Compositions containing delta-9-tetrahydrocannabinol and terpenes

Abstract

The present invention relates to a composition comprising delta-9-tetrahydrocannabinol (THC), alpha-bisabolol, guaiol, beta-caryophyllene, and at least one terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol. The present invention also relates to a pharmaceutical formulation comprising such a composition. The pharmaceutical formulation according to the present invention can be used in medicine, in particular for the treatment and / or prevention of diseases associated with pain, such as chronic cancer pain, somatic pain, visceral pain, central neuropathic pain, peripheral neuropathic pain or complex pain syndrome.

Description

DISCLOSURE OF THEINVENTION

[0001] The present invention relates to a composition comprising delta-9-tetrahydrocannabinol (THC), alpha-bisabolol, guaiol and beta-caryophyllene, and at least one terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol. The present invention also relates to a pharmaceutical formulation comprising such a composition. The composition and pharmaceutical formulation according to the present invention can be used in medicine, in particular for the treatment and / or prevention of chronic cancer pain, somatic pain, visceral pain, central neuropathic pain, peripheral neuropathic pain or complex pain syndrome.

[0002] The main active substances that make cannabis suitable as a herbal medicine are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), which are present in the cannabis plant mainly as carboxylated 9-tetrahydrocannabinolic acid (THCA) and cannabidiol acid (CBDA). Both belong to the substance class of cannabinoids, which includes a variety of individual cannabinoid substances that are chemically and pharmacologically related. While THC is psychoactive and CBD is not, nearly all cannabinoids affect the central nervous system. The said activities of cannabinoids have led to a recent revival of cannabis research, since controlled trials using THC and / or CBD as single drug substances or cannabis plant extracts have shown good results in the treatment of neuropathic pain, fibromyalgia, rheumatoid arthritis, and mixed chronic pain (Bridgeman MB and Abazia DT, P&T 2017, 42(3), pp.180-188). Furthermore, cannabis extracts derived from the plant were found to be superior in pain relief in patients with multiple sclerosis, spinal cord injuries, brachial plexus injuries, and limb amputations due to neurofibromatosis. THC and CBD were found to be effective both alone and in a 1:1 ratio (Wade, DT et al., Clin. Rehabil. 2003, 17(1), pp. 21-29). Similar results were obtained using whole plant extracts, but interestingly, it was observed that the whole plant extract was more effective than THC alone in treating pain and spasms in patients with multiple sclerosis (Zajicek J et al., Lancet. 2003, 362(9395), pp. 1517-1526). As a result, further research was devoted to the complex interactions of some cannabinoids and other substances in the whole plant extract of cannabis. In that study, Zajicek J et al., it was argued that further components of the extract may contribute synergistically to such activity of the cannabinoids.

[0003] Since the analgesic effect of cannabis was found to be induced not only by its anti-nociceptive but also by its anti-inflammatory activity (Comelli F. et al., Phytotherapy Research 2008,22(8),pp.1017-1024), both the anti-inflammatory activity and the complex interactions between the main cannabinoids (such as THC and CBD) and other components of cannabis extract were further investigated. As a result, it was found that THC is considered to be the main anti-inflammatory active substance at high doses, while CBD has anti-inflammatory activity only at low dosages and cytotoxic activity at high doses. Also, in a cell culture model using HCT-116 cells and CaCO2 cells, cannabis extract was found to have a higher activity in reducing inflammation than the single cannabinoids alone. Cannabis extracts were fractionated, but there was no specific knowledge as to which individual compounds in the fractions actually contributed to the primary activity attributed to CBD derived from CBDA (referred to in this description as CBD(A)) and / or THC derived from THCA (referred to in this description as THC(A)) (Nallathambi R. et al., Cannabis and Cannabinoid Research 2017, 2(1), pp. 167-182).

[0004] Today, there is no doubt that these cytotoxic and anti-inflammatory activities are not substantially derived only from the main components THC(A) and / or CBD(A). The cannabis plant has been shown to produce over 600 different secondary metabolites that are partially biologically active, such as terpenes and terpenoids, sterols, triglycerides, alkanes, squalene, tocopherols, etc. (Andre CM. et al., Front. Plant Sci. 2016, 7, 19). The mixture of these secondary metabolites varies depending on several factors, including the specific cannabis cultivar, the part of the cannabis plant that is extracted, the extraction method, and the processing of the extract. Specifically, terpenes have been shown to have cytotoxic and anti-inflammatory properties, but are considered to be much less potent than CBD (Gallily R. et al., Cannabis and Cannabinoid Research 2018, 3(1), pp. 282-290). A study by Namdar et al. demonstrated a significant correlation between a given set of phytocannabinoids and terpenes, and based on the association patterns of terpenes, cannabis plants that preferably contain CBD(A) can be distinguished from varieties that contain mainly THC(A) (Namdar D. et al., Molecules 2019, 24(3031), pp.1-17). Furthermore, the study showed that the activity of THC is only enhanced by its co-associated terpenes beta-thujene, alpha-pinene, camphene, beta-pinene, alpha-phellandrene, alpha-terpinene, beta-phellandrene, isosativen and alpha-guaiene, while other terpenes (e.g., those related to CBD(A)) inhibit its biological activity. CBD(A) was found to be associated, among others, with the terpenes alpha-bisabolol and guaiol (Figure 1). The authors Namdar et al. conclude that terpenes act as promoters and stimulators of therapeutic phytocannabinoid activity. Such enhanced biological activity resulting from secondary metabolites (mainly terpenes) produced by the cannabis plant is referred to as the "interentourage effect" of phytocannabinoids.Thus, certain cytotoxic and potential anti-inflammatory or antinociceptive / antihyperalgesic effects derived primarily from CBD(A) and / or THC(A), respectively, may be influenced by specific sets of terpenes associated with such primary cannabinoids.

[0005] However, a problem that remains today is the still lack of knowledge about the complex pattern of terpenes that constitute the complete mixture of cannabis-derived herbal medicines and their interaction with the supposed main components CBD(A) and / or THC(A).Therefore, there is an urgent need to better understand the interaction of cannabinoids with the individual terpenes, as well as the terpene pattern, and to determine the potentially superior ratios of these pharmacologic valuable substances.

[0006] The present invention meets this need by providing compositions and pharmaceutical formulations comprising delta-9-tetrahydrocannabinol (THC), alpha-bisabolol, guaiol and beta-caryophyllene, and at least one terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol. The combination of THC and terpenes surprisingly and unexpectedly enhances the cytotoxic effect of the terpenes. In particular, the activity of terpenes that are not correlated with THC is enhanced. As shown in the attached examples, in a cancer cell culture model subjected to a cytotoxicity assay, it was found that the IC50 value of the exemplary terpenes alpha-bisabolol and guaiol is decreased when cells are co-cultured with THC at a specific THC / alpha-bisabolol and THC / guaiol ratio.Furthermore, it was shown that administration of THC and the exemplary terpenes alpha-bisabolol and guaiol in a combination treatment at a specific THC / alpha-bisabolol and THC / guaiol ratio enhances anti-inflammatory activity compared to treatment with either THC, alpha-bisabolol or guaiol alone.Thus, the present invention is based on a surprising and unexpected effect, since it is known in the art that alpha-bisabolol and guaiol are associated with CBD as the major cannabinoids, but not THC. Although the prior art describes various compositions containing THC and terpenes (WO 2020 / 006599, WO 2020 / 006598, US 2021 / 204591, and US 2018 / 352848), none of the prior art documents describes the specific configuration and advantageous THC / terpene ratio disclosed in the present invention. This is further because the art suggests that terpenes exert an enhancing effect on cannabinoids through the "interentourage effect", but the reverse is not true.The cannabis plant extract of the present invention contains THC and the terpenes alpha-bisabolol and guaiol in the ratios tested individually in the examples (see Table 3). It is therefore believed that compositions and pharmaceutical formulations of the present invention having the same individual active ingredients and THC / terpene ratios as the cannabis plant extract disclosed in this example (Table 3) are particularly effective in providing cytotoxic and anti-inflammatory activity. Furthermore, the examples provide evidence that the pharmaceutical formulations and preferred compositions of the present invention have the superior technical effect of providing improved short-term and long-term stability of cannabinoids such as THC by including a carrier oil such as sesame oil (Example 3).

[0007] The present invention will now be described in more detail. In particular, the present invention relates to the following: [1] A composition comprising delta-9-tetrahydrocannabinol (THC), alpha-bisabolol, guaiol, and beta-caryophyllene, and at least one terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol, and geraniol. [2] The composition of paragraph 1, wherein delta-9-tetrahydrocannabinol (THC) and alpha-bisabolol are present in the composition in a ratio of between about 50:1 and 500:1, preferably between about 100:1 and 450:1, and most preferably between about 160:1 and 295:1. [3] The composition of paragraph 1 or 2, wherein delta-9-tetrahydrocannabinol (THC) and guaiol are present in the composition in a ratio of between about 10:1 and 500:1, preferably between about 50:1 and 250:1, and most preferably between about 105:1 and 200:1. [4] The composition of any one of paragraphs 1 to 3, wherein delta-9-tetrahydrocannabinol (THC) and beta-caryophyllene are present in the composition in a ratio of between about 10:1 and 500:1, preferably between about 50:1 and 250:1, and most preferably between about 105:1 and 200:1. [5] (a) delta-9-tetrahydrocannabinol (THC) and linalool are present in the composition in a ratio of between about 450:1 and 1400:1, preferably between about 500:1 and 1330:1; (b) THC and alpha-humulene are present in the composition in a ratio of between about 300:1 and 725:1, preferably between about 355:1 and 665:1; (c) THC and nerolidol are present in the composition in a ratio of between about 200:1 and 600:1, preferably between about 285:1 and 535:1; (d) THC and caryophyllene oxide are present in the composition in a ratio of between about 1000:1 and 2150:1, preferably between about 1090:1 and 2080:1; (e) THC and alpha-pinene are present in the composition in a ratio of between about 5,850:1 and 16,000:1, preferably between about 6,000:1 and 15,750:1; (f) THC and camphene are present in the composition in a ratio of between about 7300:1 and 132950:1, preferably between about 7300:1 and 132950:1; (g) THC and beta-pinene are present in the composition in a ratio of between about 6475:1 and 23100:1, preferably between about 6545:1 and 23025:1; (h) THC and beta-myrcene are present in the composition in a ratio of between about 1950:1 and 6300:1, preferably between about 2025:1 and 6210:1; (i) THC and limonene are present in the composition in a ratio of between about 1650:1 and 5050:1, preferably between about 1700:1 and 4970:1; (j) THC and eucalyptol are present in the composition in a ratio of between about 5050:1 and 38650:1, preferably between about 5140:1 and 38580:1; (k) THC and ocimene are present in the composition in a ratio of between about 2500:1 and 44700:1, preferably between about 2570:1 and 44610:1; (l) THC and gamma-terpinene are present in the composition in a ratio of between about 4700:1 and 35750:1, preferably between about 4800:1 and 35685:1; (m) THC and terpinolene are present in the composition in a ratio of between about 5450:1 and 129850:1, preferably between about 5535:1 and 129965:1; (n) THC and alpha-terpinene are present in the composition in a ratio of between about 5150:1 and 58550:1, preferably between about 5210:1 and 58480:1; (o) THC and para-cymene are present in the composition in a ratio of between about 4700:1 and 56700:1, preferably between about 4800:1 and 56625:1; (p) THC and isopulegol are present in the composition in a ratio of between about 4000:1 and 8000:1, preferably between about 4060:1 and 7915:1; and / or (q) The composition of any one of paragraphs 1 to 4, wherein THC and geraniol are present in the composition in a ratio of between about 1300:1 and 18250:1, preferably between about 1375:1 and 18150:1. [6] The composition of any one of paragraphs 1 to 5, comprising delta-9-tetrahydrocannabinol (THC) in an amount between about 2.5 percent and 10 percent, preferably between about 4 percent and 6 percent, and most preferably 5 percent, by weight of the composition. [7] The composition of any one of paragraphs 1 to 6, comprising alpha-bisabolol in an amount between about 0.008 percent and 0.065 percent, preferably between about 0.01 percent and 0.04 percent, and most preferably between about 0.017 percent and 0.031 percent by weight of the composition. [8] The composition of any one of paragraphs 1 to 7, comprising guaiol in an amount between about 0.012 percent and 0.092 percent, preferably between about 0.015 percent and 0.05 percent, and most preferably between about 0.025 percent and 0.046 percent by weight of the composition. [9] The composition of any one of paragraphs 1 to 8, comprising beta-caryophyllene in an amount between about 0.012 percent and 0.094 percent, preferably between about 0.02 percent and 0.05 percent, and most preferably between about 0.025 percent and 0.047 percent by weight of the composition.

[10] (a) linalool, in an amount between about 0.001 percent and 0.014 percent, preferably between about 0.003 percent and 0.0085 percent, and most preferably between about 0.004 percent and 0.007 percent by weight of the composition; (b) alpha-humulene, in an amount between about 0.003 percent and 0.028 percent, preferably between about 0.006 percent and 0.017 percent, and most preferably between about 0.008 percent and 0.014 percent by weight of the composition; (c) nerolidol, in an amount between about 0.004 percent and 0.035 percent, preferably between about 0.007 percent and 0.021 percent, and most preferably between about 0.009 percent and 0.017 percent by weight of the composition; (d) caryophyllene oxide, in an amount between about 0.001 percent and 0.0092 percent, preferably between about 0.001 percent and 0.0055 percent, and most preferably between about 0.002 percent and 0.005 percent, by weight of the composition; and / or (e) limonene, in an amount between about 0.0005 percent and 0.004 percent, preferably between about 0.0008 percent and 0.0022 percent, and most preferably between about 0.001 percent and 0.002 percent by weight of the composition. 10. The composition of any one of claims 1 to 9, comprising

[11] The composition of any one of paragraphs 1 to 10, which is an extract of the cannabis plant.

[12] The composition of paragraph 11, wherein the cannabis plant extract is obtainable by solvent extraction of the cannabis plant.

[13] The composition of claim 11 or 12, wherein the cannabis plant extract is obtainable by solvent extraction of flower material of the cannabis plant, which has preferably been trimmed and dried before use.

[14] The composition according to paragraph 12 or 13, wherein the cannabis plant is DKJ127 (deposited with the Community Plant Varieties Office under application number A202104053).

[15] The composition of any one of paragraphs 11 to 14, wherein the cannabis plant extract is an alcoholic extract.

[16] The composition described in any one of paragraphs 1 to 15, which is in liquid form.

[17] The composition of any one of paragraphs 1 to 16, further comprising a carrier oil, preferably sesame oil.

[18] A pharmaceutical formulation comprising the composition described in any one of paragraphs 1 to 17.

[19] The pharmaceutical formulation of paragraph 18, comprising delta-9-tetrahydrocannabinol (THC) in an amount between about 1.0 percent and 2.5 percent, preferably 2.1 percent, by weight of the formulation; THC and alpha-bisabolol are present in the formulation in a ratio of between about 100:1 and 450:1, preferably between about 160:1 and 295:1; THC and guaiol are present in the formulation in a ratio of between about 50:1 and 250:1, preferably between about 105:1 and 200:1; and / or THC and beta-caryophyllene are present in the formulation in a ratio of between about 50:1 and 250:1, preferably between about 105:1 and 200:1.

[20] The pharmaceutical formulation of paragraph 19, wherein delta-9-tetrahydrocannabinol (THC) and linalool are present in the formulation in a ratio of between about 450:1 and 1400:1, preferably between about 500:1 and 1330:1, wherein THC and alpha-humulene are present in the formulation in a ratio of between about 300:1 and 725:1, preferably between about 355:1 and 665:1, and wherein THC and nerolidol are present in the formulation in a ratio of between about 200:1 and 600:1, preferably between about 285:1 and 535:1.

[21] The pharmaceutical formulation of any one of paragraphs 18 to 20, further comprising a carrier oil, preferably sesame oil.

[22] A composition according to any one of paragraphs 1 to 17, or a pharmaceutical formulation according to any one of paragraphs 18 to 21, for use in medicine.

[23] A composition described in any one of paragraphs 1 to 17 or 22, or a pharmaceutical formulation described in any one of paragraphs 18 to 22, for use in the treatment and / or prevention of chronic cancer pain, somatic pain, visceral pain, central neuropathic pain, peripheral neuropathic pain, or complex pain syndrome.

[24] A method for the treatment and / or prevention of chronic cancer pain, somatic pain, visceral pain, central neuropathic pain, peripheral neuropathic pain or complex pain syndrome, comprising administering to a subject in need thereof an effective amount of a composition described in any one of paragraphs 1 to 15, or a pharmaceutical formulation described in paragraphs 18 to 21.

[25] A composition according to paragraph 22 or 23 for use according to paragraph 22 or 23, or a pharmaceutical formulation according to paragraph 22 or 23 for use according to paragraph 22 or 23, which is administered orally, buccal, intranasal, topical, rectal or vaginally, but preferably orally.

[26] A kit comprising component A and component B, wherein component A is a composition according to any one of paragraphs 1 to 17, or a composition for use according to paragraph 22 or 23, and component B is a carrier oil, preferably sesame oil.

[0008] Furthermore, the present invention provides the following: [1] A composition containing delta-9-tetrahydrocannabinol (THC) and alpha-bisabolol. [2] The composition of paragraph 1, wherein delta-9-tetrahydrocannabinol (THC) and alpha-bisabolol are present in the composition in a ratio of between about 50:1 and 500:1, preferably between about 100:1 and 450:1, and most preferably between about 160:1 and 295:1. [3] The composition of paragraph 1 or 2, comprising delta-9-tetrahydrocannabinol (THC) in an amount between about 2.5 percent and 10 percent, preferably between about 4 percent and 6 percent, and most preferably 5 percent, by weight of the composition. [4] The composition of any one of paragraphs 1 to 3, comprising alpha-bisabolol in an amount between about 0.008 percent and 0.065 percent, preferably between about 0.01 percent and 0.04 percent, and most preferably between about 0.017 percent and 0.031 percent by weight of the composition. [5] The composition described in any one of paragraphs 1 to 4, which is an extract of the cannabis plant. [6] The composition of paragraph 5, wherein the cannabis plant extract is obtainable by solvent extraction of the cannabis plant. [7] The composition of claim 5 or 6, wherein the cannabis plant extract is obtainable by solvent extraction of flower material of the cannabis plant, which has preferably been trimmed and dried before use. [8] The composition according to paragraph 6 or 7, wherein the cannabis plant is DKJ127 (deposited with the Community Plant Varieties Office under application number A202104053). [9] The composition of any one of paragraphs 5 to 8, wherein the cannabis plant extract is an alcoholic extract.

[10] The composition described in any one of paragraphs 1 to 9, which is in liquid form.

[11] The composition of any one of paragraphs 1 to 10, further comprising a carrier oil, preferably sesame oil.

[12] A pharmaceutical formulation comprising the composition described in any one of paragraphs 1 to 11.

[13] The pharmaceutical formulation of paragraph 12, comprising delta-9-tetrahydrocannabinol (THC) in an amount between about 1.0 percent and 2.5 percent, preferably 2.1 percent, by weight of the formulation, and wherein the THC and alpha-bisabolol are present in the formulation in a ratio of between about 50:1 and 500:1, preferably between about 100:1 and 450:1, and most preferably between about 160:1 and 295:1.

[14] The pharmaceutical formulation of paragraph 12 or paragraph 13, further comprising a carrier oil, preferably sesame oil.

[15] A composition according to any one of paragraphs 1 to 11, or a pharmaceutical formulation according to any one of paragraphs 12 to 14, for use in medicine.

[16] A composition described in any one of paragraphs 1 to 11 or 15, or a pharmaceutical formulation described in any one of paragraphs 12 to 15, for use in the treatment and / or prevention of chronic cancer pain, somatic pain, visceral pain, central neuropathic pain, peripheral neuropathic pain, or complex pain syndrome.

[17] A method for the treatment and / or prevention of chronic cancer pain, somatic pain, visceral pain, central neuropathic pain, peripheral neuropathic pain or complex pain syndrome, comprising administering to a subject in need thereof an effective amount of the composition described in any one of paragraphs 1 to 11, or the pharmaceutical formulation described in paragraphs 12 to 14.

[18] The composition according to paragraph 15 or 16 for use according to paragraph 15 or 16, or the pharmaceutical formulation according to paragraph 15 or 16 for use according to paragraph 15 or 16, which is administered orally, buccal, intranasal, topical, rectal or vaginally, preferably orally.

[19] A kit comprising component A and component B, wherein component A is a composition according to any one of paragraphs 1 to 11, or a composition for use according to paragraph 15 or 16, and component B is a carrier oil, preferably sesame oil.

[0009] Furthermore, the present invention provides the following: [1] A composition containing delta-9-tetrahydrocannabinol (THC) and guaiol. [2] The composition of paragraph 1, wherein delta-9-tetrahydrocannabinol (THC) and guaiol are present in the composition in a ratio of between about 10:1 and 500:1, preferably between about 50:1 and 250:1, and most preferably between about 105:1 and 200:1. [3] The composition of paragraph 1 or 2, comprising delta-9-tetrahydrocannabinol (THC) in an amount between about 2.5 percent and 10 percent, preferably between about 4 percent and 6 percent, and most preferably 5 percent, by weight of the composition. [4] The composition of any one of paragraphs 1 to 3, comprising guaiol in an amount between about 0.012 percent and 0.092 percent, preferably between about 0.015 percent and 0.05 percent, and most preferably between about 0.025 percent and 0.046 percent by weight of the composition. [5] The composition described in any one of paragraphs 1 to 4, which is an extract of the cannabis plant. [6] The composition of paragraph 5, wherein the cannabis plant extract is obtainable by solvent extraction of the cannabis plant. [7] The composition of claim 5 or 6, wherein the cannabis plant extract is obtainable by solvent extraction of flower material of the cannabis plant, which has preferably been trimmed and dried before use. [8] The composition according to paragraph 6 or 7, wherein the cannabis plant is DKJ127 (deposited with the Community Plant Varieties Office under application number A202104053). [9] The composition of any one of paragraphs 5 to 8, wherein the cannabis plant extract is an alcoholic extract.

[10] The composition described in any one of paragraphs 1 to 9, which is in liquid form.

[11] The composition of any one of paragraphs 1 to 10, further comprising a carrier oil, preferably sesame oil.

[12] A pharmaceutical formulation comprising the composition described in any one of paragraphs 1 to 11.

[13] The pharmaceutical formulation of paragraph 12, comprising delta-9-tetrahydrocannabinol (THC) in an amount between about 1.0 percent and 2.5 percent, preferably 2.1 percent, by weight of the formulation, and wherein THC and guaiol are present in the formulation in a ratio of between about 50:1 and 250:1, preferably between about 105:1 and 200:1.

[14] The pharmaceutical formulation of paragraph 12 or paragraph 13, further comprising a carrier oil, preferably sesame oil.

[15] A composition according to any one of paragraphs 1 to 11, or a pharmaceutical formulation according to any one of paragraphs 12 to 14, for use in medicine.

[16] A composition described in any one of paragraphs 1 to 11 or 15, or a pharmaceutical formulation described in any one of paragraphs 12 to 15, for use in the treatment and / or prevention of chronic cancer pain, somatic pain, visceral pain, central neuropathic pain, peripheral neuropathic pain, or complex pain syndrome.

[17] A method for the treatment and / or prevention of chronic cancer pain, somatic pain, visceral pain, central neuropathic pain, peripheral neuropathic pain or complex pain syndrome, comprising administering to a subject in need thereof an effective amount of the composition described in any one of paragraphs 1 to 11, or the pharmaceutical formulation described in paragraphs 12 to 14.

[18] The composition according to paragraph 15 or 16 for use according to paragraph 15 or 16, or the pharmaceutical formulation according to paragraph 15 or 16 for use according to paragraph 15 or 16, which is administered orally, buccal, intranasal, topical, rectal or vaginally, preferably orally.

[19] A kit comprising component A and component B, wherein component A is a composition according to any one of paragraphs 1 to 11, or a composition for use according to paragraph 15 or 16, and component B is a carrier oil, preferably sesame oil.

