Compositions comprising banisteriopsis caapi

Abstract

Embodiments of the invention are directed to combustibles and oils containing a Caapi powder or a Caapi infusion.

Description

COMPOSITIONS COMPRISING BANISTERIOPSIS CAA ISTATEMENT REGARDING FEDERALLY FUNDED RESEARCH

[0001] None.BACKGROUND

[0002] Classic psychedelics have been used by humans for thousands of years, with a strong tradition in indigenous cultures where they were used in healing events, rituals, and sacramentals. Despite this, research on their pharmacological use only begun to emerge significantly in the 1990s. Recent clinical trials have suggested that these substances would be safe and effective in their use in the treatment of several mental health conditions with unmet needs. The therapeutic effects of psychedelics depend on the psychedelic experience felt by the patient during treatment. Studies suggest that elements of the psychedelic experience mediate the therapeutic benefit.

[0003] Classic psychedelics include tryptamine derivatives, such as psilocybin, psilocin, N,N-dimethyltryptamine (DMT), 5-MeO-N,N-dimethyltryptamine (5-MeO-DMT), bufotenin, baeocystin and norbaeocystin. These derivatives have a pharmacological action mechanism based on their agonist action on the serotonin 5HT2A receptor.

[0004] Clinical studies of tryptamines with hallucinogenic effects include treatment of various neurological pathologies, such as depressive disorders, anxiety disorders, substance abuse, and nervous anorexia. These studies have shown that the use of these tryptamine derivatives generates benefits for the patient in the disorders mentioned above. The studies are mainly focused on the use of psilocybin, and on compositions containing DMT together with inhibitors of the enzyme monoamine oxidase (i.e., MAO), for example, ayahuasca.

[0005] Traditionally, DMT is consumed for medicinal purposes by indigenous populations of the Amazon Basin in a drink known as Ayahuasca. This drink manages to neutralize the action of MAO enzymes, allowing the DMT to take action in the central nervous system. This is achieved because it is prepared by the decoction of two plants, leaves of Psychotria viridis, which contain DMT, and the bark of the Banisteriopsis caapi vine, which is rich in iMAOs such as harmine and harmaline. In some cases, traditional preparations use other vegetable species that contain active compounds with similar biochemical properties.

[0006] Natural substances, such as plant materials, offer a plethora of pharmaceutically active agents which can provide a wide range of therapeutic and other beneficial effects. Smoking or combustible products, as well as infused oils or topicals provide a rapid and efficient method of delivery.

[0007] There remains a need for products that provide the benefits of natural products to those in need of such treatments.SUMMARY

[0008] Certain embodiments are directed to smokable products comprising a combustible material. The combustible material can include tobacco or other smokable materials mixed with a Caapi powder or Caapi extract. The Caapi powder or Caapi extract can be present in an amount of at least 1% or 25% by dry weight of the total weight of the smokable product. The smokable product can be, for example, a filtered cigarette, a filtered cigarillo, a filtered tobacco cartridge, an unfiltered cigarette, an unfiltered cigarillo and an unfiltered tobacco cartridge. In certain aspects the smokable product is smoking tobacco, for example fine-cut tobacco and pipe tobacco. The combustible products can be a tobacco-free mixture of plant material which is selected from the group consisting of coltsfoot, peppermint, stinging nettle, ripple-seed plantain, crispleaf mint, lavender, thyme, sweet cherry leaves, sour cherry leaves, knotweed leaves, rose leaves, pimento leaves, cinnamon bark, and combinations thereof. In certain aspects the combustible product is a combination of tobacco mixture and tobacco-free mixture.

[0009] Other embodiments are directed to a Caapi infused oil or ointment comprising one more oils that have been heat infused with a Caapi material at 140 to 240 °C for 2 to 6 hours. The oil or ointment composition can include one or more oils selected from balsam fir oil, black spruce, lavender oil, tea tree oil, frankincense oil, peppermint oil, eucalyptus oil, lemon oil, lemongrass oil, orange oil, rosemary oil, bergamot oil, cedarwood oil, grapeseed oil, olive oil, jojoba oil, babassu oil, caster oil, coconut oil, com oil, cotton seed oil, linseed oil, mustard oil, safflower oil, sesame oil, soybean oil, sunflower- seed oil, wheat germ oil, argan oil and marula oil. In certain aspects the composition contains 0.05 to 99.9 % volume to volume of one or more oils. The oil or ointment composition, for example, can include 70 to 90 v / v% coconut oil, 10 to 25 v / v% jojoba oil, and 0.005 to 10 v / v% vitamin E oil.

