD oil." When using a lower percentage extract, formulators will necessarily adjust the amount of CBD oil present in the disclosed compositions to ensure sufficient delivery of the desired amount of cannabidiol.

[0026] In one embodiment, the composition comprises a "cannabis distillate" containing about 80% to about 92% cannabidiol by weight. In yet a further embodiment, isolated, pure cannabidiol may be used in the composition. When a cannabis distillate containing 80% to about 92% cannabidiol by weight is used, the term "CBD oil" applies. In some descriptions of "CBD oil," this component may be referred to as "CBD resin." All CBD oil compositions contain CBD oil with less than 0.3% tetrahydrocannabinol (THC) by weight.

[0027] composition Various embodiments of the disclosed compositions and methods relate to compositions containing cannabidiol. Cannabidiol has the chemical name 2-[(1R,6R)-6-isopropenyl-3-methylcyclohex-2-en-1-yl]-5-pentylbenzene-1,3-diol. The disclosed compositions of this embodiment include CBD oil containing about 80% to about 92% cannabidiol by weight. Additionally, CBD oil extracts containing about 98% or more cannabidiol by weight contain less than about 0.15% THC.

[0028] One embodiment of the disclosed composition In one embodiment, the disclosed composition comprises: a) about 5% to about 20% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 15% to about 40% by weight of sunflower oil; c) about 5% to about 15% by weight of one or more bile salts, and d) about 35% to about 75% by weight of one or more carriers.

[0029] In one embodiment, the disclosed composition comprises: a) about 5% to about 20% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 15% to about 40% by weight of sunflower oil; c) about 7% to about 12% by weight of one or more bile salts, wherein the salts contain about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; and d) about 40% to about 70% by weight of one or more carriers selected from gum arabic, tapioca starch, tapioca flour, silicon dioxide, mannitol, colloidal silicon dioxide, microcrystalline cellulose, and mixtures thereof.

[0030] In one iteration of this embodiment, the disclosed compounds include: a) about 10% to about 30% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 20% to about 30% by weight of sunflower oil; c) about 7% to about 12% by weight of one or more bile salts, wherein the salts contain about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; and d) about 40% to about 70% by weight of tapioca starch, colloidal silicon dioxide, microcrystalline cellulose, and mixtures thereof.

[0031] In further embodiments, the disclosed compositions include: a) about 10% to about 20% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 22% to about 28% by weight sunflower oil; c) about 8% to about 11% by weight of one or more bile salts, wherein the salts contain about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; and d) about 45% to about 55% by weight of one or more carriers selected from gum arabic, tapioca starch, tapioca flour, silicon dioxide, mannitol, colloidal silicon dioxide, and mixtures thereof.

[0032] In one iteration of this embodiment, the disclosed composition includes: a) about 10% to about 20% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 22% to about 28% by weight sunflower oil; c) about 8% to about 11% by weight of one or more bile salts, wherein the salts contain about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; and d) about 45% to about 55% by weight of tapioca starch, colloidal silicon dioxide, and mixtures thereof.

[0033] One non-limiting example of this iteration includes a disclosed composition comprising: a) about 13.4% by weight CBD oil containing about 88% to about 91% by weight cannabidiol; b) approximately 26.8% sunflower oil by weight; c) about 10% by weight of one or more bile salts; and d) Approximately 25.4% by weight tapioca starch and 24.4% by weight colloidal silicon dioxide.

[0034] The disclosed compositions may contain about 5% to about 20% CBD oil by weight containing about 88% to about 91% cannabidiol by weight. In one embodiment, the composition may contain about 10% to about 30% cannabidiol by weight. In another embodiment, the composition may contain about 10% to about 20% cannabidiol by weight. For example, the amount of cannabidiol may be 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, or 20% CBD oil containing, for example, about 88% to about 91% cannabidiol by weight.

[0035] This aspect of the disclosed composition comprises about 15% to about 40% sunflower oil by weight. In one embodiment, the composition comprises about 20% to about 30% sunflower oil by weight. In another embodiment, the composition comprises about 22% to about 28% sunflower oil by weight.

[0036] The disclosed compositions can include about 15% to about 40% sunflower oil by weight, for example, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, or 40% sunflower oil by weight.

[0037] In one embodiment, the disclosed compositions for use in treating epilepsy include: a) about 30 mg to about 135 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 60 mg to about 270 mg of sunflower oil; c) about 25 mg to about 100 mg of one or more bile salts, wherein the salts contain about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; and d) 120 mg to about 500 mg of one or more carriers.

[0038] In one iteration of this embodiment, the disclosed composition for use in treating epilepsy includes: a) about 30 mg to about 87 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 60 mg to about 174 mg of sunflower oil; c) about 25 mg to about 65 mg of one or more bile salts, wherein the salts contain about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; and d) about 120 mg to about 324 mg of one or more carriers.

[0039] In one embodiment, the disclosed compositions for use in treating epilepsy include: a) about 30 mg to about 87 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 60 mg to about 174 mg of sunflower oil; c) about 25 mg to about 65 mg of one or more bile salts, wherein the salts contain about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; and d) about 120 mg to about 324 mg of tapioca starch, colloidal silicon dioxide, and mixtures thereof.

[0040] In one iteration of this embodiment, the disclosed composition for use in treating epilepsy includes: a) about 67 mg to about 87 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 134 mg to about 174 mg of sunflower oil; c) about 50 mg to about 65 mg of one or more bile salts, wherein the salts contain about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; and d) about 250 mg to about 324 mg of one or more carriers.

[0041] In one embodiment, the disclosed compositions for use in treating epilepsy include: a) about 67 mg to about 87 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 134 mg to about 174 mg of sunflower oil; c) about 50 mg to about 65 mg of one or more bile salts, wherein the salts contain about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; and d) about 250 mg to about 324 mg of tapioca starch, colloidal silicon dioxide, and mixtures thereof.

[0042] In one embodiment of this aspect, the disclosed compositions for use in treating epilepsy include: a) about 30 mg to about 135 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 60 mg to about 270 mg of sunflower oil; c) about 25 mg to about 100 mg of one or more bile salts, wherein the salts contain about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; and d) about 120 mg to about 500 mg of one or more carriers.

[0043] In one iteration of this embodiment, the disclosed composition for use in treating epilepsy includes: a) about 30 mg to about 135 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 60 mg to about 270 mg of sunflower oil; c) about 25 mg to about 100 mg of one or more bile salts, wherein the salts contain about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; and d) about 120 mg to about 500 mg of tapioca starch, colloidal silicon dioxide, and mixtures thereof.

[0044] In one embodiment of this aspect, the disclosed compositions for use in treating epilepsy include: a) about 67 mg to about 135 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 134 mg to about 270 mg of sunflower oil; c) about 50 mg to about 100 mg of one or more bile salts, wherein the salts contain about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; and d) about 250 mg to about 500 mg of one or more carriers.

[0045] In one iteration of this embodiment, the disclosed composition for use in treating epilepsy includes: a) about 67 mg to about 135 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 134 mg to about 270 mg of sunflower oil; c) about 50 mg to about 100 mg of one or more bile salts, wherein the salts contain about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; and d) about 250 mg to about 500 mg of tapioca starch, colloidal silicon dioxide, and mixtures thereof.

[0046] In one embodiment of this aspect, the disclosed compositions for use in treating epilepsy include: a) about 87 mg to about 135 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 174 mg to about 270 mg of sunflower oil; c) about 65 mg to about 100 mg of one or more bile salts, wherein the salts contain about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; and d) about 324 mg to about 500 mg of one or more carriers.

[0047] In one iteration of this embodiment, the disclosed composition for use in treating epilepsy includes: a) about 87 mg to about 135 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 174 mg to about 270 mg of sunflower oil; c) about 65 mg to about 100 mg of one or more bile salts, wherein the salts contain about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; and d) about 324 mg to about 500 mg of tapioca starch, colloidal silicon dioxide, and mixtures thereof.

[0048] In one non-limiting example, the disclosed compositions include: a) approximately 30 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) approximately 60 mg of sunflower oil; c) about 25 mg of one or more bile salts, wherein the salts contain about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; and d) Approximately 63.4 mg tapioca starch and 61.1 mg colloidal silicon dioxide.

[0049] In a further non-limiting example, the disclosed compositions include: a) approximately 67 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) approximately 134 mg of sunflower oil; c) about 50 mg of one or more bile salts, wherein the salts contain about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; and d) about 127 mg tapioca starch and about 122 mg colloidal silicon dioxide.

[0050] In another non-limiting example, the disclosed compositions include: a) approximately 87 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) approximately 174 mg of sunflower oil; c) about 65 mg of one or more bile salts, wherein the salts contain about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; and d) about 165 mg tapioca starch and about 159 mg colloidal silicon dioxide.

[0051] In a still further non-limiting example, the disclosed composition comprises: a) approximately 135 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) approximately 270 mg of sunflower oil; c) about 100 mg of one or more bile salts, wherein the salts contain about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; and d) about 255 mg tapioca starch and about 245 mg colloidal silicon dioxide.

[0052] The disclosed compositions may contain about 30 mg to about 135 mg of CBD oil containing about 88% to about 91% cannabidiol. In another embodiment, the composition contains about 30 mg to about 87 mg of CBD oil containing about 88% to about 91% cannabidiol by weight. In a further embodiment, the composition contains about 67 mg to about 135 mg of CBD oil containing about 88% to about 91% cannabidiol by weight. In yet a further embodiment, the composition contains about 87 mg to about 135 mg of CBD oil containing about 88% to about 91% cannabidiol by weight.

[0053] The composition may comprise from about 30 to about 135 mg of CBD oil containing about 88% to about 91% cannabidiol by weight, such as 30 mg, 31 mg, 32 mg, 33 mg, 34 mg, 35 mg, 36 mg, 37 mg, 38 mg, 39 mg, 40 mg, 41 mg, 42 mg, 43 mg, 44 mg, 45 mg, 46 mg, 47 mg, 48 mg, 49 mg, 50 mg, 51 mg, 52 mg, 53 mg, 54 mg, 55 mg, 56 mg, 57 mg, 58 mg, 59 mg, 60 mg, 61 mg, 62 mg, 63 mg, 64 mg, 65 mg, 66 mg, 67 mg, 68 mg, 69 mg, 70 mg, 71 mg, 72 mg, 73 mg, 74 mg, 75 mg, 76 mg, , 77mg, 78mg, 79mg, 80mg, 81mg, 82mg, 83mg, 84mg, 85mg, 86mg, 87mg, 88mg, 89mg, 90mg, 91mg, 92 mg, 93mg, 94mg, 95mg, 96mg, 97mg, 98mg, 99mg, 100mg, 101mg, 102,mg, 103,mg, 104mg, 105mg, 106 mg, 107mg, 108mg, 109mg, 110mg, 111mg, 112mg, 113mg, 114mg, 115mg, 116mg, 117mg, 118mg, 119mg, 120mg, 121mg, 122mg, 123mg, 124mg, 125mg, 126mg, 127mg, 128mg, 129mg, 130mg of CBD oil.

[0054] The disclosed compositions may contain about 60 mg to about 270 mg of sunflower oil. In one embodiment, the composition contains about 60 mg to about 174 mg of sunflower oil. In another embodiment, the composition contains about 134 mg to about 174 mg of sunflower oil. In a further embodiment, the composition contains about 60 mg to about 215 mg of sunflower oil. In yet a further embodiment, the composition contains about 134 mg to about 270 mg of sunflower oil.

[0055] The disclosed compositions may contain from about 60 mg to about 270 mg of sunflower oil, e.g., 60 mg, 61 mg, 62 mg, 63 mg, 64 mg, 65 mg, 66 mg, 67 mg, 68 mg, 69 mg, 70 mg, 71 mg, 72 mg, 73 mg, 74 mg, 75 mg, 76 mg, 77 mg, 78 mg, 79 mg, 80 mg, 81 mg, 82 mg, 83 mg, 84 mg, 85 mg, 86 mg, 87 mg, 88 mg, 89 mg, 90 mg, 91 mg, 92 mg, 93 mg, 94 mg, 95 mg, 96 mg, 97 mg, 98 mg, 99 mg, 100 mg, 101 mg, 102 mg , 103mg, 104mg, 105mg, 106mg, 107mg, 108mg, 109mg, 110mg, 111mg, 112mg, 113mg, 114mg, 115mg, 116mg, 117mg, 118mg, 119mg, 120mg, 121mg, 122mg, 123m g, 124mg, 125mg, 126mg, 127mg, 128mg, 129mg, 130mg, 131mg, 132mg, 133mg, 134mg, 135mg, 136mg, 137mg, 138mg, 139mg, 140mg, 141mg, 142mg, 143mg, 144 mg, 145mg, 146mg, 147mg, 148mg, 149mg, 150mg, 151mg, 152mg, 153mg, 154mg, 155mg, 156mg, 157mg, 158mg, 159mg, 160mg, 161mg, 162mg, 163mg, 164mg, 16 5mg, 166mg, 167mg, 168mg, 169mg, 170mg, 171mg, 172mg, 173mg, 174mg, 175mg, 167mg, 177mg, 178mg, 179mg, 180mg, 181mg, 182mg, 183mg, 184mg, 185mg, 1 86mg, 187mg, 188mg, 189mg, 190mg, 191mg, 192mg, 193mg, 194mg, 195mg, 196mg, 197mg, 198mg, 199mg, 200mg, 201mg, 202mg, 203mg, 204mg, 205mg, 206mg, 207mg, 208mg, 209mg, 210mg, 211mg, 212mg, 213mg, 214mg, 215mg, 216mg, 217mg, 218mg, 219mg, 220mg, 221mg, 222mg, 223mg, 224mg, 225mg, 226mg, 227mg,The composition may contain 228mg, 229mg, 230mg, 231mg, 232mg, 233mg, 234mg, 235mg, 236mg, 237mg, 238mg, 239mg, 240mg, 241mg, 242mg, 243mg, 244mg, 245mg, 246mg, 247mg, 248mg, 249mg, 250mg, 251mg, 252mg, 253mg, 254mg, 255mg, 256mg, 257mg, 258mg, 259mg, 260mg, 261mg, 262mg, 263mg, 264mg, 265mg, 266mg, 267mg, 268mg, 269mg, or 270mg of sunflower oil.

[0056] According to this embodiment, the ratio of CBD oil containing about 88% to about 92% cannabidiol by weight to sunflower oil is about 1:1 to about 1:3. For example, the ratio of CBD oil containing about 88% to about 92% cannabidiol by weight to sunflower oil can be 1:1, 1:1.1, 1:1.2, 1:1.3, 1:1.4, 1:1.5, 1:1.6, 1:1.7, 1:1.8, 1:1.9, 1:2, 1:2.1, 1:2.2, 1:2.3, 1:2.4, 1:2.5, 1:2.6, 1:2.7, 1:2.8, 1:2.9, or 1:3.

[0057] The disclosed compositions of this embodiment are free-flowing solids that do not contain water or moisture. Typically, the compositions are dried by any means necessary before being formed into capsules, pellets, pills, and the like. Depending on the end use, formulators may reconstitute the compositions with aqueous carriers. In that case, the further addition of an emulsifier, typically added by the user, may be necessary.

[0058] In one embodiment, the one or more carriers are not organic or inorganic acids that can lead to decarboxylation of sodium bicarbonate, especially when reconstituted by the formulator as an aqueous solution.

[0059] In this embodiment, the disclosed compositions are free-flowing solids that do not contain water or moisture. Generally, the compositions are dried by any means necessary before being formed into capsules, pellets, pills, and the like. Depending on the end use, formulators may reconstitute the compositions with aqueous carriers. In that case, the further addition of a user-added emulsifier may be necessary.

[0060] Table 1 below provides non-limiting examples of this embodiment of the disclosed compositions.

[0061] [Table 1]

[0062] Other aspects of the disclosed compositions Another aspect of the present disclosure relates to a composition comprising: a) about 5% to about 25% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) from about 5% to about 60% by weight of one or more edible oils; c) about 0.1% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 10% to about 20% by weight sodium bicarbonate, and e) The remainder is the carrier.

[0063] In one embodiment of this aspect, the composition comprises: a) about 5% to about 25% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) from about 5% to about 60% by weight of one or more edible oils; c) about 0.1% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 10% to about 20% by weight sodium bicarbonate, and e) about 30% to about 85% gum arabic by weight;

[0064] In one iteration of this embodiment, the composition includes: a) about 5% to about 25% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 5% to about 60% by weight of sunflower oil; c) about 0.1% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 10% to about 20% by weight sodium bicarbonate, and e) about 30% to about 85% gum arabic by weight;

[0065] In another iteration of this embodiment, the composition includes: a) about 5% to about 25% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 5% to about 60% by weight coconut oil; c) about 0.1% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 10% to about 20% by weight sodium bicarbonate, and e) about 30% to about 85% gum arabic by weight;

[0066] In a further iteration of this embodiment, the composition comprises: a) about 5% to about 25% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 5% to about 60% by weight of sesame oil; c) about 0.1% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 10% to about 20% by weight sodium bicarbonate, and e) about 30% to about 85% gum arabic by weight;

[0067] In another embodiment of this aspect, the composition comprises: a) about 10% to about 20% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 10% to about 40% by weight of one or more edible oils; c) about 0.5% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 10% to about 20% by weight sodium bicarbonate, and e) about 30% to about 85% gum arabic by weight;

[0068] In one iteration of this embodiment, the composition includes: a) about 10% to about 20% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 10% to about 40% by weight of sunflower oil; c) about 0.5% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 10% to about 20% by weight sodium bicarbonate, and e) About 40% to about 70% gum arabic by weight.

[0069] In one iteration of this embodiment, the composition includes: a) about 10% to about 20% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 10% to about 40% by weight of coconut oil; c) about 0.5% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 10% to about 20% by weight sodium bicarbonate, and e) About 40% to about 70% gum arabic by weight.

[0070] In one iteration of this embodiment, the composition includes: a) about 10% to about 20% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 10% to about 40% by weight of sesame oil; c) about 0.5% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 10% to about 20% by weight sodium bicarbonate, and e) About 40% to about 70% gum arabic by weight.

[0071] In one embodiment of this aspect, the composition comprises: a) about 15% to about 20% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 15% to about 40% by weight of one or more edible oils; c) about 0.5% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 12% to about 17% by weight sodium bicarbonate; and e) About 40% to about 80% gum arabic by weight.

[0072] In one iteration of this embodiment, the composition includes: a) about 15% to about 20% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 15% to about 40% by weight of sunflower oil; c) about 0.5% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 12% to about 17% by weight sodium bicarbonate; and e) About 40% to about 70% gum arabic by weight.

[0073] In one iteration of this embodiment, the composition includes: a) about 15% to about 20% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 15% to about 40% by weight coconut oil; c) about 0.5% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 12% to about 17% by weight sodium bicarbonate; and e) About 40% to about 70% gum arabic by weight.

