CANNABIS ROOT EXTRACT, METHOD OF MANUFACTURE, METHOD OF USE

[0001] Field of the Invention [0002] The invention relates to a method of manufacture for an oil soluble fraction of cannabis root, and its use in a variety of pharmaceutical and cosmetic formulations.

[0003] Background of the Invention [0004] Cannabis Root Oil

[0005] Although cannabis plant has numerous known pharmaceutical and recreational uses, the largest concentration of desirable active ingredients, and historically, the most desirable parts of the plant are found above ground, most particularly, the stem, leaves, flowers, and

seeds. Cannabis root has been generally overlooked as a pharmaceutical source.

[0006] Cannabis root has relatively small concentrations of THC as compared to other portions of the plant. Historically, traditional Chinese medicine dating from about 2700 BC appears to have used cannabis root as a medicinal ingredient, in a dried and ground form, to reduce pain, heal broken bones and recover from surgical wounds. It was also crushed to extract juice, or boiled to make a decoction, used as a diuretic, an anti-haemorrhagic to stop bleeding, to ease difficult childbirth and to reduce pain and swelling from bruises. In Roman times, cannabis root was boiled in water to make a preparation that relieved joint cramps, gout and acute pain. Boiled cannabis poultices were also used to treat inflammation, gout and other ailments. In the early l8 ^th century, in England, physicians used cannabis root, mixed with barley flour as a poultice, whereas in America, decoctions were used to treat inflammation, incontinence and venereal disease. [0007] Cannabis root is believed to contain a complex mixture of pharmaceutically active ingredients, including terpenes such as antioxidant friedelin

((4R,4aS,6aS,6aS,6bR,8aR, \2aR, \4aS,\4bS)-4,4a,6a,6b, a, 11, 11, l4a-Octamethyl- 2, 4, 5, 6, 6a, 7, 8, 9, 10, 12, l2a, 13, 14, l4b-tetradecahydro-lF/-picen-3-one), anti-tumor epifriedelanol, pentacyclic triterpene ketones, alkaloids, ketones, atropine, and choline. Interestingly, cannabis root has relatively very low amounts of the cannabinoids generally known for cannabis’ active properties, such as cannabidiol and tertrahydrocannabinol (THC), through a complex mixture of literally dozens of active cannabinoids is present in small quantities. Friedelin is thought to have liver protecting and anti-tumour effects, while certain ketones found in cannabis root are thought to cause apoptosis, with certain studies suggesting they also reduce pain, inflammation, and bacterial infection.

Friedelin

Cannabidiol

Atropine

[0008] To the inventor’s knowledge, cannabis root oil, or a purified oil soluble fraction of cannabis root, has not been used or known as a therapeutic. Typically the cannabis root, if used, is pulverized or powdered. [0009] Radiation Recall

[0010] Radiation recall is a skin reaction that is a side effect of radiation therapy when it is combined with certain chemotherapy regimens. Radiation recall is an acute, though often severe, inflammatory reaction, and its cause and management is not well understood. Radiation recall is often presented as a rash or appearing like a severe sun burn. Current treatment options are limited, and are generally based on traditional anti-inflammatory drugs, such as corticosteroids.

In certain instances, radiation recall has been known to be so severe as to require delay of chemotherapy and/or radiation therapy until the skin clears and can better withstand it, which is not desirable, since delay of chemotherapy, while good for the radiation recall, is often bad for the cancer treatment.

[0011] Even without radiation treatment, minor skin changes and/or skin irritation often occurs during, and for some time after, chemotherapy. Skin can become very itchy, sensitive, irritated and red, either in a localized manner (such as the forearms), or the entire body. Localized or entire body rashes, dryness, redness, and/or acne are also common.

[0012] Cannabis has known healing properties for skin itching. Neff et al. reported a preliminary observation that pruritus due to cholestatic liver disease can be alleviated with ingestion of 5 mg marinol (delta-9-tetrahydrocannabinol,“THC”) administration daily

(American Journal of Gastroenterology, 97, 2117-2119 (2002). Schlosburg et al. reported that systemic THC administration reduced scratching response in mice in a pruritus model involving subcutaneous administration of the mast cell degranulator compound 48/80, which evoked an intense, concentration-dependent scratching response (Journal of Pharmacology and

Experimental Therapeutics, 329(1) 314-323, 2009). More recently, a study at the University of Colorado School of Medicine found that eight of twenty-one patients who applied a cannabinoid cream twice a day for three weeks completely eliminated severe itching or pruritus. The same group found that injection of THC in mice reduced inflammation and swelling, as well as significant inhibition of melanoma tumor growth (https://www.eurekalert.org/pub_releases/20l7- 04/uoca-cms04l7l7.php). Ironically, the smoking of cannabis plant has been linked to skin irritation, acne, rashes and redness in a small but not unsignificant population.