[0010] Furthermore, the present invention provides the following: [1] A composition containing delta-9-tetrahydrocannabinol (THC) and beta-caryophyllene. [2] The composition of paragraph 1, wherein delta-9-tetrahydrocannabinol (THC) and beta-caryophyllene are present in the composition in a ratio of between about 10:1 and 500:1, preferably between about 50:1 and 250:1, and most preferably between about 105:1 and 200:1. [3] The composition of paragraph 1 or 2, comprising delta-9-tetrahydrocannabinol (THC) in an amount between about 2.5 percent and 10 percent, preferably between about 4 percent and 6 percent, and most preferably 5 percent, by weight of the composition. [4] The composition of any one of paragraphs 1 to 4, comprising beta-caryophyllene in an amount between about 0.012 percent and 0.094 percent, preferably between about 0.02 percent and 0.05 percent, and most preferably between about 0.025 percent and 0.047 percent by weight of the composition. [5] The composition described in any one of paragraphs 1 to 4, which is an extract of the cannabis plant. [6] The composition of paragraph 5, wherein the cannabis plant extract is obtainable by solvent extraction of the cannabis plant. [7] The composition of claim 5 or 6, wherein the cannabis plant extract is obtainable by solvent extraction of flower material of the cannabis plant, which has preferably been trimmed and dried before use. [8] The composition according to paragraph 6 or 7, wherein the cannabis plant is DKJ127 (deposited with the Community Plant Varieties Office under application number A202104053). [9] The composition of any one of paragraphs 5 to 8, wherein the cannabis plant extract is an alcoholic extract.

[10] The composition described in any one of paragraphs 1 to 9, which is in liquid form.

[11] The composition of any one of paragraphs 1 to 10, further comprising a carrier oil, preferably sesame oil.

[12] A pharmaceutical formulation comprising the composition described in any one of paragraphs 1 to 11.

[13] The pharmaceutical formulation of paragraph 12, comprising delta-9-tetrahydrocannabinol (THC) in an amount between about 1.0 percent and 2.5 percent, preferably 2.1 percent, by weight of the formulation, and wherein THC and beta-caryophyllene are present in the formulation in a ratio of between about 50:1 and 250:1, preferably between about 105:1 and 200:1.

[14] The pharmaceutical formulation of paragraph 12 or paragraph 13, further comprising a carrier oil, preferably sesame oil.

[15] A composition according to any one of paragraphs 1 to 11, or a pharmaceutical formulation according to any one of paragraphs 12 to 14, for use in medicine.

[16] A composition described in any one of paragraphs 1 to 11 or 15, or a pharmaceutical formulation described in any one of paragraphs 12 to 15, for use in the treatment and / or prevention of chronic cancer pain, somatic pain, visceral pain, central neuropathic pain, peripheral neuropathic pain, or complex pain syndrome.

[17] A method for the treatment and / or prevention of chronic cancer pain, somatic pain, visceral pain, central neuropathic pain, peripheral neuropathic pain or complex pain syndrome, comprising administering to a subject in need thereof an effective amount of the composition described in any one of paragraphs 1 to 11, or the pharmaceutical formulation described in paragraphs 12 to 14.

[18] The composition according to paragraph 15 or 16 for use according to paragraph 15 or 16, or the pharmaceutical formulation according to paragraph 15 or 16 for use according to paragraph 15 or 16, which is administered orally, buccal, intranasal, topical, rectal or vaginally, preferably orally.

[19] A kit comprising component A and component B, wherein component A is a composition according to any one of paragraphs 1 to 11, or a composition for use according to paragraph 15 or 16, and component B is a carrier oil, preferably sesame oil.

[0011] Furthermore, the present invention provides the following: [1] A composition comprising delta-9-tetrahydrocannabinol (THC), alpha-bisabolol and guaiol. [2] The composition of paragraph 1, wherein delta-9-tetrahydrocannabinol (THC) and alpha-bisabolol are present in the composition in a ratio of between about 50:1 and 500:1, preferably between about 100:1 and 450:1, and most preferably between about 160:1 and 295:1. [3] The composition of paragraph 1 or 2, wherein delta-9-tetrahydrocannabinol (THC) and guaiol are present in the composition in a ratio of between about 10:1 and 500:1, preferably between about 50:1 and 250:1, and most preferably between about 105:1 and 200:1. [4] The composition of any one of paragraphs 1 to 3, comprising delta-9-tetrahydrocannabinol (THC) in an amount between about 2.5 percent and 10 percent, preferably between about 4 percent and 6 percent, and most preferably 5 percent, by weight of the composition. [5] The composition of any one of paragraphs 1 to 4, comprising alpha-bisabolol in an amount between about 0.008 percent and 0.065 percent, preferably between about 0.01 percent and 0.04 percent, and most preferably between about 0.017 percent and 0.031 percent by weight of the composition. [6] The composition of any one of paragraphs 1 to 5, comprising guaiol in an amount between about 0.012 percent and 0.092 percent, preferably between about 0.015 percent and 0.05 percent, and most preferably between about 0.025 percent and 0.046 percent by weight of the composition. [7] The composition described in any one of paragraphs 1 to 6, which is an extract of the cannabis plant. [8] The composition of paragraph 7, wherein the cannabis plant extract is obtainable by solvent extraction of the cannabis plant. [9] The composition of claim 7 or 8, wherein the cannabis plant extract is obtainable by solvent extraction of flower material of the cannabis plant, which has preferably been trimmed and dried before use.

[10] The composition according to paragraph 6 or paragraph 7, wherein the cannabis plant is DKJ127 (deposited with the Community Plant Varieties Office under application number A202104053).

[11] The composition of any one of paragraphs 5 to 10, wherein the cannabis plant extract is an alcoholic extract.

[12] The composition described in any one of paragraphs 1 to 11, which is in liquid form.

[13] The composition of any one of paragraphs 1 to 12, further comprising a carrier oil, preferably sesame oil.

[14] A pharmaceutical formulation comprising the composition described in any one of paragraphs 1 to 13.

[15] The pharmaceutical formulation of paragraph 14, comprising delta-9-tetrahydrocannabinol (THC) in an amount between about 1.0 percent and 2.5 percent, preferably 2.1 percent, by weight of the formulation; THC to alpha-bisabolol are present in the formulation in a ratio of between about 100:1 and 450:1, preferably between about 160:1 and 295:1; and / or THC to guaiol are present in the formulation in a ratio of between about 50:1 and 250:1, preferably between about 105:1 and 200:1.

[16] The pharmaceutical formulation of paragraph 14 or paragraph 15, further comprising a carrier oil, preferably sesame oil.

[17] A composition according to any one of paragraphs 1 to 13, or a pharmaceutical formulation according to any one of paragraphs 14 to 16, for use in medicine.

[18] A composition described in any one of paragraphs 1 to 13 or 17, or a pharmaceutical formulation described in any one of paragraphs 14 to 17, for use in the treatment and / or prevention of chronic cancer pain, somatic pain, visceral pain, central neuropathic pain, peripheral neuropathic pain, or complex pain syndrome.

[19] A method for the treatment and / or prevention of chronic cancer pain, somatic pain, visceral pain, central neuropathic pain, peripheral neuropathic pain or complex pain syndrome, comprising administering to a subject in need thereof an effective amount of a composition described in any one of paragraphs 1 to 13, or a pharmaceutical formulation described in paragraphs 14 to 16.

[20] A composition according to paragraph 17 or 18 for use according to paragraph 17 or 18, or a pharmaceutical formulation according to paragraph 17 or 18 for use according to paragraph 17 or 18, which is administered orally, buccal, intranasal, topical, rectal or vaginally, but preferably orally.

[21] A kit comprising component A and component B, wherein component A is a composition according to any one of paragraphs 1 to 13, or a composition for use according to paragraph 17 or 18, and component B is a carrier oil, preferably sesame oil.

[0012] Furthermore, the present invention provides the following: [1] A composition containing delta-9-tetrahydrocannabinol (THC), guaiol and beta-caryophyllene. [2] The composition of paragraph 1, wherein delta-9-tetrahydrocannabinol (THC) and guaiol are present in the composition in a ratio of between about 10:1 and 500:1, preferably between about 50:1 and 250:1, and most preferably between about 105:1 and 200:1. [3] The composition of paragraph 1 or 2, wherein delta-9-tetrahydrocannabinol (THC) and beta-caryophyllene are present in the composition in a ratio of between about 10:1, preferably between about 50:1 and 250:1, and most preferably between about 105:1 and 200:1. [4] The composition of any one of paragraphs 1 to 3, comprising delta-9-tetrahydrocannabinol (THC) in an amount between about 2.5 percent and 10 percent, preferably between about 4 percent and 6 percent, and most preferably 5 percent, by weight of the composition. [5] The composition of any one of paragraphs 1 to 4, comprising guaiol in an amount between about 0.012 percent and 0.092 percent, preferably between about 0.015 percent and 0.05 percent, and most preferably between about 0.025 percent and 0.046 percent by weight of the composition. [6] The composition of any one of paragraphs 1 to 5, comprising beta-caryophyllene in an amount between about 0.012 percent and 0.094 percent, preferably between about 0.02 percent and 0.05 percent, and most preferably between about 0.025 percent and 0.047 percent by weight of the composition. [7] The composition described in any one of paragraphs 1 to 6, which is an extract of the cannabis plant. [8] The composition of paragraph 7, wherein the cannabis plant extract is obtainable by solvent extraction of the cannabis plant. [9] The composition of claim 7 or 8, wherein the cannabis plant extract is obtainable by solvent extraction of flower material of the cannabis plant, which has preferably been trimmed and dried before use.

[10] The composition according to paragraph 8 or paragraph 9, wherein the cannabis plant is DKJ127 (deposited with the Community Plant Varieties Office under application number A202104053).

[11] The composition of any one of paragraphs 5 to 10, wherein the cannabis plant extract is an alcoholic extract.

[12] The composition described in any one of paragraphs 1 to 11, which is in liquid form.

[13] The composition of any one of paragraphs 1 to 12, further comprising a carrier oil, preferably sesame oil.

[14] A pharmaceutical formulation comprising the composition described in any one of paragraphs 1 to 13.

[15] The pharmaceutical formulation of paragraph 14, comprising delta-9-tetrahydrocannabinol (THC) in an amount between about 1.0 percent and 2.5 percent, preferably 2.1 percent, by weight of the formulation; THC and guaiol are present in the formulation in a ratio of between about 50:1 and 250:1, preferably between about 105:1 and 200:1; and / or THC and beta-caryophyllene are present in the formulation in a ratio of between about 50:1 and 250:1, preferably between about 105:1 and 200:1.

[16] The pharmaceutical formulation of paragraph 14 or paragraph 15, further comprising a carrier oil, preferably sesame oil.

[17] A composition according to any one of paragraphs 1 to 13, or a pharmaceutical formulation according to any one of paragraphs 14 to 16, for use in medicine.

[18] A composition described in any one of paragraphs 1 to 13 or 17, or a pharmaceutical formulation described in any one of paragraphs 14 to 17, for use in the treatment and / or prevention of chronic cancer pain, somatic pain, visceral pain, central neuropathic pain, peripheral neuropathic pain, or complex pain syndrome.

[19] A method for the treatment and / or prevention of chronic cancer pain, somatic pain, visceral pain, central neuropathic pain, peripheral neuropathic pain or complex pain syndrome, comprising administering to a subject in need thereof an effective amount of a composition described in any one of paragraphs 1 to 13, or a pharmaceutical formulation described in paragraphs 14 to 16.

[20] A composition according to paragraph 17 or 18 for use according to paragraph 17 or 18, or a pharmaceutical formulation according to paragraph 17 or 18 for use according to paragraph 17 or 18, which is administered orally, buccal, intranasal, topical, rectal or vaginally, but preferably orally.

[21] A kit comprising component A and component B, wherein component A is a composition according to any one of paragraphs 1 to 13, or a composition for use according to paragraph 17 or 18, and component B is a carrier oil, preferably sesame oil.

[0013] Furthermore, the present invention provides the following: [1] A composition containing delta-9-tetrahydrocannabinol (THC), alpha-bisabolol and beta-caryophyllene. [2] The composition of paragraph 1, wherein delta-9-tetrahydrocannabinol (THC) and alpha-bisabolol are present in the composition in a ratio of between about 50:1 and 500:1, preferably between about 100:1 and 450:1, and most preferably between about 160:1 and 295:1. [3] The composition of paragraph 1 or 2, wherein the delta-9-tetrahydrocannabinol (THC) and beta-caryophyllene are present in the composition in a ratio of between about 10:1 and 500:1, preferably between about 50:1 and 250:1, and most preferably between about 105:1 and 200:1. [4] The composition of any one of paragraphs 1 to 3, comprising delta-9-tetrahydrocannabinol (THC) in an amount between about 2.5 percent and 10 percent, preferably between about 4 percent and 6 percent, and most preferably 5 percent, by weight of the composition. [5] The composition of any one of paragraphs 1 to 4, comprising alpha-bisabolol in an amount between about 0.008 percent and 0.065 percent, preferably between about 0.01 percent and 0.04 percent, and most preferably between about 0.017 percent and 0.031 percent by weight of the composition. [6] The composition of any one of paragraphs 1 to 5, comprising beta-caryophyllene in an amount between about 0.012 percent and 0.094 percent, preferably between about 0.02 percent and 0.05 percent, and most preferably between about 0.025 percent and 0.047 percent by weight of the composition. [7] The composition described in any one of paragraphs 1 to 6, which is an extract of the cannabis plant. [8] The composition of paragraph 7, wherein the cannabis plant extract is obtainable by solvent extraction of the cannabis plant. [9] The composition of claim 7 or 8, wherein the cannabis plant extract is obtainable by solvent extraction of flower material of the cannabis plant, which has preferably been trimmed and dried before use.

[10] The composition according to paragraph 8 or paragraph 9, wherein the cannabis plant is DKJ127 (deposited with the Community Plant Varieties Office under application number A202104053).

[11] The composition of any one of paragraphs 5 to 10, wherein the cannabis plant extract is an alcoholic extract.

[12] The composition described in any one of paragraphs 1 to 11, which is in liquid form.

[13] The composition of any one of paragraphs 1 to 12, further comprising a carrier oil, preferably sesame oil.

[14] A pharmaceutical formulation comprising the composition described in any one of paragraphs 1 to 13.

[15] The pharmaceutical formulation of paragraph 14, comprising delta-9-tetrahydrocannabinol (THC) in an amount between about 1.0 percent and 2.5 percent, preferably 2.1 percent, by weight of the formulation; THC to alpha-bisabolol being present in the formulation in a ratio of between about 100:1 and 450:1, preferably between about 160:1 and 295:1; and / or THC to beta-caryophyllene being present in the formulation in a ratio of between about 50:1 and 250:1, preferably between about 105:1 and 200:1.

[16] The pharmaceutical formulation of paragraph 14 or paragraph 15, further comprising a carrier oil, preferably sesame oil.

[17] A composition according to any one of paragraphs 1 to 13, or a pharmaceutical formulation according to any one of paragraphs 14 to 15, for use in medicine.

[18] A composition described in any one of paragraphs 1 to 13 or 17, or a pharmaceutical formulation described in any one of paragraphs 14 to 17, for use in the treatment and / or prevention of chronic cancer pain, somatic pain, visceral pain, central neuropathic pain, peripheral neuropathic pain, or complex pain syndrome.

[19] A method for the treatment and / or prevention of chronic cancer pain, somatic pain, visceral pain, central neuropathic pain, peripheral neuropathic pain or complex pain syndrome, comprising administering to a subject in need thereof an effective amount of a composition described in any one of paragraphs 1 to 13, or a pharmaceutical formulation described in paragraphs 14 to 16.

[20] A composition according to paragraph 17 or 18 for use according to paragraph 17 or 18, or a pharmaceutical formulation according to paragraph 17 or 18 for use according to paragraph 17 or 18, which is administered orally, buccal, intranasal, topical, rectal or vaginally, but preferably orally.

[21] A kit comprising component A and component B, wherein component A is a composition according to any one of paragraphs 1 to 13, or a composition for use according to paragraph 17 or 18, and component B is a carrier oil, preferably sesame oil.

[0014] Furthermore, the present invention provides the following: [1] A composition containing delta-9-tetrahydrocannabinol (THC), alpha-bisabolol, guaiol and beta-caryophyllene. [2] The composition of paragraph 1, wherein delta-9-tetrahydrocannabinol (THC) and alpha-bisabolol are present in the composition in a ratio of between about 50:1 and 500:1, preferably between about 100:1 and 450:1, and most preferably between about 160:1 and 295:1. [3] The composition of paragraph 1 or 2, wherein delta-9-tetrahydrocannabinol (THC) and guaiol are present in the composition in a ratio of between about 10:1 and 500:1, preferably between about 50:1 and 250:1, and most preferably between about 105:1 and 200:1. [4] The composition of any one of paragraphs 1 to 3, wherein delta-9-tetrahydrocannabinol (THC) and beta-caryophyllene are present in the composition in a ratio of between about 10:1 and 500:1, preferably between about 50:1 and 250:1, and most preferably between about 105:1 and 200:1. [5] The composition of any one of paragraphs 1 to 4, comprising delta-9-tetrahydrocannabinol (THC) in an amount between about 2.5 percent and 10 percent, preferably between about 4 percent and 6 percent, and most preferably 5 percent, by weight of the composition. [6] The composition of any one of paragraphs 1 to 5, comprising alpha-bisabolol in an amount between about 0.008 percent and 0.065 percent, preferably between about 0.01 percent and 0.04 percent, and most preferably between about 0.017 percent and 0.031 percent by weight of the composition. [7] The composition of any one of paragraphs 1 to 6, comprising guaiol in an amount between about 0.012 percent and 0.092 percent, preferably between about 0.015 percent and 0.05 percent, and most preferably between about 0.025 percent and 0.046 percent by weight of the composition. [8] The composition of any one of paragraphs 1 to 7, comprising beta-caryophyllene in an amount between about 0.012 percent and 0.094 percent, preferably between about 0.02 percent and 0.05 percent, and most preferably between about 0.025 percent and 0.047 percent by weight of the composition. [9] The composition described in any one of paragraphs 1 to 8, which is an extract of the cannabis plant.

[10] The composition of paragraph 9, wherein the cannabis plant extract is obtainable by solvent extraction of the cannabis plant.

[11] The composition of claim 9 or 10, wherein the cannabis plant extract is obtainable by solvent extraction of flower material of the cannabis plant, which has preferably been trimmed and dried before use.

[12] The composition according to paragraph 10 or 11, wherein the cannabis plant is DKJ127 (deposited with the Community Plant Varieties Office under application number A202104053).

[13] The composition of any one of paragraphs 9 to 11, wherein the cannabis plant extract is an alcoholic extract.

[14] The composition described in any one of paragraphs 1 to 13, which is in liquid form.

[15] The composition of any one of paragraphs 1 to 14, further comprising a carrier oil, preferably sesame oil.

[16] A pharmaceutical formulation comprising the composition described in any one of paragraphs 1 to 15.

[17] The pharmaceutical formulation of paragraph 16, comprising delta-9-tetrahydrocannabinol (THC) in an amount between about 1.0 percent and 2.5 percent, preferably 2.1 percent, by weight of the formulation; THC and alpha-bisabolol are present in the formulation in a ratio of between about 100:1 and 450:1, preferably between about 160:1 and 295:1; THC and guaiol are present in the formulation in a ratio of between about 50:1 and 250:1, preferably between about 105:1 and 200:1; and / or THC and beta-caryophyllene are present in the formulation in a ratio of between about 50:1 and 250:1, preferably between about 105:1 and 200:1.

[18] The pharmaceutical formulation of paragraph 16 or 17, further comprising a carrier oil, preferably sesame oil.

[19] A composition according to any one of paragraphs 1 to 18, or a pharmaceutical formulation according to any one of paragraphs 16 to 18, for use in medicine.

[20] A composition described in any one of paragraphs 1 to 15 or 19, or a pharmaceutical formulation described in any one of paragraphs 16 to 19, for use in the treatment and / or prevention of chronic cancer pain, somatic pain, visceral pain, central neuropathic pain, peripheral neuropathic pain, or complex pain syndrome.

[21] A method for the treatment and / or prevention of chronic cancer pain, somatic pain, visceral pain, central neuropathic pain, peripheral neuropathic pain or complex pain syndrome, comprising administering to a subject in need thereof an effective amount of a composition described in any one of paragraphs 1 to 15, or a pharmaceutical formulation described in paragraphs 16 to 18.

[22] The composition according to paragraph 19 or 20 for use according to paragraph 19 or 20, or the pharmaceutical formulation according to paragraph 19 or 20 for use according to paragraph 19 or 20, which is administered orally, buccal, intranasal, topical, rectal or vaginally, but preferably orally.

[23] A kit comprising component A and component B, wherein component A is a composition according to any one of paragraphs 1 to 15, or a composition for use according to paragraph 19 or 20, and component B is a carrier oil, preferably sesame oil.

[0015] Therefore, the present invention relates to a composition as described in the above list of paragraphs. In particular, the present invention relates to a composition comprising delta-9-tetrahydrocannabinol (THC), alpha-bisabolol, guaiol and beta-caryophyllene, and at least one terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol. The compositions of the present invention may include any amount of THC, any amount of alpha-bisabolol, any amount of guaiol, any amount of beta-caryophyllene, and any amount of at least one terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol, and geraniol, in any suitable content combination, provided that said components are present in the compositions of the present invention. Thus, the compositions of the present invention are believed to comprise a mixture of THC, alpha-bisabolol, guaiol and beta-caryophyllene and at least one terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol.

[0016] The compositions described herein may include THC, alpha-bisabolol, guaiol, and beta-caryophyllene, and at least one terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol, and geraniol, in any suitable ratio.