[0074] In one iteration of this embodiment, the composition includes: a) about 15% to about 20% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 15% to about 40% by weight of sesame oil; c) about 0.5% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 12% to about 17% by weight sodium bicarbonate; and e) About 40% to about 70% gum arabic by weight.

[0075] In another embodiment of this aspect, the composition comprises: a) about 10% to about 20% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 10% to about 40% by weight of one or more edible oils; c) about 0.5% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 10% to about 20% by weight sodium bicarbonate, and e) about 30% to about 75% gum arabic by weight.

[0076] In one iteration of this embodiment, the composition includes: a) about 10% to about 20% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 10% to about 40% by weight of sunflower oil; c) about 0.5% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 10% to about 20% by weight sodium bicarbonate, and e) About 40% to about 70% gum arabic by weight.

[0077] In a further iteration of this embodiment, the composition comprises: a) about 10% to about 20% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 10% to about 40% by weight of coconut oil; c) about 0.5% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 10% to about 20% by weight sodium bicarbonate, and e) About 40% to about 70% gum arabic by weight.

[0078] In another iteration of this embodiment, the composition includes: a) about 10% to about 20% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 10% to about 40% by weight of sesame oil; c) about 0.5% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 10% to about 20% by weight sodium bicarbonate, and e) About 40% to about 70% gum arabic by weight.

[0079] In one embodiment of this aspect, the composition comprises: a) about 15% to about 20% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 15% to about 40% by weight of sunflower oil; c) about 0.5% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 12% to about 17% by weight sodium bicarbonate; and e) About 40% to about 80% gum arabic by weight.

[0080] In one iteration of this embodiment, the composition includes: a) about 15% to about 20% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 15% to about 40% by weight of sunflower oil; c) about 0.5% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 12% to about 17% by weight sodium bicarbonate; and e) About 40% to about 80% gum arabic by weight.

[0081] In one iteration of this embodiment, the composition includes: a) about 15% to about 20% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 15% to about 40% by weight coconut oil; c) about 0.5% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 12% to about 17% by weight sodium bicarbonate; and e) About 40% to about 80% gum arabic by weight.

[0082] In one iteration of this embodiment, the composition includes: a) about 15% to about 20% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 15% to about 40% by weight of sesame oil; c) about 0.5% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 12% to about 17% by weight sodium bicarbonate; and e) The balance is about 40% to about 80% by weight gum arabic.

[0083] In another embodiment of the disclosed composition, the composition comprises: a) about 5% to about 25% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) from about 5% to about 60% by weight of one or more edible oils; c) about 0.1% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 10% to about 20% by weight sodium bicarbonate, and e) The remainder is the carrier.

[0084] In one embodiment of this aspect, the composition comprises: a) about 5% to about 25% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 5% to about 60% by weight of one or more edible oils selected from sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, and peanut oil; c) about 0.1% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 10% to about 20% by weight sodium bicarbonate, and e) about 30% to about 85% gum arabic by weight;

[0085] In one iteration of this embodiment, the composition includes: a) about 5% to about 25% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 5% to about 60% by weight of sunflower oil; c) about 0.1% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 10% to about 20% by weight sodium bicarbonate, and e) about 30% to about 85% gum arabic by weight;

[0086] In one iteration of this embodiment, the composition includes: a) about 5% to about 25% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 5% to about 60% by weight coconut; c) about 0.1% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 10% to about 20% by weight sodium bicarbonate, and e) about 30% to about 85% gum arabic by weight;

[0087] In one iteration of this embodiment, the composition includes: a) about 5% to about 25% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 5% to about 60% by weight of sesame oil; c) about 0.1% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 10% to about 20% by weight sodium bicarbonate, and e) about 30% to about 85% gum arabic by weight;

[0088] In another embodiment of this aspect, the composition comprises: a) about 10% to about 20% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 10% to about 40% by weight of one or more edible oils selected from sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, and peanut oil; c) about 0.5% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 10% to about 20% by weight sodium bicarbonate, and e) about 30% to about 85% by weight of a carrier selected from mannitol, colloidal silicon dioxide, tapioca starch, gum arabic, and mixtures thereof.

[0089] In one iteration of this embodiment, the composition includes: a) about 10% to about 20% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 10% to about 40% by weight of sunflower oil; c) about 0.5% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 10% to about 20% by weight sodium bicarbonate, and e) about 30% to about 85% gum arabic by weight;

[0090] In one iteration of this embodiment, the composition includes: a) about 10% to about 20% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 10% to about 40% by weight of coconut oil; c) about 0.5% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 10% to about 20% by weight sodium bicarbonate, and e) about 30% to about 85% gum arabic by weight;

[0091] In one iteration of this embodiment, the composition includes: a) about 10% to about 20% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 10% to about 40% by weight of sesame oil; c) about 0.5% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 10% to about 20% by weight sodium bicarbonate, and e) about 30% to about 85% gum arabic by weight;

[0092] In a further embodiment of this aspect, the composition comprises: a) about 15% to about 20% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 15% to about 40% by weight of one or more edible oils selected from sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, and peanut oil; c) about 0.5% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 12% to about 17% by weight sodium bicarbonate; and e) About 40% to about 80% gum arabic by weight.

[0093] In one iteration of this embodiment, the composition includes: a) about 15% to about 20% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 15% to about 40% by weight of sunflower oil; c) about 0.5% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 12% to about 17% by weight sodium bicarbonate; and e) about 40% to about 80% by weight of a carrier selected from mannitol (Partek-M™ mannitol), colloidal silicon dioxide (Aeroperl™ 300), and mixtures thereof.

[0094] In one iteration of this embodiment, the composition includes: a) about 15% to about 20% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 15% to about 40% by weight coconut oil; c) about 0.5% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 12% to about 17% by weight sodium bicarbonate; and e) About 40% to about 80% gum arabic by weight.

[0095] In one iteration of this embodiment, the composition includes: a) about 15% to about 20% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 15% to about 40% by weight of sesame oil; c) about 0.5% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 12% to about 17% by weight sodium bicarbonate; and e) About 40% to about 80% gum arabic by weight.

[0096] The disclosed compositions of this aspect comprise about 5% to about 25% CBD oil by weight. In one embodiment, the disclosed compositions may comprise about 10% to about 20% CBD oil by weight. In one embodiment, the compositions may comprise about 15% to about 20% CBD oil by weight. In another embodiment, the compositions may comprise about 10% to about 15% CBD oil by weight. In a further embodiment, the compositions may comprise about 12% to about 17% CBD oil by weight.

[0097] For example, the amount of CBD oil can be, for example, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, or 25%.

[0098] The disclosed compositions of this aspect may comprise about 5% to about 60% by weight of one or more edible oils. In one embodiment, the composition comprises about 10% to about 40% by weight of one or more edible oils. In one embodiment, the composition comprises about 15% to about 40% by weight of one or more edible oils. In one embodiment, the composition comprises about 20% to about 30% by weight of one or more edible oils. In one embodiment, the composition comprises about 25% to about 35% by weight of one or more edible oils. The disclosed compositions of this embodiment may contain from about 0.5% to about 60% by weight of one or more edible oils, for example, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31% by weight of one or more edible oils. , 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, 59%, or 60%, or any fraction thereof, of one or more sunflower oils.

[0099] In still further embodiments, the disclosed compositions include: a) about 5 mg to about 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 10 mg to about 65 mg of one or more edible oils selected from sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, and mixtures thereof; c) about 75 mg to about 300 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 35 mg to about 150 mg sodium bicarbonate, and e) about 110 mg to about 465 mg of a carrier.

[0100] In one embodiment of this aspect, the disclosed composition comprises: a) about 5 mg to about 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 10 mg to about 65 mg of one or more edible oils selected from sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, and mixtures thereof; c) about 75 mg to about 300 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 35 mg to about 150 mg sodium bicarbonate, and e) Approximately 110 mg to approximately 465 mg of gum arabic.

[0101] In one iteration of this embodiment, the disclosed composition includes: a) about 5 mg to about 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 10 mg to about 65 mg of sunflower oil; c) about 75 mg to about 300 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 35 mg to about 150 mg sodium bicarbonate, and e) Approximately 110 mg to approximately 465 mg of gum arabic.

[0102] In one iteration of this embodiment, the disclosed composition includes: a) about 5 mg to about 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 10 mg to about 65 mg of coconut oil; c) about 75 mg to about 300 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 35 mg to about 150 mg sodium bicarbonate, and e) Approximately 110 mg to approximately 465 mg of gum arabic.

[0103] In one iteration of this embodiment, the disclosed composition includes: a) about 5 mg to about 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 10 mg to about 65 mg of sesame oil; c) about 75 mg to about 300 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 35 mg to about 150 mg sodium bicarbonate, and e) Approximately 110 mg to approximately 465 mg of gum arabic.

[0104] In one iteration of this embodiment, the disclosed composition includes: a) about 10 mg to about 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 20 mg to about 65 mg of one or more edible oils selected from sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, and mixtures thereof; c) about 120 mg to about 300 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 60 mg to about 150 mg sodium bicarbonate, and e) Approximately 180 mg to approximately 465 mg of gum arabic.

[0105] In one iteration of this embodiment, the disclosed composition includes: a) about 10 mg to about 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 20 mg to about 65 mg of sunflower oil; c) about 120 mg to about 300 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 60 mg to about 150 mg sodium bicarbonate, and e) Approximately 180 mg to approximately 465 mg of gum arabic.

[0106] In one iteration of this embodiment, the disclosed composition includes: a) about 10 mg to about 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 20 mg to about 65 mg of coconut oil; c) about 120 mg to about 300 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 60 mg to about 150 mg sodium bicarbonate, and e) Approximately 180 mg to approximately 465 mg of gum arabic.

[0107] In one iteration of this embodiment, the disclosed composition includes: a) about 10 mg to about 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 20 mg to about 65 mg of sesame oil; c) about 120 mg to about 300 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 60 mg to about 150 mg sodium bicarbonate, and e) Approximately 180 mg to approximately 465 mg of gum arabic.

[0108] In a further iteration of this embodiment, the disclosed composition comprises: a) about 16 mg to about 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 35 mg to about 65 mg of one or more edible oils selected from sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, and mixtures thereof; c) about 180 mg to about 300 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 90 mg to about 150 mg sodium bicarbonate, and e) Approximately 270 mg to approximately 465 mg of gum arabic.

[0109] In a further iteration of this embodiment, the disclosed composition comprises: a) about 16 mg to about 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 35 mg to about 65 mg of sunflower oil; c) about 180 mg to about 300 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 90 mg to about 150 mg sodium bicarbonate, and e) Approximately 270 mg to approximately 465 mg of gum arabic.

[0110] In a further iteration of this embodiment, the disclosed composition comprises: a) about 16 mg to about 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 35 mg to about 65 mg of coconut oil; c) about 180 mg to about 300 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 90 mg to about 150 mg sodium bicarbonate, and e) Approximately 270 mg to approximately 465 mg of gum arabic.

[0111] In a further iteration of this embodiment, the disclosed composition comprises: a) about 16 mg to about 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 35 mg to about 65 mg of sesame oil; c) about 180 mg to about 300 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 90 mg to about 150 mg sodium bicarbonate, and e) Approximately 270 mg to approximately 465 mg of gum arabic.

[0112] In a further iteration of this embodiment, the disclosed composition comprises: a) about 23 mg to about 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 46 mg to about 65 mg of one or more edible oils selected from sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, and mixtures thereof; c) about 240 mg to about 300 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 120 mg to about 150 mg sodium bicarbonate, and e) Approximately 365 mg to approximately 465 mg of gum arabic.

[0113] In another iteration of this embodiment, the disclosed composition includes: a) about 23 mg to about 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 46 mg to about 65 mg of sunflower oil; c) about 240 mg to about 300 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 120 mg to about 150 mg sodium bicarbonate, and e) Approximately 365 mg to approximately 465 mg of gum arabic.

[0114] In still a further iteration of this embodiment, the disclosed composition comprises: a) about 23 mg to about 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 46 mg to about 65 mg of coconut oil; c) about 240 mg to about 300 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 120 mg to about 150 mg sodium bicarbonate, and e) Approximately 365 mg to approximately 465 mg of gum arabic.

[0115] In yet a further iteration of this embodiment, the disclosed composition comprises: a) about 23 mg to about 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 46 mg to about 65 mg of sesame oil; c) about 240 mg to about 300 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 120 mg to about 150 mg sodium bicarbonate, and e) Approximately 365 mg to approximately 465 mg of gum arabic.

[0116] In yet a further iteration of this embodiment, the disclosed composition comprises: a) about 10 mg to about 23 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 20 mg to about 46 mg of one or more edible oils selected from sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, and mixtures thereof; c) about 120 mg to about 240 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 120 mg to about 150 mg sodium bicarbonate, and e) Approximately 180 mg to approximately 365 mg of gum arabic.

[0117] In yet a further iteration of this embodiment, the disclosed composition comprises: a) about 10 mg to about 23 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 20 mg to about 46 mg of sunflower oil; c) about 120 mg to about 240 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 120 mg to about 150 mg sodium bicarbonate, and e) Approximately 180 mg to approximately 365 mg of gum arabic.

[0118] In yet a further iteration of this embodiment, the disclosed composition comprises: a) about 10 mg to about 23 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 20 mg to about 46 mg of coconut oil; c) about 120 mg to about 240 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 120 mg to about 150 mg sodium bicarbonate, and e) Approximately 180 mg to approximately 365 mg of gum arabic.

[0119] In yet a further iteration of this embodiment, the disclosed composition comprises: a) about 10 mg to about 23 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 20 mg to about 46 mg of sesame oil; c) about 120 mg to about 240 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 120 mg to about 150 mg sodium bicarbonate, and e) Approximately 180 mg to approximately 365 mg of gum arabic.

[0120] In another yet further iteration of this embodiment, the disclosed composition comprises: a) about 10 mg to about 16 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 20 mg to about 65 mg of one or more edible oils selected from sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, and mixtures thereof; c) about 180 mg to about 240 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 90 mg to about 150 mg sodium bicarbonate, and e) Approximately 180 mg to approximately 270 mg of gum arabic.

[0121] In another yet further iteration of this embodiment, the disclosed composition comprises: a) about 10 mg to about 16 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 20 mg to about 65 mg of sunflower oil; c) about 180 mg to about 240 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 90 mg to about 150 mg sodium bicarbonate, and e) Approximately 180 mg to approximately 270 mg of gum arabic.

[0122] In another yet further iteration of this embodiment, the disclosed composition comprises: a) about 10 mg to about 16 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 20 mg to about 65 mg of coconut oil; c) about 180 mg to about 240 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 90 mg to about 150 mg sodium bicarbonate, and e) Approximately 180 mg to approximately 270 mg of gum arabic.

[0123] In another yet further iteration of this embodiment, the disclosed composition comprises: a) about 10 mg to about 16 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 20 mg to about 65 mg of sesame oil; c) about 180 mg to about 240 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 90 mg to about 150 mg sodium bicarbonate, and e) Approximately 180 mg to approximately 270 mg of gum arabic.

[0124] In one non-limiting example of this embodiment of the disclosed composition, the composition comprises: a) approximately 5 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) approximately 10 mg of sunflower oil; c) about 75 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) approximately 35 mg of sodium bicarbonate, and e) Approximately 110 mg of gum arabic.

[0125] One non-limiting example of this embodiment of the disclosed composition includes: a) approximately 5 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 10 mg of coconut oil; c) about 75 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) approximately 35 mg of sodium bicarbonate, and e) Approximately 110 mg of gum arabic.

[0126] One non-limiting example of this embodiment of the disclosed composition includes: a) approximately 5 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) approximately 10 mg of sesame oil; c) about 75 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) approximately 35 mg of sodium bicarbonate, and e) Approximately 110 mg of gum arabic.

[0127] Another non-limiting example of this aspect of the disclosed compositions includes: a) approximately 10 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) approximately 20 mg of sunflower oil; c) about 120 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) approximately 60 mg of sodium bicarbonate, and e) Approximately 180 mg of gum arabic.

[0128] Another non-limiting example of this aspect of the disclosed compositions includes: a) approximately 10 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 20 mg of coconut oil; c) about 120 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) approximately 60 mg of sodium bicarbonate, and e) Approximately 180 mg of gum arabic.

[0129] Another non-limiting example of this aspect of the disclosed compositions includes: a) approximately 10 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) approximately 20 mg of sesame oil; c) about 120 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) approximately 60 mg of sodium bicarbonate, and e) Approximately 180 mg of gum arabic.

[0130] Still further non-limiting examples of the disclosed compositions include: a) approximately 16 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) approximately 35 mg of sunflower oil; c) about 180 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) approximately 90 mg of sodium bicarbonate, and e) Approximately 270 mg of gum arabic.

[0131] Still further non-limiting examples of the disclosed compositions include: a) approximately 16 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 35 mg of coconut oil; c) about 180 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) approximately 90 mg of sodium bicarbonate, and e) Approximately 270 mg of gum arabic.

[0132] Still further non-limiting examples of the disclosed compositions include: a) approximately 16 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) approximately 35 mg of sesame oil; c) about 180 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) approximately 90 mg of sodium bicarbonate, and e) Approximately 270 mg of gum arabic.

[0133] Yet another non-limiting example of the disclosed composition includes: a) approximately 23 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) approximately 46 mg of sunflower oil; c) about 240 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) approximately 120 mg of sodium bicarbonate, and e) Approximately 365 mg of gum arabic.

[0134] Yet another non-limiting example of the disclosed composition includes: a) approximately 23 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 46 mg of coconut oil; c) about 240 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) approximately 120 mg of sodium bicarbonate, and e) Approximately 365 mg of gum arabic.

[0135] Yet another non-limiting example of the disclosed composition includes: a) approximately 23 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) approximately 46 mg of sesame oil; c) about 240 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) approximately 120 mg of sodium bicarbonate, and e) Approximately 365 mg of gum arabic.

[0136] In a still further non-limiting example, the composition comprises: a) approximately 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) approximately 65 mg of sunflower oil; c) about 300 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) approximately 150 mg of sodium bicarbonate, and e) 465 mg gum arabic.

[0137] In yet another non-limiting example, the composition comprises: a) approximately 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 65 mg of coconut oil; c) about 300 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) approximately 150 mg of sodium bicarbonate, and e) 465 mg gum arabic.

[0138] In another still further non-limiting example, the composition comprises: a) approximately 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) approximately 65 mg of sesame oil; c) about 300 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) approximately 150 mg of sodium bicarbonate, and e) 465 mg gum arabic.

[0139] The disclosed compositions of this aspect contain about 5 mg to about 32 mg of CBD oil containing about 88% to about 91% cannabidiol. In one embodiment, the composition may contain about 10 mg to about 32 mg of CBD oil containing about 88% to about 91% cannabidiol. In another embodiment, the composition may contain about 16 mg to about 32 mg of CBD oil containing about 88% to about 91% cannabidiol. In a further embodiment, the composition may contain about 23 mg to about 32 mg of CBD oil containing about 88% to about 91% cannabidiol. In a still further embodiment, the composition may contain about 10 mg to about 23 mg of CBD oil containing about 88% to about 91% cannabidiol. In another further embodiment, the composition may contain about 10 mg to about 16 mg of CBD oil containing about 88% to about 91% cannabidiol.