[0010] Certain embodiments are directed to beverages and food products supplemented with Caapi or Caapi powder, or Caapi extract. The food products into which the additive(s) are addedwill generally include other ingredients. The term “food product” as used herein refers to an edible product fit for consumption. Embodiments include the use of Caapi, Caapi powder, or Caapi extract in a food product, where the food product comprises bakery products, including biscuits, donuts, cakes, pastries, muffins, breads, and cookies; snacks, including candied fruits, nougat crumbs, expanded snacks, dates, bars, chips, and dried fruits; confectionery products, including hard and soft candies, chewing gums, dragees, jelly beans; food fillings, jellies, jams, marmalades, chocopaste, chocolate, nut butter, fudges, honey, processed cheese, cream cheese, peanut butter, honey replacers, margarine, and butter.

[0011] The plant Banisteripsis caapi, referred to as Caapi or Caapi vine throughout this disclosure, is a South American liana of the family Malpighiaceae . It is commonly used as an ingredient of ayahuasca, a decoction with a long history of its entheogenic (connecting to spirit) use and its status as a "plant teacher" among the Indigenous peoples of the Amazon rainforest. Caapi is a giant vine with characteristic 12-14 mm (0.5-0.6 in) white or pale pink flowers which most commonly appear in January but are known to bloom infrequently. It resembles Banisteriopsis membramfolia and Banisteriopsis muricata, both of which are related to Caapi and can be substituted for Caapi in the compositions and methods described herein. The vine can grow up to 30 m (98 ft) in length, twining on other plants for support.

[0012] In certain aspects, Caapi can be formulated as a tablet, a capsule, a concentrate, a powder, a beverage, a baked good, chocolate, caramel, cookie, bar, and / or snack.

[0013] Other embodiments of the invention are discussed throughout this application. Any embodiment discussed with respect to one aspect of the invention applies to other aspects of the invention as well and vice versa. Each embodiment described herein is understood to be embodiments of the invention that are applicable to all aspects of the invention. It is contemplated that any embodiment discussed herein can be implemented with respect to any method or composition of the invention, and vice versa. Furthermore, compositions and kits of the invention can be used to achieve methods of the invention.

[0014] The use of the word “a” or “an” when used in conjunction with the term “comprising” in the claims and / or the specification may mean “one,” but it is also consistent with the meaning of “one or more,” “at least one,” and “one or more than one.”

[0015] Throughout this application, the term “about” is used to indicate that a value includes the standard deviation of error for the device or method being employed to determine the value.

[0016] The use of the term “or” in the claims is used to mean “and / or” unless explicitly indicated to refer to alternatives only or the alternatives are mutually exclusive, although the disclosure supports a definition that refers to only alternatives and “and / or.”

[0017] As used in this specification and claim(s), the words “comprising” (and any form of comprising, such as “comprise” and “comprises”), “having” (and any form of having, such as “have” and “has”), “including” (and any form of including, such as “includes” and “include”) or “containing” (and any form of containing, such as “contains” and “contain”) are inclusive or open-ended and do not exclude additional, unrecited elements or method steps.

[0018] As used herein, the terms “comprises,” “comprising,” “includes,” “including,” “has,” “having,” “contains”, “containing,” “characterized by” or any other variation thereof, are intended to encompass a non-exclusive inclusion, subject to any limitation explicitly indicated otherwise, of the recited components. For example, a chemical composition and / or method that “comprises” a list of elements (e.g., components or features or steps) is not necessarily limited to only those elements (or components or features or steps) but may include other elements (or components or features or steps) not expressly listed or inherent to the chemical composition and / or method.

[0019] As used herein, the transitional phrases “consists of’ and “consisting of’ exclude any element, step, or component not specified. For example, “consists of’ or “consisting of’ used in a claim would limit the claim to the components, materials or steps specifically recited in the claim except for impurities ordinarily associated therewith (i.e., impurities within a given component). When the phrase “consists of’ or “consisting of’ appears in a clause of the body of a claim, rather than immediately following the preamble, the phrase “consists of’ or “consisting of’ limits only the elements (or components or steps) set forth in that clause; other elements (or components) are not excluded from the claim as a whole.