[0017] Suitable ratios present in the compositions described herein include about 50:1, 60:1, 70:1, 80:1, 90:1, 100:1, 110:1, 120:1, 130:1, 140:1, 150:1, 160:1, 170:1, 180:1, 190:1, 200:1, 210:1, 220:1, 230:1, 240:1, 250:1, 260:1, 270:1, 280:1, 290:1, 300:1, 310:1, 320:1, 330:1, 340:1, 350:1, 360:1, 370:1, 380:1, 390:1, 400:1, 410:1, 420:1, 430:1, 440:1, 450:1, 460:1, 470:1, 480:1, 490:1, 500:1, 510:1, 520:1, 530:1, 540:1, 550:1, 560:1, 570:1, 580:1, 590:1, 600:1, 610:1, 620:1, 630:1, 640:1, 650:1, 660:1, 670:1, 680:1, 690:1, 700:1, 710:1, 720:1, 730:1, 740:1, 750:1, 760:1, Between 30:1, 440:1, 450:1, 460:1, 470:1, 480:1, 490:1 and 500:1; e.g. 75:1, 80:1, 90:1, 100:1, 110:1, 120:1, 130:1, 140:1, 150:1, 160:1, 170:1, 180:1, 190:1, 200:1, 210:1, 220:1, 230:1, 240:1, 250:1, 260:1, 270:1, 280:1, 290:1, 300:1, 310:1, 320:1, 330:1, 340:1, 350:1, 360:1, 370:1, 380:1, 390:1, Between 400:1, 410:1, 420:1, 430:1, 440:1 and 450:1; or 100:1, 110:1, 120:1, 130:1, 140:1, 150:1, 160:1, 170:1, 180:1, 190:1, 200:1, 210:1, 220:1, 230:1 , 240:1, 250:1, 260:1, 270:1, 280:1, 290:1, 300:1, 310:1, 320:1, 330:1, 340:1, 350:1, 360:1, 370:1, 380:1, 390:1, 400:1, 410:1, 420:1, 430:1, 440 :1, 450:1, 460:1, 470:1, 480:1, 490:1 and 500:1; or between 75:1, 80:1, 90:1, 100:1, 110:1, 120:1, 130:1, 140:1, 150:1, 160:1, 170:1, 180:1, 190:1, 200:1, 210:1, 220:1, 230:1, 240:1, 250:1, 260:1, 270:1, 280:1, 290:1, 300:1, 310:1, 320:1, 330:1, 340:1, 350:1, 360:1, 370:1, 380:1, 390:1 and 400:1;or between 150:1, 160:1, 170:1, 180:1, 190:1, 200:1, 210:1, 220:1, 230:1, 240:1, 250:1, 260:1, 270:1, 280:1, 290:1, 300:1, 310:1, 320:1, 330:1, 340:1, 350:1, 360:1, 370:1, 380:1, 390:1 and 400:1; or between 150:1, 160:1, 170:1, 180:1, 190:1, 200:1, 210:1, 22 THC / alpha-bisabolol ratios between 0:1, 230:1, 240:1, 250:1, 260:1, 270:1, 280:1, 290:1, 300:1, 310:1, 320:1, 330:1, 340:1 and 350:1; or alternatively, between 160:1, 170:1, 180:1, 190:1, 200:1, 210:1, 220:1, 230:1, 240:1, 250:1, 260:1, 270:1, 280:1, 290:1 and 295:1. In the context of the present invention, suitable ratios present in the compositions described herein include 50:1, 60:1, 70:1, 80:1, 90:1, 100:1, 110:1, 120:1, 130:1, 140:1, 150:1, 160:1, 170:1, 180:1, 185:1, 190:1, 200:1, 210:1, 220:1, 230:1, 240:1, 250:1, 260:1, 270:1, 280:1, 290:1, 300:1, 310:1, 320:1, 330:1, 340:1, 350:1, 360:1, 370:1, 380:1, 390:1, 400:1, 410:1, 420:1, 430:1, 440:1, 450:1, 460:1, 470:1, 480:1, 490:1, 500:1, 510:1, 520:1, 530:1, 540:1, 550:1, 560:1, 570:1, 580:1, 590:1, 600:1, 610:1, 620:1, 630:1, 640:1, 650:1, 660:1, 670:1, 680:1, 690:1, 700:1, 710:1, 720:1, 730:1, 740:1, Included are THC / alpha-bisabolol ratios of greater than 0:1, 280:1, 290:1, 300:1, 310:1, 320:1, 330:1, 340:1, 350:1, 360:1, 370:1, 380:1, 390:1, 400:1, 410:1, 420:1, 430:1, 440:1, 450:1, 460:1, 470:1, 480:1, 490:1, or 500:1. In the present invention, it is preferred that THC and alpha-bisabolol are present in the compositions of the present invention in a ratio of greater than 160:1, between 100:1 and 450:1, and even more preferably between 160:1 and 295:1;

[0018] Suitable ratios present in the compositions described herein include about 10:1, 20:1, 30:1, 40:1, 50:1, 60:1, 70:1, 80:1, 90:1, 100:1, 110:1, 120:1, 130:1, 140:1, 150:1, 160:1, 170:1, 180:1, 190:1, 200:1, 210:1, 220:1, 230:1, 240:1, 250:1, 260:1, 270:1, 280:1, 290:1, 300:1, 310:1, 320:1, 330:1, 340:1, 350:1, 360:1 , 370:1, 380:1, 390:1, 400:1, 410:1, 420:1, 430:1, 440:1, 450:1, 460:1, 470:1, 480:1, 490:1 and 500:1; for example 30:1, 40:1, 50:1, 60:1, 70:1, 80:1, 90:1, 100:1, 110:1, 120:1, 130:1, 140:1, 150:1, 160:1, 170:1, 180:1, 190:1, 200:1, 210:1, 220:1, 230:1, 240:1, 250:1, 260:1, 2 between 70:1, 280:1, 290:1, 300:1, 310:1, 320:1, 330:1, 340:1, 350:1, 360:1, 370:1, 380:1, 390:1, 400:1, 410:1, 420:1, 430:1, 440:1 and 450:1; or between 50:1, 60:1, 70:1, 80:1, 90:1, 100:1, 110:1, 120:1, 130:1, 140:1, 150:1, 160:1, 170:1, 180:1, 190:1, 200:1, 210:1, 220:1, 230:1, 24 between 0:1, 250:1, 260:1, 270:1, 280:1, 290:1, 300:1, 310:1, 320:1, 330:1, 340:1, 350:1, 360:1, 370:1, 380:1, 390:1 and 400:1; or between 50:1, 60:1, 70:1, 80:1, 90:1, 100:1, 110:1, 120:1, 130:1, 140:1, 150:1, 160:1, 170:1, 180:1, 190:1, 200:1, 210:1, 220:1, 230:1, 240:1 and 250:1;Or alternatively, THC / guaiol ratios of between 105:1, 110:1, 115:1, 120:1, 125:1, 130:1, 135:1, 140:1, 145:1, 150:1, 155:1, 160:1, 165:1, 170:1, 175:1, 180:1, 185:1, 190:1, 195:1 and 200:1 are included. In the context of the present invention, suitable ratios present in the compositions described herein include 10:1, 20:1, 30:1, 40:1, 50:1, 60:1, 70:1, 80:1, 90:1, 100:1, 105:1, 110:1, 120:1, 130:1, 140:1, 150:1, 160:1, 170:1, 180:1, 190:1, 200:1, 210:1, 220:1, 230:1, 240:1, 250:1, 260:1, 270:1, 280:1, 290:1, 300:1, 310:1, 320:1, 330:1, 340:1, 350:1, 360:1, 370:1, 380:1, 390:1, 400:1, 410:1, 420:1, 430:1, 440:1, 450:1, 460:1, 470:1, 480:1, 490:1, 500:1, 510:1, 520:1, 530:1, 540:1, 550:1, 560:1, 570:1, 580:1, 590:1, 600:1, 610:1, 620:1, 630:1, 640:1, 650:1, 660:1, 670:1, 680:1, 690:1, 700:1, 710: These include THC / guaiol ratios of greater than 50:1, 260:1, 270:1, 280:1, 290:1, 300:1, 310:1, 320:1, 330:1, 340:1, 350:1, 360:1, 370:1, 380:1, 390:1, 400:1, 410:1, 420:1, 430:1, 440:1, 450:1, 460:1, 470:1, 480:1, 490:1, or 500:1. In the present invention, it is preferred that THC and guaiol are present in the compositions of the present invention in a ratio of greater than 105:1, between 50:1 and 250:1, and even more preferably between 105:1 and 200:1;

[0019] Suitable ratios present in the compositions described herein include about 10:1, 20:1, 30:1, 40:1, 50:1, 60:1, 70:1, 80:1, 90:1, 100:1, 110:1, 120:1, 130:1, 140:1, 150:1, 160:1, 170:1, 180:1, 190:1, 200:1, 210:1, 220:1, 230:1, 240:1, 250:1, 260:1, 270:1, 280:1, 290:1, 300:1, 310:1, 320:1, 330:1, 340:1, 350:1, 360:1 , 370:1, 380:1, 390:1, 400:1, 410:1, 420:1, 430:1, 440:1, 450:1, 460:1, 470:1, 480:1, 490:1 and 500:1; for example 30:1, 40:1, 50:1, 60:1, 70:1, 80:1, 90:1, 100:1, 110:1, 120:1, 130:1, 140:1, 150:1, 160:1, 170:1, 180:1, 190:1, 200:1, 210:1, 220:1, 230:1, 240:1, 250:1, 260:1, 2 between 70:1, 280:1, 290:1, 300:1, 310:1, 320:1, 330:1, 340:1, 350:1, 360:1, 370:1, 380:1, 390:1, 400:1, 410:1, 420:1, 430:1, 440:1 and 450:1; or between 50:1, 60:1, 70:1, 80:1, 90:1, 100:1, 110:1, 120:1, 130:1, 140:1, 150:1, 160:1, 170:1, 180:1, 190:1, 200:1, 210:1, 220:1, 230:1, 24 between 0:1, 250:1, 260:1, 270:1, 280:1, 290:1, 300:1, 310:1, 320:1, 330:1, 340:1, 350:1, 360:1, 370:1, 380:1, 390:1 and 400:1; or between 50:1, 60:1, 70:1, 80:1, 90:1, 100:1, 110:1, 120:1, 130:1, 140:1, 150:1, 160:1, 170:1, 180:1, 190:1, 200:1, 210:1, 220:1, 230:1, 240:1 and 250:1;or alternatively, THC / beta-caryophyllene ratios of between 105:1, 110:1, 115:1, 120:1, 125:1, 130:1, 135:1, 140:1, 145:1, 150:1, 155:1, 160:1, 165:1, 170:1, 175:1, 180:1, 185:1, 190:1, 195:1 and 200:1. In the context of the present invention, suitable ratios present in the compositions described herein include 10:1, 20:1, 30:1, 40:1, 50:1, 60:1, 70:1, 80:1, 90:1, 100:1, 105:1, 110:1, 120:1, 130:1, 140:1, 150:1, 160:1, 170:1, 180:1, 190:1, 200:1, 210:1, 220:1, 230:1, 240:1, 250: 1, 260:1, 270:1, 280:1, 290:1, 300:1, 310:1, 320:1, 330:1, 340:1, 350:1, 360:1, 370:1, 380:1, 390:1, 400:1, 410:1, 420:1, 430:1, 440:1, 450:1, 460:1, 470:1, 480:1, 490:1 or 500:1 THC / beta-caryophyllene ratios are included. In the present invention, it is preferred that THC and beta-caryophyllene are present in the compositions of the present invention in a ratio of greater than 105:1, between 50:1 and 250:1, and even more preferably between 105:1 and 200:1;

[0020] Suitable ratios present in the compositions described herein include a THC / linalool ratio between 450:1 and 1400:1, a THC / alpha-humulene ratio between 300:1 and 725:1, a THC / nerolidol ratio between 200:1 and 600:1, a THC / caryophyllene oxide ratio between 1000:1 and 2150:1, a THC / alpha-pinene ratio between 5850:1 and 16000:1, a THC / camphene ratio between 7300:1 and 132950:1, a THC / beta-pinene ratio between 6475:1 and 23100:1, a THC / beta-myrcene ratio between 1950:1 and 6300:1, a THC / beta-myrcene ratio between 1650:1 and 5 These include a THC / limonene ratio of between 0.050:1, a THC / eucalyptol ratio of between 5050:1 and 38650:1, a THC / ocimene ratio of between 2500:1 and 44700:1, a THC / gamma-terpinene ratio of between 4700:1 and 35750:1, a THC / terpinolene ratio of between 5450:1 and 129850:1, a THC / alpha-terpinene ratio of between 5150:1 and 58550:1, a THC / para-cymene ratio of between 4700:1 and 56700:1, a THC / isopulegol ratio of between 4000:1 and 8000:1, and a THC / geraniol ratio of between 1300:1 and 18250:1.Preferred ratios present in the compositions described herein include a THC / linalool ratio between 500:1 and 1330:1, a THC / alpha-humulene ratio between 355:1 and 665:1, a THC / nerolidol ratio between 285:1 and 535:1, a THC / caryophyllene oxide ratio between 1090:1 and 2080:1, a THC / alpha-pinene ratio between 6000:1 and 15750:1, a THC / camphene ratio between 7300:1 and 132950:1, a THC / beta-pinene ratio between 6545:1 and 23025:1, a THC / beta-myrcene ratio between 2025:1 and 6210:1, a THC / beta-myrcene ratio between 1700:1 and 4 These include a THC / limonene ratio of between 970:1, a THC / eucalyptol ratio of between 5140:1 and 38580:1, a THC / ocimene ratio of between 2570:1 and 44610:1, a THC / gamma-terpinene ratio of between 4800:1 and 35685:1, a THC / terpinolene ratio of between 5535:1 and 129965:1, a THC / alpha-terpinene ratio of between 5210:1 and 58480:1, a THC / para-cymene ratio of between 4800:1 and 56625:1, a THC / isopulegol ratio of between 4060:1 and 7915:1, and a THC / geraniol ratio of between 1375:1 and 18150:1.

[0021] Thus, in the present invention, THC and alpha-bisabolol are present in the compositions of the present invention in a ratio of between 100:1 and 450:1, THC and guaiol are present in the compositions of the present invention in a ratio of between 50:1 and 250:1, THC and beta-caryophyllene are present in the compositions of the present invention in a ratio of between 50:1 and 250:1, and the compositions further comprise linalool in a THC / linalool ratio of between 450:1 and 1400:1, THC / alpha-humectanthin ratio of between 300:1 and 725:1, alpha-humulene with a THC / nerolidol ratio between 200:1 and 600:1; caryophyllene oxide with a THC / caryophyllene oxide ratio between 1000:1 and 2150:1; alpha-pinene with a THC / alpha-pinene ratio between 5850:1 and 16000:1; camphene with a THC / camphene ratio between 7300:1 and 132950:1; beta-pinene with a THC / beta-pinene ratio between 6475:1 and 23100:1; Beta-myrcene with a THC / beta-myrcene ratio between 1950:1 and 6300:1, limonene with a THC / limonene ratio between 1650:1 and 5050:1, eucalyptol with a THC / eucalyptol ratio between 5050:1 and 38650:1, ocimene with a THC / ocimene ratio between 2500:1 and 44700:1, gamma-terpinene with a THC / gamma-terpinene ratio between 4700:1 and 35750:1, THC between 5450:1 and 129850:1, Preferably, the composition comprises at least one terpene selected from the group consisting of terpinolene with a THC / terpinolene ratio of between 5150:1 and 58550:1, alpha-terpinene with a THC / alpha-terpinene ratio of between 5150:1 and 58550:1, para-cymene with a THC / para-cymene ratio of between 4700:1 and 56700:1, isopulegol with a THC / isopulegol ratio of between 4000:1 and 8000:1, and geraniol with a THC / geraniol ratio of between 1300:1 and 18250:1.In the present invention, THC and alpha-bisabolol are present in the compositions of the present invention in a ratio of between 160:1 and 295:1, THC and guaiol are present in the compositions of the present invention in a ratio of between 105:1 and 200:1, and THC and beta-caryophyllene are present in the compositions of the present invention in a ratio of between 105:1 and 200:1, and the compositions further comprise linalool in a THC / linalool ratio of between 500:1 and 1330:1, THC / alpha-humulene in a ratio of between 355:1 and 665:1, alpha-humulene with a THC / nerolidol ratio between 285:1 and 535:1; caryophyllene oxide with a THC / caryophyllene oxide ratio between 1090:1 and 2080:1; alpha-pinene with a THC / alpha-pinene ratio between 6000:1 and 15750:1; camphene with a THC / camphene ratio between 7300:1 and 132950:1; beta-pinene with a THC / beta-pinene ratio between 6545:1 and 23025:1; Beta-myrcene with a THC / beta-myrcene ratio between 25:1 and 6210:1, limonene with a THC / limonene ratio between 1700:1 and 4970:1, eucalyptol with a THC / eucalyptol ratio between 5140:1 and 38580:1, ocimene with a THC / ocimene ratio between 2570:1 and 44610:1, gamma-terpinene with a THC / gamma-terpinene ratio between 4800:1 and 35685:1, and THC / terpinene with a THC / gamma-terpinene ratio between 5535:1 and 129965:1. Even more preferably, the terpene comprises at least one terpene selected from the group consisting of terpinolene with a THC / alpha-terpinene ratio of between 5210:1 and 58480:1, para-cymene with a THC / para-cymene ratio of between 4800:1 and 56625:1, isopulegol with a THC / isopulegol ratio of between 4060:1 and 7915:1, and geraniol with a THC / geraniol ratio of between 1375:1 and 18150:1.

[0022] In the context of the present invention, the term "at least one terpene selected from the group consisting of" means that at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, or 17 additional terpenes selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol, and geraniol are present in the compositions described herein, i.e., compositions comprising THC, alpha-bisabolol, guaiol, and beta-caryophyllene. Illustratively, in the context of the present invention, the composition of the present invention preferably comprises at least 1, 2, 3, 4 or 5 terpenes selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide and limonene.

[0023] The composition may comprise at least about 2.5%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 15% or 20% THC by weight of the composition; for example, about 2.5%, 3%, 4%, 5%, 6%, 7%, 8%, 9% and 10% THC by weight of the composition; or between 2.5%, 3%, 4%, 5%, 6%, 7% and 8% by weight of the composition; or between 3%, 4%, 5%, 6% and 7%; or between 3%, 4%, 5% and 6%; or between 4%, 5% and 6% THC. Those skilled in the art will recognize that the above values ​​given in weight percent may also be provided in parts per million (ppm), such as mg / kg or mg / l. The compositions of the present invention preferably comprise THC in an amount between about 2.5% and 10%, at least about 4%, or preferably between about 4% and 6% by weight of the composition. In the present invention, the composition of the present invention most preferably contains THC in an amount of 5% by weight of the composition. As an example, an amount of THC of 5% by weight of the composition is converted to 50000 ppm.

[0024] In the context of the present invention, a composition comprises at least about 0.001%, 0.002%, 0.003%, 0.004%, 0.005%, 0.006%, 0.007%, 0.008%, 0.009%, 0.01%, 0.011%, 0.012%, 0.013%, 0.014%, 0.015%, 0.016%, 0.017%, 0.018%, 0.019%, 0.02%, 0.021%, 0.022%, 0.023%, 0.024%, 0.025%, 0.026%, 0.027%, 0.028%, 0.029%, 0.030%, 0.031%, 0.032%, 0.033%, 0.034%, 0.035%, 0.036%, 0.037%, 0.038%, 0.039%, 0.040%, 0.041%, 0.042%, 0.043%, 0.044%, 0.045%, 0.046%, 0.047%, 0.048%, 0.049%, 0.050%, 0.051%, 0.052%, 0.053%, 0.054%, 0.055%, 0.056%, 0.057%, 0.058%, 0.059%, 0.060%, 0.061%, 0.062%, 0.063%, 0.064%, 0.065%, 0.066%, 0.067%, 0.068%, 0.069%, 0.070%, 0.071%, 0 %, 0.033%, 0.034%, 0.035%, 0.036%, 0.037%, 0.038%, 0.039% or 0.04% alpha-bisabolol; for example between about 0.005%, 0.008%, 0.01%, 0.015%, 0.02%, 0.025%, 0.03%, 0.035%, 0.04%, 0.045%, 0.05%, 0.055%, 0.06% and 0.065% by weight of the composition; or 0.001%, 0.002%, 0.003%, 0.004%, 0.005%, 0.006%, 0.007%, 0.008%, 0.009%, 0.01%, 0. between 0.011%, 0.012%, 0.013%, 0.014%, 0.015%, 0.016%, 0.017%, 0.018%, 0.019%, 0.02%, 0.021%, 0.022%, 0.023%, 0.024%, 0.025%, 0.026%, 0.027%, 0.028%, 0.029%, 0.030%, 0.031%, 0.032%, 0.033%, 0.034%, 0.035%, 0.036%, 0.037%, 0.038%, 0.039% and 0.04%; or alternatively, between 0.005%, 0.006%, 0.007%, 0.008%, 0.009% %, 0.01%, 0.011%, 0.012%, 0.013%, 0.014%, 0.015%, 0.016%, 0.017%, 0.018%, 0.019%, 0.02%, 0.021%, 0.022%, 0.023%, 0.024%, 0.025%, 0.026%, 0.027% , 0.028%, 0.029% and 0.03%; or between 0.011%, 0.012%, 0.013%, 0.014%, 0.015%, 0.016%, 0.017%, 0.018%, 0.019%, 0.02%, 0.021%, 0.022%, 0.023%, 0.024%, 0.or alternatively, between 0.014%, 0.015%, 0.016%, 0.017%, 0.018%, 0.019%, 0.02%, 0.021%, 0.022%, 0.023%, 0.024%, 0.025%, 0.026%, 0.027%, 0.028%, 0.029%, and 0.03% alpha-bisabolol. The compositions of the present invention may contain alpha-bisabolol in an amount between 0.008% and 0.065%, preferably between 0.01% and 0.04%, by weight of the composition. Even more preferably, the compositions of the present invention comprise alpha-bisabolol in an amount of at least 0.017% by weight of the composition, or most preferably between 0.017% and 0.031% by weight of the composition.

[0025] Thus, the compositions of the present invention may contain THC in an amount between about 2.5% and 10% by weight of the composition, and alpha-bisabolol in an amount between about 0.008% and 0.065% by weight of the composition. More preferably, the compositions of the present invention may contain THC in an amount between about 4% and 6% by weight of the composition, and alpha-bisabolol in an amount between about 0.01% and 0.04% by weight of the composition. Thus, the compositions of the present invention may contain THC in an amount between about 2.5% and 10% by weight of the composition, at least 4%, preferably between 4% and 6%, and alpha-bisabolol in an amount of at least 0.008% by weight of the composition, between about 0.008% by weight of the composition and 0.065% by weight of the composition, preferably between about 0.01% by weight of the composition and 0.04% by weight of the composition.

[0026] Most preferably, the compositions described herein comprise THC in an amount of 5% by weight of the composition and alpha-bisabolol in an amount between about 0.017% and 0.031% by weight of the composition. In the context of the present invention, the compositions described herein may comprise THC in an amount of 5% by weight of the composition and alpha-bisabolol in an amount of at least about 0.017% by weight of the composition.

[0027] In the present invention, the compositions of the present invention may contain THC in an amount between about 2.5% and 10% by weight of the composition and a THC / alpha-bisabolol ratio between 100:1 and 450:1. Further, in the context of the present invention, the compositions of the present invention may contain alpha-bisabolol in an amount between about 0.008% and 0.065% by weight of the composition and a THC / alpha-bisabolol ratio between 100:1 and 450:1.

[0028] More preferably, in the present invention, the compositions of the present invention may contain THC in an amount between about 4% and 6% by weight of the composition and with a THC / alpha-bisabolol ratio between 100:1 and 450:1.Further, in the context of the present invention, the compositions of the present invention may contain alpha-bisabolol in an amount between about 0.01% and 0.04% by weight of the composition and with a THC / alpha-bisabolol ratio between 100:1 and 450:1.

[0029] Most preferably, in the present invention, the compositions of the present invention may contain THC in an amount of 5% THC by weight of the composition, and a THC / alpha-bisabolol ratio of between 160:1 and 295:1.Further, in the context of the present invention, the compositions of the present invention may contain alpha-bisabolol in an amount of between about 0.014% and 0.031% by weight of the composition, and a THC / alpha-bisabolol ratio of between 160:1 and 295:1.

[0030] In accordance with the present invention, the compositions of the present invention may also contain THC in an amount of 5% by weight of the composition and with a THC / alpha-bisabolol ratio of at least about 160: 1. In accordance with the present invention, the compositions of the present invention may contain alpha-bisabolol in an amount of at least 0.01% by weight of the composition, preferably between about 0.01% and 0.04% by weight of the composition, and with an alpha-bisabolol / THC ratio of greater than 1:100.

[0031] In the context of the present invention, the composition also comprises at least about 0.001%, 0.002%, 0.003%, 0.004%, 0.005%, 0.006%, 0.007%, 0.008%, 0.009%, 0.01%, 0.011%, 0.012%, 0.013%, 0.014%, 0.015%, 0.016%, 0.017%, 0.018%, 0.019%, 0.02%, 0.021%, 0.022%, 0.023%, 0.024%, 0.025%, 0.026%, 0.027%, 0.028%, 0.029%, 0.030%, 0.031%, 0.032%, 0.033%, 0.034%, 0.035%, 0.036%, 0.037%, 0.038%, 0.040%, 0.041%, 0.042%, 0.043%, 0.044%, 0.045%, 0.046%, 0.047%, 0.048%, 0.049%, 0.050%, 0.051%, 0.052%, 0.053%, 0.054%, 0.055%, 0.056%, 0.057%, 0.058%, 0.060%, 0.061%, 0.062%, 0.063%, 0.064%, 0.065%, 0.066%, 0.067%, 0.068%, 0.069%, 0.070%, 0.071%, 0.072%, 0.073%, 32%, 0.033%, 0.034%, 0.035%, 0.036%, 0.037%, 0.038%, 0.039% or 0.04% guaiol; for example between about 0.012%, 0.015%, 0.02%, 0.025%, 0.03%, 0.035%, 0.04%, 0.045%, 0.05%, 0.055%, 0.06%, 0.065%, 0.07%, 0.075%, 0.08%, 0.085%, 0.09% and 0.092% by weight of the composition; or 0.001%, 0.002%, 0.0025%, 0.003%, 0.0035%, 0.004%, 0.00 45%, 0.005%, 0.0055%, 0.006%, 0.0065%, 0.007%, 0.0075%, 0.008%, 0.0085%, 0.009%, 0.0095%, 0.01%, 0.015%, 0.02%, 0.025%, 0.03%, 0.035%, 0.04%, Between 0.045%, 0.05%, 0.055%, 0.06%, 0.065%, 0.07%, 0.075% and 0.08%; or between 0.015%, 0.016%, 0.017%, 0.018%, 0.019%, 0.020%, 0.021%, 0.022%, 0.023%, 0.024% %, 0.025%, 0.026%, 0.027%, 0.028%, 0.029%, 0.030%, 0.031%, 0.032%, 0.033%, 0.034%, 0.035%, 0.036%, 0.037%, 0.038%, 0.039%, 0.04%, 0.041%, 0.042%, 0.043%, 0.044%, 0.045%, 0.046%, 0.047%, 0.048%, 0.049% and 0.05%; or alternatively, between 0.025%, 0.026%, 0.027%, 0.028%, 0.029%, 0.030%, 0.031%, 0.032%, 0.The compositions of the present invention may comprise guaiol in an amount between 0.012% and 0.092%, preferably between 0.015% and 0.05% by weight of the composition. Even more preferably, the compositions of the present invention comprise guaiol in an amount of at least 0.025% by weight of the composition, or most preferably between 0.025% and 0.046% by weight of the composition.