[0140] Compositions may contain, for example, 5 mg, 6 mg, 7 mg, 8 mg, 9 mg, 10 mg, 11 mg, 12 mg, 13 mg, 14 mg, 15 mg, 16 mg, 17 mg, 18 mg, 19 mg, 20 mg, 21 mg, 22 mg, 23 mg, 24 mg, 25 mg, 26 mg, 27 mg, 28 mg, 29 mg, 30 mg, 31 mg, or 32 mg of CBD oil containing about 88% to about 91% cannabidiol.

[0141] The disclosed compositions of this aspect contain about 10 mg to about 65 mg of one or more edible oils selected from sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, and mixtures thereof. In one embodiment, the disclosed compositions contain about 5 mg to about 32 mg of one or more edible oils. In another embodiment, the disclosed compositions contain about 23 mg to about 32 mg of one or more edible oils. In a further embodiment, the disclosed compositions contain about 10 mg to about 23 mg of one or more edible oils. In another embodiment, the disclosed compositions contain about 10 mg to about 32 mg of one or more edible oils. In a further embodiment, the disclosed compositions contain about 10 mg to about 16 mg of one or more edible oils. In another embodiment, the disclosed compositions contain about 10 mg to about 32 mg of one or more edible oils.

[0142] The disclosed compositions of this embodiment can include from about 10 mg to about 650 mg of one or more edible oils. For example, the present disclosure provides compositions containing from about 10 mg to about 500 mg of bile salts, e.g., 10 mg, 11 mg, 12 mg, 13 mg, 14 mg, 15 mg, 16 mg, 17 mg, 18 mg, 19 mg, 20 mg, 21 mg, 22 mg, 23 mg, 24 mg, 25 mg, 26 mg, 27 mg, 28 mg, 29 mg, 30 mg, 31 mg, 32 mg, 33 mg, 34 mg, 35 mg, 36 mg, 37 mg, 38 mg, 39 mg, 40 mg, 41 mg, 42 mg, 43 mg, 44 mg, 45 mg, 46 mg, 47 mg, 48 mg, 49 mg, 50 mg, 51 mg, 52 mg, 53 mg, 54 mg, 55 mg, 56 mg, 57 mg, 58 mg, 59 mg, 60 mg, 61 mg, 62 mg, 63 mg, 64 mg, 65 mg, 66 mg, 67 mg, 68 mg, 69 mg, 70 mg, 71 mg, 72 mg, 73 mg, 74 mg, 75 mg, 76 mg, 77 mg, 78 mg, 79 mg, 80 mg, 81 mg, 82 mg, 83 mg, 84 mg, 85 mg, 86 mg, 87 mg, 88 mg, 89 mg, 90 mg, 91 mg, 92 mg, 93 mg, 94 mg, 95 mg, 96 mg, 97 mg, 98 mg, 9 6mg, 37mg, 38mg, 39mg, 40mg, 41mg, 42mg, 43mg, 44mg, 45mg, 46mg, 47mg, 48mg, 49mg, 50mg, 51mg, 52mg, 53mg, 54mg, 55mg, 56mg, 57mg, 58mg, 59mg, 60mg, 61mg, 62mg, 63mg, 64mg, or 65mg of one or more edible oils.

[0143] Tables 2A, 2B, and 2C disclose non-limiting examples of the disclosed compositions according to this embodiment.

[0144] [Table 2]

[0145] [Table 3]

[0146] [Table 4]

[0147] Further aspects of the disclosed compositions A further aspect of the present disclosure relates to a composition comprising: a) about 5% to about 25% by weight of a CBD oil extract containing at least about 98% by weight of cannabidiol; b) about 5% to about 60% by weight of one or more edible oils selected from olive oil, sunflower oil, sesame oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, and peanut oil; c) about 0.1% to about 1% by weight of deoxycholic acid; d) The remainder is the carrier.

[0148] In one embodiment of this aspect, the composition comprises: a) about 5% to about 25% by weight of a CBD oil extract containing at least about 98% by weight of cannabidiol; b) about 5% to about 60% by weight olive oil; c) about 0.1% to about 1% by weight of deoxycholic acid; d) about 30% to about 85% by weight of a carrier selected from mannitol, colloidal silicon dioxide, tapioca starch, gum arabic, and mixtures thereof.

[0149] In one iteration of this embodiment, the composition includes: a) about 5% to about 25% by weight of a CBD oil extract containing at least about 98% by weight of cannabidiol; b) about 5% to about 60% by weight olive oil; c) about 0.1% to about 1% by weight of deoxycholic acid; d) about 30% to about 85% by weight of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0150] In another embodiment of this aspect, the composition comprises: a) about 10% to about 20% by weight of a CBD oil extract containing at least about 98% by weight of cannabidiol; b) about 10% to about 40% by weight olive oil; c) about 0.5% to about 1% by weight of deoxycholic acid; d) about 30% to about 85% by weight of a carrier selected from mannitol, colloidal silicon dioxide, tapioca starch, gum arabic, and mixtures thereof.

[0151] In one iteration of this embodiment, the composition includes: a) about 10% to about 20% by weight of a CBD oil extract containing at least about 98% by weight of cannabidiol; b) about 10% to about 40% by weight olive oil; c) about 0.5% to about 1% by weight of deoxycholic acid; d) about 40% to about 70% by weight of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0152] In one embodiment of this aspect, the composition comprises: a) about 15% to about 20% by weight of a CBD oil extract containing at least about 98% by weight of cannabidiol; b) about 15% to about 40% by weight olive oil; c) about 0.5% to about 1% by weight of deoxycholic acid; d) about 40% to about 80% by weight of a carrier selected from mannitol, colloidal silicon dioxide, tapioca starch, gum arabic, and mixtures thereof.

[0153] In one iteration of this embodiment, the composition includes: a) about 15% to about 20% by weight of a CBD oil extract containing at least about 98% by weight of cannabidiol; b) about 15% to about 40% by weight olive oil; c) about 0.5% to about 1% by weight of deoxycholic acid; d) about 40% to about 80% by weight of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0154] In another embodiment of this aspect, the composition comprises: a) about 10% to about 20% by weight of a CBD oil extract containing at least about 98% by weight of cannabidiol; b) about 10% to about 40% by weight olive oil; c) about 0.5% to about 1% by weight of deoxycholic acid; d) about 30% to about 85% by weight of a carrier selected from mannitol, colloidal silicon dioxide, tapioca starch, gum arabic, and mixtures thereof.

[0155] In one iteration of this embodiment, the composition includes: a) about 10% to about 20% by weight of a CBD oil extract containing at least about 98% by weight of cannabidiol; b) about 10% to about 40% by weight olive oil; c) about 0.5% to about 1% by weight of deoxycholic acid; d) about 40% to about 70% by weight of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0156] In one embodiment of this aspect, the composition comprises: a) about 15% to about 20% by weight of a CBD oil extract containing at least about 98% by weight of cannabidiol; b) about 15% to about 40% by weight olive oil; c) about 0.5% to about 1% by weight of deoxycholic acid; d) about 40% to about 80% by weight of a carrier selected from mannitol, colloidal silicon dioxide, tapioca starch, gum arabic, and mixtures thereof.

[0157] In one iteration of this embodiment, the composition includes: a) about 15% to about 20% by weight of a CBD oil extract containing at least about 98% by weight of cannabidiol; b) about 15% to about 40% by weight olive oil; c) about 0.5% to about 1% by weight of deoxycholic acid; d) about 40% to about 80% by weight of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0158] In another embodiment of the disclosed composition, the composition comprises: a) about 5% to about 25% by weight of a CBD oil extract containing at least about 98% by weight of cannabidiol; b) from about 5% to about 60% by weight of one or more edible oils; c) about 0.1% to about 1% by weight of deoxycholic acid; d) The remainder is the carrier.

[0159] In one embodiment of this aspect, the composition comprises: a) about 5% to about 25% by weight of a CBD oil extract containing at least about 98% by weight of cannabidiol; b) about 5% to about 60% by weight of one or more edible oils selected from olive oil, sunflower oil, sesame oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, and peanut oil; c) about 0.1% to about 1% by weight of deoxycholic acid; d) about 30% to about 85% by weight of a carrier selected from mannitol, colloidal silicon dioxide, tapioca starch, gum arabic, and mixtures thereof.

[0160] In one iteration of this embodiment, the composition includes: a) about 5% to about 25% by weight of a CBD oil extract containing at least about 98% by weight of cannabidiol; b) about 5% to about 60% by weight of sunflower oil; c) about 0.1% to about 1% by weight of deoxycholic acid; d) about 30% to about 85% by weight of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0161] In one iteration of this embodiment, the composition includes: a) about 5% to about 25% by weight of a CBD oil extract containing at least about 98% by weight of cannabidiol; b) about 5% to about 60% by weight coconut; c) about 0.1% to about 1% by weight of deoxycholic acid; d) about 30% to about 85% by weight of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0162] In one iteration of this embodiment, the composition includes: a) about 5% to about 25% by weight of a CBD oil extract containing at least about 98% by weight of cannabidiol; b) about 5% to about 60% by weight of sesame oil; c) about 0.1% to about 1% by weight of deoxycholic acid; d) about 30% to about 85% by weight of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0163] In another embodiment of this aspect, the composition comprises: a) about 10% to about 20% by weight of a CBD oil extract containing at least about 98% by weight of cannabidiol; b) about 10% to about 40% by weight of one or more edible oils selected from olive oil, sunflower oil, sesame oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, and peanut oil; c) about 0.5% to about 1% by weight of deoxycholic acid; d) about 30% to about 85% by weight of a carrier selected from mannitol, colloidal silicon dioxide, tapioca starch, gum arabic, and mixtures thereof.

[0164] In one iteration of this embodiment, the composition includes: a) about 10% to about 20% by weight of a CBD oil extract containing at least about 98% by weight of cannabidiol; b) about 10% to about 40% by weight of sunflower oil; c) about 0.5% to about 1% by weight of deoxycholic acid; d) about 30% to about 85% by weight of a carrier selected from mannitol, colloidal silicon dioxide, tapioca starch, gum arabic, and mixtures thereof.

[0165] In one iteration of this embodiment, the composition includes: a) about 10% to about 20% by weight of a CBD oil extract containing at least about 98% by weight of cannabidiol; b) about 10% to about 40% by weight of coconut oil; c) about 0.5% to about 1% by weight of deoxycholic acid; d) about 30% to about 85% by weight of a carrier selected from mannitol, colloidal silicon dioxide, tapioca starch, gum arabic, and mixtures thereof.

[0166] In one iteration of this embodiment, the composition includes: a) about 10% to about 20% by weight of a CBD oil extract containing at least about 98% by weight of cannabidiol; b) about 10% to about 40% by weight of sesame oil; c) about 0.5% to about 1% by weight of deoxycholic acid; d) about 30% to about 85% by weight of a carrier selected from mannitol, colloidal silicon dioxide, tapioca starch, gum arabic, and mixtures thereof.

[0167] In a further embodiment of this aspect, the composition comprises: a) about 15% to about 20% by weight of a CBD oil extract containing at least about 98% by weight of cannabidiol; b) about 15% to about 40% by weight of one or more edible oils selected from olive oil, sunflower oil, sesame oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, and peanut oil; c) about 0.5% to about 1% by weight of deoxycholic acid; d) about 40% to about 80% by weight of a carrier selected from mannitol, colloidal silicon dioxide, tapioca starch, gum arabic, and mixtures thereof.

[0168] In one iteration of this embodiment, the composition includes: a) about 15% to about 20% by weight of a CBD oil extract containing at least about 98% by weight of cannabidiol; b) about 15% to about 40% by weight of sunflower oil; c) about 0.5% to about 1% by weight of deoxycholic acid; d) about 40% to about 80% by weight of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0169] In one iteration of this embodiment, the composition includes: a) about 15% to about 20% by weight of a CBD oil extract containing at least about 98% by weight of cannabidiol; b) about 15% to about 40% by weight coconut oil; c) about 0.5% to about 1% by weight of deoxycholic acid; d) about 40% to about 80% by weight of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0170] In one iteration of this embodiment, the composition includes: a) about 15% to about 20% by weight of a CBD oil extract containing at least about 98% by weight of cannabidiol; b) about 15% to about 40% by weight of sesame oil; c) about 0.5% to about 1% by weight of deoxycholic acid; d) about 40% to about 80% by weight of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0171] The disclosed compositions of this aspect comprise about 5% to about 25% CBD oil by weight. In one embodiment, the disclosed compositions may comprise about 10% to about 20% CBD oil by weight. In one embodiment, the compositions may comprise about 15% to about 20% CBD oil by weight. In another embodiment, the compositions may comprise about 10% to about 15% CBD oil by weight. In a further embodiment, the compositions may comprise about 12% to about 17% CBD oil by weight.

[0172] For example, the amount of CBD oil can be, for example, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, or 25%.

[0173] The disclosed compositions of this aspect may contain about 5% to about 60% by weight of one or more edible oils selected from olive oil, sunflower oil, sesame oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, and peanut oil. In one embodiment, the composition contains about 10% to about 40% by weight of one or more edible oils. In one embodiment, the composition contains about 15% to about 40% by weight of one or more edible oils. In one embodiment, the composition contains about 20% to about 30% by weight of one or more edible oils. In one embodiment, the composition contains about 25% to about 35% by weight of one or more edible oils. The disclosed compositions of this embodiment may contain from about 0.5% to about 60% by weight of one or more edible oils, for example, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31% by weight of one or more edible oils. , 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, 59%, or 60%, or any fraction thereof, of one or more edible oils.

[0174] In still further embodiments, the disclosed compositions include: a) about 35 mg to about 150 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 70 mg to about 300 mg of one or more edible oils selected from olive oil, sunflower oil, sesame oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, and peanut oil; c) about 3 mg to about 13 mg of deoxycholic acid; d) about 135 mg to about 560 mg of one or more carriers.

[0175] In one embodiment of this aspect, the disclosed composition comprises: a) about 35 mg to about 150 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 70 mg to about 300 mg of one or more edible oils; c) about 3 mg to about 13 mg of deoxycholic acid; d) about 135 mg to about 560 mg of a carrier selected from mannitol, colloidal silicon dioxide, tapioca starch, gum arabic, and mixtures thereof.

[0176] In one embodiment of this aspect, the disclosed composition comprises: a) about 35 mg to about 150 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 70 mg to about 300 mg olive oil; c) about 3 mg to about 13 mg of deoxycholic acid; d) about 135 mg to about 560 mg of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0177] In one embodiment of this aspect, the disclosed composition comprises: a) about 35 mg to about 150 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 70 mg to about 300 mg of sunflower oil; c) about 3 mg to about 13 mg of deoxycholic acid; d) about 135 mg to about 560 mg of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0178] In one embodiment of this aspect, the disclosed composition comprises: a) about 35 mg to about 150 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 70 mg to about 300 mg of coconut oil; c) about 3 mg to about 13 mg of deoxycholic acid; d) about 135 mg to about 560 mg of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0179] In one embodiment of this aspect, the disclosed composition comprises: a) about 35 mg to about 150 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 70 mg to about 300 mg of sesame seed oil; c) about 3 mg to about 13 mg of deoxycholic acid; d) about 135 mg to about 560 mg of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0180] In one non-limiting iteration of this embodiment, the composition comprises: a) about 35 mg to about 150 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 70 mg to about 300 mg olive oil; c) about 3 mg to about 13 mg of deoxycholic acid; d) about 67 mg to about 280 mg of colloidal silicon dioxide and about 68 mg to about 280 mg of mannitol, and mixtures thereof.

[0181] In one iteration of this embodiment, the disclosed composition includes: a) about 35 mg to about 120 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 70 mg to about 240 mg olive oil; c) about 3 mg to about 10.5 mg of deoxycholic acid; d) about 135 mg to about 440 mg of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0182] In one iteration of this embodiment, the disclosed composition includes: a) about 35 mg to about 120 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 70 mg to about 240 mg of sunflower oil; c) about 3 mg to about 10.5 mg of deoxycholic acid; d) about 135 mg to about 440 mg of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0183] In one iteration of this embodiment, the disclosed composition includes: a) about 35 mg to about 120 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 70 mg to about 240 mg of coconut oil; c) about 3 mg to about 10.5 mg of deoxycholic acid; d) about 135 mg to about 440 mg of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0184] In one iteration of this embodiment, the disclosed composition includes: a) about 35 mg to about 120 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 70 mg to about 240 mg of sesame oil; c) about 3 mg to about 10.5 mg of deoxycholic acid; d) about 135 mg to about 440 mg of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0185] In a further iteration of this embodiment, the disclosed composition comprises: a) about 35 mg to about 120 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 70 mg to about 240 mg olive oil; c) about 3 mg to about 10.5 mg of deoxycholic acid; d) about 67 mg to about 220 mg of colloidal silicon dioxide and about 68 mg to about 220 mg of mannitol, and mixtures thereof.