[0013] Fibromyalgia

[0014] Fibromyalgia is a devastating condition characterized by chronic widespread pain and a heightened pain response to tactile pressure. Though the cause of fibromyalgia is not known, it is frequently associated with post-traumatic stress disorder, depression, and anxiety. There is no satisfactory treatment for fibromyalgia; serotonin-norepinephrine reuptake inhibitors such as duloxetine and milnacipran, and selective calcium channel inhibitors such as pregabalin are used to varying effect. In some cases, opioids are used to treat the pain. [0015] Although the cause of fibromyalgia is unknown, most hypotheses are to a systemic, nervous system pain processing dysfunction, which comes as a result of hyper-excitability of pain processing pathways and/or under-activity of inhibitory pain pathways. Pain-sensitive nerve cells in the spinal cord or brain may have increased reactivity. Another hypothesis relates to impairments in proinflammatory cytokine signalling, or opioid signalling. Because of this, most treatments for fibromyalgia have focused on systemic administration of small molecules that can cross the blood/brain barrier, either through ingestion or injection.

[0016] Interestingly, fibromyalgia has been correlated with increased levels of pro-inflammatory cytokines, specifically, increased levels of interleukin- 1RA, interleukin 6 and interleukin 8, suggesting that there may be an inflammatory aspect to the disease.

[0017] Multiple Sclerosis [0018] Multiple Sclerosis (MS) is a nervous tissue disease, involving the demyelination of nerve cells in the brain and spinal cord. Symptoms include motor or sensory problems, optic neuritis, brainstem dysfunction, either as episodes or as a gradual worsening. Spasticity, centrally mediated pain and painful spasms are some of its symptoms. It is believed to be an immune- mediated disorder, with no known cure and very few treatments. In some isolated studies, oral cannabis extract was suggested as effective treatment against the spasticity, centrally mediated pain and painful spasms associated with MS. To the knowledge of the inventor, topical forms of cannabis have not been used for MS, and would be counter-intuitive because MS is known to be disease primarily associated with nervous tissue in the brain and spinal cord.

[0019] Dysmenorrhea [0020] Dysmenorrhea, also known as painful periods or menstrual cramps, are typically a pain in the pelvis or lower abdomen which occurs around the time that menstruation begins, sometimes associated with bloating, headache, mood variation, and other symptoms. It is the most common menstrual disorder, with some studies suggesting it affects as many as 90% of women. Dysmenorrhea often occurs without an underlying problem, especially in women with heavy periods, irregular periods, or women with low body weight. Dysmenorrhea is also often due to, or exacerbated by, an underlying problem such as uterine fibroids, adenomyosis, or endometriosis. [0021] Likely the most often used medications for treatment of dysmenorrhea are non-steroidal anti-inflammatory drugs such as acetylsalicylic acid, isobutylphenylpropionic acid, and naproxen; or acetaminophen. Hormonal birth control often mitigates the symptoms of dysmenorrhea. It has also been suggested that vitamin B or magnesium supplements may help with the symptoms.

[0022] Dysmenorrhea is often associated with other symptoms, such as nausea, vomiting, headaches, dizziness, disorientation, diarrhea, constipation, hypersensitivity to sound, light, smell or touch, and fatigue. [0023] It would be desirable to have novel, effective treatments for dysmenorrhea, specifically, menstrual pain associated with uterine fibroids, adenomyosis, or endometriosis.

[0024] Cancer [0025] Cancer is a large family of diseases related to abnormal and/or unregulated cell growth, which may spread to other parts of the body. It is one of the most important diseases of our time, effecting an estimated 90 million people, with approximately 14 million new cases every year. Cancers have a wide variety of causes, epidemiologies, and physiologies, and are typically classified by the type of cell from which the tumor/cancerous cell originates.

[0026] Cancer treatments can be quite severe and invasive, and include surgery to remove the cancerous cells; chemotherapy utilizing a variety of agents, which typically act either by killing all rapidly dividing cells, or in a more targeted manner by acting at specific, known, molecular differences between cancer cells and non-cancerous cells; immunotherapy, which is loosely based on triggering or heightening the body’s immune response to the cancerous cells; and radiation therapy, which utilizes localized ionizing radiation in the region of the tumor.

Unfortunately, most treatments err on the side of broadness, and end up killing many healthy cells, either surrounding the tumor tissue, or resembling the tumor tissue in some way. For example, many chemotherapeutic drugs act by killing cells during the reproductive cycle, leading to the killing of the rapidly dividing cells in the tumor, but also killing other rapidly dividing cells, such as stem cells.

[0027] Certain types of cancers, such as non-Hodgkin lymphoma, have been observed to express higher levels of cannabinoid receptors type 1 and type 2, suggesting that therapies using cannabinoid receptor ligands may have efficiency in reducing tumor burden in certain types of malignant lymphomas. Cannabinoid receptor type 2 has been associated with cell growth and reproduction, with one study suggesting that cannabinoid receptor type 2 agonists may be able to inhibit cell growth and arrest cell reproduction at the G0/G1 stage.

[0028] Cancer treatments are wrought with often debilitating side effects, which can include pain, nausea, vomiting, and appetite suppression.

[0029] It would be desirable to have novel, effective treatments for cancer, either to be used alone, or in combination, preferably synergistic combination, with conventional cancer treatments. It would also be desirable to have novel, effective ways to decrease the side effects of conventional cancer drugs.

[0030] Vaginal Yeast Infections

[0031] Vaginal yeast infection, or Candida vulvovaginitis, is a common affliction resulting from an excessive growth of yeast, typically Candida albicans but sometimes other Candida , or Saccaromyces cerevisiae. Symptoms of vaginal yeast infection include vaginal itching, burning or pain while urinating, vaginal discharge, pain or discomfort during sexual intercourse, localized inflammation, and redness.