[0020] As used herein, the transitional phrases “consists essentially of’ and “consisting essentially of’ are used to define a chemical composition and / or method that includes materials, steps, features, components, or elements, in addition to those literally disclosed, provided that these additional materials, steps, features, components, or elements do not materially affect the basic and novel characteristic(s) of the claimed invention. The term “consisting essentially of’ occupies a middle ground between “comprising” and “consisting of’.

[0021] Other objects, features and advantages of the present invention will become apparent from the following detailed description. It should be understood, however, that the detailed description and the specific examples, while indicating specific embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description.DESCRIPTION

[0022] The following discussion is directed to various embodiments of the invention. The term “invention” is not intended to refer to any particular embodiment or otherwise limit the scope of the disclosure. Although one or more of these embodiments may be preferred, the embodiments disclosed should not be interpreted, or otherwise used, as limiting the scope of the disclosure, including the claims. In addition, one skilled in the art will understand that the following description has broad application, and the discussion of any embodiment is meant only to be an example of that embodiment, and not intended to imply that the scope of the disclosure, including the claims, is limited to that embodiment.

[0023] A powdered Banisteripsis caapi vine or a Caapi vine extract can be a component of a Caapi infused ointment / oil, a combustible product, a tobacco product, or a vaporization product according to the invention.

[0024] The term "tobacco products" used in this description is to be understood as meaning both cigarettes, cigarillos and tobacco cartridges (so-called tobacco-"rolls") with or without a filter and fine-cut and pipe tobacco, which consist entirely or proportionally of tobacco and / or another smokable material. Certain embodiments are directed to combustible products resembling tobacco products, such as compositions of smokable spices or tobacco-free plant combustibles. Other natural substances can be a component of the composition of the invention and include vanillin, ethylvanillin, cinnamaldehyde, anisaldehyde, coumarin, 6-methylcoumarin, eugenol, jasmine aldehyde, anethole, p-anisyl acetone, limonene, cinnamon and cinnamon extract.

[0025] A Caapi powder or smokable may be prepared by shredding, grinding, dry milling, wet milling or cryomilling of the Caapi vine. In one example the method includes drying Caapi stems, leaves, and / roots to obtain a dry Caapi material; grinding the Caapi material to obtain aground powder. The plant material can be maintained at a grinding temperature of 0, 5, 10, 20, 30, up to 40° C.

[0026] In one embodiment a powdered Caapi preparation can be prepared by cryogenic milling with any commercially available mill capable of milling under cryogenic conditions and the operating temperatures. An example of a suitable device for this purpose can be an appropriately equipped vibrating mill offered by MBE Coal & Minerals Technology GmbH for liquid nitrogen cooling or a similar device suitable for operating temperatures and vibration frequencies. The plant material is placed in the cooled mill chamber. The cooling system is then activated and the plant material is frozen. Pre-cooling is carried out for about 1 hour by introducing liquid nitrogen into the cooling system under a pressure of 0.15 to 0.25 atm. The temperature of the coolant being introduced is from -185° C to -110° C, preferably about -130° C on average, and the gas temperature leaving the cooling system is from -40° C to -15° C, preferably about -30° C on average. The plant material can be frozen to a temperature below -90° C, e.g., to a temperature between -150° C and -110° C. The grinding process is carried out by grinding the frozen plant material for 1 minute to 15 minutes, e.g., 5 to 10 minutes. The grinding is carried out at a temperature ranging from -150° C to -15° C.

[0027] In certain aspects the grain size of the powder obtained is normalized and plant fragments which have not been milled properly are separated. This separation can be performed by sieving the powder through a sieve with a mesh size ranging from 400 pm to 150 pm.