[0186] In a further iteration of this embodiment, the disclosed composition comprises: a) about 35 mg to about 95 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 70 mg to about 190 mg olive oil; c) about 3 mg to about 8.5 mg of deoxycholic acid; d) about 135 mg to about 360 mg of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0187] In a further iteration of this embodiment, the disclosed composition comprises: a) about 35 mg to about 95 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 70 mg to about 190 mg of sunflower oil; c) about 3 mg to about 8.5 mg of deoxycholic acid; d) about 135 mg to about 360 mg of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0188] In a further iteration of this embodiment, the disclosed composition comprises: a) about 35 mg to about 95 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 70 mg to about 190 mg of coconut oil; c) about 3 mg to about 8.5 mg of deoxycholic acid; d) about 135 mg to about 360 mg of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0189] In a further iteration of this embodiment, the disclosed composition comprises: a) about 35 mg to about 95 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 70 mg to about 190 mg of sesame oil; c) about 3 mg to about 8.5 mg of deoxycholic acid; d) about 135 mg to about 360 mg of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0190] In a further iteration of this embodiment, the disclosed composition comprises: a) about 35 mg to about 90 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 70 mg to about 190 mg of sesame oil; c) about 3 mg to about 8.5 mg of deoxycholic acid; d) about 135 mg to about 360 mg of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0191] In another iteration of this embodiment, the disclosed composition includes: a) about 35 mg to about 75 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 70 mg to about 150 mg olive oil; c) about 3 mg to about 6.6 mg of deoxycholic acid; d) about 135 mg to about 280 mg of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0192] In another iteration of this embodiment, the disclosed composition includes: a) about 35 mg to about 75 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 70 mg to about 150 mg of sunflower oil; c) about 3 mg to about 6.6 mg of deoxycholic acid; d) about 135 mg to about 280 mg of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0193] In another iteration of this embodiment, the disclosed composition includes: a) about 35 mg to about 75 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 70 mg to about 150 mg of coconut oil; c) about 3 mg to about 6.6 mg of deoxycholic acid; d) about 135 mg to about 280 mg of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0194] In another iteration of this embodiment, the disclosed composition includes: a) about 35 mg to about 75 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 70 mg to about 150 mg of sesame oil; c) about 3 mg to about 6.6 mg of deoxycholic acid; d) about 135 mg to about 280 mg of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0195] In still further embodiments of this aspect, the disclosed compositions include: a) about 75 mg to about 150 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 150 mg to about 300 mg olive oil; c) about 6.6 mg to about 13 mg of deoxycholic acid; d) about 280 mg to about 560 mg of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0196] In still further embodiments of this aspect, the disclosed compositions include: a) about 75 mg to about 150 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 150 mg to about 300 mg of sunflower oil; c) about 6.6 mg to about 13 mg of deoxycholic acid; d) about 280 mg to about 560 mg of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0197] In still further embodiments of this aspect, the disclosed compositions include: a) about 75 mg to about 150 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 150 mg to about 300 mg of coconut oil; c) about 6.6 mg to about 13 mg of deoxycholic acid; d) about 280 mg to about 560 mg of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0198] In still further embodiments of this aspect, the disclosed compositions include: a) about 75 mg to about 150 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 150 mg to about 300 mg of sesame oil; c) about 6.6 mg to about 13 mg of deoxycholic acid; d) about 280 mg to about 560 mg of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0199] In still further embodiments of this aspect, the disclosed compositions include: a) about 75 mg to about 120 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 150 mg to about 240 mg olive oil; c) about 6.6 mg to about 10.5 mg of deoxycholic acid; d) about 280 mg to about 4400 mg of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0200] In still further embodiments of this aspect, the disclosed compositions include: a) about 75 mg to about 150 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 150 mg to about 300 mg of sunflower oil; c) about 6.6 mg to about 13 mg of deoxycholic acid; d) about 280 mg to about 560 mg of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0201] In still further embodiments of this aspect, the disclosed compositions include: a) about 75 mg to about 150 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 150 mg to about 300 mg of coconut oil; c) about 6.6 mg to about 13 mg of deoxycholic acid; d) about 280 mg to about 560 mg of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0202] In still further embodiments of this aspect, the disclosed compositions include: a) about 75 mg to about 150 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 150 mg to about 300 mg of sesame oil; c) about 6.6 mg to about 13 mg of deoxycholic acid; d) about 280 mg to about 560 mg of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0203] In still further embodiments of this aspect, the disclosed compositions include: a) about 95 mg to about 150 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 190 mg to about 300 mg olive oil; c) about 8.5 mg to about 13 mg of deoxycholic acid; d) about 360 mg to about 560 mg of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0204] In still further embodiments of this aspect, the disclosed compositions include: a) about 95 mg to about 150 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 190 mg to about 300 mg of sunflower oil; c) about 8.5 mg to about 13 mg of deoxycholic acid; d) about 360 mg to about 560 mg of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0205] In still further embodiments of this aspect, the disclosed compositions include: a) about 95 mg to about 150 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 190 mg to about 300 mg of coconut oil; c) about 8.5 mg to about 13 mg of deoxycholic acid; d) about 360 mg to about 560 mg of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0206] In still further embodiments of this aspect, the disclosed compositions include: a) about 95 mg to about 150 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 190 mg to about 300 mg of sesame oil; c) about 8.5 mg to about 13 mg of deoxycholic acid; d) about 360 mg to about 560 mg of a carrier selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0207] One non-limiting example of this embodiment of the disclosed composition includes: a) about 35 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) approximately 70 mg of olive oil; c) approximately 3 mg of deoxycholic acid; d) about 67 mg mannitol and about 68 mg colloidal silicon dioxide.

[0208] In another non-limiting example of this aspect of the disclosed composition, the composition comprises: a) about 75 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) approximately 150 mg of olive oil; c) approximately 6.6 mg of deoxycholic acid; d) about 139 mg mannitol and about 141 mg colloidal silicon dioxide.

[0209] Still further non-limiting examples of the disclosed compositions include: a) about 75 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) approximately 150 mg of olive oil; c) approximately 6.6 mg of deoxycholic acid; d) about 143 mg mannitol and about 144 mg colloidal silicon dioxide.

[0210] Yet another non-limiting example of the disclosed composition includes: a) about 120 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) approximately 240 mg of olive oil; c) approximately 10.5 mg of deoxycholic acid; d) about 219 mg mannitol and about 221 mg colloidal silicon dioxide.

[0211] The disclosed compositions of this aspect comprise about 35 mg to about 150 mg of CBD oil extract containing at least about 98% cannabidiol by weight. In one embodiment, the composition may comprise about 35 mg to about 120 mg of CBD oil extract containing at least about 98% cannabidiol by weight. In another embodiment, the composition may comprise about 35 mg to about 95 mg of CBD oil extract containing at least about 98% cannabidiol by weight. In a further embodiment, the composition may comprise about 35 mg to about 75 mg of CBD oil extract containing at least about 98% cannabidiol by weight. In a still further embodiment, the composition may comprise about 75 mg to about 150 mg of CBD oil extract containing at least about 98% cannabidiol by weight. In a still yet further embodiment, the composition may comprise about 75 mg to about 120 mg of CBD oil extract containing at least about 98% cannabidiol by weight. In yet another embodiment, the composition may comprise from about 95 mg to about 150 mg of CBD oil extract containing at least about 98% cannabidiol by weight.

[0212] The compositions may include 35mg, 36mg, 37mg, 38mg, 39mg, 40mg, 41mg, 42mg, 43mg, 44mg, 45mg, 46mg, 47mg, 48mg, 49mg, 50mg, 51mg, 52mg, 53mg, 54mg, 55mg, 56mg, 57mg, 58mg, 59mg, 60mg, 61mg, 62mg containing at least about 98% cannabidiol by weight. g, 63mg, 64mg, 65mg, 66mg, 67mg, 68mg, 69mg, 70mg, 71mg, 72mg, 73mg, 74mg, 75mg, 76mg, 77mg, 78mg, 79m g, 80mg, 81mg, 82mg, 83mg, 84mg, 85mg, 86mg, 87mg, 88mg, 89mg, 90mg, 91mg, 92mg, 93mg, 94mg, 95mg, 96m g, 97mg, 98mg, 99mg, 100mg, 101mg, 102,mg, 103,mg, 104mg, 105mg, 106mg, 107mg, 108mg, 109mg, 110mg , 111mg, 112mg, 113mg, 114mg, 115mg, 116mg, 117mg, 118mg, 119mg, 120mg, 121mg, 122mg, 123mg, 124mg, It may contain 125mg, 126mg, 127mg, 128mg, 129mg, 130mg, 31mg, 132mg, 133mg, 134mg, 135mg, 136mg, 137mg, 138mg, 139mg, 140mg, 141mg, 142mg, 143mg, 144mg, 145mg, 146mg, 147mg, 148mg, 149mg, or 150mg of CBD oil extract.

[0213] The disclosed compositions of this aspect comprise about 70 mg to about 300 mg of one or more edible oils selected from sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, and peanut oil. In one embodiment, the disclosed compositions comprise about 70 mg to about 240 mg of one or more edible oils. In another embodiment, the disclosed compositions comprise about 70 mg to about 190 mg of one or more edible oils. In a further embodiment, the disclosed compositions comprise about 70 mg to about 150 mg of one or more edible oils. In a still further embodiment, the disclosed compositions comprise about 150 mg to about 300 mg of one or more edible oils. In a still further embodiment, the disclosed compositions comprise about 90 mg to about 300 mg of one or more edible oils.

[0214] The disclosed compositions of this embodiment may comprise from about 80 mg to about 340 mg of one or more edible oils, e.g., 70 mg, 71 mg, 72 mg, 73 mg, 74 mg, 75 mg, 76 mg, 77 mg, 78 mg, 79 mg, 80 mg, 81 mg, 82 mg, 83 mg, 84 mg, 85 mg, 86 mg, 87 mg, 88 mg, 89 mg, 90 mg, 91 mg, 92 mg, 93 mg, 94 mg, 95 mg, 96 mg, 97 mg, 98 mg, 99 mg, 100 mg, 101 mg, 102 mg, 103 mg, 104 mg, 105 mg, 106 mg, 107 mg, 108 mg, 110 mg, 111 mg, 112 mg, 113 mg, 114 mg, 115 mg, 116 mg, 117 mg, 118 mg, 119 mg, 120 mg, 121 mg, 122 mg, 123 mg, 124 mg, 125 mg, 126 mg, 127 mg, 128 mg, 129 mg, 130 mg, 131 mg, 132 mg, 133 mg, 134 mg, 135 mg, 136 mg, 137 mg, 138 mg, 139 mg, 140 mg, 141 mg, 142 mg, 143 mg, 144 mg, 145 mg, 146 mg, 147 mg, 148 mg, 149 mg, 150 mg, 151 mg, 152 mg, 153 mg, 154 mg, 09mg, 110mg, 111mg, 112mg, 113mg, 114mg, 115mg, 116mg, 117mg, 118mg, 119mg, 120mg, 121mg, 122mg, 123mg, 124mg, 125mg, 126mg, 127mg, 128mg, 129mg , 130mg, 31mg, 132mg, 133mg, 134mg, 135mg, 136mg, 137mg, 138mg, 139mg, 140mg, 141mg, 142mg, 143mg, 144mg, 145mg, 146mg, 147mg, 148mg, 149mg, 150mg , 151mg, 152mg, 153mg, 154mg, 155mg, 156mg, 157mg, 158mg, 159mg, 160mg, 161mg, 162mg, 163mg, 164mg, 165mg, 166mg, 167mg, 168mg, 169mg, 170mg, 171 mg, 172mg, 173mg, 174mg, 175mg, 167mg, 177mg, 178mg, 179mg, 180mg, 181mg, 182mg, 183mg, 184mg, 185mg, 186mg, 187mg, 188mg, 189mg, 190mg, 191mg, 19 2mg, 193mg, 194mg, 195mg, 196mg, 197mg, 198mg, 199mg, 200mg, 201mg, 202mg, 203mg, 204mg, 205mg, 206mg, 207mg, 208mg, 209mg, 210mg, 211mg, 212mg, 2 13mg, 214mg, 215mg, 216mg, 217mg, 218mg, 219mg, 220mg, 221mg, 222mg, 223mg, 224mg, 225mg, 226mg, 227mg, 228mg, 229mg, 230mg, 231mg, 232mg, 233mg,234mg, 235mg, 236mg, 237mg, 238mg, 239mg, 240mg, 241mg, 242mg, 243mg, 244mg, 245mg, 246mg, 247mg, 248mg, 249mg, 250mg, 251m g, 252mg, 253mg, 254mg, 255mg, 256mg, 257mg, 258mg, 259mg, 260mg, 261mg, 262mg, 263mg, 264mg, 265mg, 266mg, 267mg, 268mg, 26 9mg, 270mg, 271mg, 272mg, 273mg, 274mg, 275mg, 276mg, 277mg, 278mg, 279mg, 280mg, 281mg, 282mg, 283mg, 284mg, 285mg, 286mg, 287mg, 288mg, 289mg, 290mg, 290mg, 291mg, 292mg, 293mg, 294mg, 295mg, 296mg, 297mg, 298mg, 299mg, or 300mg of one or more edible oils.

[0215] According to this embodiment, the ratio of CBD oil extract containing at least about 98% cannabidiol by weight to high oleic olive oil is from about 1:1 to about 1:3. For example, the ratio of CBD oil extract to olive oil can be 1:1, 1:1.1, 1:1.2, 1:1.3, 1:1.4, 1:1.5, 1:1.6, 1:1.7, 1:1.8, 1:1.9, 1:2, 1:2.1, 1:2.2, 1:2.3, 1:2.4, 1:2.5, 1:2.6, 1:2.7, 1:2.8, 1:2.9, or 1:3.

[0216] Table 3 discloses non-limiting examples of the disclosed compositions according to this embodiment.

[0217] [Table 5]

[0218] According to this embodiment, the ratio of CBD oil extract containing at least about 98% cannabidiol by weight to olive oil is from about 1:1 to about 1:3. For example, the ratio of CBD oil extract to olive oil can be 1:1, 1:1.1, 1:1.2, 1:1.3, 1:1.4, 1:1.5, 1:1.6, 1:1.7, 1:1.8, 1:1.9, 1:2, 1:2.1, 1:2.2, 1:2.3, 1:2.4, 1:2.5, 1:2.6, 1:2.7, 1:2.8, 1:2.9, or 1:3.

[0219] edible oil The disclosed compositions can include one or more edible oils. The disclosed edible oils include oils that are primarily triglyceride-containing oils. However, some amounts of diglycerides and monoglycerides may be present. Non-limiting examples of such oils are selected from sunflower oil, coconut oil, olive oil, sesame seed oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, and mixtures thereof. The disclosed compositions can include a single edible oil. In one example, the composition can include sunflower oil. In a further example, the composition can include high oleic sunflower oil. In another example, the composition can include olive oil. In a still further example, the composition can include high oleic olive oil. In a still further example, the composition can include coconut oil. In a still further example, the composition can include high oleic sesame seed oil.

[0220] Bile salts The disclosed compositions can include one or more bile salts as described herein. The source of the bile salt can be any commercially available salt.

[0221] For purposes of this disclosure, the terms "bile salts" and "bile acids" are used interchangeably herein. Bile acids are steroid acids found primarily in the bile of mammals, such as cows, goats, and other livestock. Bile salts are conjugated with the amino acids taurine or glycine to form bile salts. The extracted bile salts may include unconjugated bile acids.

[0222] Cholic acid, also known as 3α,7α,12α-trihydroxy-5β-cholan-24-oic acid, is the primary bile acid found in bile extracts. It is insoluble in water (soluble in alcohol and acetic acid) and is obtained as a white crystalline substance. Salts of cholic acid are called cholates. Cholic acid, along with chenodeoxycholic acid, is one of two major bile acids produced by the mammalian liver, where it is synthesized from cholesterol. These two major bile acids are approximately equal in concentration in the extract. [4] Bile salts themselves are made from choline-CoA, which exchanges its CoA for either glycine or taurine to yield glycochol and taurocholate, respectively. Other bile salts include taurochenodeoxycholate and glycochenodeoxycholate (derivatives of chenodeoxycholate). These, along with glycochol and taurocholate, constitute the major components of bile salts.

[0223] One embodiment of the disclosed bile salts is a bile salt containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof.

[0224] In one aspect, the compositions of the present disclosure comprise about 5% to about 15% by weight of bile salts. In one embodiment, the compositions comprise about 5% to about 10% by weight of bile salts. In one embodiment, the compositions comprise about 7% to about 10% by weight of bile salts. In one embodiment, the compositions comprise about 7% to about 12% by weight of bile salts. In one embodiment, the compositions comprise about 8% to about 11% by weight of bile salts. In one embodiment, the compositions comprise about 5% to about 12% by weight of bile salts.

[0225] Compositions of this aspect of the disclosure can include about 5% to about 15% bile salts by weight, for example, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, or 15% bile salts by weight.

[0226] The composition of this aspect of the disclosure comprises about 25 mg to about 100 mg of bile salts. In one embodiment, the composition comprises about 25 mg to about 65 mg of one or more bile salts. In one embodiment, the composition comprises about 50 mg to about 65 mg of one or more bile salts. In one embodiment, the composition comprises about 50 mg to about 100 mg of one or more bile salts. In one embodiment, the composition comprises about 65 mg to about 100 mg of one or more bile salts. In one embodiment, the composition comprises about 25 mg to about 65 mg of one or more bile salts.

[0227] The compositions of the present disclosure may contain from about 25 mg to about 100 mg of bile salts, e.g., 25 mg, 26 mg, 27 mg, 28 mg, 29 mg, 30 mg, 31 mg, 32 mg, 33 mg, 34 mg, 35 mg, 36 mg, 37 mg, 38 mg, 39 mg, 40 mg, 41 mg, 42 mg, 43 mg, 44 mg, 45 mg, 46 mg, 47 mg, 48 mg, 49 mg, 50 mg, 51 mg, 52 mg, 53 mg, 54 mg, 55 mg, 56 mg, 57 mg, 58 mg, 59 mg, 60 mg , 61 mg, 62 mg, 63 mg, 64 mg, 65 mg, 66 mg, 67 mg, 68 mg, 69 mg, 70 mg, 71 mg, 72 mg, 73 mg, 74 mg, 75 mg, 76 mg, 77 mg, 78 mg, 79 mg, 80 mg, 81 mg, 82 mg, 83 mg, 84 mg, 85 mg, 86 mg, 87 mg, 88 mg, 89 mg, 90 mg, 91 mg, 92 mg, 93 mg, 94 mg, 95 mg, 96 mg, 97 mg, 98 mg, 99 mg, or 100 mg of bile salts.

[0228] In another aspect of the present disclosure, the composition may comprise about 0.1% to about 1% by weight of bile salts. In one embodiment, the composition may comprise about 0.5% to about 1% by weight of bile salts. In another embodiment, the composition may comprise about 0.5% to about 0.75% by weight of bile salts. In one embodiment, the composition may comprise about 0.1% to about 0.75% by weight of bile salts. The disclosed compositions may comprise about 0.1% to about 1% by weight of bile salts, for example, 0.1%, 0.15%, 0.2%, 0.25%, 0.3%, 0.35%, 0.4%, 0.45%, 0.5%, 0.55%, 0.6%, 0.65%, 0.7%, 0.75%, 0.8%, 0.85%, 0.9%, 0.95%, or 1%.

[0229] The compositions of this aspect of the disclosure can include about 75 mg to about 300 mg of bile salts. In one embodiment, the compositions can include about 120 mg to about 300 mg of bile salts. In one embodiment, the compositions can include about 180 mg to about 300 mg of bile salts.

[0230] In another embodiment, the composition may comprise about 240 mg to about 300 mg of bile salts. In a further embodiment, the composition may comprise about 120 mg to about 240 mg of bile salts. In a still further embodiment, the composition may comprise about 180 mg to about 240 mg of bile salts. In yet another embodiment, the composition may comprise about 75 mg to about 240 mg of bile salts. In yet another embodiment, the composition may comprise about 75 mg to about 180 mg of bile salts. In yet another embodiment, the composition may comprise about 75 mg to about 120 mg of bile salts.