[0032] Vaginal yeast infection is usually treated with intravaginally administered anti- fungal agents, such as clotrimazole, nystatin, butoconazole, miconazole, or terconazole; or using an oral dose of fluconazole. It has been reported that up to 40% of women with vaginal yeast infections seek alternative treatments, such as herbal preparations, probiotics, cleansing diets, and gentian violet. The majority of studies of such alternative treatments are inconclusive or negative as to benefits. [0033] Bacterial vaginosis, sometimes called vaginal bacteriosis, is another common affliction, resulting from excessive growth of bacteria in the vagina. Symptoms of bacterial vaginosis include increased vaginal discharge, and pain or burning while urinating. Bacterial vaginosis can increase the risk of infection by sexually transmitted diseases, and can increase the risk of early delivery among pregnant women.

[0034] Bacterial vaginosis is usually treated with an antibiotic, such as clindamycin or metronidazole, either orally or intravaginally. Recurrence rates after antibiotic treatment are extremely high. [0035] Vaginitis is a broad term describing any inflammation of the vagina. It is typically a symptom of an infection of the vagina, such as a vaginal yeast infection or bacterial vaginosis. It may also be caused by trichomoniasis.

[0036] It would be desirable to have novel, effective treatments for vaginal yeast infection, bacterial vaginosis and vaginitis.

[0037] Menopause

[0038] Menopause occurs in most women between 49 and 52 years of age. It is generally defined as having occurred when a woman has not had any vaginal bleeding for a year. For a time leading up to menopause, a woman’ s periods may become irregular, either lighter or heavier, or longer or shorter. During this time, women often experience hot flashes, which typically last from 30 seconds to 10 minutes, and may be associated with shivering, sweating, and reddening of the skin. Other symptoms occurring either in the time leading up to

menopause, or post-menopause, include mood changes, vaginal dryness, and trouble sleeping. Menopause is associated with, and likely triggered by, a decrease in the ovaries’ production of estrogen and progesterone.

[0039] Likely the most often used medications for treatment of the symptoms of menopause or pre-menopause include menopausal hormone therapy, clonidine, SSRIs, or gabapentin. Non- medicinal, behavioural changes that may improve these symptoms include avoiding smoking, caffeine and alcohol, and increasing exercise. [0040] It would be desirable to have novel, effective treatments for certain effects of menopause and pre-menopause, such as for improvement of mood, relieving of dryness, aiding in sleep, and calming of hot flashes. [0041] Skin Care

[0042] Skin care is a billion dollar industry. A wide range of skin moisturizing formulations are known. Literally thousands of such products are sold, for moisturizing dry skin, removing fine lines and wrinkles, and obtaining fresh and youthful looking skin. A wide range of anti-aging serum formulations are known. These are intended for maintaining the firmness, suppleness, plumpness and pliability of skin, as well as decreasing the appearance of wrinkles. The total skin care market is estimated to be $116.3 billion in 2015, with some estimating the total market to be $180 billion by 2024. In one survey in 2016, 57 percent of U.S. women said it was important to buy all-natural skin care products. The U.S. anti-aging skin care market was estimated to generate about 2.11 billion U.S. dollars in 2013. Some of the manufacturers and suppliers of skin moisturizing formulations include Dow Chemicals, LOreal SA, Unilever PLC, Beiseidorf AG, Colgate Palmolive, Procter & Gamble, Estee Lauder, Johnson and Johnson, and Avon Product Inc. Face moisturizing products represent more than 50% of the skin moisturizing products sold.

[0043] Female Sexual Dysfunction [0044] Sexual dysfunction has been a persistent and relatively unaddressed problem, especially in an aging, sexually active population. Female sexual dysfunction, in particular, has not received as much attention or treatment as male sexual dysfunction, for which a variety of treatments currently exist. [0045] Female sexual behaviour is typically described in a sexual response cycle consisting of desire, excitement, orgasm, and resolution. Female sexual arousal disorder (FSAD) is the persistent or recurrent inability to attain, or to maintain, sufficient sexual excitement, a lack of genital response (such as lubrication and swelling), and/or lack of other somatic responses.

Female sexual arousal disorder is one form of female sexual dysfunction, and is associated with the excitement phase, though it typically also results in an inability to reach orgasm and resolution. [0046] It is believed that a certain amount of female sexual dysfunction is related to vascular insufficiency which results in insufficient swelling, specifically, in the smooth muscle of the muscularis portion. Certain vasodilators have been implicated in the mediation of vaginal vasodilation and the formation of lubricating fluid during sexual arousal. It may also be a nervous dysfunction: the vagina has significant nerve fibers, with significantly more nerve fibers in the distal areas of the vagina compared to the more proximal parts, with the anterior wall showing a denser innervation than the posterior wall.

[0047] Female sexual dysfunction may also be related to insufficient lubrication: the vaginal canal is lubricated primarily from a transudate originating from the subepithelial vascular bed, passively transported through intercellular channels. Additional moistening during intercourse comes from secretion from Bartholin’s glands.