[0032] Thus, the compositions of the present invention may contain THC in an amount between about 2.5% and 10% by weight of the composition, and guaiol in an amount between about 0.012% and 0.092% by weight of the composition. More preferably, the compositions of the present invention may contain THC in an amount between about 4% and 6% by weight of the composition, and guaiol in an amount between about 0.015% and 0.05% by weight of the composition. Thus, the compositions of the present invention may contain THC in an amount between about 2.5% and 10% by weight of the composition, at least 4%, preferably between 4% and 6%, and guaiol in an amount of at least 0.012% by weight of the composition, between about 0.012% and 0.092% by weight of the composition, preferably between about 0.015% and 0.05% by weight of the composition. Most preferably, the compositions described herein contain THC in an amount of 5% by weight of the composition, and guaiol in an amount between about 0.025% and 0.046% by weight of the composition. In the context of the present invention, the compositions described herein may comprise THC in an amount of 5% by weight of the composition and guaiol in an amount of at least about 0.025% by weight of the composition.

[0033] In the present invention, the compositions of the present invention may contain THC in an amount between about 2.5% and 10% by weight of the composition and in a THC / guaiol ratio between 50:1 and 250:1. Furthermore, in the context of the present invention, the compositions of the present invention may contain guaiol in an amount between about 0.012% and 0.092% by weight of the composition and in a THC / guaiol ratio between 50:1 and 250:1.

[0034] More preferably, in accordance with the present invention, the compositions of the present invention may contain THC in an amount between about 4% and 6% by weight of the composition, and in a THC / guaiol ratio between 50:1 and 250:1. Furthermore, in the context of the present invention, the compositions of the present invention may contain guaiol in an amount between about 0.015% and 0.05% by weight of the composition, and in a THC / guaiol ratio between 50:1 and 250:1.

[0035] Most preferably, in accordance with the present invention, the composition of the present invention may contain THC in an amount of 5% by weight of the composition and in a THC / guaiol ratio of between 105:1 and 200:1. Furthermore, in the context of the present invention, the composition of the present invention may contain guaiol in an amount of between about 0.025% and 0.046% by weight of the composition and in a THC / guaiol ratio of between 105:1 and 200:1.

[0036] In accordance with the present invention, the compositions of the present invention may contain THC in an amount of 5% by weight of the composition and with a THC / guaiol ratio of at least about 105: 1. In accordance with the present invention, the compositions of the present invention may also contain guaiol in an amount of at least 0.015% by weight of the composition, preferably between about 0.015% and 0.05% by weight of the composition, and with a guaiol / THC ratio of more than 1:50.

[0037] In the context of the present invention, a composition comprises at least about 0.001%, 0.002%, 0.003%, 0.004%, 0.005%, 0.006%, 0.007%, 0.008%, 0.009%, 0.01%, 0.011%, 0.012%, 0.013%, 0.014%, 0.015%, 0.016%, 0.017%, 0.018%, 0.019%, 0.02%, 0.021%, 0.022%, 0.023%, 0.024%, 0.025%, 0.026%, 0.027%, 0.028%, 0.029%, 0.030%, 0.031%, 0.032%, 0.033%, 0.034%, 0.035%, 0.036%, 0.037%, 0.038%, 0.039%, 0.040%, 0.041%, 0.042%, 0.043%, 0.044%, 0.045%, 0.046%, 0.047%, 0.048%, 0.049%, 0.050%, 0.051%, 0.052%, 0.053%, 0.054%, 0.055%, 0.056%, 0.057%, 0.058%, 0.059%, 0.060%, 0.061%, 0.062%, 0.063%, 0.064%, 0.065%, 0.066%, 0.067%, 0.068%, 0.069%, 0.070%, 0.071%, 0 %, 0.033%, 0.034%, 0.035%, 0.036%, 0.037%, 0.038%, 0.039% or 0.04% beta-caryophyllene; for example, between about 0.012%, 0.015%, 0.02%, 0.025%, 0.03%, 0.035%, 0.04%, 0.045%, 0.05%, 0.055%, 0.06%, 0.065%, 0.07%, 0.075%, 0.08%, 0.085%, 0.09% and 0.094% by weight of the composition; or 0.001%, 0.002%, 0.0025%, 0.003%, 0.0035%, 0.004%, 0.0045%, 0.005%, 0.0055%, 0.006%, 0.0065%, 0.007%, 0.0075%, 0.008%, 0.0085%, 0.009%, 0.0095%, 0.01%, 0.015%, 0.02%, 0.025%, 0.03%, 0.035%, 0. between 0.04%, 0.045%, 0.05%, 0.055%, 0.06%, 0.065%, 0.07%, 0.075% and 0.08%; or between 0.015%, 0.016%, 0.017%, 0.018%, 0.019%, 0.020%, 0.021%, 0.022%, 0.023%, 0.024%, 0.025%, 0.026%, 0.027%, 0.028%, 0.030%, 0.031%, 0.032%, 0.033%, 0.034%, 0.035%, 0.036%, 0.037%, 0.038%, 0.039%, 0.040%, 0.045%, 0.05%, 0.0 .024%, 0.025%, 0.026%, 0.027%, 0.028%, 0.029%, 0.030%, 0.031%, 0.032%, 0.033%, 0.034%, 0.035%, 0.036%, 0.037%, 0.038%, 0.039%, 0.04%, 0.041%, Between 0.042%, 0.043%, 0.044%, 0.045%, 0.046%, 0.047%, 0.048%, 0.049% and 0.05%; or between 0.025%, 0.026%, 0.027%, 0.028%, 0.029%, 0.030%, 0.031%, 0.032%, 0.The compositions of the present invention may also contain beta-caryophyllene in an amount between 0.0012% and 0.094%, preferably between 0.02% and 0.05% by weight of the composition. Even more preferably, the compositions of the present invention contain beta-caryophyllene in an amount of at least 0.025% by weight of the composition, or most preferably between 0.025% and 0.047% by weight of the composition.

[0038] Thus, the compositions of the present invention may contain THC in an amount between about 2.5% and 10% by weight of the composition, and beta-caryophyllene in an amount between about 0.012% and 0.094% by weight of the composition. More preferably, the compositions of the present invention may contain THC in an amount between about 4% and 6% by weight of the composition, and beta-caryophyllene in an amount between about 0.02% and 0.05% by weight of the composition. Thus, the compositions of the present invention may contain THC in an amount between about 2.5% and 10% by weight of the composition, at least 4%, preferably between 4% and 6%, and beta-caryophyllene in an amount of at least 0.012% by weight of the composition, between about 0.012% by weight of the composition and 0.094% by weight of the composition, preferably between about 0.02% by weight of the composition and 0.05% by weight of the composition.

[0039] Most preferably, the compositions described herein comprise THC in an amount of 5% by weight of the composition and beta-caryophyllene in an amount between about 0.025% and 0.047% by weight of the composition. In the context of the present invention, the compositions described herein may comprise THC in an amount of 5% by weight of the composition and beta-caryophyllene in an amount of at least about 0.025% by weight of the composition.

[0040] In the present invention, the compositions of the present invention may contain THC in an amount between about 2.5% and 10% by weight of the composition and a THC / beta-caryophyllene ratio between 50:1 and 250:1. Further, in the context of the present invention, the compositions of the present invention may contain beta-caryophyllene in an amount between about 0.012% and 0.094% by weight of the composition and a THC / beta-caryophyllene ratio between 50:1 and 250:1.

[0041] More preferably, in the present invention, the composition of the present invention may contain THC in an amount between about 4% and 6% by weight of the composition and a THC / beta-caryophyllene ratio between 50:1 and 250:1. Furthermore, in the context of the present invention, the composition of the present invention may contain beta-caryophyllene in an amount between about 0.02% and 0.05% by weight of the composition and a THC / beta-caryophyllene ratio between 50:1 and 250:1.

[0042] Most preferably, in the present invention, the composition of the present invention may contain THC in an amount of 5% by weight of the composition and a THC / beta-caryophyllene ratio of between 105:1 and 200:1. Further, in the context of the present invention, the composition of the present invention may contain beta-caryophyllene in an amount of between about 0.025% and 0.047% by weight of the composition and a THC / beta-caryophyllene ratio of between 105:1 and 200:1.

[0043] In the present invention, the compositions of the present invention may also contain THC in an amount of 5% by weight of the composition and with a THC / beta-caryophyllene ratio of at least about 105: 1. In the present invention, the compositions of the present invention may also contain beta-caryophyllene in an amount of at least 0.025% by weight of the composition, preferably between about 0.02% and 0.05% by weight of the composition, and with a beta-caryophyllene / THC ratio of greater than 1:50.

[0044] The composition further comprises at least one terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol, and geraniol. In the present invention, the composition comprises linalool in an amount between 0.001% and 0.014% by weight of the composition, alpha-humulene in an amount between 0.003% and 0.028% by weight of the composition, nerolidol in an amount between 0.004% and 0.035% by weight of the composition, caryophyllene oxide in an amount between 0.001% and 0.0092% by weight of the composition, alpha-pinene in an amount between 0.0001% and 0.002% by weight of the composition, camphene in an amount between 0.00001% and 0.0015% by weight of the composition, beta-pinene in an amount between 0.0001% and 0.0015% by weight of the composition, beta-myrcene in an amount between 0.0004% and 0.005% by weight of the composition, beta-myrcene in an amount between 0.0005% and 0.0006% by weight of the composition, beta-myrcene in an amount between 0.0005% and 0.0009 ... limonene in an amount between 0.00006% and 0.002% by weight of the composition, eucalyptol in an amount between 0.00005% and 0.004% by weight of the composition, ocimene in an amount between 0.00007% and 0.002% by weight of the composition, gamma-terpinene in an amount between 0.00007% and 0.002% by weight of the composition, terpinolene in an amount between 0.00002% and 0.002% by weight of the composition, alpha-terpinene in an amount between 0.00004% and 0.002% by weight of the composition, para-cymene in an amount between 0.00004% and 0.002% by weight of the composition, isopulegol in an amount between 0.0003% and 0.003% by weight of the composition, and / or geraniol in an amount between 0.0001% and 0.008% by weight of the composition.

[0045] Preferably, the composition comprises linalool in an amount between 0.003% and 0.0085% by weight of the composition, alpha-humulene in an amount between 0.006% and 0.017% by weight of the composition, nerolidol in an amount between 0.007% and 0.021% by weight of the composition, caryophyllene oxide in an amount between 0.001% and 0.0055% by weight of the composition, alpha-pinene in an amount between 0.0002% and 0.001% by weight of the composition, camphene in an amount between 0.00003% and 0.00082% by weight of the composition, beta-pinene in an amount between 0.0001% and 0.00092% by weight of the composition, beta-myrcene in an amount between 0.0004% and 0.005% by weight of the composition, and 0.0008% and 0.0009% by weight of the composition. limonene in an amount between 0.0001% and 0.0012% by weight of the composition, eucalyptol in an amount between 0.00009% and 0.0023% by weight of the composition, gamma-terpinene in an amount between 0.0001% and 0.0013% by weight of the composition, terpinolene in an amount between 0.00003% and 0.001% by weight of the composition, alpha-terpinene in an amount between 0.00006% and 0.0012% by weight of the composition, para-cymene in an amount between 0.00007% and 0.0013% by weight of the composition, isopulegol in an amount between 0.0005% and 0.0015% by weight of the composition, and / or geraniol in an amount between 0.0002% and 0.0044% by weight of the composition.

[0046] In the present invention, the compositions of the present invention may contain THC in an amount of between about 2.5% and 10% by weight of the composition, a THC / alpha-bisabolol ratio of between 100:1 and 450:1, a THC / guaiol ratio of between 50:1 and 250:1, a THC / beta-caryophyllene ratio of between 50:1 and 250:1, and a linalool ratio of between 650:1 and 1400:1, a THC / alpha-humulene ratio of between 300:1 and 725:1. Alpha-humulene, nerolidol with a THC / nerolidol ratio between 200:1 and 600:1, caryophyllene oxide with a THC / caryophyllene oxide ratio between 1000:1 and 2150:1, alpha-pinene with a THC / alpha-pinene ratio between 5850:1 and 16000:1, camphene with a THC / camphene ratio between 7300:1 and 132950:1, beta-pinene with a THC / beta-pinene ratio between 6475:1 and 23100:1, 1 Beta-myrcene with a THC / beta-myrcene ratio between 950:1 and 6300:1, limonene with a THC / limonene ratio between 1650:1 and 5050:1, eucalyptol with a THC / eucalyptol ratio between 5050:1 and 38650:1, ocimene with a THC / ocimene ratio between 2500:1 and 44700:1, gamma-terpinene with a THC / gamma-terpinene ratio between 4700:1 and 35750:1, THC / gamma-terpinene with a THC / gamma-terpinene ratio between 5450:1 and 129850:1, The composition further comprises at least one terpene selected from the group consisting of terpinolene with a THC / terpinolene ratio, alpha-terpinene with a THC / alpha-terpinene ratio of between 5150:1 and 58550:1, para-cymene with a THC / para-cymene ratio of between 4700:1 and 56700:1, isopulegol with a THC / isopulegol ratio of between 4000:1 and 8000:1, and geraniol with a THC / geraniol ratio of between 1300:1 and 18250:1.

[0047] Furthermore, in the context of the present invention, the compositions of the present invention may comprise alpha-bisabolol in an amount between about 0.008% and 0.065% by weight of the composition, guaiol in an amount between about 0.012% and 0.092% by weight of the composition, beta-caryophyllene in an amount between about 0.012% and 0.094% by weight of the composition, as well as linalool in an amount between 0.001% and 0.014% by weight of the composition, alpha-humulene in an amount between 0.003% and 0.028% by weight, nerolidol in an amount between 0.004% and 0.035% by weight, caryophyllene oxide in an amount between 0.001% and 0.0092% by weight, alpha-pinene in an amount between 0.0001% and 0.002% by weight, camphene in an amount between 0.00001% and 0.0015% by weight, beta-pinene in an amount between 0.0001% and 0.0015% by weight, beta-myrcene in an amount between 0.0004% and 0.005% by weight, limonene in an amount between 0.0005% and 0.004% by weight, eucalyptol in an amount between 0.00006% and 0.002% by weight, ocimene in an amount between 0.00005% and 0.004% by weight, 0.00007% by weight and 0.00008% by weight. and 0.002% by weight, gamma-terpinene in an amount between 0.00002% and 0.002% by weight, terpinolene in an amount between 0.00004% and 0.002% by weight, alpha-terpinene in an amount between 0.00004% and 0.002% by weight, para-cymene in an amount between 0.00004% and 0.002% by weight, isopulegol in an amount between 0.0003% and 0.003% by weight, and 0.0001% and 0.0002% by weight.008% by weight of at least one terpene selected from the group consisting of geraniol, a THC / alpha-bisabolol ratio of between 100:1 and 450:1, a THC / guaiol ratio of between 50:1 and 250:1, and a THC / beta-caryophyllene ratio of between 50:1 and 250:1, linalool with a THC / linalool ratio of between 450:1 and 1400:1, alpha-humulene with a THC / alpha-humulene ratio of between 300:1 and 725:1, nerolidol with a THC / nerolidol ratio of between 200:1 and 600:1, caryophyllene oxide with a THC / caryophyllene oxide ratio of between 1000:1 and 2150:1, THC / alpha-caryophyllene oxide ratio of between 5850:1 and 16000:1, -Alpha-pinene with a THC / camphene ratio between 7300:1 and 132950:1; beta-pinene with a THC / beta-pinene ratio between 6475:1 and 23100:1; beta-myrcene with a THC / beta-myrcene ratio between 1950:1 and 6300:1; limonene with a THC / limonene ratio between 1650:1 and 5050:1. nene, eucalyptol with a THC / eucalyptol ratio between 5,050:1 and 38,650:1, ocimene with a THC / ocimene ratio between 2,500:1 and 44,700:1, gamma-terpinene with a THC / gamma-terpinene ratio between 4,700:1 and 35,750:1, terpinolene with a THC / terpinolene ratio between 5,450:1 and 129,850:1. The composition further comprises at least one terpene selected from the group consisting of alpha-terpinene with a THC / alpha-terpinene ratio between 5150:1 and 58550:1, para-cymene with a THC / para-cymene ratio between 4700:1 and 56700:1, isopulegol with a THC / isopulegol ratio between 4000:1 and 8000:1, and geraniol with a THC / geraniol ratio between 1300:1 and 18250:1.

[0048] More preferably, in the present invention, the compositions of the present invention may contain THC in an amount between about 4% and 6% by weight of the composition, with a THC / alpha-bisabolol ratio between 100:1 and 450:1, a THC / guaiol ratio between 50:1 and 250:1, and a THC / beta-caryophyllene ratio between 50:1 and 250:1, as well as a linalool ratio between 450:1 and 1400:1, a THC / alpha-humulene ratio between 300:1 and 725:1. alpha-humulene with a THC / nerolidol ratio between 200:1 and 600:1; caryophyllene oxide with a THC / caryophyllene oxide ratio between 1000:1 and 2150:1; alpha-pinene with a THC / alpha-pinene ratio between 5850:1 and 16000:1; camphene with a THC / camphene ratio between 7300:1 and 132950:1; beta-pinene with a THC / beta-pinene ratio between 6475:1 and 23100:1 , beta-myrcene with a THC / beta-myrcene ratio between 1950:1 and 6300:1, limonene with a THC / limonene ratio between 1650:1 and 5050:1, eucalyptol with a THC / eucalyptol ratio between 5050:1 and 38650:1, ocimene with a THC / ocimene ratio between 2500:1 and 44700:1, gamma-terpinene with a THC / gamma-terpinene ratio between 4700:1 and 35750:1, and 5450:1. The composition may comprise at least one terpene selected from the group consisting of terpinolene with a THC / terpinolene ratio of between 5150:1 and 58550:1, alpha-terpinene with a THC / alpha-terpinene ratio of between 5150:1 and 58550:1, para-cymene with a THC / para-cymene ratio of between 4700:1 and 56700:1, isopulegol with a THC / isopulegol ratio of between 4000:1 and 8000:1, and geraniol with a THC / geraniol ratio of between 1300:1 and 18250:1.

[0049] Furthermore, in the context of the present invention, the compositions of the present invention may contain alpha-bisabolol in an amount between about 0.01% and 0.04% by weight of the composition, guaiol in an amount between about 0.015% and 0.05% by weight of the composition, beta-caryophyllene in an amount between about 0.02% and 0.05% by weight of the composition, as well as linalool in an amount between about 0.003% and 0.0085% by weight of the composition, and 0.006% and 0.008% by weight of the composition. alpha-humulene in an amount between 0.017% and 0.017% by weight of the composition, nerolidol in an amount between 0.007% and 0.021% by weight of the composition, caryophyllene oxide in an amount between 0.001% and 0.0055% by weight of the composition, alpha-pinene in an amount between 0.0002% and 0.001% by weight of the composition, camphene in an amount between 0.00003% and 0.00082% by weight of the composition, camphene in an amount between 0.0001% and 0.0005% by weight of the composition, and beta-pinene in an amount between 0.0004% and 0.005% by weight of the composition; limonene in an amount between 0.0008% and 0.0022% by weight of the composition; eucalyptol in an amount between 0.0001% and 0.0012% by weight of the composition; ocimene in an amount between 0.00009% and 0.0023% by weight of the composition; %, gamma-terpinene in an amount between 0.00003% and 0.001% by weight of the composition, terpinolene in an amount between 0.00006% and 0.0012% by weight of the composition, alpha-terpinene in an amount between 0.00007% and 0.0013% by weight of the composition, para-cymene in an amount between 0.00007% and 0.0013% by weight of the composition, isopulegol in an amount between 0.0005% and 0.0015% by weight of the composition, and 0.0002% and 0.0004% by weight of the composition.0044% by weight of geraniol and having a THC / alpha-bisabolol ratio of between 100:1 and 450:1, a THC / guaiol ratio of between 50:1 and 250:1, and a THC / beta-caryophyllene ratio of between 50:1 and 250:1, as well as a linalool ratio of between 450:1 and 1400:1, a THC / alpha-humulene ratio of between 300:1 and 725:1, Alpha-humulene, nerolidol with a THC / nerolidol ratio between 200:1 and 600:1, caryophyllene oxide with a THC / caryophyllene oxide ratio between 1000:1 and 2150:1, alpha-pinene with a THC / alpha-pinene ratio between 5850:1 and 16000:1, camphene with a THC / camphene ratio between 7300:1 and 132950:1, beta-pinene with a THC / beta-pinene ratio between 6475:1 and 23100:1, 1 Beta-myrcene with a THC / beta-myrcene ratio between 950:1 and 6300:1, limonene with a THC / limonene ratio between 1650:1 and 5050:1, eucalyptol with a THC / eucalyptol ratio between 5050:1 and 38650:1, ocimene with a THC / ocimene ratio between 2500:1 and 44700:1, gamma-terpinene with a THC / gamma-terpinene ratio between 4700:1 and 35750:1, THC / gamma-terpinene with a THC / gamma-terpinene ratio between 5450:1 and 129850:1, The composition further comprises at least one terpene selected from the group consisting of terpinolene with a THC / terpinolene ratio, alpha-terpinene with a THC / alpha-terpinene ratio between 5150:1 and 58550:1, para-cymene with a THC / para-cymene ratio between 4700:1 and 56700:1, isopulegol with a THC / isopulegol ratio between 4000:1 and 8000:1, and geraniol with a THC / geraniol ratio between 1300:1 and 18250:1.

[0050] One of ordinary skill in the art will appreciate that certain terpenes selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol may be present in the composition but may not be detectable as their concentration may be below the identification threshold or detection limit. Thus, in the present invention, the composition of the present invention may comprise THC in an amount of 5% THC, and at least one of the group consisting of linalool in an amount between 0.003% and 0.0085%, most preferably between 0.004% and 0.007%, alpha-humulene in an amount between 0.006% and 0.017%, most preferably between 0.008% and 0.014% of the weight of the composition, nerolidol in an amount between 0.007% and 0.021%, most preferably between 0.009% and 0.017%, caryophyllene oxide in an amount between 0.001% and 0.0055%, most preferably between 0.002% and 0.005%, and limonene in an amount between 0.0008% and 0.0022%, most preferably between 0.001% and 0.002% of the weight of the composition. The composition may also contain THC in an amount of 5% by weight of the composition, a THC / alpha-bisabolol ratio of between 160:1 and 295:1, a THC / guaiol ratio of between 105:1 and 200:1, and a THC / beta-caryophyllene ratio of between 105:1 and 200:1, and further contain at least one terpene selected from the group consisting of linalool in a THC / linalool ratio of between 500:1 and 1330:1, alpha-humulene in a THC / alpha-humulene ratio of between 355:1 and 665:1, nerolidol in a THC / nerolidol ratio of between 285:1 and 535:1, caryophyllene oxide in a THC / caryophyllene oxide ratio of between 1090:1 and 2080:1, and limonene in a THC / limonene ratio of between 1700:1 and 4970:1.

[0051] Furthermore, in the context of the present invention, the compositions of the present invention may comprise at least one selected from the group consisting of alpha-bisabolol in an amount between about 0.017% and 0.031% by weight of the composition, guaiol in an amount between about 0.025% and 0.046% by weight of the composition, beta-caryophyllene in an amount between about 0.025% and 0.047% by weight of the composition, linalool in an amount between 0.004% and 0.007% by weight of the composition, alpha-humulene in an amount between 0.008% and 0.014% by weight of the composition, nerolidol in an amount between 0.009% and 0.017% by weight of the composition, caryophyllene oxide in an amount between 0.002% and 0.005% by weight of the composition, and limonene in an amount between 0.001% and 0.002% by weight of the composition. and may further comprise a THC / alpha-bisabolol ratio of between 160:1 and 295:1, a THC / guaiol ratio of between 105:1 and 200:1, and a THC / beta-caryophyllene ratio of between 105:1 and 200:1, and may further comprise at least one terpene selected from the group consisting of linalool with a THC / linalool ratio of between 500:1 and 1330:1, alpha-humulene with a THC / alpha-humulene ratio of between 355:1 and 665:1, nerolidol with a THC / nerolidol ratio of between 285:1 and 535:1, caryophyllene oxide with a THC / caryophyllene oxide ratio of between 1090:1 and 2080:1, and limonene with a THC / limonene ratio of between 1700:1 and 4970:1.