[0028] Caapi infused ointments / oils. Dried or powdered plant can be placed into a suitable container and covered with oil forming an infusion mixture. The infusion mixture is incubated at an elevated temperature, e.g., at least 140, 150, 160, 170, 180, 190, 200, 210, 220, up to 240 °C. in certain embodiments the infusion mixture is incubated at about 180 °C. The incubation can be for 1, 2, 3, 4, 5, 6, 7, 8, 9, up to 10 hours. In certain embodiments the incubation is for about 4 hours. The infusion mixture can include 1, 5, 10, 15, 20, 25, 30, 35, 40, 45, to 50 weight percent Caapi material (powdered, shredded, or macerated) and 50, 55, 65, 70, 75, 80, 85, 90, 95, to 99 weight percent of an oil or oil mixture. After incubation the oil is filtered or strained to remove the Caapi material forming a Caapi infused oil preparation. An infusion mixture can contain Bcmisteriopsis Caapi'. 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, to 60 grams of Caapi, including all values and ranges there between; a base Oil (e.g., coconut oil or the equivalent): 8, 16, 24, 32, 40, 48, 56, to 64 ounces; one or more supplementary oils (e.g., Jojoba Oil orequivalents): independently 0.05, 0.1, 0.25. 0.50, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, to 21 ounces of each supplementary oil included. In certain aspects the Caapi material is filtered or separated forming a Caapi infusion or oil extract (“Caapi extract”).

[0029] A range of oils can be used in singular or multiple combinations. Any oil or oil combination may be used as the oil component in the oil infusions so long as it does not cause skin sensitization. The oil component can be mixture of oils. Infusion of an oil enables bioactive compounds present in the oil infusions to effectively penetrate into the skin, without the need to use skin-sensitizing essential oils, and while still facilitating the desired degree of efficacy. Oils that may be used include, but are not limited to, balsam fir oil, black spruce, lavender oil, tea tree oil, frankincense oil, peppermint oil, eucalyptus oil, lemon oil, lemongrass oil, orange oil, rosemary oil, bergamot oil, cedarwood oil, grapeseed oil, olive oil, jojoba oil, babassu oil, caster oil, coconut oil, corn oil, cotton seed oil, linseed oil, mustard oil, safflower oil, sesame oil, soybean oil, sunflower-seed oil, wheat germ oil, argan oil and marula oil. In certain embodiments the oil can be a cooking oil including but not limited to olive oil, palm oil, soybean oil, canola oil (rapeseed oil), corn oil, peanut oil and other vegetable oils, as well as animal-based oils like butter and lard.

[0030] In one embodiment an infusion mixture can contain Banisteriopsis Caapi'. 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, to 60 grams of Caapi, including all values and ranges there between; Coconut Oil: 8, 16, 24, 32, 40, 48, 56, to 64 ounces; Jojoba Oil: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, to 21 ounces; Vitamin E Oil: 0.05 to 3 ounces.

[0031] According to certain embodiments, Caapi powder or Caapi extract are contained in a tobacco or combustible product individually or in combination, the relative amounts based on the total weight of the composition of a smokable tobacco product or vaporization product. Caapi powder or extract can be incorporated in a smoking tobacco or vaporization composition including the customary additives and components of tobacco or vaporization products. The products described herein can be associated with fdters, wrapping papers, carriers, seam glue and other smokable or vaporization accessories or agents.

[0032] If a Caapi powder or Caapi extract is added to tobacco, the preferred relative amount is in the range from 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, to 25% dry weight percent.

[0033] If a Caapi powder or Caapi extract can be contained in a non-tobacco smokable mixture, the preferred relative amount is in the range from 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, to 25% dry weight percent.

[0034] The Caapi powder or Caapi extract according to the invention can be added to cut leaves and / or cut stems in a manner known for preparing a smokable mixture. The Caapi powder or Caapi extract can be incorporated in tobacco. A non-tobacco-containing plant can also be used. The smokable base material can be tobacco or a mixture of tobaccos or a tobacco-free mixture of plant material. A tobacco-free plant material can be coltsfoot, peppermint, stinging nettle, ripple-seed plantain, crispleaf mint, lavender, thyme, sweet or sour cherry leaves, knotweed leaves, rose leaves, pimento leaves or cinnamon bark. Consuming or smoking the product according to the invention provides a Caapi enriched smoke or vapor.

[0035] The tobacco mixture can comprise about 1 percent to about 25 percent, about 5 percent to about 20 percent, or 10 percent to 15 percent by weight Caapi powder or Caapi extract.