[0048] Estrogen is also believed to effect maintenance and function of female genitalia, with estriol stimulation, vaginal lubrication, and thickness of the vaginal wall all being estrogen- dependent. Vaginal dryness can be controlled by estrogen replacement therapy.

[0049] The clitoris is also believed to play a major role during sexual activity in that it is not only part of what makes the sexual act enjoyable for the woman but also enhances her response to coitus upon clitoral stimulation. Clitoral stimulation may induce local autonomic and somatic reflexes causing vaginal vasocongestion, engorgement, and subsequent transudation, lubricating the introital canal making the sexual act easier, more comfortable, and more pleasurable. The more stimulation, the higher the level of arousal and the easier it is to further increase stimulations.

[0050] It is believed that a multisynaptic circuit of neurons may be involved in clitoral neurological control. Autonomic innervation of the clitoris passes from the pelvic and hypogastric nerves to the clitoris through the urogenital diaphragm; pelvic nerve stimulation results in clitoral smooth muscle relaxation and arterial smooth muscle dilation.

[0051] Female sexual dysfunction can included disorders of desire/libido, disorders of arousal, pelvic pain disorders, and inhibited orgasm. Patient surveys estimate that 18-76% of adult women have such complaints during sexual activity.

[0052] THC

[0053] THC, or Delta-9-tetrahydrocannabinol, is the principal psychoactive constituent of cannabis. It is a partial agonist of cannabinoid receptors CB1 and CB2. Because THC is an illegal drug in many countries, medical research has been limited and often anecedotal. The American Cancer Society has reported that patients with kidney cancer have required less pain medication when it was combined with cannabis extracts containing THC. Smoking cannabis has been found to alleviate nausea and vomiting in chemotherapy patients. Certain patients with suppressed appetite, including patients taking HIV drugs, have reported that smoking cannabis has improved and promoted food intake. Cannabis has also been documented as a pain relief agent, when inhaled. [0054] Surprisingly, recent studies have suggested that cannabinoids may inhibit cancer cell proliferation and induce cancer cell apoptosis. A 2013 Korean study has suggested that THC may be useful in treating stomach cancer, even drug resistant stomach cancer, by inducing apoptosis in the cancer cells. There are studies suggesting cannabinoids reduce expression of vascular endothelial growth factor (VEGF) in cancer cells, reducing the tumor blood supply. It appears THC and CBD may have anti-metastatic properties, though the mechanism of action is not completely understood.

[0055] THC has known anti-inflammatory properties for skin itching. Neff et al. reported a preliminary observation that pruritus due to cholestatic liver disease can be alleviated with ingestion of 5 mg marinol (THC) administration daily (American Journal of Gastroenterology, 97, 2117-2119 (2002). Schlosburg et al. reported that systemic THC administration reduced scratching response in mice in a pruritus model involving subcutaneous administration of the mast cell degranulator compound 48/80, which evoked an intense, concentration-dependent scratching response (Journal of Pharmacology and Experimental Therapeutics, 329(1) 314-323, 2009). More recently, a study at the University of Colorado School of Medicine found that eight of twenty-one patients who applied a cannabinoid cream twice a day for three weeks completely eliminated severe itching or pruritus. The same group found that injection of THC in mice reduced inflammation and swelling, as well as significant inhibition of melanoma tumor growth (https://www.eurekalert.org/pub_releases/20l7-04/uoca-cms04l 7l7.php). Ironically, the smoking of cannabis plant has been linked to skin irritation, acne, rashes and redness in a small but not unsignificant population.

[0056] THC-containing topical medications, including lotions, balms and oils, are known and utilized for localized relief of pain, soreness and inflammation.

[0057] CBD [0058] Cannabidiol is one of the active ingredients found in Cannabis. It is believed to have antioxidant, anti-inflammatory, anti-anxiety and anti-epileptic properties.

[0059] Ashwagandha Oil

[0060] Ashwagandha oil is an essential oil made from the root of the ashwagandha plant, also known as Withania Somnifera. The root is also known as Indian Ginseng, Winter Cherry, or poison gooseberry. Ashwagandha oil is a steam distilled extract of the root of the plant.

[0061] Ashwagandha oil has been used and known in the Ayurvedic system of medicine for centuries, and has been used to increase immunity to infection and disease, for treatment of arthritis, cramps and pains, and for its analgesic effects. The oil has been used as an anti- depressive, and in massage oil for relief of stress and anxiety. As a member of the nightshade family, oil of Ashwagandha has also been used in the treatment of insomnia, and is known for its potential to promote sleep. Made into a tonic, it has been used for rheumatism, insomnia, arthritis, impotence, fatigue, and depression. It is rumored to be useful as an anti-stress, aphrodisiac, astringent, antioxidant, diuretic, stimulant, antibacterial, anti-tumor, anti inflammatory, anti-carcinogenic, cardio-protective, immunomodulatory and anti-depressant. Ashwaganda root extract has been seen to have anticonvulasant effects; pretreatment with root extract is believed to have an anti-parkinsonian effect. It is claimed to be the most powerful aphrodisiac known to humanity; believed to be useful for treating loss of libido, impotence, premature ejaculation, erectile dysfunction, as well as, in women, to strengthen the uterine walls, ovaries and ligaments to support pregnancy. Ashwagandha has been found to stimulate nitric oxide production. Nitric oxide is believed to be involved in the mediation of clitoral and arterial smooth muscle dilation. [0062] Ashwaganda oil contains alkaloids, including anaferine, isopelletierine (l-(l-Methyl-2- piperidinyl)acetone), anahygrine, cuscohygrine, psudeotropine, tropanol, and pellertierine, steroidal lactones, including withaferins and withanolides, as well as saponins. It is commercially available.