[0052] In the present invention, it is most preferred that the composition of the present invention comprises the components set forth in Table 1 below. TIFF2025504971000001.tif64170

[0053] Suitable methods for qualitatively and quantitatively determining, analyzing, controlling or setting the content of THC, alpha-bisabolol, guaiol, beta-caryophyllene and / or terpenes selected from the group of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol are known in the art and include methods such as thin layer chromatography (TLC) or high performance liquid chromatography (HPLC) (Eingestellter Cannabisextrakt (Cannabis extractum normatum), Deutsches Arzneibuch (DAB) 2021, ISBN: 978-3-7692-7804-0) and gas chromatography (GC) with detection by mass spectrometry (Ferrer I. and Thurman ME, Elsevier 2020. ISBN: 978-0-4446-4341-4; Opie SR, Springer Nature 2021. ISBN: 978-3-030-62715-7).

[0054] The composition of the present invention may be any suitable composition, so long as it contains a combination of substances / ingredients of THC, alpha-bisabolol, guaiol, beta-caryophyllene, and at least one terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol. The composition is preferably in liquid form. In the context of the present invention, the composition may also be provided in the form of a solid, for example a powder, which is subjected to reconstitution into a liquid form, thereby providing the composition of the present invention. The composition may be an aqueous or non-aqueous solution, such as an alcoholic solution, or a mixture of both in a suitable ratio. The compositions may be prepared from precursors that naturally contain THC or its prodrug THCA, alpha-bisabolol, guaiol, beta-caryophyllene, or a terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol, and geraniol. * It is clear to those skilled in the art that "THC content" may refer to the sum of THC equivalents, which is the sum of 0.877. Thus, in the context of the present invention, "THC content" may refer to the sum of THC and THCA. THC and THCA can be determined and quantified by methods known in the art, for example, by using liquid chromatography with the addition of respective THC and THCA reference standards (Deutsches Arzneibuch (DAB) 2018, ISBN: 978-3-7692-7217-8, and Danish Medicines Standards 2020.0, BEK Nr. 1231af.).

[0055] In the context of the present invention, it is understood that the THC used in the present invention may initially exist as a carboxylated form, THCA, which is decarboxylated to the active THC contained in the composition of the present invention. In the present invention, the decarboxylation of THCA to THC (similar to other cannabinoids) can be carried out by any suitable method known in the art. Preferably, the decarboxylation of, for example, cannabis plant extract is carried out by thermally induced decarboxylation under vacuum (in vacuum). Thus, a rotary evaporator is used with the water bath temperature, pressure and rotation adjusted to 80°C, 185 mbar and 150 rpm, respectively. The suitable decarboxylation time is 72 hours. A non-limiting example of a precursor for producing a composition of the present invention may be an extract, such as an extract described herein, that naturally contains THC(A), alpha-bisabolol, guaiol, beta-caryophyllene, and at least one terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol, and geraniol. In the context of the present invention, THC, alpha-bisabolol, guaiol, beta-caryophyllene, and at least one terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol, and geraniol may be artificially added / combined for inclusion in the composition of the present invention.When THC, alpha-bisabolol, guaiol, beta-caryophyllene, and at least one terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol, and geraniol are artificially added / combined and included in the composition of the present invention, the pure substance THC (or The terpene or a suitable precursor selected from the group consisting of THCA, which is subjected to decarboxylation as described above, alpha-bisabolol, guaiol, beta-caryophyllene, and linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol, and geraniol, or a suitable precursor may be obtained commercially. As described in the Examples section, THC (e.g., naturally produced or isolated, or synthetically produced dronabinol) can be obtained from commercial suppliers such as LGC Standards, Smolecule, Benchchem, or Cerilliant, and alpha-bisabolol, guaiol, beta-caryophyllene, and at least one terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol, and geraniol can be obtained from commercial suppliers such as Sigma-Aldrich, Biomol / Cayman, LGC Standards, Alfa Chemistry, Molport, or Restek, respectively. They can also be isolated, chemically synthesized by means known in the art, or produced heterologously in a suitable cell or organism.For example, THC or its prodrug THCA used in the compositions of the present invention can be produced by heterologous cannabinoid production in a biosynthetic process, for example as reported in the literature (e.g., Lou et al., Nature 2019, 567:123-126). Those skilled in the art will be aware of suitable methods for harvesting and purifying recombinant products. For example, THC can be isolated by chromatographic methods, such as continuous simulated moving bed (SMB) chromatography or centrifugal partition chromatography (CPC) (Gotz MR, Dissertation, Julius Maximilians Universitat Wurzburg 2018), and terpenes, such as alpha-bisabolol, guaiol, beta-caryophyllene, and terpenes selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol, and geraniol, can be isolated, for example, by short path distillation and purified by liquid gas chromatography (Breitmaier E., John Wiley & Sons 2012, ISBN:978-3-527-31498-0;Rostagno,MA and Prado JM,Royal Society of Chemistry,2013,ISBN:978-1-84973-606-0;Patil AS,Studera Press 2020,ISBN:978-9-38588-319-4,Mandal SC,Mandal V., and Das AK, Academic press 2015, ISBN:9780128023259).

[0056] In the present invention, it is preferred that the composition naturally contains THC, alpha-bisabolol, guaiol, beta-caryophyllene, and at least one terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol, and geraniol. That is, the composition of the present invention preferably comprises an extract derived / obtainable from a plant that contains or produces endogenously THC(A), alpha-bisabolol, guaiol, beta-caryophyllene, and at least one terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol. In the context of the present invention, the term "extract" is intended to refer generally to any form of the extraction product, optionally excluding the extracting agent, without further specification, regardless of its physical form (e.g. viscous, pasty or solid). When an extract is derived / obtainable from a plant, such an extract is called "plant extract". Thus, in the context of the present invention, the term "plant extract" refers to an extract of plant material in a suitable extracting agent, optionally excluding the extracting agent.

[0057] Such plant extracts may preferably be derived / obtainable from plants that endogenously contain or produce cannabinoids, cannabinoid-like substances and / or cannabimimetic compounds and terpenes and / or terpenoids, provided that such plants are capable of producing at least one terpene selected from the group consisting of THC(A), alpha-bisabolol, guaiol, beta-caryophyllene and linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol. Those skilled in the art will understand that plants that endogenously contain or produce cannabinoids, cannabinoid-like substances and / or cannabimimetic compounds, and terpenes and / or terpenoids may be genetically modified, i.e. transgenic plants or transgenic plant cells that are different from those that occur in nature due to genetic modification. The term "cannabinoid" as used herein refers to any cannabinoid isolated from a plant or synthetically or recombinantly produced to have activity in the endocannabinoid system, including cannabinoid-like substances and / or cannabimimetic compounds. Cannabinoids synthesized by plant sources are considered to be phytocannabinoids, i.e. plant-based cannabinoids. In the context of the present invention, the term "cannabinoid" may be used interchangeably with "phytocannabinoid". The term "cannabinoid fraction" is used to describe the combination of cannabinoids, cannabinoid-like substances or cannabimimetic compounds present in a plant extract. To date, more than 100 cannabinoids have been identified in the cannabis plant.A comprehensive, non-exhaustive list of such cannabinoids found in cannabis can be found in ElSohly MA and Gul W., Handbook of Cannabis, Oxford University Press (2014), pp. 3-22 and Radwan, MM et al. Molecules 2021, 26(9):2774. One example is delta-9-tetrahydrocannabinol (THC). The term "terpene" or "terpenoid" as used herein refers to a class of hydrocarbon molecules. Terpenes are derived from isoprene units, and the base molecular formula of terpenes is a multiple of isoprene units, i.e. (C. 5 H 8 ) nwhere n is the number of linked isoprene units. Examples are alpha-bisabolol, guaiol, beta-caryophyllene, linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol. A comprehensive list of cannabis terpenes is further known in the art and includes inene, terpineol, valencene, beta-bisabolol, phellandrene, carene, fenchol, borneol, phytol, sabinene, camphor, isoborneol, menthol, and cedrane (Radwan, MM et al. Molecules 2021, 26(9):2774). Terpenoids are typically terpene compounds that have been further metabolized in plants through oxidation processes, and therefore usually contain at least one oxygen atom. The term "terpene fraction" is used to describe the combination of terpenes and terpenoid compounds present in a plant extract. Cannabinoids are described as unique terpenophenol metabolites found only in the cannabis plant (Sirikantaramas and Taura, Springer 2017, 1st edition, Chapter 8, pp.183-206). However, alternative cannabinoid-like substances or cannabimimetic compounds have been reported not only in cannabis but also in plants such as Acmella oleracea (Dallazan et al., Inflammopharmacology 2019, 28, pp. 175-186), Echinaceae angustifolia (Raduner et al., J Biol Chem. 2006, 281(20), pp. 14192-14206), Echinaceae purpurea (Raduner et al., J Biol Chem. 2006, 281(20), pp. 14192-14206), Helichrysum umbraculigerum (Pollastro et al., Fitoterapia 2018, 126, pp.35-39), Heliopsis helianthoides (Hajdu et al., J Nat Prod. 2014, 77(7), pp. 1663-1669), Maca (Lepidium meyenii) (Hajdu et al., J Nat Prod. 2014, 77(7), pp. 1663-1669), Cava (Piper methysticum) (Ligresti et al., Pharmacol Res. 2012, 6(2), pp. 163-169), Piper nigrum (Reynoso-Moreno et al., J Agric Food Chem. 2017, 65(43), pp. 9435-9442), Radula marginata (Hussain et al., Phytochem rev. (2019), 18, pp. 953-965), Radula perrottetii (Chicca et al., Neurophysiol. 2018, 4(10)), Rhododendron anthopogonoides (Iwata and Kitanaka, Chem Pharm Bull. 2011, 59(11), pp. 1409-1412) and Tuber melanosporum (Degenhardt et al., Biology, Pharmacology, Diagnosis, and Treatment 2017, Chapter 2, p. 13-23), (Pacioni et al., Phytochemistry 2015, 110, pp. 104-110).

[0058] Thus, in the context of the present invention, the compositions of the present invention may also include extracts derived / obtained from plants that can produce cannabinoids, cannabinoid-like substances or cannabimimetic compounds, and terpenes and / or terpenoids, but do not contain or produce them endogenously. Thus, the skilled artisan will understand that plant extracts may be obtained from transgenic plants or plant cells that differ from those that occur in nature due to genetic modification. Transgenic plants or plant cells are non-naturally occurring, i.e. cannot be found in nature, and differ substantially from naturally occurring plants or plant cells due to the introduction of foreign genetic material, e.g. foreign nucleic acid molecules. For example, the plant extract used in the present invention may be derived from a transgenic plant capable of heterologously producing, during biosynthesis, THC(A), alpha-bisabolol, guaiol, beta-caryophyllene, and at least one terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol. When the composition of the present invention comprises an extract derived / obtained from a plant as described herein, the extract preferably has substantially the same THC / terpene ratio as the original plant used to obtain the extract, and may be concentrated in a more potent form. Furthermore, in the context of the present invention, it may be preferred that the plant extract is also decarboxylated to ensure that the THCA endogenously present in the plant extract is converted to THC.

[0059] In the context of the present invention, the term "plant" refers to any of a variety of photosynthetic eukaryotic multicellular organisms of the kingdom Plantae that characteristically produce embryos, contain chloroplasts, have cellulose cell walls, and lack spontaneous movement. As used herein, "plant" includes plants or parts of plants at any stage of development, and their progeny, that contain cannabinoids, terpenes, and terpenoid compounds. The plant material may be obtained from, but is not limited to, solid plant material. The solid plant material may be obtained from whole plants or parts thereof, including plant cells, plant organs, leaves (in the context of the present invention, the term "leaf" includes leaves of any plant, including flower leaves, sugar leaves, fan leaves, etc.), flowers, stems, fruits, roots, trichomes, meristems, plant seeds, protoplasts, calli, and any group of plant cells organized into structural and / or functional units. Furthermore, in the context of the present invention, the plant material may be a plant cell culture, specifically a plant suspension cell culture in a liquid medium. Methods for establishing in vitro plant cell cultures from solid plant material are known to those skilled in the art and include callogenesis (Espinosa-Leal et al., Planta (2018), 248:1-18). In the present invention, when a cannabis plant is used to obtain the extracts described herein, which are preferably contained in the compositions of the present invention, the plant material is preferably a material rich in plant trichomes. Thus, in the present invention, the plant material is preferably obtained from the flower material of a cannabis plant. When the flower material is obtained from a cannabis plant, the flower material is preferably trimmed and dried before use, and the flower material subjected to extraction preferably does not exceed its storage period.

[0060] "Drying" as used herein means that the moisture / humidity in the plant material is reduced. Several drying methods are known to the skilled person, including freeze-drying. In the context of the present invention, drying is preferably carried out in a drying room by placing the plant material on trays through which air flows. Such drying in a drying room is usually carried out at a temperature of 18°C ​​to 30°C by continuously flowing dehumidified air over the product. In the context of the present invention, drying is preferably carried out for at least 4 days (96 hours) or until the moisture content of the plant material, e.g., flower material, is less than 10 percent. The skilled person knows how to measure the temperature by standard methods. Furthermore, the skilled person knows how to determine the moisture content of the plant material, as described, for example, in the European Pharmacopoeia 10th edition, Deutscher Apotheker Verlag 2019, ISBN: 978-3-7692-7453-0. The term "trimming" in the context of flower material as used herein means that the leaves, in particular the sugar leaves and / or fan leaves, are removed from the flower. Trimming of the flower material can be carried out as described below. The flowers of the cannabis plant can be separated from the rest of the plant by hand (e.g., by hand with scissors) or by using a destalker (e.g., MB Bucker 500; Master Bucker 500; www.masterproducts.es).

[0061] The terms "flower", "floral material" and "blossom" are used interchangeably herein. The skilled artisan knows that in the cannabis plant the flowers are arranged in so-called colas. Thus, flower material as used herein also refers to said colas. The leaves of the cannabis plant can be differentiated into fan leaves and sugar leaves. Fan leaves are the large, primary leaves of the cannabis plant. Sugar leaves develop and grow from the cannabis flower during the flowering phase of the plant. In the present invention, it is preferred that said sugar leaves are removed from the flower material as described herein.

[0062] Trichomes (i.e. resin glands) of cannabis plant material are nearly microscopic mushroom-like projections that protrude from the surface of the cannabis plant, mainly from the flower buds. Although relatively complex, trichomes are primarily composed of a stem and a head. The production of cannabinoids, such as THC, occurs primarily in the heads of the trichomes. The cannabinoids are concentrated in the trichomes of the plant. It will therefore be apparent to one skilled in the art that the extracts described herein may be provided by using (isolated) trichomes of the cannabis plant.

[0063] In the context of the present invention, the plant material used to obtain the extract may be fresh, freeze-dried, dried or frozen, but is preferably dried. The plant material used here may be crushed to produce smaller sized plant material, in addition to trimming. In other words, the plant material may be mechanically crushed before or during mixing with the extractant. All crushing methods known to the skilled artisan are suitable, including grinding, milling, crushing, and chipping (Salman, AD, Ghadiri M., and Michael Hounslow MJ, Elsevier Science & Technology 2007, ISBN: 978-0-08055-346-7). The plant extract described here may be a crude extract or may be optionally subjected to further conventional steps, the extract may be fractionated, subfractionated, separated, isolated, purified, and / or subjected to centrifugation, purification, and / or concentration, without limitation. Concentration may be performed by methods known in the art. In the context of the present invention, the extraction solvent is preferably concentrated by evaporation in vacuum using a rotary evaporator. As an example, the vacuum evaporation can be carried out in a water bath at a temperature of 72° C., a pressure of 185 mbar, and a rotation speed of 150 rpm. In the present invention, it is preferred that an almost solvent-free extract is thus established. A person skilled in the art will understand that other suitable conditions for vacuum evaporation are known in the art and can be easily established. Thus, in the present invention, when the composition of the present invention comprises a plant extract, it is preferred that it comprises an extract that has been subjected to evaporation, for example, as described above. In other words, in the present invention, when the composition of the present invention comprises an extract, it is preferred that the accompanying extractant / solvent described herein is completely or almost completely removed before incorporating the extract in the composition of the present invention, so that the composition is solvent-free or almost solvent-free. Furthermore, it is preferred that such an extract has been subjected to decarboxylation to produce THC from THCA.

[0064] In the present invention, it is even more preferred that the extract is a plant extract (hereinafter referred to as "cannabis plant extract" or "cannabis soft extract") obtained from a cannabis plant or its progeny. In the context of the present invention, the term "cannabis plant" is understood to describe a plant of the genus Cannabis (Cannabaceae). Cannabis species include cannabis (Cannabis sativa) and cannabis (Cannabica), and cannabis varieties such as Jack Herer, Chem Dog, Bubba Kush, Trainwreck, Super Silver Haze, Pure Kush, El Niño, Himalayan Gold, Skunk #1, White Widow, Warlock CBD, Pink Kush, OG Kush, Super Lemon Haze, Jack the Ripper, Lemon Skunk, and Hash Plant are known in the art. Furthermore, it includes cannabis plants resulting from genetic crosses, self-crosses, natural selection or hybridization of the above-mentioned plants and cannabis chemovariets. Even more preferably, the plant extract, i.e. the cannabis plant extract, is obtained from a cannabis plant of the strain "Jack Herer" or its progeny. In the context of the present invention, such progeny may be, for example, but not limited to, cannabis plants obtained by natural selection of seeds of cannabis plants, for example, the strain "Jack Herer". For example, cannabis plants of the strain "Jack Herer" may be selected to produce THC(A), alpha-bisabolol, guaiol, beta-caryophyllene, and at least one terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol, by the methods described below by way of example. For example, cannabis plant seeds of the strain "Jack Herer" can be commercially obtained. The seeds may be cultivated by conventional cultivation methods known to those skilled in the art, for example for 3 to 14 days until germination. Based on the germination and growth behavior, one skilled in the art can select a particular seed for further cultivation. Such a decision can generally be made based on analytical results and / or observations of the cultivar during cultivation.Once the selected seeds germinate and take root, they can be cultivated for another 3 to 6 weeks by normal cultivation methods known to those skilled in the art to establish the rootstock of the seed plant. Fertilization, watering, pest control, disease monitoring, and plant trimming can be optimized by those skilled in the art. Based on the growth behavior, those skilled in the art can select specific seed plants for further cultivation. From these selected plants (referred to as individual plants in the following section), cuttings can be taken to secure the genetic material of the individual plants. The individual plants can then be brought to a flowering stage by reducing the day length from more than 18 hours to less than 12 hours of sunlight. In general, the environmental conditions for the rooting stage, vegetative growth stage, and flowering stage need to be met. The individual plants can then be finally selected based on the following criteria: growth behavior, flowering behavior, successful cultivation and good rooting behavior of the cuttings taken therefrom, susceptibility to diseases (e.g., gray mold), analysis results such as THC content, other cannabinoid content, and terpene profile. As part of the selection process, batch-to-batch consistency can be analyzed based on cannabinoid and terpene profiles. Alternative methods for obtaining such offspring can be, for example, selective breeding or cross-breeding, and genetic engineering using methods such as CRISPR / Cas technology. Those skilled in the art routinely know how to test such offspring for the production of THC(A), alpha-bisabolol, guaiol, beta-caryophyllene, linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and / or geraniol, for example by using TLC, HPLC, or GC with mass spectrometry detection as described above. Such selected progeny, or chemovarietals (plants that are distinguished by the cannabinoids they produce rather than by the morphological characteristics of the plant), can be bred by a variety of plant breeding techniques well known to those skilled in the art. Propagating the plant from cuttings as production material fixes the genotype and ensures that each harvest of the plant contains substantially the same ratio of cannabinoids.

[0065] Most preferably, the plant extract used in the present invention, i.e. the cannabis plant extract, is obtained from the cannabis variety called DKJ127 and deposited by the Community Plant Varieties Office (deposited by Vertanical GmbH under application number A202104053 (provisional designation of variety: dk-j127, plant taxon: Cannabis sativa L., breeder reference: DK-J127, variety designation: DKJ127, application number: 2021 / 3223, electronic application number: A202104053; date of receipt by the Community Plant Varieties Office: 9 December 2021)) and / or is obtained by the method described in European Patent Application No. 22154007.3 (PCT / EP2023 / 052073). The cannabis plant extracts described herein may comprise a saponifiable fraction, including e.g. fatty acids and triglycerides, and an unsaponifiable fraction, including e.g. cannabinoids such as THC(A) and CBG, and terpenes and / or terpenoids. The saponifiable fraction is understood as the portion of the total lipids in the extract that is soluble in water and insoluble in ether after hot alkaline treatment. In the present invention, the saponifiable fraction may be between 5% and 20%, 5% and 30%, or 5% and 40% of the cannabis plant extracts described herein. Preferably, the saponifiable fraction may be between 10% and 20% of the cannabis plant extracts described herein. In the present invention, the unsaponifiable fraction may be between 60% and 95%, 70% and 95%, or 80% and 95% of the cannabis plant extracts disclosed herein. The THC(A) contained in the unsaponifiable fraction may constitute more than 50%, 60%, 70%, 80% or 85% of the cannabis plant extract disclosed herein. Preferably, the THC(A) contained in the unsaponifiable fraction constitutes more than 85%, preferably between 80% or 90% of the cannabis plant extract disclosed herein. The alpha-bisabolol contained in the unsaponifiable fraction may constitute more than 0.1%, 0.2%, 0.25%, 0.27%, 0.275%, 0.28%, 0.3% or 0.4% of the cannabis plant extract disclosed herein. Preferably, the alpha-bisabolol contained in the unsaponifiable fraction constitutes more than 0.25% of the cannabis plant extract disclosed herein, preferably between 0.25% and 0.35% of the cannabis plant extract disclosed herein.The guaiol contained in the unsaponifiable fraction may constitute more than 0.3%, 0.4%, 0.49%, 0.5%, 0.6%, or 0.7% of the cannabis plant extract disclosed herein. Preferably, the guaiol contained in the unsaponifiable fraction constitutes more than 0.49% of the cannabis plant extract disclosed herein, preferably between 0.49% and 0.67% of the cannabis plant extract disclosed herein. The beta-caryophyllene contained in the unsaponifiable fraction may constitute more than 0.3%, 0.4%, 0.49%, 0.5%, 0.6%, or 0.7% of the cannabis plant extract disclosed herein. Preferably, the beta-caryophyllene contained in the unsaponifiable fraction constitutes more than 0.5% of the cannabis plant extract disclosed herein, preferably between 0.5% and 0.73% of the cannabis plant extract disclosed herein. Each of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and / or geraniol contained in the unsaponifiable fraction may constitute greater than 0.001%, 0.005%, 0.01%, 0.05%, 0.1%, or 0.25% of the cannabis plant extract disclosed herein.Linalool in the unsaponifiable fraction preferably constitutes between 0.09% and 0.17% of the cannabis plant extract disclosed herein, alpha-humulene in the unsaponifiable fraction preferably constitutes between 0.15% and 0.29% of the cannabis plant extract disclosed herein, nerolidol in the unsaponifiable fraction preferably constitutes between 0.12% and 0.23% of the cannabis plant extract disclosed herein, caryophyllene oxide in the unsaponifiable fraction preferably constitutes between 0.02% and 0.06% of the cannabis plant extract disclosed herein, alpha- Pinene preferably constitutes between 0.006% and 0.02% of the cannabis plant extract disclosed herein, camphene contained in the unsaponifiable fraction preferably constitutes between 0.003% and 0.07% of the cannabis plant extract disclosed herein, beta-pinene contained in the unsaponifiable fraction preferably constitutes between 0.005% and 0.02% of the cannabis plant extract disclosed herein, beta-myrcene contained in the unsaponifiable fraction preferably constitutes between 0.01% and 0.04% of the cannabis plant extract disclosed herein, and limonene contained in the unsaponifiable fraction preferably constitutes between 0.005% and 0.02% of the cannabis plant extract disclosed herein. Constitutes between 0.02% and 0.05% of the hemp plant extract, eucalyptol contained in the unsaponifiable fraction preferably constitutes between 0.005% and 0.01% of the cannabis plant extract disclosed herein, ocimene contained in the unsaponifiable fraction preferably constitutes between 0.01% and 0.03% of the cannabis plant extract disclosed herein, gamma-terpinene contained in the unsaponifiable fraction preferably constitutes between 0.005% and 0.015% of the cannabis plant extract disclosed herein, and terpinolene contained in the unsaponifiable fraction preferably constitutes between 0.005% and 0.015% of the cannabis plant extract disclosed herein. 0.01%, alpha-terpinene contained in the unsaponifiable fraction preferably constitutes between 0.005% and 0.01% of the cannabis plant extract disclosed herein, para-cymene contained in the unsaponifiable fraction preferably constitutes between 0.006% and 0.02% of the cannabis plant extract disclosed herein, isopulegol contained in the unsaponifiable fraction preferably constitutes between 0.01% and 0.05% of the cannabis plant extract disclosed herein, and / or geraniol contained in the unsaponifiable fraction preferably constitutes between 0.02% and 0.05% of the cannabis plant extract disclosed herein.