[0036] In some embodiments of the present disclosure there is provided a method of pulmonary delivery to a subject of a Caapi powder or Caapi extract. The method of pulmonary delivery can be a metered dose inhaler device configured to vaporize at least one pre-determined vaporized amount of the Caapi powder or Caapi extract upon controllably heating the material.

[0037] The desired effect of delivery of components of Caapi powder or Caapi extract includes amelioration of a symptom such as pain, migraine, depression, cognitive function deficit, attention deficit, hyperactivity, anxiety disorders, insomnia, delirium, post-traumatic stress disorder (PTSD) symptoms, drug addiction and craving, withdrawal symptoms, tremors and other movement disorders.

[0038] According to some embodiments, a psychotropic effect can corresponds to a symptom that includes paranoia, anxiety, panic attack, euphoria, pseudo-hallucinatory, ataxia, sedation, conscious perception variation, joviality, metacognition and introspection, an enhanced recollection (episodic memory), amnesia, a sensuality variation, a variation in awareness of sensation and a variation in libido, dizziness, ataxia, euphoria, perceptual alterations, temporal distortion, intensification of ordinary sensory experiences, short term memory, and attention, impaired reaction, skilled activity, verbal fluency, dependence and depression.

[0039] According to some embodiments of the present invention, the compositions, methods, devices and systems provided herein are capable of delivering an amount of an active agent contained in a Caapi powder or Caapi extract that induce one or more effects in a subject.

[0040] The term “patient” is used interchangeably with the terms “subject”, “user” and “a person in need thereof’ to refer to the entity that uses any of the compositions, devices and systems provided herein and being the subject of any of the methods provided herein.

[0041] According to an aspect of some embodiments of the present disclosure, there is provided a method of smoking or vaporizing Caapi powder or Caapi extract being suitable for inhalation by a subject. The Caapi composition can be a solid (e.g., powder) or a liquid (e.g., oil extract) form. According to some embodiments of the present disclosure, the compositions are vaporizable by heat, thereby can be released from the substance by being heat-induced vaporization or burning.

[0042] According to some embodiments, a composition contains a burnable or vaporizable Caapi powder or Caapi extract.

[0043] The Caapi powder or Caapi extract can be administered in a predetermined regimen. A regimen is a plurality of predetermined doses that can be different in amounts or similar, given at various time intervals, which can be different or similar in terms of duration. In some embodiments, a regimen also encompasses a time of a delivery period (e.g., agent administration period, or treatment period).

[0044] In the context of some embodiments of the present disclosure, the term “treatment” refers to any one of: a single administration of an agent at a given dose; a fixed and limited series of administrations of an agent, given at the same or different doses at the same or different dose intervals (regimen); a chronic treatment which is administered as the limited series, but without a planned termination of the treatment (continuous treatment); and / or any combination thereof. Typically, a series of pre-determined doses given at predetermined intervals, is referred to herein as a treatment regimen, or a regimen.

[0045] A “personally perceived effect” is a subjective assessment of a patient pertaining to an effect of a given agent or treatment in the patient's body. The personally perceived effect may include one or more of a personally perceived therapeutic effect or a personally perceived adverse effect.

[0046] A psychotropic effect corresponds to a symptom that can be perceived by the patient. It is noted that in some cases a psychotropic effect may not be accurately perceived by the patient. Examples of psychotropic symptoms include, without limitation, paranoia, anxiety, panic attack, euphoria, pseudo-hallucinatory, sedation, conscious perception variation, joviality, metacognition and introspection, an enhanced recollection (episodic memory), amnesia, a sensuality variation, a variation in awareness of sensation and a variation in libido, dizziness, ataxia, euphoria, perceptual alterations, temporal distortion, intensification of ordinary sensory experiences, short term memory, and attention, impaired reaction, skilled activity, verbal fluency, dependence, melancholy and depression.

[0047] A “personally perceived therapeutic effect” is a subjective assessment of a patient pertaining to a beneficial (desired) effect of a given agent in the patient's body. In some embodiments, a desired effect includes a relief of a symptom and / or an alleviation of cause of a medical condition. For example, if the desired therapeutic effect is defined as an alleviation of pain, the patient may report a level of pain by means of a pain scale evaluation protocol. A pain scale protocol measures a patient's pain intensity and / or other features. In general, all personally perceived (subjective) assessments by a patient can be used as feedback for self-titration and personalization of a treatment.