Anaferine

Isopelletierine

Anahygrine

Cuscohygrine

Psudeotropine

T

Pellertierine

[0063] Anaferine is known as an immunomodulatory which induces interferon alpha.

Suscohygrine is known as a CNS stimulant.

[0064] To the inventor’s knowledge, THC has not been used topically in a female sexual lubricant, or as a treatment of female sexual dysfunction. To the inventor’s knowledge ashwagandha oil (an extract of the root of the ashwagandha plant) has not been used topically in a female sexual lubricant, or as a topical treatment of sexual dysfunction. The combination of THC and ashwagandha oil has accordingly also never been used. The combination of THC, ashwagandha oil, and cannabis root oil has accordingly also never been used. [0065] Hyaluronic Acid

[0066] Hyaluronic acid (HA) is found in the basal layer of the epidermis, where proliferating keratinocytes are found. It appears to play an important role in the normal epidermis, and may function in the re-epithelization process. It serves as an integral part of the extracellular matrix of basal keratinocytes and may have both a free-radical scavenging function and a role in keratinocyte proliferation and migration.

[0067] HA has water retention properties and certain formulations of HA are commercially available as Restylane ®, an injectable formulation used for lip volume enhancement, to diminish wrinkles and aging lines, and for filling aging-related facial hollows, such as those under the eyes) and for contouring of the chin, forehead, and nose.

[0068] HA is used in anti-aging serums. [0069] Arnica Montana

[0070] Extract can be made from arnica montana flowers, using supercritical fluid extraction with natural carbon dioxide. The extract can be made into an essential oil by adding a lipid. Arnica montana extract is believed to have analgetic, anti-arthritic, antibacterial, anti- inflammatory, anti-septic properties. It is used for muscle soreness, fibrositis, relief of muscle and joint pain.

[0071] Menthol [0072] Menthol is a known compound, either made synthetically, or extracted from mentha arvensis (wild mint). Its most common production method is by freezing peppermint oil, then separating the resultant crystal of menthol by filtration. Natural menthol is most abundantly found in the L configuration (-)-menthol. It provides a cooling sensation when inhaled, eaten or applied to the skin, and provides analgesic properties through selective activation of K-opioid receptors. Menthol has been used as a pain reliever.

[0073] Clary Sage

[0074] Clary sage {Salvia sclarea) seeds provide an essential oil widely used in perfumes and as a muscatel flavoring for vermouth, wine and liqueur. It has use in traditional medicine, and is believed to maintain good health of the uterus. Some literature has suggested it may be useful in treatment of uterine and ovarian cancers, by regulating certain hormones such as estrogen. Some traditional medicine use includes stimulating the opening of obstructed menses, curing dizziness and mental irritation during menses, and alleviation of symptoms of post-menopausal syndrome.

[0075] It is believed that clary sage essential oil may reduce the symptoms and negative effects associated with menstruation like cramping, bloating, mood swings, cravings for food. As usual with‘traditional’ medicines, there is varied and largely unsupported literature suggesting clary sage essential oil may have antidepressant, anticonvulsant, antispasmodic, antiseptic, aphrodisiac, astringent, bactericidal, carminative, deodorant, digestive, emmenagogue, euphoric, hypotensive, nervine, sedative, stomachic, and uterine effects. [0076] Geranium

[0077] Geranium essential oil is an essential oil obtained from Pelargonium roseum. It is primarily cultivated for its scent and flavoring agent. However, it has a history in traditional medicine use, and believed to have astringent, hemostatic, cicatrizant, cytophylactic, diuretic, deodorant, styptic, tonic, vermifuge, and vulnerary properties. It is believed, as an aromatherapy, to aid in skin care, balance hormones, relieve stress and depression , reduce inflammation and irritation, alleviate the effects of menopause, improve circulation, benefit dental health, boost kidney health, and reduce blood pressure. Sometimes referred to as“women’s oil”, geranium essential oil has a traditional use in treating feminine problems like excessive menstrual flow, vaginal infections, and discharges during menopause. For example, it is believed that massaging the lower abdomen and back with geranium essential oil helps in treating painful menstration, excessive bleeding, mood fluctuations, fatigue and anxiety during menses and menopause. It is believed to be provide calming, soothing, tonic and stimulant effect, relieving pain, stress and mood fluctuations. It is also used as a flavouring agent for food and pipe tobacco, and in massage oil. It is believed to improve blood circulation just below the surface of the skin and aids in distribution of melanin. Geranium essential oil may have astringent properties. [0078] Chamomile

[0079] Chamomile essential oil is an essential oil obtained from Chamaemelum nobile. It is used as a scent, a flavor, and is believed to reduce stress and aid in sleep when used as an aromatherapy. Chamomile essential oil is believed to be useful in the treatment of cracked nipples that develop during breastfeeding; it may also be a treatment to Candida vulvovaginitis.