[0066] Preferably, the cannabinoid fraction in the unsaponifiable fraction, excluding the main cannabinoid, THC, may be present in an amount of 5% or less by weight of the cannabis plant extract.

[0067] The skilled artisan knows the routine procedures for preparing compositions of the invention from plant extracts, for example, containing fixed contents of THC, alpha-bisabolol, guaiol, beta-caryophyllene, linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and / or geraniol. An exemplary procedure is described below: a plant extract, for example a cannabis plant extract, is standardized to a THC content of 5% (by weight of the composition) with a carrier oil, for example pharmaceutical grade refined sesame oil, to provide a composition of the invention. This standardization can be carried out in multiple, for example three, dilution steps. At each dilution step, an analytical sample is taken and the THC content is quantified by HPLC analysis to accurately determine the remaining amount of carrier oil needed to adjust the previous dilution to the desired 5% THC content. After HPLC analysis, only 80% of the calculated remaining amount of carrier oil is added. At the final dilution step, the exact calculated amount of carrier oil is added to obtain a composition containing the desired content of 5% THC by weight of the composition.

[0068] In accordance with the present invention, the plant extracts described herein are preferably substantially free of waxes and other non-specific lipid soluble substances, but preferably contain substantially all of the cannabinoids naturally present in the plant, most preferably in substantially the same ratios as they are present in an intact plant, such as the cannabis plant.

[0069] In the present invention, the plant extract as defined herein may be obtained by extraction of the plant material. Any extract obtained by solvent extraction, distillation, expression and sublimation, decoction, digestion, percolation, maceration or other suitable extraction methods known to the skilled artisan, or a combination thereof, may be used, as described in Rostagno, MA and Prado JM, Royal Society of Chemistry, 2013, ISBN: 978-1-84973-606-0, Patil AS, Studera Press 2020, ISBN: 978-9-38588-319-4, and Mandal SC, Mandal V., and Das AK, Academic press 2015, ISBN: 9780128023259. In the present invention, the extract described herein is preferably obtained by a combination of maceration and percolation, preferably maceration is applied first.

[0070] The extract may be formed by contacting the plant material as defined herein with an extractant. Preferred here is solvent extraction, i.e. extraction using a solvent. It is envisaged that the plant material, preferably the cannabis plant material, is contacted with a solvent, which may also be called an extractant. In other words, in the context of the present invention, the term "extractant" refers to a suitable solvent used in extracting substances from liquid or solid materials. Thus, the plant material, preferably the cannabis plant material, is treated with a solvent. In the present invention, it is preferred that the plant extract as defined herein may be obtained by solvent extraction. Solvent extraction is a technique that allows the extraction of soluble organic compounds from solids using an extractant. As mentioned above, the extraction described herein is preferably carried out by percolation. Percolation is understood as a process in which the herbs to be extracted are cut into pieces of suitable size, thoroughly mixed with a portion of the defined extractant and left for a suitable time, unless otherwise specified. The mixture is prepared in a percolator or transferred to a percolator, and further extractant is added until the herbs are covered with a layer of extractant. The infusion liquid then slowly flows out of the base of the percolator and is collected in a tank. Infusion continues until the infusion liquid is collected. The residue is pressed, mixing the two liquids. It is assumed that the desired (pharmacologically active) substances from the plant material are dissolved in the solvent. Thus, for example, it is assumed that the cannabinoids (preferably THC) and / or other (pharmacologically active) substances (preferably alpha-bisabolol, guaiol, beta-caryophyllene, linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and / or geraniol) from the cannabis plant material are dissolved in the solvent.That is, after treating the cannabis plant material with the solvent, for example cannabinoids (e.g., THC and / or CBD) and / or other (pharmacologically active) substances (e.g., terpenes, preferably alpha-bisabolol, guaiol, beta-caryophyllene, linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and / or geraniol) are no longer present in the cannabis plant material and are dissolved in the solvent. In other words, the solvent "removes" for example cannabinoids (e.g., THC and / or CBD) and / or other (pharmacologically active) substances (e.g., terpenes) from the plant material. In other words, e.g. cannabinoids (preferably THC) and / or other (pharmacologically active) substances (e.g. terpenes) are extracted from the plant material. The solvent containing dissolved e.g. cannabinoids (e.g. THC and / or CBD) and / or other (pharmacologically active) substances (e.g. terpenes) may then be separated (i.e. extracted) from the plant material. The solvent containing dissolved e.g. cannabinoids (e.g. THC and / or CBD) and / or other (pharmacologically active) substances (e.g. terpenes) separated from the plant material, preferably cannabis plant material, is called a plant extract, preferably a cannabis plant extract.

[0071] The extraction time and temperature may vary depending on the extraction medium and method and may be easily optimized by a person skilled in the art. Extraction times between 1 hour and 10 days may be applied. More specifically, times between 85 and 120 hours, preferably between 93 and 110 hours, may be applied. The temperature used for extraction may preferably be between 15°C and 25°C. The extraction process is preferably carried out by excluding light.

[0072] Non-limiting examples of potentially suitable solvents include alcohols (e.g., methanol, ethanol, propanol, butanol, propylene glycol, etc.), water, hydrocarbons (e.g., butane, hexane, etc.), polar organic solvents (e.g., ethyl acetate, polyethylene glycol, etc.), or supercritical fluids (e.g., liquid CO 2 ). Suitable non-polar solvents may be C5-C12 straight or branched chain alkanes, C1-C12 alcohols, or carbonates of C1-C12 alcohols. More volatile solvents may be particularly useful as they are more easily removed from the extract if desired. It is noted that, as will be completely clear to the skilled artisan, mixtures of the aforementioned solvents may also be used in the methods described herein. Preferably, the solvent is ethanol, butanol, pentane, heptane, propane, ethyl ether, tert-butyl-methyl-ether, methyl-ethyl-ketone, acetone, ethyl acetate and CO. 2 The corresponding solution may contain a solvent, such as an alcoholic solvent, in any volume / volume (v / v) ratio suitable for extraction. In the context of the present invention, the extraction is most preferably carried out using 96% (v / v) ethanol as the solvent. In the context of the present invention, pharmaceutical grade solvents are preferably used.

[0073] Suitable conditions for extraction are known to those skilled in the art. Certain parameters such as temperature, solvent / plant material ratio, and extraction time may be optimized. Those skilled in the art can easily determine the appropriate ratio of plant material to solvent. As an example, when performing the extraction using 96% (v / v) ethanol, a cost- and time-efficient extraction process may be performed using between 15.9 kg and 17.5 kg (e.g., 16.7 kg) of 96% (v / v) ethanol per kg of dried flowers. The solvent / extractant described herein is preferably pharmaceutical grade. Thus, the plant material, preferably cannabis plant material, more preferably cannabis plant flower material, described herein and the solvent are preferably present in a ratio of about 1:16.8 (w / w). As used herein, the term "about" means 10 percent more or less than the indicated value.

[0074] In the present invention, any method suitable for providing the extract described herein can be used. Methods suitable for preparing such extracts are routinely known to the skilled artisan and are further described in the detailed description above. In the present invention, the plant extract is preferably obtainable by solvent extraction of a plant suitable for providing the extract described herein, with the cannabis plant being a preferred example. Even more preferably, the plant extract is obtainable by solvent extraction of the flower material of the cannabis plant described herein. Thus, the plant extract comprised in the composition of the present invention is even more preferably obtainable by solvent extraction of the flower material of the cannabis plant. In the present invention, the plant extract that may be comprised in the composition of the present invention is most preferably a plant extract obtainable by solvent extraction of the flower material of the cannabis plant deposited by the Community Plant Variety Office under application number A202104053 or obtainable / produced by the method described in patent application EP22154007.3 (PCT / EP2023 / 052073). The flower material used for extraction in the context of the present invention, for example the flower material of the cannabis plant deposited by the Community Plant Varieties Office under application number A202104053, is preferably trimmed and dried before being subjected to extraction and / or decarboxylation.

[0075] The extract described herein may be any extract suitable for providing the composition of the invention and may therefore be present in liquid, viscous, pasty or solid form. In the context of the present invention, it is preferred that the extract described herein is present in liquid form, more particularly as an aqueous alcoholic extract after evaporation. Thus, the extract used to provide the composition of the invention is most preferably an aqueous alcoholic extract obtained by solvent extraction of the flower material of the cannabis plant deposited by the Community Plant Variety Office under application number A202104053, after evaporation and / or decarboxylation. In the context of the present invention, the composition may also comprise a plant extract that may be obtained / produced by the method described in patent application EP22154007.3 (PCT / EP2023 / 052073).

[0076] It should be noted that in the context of the present invention, the composition of the present invention may comprise the extract described herein, but does not consist of the extract described herein. In other words, in the context of the present invention, the composition comprises the extract described herein, preferably the plant extract described herein, and at least one suitable additional substance. That is, the composition of the present invention may comprise the extract described herein, e.g. the plant extract or a number of different extracts described herein, e.g. the plant extract, and at least one suitable additional substance. In the present invention, the composition of the present invention may preferably comprise the extract described herein and a suitable amount of a suitable carrier oil (or a mixture of such oils). As an example, the composition of the present invention comprises / consists of the extract described herein and the carrier oil described herein (or a mixture of such oils), and the THC content of the composition is adjusted to between about 2.5% and 10% by weight or 5% by weight of the composition. In another example, the composition of the invention comprises / consists of an extract as described herein and a carrier oil as described herein (or a mixture of such oils), the alpha-bisabolol content of the composition is adjusted to between 0.008% and 0.065%, preferably between 0.01% and 0.04%, or most preferably between 0.017% and 0.031% by weight of the composition, the guaiol content of the composition is adjusted to between 0.012% and 0.092%, preferably between 0.015% and 0.05%, or most preferably between 0.025% and 0.046% by weight of the composition, the beta-caryophyllene content of the composition is adjusted to between 0.012% and 0.094%, preferably between 0.02% and 0.05%, or most preferably between 0.025% and 0.046% by weight of the composition, is most preferably adjusted between 0.025% and 0.047%, and / or the content of one or more of linalool is adjusted between 0.001% and 0.014%, preferably between 0.003% and 0.0085% of the weight of the composition, alpha-humulene is adjusted between 0.003% and 0.028%, preferably between 0.006% and 0.017%, nerolidol is adjusted between 0.004% and 0.035%, preferably between 0.007% and 0.021%, caryophyllene oxide is adjusted between 0.001% and 0.0092%, preferably between 0.001% and 0.0055%, alpha-pinene is adjusted between 0.001% and 0.0092%, preferably between 0.001% and 0.0055%, and alpha-pinene is adjusted between 0.001% and 0.0092%, preferably between 0.001% and 0.0055%, of the weight of the composition.camphene is adjusted between 0.00001% and 0.0015%, preferably between 0.00003% and 0.00082% by weight of the composition; beta-pinene is adjusted between 0.0001% and 0.0015%, preferably between 0.0001% and 0.00092% by weight of the composition; beta-myrcene is adjusted between 0.0004% and 0.0005% by weight of the composition; 05%, preferably between 0.0004% and 0.005%, limonene is adjusted between 0.0005% and 0.004%, preferably between 0.0008% and 0.0022% by weight of the composition, eucalyptol is adjusted between 0.00006% and 0.002%, preferably between 0.0001% and 0.0012%, ocimene is adjusted between 0.00005% and 0.004%, preferably between 0.00009% by weight of the composition. and 0.0023%, gamma-terpinene is adjusted between 0.00007% and 0.002%, preferably between 0.0001% and 0.0013%, terpinolene is adjusted between 0.00002% and 0.002%, preferably between 0.00003% and 0.001%, alpha-terpinene is adjusted between 0.00004% and 0.002%, preferably between 0.00006% and 0.001%, and alpha-terpinene is adjusted between 0.00004% and 0.002%, preferably between 0.00006% and 0.001%, of the weight of the composition. 0.012%, para-cymene is adjusted between 0.00004% and 0.002%, preferably between 0.00007% and 0.0013%, isopulegol is adjusted between 0.0003% and 0.003%, preferably between 0.0005% and 0.0015%, and geraniol is adjusted between 0.0001% and 0.008%, preferably between 0.0002% and 0.0044%, of the weight of the composition.

[0077] In a more preferred embodiment, the composition of the invention comprises / consists of an extract as described herein and a carrier oil as described herein (or a mixture of such oils), the THC content of the composition is adjusted to between about 2.5% and 10% by weight of the composition, more preferably 5% by weight, the alpha-bisabolol content of the composition is adjusted to between 0.008% and 0.065%, preferably between 0.01% and 0.04%, or most preferably between 0.017% and 0.031% by weight of the composition, and the guaiol content of the composition is adjusted to between 0.012% and 0.092%, preferably 0.015% by weight of the composition. %, preferably between 0.025% and 0.046%, the beta-caryophyllene content of the composition is adjusted to between 0.012% and 0.094%, preferably between 0.02% and 0.05%, or most preferably between 0.025% and 0.047% by weight of the composition, linalool is adjusted to between 0.001% and 0.014%, preferably between 0.003% and 0.0085%, alpha-humulene is adjusted to between 0.003% and 0.028%, preferably between 0.006% and 0.017%, and nerolide is adjusted to between 0.003% and 0.028%, preferably between 0.006% and 0.017%, by weight of the composition. caryophyllene oxide is adjusted between 0.001% and 0.0092% by weight of the composition, preferably between 0.001% and 0.0055% by weight of the composition; alpha-pinene is adjusted between 0.0001% and 0.002% by weight of the composition, preferably between 0.0002% and 0.001% by weight of the composition; camphene is adjusted between 0.00001% and 0.0015% by weight of the composition, preferably between 0.00003% and 0.00082% by weight of the composition; beta-pinene is adjusted between 0.00001% and 0.0015% by weight of the composition, preferably between 0.00003% and 0.00082% by weight of the composition; beta-myrcene is adjusted between 0.0001% and 0.0015%, preferably between 0.0001% and 0.00092% by weight of the composition, beta-myrcene is adjusted between 0.0004% and 0.005%, preferably between 0.0004% and 0.005%, limonene is adjusted between 0.0005% and 0.004%, preferably between 0.0008% and 0.0022%, eucalyptol is adjusted between 0.00006% and 0.002%, preferably between 0.0001% and 0.0012%, ocimene is adjusted between 0.00005% and 0.002% by weight of the composition,0.004%, preferably between 0.00009% and 0.0023%, gamma-terpinene is adjusted between 0.00007% and 0.002%, preferably between 0.0001% and 0.0013%, terpinolene is adjusted between 0.00002% and 0.002%, preferably between 0.00003% and 0.001%, alpha-terpinene is adjusted between 0.00004% and 0.002%, preferably between 0.0 ... 6% and 0.0012%, para-cymene is adjusted between 0.00004% and 0.002%, preferably between 0.00007% and 0.0013%, isopulegol is adjusted between 0.0003% and 0.003%, preferably between 0.0005% and 0.0015%, and / or geraniol is adjusted between 0.0001% and 0.008%, preferably between 0.0002% and 0.0044%, of the weight of the composition.

[0078] Preferably, the composition of the invention comprises / consists of an extract as described herein and a carrier oil as described herein, and has a THC / alpha-bisabolol ratio between 100:1 and 450:1, more preferably between 160:1 and 295:1, a THC / guaiol ratio between 50:1 and 250:1, more preferably between 105:1 and 200:1, a THC / beta-caryophyllene ratio between 50:1 and 250:1, more preferably between 105:1 and 200:1, a THC / linalool ratio between 450:1 and 1400:1, more preferably between 500:1 and 1330:1, THC / alpha-humulene ratio between 300:1 and 725:1, preferably between 355:1 and 665:1; THC / nerolidol ratio between 200:1 and 600:1, preferably between 1090:1 and 2080:1; THC / caryophyllene oxide ratio between 1000:1 and 2150:1, preferably between 1090:1 and 2080:1; THC / alpha-pinene ratio between 5850:1 and 16000:1, preferably between 6000:1 and 15750:1; THC / alpha-pinene ratio between 7300:1 and 132950:1, preferably between 7300:1 and 132950:1 C / camphene ratio between 6475:1 and 23100:1, preferably between 6545:1 and 23025:1; THC / beta-pinene ratio between 1950:1 and 6300:1, preferably between 2025:1 and 6210:1; THC / beta-myrcene ratio between 1650:1 and 5050:1, preferably between 1700:1 and 4970:1; THC / limonene ratio between 5050:1 and 38650:1, preferably between 5140:1 and 38580:1; THC / eucalyptol ratio between 2500:1 and 44700:1, preferably between 2570:1 and 4461 THC / ocimene ratio between 0:1, THC / gamma-terpinene ratio between 4700:1 and 35750:1, preferably between 4800:1 and 35685:1, THC / terpinolene ratio between 5450:1 and 129850:1, preferably between 5535:1 and 129965:1, THC / alpha-terpinene ratio between 5150:1 and 58550:1, preferably between 5210:1 and 58480:1, THC / para-cymene ratio between 4700:1 and 56700:1, preferably between 4800:1 and 56625:1, THC / para-cymene ratio between 4000:1 and 8000:1,Preferably, it has a THC / isopulegol ratio between 4060:1 and 7915:1, and / or a THC / geraniol ratio between 1300:1 and 18250:1, preferably between 1375:1 and 18150:1.

[0079] The carrier oil that may be provided with the composition of the present invention together with the extract described herein may constitute any percentage of such composition, as long as the percentage complies with the definitions provided above for the content of THC, alpha-bisabolol, guaiol, beta-caryophyllene, and the group of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and / or geraniol. In a preferred example, the carrier oil may be present in an amount between 85% and 97% by weight of the composition. Such carrier oil may be a naturally derived oil (e.g., essential oil), or one or more waxes, or any combination thereof.

[0080] "Essential oil" refers to oils obtained by extraction (e.g., steam extraction, or contacting plant material with an extractant) or expression, and includes the components of plant material that are primarily hydrophobic and generally aromatic. Suitable naturally occurring oils and waxes include sesame oil, olive oil, arnica oil, lavender oil, frankincense oil, lemongrass essential oil, cinnamon leaf oil, rosemary cineole oil, rosemary oil, bergamot oil, myrrh oil, sage oil, coconut oil, hemp seed oil, castor oil, beeswax, or any other edible oil, or combinations thereof. Preferably, the carrier oil can be selected from the list of sesame oil, rapeseed oil, peanut oil, almond oil, wheat germ oil, sunflower oil, olive oil, cottonseed oil, peanut oil, almond oil, borage oil, safflower oil, soybean oil, fish oil, linseed oil, and medium chain triglycerides. In the present invention, it is most preferred that the composition of the present invention comprises a plant extract, such as a cannabis plant extract as described herein, and sesame oil according to the definition set out above. As explained herein above, the extract as described herein is preferably a plant extract as described herein, and even more preferably a cannabis plant extract as described herein. The carrier oil as described herein used to provide the composition of the present invention is preferably refined and of pharmaceutical grade.

[0081] The compositions described herein may contain natural extracts, such as plant extracts described herein, or the extracts may be additionally modified by changing their composition, for example, but not limited to, by changing the pH, or by adding one or more solvents at a preferred concentration. The extracts described herein may also be reconstituted by mixing with a suitable solvent. In some cases, the extracts described herein may also be filtered to remove particulate matter, for example, by passing the extract through a filter paper, a particle filter, or a fine sieve with a pore size suitable for filtration. As an example, a suitable sedimentation rate would be 1.5 μm. The operating pressure and temperature during filtration may be optimized by the skilled artisan, but should preferably not exceed 5 bar and 50° C. As will be appreciated, one or more additional compounds (e.g., cannabinoids, terpenes, or terpenoid compounds) may be added to the compositions described herein. The addition of compounds may be made to compensate for natural variations in the relative amounts of a given compound expressed by the cannabis plant resulting in the extract. The added compound may be a natural or synthetic form of the desired compound.

[0082] References to "THC" or "delta-9-tetrahydrocannabinol" and "cannabidiol" or "CBD" or "cannabinoids" as used herein are understood to also encompass pharma- ceutically acceptable salts of such compounds. The term "pharma-ceutically acceptable salts" refers to salts or esters prepared from pharma-ceutically acceptable non-toxic bases or acids, including inorganic bases or acids and organic bases or acids, as is well known to those skilled in the art. Many suitable inorganic and organic bases are known in the art.

[0083] In the context of the present invention, the composition is considered to contain THC as the predominant cannabinoid, but the optional presence of other cannabinoids is not excluded, including, without limitation, delta-9-tetrahydrocannabinol (Δ9-THC), delta-8-tetrahydrocannabinol (Δ8-THC), cannabidiol (CBD), cannabidiolic acid (CBDA), cannabichromene (CBC), tetrahydrocannabinolic acid (THCA), tetrahydrocannabivarin (THCV), cannabinol (CBN), cannabigerolic acid (CBGA), and cannabigerol (CBG). In particular, it is understood that compositions of the present invention that contain THC as the predominant cannabinoid may contain low amounts of CBD, for example less than 20% CBD by weight of the composition, or less than 15%, 10%, 5% or 2.5% CBD by weight of the composition, or may not contain any measurable CBD. In the present invention, it is preferred that the composition contains less than 0.5% CBD by weight of the composition, or even more preferably less than 0.1% CBD by weight. Total cannabinoids, i.e. the cannabinoid fraction, typically comprise the majority of the compounds present in the compositions of the present invention.

[0084] In the context of the present invention, the compositions described herein may be used in a kit as defined herein.

[0085] The present invention further provides a pharmaceutical formulation comprising the composition described herein. That is, the formulation of the present invention may comprise the composition described herein and at least one suitable additional substance. In the present invention, it is preferred that the formulation of the present invention may comprise the composition described herein and a suitable amount of a suitable carrier oil (or a mixture of such oils). Thus, the formulation of the present invention essentially comprises the same individual components as the composition of the present invention, as well as the same ratios of THC / alpha-bisabolol, THC / guaiol and THC / beta-caryophyllene, and THC and linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol, but further diluted with a suitable carrier oil (and optionally other additional substances included in the formulation). In the context of the present invention, the compositions of the present invention are diluted in a specific ratio so that a specific THC content contained in the resulting pharmaceutical composition of the present invention is set / fixed.

[0086] In the present invention, a pharmaceutical formulation of the present invention comprises a composition of the present invention and a suitable carrier oil such that the THC content of the formulation is diluted / adjusted to between about 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 1.1%, 1.2%, 1.3%, 1.4%, 1.5%, 1.6%, 1.7%, 1.8%, 1.9%, 2.0%, 2.05%, 2.1%, 2.15%, 2.2%, 2.25%, 2.3%, 2.35%, 2.4%, 2.45%, and 2.5% by weight of the formulation. Thus, in the context of the present invention, the composition differs from a pharmaceutical formulation in that an additional carrier oil is added to the composition described herein. Furthermore, in the context of the present invention, the pharmaceutical formulation of the present invention comprises the composition of the present invention and a suitable carrier oil, such that the THC content of the formulation is diluted / adjusted to less than 2.5% by weight of the formulation. In the present invention, the pharmaceutical formulation of the present invention preferably comprises the composition of the present invention and a suitable carrier oil, such that the THC content of the formulation is adjusted to between 1.0% and 2.5% by weight of the formulation, and even more preferably to 2.1% by weight. In the present invention, the pharmaceutical formulation of the present invention comprises the composition of the present invention and a suitable carrier oil, such that the alpha-bisabolol content in the composition is adjusted to between about 0.003% and 0.016% by weight of the formulation, the guaiol content of the composition is adjusted to between about 0.01% and 0.023% by weight of the formulation, and the beta-caryophyllene content of the composition is adjusted to between about 0.01% and 0.024% by weight of the formulation. Furthermore, one skilled in the art will appreciate that certain terpenes from the group of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol may be present in the composition but may not be detectable since their concentration may be below the identification threshold or detection limit after dilution to provide the pharmaceutical formulation of the present invention.Thus, the pharmaceutical formulations of the present invention comprise a composition of the present invention and a suitable carrier oil such that the linalool content of the composition is adjusted to between about 0.0007% and 0.004% by weight of the formulation, the alpha-humulene content of the composition is adjusted to between about 0.001% and 0.007% by weight of the formulation, and / or the nerolidol content of the composition is adjusted to between about 0.001% and 0.009% by weight of the formulation.