[0231] Compositions of this aspect of the disclosure may contain from about 75 mg to about 300 mg of bile salts, e.g., 75 mg, 76 mg, 77 mg, 78 mg, 79 mg, 80 mg, 81 mg, 82 mg, 83 mg, 84 mg, 85 mg, 86 mg, 87 mg, 88 mg, 89 mg, 90 mg, 91 mg, 92 mg, 93 mg, 94 mg, 95 mg, 96 mg, 97 mg, 98 mg, 99 mg, 100 mg, 101 mg, 102 mg, 103 mg, 104 mg, 105 mg, 106 mg, 107 mg, 108 mg, 109 mg, 110 mg, 111 mg, 112 mg, 113 mg, 114 mg, 115 mg, 116 mg, 117 mg, 118 mg, 119 mg, 120 mg, 121 mg, 122 mg, 123 mg, 124 mg, 125 mg, 126 mg, 127 mg, 128 mg, 129 mg, 130 mg, 131 mg, 132 mg, 133 mg, 134 mg, 135 mg, 136 mg, 137 mg, 138 mg, 139 mg, 140 mg, 141 mg, 142 mg, 143 mg, 144 mg, 145 mg, 146 mg, 147 mg, 148 mg, 149 mg, 150 mg, 151 mg, 152 mg, 153 mg, 154 mg, 155 mg, 156 mg, 157 mg, 15 14mg, 115mg, 116mg, 117mg, 118mg, 119mg, 120mg, 121mg, 122mg, 123mg, 124mg, 125mg, 126mg, 127mg, 128mg, 129mg, 130mg, 31mg, 132mg, 133mg, 134mg, 135mg, 136mg, 137mg, 138mg, 139mg, 140mg, 141mg, 142mg, 143mg, 144mg, 145mg, 146mg, 147mg, 148mg, 149mg, 150mg, 151mg, 152mg, 153mg, 154mg, 155mg , 156mg, 157mg, 158mg, 159mg, 160mg, 161mg, 162mg, 163mg, 164mg, 165mg, 166mg, 167mg, 168mg, 169mg, 170mg, 171mg, 172mg, 173mg, 174mg, 175mg, 167 mg, 177mg, 178mg, 179mg, 180mg, 181mg, 182mg, 183mg, 184mg, 185mg, 186mg, 187mg, 188mg, 189mg, 190mg, 191mg, 192mg, 193mg, 194mg, 195mg, 196mg, 19 7mg, 198mg, 199mg, 200mg, 201mg, 202mg, 203mg, 204mg, 205mg, 206mg, 207mg, 208mg, 209mg, 210mg, 211mg, 212mg, 213mg, 214mg, 215mg, 216mg, 217mg, 2 18mg, 219mg, 220mg, 221mg, 222mg, 223mg, 224mg, 225mg, 226mg, 227mg, 228mg, 229mg, 230mg, 231mg, 232mg, 233mg, 234mg, 235mg, 236mg, 237mg, 238mg,239mg, 240mg, 241mg, 242mg, 243mg, 244mg, 245mg, 246mg, 247mg, 248mg, 249mg, 250mg, 251mg, 252mg, 253mg, 254mg, 255mg, 256mg, 257mg, 258mg, 259mg, 260mg, 261mg, 262mg, 263mg, 264mg, 265mg, 266mg, 267mg, 268mg, 269mg, 270mg, It may contain 271 mg, 272 mg, 273 mg, 274 mg, 275 mg, 276 mg, 277 mg, 278 mg, 279 mg, 280 mg, 281 mg, 282 mg, 283 mg, 284 mg, 285 mg, 286 mg, 287 mg, 288 mg, 289 mg, 290 mg, 290 mg, 291 mg, 292 mg, 293 mg, 294 mg, 295 mg, 296 mg, 297 mg, 298 mg, 299 mg, or 300 mg.

[0232] In a further aspect, the disclosed compositions can comprise from about 2 mg to about 7 mg of the bile salt deoxycholic acid. In one embodiment, the compositions can comprise from about 3.4 mg to about 7 mg of the bile salt deoxycholic acid.

[0233] In one embodiment, the composition may comprise about 4.2 mg to about 7 mg of the bile salt deoxycholic acid. In another embodiment, the composition may comprise about 5.1 mg to about 7 mg of the bile salt deoxycholic acid. In a further embodiment, the composition may comprise about 2 mg to about 5.1 mg of the bile salt deoxycholic acid. In a still further embodiment, the composition may comprise about 2 mg to about 4.2 mg of the bile salt deoxycholic acid.

[0234] The disclosed compositions of this embodiment contain from about 2 mg to about 7 mg of the bile salt deoxycholic acid, e.g., 2 mg, 2.1 mg, 2.2 mg, 2.3 mg, 2.4 mg, 2.5 mg, 2.6 mg, 2.7 mg, 2.8 mg, 2.9 mg, 3 mg, 3.1 mg, 3.2 mg, 3.3 mg, 3.4 mg, 3.5 mg, 3.6 mg, 3.7 mg, 3.8 mg, 3.9 mg, 4 mg, 4.1 mg, 4.2 mg, 4.3 mg, 4.4 mg, 4.5 mg, 4.6 mg, 4.7 mg, 4.8 mg, 4.9 mg, 5 ... mg, 4.3 mg, 4.4 mg, 4.5 mg, 4.6 mg, 4.7 mg, 4.8 mg, 4.9 mg, 5 mg, 5.1 mg, 5.2 mg, 5.3 mg, 5.4 mg, 5.5 mg, 5.6 mg, 5.7 mg, 5.8 mg, 5.9 mg, 6 mg, 6.1 mg, 6.2 mg, 6.3 mg, 6.4 mg, 6.5 mg, 6.6 mg, 6.7 mg, 6.8 mg, 6.9 mg, or 7 mg. Sodium bicarbonate (NaHCO3)

[0235] The disclosed compositions contain about 10% to about 20% sodium bicarbonate by weight. In one embodiment, the composition contains about 12.5% ​​to about 20% sodium bicarbonate by weight. In another embodiment, the composition contains about 10% to about 17.5% sodium bicarbonate by weight. In a further embodiment, the composition contains about 10% to about 15% sodium bicarbonate by weight. The compositions may contain, for example, 10%, 10.5%, 11%, 11.5%, 12%, 12.5%, 13%, 13.5%, 14%, 14.5%, 15%, 15.5%, 16%, 16.5%, 17%, 17.5%, 18%, 18.5%, 19%, 19.5%, or 20% NaHCO3 by weight.

[0236] The compositions of the present disclosure contain about 35 mg to about 150 mg of sodium bicarbonate. In one embodiment, the composition contains about 50 mg to about 115 mg of sodium bicarbonate. In one embodiment, the composition contains about 35 mg to about 115 mg of sodium bicarbonate. In one embodiment, the composition contains about 60 mg to about 150 mg of sodium bicarbonate. In one embodiment, the composition contains about 90 mg to about 150 mg of sodium bicarbonate. In one embodiment, the composition contains about 120 mg to about 150 mg of sodium bicarbonate.

[0237] The compositions of the present disclosure may contain from about 35 mg to about 150 mg of sodium bicarbonate, e.g., 35 mg, 36 mg, 37 mg, 38 mg, 39 mg, 40 mg, 41 mg, 42 mg, 43 mg, 44 mg, 45 mg, 46 mg, 47 mg, 48 mg, 49 mg, 50 mg, 51 mg, 52 mg, 53 mg, 54 mg, 55 mg, 56 mg, 57 mg, 58 mg, 59 mg, 60 mg, 61 mg , 62mg, 63mg, 64mg, 65mg, 66mg, 67mg, 68mg, 69mg, 70mg, 71mg, 72mg, 73mg, 74mg, 75mg, 76mg, 77mg, 78mg , 79mg, 80mg, 81mg, 82mg, 83mg, 84mg, 85mg, 86mg, 87mg, 88mg, 89mg, 90mg, 91mg, 92mg, 93mg, 94mg, 95mg, 96mg, 97mg, 98mg, 99mg, 100mg, 101mg, 102,mg, 103,mg, 104mg, 105mg, 106mg, 107mg, 108mg, 109mg, 110 mg, 111mg, 112mg, 113mg, 114mg, 115mg, 116mg, 117mg, 118mg, 119mg, 120mg, 121mg, 122mg, 123mg, 124m g, 125mg, 126mg, 127mg, 128mg, 129mg, 130mg, 31mg, 132mg, 133mg, 134mg, 135mg, 136mg, 137mg, 138mg, 139mg, 140mg, 141mg, 142mg, 143mg, 144mg, 145mg, 146mg, 147mg, 148mg, 149mg, or 150mg of sodium bicarbonate.

[0238] Carrier In this disclosure, the terms "carrier" and "auxiliary ingredient" refer to the same ingredient, and these terms may be used interchangeably in this disclosure. For purposes of this disclosure, a "carrier" is further defined herein as a compound that can be suitably combined with an active ingredient disclosed herein to serve one or more purposes, such as, for example, as a bulking agent, a delivery agent, a solubilizer, an anti-caking agent, a digestible filler, and the like. Although listed individually under a particular theme, such as generally as a carrier, or specifically as an anti-caking agent, bulking agent, or delivery aid, a carrier may serve more than one purpose. In many cases, the formulator may select a carrier that serves more than one purpose. This disclosure will, in examples, state the purpose of a particular carrier; however, this does not restrict the use of that carrier for other purposes.

[0239] In one embodiment, the disclosed carrier is a polysaccharide. Non-limiting examples of polysaccharide carriers include inulin, galactogen, cellulose, chitin, pectin, psyllium, guar, hemicellulose, potato starch, and partially hydrolyzed polysaccharides. In another embodiment, the carrier is a sugar alcohol, such as sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomaltose, or any combination thereof. In further aspects, the carrier component is based on natural or modified agar, alginate, carrageenan gum, cellulose, chitosan, chitin, cyclodextrin, dextran, gellan gum, glycogen, glycosaminoglycans, karaya gum, inulin, pectin, polydextrose, xanthan gum, or any other starch, gum, or other polysaccharide, including functionalized derivatives, dextrinized, hydrolyzed, oxidized, alkylated, hydroxyalkylated, acetylated, classified, and physically modified starches, and mixtures thereof. In some embodiments, glycine and / or propylene glycol may be added as a carrier.

[0240] In another embodiment, the carrier is selected from gum arabic, inulin, mannitol, silicon dioxide, colloidal silicon dioxide, microcrystalline cellulose, D-lactose monohydrate, tapioca starch, tapioca flour, quillaja, or a mixture thereof. In a further example, the carrier is gum arabic. In another example, the carrier is inulin. In yet another example, the carrier is microcrystalline cellulose. In a still further example, the carrier is D-lactose monohydrate. In yet another example, the carrier is quillaja. The carrier can be a combination of gum arabic, inulin, microcrystalline cellulose, D-lactose monohydrate, or quillaja.

[0241] In one non-limiting example, the carrier is Partek™ mannitol. In a further non-limiting example, the carrier is microcrystalline cellulose. In a still further example, the carrier is colloidal silicon dioxide.

[0242] Generally, depending on the particular aspect, embodiment, iteration, or example, the disclosed compositions can comprise from about 5% to about 95% by weight of the disclosed composition.

[0243] In one aspect of the disclosure, the composition comprises about 35% to about 75% by weight of one or more carriers. In one embodiment of this aspect, the carrier is selected from gum arabic, tapioca starch, tapioca flour, silicon dioxide, mannitol, colloidal silicon dioxide, microcrystalline cellulose, and mixtures thereof. In one iteration of this embodiment, the carrier comprises tapioca starch, colloidal silicon dioxide, and mixtures thereof.

[0244] In a further embodiment of this aspect, the composition comprises about 45% to about 70% by weight of one or more carriers. In another embodiment of this aspect, the composition comprises about 45% to about 55% by weight of one or more carriers. According to this aspect of the disclosure, the composition comprises about 35% to about 75% by weight of one or more carriers, e.g., 45%, 46%, 47%, 48%, 49%, 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, or 70%.

[0245] In this aspect of the disclosed compositions, the compositions comprise from about 120 mg to about 500 mg of one or more carriers. In further embodiments, the disclosed compositions comprise from about 120 mg to about 324 mg of one or more carriers. In further embodiments, the disclosed compositions comprise from about 250 mg to about 324 mg of one or more carriers. In further embodiments, the disclosed compositions comprise from about 324 mg to about 500 mg of one or more carriers.

[0246] In one iteration, the carrier includes tapioca starch and colloidal silicon dioxide, and mixtures thereof.

[0247] In this embodiment, the composition comprises from about 120 mg to about 500 mg of one or more carriers, e.g., 120 mg, 121 mg, 122 mg, 123 mg, 124 mg, 125 mg, 126 mg, 127 mg, 128 mg, 129 mg, 130 mg, 31 mg, 132 mg, 133 mg, 134 mg, 135 mg, 136 mg, 137 mg, 138 mg, 139 mg, 140 mg, 141 mg, 142 mg, 143 mg, 144 mg, 145 mg, 146 mg, 147 mg, 148 mg, 149 mg, 150 mg, 151 mg, 152 mg, 153 mg, 154 mg, 155mg, 156mg, 157mg, 158mg, 159mg, 160mg, 161mg, 162mg, 163mg, 164mg, 165mg, 166mg, 167mg, 168mg, 169mg, 170mg, 171mg, 172mg, 173mg, 174mg, 175mg , 167mg, 177mg, 178mg, 179mg, 180mg, 181mg, 182mg, 183mg, 184mg, 185mg, 186mg, 187mg, 188mg, 189mg, 190mg, 191mg, 192mg, 193mg, 194mg, 195mg, 196m g, 197mg, 198mg, 199mg, 200mg, 201mg, 202mg, 203mg, 204mg, 205mg, 206mg, 207mg, 208mg, 209mg, 210mg, 211mg, 212mg, 213mg, 214mg, 215mg, 216mg, 217 mg, 218mg, 219mg, 220mg, 221mg, 222mg, 223mg, 224mg, 225mg, 226mg, 227mg, 228mg, 229mg, 230mg, 231mg, 232mg, 233mg, 234mg, 235mg, 236mg, 237mg, 23 8mg, 239mg, 240mg, 241mg, 242mg, 243mg, 244mg, 245mg, 246mg, 247mg, 248mg, 249mg, 250mg, 251mg, 252mg, 253mg, 254mg, 255mg, 256mg, 257mg, 258mg, 2 59mg, 260mg, 261mg, 262mg, 263mg, 264mg, 265mg, 266mg, 267mg, 268mg, 269mg, 270mg, 271mg, 272mg, 273mg, 274mg, 275mg, 276mg, 277mg, 278mg, 279mg,280mg、281mg、282mg、283mg、284mg、285mg、286mg、287mg、288mg、289mg、290mg、290mg、291mg、292mg、293mg、294mg、295mg、296mg、297mg、298mg、299mg、300mg、304mg、305mg、306mg、307mg、308mg、309mg、310mg、311mg、312mg、313mg、314mg、315mg、316mg、317mg、318mg、319mg、320mg、321mg、322mg、323mg、324mg、325mg、326mg、327mg、328mg、329mg、330mg、331mg、332mg、333mg、334mg、335mg、336mg、337mg、338mg、339mg、340mg、341mg、342mg、343mg、344mg、345mg、346mg、347mg、348mg、349mg、350mg、351mg、352mg、353mg、354mg、355mg、356mg、357mg、358mg、359mg、360mg、361mg、362mg、363mg、364mg、365mg、366mg、367mg、368mg、369mg、370mg、371mg、372mg、373mg、374mg、375mg、376mg、377mg、378mg、379mg、380mg、381mg、382mg、383mg、384mg、385mg、386mg、387mg、388mg、389mg、390mg、390mg、391mg、392mg、393mg、394mg、395mg、396mg、397mg、398mg、399mg、400mg、401mg、402mg、403mg、404mg、405mg、406mg、407mg、408mg、409mg、410mg、411mg、412mg、413mg、414mg、415mg、416mg、417mg、418mg、419mg、420mg、421mg、422mg、423mg、424mg、425mg、426mg、427mg、428mg、429mg、430mg、431mg、432mg、433mg、434mg、435mg、436mg、437mg、438mg、439mg、440mg、441mg、442mg、443mg、444mg、445mg、446mg、447mg, 448mg, 449mg, 450mg, 451mg, 452mg, 453mg, 454mg, 455mg, 456mg, 457mg, 458mg, 459mg, 460mg, 4 61mg, 462mg, 463mg, 464mg, 465mg, 466mg, 467mg, 468mg, 469mg, 470mg, 471mg, 472mg, 473mg, 474mg, 475 mg, 476 mg, 477 mg, 478 mg, 479 mg, 480 mg, 481 mg, 482 mg, 483 mg, 484 mg, 485 mg, 486 mg, 487 mg, 488 mg, 489 mg, 490 mg, 490 mg, 491 mg, 492 mg, 493 mg, 494 mg, 495 mg, 496 mg, 497 mg, 498 mg, 499 mg, or 500 mg of one or more carriers.

[0248] In another aspect of the present disclosure, the composition comprises about 30% to about 85% by weight of one or more carriers. In one embodiment of this aspect, the carrier is selected from gum arabic, tapioca starch, tapioca flour, silicon dioxide, mannitol, colloidal silicon dioxide, microcrystalline cellulose, and mixtures thereof. In one iteration of this embodiment, the carrier comprises tapioca starch, colloidal silicon dioxide, and mixtures thereof.

[0249] In one embodiment, the composition comprises about 40% to about 70% by weight of one or more carriers. The composition may comprise about 30% to about 85% by weight of one or more carriers, for example, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, 100%, 101%, 102%, 103%, 104%, 105%, 106%, 107%, 108%, 109%, 1109%, 1110, 112%, 113%, 114%, 115%, 116%, 117%, 118%, 119%, 120%, 121%, 122%, 123%, 124%, 125%, 126%, 127%, 128%, 129%, 130%, 131%, 132%, 133%, 134%, and containing one or more carriers of 5%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%, 83%, 84%, or 85%.

[0250] In this aspect of the disclosed composition, the composition comprises about 110 mg to about 465 mg of one or more carriers. In one embodiment, the composition comprises about 180 mg to about 465 mg of one or more carriers. In another embodiment, the composition comprises about 270 mg to about 465 mg of one or more carriers. In a further embodiment, the composition comprises about 365 mg to about 465 mg of one or more carriers. In a still further embodiment, the composition comprises about 180 mg to about 465 mg of one or more carriers. In a still further embodiment, the composition comprises about 110 mg to about 180 mg of one or more carriers. In yet another embodiment, the composition comprises about 110 mg to about 270 mg of one or more carriers. In yet another embodiment, the composition comprises about 180 mg to about 270 mg of one or more carriers.