[0080] Lavender

[0081] Lavender oil is the essential oil of Lavandula angustifolia. It is believed to have antiseptic, antifungal, and anti-inflammatory properties, but is most used as a fragrance. It consists primarily of monoterpeneoids and sesquiterpeneoids, and can include: the

monoterpenols linalool, alpha-terpineol, gamma-terpineol, borneol, isoborneol, terpinen-4-ol, nerol, and lavandulol; the terpene esters linalyl acetate, geranyl acetate, neryl acetate, octane-3 -yl acetate, and lavandulyl acetate; the monoterpenes (E)-beta-ocimene, (z)-beta-ocimene, camphene, beta-pinene, alpha-pinene, myrcene, and beta-phellandrene; the terpene oxide 1,8- cineol; the sesquiterpenes beta-caryophyllene, beta-farnesene, germacrene, and alpha-humulene; and the keytones camphor, 3-octanone, and cryptone. Lavender oil is used in aromatherapy to decrease stress and anxiety levels in patients. It is believed to be useful in treatment of Candida vulvovaginitis (vaginal yeast infection) and vaginal discharges. Lavendere is used in

commercially available mosquito repellants, skin cleansers, toners, serums and creams.

[0082] Rosemary

[0083] Rosemary essential oil is an extract from rosmarinus officinalis, an herb known primarily for its culinary purposes but containing a number of phytochemicals such as rosmarinic acid, about 10-20% camphor, caffeic acid, ursolic acid, betunlinic acid, carnosic acid, and carnosol. [0084] Basil

[0085] Basil, or Saint- Joseph’ s-wort, is most frequently used as a culinary herb. An essential oil of European basil is reported to contain high concentrations of linalool and methyl chavicol, as well as other ingredients such as l,8-cineole, eugenol and myrcene. Basil has deep roots in many religious and cultural ceremonies, used to sprinkle or make holy water, and is even thought to protect against scorpions. It is also thought to be a mental stimulant, which aids in

concentration; it is believed to have anti-depressive properties.

[0086] Basil oil is also believed to have anti-inflammatory properties, making it useful as a skin remedy for irritations, small wounds and sores. It has a soothing and relaxing effect that helps while dealing with eczema. Basil oil contains vitamin C that boosts skin cell metabolism; it also is believed to maintain skin collagen. It can be useful as a remedy for a number of chronic skin conditions such as acne. Acne can result from overactive sebaceous glands. Accumulation of excess sebum and dirt manifests the growth of bacteria and thereby produce painful red swellings on your face. Applying a face pack using basil oil on a daily basis is beneficial for acne-inflamed skin due to its anti-inflammatory and antibacterial properties. [0087] Frankincense

[0088] Frankincense is an aromatic resin used in incense and perfumes, and is obtained from trees of Boswellia burseraceae. It contains an acid resin having the formula C20H32O4, a gum, 3-acetyl-beta-boswellic acid, alpha-boswellic acid, 4-O-methyl-glucuronic acid, incensole acetate, phellandrene, and (+) cis and trans olibanic acids. Frankincense essential oil is obtained by steam distillation of the dry resin, and contains monoterpenes, sesquiterpenes,

monoterpenoles, sesquiterpenols,, and ketones, such as alpha-pinene, limonene, alpha-thujene, and beta-pinene. Frankincense essential oil and/or resin appears to have anti-mutagenic and apoptotic properties in vitro and in cell culture, and is thought to potentially have anti- inflammatory and anti-cancer potential. One conference paper (Salmani, 2015) has suggested that frankincense, particularly its primarily biologically active component, 3-O-acetyl- 1 l-keto- beta-boswellic acid, may have cytotoxicity towards high grade serous ovarian cancer cell lines.

[0089] Frankincense oil is also believed to be a cytophylactic, promoting regeneration of healthy cells and keeping existing cells and tissues healthy. Frankincense oil is also believed to have astringent capabilities, and may be useful as an anti-aging agent for skin. It may be helpful in elimination of sun spots, removing micro-wrinkles around the eyes and cheeks, and generally tone and tighten skin.

[0090] Carrot Seed [0091] Carrot seed oil is believed to be high in antioxidants. It also contains the sesquiterpene alcohol carotol, vitamin E and vitamin C. Carotol is believed to have antifungal, herbicidal and insecticidal properties.

Carotol

[0092] Cypress

[0093] Essential oil of the Mediterranean cypress (Cupressus sempervirens L.) has been used in traditional medicine as a treatment of stomach pain, diabetes, inflammation, toothache, and laryngitis. It has also been used as a contraceptive. Such uses, while documented, are neither well understood nor known through rigorous scientific methodology to be effective. The main components of cypress essential oil appear to be alpha-pinene, d-3-carene, limonene, and alpha- terpinolene. In vitro studies suggest that cypress essential oil may have antimicrobial and antibiofilm activity.