[0087] In the present invention, the pharmaceutical formulation of the present invention preferably comprises the composition of the present invention and a suitable carrier oil such that the alpha-bisabolol content of the formulation is adjusted to between about 0.006% and 0.014% by weight of the formulation, the guaiol content of the formulation is adjusted to between about 0.01% and 0.019% by weight of the formulation, the beta-caryophyllene content of the formulation is adjusted to between about 0.01% and 0.02% by weight of the formulation, and / or the linalool content of the composition is adjusted to between about 0.001% and 0.003% by weight of the formulation, the alpha-humulene content of the composition is adjusted to between about 0.003% and 0.006% by weight of the formulation, and / or the nerolidol content of the composition is adjusted to between about 0.003% and 0.008% by weight of the formulation.

[0088] In a more preferred embodiment, a pharmaceutical formulation of the present invention comprises a composition of the present invention and a carrier oil (or mixture of such oils) as described herein, wherein the THC content of the composition is adjusted to between about 1.0% and 2.5% by weight of the composition, the alpha-bisabolol content of the composition is adjusted to between 0.003% and 0.016% by weight of the formulation, the guaiol content of the composition is adjusted to between 0.01% and 0.023% by weight of the formulation, and / or the beta-caryophyllene content of the composition is adjusted to between 0.01% and 0.024% by weight of the formulation, the linalool content of the composition is adjusted to between about 0.0007% and 0.004% by weight of the formulation, the alpha-humulene content of the composition is adjusted to between about 0.001% and 0.007% by weight of the formulation, and / or the nerolidol content of the composition is adjusted to between about 0.001% and 0.009% by weight of the formulation. In the present invention, the pharmaceutical composition most preferably comprises the ingredients set forth in Table 2 below. TIFF2025504971000002.tif53170

[0089] In accordance with the present invention, a formulation of the present invention comprises / consists of a composition as described herein and a carrier oil as described herein and has a THC / alpha-bisabolol ratio of between 100:1 and 450:1, more preferably between 160:1 and 295:1, a THC / guaiol ratio of between 50:1 and 250:1, more preferably between 105:1 and 200:1, a THC / beta-caryophyllene ratio of between 50:1 and 250:1, more preferably between 105:1 and 200:1, a THC / linalool ratio of between 450:1 and 1400:1, more preferably between 500:1 and 1330:1, a THC / alpha-humulene ratio of between 300:1 and 725:1, more preferably between 355:1 and 665:1, and / or a THC / nerolidol ratio of between 200:1 and 600:1, more preferably between 285:1 and 535:1. Suitable methods for qualitatively and quantitatively determining, analyzing, controlling or setting the content of THC, alpha-bisabolol, guaiol, beta-caryophyllene, linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and / or geraniol are known in the art and have already been described above, including TLC, HPLC and GC with mass spectrometry detection as described above. The skilled person will know the standard procedures for preparing the formulations of the present invention by diluting the compositions of the present invention, and an exemplary procedure is described below: To prepare a pharmaceutical formulation of the present invention containing 2.1% THC by weight of the formulation, the composition of the present invention containing 5% THC by weight of the composition is further diluted to a content of 2.1% by directly adding the required amount of carrier oil. In another example, 10 g of a composition of the invention containing a THC content of 5% by weight of the composition is weighed out and mixed with 15 g of a carrier oil, preferably sesame oil (e.g., as contained in the commercially available Vertanical Production Kit, Vertanical GmbH, catalog number 15876554), to obtain a homogenous mixture, i.e., a pharmaceutical formulation containing 2.0% THC by weight of the formulation.

[0090] The carrier oils providing the formulations of the present invention with the compositions described herein may constitute any percentage of such formulations, as long as the percentages meet the definitions set forth above for the content of THC, alpha-bisabolol, guaiol, beta-caryophyllene, and terpenes selected from linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol and geraniol in the formulations. Such carrier oils may be oils of natural origin (e.g., essential oils) or one or more waxes or any combination thereof, as disclosed above in the context of the compositions of the present invention. Thus, any carrier oil that can be used or is particularly useful in the context of the compositions of the present invention is applicable in the context of the formulations of the present invention.

[0091] In the context of the present invention, those skilled in the art will understand that, as applicable to the compositions of the present invention, the formulations of the present invention contain THC as the primary cannabinoid, but the optional presence of other cannabinoids, including, without limitation, cannabidiol (CBD), is not excluded. Thus, it is envisaged that other cannabinoids, such as cannabidiol (CBD), can be added to the compositions of the present invention or to the formulations of the present invention in any desired amount.

[0092] Both the composition of the present invention and the pharmaceutical preparation of the present invention may contain, in addition to the above-mentioned components, further substances such as, but not limited to, antioxidants, colorants and flavorings, in any suitable concentration. Other suitable additives are known to those skilled in the art, and detailed examples are further listed in the following detailed description. When the composition of the present invention contains an extract obtained by extraction, the extracting agent, such as the solvent described herein, can be partially or preferably completely removed, for example by heating the extract under reduced pressure (e.g. under vacuum), before incorporating the composition into the pharmaceutical preparation. Those skilled in the art are aware that some volatile plant metabolites may be removed with the extracting agent. In the context of the present invention, the extracting agent may be included in the pharmaceutical preparation.

[0093] The terms "composition" and "pharmaceutical formulation" as used herein generally define a composition or formulation suitable for application / administration to the body to treat, care for, or improve the appearance of the body. The compositions of the present invention may be applied / administered to a subject, preferably a human patient. The pharmaceutical formulations of the present invention are particularly intended to be applied / administered to a subject, preferably a human patient. Thus, the term "pharmaceutical formulation" may be used interchangeably with "drug". In the present invention, the compositions and pharmaceutical formulations described herein are particularly useful in medicine. In particular, the compositions and pharmaceutical formulations of the present invention may be used for the treatment and / or prevention of pain-related conditions / diseases, more particularly, for the treatment and / or prevention of cancer pain, acute non-cancer pain, chronic non-cancer pain, and / or complex pain syndrome. A particular example of cancer pain would be chronic cancer pain. Specific examples of acute non-cancer pain are somatic pain, including pain caused by tooth extraction, minor skin surgery, skeletal trauma, orthopedic surgery, or tension headache, and visceral pain, including pain caused by dysmenorrhea, acute pancreatitis, or renal / biliary colic.Specific examples of chronic non-cancer pain are central neuropathic pain, including pain caused by post-stroke thalamic pain or spinal cord injury, and neuropathic pain, such as peripheral neuropathic pain, including pain caused by post-herpetic neuralgia, diabetic painful neuropathy, trigeminal neuralgia, idiopathic small fiber polyneuropathy, or antiretroviral therapy-induced neuropathy.Specific examples of complex pain syndromes include fibromyalgia syndrome, complex regional pain syndrome, and migraine.

[0094] The present invention also provides a method for the treatment and / or prevention of a condition / disease associated with pain as disclosed herein, comprising administering an effective amount of the composition or pharmaceutical formulation described herein to a patient in need thereof. The term "effective amount" is understood as an amount sufficient for the drug to achieve a desired effect when administered to a patient. In the case of a therapeutic method, the effect may be, for example, the treatment and / or prevention of cancer pain, acute non-cancer pain, chronic non-cancer pain or complex pain syndrome, more specifically chronic cancer pain, somatic pain, visceral pain, central neuropathic pain, peripheral neuropathic pain and complex pain syndrome, i.e., the "effective amount" is considered to be a therapeutically effective amount. A "therapeutically effective amount" refers to the administration of an amount of a given compound to a subject in need thereof that achieves a desired therapeutic effect. The term "continuously" means that each of the compositions or pharmaceutical formulations and the other active agent are administered separately and / or at different times. In the present invention, it is preferred that the present invention provides a method for the treatment and / or prevention of cancer pain, acute non-cancer pain, chronic non-cancer pain or complex pain syndrome, comprising administering an effective amount of a composition or pharmaceutical formulation described herein to a patient in need thereof. In the present invention, it is even more preferred that the present invention provides a method for the treatment and / or prevention of chronic cancer pain, somatic pain, visceral pain, central neuropathic pain, peripheral neuropathic pain or complex pain syndrome, comprising administering an effective amount of a composition or pharmaceutical formulation described herein to a patient in need thereof. The method disclosed herein may include administering more than one composition or formulation of the present invention to a patient in need thereof. The method may also include administering an active agent other than the composition or formulation of the present invention. The active agent may be administered simultaneously or consecutively with the composition or formulation. The composition or pharmaceutical formulation described herein may be administered before or after the other active agent. Furthermore, the route of administration may be the same or different.

[0095] As used herein, the terms "treat", "treatment" and the like are understood to affect a subject, tissue or cell to obtain a desired pharmacological and / or physiological effect in terms of partial or complete cure of a disease or associated symptoms. The terms "prevent", "prevention" and the like are understood to refer to prophylactic treatment of a subject in terms of completely or partially preventing the onset, arresting the progression, or reducing the severity of a disease or associated symptoms. As used herein, the term "subject" refers to a mammal, preferably a human.

[0096] The compositions and pharmaceutical formulations disclosed herein are particularly useful for medicine as described above and may be administered locally or systemically. They may be administered by any suitable means, including oral, oral mucosal (including buccal and sublingual), rectal, intranasal, topical (including transdermal), intravaginal or parenteral (including intramuscular, subcutaneous and intravenous) administration, or in a form suitable for administration by inhalation or insufflation. In the present invention, the compositions or pharmaceutical formulations disclosed herein are preferably administered orally. The compositions or pharmaceutical formulations disclosed herein may be in any suitable form, including but not limited to aerosol, liquid or powder form, and may be provided in any suitable design, such as liquid, lotion, ampoule, spray or tablet. Such suitable forms and administration designs are known to those skilled in the art and are further exemplarily listed in the following detailed description, without being limited thereto. Those skilled in the art will understand that the compositions or pharmaceutical formulations disclosed herein may contain additional components such as acceptable carriers, diluents, adjuvants, additives, etc., or any combination thereof, which depend on the form and route of administration and are provided by way of example in the detailed description below. Those skilled in the art will understand that the compositions or pharmaceutical formulations of the present invention can be prepared by any means known in the art. It can be used in the form of a suppository for rectal administration, in the form of an aerosol, or in the form of a sterile injectable solution for parenteral (including subcutaneous) use, all for oral use, as a pressurized preparation, or as a solid or semi-solid, such as a tablet or filled capsule, or as a liquid for external or internal use, such as a solution, suspension, emulsion, elixir, or capsule filled therewith. Compositions / formulations for parenteral administration include sterile aqueous or non-aqueous solutions, suspensions, and emulsions. Examples of non-aqueous solvents are propylene glycol, polyethylene glycol, vegetable oils such as olive oil, and injectable organic esters such as ethyl oleate. Examples of suitable pharmaceutical carriers are well known in the art and include both solid and liquid carriers. Solid carriers can be in the form of powders, tablets, pills, capsules, cachets, suppositories, and disposable granules. A solid carrier can be one or more substances which may also act as diluents, flavoring agents, solubilizers, lubricants, suspending agents, binders, tablet disintegrating agents, or an encapsulating material.Liquid carriers include water, alcoholic / aqueous solutions, emulsions or suspensions including saline and buffered media, various types of wetting agents, and the like. Parenteral vehicles include sodium chloride solution, Ringer's dextrose, dextrose and sodium chloride, lactated Ringer's, or fixed oils. Intravenous vehicles include fluid and nutrient replenishers, electrolyte replenishers (such as those based on Ringer's dextrose), and the like. In addition, the compositions or pharmaceutical formulations of the present invention may include a proteinaceous carrier, preferably of human origin, such as serum albumin or immunoglobulin, and may optionally include suitable formulation stabilizers and / or additives. Preservatives and other additives, such as antimicrobial agents, antioxidants, chelating agents, and inert gases, may also be present. As described above, the compositions described herein may be mixed with one or more naturally occurring oils (e.g., essential oils) or waxes to provide pharmaceutical formulations of the present invention.

[0097] The compositions or pharmaceutical formulations described herein may be provided in any suitable form, including, but not limited to, unit dosage forms in ampoules, pre-filled syringes, small volume infusions, multi-dose containers, droppers, pipettes, sprays, ointments, creams, lotions, or transdermal patches. Unit dosage form, as used herein, refers to a physically discrete unit suitable as a unitary dosage for the subject to be treated. It is also contemplated that the compositions or formulations described herein may be in powder form, obtained by aseptic isolation of a sterile solid for constitution with a suitable vehicle, e.g., sterile pyrogen-free water, prior to use. The compositions or pharmaceutical formulations described herein may be administered orally, preferably enclosed in hard or soft shell gelatin capsules, compressed into ingestible tablets or buccal tablets, lozenges, troches, capsules, elixirs, suspensions, syrups, wafers, sprays, chewing gums, mouthwashes, or the like, or incorporated directly into the food of the diet. Such compositions or formulations for oral administration may also contain additional ingredients such as carriers, colorants, stabilizers, buffers, coatings, binders, excipients, disintegrants, sweeteners and / or flavorings. Administration to the respiratory tract may also be achieved by means of an aerosol composition or formulation in which the active ingredient is provided in a pressurized pack with a suitable propellant, such as chlorofluorocarbons (CFCs) or other suitable gas.

[0098] One of skill in the art will appreciate that the compositions or pharmaceutical formulations described herein will be formulated so as to be suitable for application to a patient, compatible with the active agents present in the composition / formulation, and not to raise undue safety or toxicity concerns. Thus, the compositions or pharmaceutical formulations described herein may be subject to further processing, such as pH adjustment.

[0099] The compositions or pharmaceutical formulations described herein can be administered to a subject in any suitable dose. The dosing schedule is determined by the attending physician and clinical factors. As is well known in the medical art, the dosage per patient depends on many factors, including the patient's size, body surface area, age, the specific compound administered, sex, time and route of administration, general health, and other medications administered at the same time. As an example, the dosing schedule can be determined based on the experience / sensation of pain and adverse events. A subject, preferably a human patient, can receive a dose of 2.5 mg of THC by administering a corresponding amount of the compositions or pharmaceutical formulations described herein in the evening of the first day. If the subject does not experience adverse effects but still experiences pain, the subject can receive the same 2.5 mg THC dose in the evening for two more days. If the subject does not experience adverse effects but still experiences pain on the third day, the dose administered in the evening of the fourth day is increased, for example, to a 5 mg THC dose. Further, on the fourth day, the subject may begin to receive a 2.5 mg THC booster dose in the morning by administering a corresponding amount of a composition or pharmaceutical formulation described herein. The subject may receive the same dose of 5 mg THC in the evening and 2.5 mg THC in the morning for two more days. If the subject does not experience side effects on the sixth day but still experiences pain, the dose administered in the evening on the seventh day is increased to a 7.5 mg THC dose, for example, by administering a corresponding amount of a composition or pharmaceutical formulation described herein. Further, on the seventh day, the subject may increase the morning booster dose to 5 mg THC by administering a corresponding amount of a composition or pharmaceutical formulation described herein. If the subject experiences side effects, for example, on the third day, the dose administered in the evening on the fourth day is reduced to a 2.5 mg THC dose. The subject may then receive the same 2.5 mg THC dose in the evening for two more days. If the subject does not experience side effects and does not experience pain, the dose remains constant and is not increased or decreased.

[0100] It is envisioned that the compositions or formulations of the present invention may contain, in addition to the compositions of the present invention, additional biologically active agents depending on the intended use of the composition or pharmaceutical formulation. Any suitable active agent may be used as long as the activity of the active agent and / or the composition / formulation is not reduced when combined. By way of example, such additional active agents may be anti-inflammatory agents, such as commercially available drugs such as Aspirin®, ibuprofen, naproxen, celecoxib or diclofenac. Furthermore, the present invention contemplates co-administration protocols with other compounds, such as commercially available inflammatory agents such as those mentioned above, or co-treatment with radiation therapy, chemotherapy, radionuclides, or hormone therapy.

[0101] The present invention further relates to a kit comprising component A) the composition of the present invention and component B) a carrier oil. The carrier oil included in the kit described herein is preferably refined and pharmaceutical grade and can be provided in an appropriate amount to produce a desired amount of product when mixed with the composition of the present invention. Such a carrier oil can be a naturally occurring oil (e.g., essential oil) or one or more waxes or any combination thereof. Suitable naturally occurring oils and waxes are known to those skilled in the art and are further described herein. Any carrier oil that can be used or is particularly useful in connection with the composition of the present invention or the formulation of the present invention can be applied in connection with the kit of the present invention.

[0102] In the context of the present invention, sesame oil can be used as a preferred carrier oil to provide component B. In the present invention, component A described herein comprises THC in an amount of 5% by weight of component A, alpha-bisabolol in an amount of at least 0.017% by weight of component A, preferably between 0.017% and 0.031% by weight of component A, guaiol in an amount of at least 0.025% by weight of component A, preferably between 0.025% and 0.046% by weight of component A, beta-caryophyllene in an amount of at least 0.025% by weight of component A, preferably between 0.025% and 0.047% by weight of component A, and linalool in an amount of at least 0.004% by weight of component A, preferably between 0.004% and 0.007% by weight of component A. alpha-humulene in an amount of at least 0.008% by weight of component A, preferably between 0.008% and 0.014% by weight of component A; nerolidol in an amount of at least 0.004% by weight of component A, preferably between 0.009% and 0.017% by weight of component A; caryophyllene oxide in an amount of at least 0.002% by weight of component A, preferably between 0.003% and 0.005% by weight of component A; and limonene in an amount of at least 0.001% by weight of component A, preferably between 0.001% and 0.002% by weight of component A.

[0103] In the context of the present invention, component A as described herein preferably comprises THC in an amount of 5% by weight of component A, alpha-bisabolol with a THC / alpha-bisabolol ratio of more than 160:1, preferably between 160:1 and 295:1, guaiol with a THC / guaiol ratio of more than 105:1, preferably between 105:1 and 200:1, beta-caryophyllene with a THC / beta-caryophyllene ratio of more than 105:1, preferably between 105:1 and 200:1, and linalool with a THC / linalool ratio of more than 450:1 and 1400:1, more preferably between 500:1 and 1330:1. alpha-humulene with a THC / alpha-humulene ratio of between 300:1 and 725:1, more preferably 355:1 and 665:1; nerolidol with a THC / nerolidol ratio of between 200:1 and 600:1, more preferably 285:1 and 535:1; caryophyllene oxide with a THC / caryophyllene oxide ratio of between 1000:1 and 2150:1, preferably 1090:1 and 2080:1; and limonene with a THC / limonene ratio of between 1650:1 and 5050:1, preferably 1700:1 and 4970:1.

[0104] The kits described herein further include instructions for use of the kit. Specifically, the kit instructs the user to mix component A and component B in a suitable ratio. In the context of the present invention, a suitable dilution ratio would be a component A / component B ratio between 1:1 and 1:1.5. More preferably, the kit instructs the user to mix component A and component B in a component A / component B ratio of 1:1.38. In the context of the present invention, the kit instructs the user to mix component A and component B such that the product obtained by mixing component A and component B contains between 1.0% and 2.5% THC. Preferably, the kit provides a user with component A and component B, and a product obtained by mixing component A and component B has between 1.0% and 2.5% THC, alpha-bisabolol with a THC / alpha-bisabolol ratio of between 100:1 and 450:1, preferably between 160:1 and 295:1, guaiol with a THC / guaiol ratio of between 50:1 and 250:1, preferably between 105:1 and 200:1, and / or beta-caryophyllene with a THC / beta-caryophyllene ratio of between 50:1 and 250:1, preferably between 105:1 and 200:1. and / or at least one terpene selected from the group consisting of linalool, alpha-humulene and nerolidol in a THC / linalool ratio of between 450:1 and 1400:1, more preferably between 500:1 and 1330:1, a THC / alpha-humulene ratio of between 300:1 and 725:1, more preferably between 355:1 and 665:1, and a THC / nerolidol ratio of between 200:1 and 600:1, more preferably between 285:1 and 535:1. More preferably, the kit instructs the user to mix components A and B such that the product obtained by mixing components A and B contains 2.1% THC, alpha-bisabolol with a THC / alpha-bisabolol ratio of greater than 160:1, guaiol with a THC / guaiol ratio of greater than 105:1, beta-caryophyllene with a THC / beta-caryophyllene ratio of greater than 105:1, and / or at least one terpene selected from the group consisting of linalool, alpha-humulene and nerolidol with a THC / linalool ratio of greater than 715:1, a THC / alpha-humulene ratio of greater than 355:1 and a THC / nerolidol ratio of greater than 285:1.

[0105] Most preferably, in the context of the present invention, the kit instructs the user to mix component A with component B such that the product obtained by mixing components A and B contains 2.1% THC, alpha-bisabolol in a THC / alpha-bisabolol ratio of between 160:1 and 295:1, guaiol in a THC / guaiol ratio of between 105:1 and 200:1, beta-caryophyllene in a THC / beta-caryophyllene ratio of between 105:1 and 200:1, and / or at least one terpene selected from the group consisting of linalool, alpha-humulene and nerolidol in a THC / linalool ratio of between 500:1 and 1330:1, a THC / alpha-humulene ratio of between 355:1 and 665:1, and a THC / nerolidol ratio of between 285:1 and 535:1.

[0106] When the kit's instructions are properly followed, the resulting product results in a pharmaceutical composition of the invention. Thus, the kit of the invention can be used for various applications mentioned in the context of the compositions and / or pharmaceutical formulations disclosed herein. In particular, the kits described herein are particularly useful in medicine. Moreover, the kits described herein are particularly useful for the treatment and / or prevention of pain-related conditions / diseases described herein above. Moreover, the kits described herein can be advantageously used to carry out, inter alia, the methods for the treatment and / or prevention of pain-related conditions / diseases disclosed herein.

[0107] The kit may further comprise additional components for user convenience, such as suitable containers, preferably amber glass flasks, suitable dropper inserts / suitable dropper inserts to allow more accurate dosing, and / or child-resistant closure / sealing caps for safety reasons. Such additional components are preferably pharmaceutical grade and / or sterile. Furthermore, the parts of the kit of the present invention may be packaged individually in vials or bottles or combined in containers or multi-container units.

[0108] In the context of the present invention, a person skilled in the art will understand that, where applicable to the compositions of the present invention and pharmaceutical preparations of the present invention, THC is included as the primary cannabinoid, but the optional presence of other cannabinoids, including, but not limited to, cannabidiol (CBD), is not excluded. It is therefore envisaged that the kit may further include additional cannabinoid preparations, such as alcoholic solutions that include cannabinoids other than THC as the primary cannabinoid, with CBD being a preferred example (e.g., 1×Cannabis Vollextrakt VERTANICAL CBD50 solution, marketed by Vertanical GmbH, catalog number: 16234579). In that case, the kit may instruct the user to combine component A, component B and additional cannabinoid preparations into one product.

[0109] In the foregoing detailed description of the invention, many individual elements, features, techniques, and / or steps are disclosed. It is readily recognized that each of these has individual advantages when considered or used alone, as well as advantages when considered and used in combination with one another. Thus, to avoid overly repetitive and lengthy text, this specification refrains from repeating every possible combination and permutation. It is understood, however, that such combinations, whether or not explicitly described, are fully within the scope of the subject matter of this disclosure.

[0110] All technical and scientific terms used herein are intended to have the same meaning as commonly understood by one of ordinary skill in the art, unless otherwise defined. References to technology as used herein are intended to refer to technology as commonly understood in the art, and include variations of those technologies or equivalent technology alternatives that are apparent to those of ordinary skill in the art.