[0251] In this embodiment of the disclosed compositions, the composition comprises from about 110 mg to about 465 mg of one or more carriers, e.g., 110 mg, 111 mg, 112 mg, 113 mg, 114 mg, 115 mg, 116 mg, 117 mg, 118 mg, 119 mg, 120 mg, 121 mg, 122 mg, 123 mg, 124 mg, 125 mg, 126 mg, 127 mg, 128 mg, 129 mg, 130 mg, 131 mg, 132 mg, 133 mg, 134 mg, 135 mg, 136 mg, 137 mg, 138 mg, 139 mg, 140 mg, 141 mg, 142 mg, 143 mg, 144 mg, 145 mg, 146 mg, 147 mg, 148 mg, 149 mg, 150 mg, 151 mg, 152 mg, 153 mg, 154 mg, 155 mg, 156 mg, 157 mg, 158 mg, 159 mg, 160 mg, 161 mg, 162 mg, 163 mg, 164 mg, 165 mg, 166 mg, 167 mg, 168 mg, 169 mg, 170 mg, 171 mg, 172 mg, 173 mg, 174 mg, 175 mg, 176 mg, 177 mg, 178 mg, 179 mg, 180 mg, 181 mg, 182 mg, 183 mg, 184 mg, 185 mg, 186 mg, 187 mg, 188 mg, 43mg, 144mg, 145mg, 146mg, 147mg, 148mg, 149mg, 150mg, 151mg, 152mg, 153mg, 154mg, 155mg, 156mg, 157mg, 158mg, 159mg, 160mg, 161mg, 162mg, 163mg, 164mg, 165mg, 166mg, 167mg, 168mg, 169mg, 170mg, 171mg, 172mg, 173mg, 174mg, 175mg, 167mg, 177mg, 178mg, 179mg, 180mg, 181mg, 182mg, 183mg, 184mg , 185mg, 186mg, 187mg, 188mg, 189mg, 190mg, 191mg, 192mg, 193mg, 194mg, 195mg, 196mg, 197mg, 198mg, 199mg, 200mg, 201mg, 202mg, 203mg, 204mg, 205 mg, 206mg, 207mg, 208mg, 209mg, 210mg, 211mg, 212mg, 213mg, 214mg, 215mg, 216mg, 217mg, 218mg, 219mg, 220mg, 221mg, 222mg, 223mg, 224mg, 225mg, 22 6mg, 227mg, 228mg, 229mg, 230mg, 231mg, 232mg, 233mg, 234mg, 235mg, 236mg, 237mg, 238mg, 239mg, 240mg, 241mg, 242mg, 243mg, 244mg, 245mg, 246mg, 2 47mg, 248mg, 249mg, 250mg, 251mg, 252mg, 253mg, 254mg, 255mg, 256mg, 257mg, 258mg, 259mg, 260mg, 261mg, 262mg, 263mg, 264mg, 265mg, 266mg, 267mg,268mg、269mg、270mg、271mg、272mg、273mg、274mg、275mg、276mg、277mg、278mg、279mg、280mg、281mg、282mg、283mg、284mg、285mg、286mg、287mg、288mg、289mg、290mg、290mg、291mg、292mg、293mg、294mg、295mg、296mg、297mg、298mg、299mg、300mg、304mg、305mg、306mg、307mg、308mg、309mg、310mg、311mg、312mg、313mg、314mg、315mg、316mg、317mg、318mg、319mg、320mg、321mg、322mg、323mg、324mg、325mg、326mg、327mg、328mg、329mg、330mg、331mg、332mg、333mg、334mg、335mg、336mg、337mg、338mg、339mg、340mg、341mg、342mg、343mg、344mg、345mg、346mg、347mg、348mg、349mg、350mg、351mg、352mg、353mg、354mg、355mg、356mg、357mg、358mg、359mg、360mg、361mg、362mg、363mg、364mg、365mg、366mg、367mg、368mg、369mg、370mg、371mg、372mg、373mg、374mg、375mg、376mg、377mg、378mg、379mg、380mg、381mg、382mg、383mg、384mg、385mg、386mg、387mg、388mg、389mg、390mg、390mg、391mg、392mg、393mg、394mg、395mg、396mg、397mg、398mg、399mg、400mg、401mg、402mg、403mg、404mg、405mg、406mg、407mg、408mg、409mg、410mg、411mg、412mg、413mg、414mg、415mg、416mg、417mg、418mg、419mg、420mg、421mg、422mg、423mg、424mg、425mg、426mg、427mg、428mg、429mg、430mg、431mg、432mg、433mg、434mg、435 mg, 436 mg, 437 mg, 438 mg, 439 mg, 440 mg, 441 mg, 442 mg, 443 mg, 444 mg, 445 mg, 446 mg, 447 mg, 448 mg, 449 mg, 450 mg, 451 mg, 452 mg, 453 mg, 454 mg, 455 mg, 456 mg, 457 mg, 458 mg, 459 mg, 460 mg, 461 mg, 462 mg, 463 mg, 464 mg, or 465 mg of a carrier.

[0252] A non-limiting list of carriers suitable for use in the disclosed compositions includes carriers that may also act as binders, pH stabilizers, disintegrants, and lubricants, such as lactose monohydrate, mannitol, polyvinylpyrrolidone, crospovidone (crospovidone is a polyvinylpyrrolidone having a molar mass of about 2,500 g / mol to about 2,500.00 g / mol), tapioca starch, citric acid, sodium citrate, magnesium stearate, calcium carbonate, magnesium carbonate, calcium stearate, magnesium stearate, tricalcium phosphate, powdered cellulose, magnesium stearate, sodium ferrocyanide, potassium ferrocyanide, calcium ferrocyanide, calcium phosphate, sodium silicate, calcium silicate, magnesium trisilicate, sodium aluminosilicate, potassium aluminum silicate, calcium aluminosilicate, bentonite, aluminum silicate, stearic acid, polydimethylsiloxane, and the like.

[0253] method Disclosed herein are methods for treating epilepsy, where epilepsy can manifest in any of its recognized or classified forms. In one embodiment, disclosed herein is a method for reducing seizures in a patient suffering from epilepsy, comprising administering to a patient in need of treatment a composition disclosed herein.

[0254] epilepsy The term epilepsy is generally defined as "a central nervous system (neurological) disorder in which brain activity becomes abnormal, causing seizures or periods of unusual behavior, sensation, and sometimes loss of awareness."

[0255] Without wishing to be bound by theory, the symptoms of epileptic seizures can vary widely. Some individuals with epilepsy simply stare into space for a few seconds during a seizure, while others repeatedly twitch their arms or legs. Having a single seizure does not determine that an individual suffers from epilepsy. General consensus requires that at least two seizures without a known trigger (unprovoked seizures) occurring at least 24 hours apart are generally required for a diagnosis of epilepsy. Typically, epilepsy is characterized by one or more symptoms, particularly psychological symptoms that include temporary delirium, staring attacks, muscle rigidity, uncontrollable jerking movements of the arms and legs, loss of consciousness or awareness, fear, anxiety, or déjà vu.

[0256] There are various commonly recognized forms of seizures. i) Absence seizures, formerly known as petit mal seizures. These seizures typically occur in children. They are characterized by a blank stare with or without slight body movements such as blinking or clicking the tongue, and last only 5-10 seconds. These seizures occur in clusters, often as many as 100 per day, and can cause a brief loss of awareness. ii) Tonic seizures, which cause muscle rigidity and can affect consciousness. These seizures typically affect the muscles of the subject's back, arms, and legs, and can cause the subject to fall to the ground. iii) Cataplexy, also known as drop attacks, causes loss of muscle control. Because this type of attack most often affects the legs, it often causes the subject to suddenly collapse or fall. iv) Clonic seizures are associated with repetitive or rhythmic jerking muscle movements. These seizures usually affect the neck, face, and arms. v) Myoclonic seizures usually present as sudden, brief jerks or spasms, usually affecting the upper body, arms, and legs. vi) Tonic-clonic seizures, formerly known as grandmal seizures, are the most dramatic type of epileptic seizure. They can cause a sudden loss of consciousness and stiffening, convulsions, and shaking of the body. These seizures can cause loss of bladder control or the subject to bite their tongue.

[0257] Treatment-resistant epilepsy In addition to the commonly recognized seizures listed above, there are individual syndromes associated with epilepsy, such as treatment-resistant childhood-onset epilepsy, particularly syndromes that are not generally responsive to treatment with standard antiepileptic medications. For example, the following are non-limiting examples of childhood epilepsies: Dravet syndrome, myoclonic absence epilepsy, Lennox-Gastaut syndrome, generalized epilepsy of unknown origin, CDKL5 mutations, Aicardi syndrome, bilateral polymicrogyria, Dup15q, SNAP25, as well as febrile infection-related epilepsy syndrome (FIRES), benign rolandic epilepsy, juvenile myoclonic epilepsy, infantile spasms (West syndrome), and Landau-Kleffner syndrome.

[0258] Without wishing to be bound by theory, Dravet syndrome is an epileptic syndrome that begins in infancy or early childhood and can encompass a spectrum of symptoms ranging from mild to severe. Children with Dravet syndrome initially exhibit focal (localized to one area) or generalized (whole brain) convulsive seizures, which begin before 15 months of age (often before 1 year of age). These initial seizures are often protracted and may involve one side of the body, followed by seizures that switch to the other side. Other seizure types develop after 12 months of age and can vary considerably. Status epilepticus, a state of ongoing seizures requiring emergency medical care, can occur frequently, particularly in the first five years of life. The U.S. Food and Drug Administration (FDA) has approved cannabidiol for treating seizures due to Dravet syndrome in individuals aged 2 years and older. Thus, the present composition provides a treatment for treating Dravet syndrome in subjects.

[0259] Without wishing to be bound by theory, Lennox-Gastaut syndrome is a severe condition characterized by recurrent seizures (epilepsy) that begin early in life. Affected individuals have multiple types of seizures, specific patterns of brain activity (called slow spike-and-wave complexes) measured by a test called an electroencephalogram (EEG), and impaired intelligence.

[0260] In Lennox-Gastaut syndrome, epilepsy begins in early childhood, usually between the ages of 3 and 5. The most common type of seizure is a tonic seizure, which causes muscles to stiffen (contract) uncontrollably. These seizures typically occur during sleep. They can also occur during wakefulness and can cause sudden falls. Atypical absence seizures are also common, which cause a very brief partial or complete loss of consciousness. In addition, many affected individuals have episodes called drop attacks, which cause sudden falls that can result in serious or life-threatening injuries. Drop attacks can be caused by a sudden loss of muscle tone (described as atonia) or by abnormal muscle contractions (described as rigors). Other types of seizures are reported less frequently in individuals with Lennox-Gastaut syndrome. Seizures associated with Lennox-Gastaut syndrome often do not respond well to treatment with antiepileptic drugs. Thus, the present compositions provide a therapy for treating Lennox-Gastaut syndrome in a subject.

[0261] Without wishing to be limited by theory, Aicardi syndrome is caused by a genetic abnormality that results in the complete or partial absence of the corpus callosum in the brain. Children with Aicardi syndrome often also exhibit retinal abnormalities. Seizures usually begin in infancy (typically as infantile spasms) and tend to progress to recurrent seizures that can be difficult to treat. Seizures associated with Aicardi syndrome include focal impairment seizures, infantile spasms, clonic seizures, tonic seizures, tonic-clonic seizures, atonic seizures, myoclonic seizures, absence seizures, and focal seizures that evolve into secondarily generalized seizures. In many cases, Aicardi syndrome is resistant to treatment with standard antiseizure medications. Thus, the present composition provides a therapy for treating Aicardi syndrome in a subject.

[0262] Any of the compositions disclosed herein can be used to treat epilepsy. The following are provided as non-limiting examples only:

[0263] In one embodiment, a method for treating epilepsy is disclosed herein, comprising administering to a patient in need thereof a composition comprising: a) about 5% to about 20% by weight of CBD oil containing about 88% to about 92% cannabidiol by weight; b) about 15% to about 40% by weight of high oleic sunflower oil; c) about 5% to about 15% by weight of one or more bile salts, and d) about 35% to about 75% by weight of one or more carriers.

[0264] In one embodiment of this aspect, the composition comprises: a) about 30 mg to about 135 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 60 mg to about 270 mg high oleic sunflower oil; c) about 25 mg to about 100 mg of one or more bile salts, wherein the salts contain about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; and d) 120 mg to about 500 mg of one or more carriers.

[0265] In a further aspect, a method for treating epilepsy is disclosed herein, comprising administering to a patient in need thereof a composition comprising: a) about 5% to about 25% by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) from about 5% to about 60% by weight of one or more edible oils; c) about 0.1% to about 1% by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 10% to about 20% by weight sodium bicarbonate, and e) The remainder is the carrier.

[0266] In one embodiment of this aspect, the composition comprises: a) about 5 mg to about 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 10 mg to about 65 mg of one or more edible oils selected from sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, and mixtures thereof; c) about 75 mg to about 300 mg of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 35 mg to about 150 mg sodium bicarbonate, and e) about 110 mg to about 465 mg of a carrier.

[0267] In yet a further aspect, a method for treating epilepsy is disclosed herein, comprising administering to a patient in need thereof a composition comprising: a) about 5% to about 25% by weight of a CBD oil extract containing at least about 98% by weight of cannabidiol; b) about 5% to about 60% by weight of high oleic olive oil; c) about 0.1% to about 1% by weight of deoxycholic acid; d) about 10% to about 20% by weight sodium bicarbonate, and e) The remainder is the carrier.

[0268] In one embodiment of this aspect, the composition comprises: a) about 40 mg to about 170 mg of CBD oil extract containing at least about 98% cannabidiol by weight; b) about 80 mg to about 340 mg of one or more edible oils; c) about 1.5 mg to about 8 mg of deoxycholic acid; d) about 35 mg to about 150 mg sodium bicarbonate, and e) about 80 mg to about 350 mg of one or more carriers.

[0269] Disclosed herein is a method for treating Dravet Syndrome in a patient suffering from Dravet Syndrome and in need of treatment, comprising administering to the patient in need of treatment a composition comprising: a) about 5% to about 20% by weight of CBD oil containing about 88% to about 92% cannabidiol by weight; b) about 15% to about 40% by weight of high oleic sunflower oil; c) about 5% to about 15% by weight of one or more bile salts, and d) about 35% to about 75% by weight of one or more carriers.

[0270] In a further embodiment, the method comprises administering to a patient in need of treatment a composition comprising: a) about 30 mg to about 135 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 60 mg to about 270 mg high oleic sunflower oil; c) about 25 mg to about 100 mg of one or more bile salts, wherein the salts contain about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; and d) 120 mg to about 500 mg of one or more carriers.

[0271] In another embodiment, the method comprises administering to a patient in need of treatment a composition comprising: a) about 5 mg to about 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 10 mg to about 65 mg of one or more edible oils selected from sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, and mixtures thereof; c) about 75 mg to about 300 mg of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 35 mg to about 150 mg sodium bicarbonate, and e) about 110 mg to about 465 mg of a carrier.

[0272] In a further aspect, a method for treating epilepsy in a subject is disclosed, comprising administering to the subject a composition comprising: a) about 35 mg to about 150 mg of CBD oil containing at least about 98% cannabidiol by weight; b) about 70 mg to about 300 mg olive oil; c) about 3 mg to about 13 mg of deoxycholic acid, and d) about 135 mg to about 560 mg of one or more carriers selected from mannitol, colloidal silicon dioxide, and mixtures thereof.

[0273] In a non-limiting example of this embodiment, the composition comprises: a) about 35 mg of CBD oil containing at least about 98% cannabidiol by weight; b) approximately 70 mg of olive oil; c) approximately 3 mg of deoxycholic acid, and d) about 67 mg mannitol and about 68 mg colloidal silicon dioxide.

[0274] In a still further non-limiting example of this embodiment, the composition comprises: a) about 75 mg of CBD oil containing at least about 98% cannabidiol by weight; b) approximately 150 mg of olive oil; c) approximately 6.6 mg of deoxycholic acid, and d) about 139 mg mannitol and about 141 mg colloidal silicon dioxide.

[0275] In still further non-limiting examples of this aspect of the disclosed methods, the composition comprises: a) about 120 mg of CBD oil containing at least about 98% cannabidiol by weight; b) approximately 240 mg of olive oil; c) approximately 10.5 mg of deoxycholic acid, and d) about 219 mg mannitol and about 221 mg colloidal silicon dioxide.

[0276] Any of the disclosed compositions can be used to treat treatment-resistant epilepsy in a subject.

[0277] Further disclosed herein is a method for treating Lennox-Gastaut syndrome in a subject suffering from Lennox-Gastaut syndrome and in need of treatment, comprising administering to a patient in need of treatment a composition comprising: a) about 5% to about 20% by weight of CBD oil containing about 88% to about 92% cannabidiol by weight; b) about 15% to about 40% by weight of sunflower oil; c) about 5% to about 15% by weight of one or more bile salts, and d) about 35% to about 75% by weight of one or more carriers.

[0278] In still a further embodiment, to treat Lennox-Gastaut syndrome, the method comprises administering to a patient in need of treatment a composition comprising: a) about 30 mg to about 135 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 60 mg to about 270 mg of sunflower oil; c) about 25 mg to about 100 mg of one or more bile salts, wherein the salts contain about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; and d) 120 mg to about 500 mg of one or more carriers.

[0279] In a still yet further embodiment, a method for treating Lennox-Gastaut syndrome comprises administering to a patient in need of treatment a composition comprising: a) about 5 mg to about 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 10 mg to about 65 mg of one or more edible oils selected from sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, and mixtures thereof; c) about 75 mg to about 300 mg of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 35 mg to about 150 mg sodium bicarbonate, and e) about 110 mg to about 465 mg of a carrier.

[0280] A still further method of the present application is a method for treating Aicardi syndrome in a patient suffering from Aicardi syndrome and in need of treatment, comprising administering to the patient in need of treatment a composition comprising: a) about 5% to about 20% by weight of CBD oil containing about 88% to about 92% cannabidiol by weight; b) about 15% to about 40% by weight of high oleic sunflower oil; c) about 5% to about 15% by weight of one or more bile salts, and d) about 35% to about 75% by weight of one or more carriers.

[0281] In yet a further embodiment, the method is for treating Aicardi syndrome, the method comprising administering to a patient in need of treatment a composition comprising: a) about 30 mg to about 135 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 60 mg to about 270 mg high oleic sunflower oil; c) about 25 mg to about 100 mg of one or more bile salts, wherein the salts contain about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; and d) 120 mg to about 500 mg of one or more carriers.

[0282] In another embodiment, a method for treating Aicardi syndrome comprises administering to a patient in need of treatment a composition comprising: a) about 5 mg to about 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 10 mg to about 65 mg of one or more edible oils selected from sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, and mixtures thereof; c) about 75 mg to about 300 mg of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 35 mg to about 150 mg sodium bicarbonate, and e) about 110 mg to about 465 mg of a carrier.

[0283] Any of the compositions disclosed above are suitable for treating Dravet syndrome, Lennox-Gastaut syndrome, or Aicardi syndrome.

[0284] As with all diseases, there is variability between children and adults. This difference can be based on age, weight, frequency of seizures, and the like. In addition, anti-seizure medications (AEDs) can be added as secondary active ingredients. Non-limiting examples of anti-seizure medications include clobazam, levetiracetam, topiramate, stiripentol, phenobarbital, lacosamide, valproic acid, zonisamide, perampanel, and fosphenytoin.