[0094] Tea Tree

[0095] Tea tree oil, also known as melaleuca oil or ti tree oil, is an essential oil from the leaves of the tea tree, Melaleuca alternifolia. It contains a wide variety of compounds, including terpinen-4-ol, its major component, as well as gamma-terpinene, alpha-terpinene, terpinolene, alpha-terpineol, alpha-pinene, and p-cymene. It may also contain l,8-cineole. Though toxic when taken by mouth, it is used topically in certain folk medicines, and is claimed to be useful in treatment of skin conditions such as lice, herpes, scabies, insect bites, dandruff, acne, and skin fungal or bacterial infections such as athlete’s foot. As with many traditional medicines, there is little evidence to support these uses. There have been traditional medicine studies suggesting it may be useful in treatment of bacterial vaginosis. [0096] Thyme

[0097] Thyme essential oil contains 20-54% thymol, an antiseptic used in various commercially produced mouthwashes and hand sanitizers. Thyme oil also contains p-cymene, myrcene, borneol, and linalool. Before modern antibiotics, thyme essential oil was used to medicate bandages and to treat toenail fungal infections. There have been some studies suggesting that thyme oil may be useful for treating bacterial vaginosis, and that thymol may prevent the growth and biofilm formation of Gardnerella vaginalis.

[0098] Manuka

[0099] Manuka essential oil is obtained from the leaves of Leptospermum scoparium , a plant native to Australia and New Zealand. It has been used in traditional Maori medicine for treating head colds, to soothe stiff muscles and aching joints, and for urinary complaints. It is believed to have antimicrobial efficacy, especially against gram-positive bacteria, and against certain antibiotic-resistant strains.

[0100] Helichrysum

[0101] Helichrysum oil is an essential oil of the blossoms of Helichrysum italicum , often also called immortelle or curry plant. Often used in perfumes, it has an intense fragrance, and anti inflammatory, fungicidal and astringent properties. It has been used to soothe burns and raw chapped skin. As with many traditional herbal remedies and medicines, there is little evidence, but some suggestions of usefulness for a wide variety of conditions: it is believed to have anti- fungal, anti-viral, and anti-inflammatory properties, and is used to treat bruises, burns, acne, allergies, exzema, broken veins, stretch marks, inflammation, spots, warts, wounds, chronic dermatitis, muscular aches and pains, rheumatism, sprains, whooping cough, headaches, pulmonary spasms, stress-related conditions, depression, psoriasis, stomach cramps, sinus infection, phlebitis, hematoma, viral colitis, gallbladder infection, sciatica, and sunburns.

[0102] Vitex Berry

[0103] Vitex berry essential oil is an essential oil of the fruit of the Vitex agnus-castus , or chasteberry plant. It has long been believed to be an aphrodisiac, and there have been occasional, largely non-clinical studies suggesting it may be useful for management of premenstrual stress syndrome, including premenstrual dysphoric disorder and latent

hyperprolactinaemia. The berries are the most popular part of the plant used and contain a wide range of potentially active constituents, including essential oils, iridoids, and flavonoids. In humans, it has been shown (at doses of 120 mg/d) to reduce levels of FSH and increase LH resulting in decreased estrogen and increased progesterone and prolactin levels. One proposed mechanism of action is that this herb (doses of approximately 480 mg/d) causes a decrease in prolactin, which leads to a reversal of LH suppression allowing full development of the corpus luteum, increasing progesterone levels, and reducing symptoms of PMS. However, chaste berry also appears to have dopamine-agonistic properties at higher doses. A double-blind study involving 217 women tested Vitex against placebo for the treatment of premenstrual syndrome. For a period of 3 months, 105 women took chaste berry 300 mg tablets three times daily, whereas 112 women took placebos. The results of the study showed a dramatic improvement at the end of the first cycle for both groups with relative stability over the remaining two cycles. Vitex improved the symptom“feel jittery or restless,” but there was a difference observed between placebo and the herb for other symptoms. A study compared the efficacy of chaste berry to pyridoxine (B6) in the treatment of PMS over three menstrual cycles. Ninety participants were given one capsule of Agnolyt (each capsule containing 3.5 to 4.2 mg of dried chaste berry), and one placebo capsule daily. The other 85 participants were given placebo twice daily from day 1 to 15 and then 100 mg bid of pyridoxine from days 16 to 35. When assessed by patients and the investigators, the chaste tree group achieved a significantly greater improvement in typical PMS complaints such as breast tenderness, edema, inner tension, headache, constipation, and depression compared with pyridoxine. Both preparations were well tolerated with only mild reactions reported in a few patients. Five patients from the chaste tree group became pregnant. Another double-blind, placebo controlled study examined the tolerability and efficacy of chaste berry extract for premenstrual mastalgia. The treatment or placebo was given over three menstrual cycles. Mastalgia during at least 5 days of the cycle before the treatment was the strict inclusion criteria. The results showed the intensity of the cyclical breast pain diminished in the chaste berry group and the herb was well tolerated. In a prospective, multicenter trial the efficacy of a chaste berry was investigated in 43 patients with PMS. The patients took 20 mg Vitex extract daily for three menstrual cycles. Symptoms in three posttreatment cycles were compared with baseline cycles before administration of the herb. A menstrual distress questionnaire was the tool used for self-assessment. At the end of the study, symptoms were reduced in the late luteal phase by 47.2%. Although symptoms gradually returned after treatment cessation, a difference from baseline remained for up to three cycles. A multicentric open trial investigated the efficacy and tolerance of Vitex in 1634 patients suffering from PMS. A specific questionnaire was developed for determining the effect of chaste berry on the four characteristic PMS symptom complexes: depression, anxiety, craving, and fluid retention. After three menstrual cycles, 93% of patients reported a decrease in the number of symptoms or symptom complexes or even cessation of PMS complaints and 85% of physicians rated the treatment as good or very good. The severity and frequency of breast pain reduced after 3 months. The majority of patients assessed the tolerance of Vitex as good or very good. Adverse drug reactions were suspected in only 1.2% of patients, but none were serious. A randomized, double-blind, placebo-controlled trial compared chaste berry with placebo in 170 women with premenstrual syndrome over three menstrual cycles. Women undertook self-assessment of irritability, mood alteration, headache, breast fullness, and other menstrual symptoms and were also assessed for changes in clinical global impression. The study showed that chaste berry was an effective and well-tolerated treatment for the relief of PMS symptoms in 52% of the trial participants compared with 24% placebo. As with all herbal remedies, a variety of chaste berry preparations are used that can differ substantially in terms of, for instance, concentration of active ingredients or bioavailability. Surveys of members of the National Institute of Medical Herbalists, and the American Herbalists Guild, showed that the tincture is the most popular preparation among herbalists, in a dose of 3 to 5 mL qd-bid, but fluid extracts and powdered herb preparations are also used. Chaste berry is approved by the German Commission E for irregularities of the menstrual cycle, PMS, and mastodynia. [0104] Jojoba