[0111] The invention will now be further described with reference to the following non-limiting figures and examples. [Brief description of the drawings]

[0112] [Figure 1] Exemplary IC50 titration curves obtained in HCT-116 cell line exposed to cannabis plant extract as described in example 1. Concentrations on the x-axis are normalized to the THC content in the cannabis plant extract as a reference for the entire mixture. The measured average values ​​are indicated by circles. [Diagram 2] IC50 values ​​in MCF7 cell line of single substances compared to substance mixtures. Figure 2 shows a comparison of the single IC50 concentrations measured in MCF7 cell line for THC as single substances in μg / ml, alpha-bisabolol and guaiol in ng / ml, and the individual IC50 concentrations measured and derived for each combination of THC, alpha-bisabolol and guaiol. [Diagram 3] IC50 values ​​in HCT-116 cell line of single substances compared to substance mixtures. Figure 3 shows a comparison of the single IC50 concentrations measured in HCT116 cell line for THC as single substances in μg / ml, alpha-bisabolol and guaiol in ng / ml, and the individual IC50 concentrations measured and derived for each combination of THC, alpha-bisabolol and guaiol. [Figure 4] IC50 values ​​in CaCO2 cell line for single substances compared to substance mixtures. Figure 4 shows a comparison of the single IC50 concentrations measured in CaCO2 cell line for THC as single substances in μg / ml, alpha-bisabolol and guaiol in ng / ml, and the individual IC50 concentrations measured and derived for each combination of THC, alpha-bisabolol and guaiol. [Figure 5A-5B] Single substance-dependent PBMC inflammatory cytokine secretion compared to substance mixtures without PHA stimulation. Figure 5 shows the measured concentrations of each of the various cytokines shown in the figure at different concentrations of THC (A), alpha-bisabolol (B), guaiol (C) and a mixture of THC, alpha-bisabolol and guaiol (D) in non-PHA stimulated control PBMCs. [Figure 5C] (the above) [Figure 5D] (the above) [Figure 6A-6B] PHA-induced inflammatory cytokine secretion dependent on single substances compared to substance mixtures. Figure 6 shows the measured concentrations of the various cytokines shown in the figure at different concentrations of THC (A), alpha-bisabolol (B), guaiol (C) and a mixture of THC, alpha-bisabolol and guaiol (D) in PHA-stimulated PBMCs. [Figure 6C] (the above) [Figure 6D] (the above) [Figure 7] Cytokine secretion when THC, alpha-bisabolol and guaiol are administered as single substances versus a mixture of substances. Figure 7 shows the calculated concentration-dependent relative differences in secretion by PBMCs of the various cytokines shown in the figure when THC, alpha-bisabolol, guaiol are administered as single substances versus a mixture of THC, alpha-bisabolol and guaiol. The calculation of the relative values ​​is based on the experimental data shown in Figures 5 and 6, where the PHA-induced inflammatory cytokine secretion was normalized to the non-PHA stimulated control value. EXAMPLES

[0113] The following examples illustrate the invention:

[0114] Example 1 Cell viability of stimulated cancer cell lines The following examples demonstrate that the cytotoxic activity of exemplary terpenes alpha-bisabolol and guaiol is enhanced in combination treatment with THC when compared to treatment with alpha-bisabolol or guaiol alone.

[0115] 1.1 Cell line culture The following cell lines were used in the experiments: CaCO2 (Pharmacelsus), HCT-116 (ATCC, Cat#CCL-247), and MCF-7 (ECACC, Cat#86012803). All cell lines were maintained at 37°C, 5% CO2, and 95% humidity. Medium was changed three times a week, and monolayers were subcultured at a ratio of 1:5 when cultures reached 80% confluence. The specific culture media for each cell line is as follows: CaCO2 cell line was cultured in DMEM (PAN-Biotech, Cat#P04-03500) supplemented with 10% FBS Good (PAN-Biotech, Cat#P40-37500) and 1% NEAA (PAN-Biotech, Cat#P08-32100), HCT-116 cell line was cultured in McCoy's A5 medium (PAN-Biotech, Cat#P04-05500) supplemented with 10% FBS Good, and MCF-7 cell line was cultured in RPMI1640 (PAN-Biotech, Cat#P04-16500) supplemented with 10% FBS and 2 mM GlutaMAX (Gibco, Cat#35050). All cell culture media were routinely supplemented with 1% penicillin / streptomycin (PAN-Biotech, Cat#P06-07100).

[0116] For cytotoxicity assays, cells were seeded in 96-well flat-bottom microtiter plates at a density of 10,000 cells / well and allowed to attach to the plates for 24 h before the start of the experiment.

[0117] 1.2 Cytotoxicity assay 1.2.1 Preparation of test substances Dronabinol (Pharma Wernigerode GmbH, THC content: 95.37%), cannabis plant extracts specified in Table 3 (Pharma Wernigerode GmbH, obtainable by the method described in patent application EP22154007.3 (PCT / EP2023 / 052073)), alpha-bisabolol (Sigma, Cat#14462) and guaiol (Cayman Chemicals, Cat#23172) prepared in dimethylsulfoxide (DMSO, Carl Roth, Cat#4720.2) were diluted in cell culture medium to obtain the final concentrations for the different cell lines shown in Tables 4 to 6. Each concentration was tested in technical triplicate for the single substances measured and for the combinations of substances shown.

[0118] As negative controls, cell culture medium was used containing the same amount of each solvent (0.5% DMSO) that was also present in the samples to ensure that any toxicity observations were due to the test article and not the solvent. As positive controls, 1% Triton X-100 (Alfa Aesar, Cat#A16046) was added to the cell culture medium. Medium alone was used as a blank. TIFF2025504971000003.tif190170

[0119] 1.2.2 Measured concentration of test substance TIFF2025504971000004.tif75170TIFF2025504971000005.tif68170TIFF2025504971000006.tif50170

[0120] 1.2.3 Assay procedure Quantification of viable cells was performed using a commercially available MTT assay kit (Cell Proliferation Kit I (MTT), Sigma, Cat#11465007001). The MTT assay is based on the cleavage of the yellow tetrazolium salt MTT into purple formazan crystals by metabolically active cells. The formed formazan crystals are solubilized and the resulting colored solution is quantified.

[0121] Cells were prepared as described in Example 1.1. The cell culture medium was completely removed from the cells by vacuum aspiration and 200 μl of test article solution was added to the cells. The cells were incubated at 37° C., 5% CO 2 The cells were exposed to the test substances for 48 hours at 37°C and 95% humidity. After the incubation period, the supernatant was discarded and the cells were washed with PBS (PAN, Cat#P04-36500). Fresh cell culture medium containing 10% MTT reagent was added to each well. The cells were incubated at 37°C, 5% CO 2 After the incubation period, 200 μl of solubilization solution was added to each well and the cells were incubated at 37° C., 5% CO 2 and further incubated overnight at 95% humidity. The conversion of MTT to formazan was recorded by measuring the absorbance at 570 nm with a reference wavelength of 650 nm using a spectrophotometer (Spectramax Plus, Molecular Devices).

[0122] 1.3 Results The results shown in Figures 2 to 4 are derived from primary data obtained according to Example 1. To obtain the specific data shown, each measurement performed in triplicate was averaged and a mean relative survival rate was established in relation to the concentration of each compound applied (in the case of single substances).

[0123] As an example, Figure 1 shows the average relative viability of the HCT-116 cell line exposed to cannabis plant extracts, but only the concentration of THC is shown on the x-axis, since the relative fraction of other compounds changes with their concentration (as the extract is a mixture of many different compounds). The measured average values ​​are indicated by circles, and the dashed line represents the theoretically ideal curve of the IC50 titration. Said curve follows the formula: TIFF2025504971000007.tif8170

[0124] As can be seen, obtaining a particular relative viability at any given concentration "c" of a compound depends on the values ​​of "A" and "B" in the above formula. To obtain such values ​​"A" and "B", the formula is fitted to the measured values ​​using the relative viabilities measured at known concentrations for numerical approximation. To achieve this, the Microsoft® Excel Solver algorithm was used to search for the minimum standard deviation between each relative viability calculated numerically (by the above formula) and the respective relative viability determined experimentally at the known concentration. The Solver algorithm used the GRG nonlinear algorithm module to adjust the values ​​A and B, searching for the minimum sum of all of the above standard deviations at the known concentrations.

[0125] Once "A" and "B" are determined, the above formula provides a way to continuously set the correlation between relative viability and concentration. At that point, it is numerically determined what value of "c" needs to be inserted into the above formula to achieve 50% relative viability. The resulting determined value of "c" is the IC50. As an example, the IC50 value read from Figure 1 is approximately 29 μg / ml THC.

[0126] As is evident from figures 4-6 presenting IC50 values ​​for different cancer cell lines, the IC50 values ​​of alpha-bisabolol and guaiol are significantly reduced in combination treatment with THC when compared to treatment with alpha-bisabolol or guaiol alone. The IC50 value of THC does not change between monotherapy and combination treatment with alpha-bisabolol and guaiol. Thus, the cytotoxic activity of the terpenes alpha-bisabolol and guaiol is enhanced by the presence of THC when the components are present in a THC / alpha-bisabolol ratio between 100:1 and 450:1, specifically between 160:1 and 295:1, and / or a THC / guaiol ratio between 50:1 and 250:1, specifically between 105:1 and 200:1. The cannabis plant extract of the present invention contains THC and the terpenes alpha-bisabolol and guaiol in the ratios tested individually in the examples (see Table 3). Therefore, the compositions and pharmaceutical preparations of the present invention having the same individual active ingredients and THC / terpene ratio as the cannabis extract disclosed in this example are likely to be particularly effective in producing cytotoxic activity. Thus, the cytotoxic activity of alpha-bisabolol, guaiol, beta-caryophyllene, and at least one terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol, and geraniol is likely to be enhanced by the presence of THC. From these results, the compositions and preparations of the present invention are likely to have the superior effect of having increased terpene-related cytotoxic activity.

[0127] Example 2 Cytokine secretion of stimulated PBMCs The following examples demonstrate that administration of THC and the exemplary terpenes alpha-bisabolol and guaiol in a combination treatment enhances anti-inflammatory activity compared to treatment with either THC, alpha-bisabolol or guaiol alone.

[0128] 2.1 PBMC culture PBMCs from four different healthy Caucasian donors with no history of autoimmune disease diagnoses were obtained commercially (Immunospot) and used in the experiment: PBMC No. 1 (male, 24 years old, CTL, #HHU20210720), PBMC No. 2 (female, 24 years old, CTL, #HHU20210722), PBMC No. 3 (female, 44 years old, CTL, #HHU20210727), and PBMC No. 4 (male, 20 years old, CTL, #HHU20210729). Cells from all four donors were pooled for the experiment.

[0129] PBMCs were cultured in RPMI1640 (PAN-Biotech, Cat#P04-16500) supplemented with 10% FBS. For the assay, pooled PBMCs were seeded in 96-well plates at a concentration of 200000 cells / well and used immediately in the assay. Test substances (prepared in 2.2) were added and after 30 min of preincubation, 10 μg / ml (final) phytohemagglutinin L (PHA) (Roche, Cat#11249738001) was added as a proinflammatory stimulus or medium was added as a control. After 48 h, plates were centrifuged, supernatants were collected for cytokine measurements, and the remaining cells were used for cell viability tests.

[0130] 2.2 Preparation of test substances Dronabinol (described in Example 1.2.1), cannabis plant extract as defined in Example 1 (Table 3), alpha-bisabolol (Sigma, Cat#14462) and guaiol (Cayman Chemicals, Cat#23172) prepared in dimethylsulfoxide (DMSO, Carl Roth, Cat#4720.2) were diluted in cell culture medium to obtain the final concentrations shown in Tables 7 and 8. Each concentration of the measured single substances and the indicated substance combinations was tested in technical triplicate.

[0131] As negative controls, PBMCs were cultured in culture medium containing the same amount of each solvent (0.4% DMSO) that was also present in the samples to ensure that any toxicity observations were due to the test article and not the vehicle. As positive controls, 10 μg / ml PHA was added to PBMCs in cell culture medium. Medium alone was used as a blank.

[0132] 2.2.1 Measured concentration of test substance TIFF2025504971000008.tif94170TIFF2025504971000009.tif71170

[0133] 2.3 Assay procedure 2.3.1 Cytokine quantification Quantification of cytokines IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-10, IL-13, IL-12p70, TNF-α, IL-5 and GM-CSF was performed using V-Plex MSD kit (MSD, Cat#K151A9H-2) and MESO QuickPlex SQ120MM system (Meso Scale Discovery). Human PBMC cells (200000 cells) were mixed with test articles (except PHA) at the concentrations and combinations shown in Tables 5 and 6 and incubated at 37°C for 30 minutes. Then, PHA or each volume of medium as a control was added and incubated for 48 hours. After that, 200 μl of supernatant was collected and frozen. Less than 30 μl of supernatant (depending on the dilution) was used for cytokine quantification. Dilution of the collected supernatant may be required to measure cytokines accurately. The correct dilution is established by duplicate test measurements of cell supernatants with and without PHA stimulation.

[0134] For the measurement, samples, calibrators (part of the V-Plex MSD kit), and controls were transferred from the samples to a special assay plate coated with a capture antibody capable of binding to the cytokine of interest. After incubating the plate for 2 hours at room temperature, the detection antibody was added and the plate was incubated for another 2 hours at room temperature. The test plate was then washed and read buffer was added. The detection antibody contained a special ruthenium tag (SULFO-TAG TM ) in the electrochemical readout buffer, and tripropylamine (TPrA) in the readout buffer. Tripropylamine (TPrA) is oxidized at the electrode to produce a radical cation (TprA° + ), which is rapidly deprotonated (half-life ~200 μs) to form the radical (TprA°). The radical and radical cation react with the electrochemiluminescent phosphor (Ru(bpy) 3 2+ ) reacts with the excited luminescent material Ru 2+* relaxes to the ground state and emits a photon at 620 nm. The QuickPlex SQ 120MM (Meso Scale Discovery) detects the emission using a CCD camera and acquires images of the plate during reading. The results obtained were quantified using special software (MSD Discovery workbench) and calibration standards.

[0135] 2.3.2 Viability studies Viable cells were quantified using the CellTiter-Glo® luminescent cell viability assay (Cell Viability Kit I, Promega, Cat#G7570). This test is based on the quantification of ATP present, which indicates the amount of metabolically active cells. ATP and Mg 2+ A single reagent containing luciferin, which is converted to oxyluciferin in the presence of , was added to the cells, mixed for 2 min, and allowed to stabilize for a further 10 min before luminescence was measured using a Wallac 1420 multilabel counter (Perkin Elmer GmbH).

[0136] 2.3.3 Data Analysis For dose-response relationships, absolute absorbance (OD of treated wells minus background) was related to the negative (medium) control and relative viability values ​​were plotted against test article concentration.

[0137] 2.4 Results Figure 7 shows the beneficial interaction of THC with the terpenes alpha-bisabolol and guaiol in terms of anti-inflammatory activity. To obtain the values ​​presented in Figure 7, for each data point of THC, alpha-bisabolol or guaiol concentration, each cytokine secretion measured in the PHA-stimulated group was corrected with the cytokine secretion of the non-PHA-stimulated control. The respective experimental data of cytokine secretion in non-PHA-stimulated control PBMCs and in PHA-stimulated PBMCs are shown in Figures 5 and 6. The correction values ​​of the individual compounds THC, alpha-bisabolol or guaiol were set in relation to the correction values ​​of the respective mixtures of THC, alpha-bisabolol and guaiol.

[0138] As an example, calculations for the exemplary cytokine IL-2 shown in FIG. 7 were accomplished using the following formula: TIFF2025504971000010.tif34170Since all the cytokines tested are indicative of the inflammatory response of PBMC in response to PHA-inducing stimulation, a reduction in cytokine secretion after administration of either THC, alpha-bisabolol or guaiol alone or all three components in combination is indicative of anti-inflammatory activity when compared to a non-stimulated control. The above formula allows direct comparisons to be drawn between the anti-inflammatory activity of the single substances THC, alpha-bisabolol and guaiol and their respective mixtures. A value greater than 1 means that the cytokine secretion of the mixture (denominator) is less than the sum of the cytokine secretions of each individual substance. Thus, in such cases, the anti-inflammatory activity of the mixture exceeds the combined anti-inflammatory activity of the individual compounds.

[0139] As can be seen from Figure 7, administration of THC, alpha-bisabolol and guaiol in combination reduces cytokine secretion compared to THC, alpha-bisabolol or guaiol alone. These results indicate that administration of THC, alpha-bisabolol and guaiol in combination treatments with THC / alpha-bisabolol ratios between 100:1 and 450:1, specifically between 160:1 and 295:1, and / or THC / guaiol ratios between 50:1 and 250:1, specifically between 105:1 and 200:1 enhances anti-inflammatory activity. The cannabis plant extract of the present invention contains THC and the terpenes alpha-bisabolol and guaiol in the ratios tested individually in the examples (see Table 3). It is therefore believed that compositions and pharmaceutical formulations of the present invention having the same individual active ingredients and THC / terpene ratios as the cannabis extract disclosed in this example (Table 3) are particularly effective in providing anti-inflammatory activity. Therefore, the anti-inflammatory activity of alpha-bisabolol, guaiol, beta-caryophyllene, and at least one terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol, and geraniol is considered to be enhanced by the presence of THC. From these results, it is reasonable to consider that the composition and preparation of the present invention have the excellent effect of having increased anti-inflammatory activity.

[0140] Example 3 Stability of the composition The following example demonstrates that the stability of THC in a plant extract can be increased by the addition of a carrier oil such as sesame oil.

[0141] 3.1 Test substances For the experiments, cannabis plant extracts / cannabis soft extracts were used, which may be obtained from cannabis plants deposited at the Community Plant Variety Office under application number A202104053 by Vertanical GmbH or by the method described in patent application EP22154007.3 (PCT / EP2023 / 052073) (Table 1). The aforementioned cannabis plant extracts were further processed by distillation and / or further dilution, if necessary. A distillate was produced from the cannabis plant extract by short path distillation. The cannabinoids and terpenes present in the extract are evaporated and collected as distillate. Heavy substances such as chlorophyll, sugars, salts and fats could not be evaporated and remained as residue. Dilution of the cannabis plant extract was carried out by adjusting the THC content of the extract to 10% or 5% by weight by adding the respective given volumes of ethanol or sesame oil.

[0142] 3.2 Results TIFF2025504971000011.tif73170 As can be seen from table 7, THC in cannabis plant extract is relatively unstable at high temperatures of 50°C, showing a degradation of 15% THC after 14 days of storage. Cannabis plant extract diluted with ethanol to 10% or 5% THC is more stable at high temperatures compared to cannabis plant extract without further processing, but still relatively unstable. Cannabis plant extract standardized to 5% THC by addition of sesame oil is stable for more than 2 weeks, even when stored at a very high temperature of 70°C.

[0143] Further studies have demonstrated the long-term stability of cannabis plant extract standardized to 5% THC with the addition of sesame oil, as shown in Tables 8 and 9. TIFF2025504971000012.tif34170TIFF2025504971000013.tif33170

[0144] These results show that the preferred compositions of the invention comprising cannabis plant extract and sesame oil, such as preferably the cannabis plant extract as described in table 3 diluted with sesame oil, have the excellent technical effect of providing improved short and long term stability of cannabinoids such as THC.

Claims

1. 1. A composition comprising delta-9-tetrahydrocannabinol (THC), alpha-bisabolol, guaiol, and beta-caryophyllene, and at least one terpene selected from the group consisting of linalool, alpha-humulene, nerolidol, caryophyllene oxide, alpha-pinene, camphene, beta-pinene, beta-myrcene, limonene, eucalyptol, ocimene, gamma-terpinene, terpinolene, alpha-terpinene, para-cymene, isopulegol, and geraniol.

2. 10. The composition of claim 1, wherein the delta-9-tetrahydrocannabinol (THC) and alpha-bisabolol are present in the composition in a ratio of between 100:1 and 450:

1.

3. 3. The composition of claim 1, wherein the delta-9-tetrahydrocannabinol (THC) and guaiol are present in the composition in a ratio of between 50:1 and 250:

1.

4. 3. The composition of claim 1, wherein delta-9-tetrahydrocannabinol (THC) and beta-caryophyllene are present in the composition in a ratio of between 50:1 and 250:

1.

5. (a) delta-9-tetrahydrocannabinol (THC) and linalool are present in the composition in a ratio of between 450:1 and 1400:1; (b) THC and alpha-humulene are present in the composition in a ratio of between 300:1 and 725:1; (c) THC and nerolidol are present in the composition in a ratio of between 200:1 and 600:1; (d) the THC and caryophyllene oxide are present in the composition in a ratio of between 1000:1 and 2150:1; (e) the THC and alpha-pinene are present in the composition in a ratio of between 5850:1 and 16000:1; (f) THC and camphene are present in the composition in a ratio of between 7300:1 and 132950:1; (g) THC and beta-pinene are present in the composition in a ratio of between 6475:1 and 23100:1; (h) the THC and beta-myrcene are present in the composition in a ratio of between 1950:1 and 6300:1; (i) THC and limonene are present in the composition in a ratio of between 1650:1 and 5050:1; (j) the THC and eucalyptol are present in the composition in a ratio of between 5050:1 and 38650:1; (k) THC and ocimene are present in the composition in a ratio of between 2500:1 and 44700:1; (l) the THC and gamma-terpinene are present in the composition in a ratio of between 4700:1 and 35750:1; (m) THC and terpinolene are present in the composition in a ratio of between 5450:1 and 129850:1; (n) the THC and alpha-terpinene are present in the composition in a ratio of between 5150:1 and 58550:1; (o) THC and para-cymene are present in the composition in a ratio of between 4700:1 and 56700:1; (p) THC and isopulegol are present in the composition in a ratio of between 4000:1 and 8000:1; and / or (q) The composition of claim 1 or 2, wherein THC and geraniol are present in the composition in a ratio of between 1300:1 and 18250:

1.

6. 3. The composition of claim 1 or 2, comprising delta-9-tetrahydrocannabinol (THC) in an amount between 2.5 and 10 percent by weight of the composition.

7. 3. The composition of claim 1, comprising alpha-bisabolol in an amount between 0.008 and 0.065 percent by weight of the composition.

8. 3. The composition of claim 1, comprising guaiol in an amount between 0.012 and 0.092 percent by weight of the composition.

9. 3. The composition of claim 1, comprising beta-caryophyllene in an amount between 0.012 and 0.094 percent by weight of the composition.

10. (a) linalool, in an amount between 0.001 and 0.014 percent by weight of the composition; (b) alpha-humulene in an amount between 0.003 and 0.028 weight percent of the composition; (c) nerolidol in an amount between 0.004 and 0.035 percent by weight of the composition; (d) caryophyllene oxide in an amount between 0.001 and 0.0092 percent by weight of the composition; and / or (e) limonene in an amount between 0.0005 and 0.004 percent by weight of the composition; The composition of claim 1 or 2, comprising:

11. 3. The composition of claim 1 or 2, which is a cannabis plant extract.

12. 12. The composition according to claim 11 , wherein the cannabis plant extract is obtainable by solvent extraction of the cannabis plant.

13. 12. The composition according to claim 11 , wherein the cannabis plant extract is obtainable by solvent extraction of flower material of the cannabis plant.

14. 12. The composition of claim 11, wherein the cannabis plant extract is an alcoholic extract.

15. 3. The composition of claim 1 or 2, in liquid form.

16. 3. The composition of claim 1, further comprising a carrier oil.

17. A pharmaceutical formulation comprising the composition of claim 1 or 2.

18. 18. The pharmaceutical formulation of claim 17 comprising delta-9-tetrahydrocannabinol (THC) in an amount between 1.0 percent and 2.5 percent, wherein the THC and alpha-bisabolol are present in the formulation in a ratio of between 100:1 and 450:1, the THC and guaiol are present in the formulation in a ratio of between 50:1 and 250:1, and / or the THC and beta-caryophyllene are present in the formulation in a ratio of between 50:1 and 250:

1.

19. 19. The pharmaceutical formulation of claim 18, wherein delta-9-tetrahydrocannabinol (THC) and linalool are present in the formulation in a ratio of between 500:1 and 1330:1, wherein THC and alpha-humulene are present in the formulation in a ratio of between 355:1 and 665:1, and wherein THC and nerolidol are present in the formulation in a ratio of between 285:1 and 535:

1.

20. 18. The pharmaceutical formulation of claim 17, further comprising a carrier oil.

21. 3. A composition according to claim 1 or 2 for use in medicine.

22. 3. The composition according to claim 1 or 2 for use in the treatment and / or prevention of chronic cancer pain, somatic pain, visceral pain, central neuropathic pain, peripheral neuropathic pain or complex pain syndrome.

23. 22. The composition of claim 21, which is administered by oral, buccal, intranasal, topical, rectal or vaginal administration.

24. A kit comprising component A and component B, wherein component A is the composition of claim 1 or 2, and component B is a carrier oil.

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