[0048] A personally perceived therapeutic effect may be associated with or corresponds to, directly or indirectly, a symptom of the medical condition which the patient is being treated for. In some cases a patient may perceive a change in the perceived level of the symptom, and when the symptom of the medical condition is alleviated (a diminution in the level of the symptom), the person perceives this change as a therapeutic effect of agent delivered during the treatment. Hence, according to embodiments, a personally perceived therapeutic effect corresponds to a reduction in a level of a symptom such as, but not limited to, pain, migraine, depression, cognitive function deficit, attention deficit, hyperactivity, anxiety disorders, diarrhea, nausea, vomiting, insomnia, delirium, appetite variations, sexual dysfunction, spasticity, increased intra ocular pressure, bladder dysfunction, tics, Tourette symptoms, posttraumatic stress disorder (PTSD) symptoms, inflammatory bowel disease (IBD) symptoms, irritable bowel syndrome (IBS) symptoms, hyper tension, hemorrhagic symptoms, septic and cardiogenic shock, drug addiction and craving, withdrawal symptoms, tremors and other movement disorders symptoms.

[0049] Some plants which can be used in the context of the present disclosure, include, without limitation, Cannabis saliva, Cannabis indica, Cannabis ruderalis, Acacia spp, Amanita mnscaria, Yage, Atropa belladonna, Areca catechu, Brugmansia spp., Brunfelsia latifolia, Desmanthus illinoensis, Banisteriopsis caapi, Trichocereus spp., Theobroma cacao, Capsicum spp., Ce strum spp., Erythroxylum coca, Solenostemon scutellarioides, Arundo donax, Coffea arabica, Datura spp., Desfontainia spp., Diplopterys cabrerana, Ephedra sinica, Claviceps purpurea, Paullinia cupana, Argyreia nervosa, Hyoscyamus niger, Tabernanthe iboga, Lagochilus inebriens, Justicia pectoralis, Sceletium tortuosum, Piper methysticum, Catha edulis, Mitragyna speciosa, Leonotis leonurus, Nymphaea spp., Nelumbo spp., Sophora secundiflora, Mucuna pruriens, Mandragora officinarum, Mimosa tenuiflora, Ipomoea violacea, Psilocybe spp., Panaeolus spp., Myristica fragrans, Turbina corymbosa, Passiflora incarnate, Lophophora williamsii, Phalaris spp., Duboisia hopwoodii, Papaver somniferum, Psychotria viridis, spp., Salvia divinorum, Combretum quadrangulare , Trichocereus pachanoi, Heimia salicifolia, Stipa robusta, Solandra spp., Hypericum perforatum, Peganum harmala, Tabernae montana spp., Camellia sinensis, Nicotiana tabacum, rusticum, Virola theidora, Voacanga africana, Lactuca virosa, Artemisia absinthium, Ilex paraguariensis, Anadenanthera spp., Corynanthe yohimbe, Calea zacatechichi, Coffea spp. (Rubiaceae), Sapindaceae, Camellia spp., Malvaceae spp., Aquifoliaceae spp., Hoodia spp., Chamomilla recutita, Passiflora incarnate, Camellia sinensis, Mentha piperita, Mentha spicata, Rubus idaeus, Eucalyptus globulus, Lavandula officinalis, Thymus vulgaris, Melissa officinalis, any part and any combination thereof.

[0050] Other plants and plant materials, which can be used beneficially to burn or vaporize at least one agent in the context of embodiments of the present disclosure include, without limitation, Aloe Vera, Angelica, Anise, Ayahuasca (Banisteriopsis caapi). Barberry, Black Horehound, Blue Lotus, Burdock, Camomille / Chamomile, Caraway, Cat's Claw, Clove, Comfrey, Com Silk, Couch Grass, Damiana, Damiana, Dandelion, Ephedra, Eucalyptus, Evening Primrose, Fennel, Feverfew, Fringe Tree, Garlic, Ginger, Ginkgo, Ginseng, Goldenrod, Goldenseal, Gotu Kola, Green Tea, Guarana, Hawthorn, Hops, Horsetail, Hyssop, Kola Nut, Kratom, Lavender, Lemon Balm, Licorice, Lion's Tail (Wild Dagga), Maca Root, Marshmallow, Meadowsweet, Milk Thistle, Motherwort, Passion Flower, Passionflower, Peppermint, Prickly Poppy, Purslane, Raspberry Leaf, Red Poppy, Sage, Saw Palmetto, Sida Cordifolia, Sinicuichi (Mayan Sun Opener), Spearmint, Sweet Flag, Syrian Rue (Peganum harmala), Thyme, Turmeric,Valerian, Wild Yam, Wormwood, Yarrow, Yerba Mate, Yohimbe, and any part and any combination thereof.I. Food Stuffs (Beverages and Food Products)