[0285] The effective dose required to achieve control of a patient's epilepsy is based on the amount of cannabidiol delivered to the patient in need. This amount is determined by a physician after a period of patient observation. The present disclosure relates to cannabidiol intakes of about 5 mg / kg / day or greater. Thus, for an 80 kg patient, a dose equal to or greater than 400 mg of CBD per day would be provided. Doses greater than 5 mg / kg / day, such as greater than 10 mg / kg / day, greater than 15 mg / kg / day, greater than 20 mg / kg / day, and greater than 25 mg / kg / day, may also be effective for treating epilepsy.

[0286] In one non-limiting embodiment, after providing an original dose from 2 mg / kg / day, the amount can be gradually increased depending on the subject's observation, for example, from 2 mg / kg / day to 3 mg / kg / day, from 2 mg / kg / day to 4 mg / kg / day, from 2 mg / kg / day to 5 mg / kg / day, from 5 mg / kg / day to 7.5 mg / kg / day, or from 5 mg / kg / day to 10 mg / kg / day, until an effective dose in the subject is determined. In one iteration, the amount of cannabidiol that may be given is 2.5 mg / kg / day, 2.6 mg / kg / day, 2.7 mg / kg / day, 2.8 mg / kg / day, 2.9 mg / kg / day, 3.0 mg / kg / day, 3.1 mg / kg / day, 3.2 mg / kg / day, 3.3 mg / kg / day, 3.4 mg / kg / day, 3.5 mg / kg / day, 3.6 mg / kg / day, 3.7 mg / kg / day, 3.8 mg / kg / day, 3.9 mg / kg / day, 4.0 mg / kg / day, 4.1 mg / kg / day, 4.2 mg / kg / day, 4.3 mg / kg / day, 4.4 mg / kg / day, 4.5 mg / kg / day, 4.6 mg / kg / day, 4.7 mg / kg / day, 4.8 mg / kg / day, or 4.9 mg / kg / day.

[0287] In further iterations, the amount of cannabinol intake can be 5mg / kg / day, 6mg / kg / day, 7mg / kg / day, 8mg / kg / day, 9mg / kg / day, 10mg / kg / day, 11mg / kg / day, 12mg / kg / day, 13mg / kg / day, 14mg / kg / day, 15mg / kg / day, 16mg / kg / day, 17mg / kg / day, 18mg / kg / day, 19mg / kg / day, 20mg / kg / day, 21mg / kg / day, 22mg / kg / day, 23mg / kg / day, 24mg / kg / day, or 25mg / kg / day. [Example]

[0288] Disclosed exam outline The results of studies comparing Epidiolex™ to the disclosed compositions are disclosed herein. The studies include both human and animal studies.

[0289] The first disclosed study compares Epidiolex™ to the disclosed compositions and a control. The study utilized is an acute maximal electroshock (MES) model that compares the efficacy of the compositions to Epidiolex™ in a model of epilepsy.

[0290] Next, a human clinical trial comparison between Epidiolex™ and the disclosed compositions is described herein. These data were compared to the disclosed human clinical trials in humans using the disclosed compositions.

[0291] A literature comparison was made between literature pharmacokinetic studies and the disclosed studies utilizing the compositions of the present disclosure.

[0292] Comparison of Epidiolex™ with the disclosed composition in animal studies The disclosed compositions were tested against a control and Epidiolex™ in the following efficacy studies.

[0293] Study design The following study was conducted to test and evaluate the therapeutic efficacy of the disclosed compositions for treating epilepsy in subjects suffering from or diagnosed with epilepsy, which is characterized by recurrent seizures that can vary from brief and nearly undetectable periods to long periods of severe shaking caused by abnormal electrical activity in the brain.

[0294] The acute maximal electroshock (MES) model was used in the disclosed animal studies to determine the efficacy of the disclosed compounds against a vehicle control and Epidiolex™, an FDA-approved treatment for epilepsy. Two studies were conducted: a pilot study to determine the effective dose of the disclosed compositions, and a paired comparison study against the control and Epidiolex™ at the doses determined in the pilot study.

[0295] A second study was used to determine the time to peak effect of the disclosed compositions at the effective dose determined by the pilot study. Primary endpoints of these studies included clinical observations, maximum seizure severity scores, and inhibition of tonic hindlimb extension (HLE) after the MES test.

[0296] In a pilot study, MES testing was performed 1.5 hours ± 30 minutes after treatment with the disclosed composition from Table 1, Example 3, Epidiolex, or vehicle. Animals treated with 50 mg / kg of Epidiolex or vehicle exhibited complete HLE after the MES test, indicating no protection at this time point. Treatment with 50 mg / kg of the disclosed composition in a single test subject resulted in partial HLE, characterized by partial or incomplete extension of one or both hind limbs. Treatment with 75 mg / kg of the disclosed composition revealed complete protection (no HLE) in 66.6% of test subjects after the MES test, compared to 50% of the Epidiolex group and 0% of the vehicle-treated group. At the 100 mg / kg dose level, Epidiolex provided the highest level of protection, with 75% of animals exhibiting no HLE, compared to 33% in the disclosed composition group and 0% in the vehicle-treated group. Based on these results, the effective dose of the disclosed composition was determined to be 75 mg / kg.

[0297] In a paired comparison study, MES testing was performed at five separate time points (15 minutes ± 5 minutes, 30 minutes ± 10 minutes, 1 hour ± 15 minutes, 2 hours ± 20 minutes, and 4 hours ± 30 minutes) after treatment with the disclosed composition, Epidiolex, or vehicle at an effective dose (75 mg / kg) determined by pilot studies. At the 15-minute time point, all animals from all groups exhibited complete HLE. Specifically, at 30 minutes, administration of 75 mg / kg of the disclosed composition resulted in partial HLE in 37.5% of animals and no HLE in 12.5% ​​of test subjects, compared with 0% of the Epidiolex group and 0% of the vehicle group. At the 1-hour time point, 75% of animals treated with the disclosed composition did not exhibit complete HLE, compared with 50% of the Epidiolex-treated group and 0% of the vehicle-treated group. At the 2-hour time point, treatment with the disclosed composition and Epidiolex was comparable, with 50% of subjects showing complete protection and 12.5% ​​having partial protection. At the 4-hour time point, Epidiolex demonstrated the highest level of protection, with 50% of animals exhibiting no HLE compared to 12.5% ​​of subjects in the disclosed composition group. However, it is worth noting that between the 30-minute and 4-hour time points, animals in the vehicle-treated group exhibited partial (12.5-25%) or complete protection (12.5%), likely due to variability resulting from technical, biological (circadian or hormone-induced rhythms), and / or environmental factors. Based on these results, 1 hour was determined to be the time of peak effect for the disclosed composition, although the disclosed composition may potentially have a more rapid onset of efficacy, as indicated by partial protection beginning 30 minutes postdose.

[0298] After the quarantine period and prior to the start of treatment, male Sprague-Dawley rats were randomly assigned to their respective treatment groups (Table A for the pilot study and Table B for the paired comparison). On the study day, after treatment with the composition disclosed in Table 4, Example 3, Epidiolex™, or vehicle, HLE was evoked at various time points using the MES test delivered via corneal electrodes. In the pilot and paired comparison studies, the pretreatment time before the MES test was based on the published bioactivity of the positive control Epidiolex (Patra et al., 2018). Acute clinical signs and suppression of HLE were assessed immediately after the MES test. All drugs were administered by oral gavage at mg / kg doses as outlined in Tables I and II. n = 21 for the pilot study and n = 28 for the paired comparison study. Table 1 below provides a non-limiting example of this embodiment of the disclosed composition.

[0299] Test Composition The disclosed composition from Table 1, Example 3, was formulated fresh each day of dosing with sterile water to achieve a concentration of 5 mg / mL, taking into account the potency. Upon reconstitution, the suspension was thoroughly vortexed and then placed in a water bath sonicator for 1 minute to achieve a uniform formulation. The formulation was kept on wet ice and protected from light during use. Immediately prior to administration, the formulation was briefly mixed by vortexing and / or inversion to ensure uniformity. The formulation was used within 12 hours. Discard upon completion of dosing.

[0300] [Table 6]

[0301] The composition disclosed in Example 3 of Table 1 was used in the rodent MES epilepsy study disclosed herein below.

[0302] base The base formulation did not contain any CBD content and was formulated fresh each day with sterile water to achieve a concentration of 5 mg / mL. Upon reconstitution, the suspension was thoroughly vortexed and then placed in a water bath sonicator for 1 minute to achieve a uniform formulation. The formulation was kept on wet ice and protected from light during use. Immediately prior to administration, the formulation was briefly mixed by vortexing and / or inversion to ensure uniformity. The formulation was used within 12 hours and discarded upon completion of dosing.

[0303] Prescription-grade Epidiolex™ was used in the disclosed MES study. Each milliliter of this material contains 100 mg of cannabidiol, 79 mg of absolute ethanol, 736 mg of refined sesame oil, sucralose, and strawberry flavor. Epidiolex™ is supplied ready-to-use with a CBD content of 100 mg / mL and should be used within one month of opening (stored at room temperature).

[0304] MES exam Efficacy pilot study design

[0305] [Table 7]

[0306] [Table 8]

[0307] The following terms in Tables I-VIII are used in this application to describe the experimental results of the data disclosed below.

[0308] [Table 9]

[0309] Pilot study results Vehicle control

[0310] [Table 10]

[0311] Disclosed compositions *

[0312] [Table 11]

[0313] EPIDIOLEX(TM)

[0314] [Table 12]

[0315] A pilot study determined that the amount of the disclosed composition to be used in the main paired comparison study was 75 mg / kg.

[0316] Results of the main paired comparison test (time to peak efficiency) Vehicle control

[0317] [Table 13]

[0318] Disclosed compositions *

[0319] [Table 14]

[0320] EPIDIOLEX(TM) composition

[0321] [Table 15]

[0322] overview The disclosed compositions enhanced efficacy based on rapidity of action. At 30 minutes, 50% of animals receiving the disclosed compositions showed a partial reduction or complete elimination of seizure activity, while 100% of animals receiving Epidiolex™ showed complete seizure activity at 30 minutes. At 60 minutes, 87.5% of animals receiving the disclosed compositions showed a partial reduction or complete elimination of seizure activity, compared to 62.5% of animals receiving Epidiolex™. Epidiolex™ showed some enhanced seizure reduction potential at later time points in the study.

[0323] Pharmacokinetic studies A study comparing the disclosed composition with EPIDIOLEX™ in humans Pharmacokinetic Studies of the Disclosed Compositions Pharmacokinetic studies were conducted in humans to examine the amount of cannabidiol present in plasma levels at various doses. Patients enrolled in the study received the disclosed composition from Table 4, No. 3, at a dose of 3.28 mg / kg / day, achieving a pre-dose plasma level of 33.3 ng / mL after the first 2.5 weeks (i.e., Period 1), and then increased to a dose of 4.46 mg / kg / day, achieving a pre-dose plasma level of 53.7 ng / mL after the final 2.5 weeks (i.e., Period 2) of the study.

[0324] The results of this pharmacokinetic study in humans are summarized in Table 5 below.

[0325] [Table 16]

[0326] Pharmacokinetic Studies Using the Disclosed Compositions A pharmacokinetic study of the disclosed compositions was designed as a triple-blind (participant, investigator, outcome assessor), placebo-controlled, crossover pilot study. 70 volunteers (ages 40-70 years) received either the composition disclosed in Table 1, No. 3 or a placebo in a crossover fashion. The study protocol was registered with ClinicalTrials.gov (accessed April 7, 2022) (NCT05346562). The order of participants' treatments was generated by Research Randomizer, and participants completed (1) placebo control and (2) the composition from Table 1, No. 3 (225-300 mg in three divided doses daily for the first 2.5 weeks, equivalent to 3.28 mg / Kg / day, and 375-450 mg in three divided doses for the next 2.5 weeks, equivalent to 4.46 mg / Kg / day). Then, after a two-week washout, participants repeated the study for another five weeks under different conditions. Participants visited the laboratory a total of six times (three in each study arm), each time after an overnight fast. The complete study process was conducted at the Department for Integrative Physiology, University of Split School of Medicine, Split, Croatia. The study design, implementation, and reporting adhered to CONSORT guidelines and included a 25-item checklist and flow diagram. The study was conducted in accordance with the guidelines of the Declaration of Helsinki and was approved by the Ethics Committee of the University of Split School of Medicine on December 15, 2021 (Class: 003-08 / 21-03 / 0003; Reg. No.: 2181-198-03-04-21-0091). Prior to enrollment, the procedures, process, and objectives of the study were explained to each participant, and each participant individually signed an informed consent form.

[0327] Each patient underwent a total of six laboratory visits. At each visit, a venous blood sample was drawn from the forearm after an overnight fast, and a urine sample was obtained. All blood and urine samples were analyzed in the same certified biochemistry laboratory using standard operating procedures.

[0328] Each subject completed a daily diary to confirm the timing of daily CBD and placebo dose administration. In addition, a 24-h physical activity and dietary diary was provided for each subject at each visit. Participants were instructed to adhere to the same dietary intake and physical activity patterns across all visits. If a participant missed a dose, up to one capsule (75 mg) was added to the next dose. Adherence to the intervention was considered successful if ≥90% of treatment was taken based on the number of remaining capsules and the patient's self-reported dietary diary.

[0329] Finally, the safety and tolerability profile of the composition from Formulation No. 3 in Table 1 during 5 weeks of administration was determined by circulating (steady-state) plasma and urinary concentrations of CBD, as well as adverse event reports. Liver (ALT, AST, ALP, GGT, and total bilirubin) markers were also measured.

[0330] Summary of adverse events A total of eight participants experienced adverse effects (AEs) during the course of the intervention arm of the study (Dosing Periods 1 and 2). There were six reports of AEs in the placebo study. Based on MedDRA (version 25.1) and CTCAE-V.5.0 terminology, all reported AEs were classified as Grade I (mild; intervention not indicated) and were distributed across the first and second dosing periods. No serious AEs were reported, and no participants discontinued treatment as a result of an AE. AEs reported / observed during the dosing periods are listed in Table 6 below.

[0331] [Table 17]

[0332] Liver enzymes The effect of dosing with a composition from Table 3 on liver enzymes was also evaluated. Administration of a composition from the formulation in Table 2 for 5 weeks did not result in changes in alanine transferase (ALT) (Figure 2), alkaline phosphatase (ALP) (Figure 3), or total bilirubin (Figure 4). Gamma-glutamyltransferase (GGT) (main effect of dose: P = 0.038; Figure 5) was mildly elevated during CBD compared with placebo, but there was no interaction effect. In contrast, aspartate transaminase (AST) was higher under the placebo condition (main effect of dose: P = 0.047; Figure 6), again with no interaction effect. Furthermore, these changes were <1 standard deviation and therefore considered clinically insignificant. As previously noted, changes >3 SD from baseline were classified as AEs.

[0333] Figure 2 shows plasma alanine transaminase concentrations for CBD and placebo. Figure 2 indicates that plasma alanine transaminase concentrations remained effectively unchanged over time. Figure 3 shows plasma alkaline phosphatase concentrations for CBD and placebo. Figure 4 indicates that plasma alkaline phosphatase remained effectively unchanged over time. Figure 4 shows plasma total bilirubin concentrations for CBD and placebo. Figure 4 indicates that plasma total bilirubin concentrations remained effectively unchanged over time. Figure 5 shows plasma gamma-glutamyltransferase concentrations for CBD and placebo. Figure 5 indicates that plasma gamma-glutamyltransferase concentrations remained effectively unchanged over time. Figure 6 shows plasma aspartate transaminase concentrations for CBD and placebo. FIG. 6 indicates that plasma aspartate transaminase concentrations remained effectively unchanged over time.

[0334] Prior Art Testing The above results are compared to cannabidiol compositions, such as Epidiolex, which do not contain adjunct ingredients found in the pharmaceutical and non-pharmaceutical compositions of Applicant's disclosure. The following prior art disclosures and results were compared to human study results as they relate to the plasma concentrations of each sample.

[0335] A randomized, dose-ranging safety trial of cannabidiol in Dravet syndrome was conducted to evaluate the safety and preliminary pharmacokinetics of a pharmaceutical formulation of purified cannabidiol (CBD) in children with Dravet syndrome (Devinsky, O. et al., "Randomized, dose-ranging safety trial of cannabidiol in Dravet syndrome," Neurology 2018, Vol. 90, pp. e1204-e1211).

[0336] methodology Patients aged 4 to 10 years were randomized 4:1 to receive CBD (5, 10, or 20 mg / kg / d) taken twice daily or placebo. The double-blind study included a 4-week baseline, 3 weeks of treatment (including titration), a 10-day taper, and a 4-week follow-up period.

[0337] result A total of 34 patients were randomized: 30 patients at 8 centers in the United States and 4 patients at 3 centers in the United Kingdom. 32 patients (94%) completed the treatment period, and of these, 24 (75%) entered the open-label long-term study. Two CBD patients discontinued during the treatment period. All 34 randomized patients were included in the safety analysis set: 10, 8, and 9 patients in the 5, 10, and 20 mg / kg / d CBD groups, respectively, and 7 patients in the placebo group. The results are summarized herein below in Table 15.

[0338] [Table 18]

[0339] Figure 1 compares the results of a pre-dose steady-state pharmacokinetic study of cannabidiol using cannabidiol oral solution (GW Pharmaceuticals) conducted by Devinsky (see Devinsky, O. et al., "Randomized, dose-ranging safety trial of cannabidiol in Dravet syndrome," Neurology 2018, Vol. 90, pp. e1204-e1211) to a pre-dose steady-state pharmacokinetic study of the compositions disclosed herein in humans at the two dose levels examined. The solid black line beginning at point A connects the plasma levels at the two steady-state dose levels examined in this study (i.e., 3.28 mg / kg / day and 4.46 mg / kg / day, respectively). The black dotted line extrapolates the results of this data to Devinski's point at approximately 5 mg / kg / day. This demonstrates the greater plasma level of >60 ng / mL (point B) versus the approximately 23 ng / mL achieved by Devinski (point D), demonstrating the ability of the disclosed compositions to pharmacokinetically outperform Devinski. The plot continues linearly for comparison of this data extrapolated forward to 10 mg / kg / day for that same Devinski level.

[0340] The safety and tolerability profile of Epidiolex™ has also been extensively reviewed (Center for Drug Evaluation and Research; Application No. 210365ORIG1S000; see "A Combined Clinical and Statistical Review NDA210365 by Natalie Getzoff, MD, and Xiang Ling, PhD"). Epidiolex™ is approved for doses up to 25 mg / kg / day given as divided doses. In controlled trials of Epidiolex™, hepatic (primarily elevated liver enzymes), gastrointestinal (primarily diarrhea), and central nervous system (primarily somnolence and lethargy) side effects were the most common adverse events reported. Table XX below provides a summary of the significant safety findings reported for Epidiolex™ by the references provided above.