[0051] Disclosed herein are beverages and food products supplemented with Caapi or Caapi powder, or Caapi extract. The food products into which the additive(s) are added will generally include other ingredients. The term “food product” as used herein refers to an edible product fit for consumption. Embodiments include the use of Caapi, Caapi powder, or Caapi extract in a food product, where the food product comprises bakery products, including biscuits, donuts, cakes, pastries, muffins, breads, and cookies; snacks, including candied fruits, nougat crumbs, expanded snacks, dates, bars, chips, and dried fruits; confectionery products, including hard and soft candies, chewing gums, dragees, jelly beans; food fillings, jellies, jams, marmalades, chocopaste, chocolate, nut butter, fudges, honey, processed cheese, cream cheese, peanut butter, honey replacers, margarine, and butter.

[0052] Non-limiting examples of beverages that can be supplemented with Caapi, Caapi powder, or Caapi extract powder include naturally or artificially flavored fruit or vegetable juices such as apple juice, carrot juice, cherry juice, cranberry juice, grape juice, grapefruit juice, orange juice, pear juice, tomato juice, or a combination thereof; milk; commercially available sports drinks (sugar or juice based); soda; flavored waters; soy milk; coffee, cacao beverages, and nutrition beverages. The beverage can be carbonated or non-carbonated. In particular embodiments, the beverage is in a concentrated form for later dilution by the consumer or ready- to-drink. Alcoholic beverages are also encompassed by this disclosure, such as wine, wine coolers, malt beverages and coolers, and beer.

[0053] Certain embodiments of the disclosed food products are thermally processed after Caapi, Caapi powder, or Caapi extract included in the food composition. Examples of thermal processing include, but are not limited to, baking, roasting, broiling, and frying. Non-limiting examples of food products include flour- and grain-based products, such as bakery products, for example bread, cookies, muffins, rolls, brownies, pies, and cakes (or mixes to prepare such products, such as cake mixes). Other non-limiting examples include breakfast cereals, nutrition bars, snack bars, granola bars, animal feed products, bread crumbs, yogurt, gum, candy, and canned-goods, such as soups, pastas, vegetables, fruits (such as pie fillings) and meats.

[0054] Solid dosage forms for oral administration include capsules, tablets, powders, granules, and food stuffs. In such solid dosage forms, the Caapi, Caapi powder, or Caapi extract is admixed with at least one inert customary excipient (or carrier) such as sodium citrate or dicalcium phosphate or (a) fillers or extenders, as for example, starches, lactose, sucrose, mannitol, or silicic acid; (b) binders, as for example, carboxymethylcellulose, alginates, gelatin, polyvinylpyrrolidone, sucrose, or acacia; (c) humectants, as for example, glycerol; (d) disintegrating agents, as for example, agar-agar, calcium carbonate, potato or tapioca starch, alginic acid, certain complex silicates, or sodium carbonate; (e) solution retarders, as for example, paraffin; (f) absorption accelerators, as for example, quaternary ammonium compounds; (g) wetting agents, as for example, cetyl alcohol or glycerol monostearate; (h) adsorbents, as for example, kaolin or bentonite; and / or (i) lubricants, as for example, talc, calcium stearate, magnesium stearate, solid polyethylene glycols, sodium lauryl sulfate, or mixtures thereof. In the case of capsules and tablets, the dosage forms may also comprise buffering agents.

[0055] Solid compositions of a similar type may also be used as fillers in soft or hard filled gelatin capsules using such excipients as lactose or milk sugar, as well as high molecular weight polyethylene glycols, and the like.

[0056] Solid dosage forms such as tablets, capsules, and granules can be prepared with coatings or shells, such as enteric coatings and others well known in the art. They may also contain opacifying agents and can also be of such composition that they release the active compound or compounds in a delayed manner. Examples of embedding compositions that can be used are polymeric substances and waxes. The active compounds can also be in micro- encapsulated form, if appropriate, with one or more of the above-mentioned excipients.

[0057] Liquid dosage forms for oral administration include acceptable emulsions, solutions, suspensions, syrups, and elixirs. In addition to the active compounds, the liquid dosage form may contain inert diluents commonly used in the art, such as water or other solvents, solubilizing agents and emulsifiers, as for example, ethyl alcohol, isopropyl alcohol, ethyl carbonate, ethyl acetate, benzyl alcohol, benzyl benzoate, propylene glycol, 1,3-butylene glycol, dimethylformamide, oils, in particular, cottonseed oil, groundnut oil, corn germ oil, olive oil, castor oil, sesame seed oil, glycerol, tetrahydrofurfuryl alcohol, polyethylene glycols, fatty acid esters of sorbitan, or mixtures of these substances, and the like.

[0058] Suspensions, in addition to the active compound(s), may contain suspending agents, as for example, ethoxylated isostearyl alcohols, polyoxyethylene sorbitol or sorbitan esters, microcrystalline cellulose, aluminum metahydroxide, bentonite, agar-agar, or tragacanth, or mixtures of these substances, and the like.

[0059] Dosage forms for topical administration of Caapi, Caapi powder, or Caapi extract include ointments, powders, sprays and inhalants. The compound(s) are admixed with a physiologically acceptable carrier, and any preservatives, buffers, and / or propellants that may be required.

[0060] For Caapi, Caapi powder, or Caapi extract of the present invention, alone or as part of a supplement composition, the doses are between about 1, 100, 200, 300, 400, 500, 600 to 500, 600, 700, 800, 900, 1000 mg, preferably between 200 and 600 mg. In certain aspects, Caapi, Caapi powder, or Caapi extract is administered 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 times per day. In certain aspects, Caapi, Caapi powder, or Caapi extract is administered once every 1, 2, 3, 4, 5, 6, or 7 days.

Claims

CLAIMS1. A smokable product comprising a combustible material, the combustible material including tobacco or other smokable materials, and a Caapi powder or Caapi extract, wherein the Caapi powder or Caapi extract are present in an amount of at least 1% or 25% by dry weight of the total weight of the smokable product.

2. The smokable product according to claim 1, wherein the smokable product is a filtered cigarette, a filtered cigarillo, a filtered tobacco cartridge, an unfiltered cigarette, an unfiltered cigarillo and an unfiltered tobacco cartridge.

3. The smokable product according to claim 2, wherein the smokable product is smoking tobacco selected from fine-cut tobacco and pipe tobacco.

4. The smokable product according to claim 1, wherein the combustible products are a tobacco- free mixture of plant material which is selected from the group consisting of coltsfoot, peppermint, stinging nettle, ripple-seed plantain, crispleaf mint, lavender, thyme, sweet cherry leaves, sour cherry leaves, knotweed leaves, rose leaves, pimento leaves, cinnamon bark, and combinations thereof.

5. The smokable product according to claim 1, wherein the combustible products are a combination of tobacco mixture and tobacco-free mixture.

6. A Caapi infused oil or ointment comprising one more oils that have been heat infused with a Caapi material at 140 to 240 °C for 2 to 6 hours.

7. The oil or ointment composition of claim 6, wherein the oil comprises one or more oils selected from balsam fir oil, black spruce, lavender oil, tea tree oil, frankincense oil, peppermint oil, eucalyptus oil, lemon oil, lemongrass oil, orange oil, rosemary oil, bergamot oil, cedarwood oil, grapeseed oil, olive oil, jojoba oil, babassu oil, caster oil, coconut oil, corn oil, cotton seed oil, linseed oil, mustard oil, safflower oil, sesame oil, soybean oil, sunflower- seed oil, wheat germ oil, argan oil and marula oil.

8. The oil or ointment composition of claim 7, wherein the selected oil comprises 0.05 to 99.9 % volume to volume of the oil or ointment composition.

9. The oil or ointment composition of claim 6, comprising 70 to 90 v / v% coconut oil, 10 to 25 v / v% Jojoba Oil, and 0.005 to 10 v / v% Vitamin E Oil.