[0341] [Table 19]

[0342] overview As shown in Figure 1, the amount of the disclosed composition required to achieve the same plasma level of cannabidiol as commercially available Epidiolex™ is significantly reduced. Because of this, not only do lower doses of the disclosed composition need to be administered to achieve therapeutic plasma levels relative to Epidiolex™, but these reduced doses also incorporate much lower amounts of edible oil. Without wishing to be bound by theory, the approximately 9:1 ratio of sesame oil to cannabidiol in Epidiolex™ is believed to contribute to the gastrointestinal side effects commonly reported by Epidiolex™ users. These include, for example, the incidence of diarrhea, which was significantly lower in clinical trials with the disclosed composition at a rate of 4.3% compared to the 9% reported with Epidiolex™ and Epidiolex placebo compositions.

[0343] The disclosed compositions are free-flowing solids that can be incorporated into any acceptable form, such as capsules, pills, lozenges, and the like, where each dose of the disclosed compositions delivers greater plasma levels of cannabidiol without the need for excessive intake of edible oil carriers.

[0344] Other advantages, both obvious and inherent in the present disclosure, will be apparent to those skilled in the art. It will be understood that certain features and subcombinations are useful and may be employed without reference to other features and subcombinations. This is contemplated by and within the scope of the claims. Because many possible embodiments of the present disclosure can be made without departing from its scope, it should be understood that all matter set forth in this specification or shown in the accompanying drawings is to be interpreted in an illustrative and not a limiting sense.

Claims

1. A composition comprising: a) about 5 mg to about 32 mg by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 10 mg to about 65 mg by weight of one or more edible oils selected from sunflower oil, coconut oil, sesame oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, and mixtures thereof; c) about 75 mg to about 300 mg by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 35 mg to about 150 mg by weight of sodium bicarbonate; and e) about 110 mg to about 465 mg of a carrier.

2. 10. The composition of claim 1, comprising about 10 mg to about 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight.

3. 10. The composition of claim 1, comprising about 16 mg to about 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight.

4. 10. The composition of claim 1, comprising about 23 mg to about 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight.

5. 10. The composition of claim 1, comprising about 10 mg to about 23 mg of CBD oil containing about 88% to about 91% cannabidiol by weight.

6. 10. The composition of claim 1, comprising about 10 mg to about 16 mg of CBD oil containing about 88% to about 91% cannabidiol by weight.

7. 7. The composition of any one of claims 1 to 6, comprising about 20 mg to about 65 mg of one or more edible oils selected from sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, and mixtures thereof.

8. 7. The composition of any one of claims 1 to 6, comprising about 35 mg to about 65 mg of one or more edible oils selected from sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, and mixtures thereof.

9. 7. The composition of any one of claims 1 to 6, comprising about 46 mg to about 65 mg of one or more edible oils selected from sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, and mixtures thereof.

10. 7. The composition of any one of claims 1 to 6, comprising about 20 mg to about 46 mg of one or more edible oils selected from sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, and mixtures thereof.

11. 7. The composition of any one of claims 1 to 6, comprising about 20 mg to about 65 mg of one or more edible oils selected from sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, and mixtures thereof.

12. 7. The composition of any one of claims 1 to 6, comprising about 10 mg to about 32 mg of one or more edible oils selected from sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, and mixtures thereof.

13. 13. The composition according to any one of claims 1 to 12, wherein the edible oil is sunflower oil.

14. 13. The composition of any one of claims 1 to 12, wherein the edible oil is coconut oil.

15. The composition according to any one of claims 1 to 12, wherein the edible oil is sesame oil.

16. The composition of any one of claims 1 to 12, wherein the edible oil is canola oil.

17. The composition according to any one of claims 1 to 12, wherein the edible oil is palm oil.

18. The composition according to any one of claims 1 to 12, wherein the edible oil is soybean oil.

19. The composition of any one of claims 1 to 12, wherein the edible oil is corn oil.

20. The composition according to any one of claims 1 to 12, wherein the edible oil is safflower oil.

21. 13. The composition of any one of claims 1 to 12, wherein the edible oil is peanut oil.

22. 22. The composition of any one of claims 1 to 21, comprising about 120 mg to about 300 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof.

23. 22. The composition of any one of claims 1 to 21, comprising about 180 mg to about 300 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof.

24. 22. The composition of any one of claims 1 to 21, comprising about 240 mg to about 300 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof.

25. 22. The composition of any one of claims 1 to 21, comprising about 120 mg to about 240 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof.

26. 22. The composition of any one of claims 1 to 21, comprising about 180 mg to about 240 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof.

27. 22. The composition of any one of claims 1 to 21, comprising about 120 mg to about 300 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof.

28. 28. The composition of any one of claims 1 to 27, comprising about 60 mg to about 150 mg of sodium bicarbonate.

29. 28. The composition of any one of claims 1 to 27, comprising about 90 mg to about 150 mg of sodium bicarbonate.

30. 28. The composition of any one of claims 1 to 27, comprising about 120 mg to about 150 mg of sodium bicarbonate.

31. 28. The composition of any one of claims 1 to 27, comprising about 90 mg to about 150 mg of sodium bicarbonate.

32. 31. The composition of any one of claims 1 to 30, comprising about 110 mg to about 465 mg of gum arabic.

33. 31. The composition of any one of claims 1 to 30, comprising about 180 mg to about 465 mg of gum arabic.

34. 31. The composition of any one of claims 1 to 30, comprising about 270 mg to about 465 mg of gum arabic.

35. 31. The composition of any one of claims 1 to 30, comprising about 365 mg to about 465 mg of gum arabic.

36. 31. The composition of any one of claims 1 to 30, comprising about 180 mg to about 365 mg of gum arabic.

37. 31. The composition of any one of claims 1 to 30, comprising about 180 mg to about 270 mg of gum arabic.

38. 10. The composition of claim 1 comprising: a) about 5 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 10 mg high oleic sunflower oil; c) about 75 mg bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 35 mg sodium bicarbonate, and e) Approximately 110 mg gum arabic.

39. 10. The composition of claim 1 comprising: a) about 5 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 10 mg coconut oil; c) about 75 mg bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 35 mg sodium bicarbonate, and e) Approximately 110 mg gum arabic.

40. 10. The composition of claim 1 comprising: a) about 5 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 10 mg of sesame oil; c) about 75 mg bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 35 mg sodium bicarbonate, and e) Approximately 110 mg gum arabic.

41. 10. The composition of claim 1 comprising: a) about 10 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 20 mg of sunflower oil; c) about 120 mg bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 60 mg sodium bicarbonate, and e) Approximately 180 mg of gum arabic.

42. 10. The composition of claim 1 comprising: a) about 10 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 20 mg coconut oil; c) about 120 mg bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 60 mg sodium bicarbonate, and e) Approximately 180 mg of gum arabic.

43. 10. The composition of claim 1 comprising: a) about 10 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 20 mg of sesame oil; c) about 120 mg bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 60 mg sodium bicarbonate, and e) Approximately 180 mg of gum arabic.

44. 10. The composition of claim 1 comprising: a) about 16 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 35 mg high oleic sunflower oil; c) about 180 mg bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 90 mg sodium bicarbonate, and e) Approximately 270 mg gum arabic.

45. 10. The composition of claim 1 comprising: a) about 23 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 46 mg high oleic sunflower oil; c) about 240 mg bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 120 mg sodium bicarbonate, and e) Approximately 365 mg gum arabic.

46. 10. The composition of claim 1 comprising: a) about 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 65 mg high oleic sunflower oil; c) about 300 mg bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 150 mg sodium bicarbonate, and e) 465 mg gum arabic.

47. 1. A method for treating epilepsy in a subject, comprising administering to said subject a composition comprising: a) about 5 mg to about 32 mg by weight of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 10 mg to about 65 mg by weight of one or more edible oils selected from sunflower oil, coconut oil, sesame oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, and mixtures thereof; c) about 75 mg to about 300 mg by weight of bile salts containing about 45% to about 55% by weight of cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 35 mg to about 150 mg by weight of sodium bicarbonate; and e) about 110 mg to about 465 mg of a carrier.

48. 48. The method of claim 47, comprising about 10 mg to about 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight.

49. 48. The method of claim 47, comprising about 16 mg to about 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight.

50. 48. The method of claim 47, comprising about 23 mg to about 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight.

51. 48. The method of claim 47, comprising about 10 mg to about 23 mg of CBD oil containing about 88% to about 91% cannabidiol by weight.

52. 48. The method of claim 47, comprising about 10 mg to about 16 mg of CBD oil containing about 88% to about 91% cannabidiol by weight.

53. 53. The method of any one of claims 47-52, comprising about 20 mg to about 65 mg of one or more edible oils selected from sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, and mixtures thereof.

54. 53. The method of any one of claims 47-52, comprising about 35 mg to about 65 mg of one or more edible oils selected from sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, and mixtures thereof.

55. 53. The method of any one of claims 47-52, comprising about 46 mg to about 65 mg of one or more edible oils selected from sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, and mixtures thereof.

56. 53. The method of any one of claims 47-52, comprising about 20 mg to about 46 mg of one or more edible oils selected from sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, and mixtures thereof.

57. 53. The method of any one of claims 47-52, comprising about 20 mg to about 65 mg of one or more edible oils selected from sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, and mixtures thereof.

58. 53. The method of any one of claims 47-52, comprising about 10 mg to about 32 mg of one or more edible oils selected from sunflower oil, coconut oil, canola oil, palm oil, soybean oil, corn oil, safflower oil, peanut oil, and mixtures thereof.

59. 59. The method of any one of claims 47 to 58, wherein the edible oil is sunflower oil.

60. 59. The method of any one of claims 47 to 58, wherein the edible oil is coconut oil.

61. 59. The method of any one of claims 47 to 58, wherein the edible oil is sesame oil.

62. 59. The method of any one of claims 47 to 58, wherein the edible oil is canola oil.

63. 59. The method of any one of claims 47 to 58, wherein the edible oil is palm oil.

64. 59. The method of any one of claims 47 to 58, wherein the edible oil is soybean oil.

65. 59. The method of any one of claims 47 to 58, wherein the edible oil is corn oil.

66. 59. The method of any one of claims 47 to 58, wherein the edible oil is safflower oil.

67. 59. The method of any one of claims 47 to 58, wherein the edible oil is peanut oil.

68. 68. The method of any one of claims 47 to 67, comprising about 120 mg to about 300 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof.

69. 68. The method of any one of claims 47 to 67, comprising about 180 mg to about 300 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof.

70. 68. The method of any one of claims 47 to 67, comprising about 240 mg to about 300 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof.

71. 68. The method of any one of claims 47 to 67, comprising about 120 mg to about 240 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof.

72. 68. The method of any one of claims 47 to 67, comprising about 180 mg to about 240 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof.

73. 68. The method of any one of claims 47 to 67, comprising about 120 mg to about 300 mg of bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof.

74. 28. The method of any one of claims 1 to 27, comprising about 60 mg to about 150 mg of sodium bicarbonate.

75. 28. The method of any one of claims 1 to 27, comprising about 90 mg to about 150 mg of sodium bicarbonate.

76. 28. The method of any one of claims 1 to 27, comprising about 120 mg to about 150 mg of sodium bicarbonate.

77. 28. The method of any one of claims 1 to 27, comprising about 90 mg to about 150 mg of sodium bicarbonate.

78. 74. The method of any one of claims 47 to 73, comprising about 110 mg to about 465 mg of gum arabic.

79. 74. The method of any one of claims 47 to 73, comprising about 180 mg to about 465 mg of gum arabic.

80. 74. The method of any one of claims 47 to 73, comprising about 270 mg to about 465 mg of gum arabic.

81. 74. The method of any one of claims 47 to 73, comprising about 365 mg to about 465 mg of gum arabic.

82. 74. The method of any one of claims 47 to 73, comprising about 180 mg to about 365 mg of gum arabic.

83. 74. The method of any one of claims 47 to 73, comprising about 180 mg to about 270 mg of gum arabic.

84. 48. The method of claim 47, wherein the composition comprises: a) about 5 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 10 mg high oleic sunflower oil; c) about 75 mg bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 35 mg sodium bicarbonate, and e) Approximately 110 mg gum arabic.

85. 48. The method of claim 47, wherein the composition comprises: a) about 5 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 10 mg coconut oil; c) about 75 mg bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 35 mg sodium bicarbonate, and e) Approximately 110 mg gum arabic.

86. 48. The method of claim 47, wherein the composition comprises: a) about 5 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 10 mg of sesame oil; c) about 75 mg bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 35 mg sodium bicarbonate, and e) Approximately 110 mg gum arabic.

87. 48. The method of claim 47, wherein the composition comprises: a) about 10 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 20 mg of sunflower oil; c) about 120 mg bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 60 mg sodium bicarbonate, and e) Approximately 180 mg of gum arabic.

88. 49. The method of claim 48, wherein the composition comprises: a) about 10 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 20 mg coconut oil; c) about 120 mg bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 60 mg sodium bicarbonate, and e) Approximately 180 mg of gum arabic.

89. 48. The method of claim 47, wherein the composition comprises: a) about 10 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 20 mg of sesame oil; c) about 120 mg bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 60 mg sodium bicarbonate, and e) Approximately 180 mg of gum arabic.

90. 48. The method of claim 47, wherein the composition comprises: a) about 16 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 35 mg high oleic sunflower oil; c) about 180 mg bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 90 mg sodium bicarbonate, and e) Approximately 270 mg gum arabic.

91. 48. The method of claim 47, wherein the composition comprises: a) about 23 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 46 mg high oleic sunflower oil; c) about 240 mg bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 120 mg sodium bicarbonate, and e) Approximately 365 mg gum arabic.

92. 48. The method of claim 47, wherein the composition comprises: a) about 32 mg of CBD oil containing about 88% to about 91% cannabidiol by weight; b) about 65 mg high oleic sunflower oil; c) about 300 mg bile salts containing about 45% to about 55% cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 150 mg sodium bicarbonate, and e) 465 mg gum arabic.

93. 93. The method of any one of claims 47 to 92, wherein the composition is administered such that the amount of cannabidiol administered is from about 2.5 mg / kg / day to about 10 mg / kg / day.

94. 93. The method of any one of claims 47 to 92, wherein the composition is administered such that the amount of cannabidiol administered is from about 5 mg / kg / day to about 20 mg / kg / day.

95. 93. The method of any one of claims 47 to 92, wherein the composition is administered to treat Lennox-Gastaut syndrome.

96. 94. The method of any one of claims 47 to 93, wherein the composition is administered to treat Aicardi syndrome.

97. A composition comprising: a) about 5% to about 25% by weight of CBD oil containing about 88% to about 91% by weight of cannabidiol; b) from about 5% to about 60% by weight of one or more edible oils; c) about 0.1% to about 1% by weight bile salts containing about 45% to about 55% by weight cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 10% to about 20% by weight sodium bicarbonate; and e) The remainder is the carrier.

98. 98. The composition of claim 97, comprising about 10% to about 20% by weight of CBD oil containing about 88% to about 91% by weight of cannabidiol.

99. 98. The composition of claim 97, comprising about 15% to about 20% by weight of CBD oil containing about 88% to about 91% by weight of cannabidiol.

100. 98. The composition of claim 97, comprising about 5% to about 25% by weight of CBD oil containing about 88% to about 91% by weight of cannabidiol.

101. 101. The composition of any one of claims 97-100, comprising from about 10% to about 40% by weight of one or more edible oils.

102. 101. The composition of any one of claims 97-100, comprising from about 15% to about 40% by weight of one or more edible oils.

103. 103. The composition of any one of claims 97 to 102, wherein the edible oil is sunflower oil.

104. 103. The composition of any one of claims 96 to 102, wherein the edible oil is coconut oil.

105. 105. The composition of any one of claims 96 to 104, comprising from about 0.1% to about 1% by weight of deoxycholic acid.

106. 106. The composition of any one of claims 96 to 105, comprising about 0.5% to about 1% by weight of deoxycholic acid.

107. 107. The composition of any one of claims 96 to 106, comprising about 12% to about 17% by weight sodium bicarbonate.

108. 108. The composition of any one of claims 96 to 107, comprising from about 30% to about 85% by weight of gum arabic.

109. 108. The composition of any one of claims 96 to 107, comprising about 40% to about 70% by weight of gum arabic.

110. 108. The composition of any one of claims 96 to 107, comprising from about 40% to about 85% by weight of gum arabic.

111. 1. A method for treating epilepsy in a subject, comprising administering to said subject a composition comprising: a) about 5% to about 25% by weight of CBD oil containing about 88% to about 91% by weight of cannabidiol; b) from about 5% to about 60% by weight of one or more edible oils; c) about 0.1% to about 1% by weight bile salts containing about 45% to about 55% by weight cholic acid, deoxycholic acid, taurocholate, glycocholate, and mixtures thereof; d) about 10% to about 20% by weight sodium bicarbonate; and e) The remainder is the carrier.

112. 112. The method of claim 111, comprising about 10% to about 20% by weight of CBD oil containing about 88% to about 91% by weight of cannabidiol.

113. 112. The method of claim 111, comprising about 15% to about 20% by weight of CBD oil containing about 88% to about 91% by weight of cannabidiol.

114. 112. The method of claim 111, comprising about 5% to about 25% by weight of CBD oil containing about 88% to about 91% by weight of cannabidiol.

115. 115. The method of any one of claims 111-114, comprising about 10% to about 40% by weight of one or more edible oils.

116. 115. The method of any one of claims 111-114, comprising about 15% to about 40% by weight of one or more edible oils.

117. 117. The method of any one of claims 111 to 116, wherein the edible oil is sunflower oil.

118. 117. The method of any one of claims 111 to 116, wherein the edible oil is coconut oil.

119. 117. The method of any one of claims 111 to 116, wherein the edible oil is sesame oil.

120. 120. The method of any one of claims 111 to 119, comprising about 0.1% to about 1% deoxycholic acid by weight.

121. 120. The method of any one of claims 111 to 119, comprising about 0.5% to about 1% deoxycholic acid by weight.

122. 120. The method of any one of claims 111 to 119, comprising about 12% to about 17% by weight sodium bicarbonate.

123. 123. The method of any one of claims 111 to 122, comprising about 30% to about 85% gum arabic by weight.

124. 123. The method of any one of claims 111 to 122, comprising about 40% to about 70% by weight gum arabic.

125. 123. The method of any one of claims 111 to 122, comprising about 40% to about 85% by weight gum arabic.

126. 123. The method of any one of claims 111 to 122, comprising about 40% to about 80% gum arabic by weight.

127. 127. The method of any one of claims 111 to 126, wherein the composition is administered such that the amount of cannabidiol administered is from about 2.5 mg / kg / day to about 10 mg / kg / day.

128. 127. The method of any one of claims 111 to 126, wherein the composition is administered such that the amount of cannabidiol administered is from about 5 mg / kg / day to about 20 mg / kg / day.

129. 127. The method of any one of claims 111 to 126, wherein the composition is administered to treat Lennox-Gastaut syndrome.

130. 127. The method of any one of claims 112 to 126, wherein the composition is administered to treat Aicardi syndrome.

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