[0105] Jojoba oil, a liquid or wax produced in the seed of the Simmondsia chinensis

(jojoba)plant, is known to contain Vitamin E and B, as well as antioxidants and minerals like chromium, copper, and zinc, all of which are believed to nourish and protect the skin. Jojoba oil is known to be similar to human skin oil, and is excellent as penetrating skin and smooths easily. It is commonly used as a replacement for whale oil in the cosmetics industry.

[0106] Avocado [0107] Avocado oil is an edible oil pressed from the fruit of the Per sea Americana (avocado). It is most used as a cooking oil and as a food ingredient. It is believed to be an excellent skin nourishing product, boosting collagen production in skin and promoting soft, youthful skin and delaying aging. [0108] Apricot

[0109] Apricot oil, obtained from the kernel of the Prunus armeniaca (apricot), contains vitamin E, A, unsaturated fatty acids, and vitamin C, which promotes collagen production. Vitamin A is believed to repair UV-related skin damage and smooths skin to reduce wrinkles, fine lines and rough skin. Vitamin E is believed to combat free-radical damage and inflammation.

Un saturated fatty acids are believed to enhance skin elasticity.

[0110] Tumeric [0111] Tumeric ( Curcuma longa) is a plant of the ginger family. Turmeric oil, containing curcumin, have received a fair amount of press recently as a potential pharmaceutical. It is typically ingested. It has been used in Ayurvedic practices to treat internal disorders, such as indigestion, throat infections, common colds, or liver ailments, as well as topically to cleanse wounds or treat skin sores.

[0112] Juniper Berry

[0113] Juniper berry is the female seed cone produced by Juniperus communis. Its oil is believed to have antibacterial, antiseptic, astringent and detoxifying properties, and is believed useful in the treatment of acne, weeping eczema, dermatitis and psoriasis.

[0114] Rose oil [0115] Rose oil, the essential oil extracted form the petals of various types of rose, is widely used for its scent. It is believed to have antioxidant effect.

[0116] Jasmine [0117] Jasmine oil also has antioxidant effect.

[0118] Sandalwood

[0119] Sandalwood oil is believed to have antiseptic and antimicrobial properties, and is often used to provide relief to itching and redness caused by exzema, rosacea and psoriasis.

[0120] Copaiba [0121] Copaiba oil is a steam distilled extract of an oleoresin exudate obtained from the trunk of Copaifera tree. It has been traditionally used in folk medicine to impart knowledge and ward off hexes, it is believed to have anti-inflammatory, anti-tumor, anti-tetanus, antiseptic, and antihemorrhagic properties.

[0122] Pomegranate

[0123] Pomegranate seed oil comprises over 65% punicic acid, as well as palmitic acid, stearic acid, oleic acid, and linoleic acid. Punicic acid is believed to reduce skin inflammation, enhances skin repair, and hydrates the skin. Pomegranate oil is believed to stimulate

keratinocyte proliferation, helping skin retain its youthful appearance by creating new skin cells. Pomegranate seed oil also contains a human compatible form of pro-estrogen which is believed to enhance skin texture by supporting hormonal balance. [0124] Sweet almond

[0125] Sweet almond oil, derived from the seeds of Prunus dulcis var. dulcis is a rich source of of minerals like calcium, zinc, manganese, phosphorus, magnesium, and potassium. Almonds contain L-carnitine and phenylalanine, the chemicals that improve cognitive function and enhance mood. The phenylalanine in this quick-absorbing oil is carried through the skin to support the secretion of mood-boosting hormones, including dopamine and adrenaline. Sweet almond oil is believed to provide topical and systemic anti-inflammatory effects, and is believed to be useful in treatment of eczema, psoriasis and rosacea. [0126] Ginger

[0127] Ginger oil or ginger paste is often often topically massaged on aching muscles to remove muscle strain. It is further believed that regular use of ginger leads to the reduction of prostaglandins, which are the compounds associated with pain. Therefore, ginger helps in pain relief. Extract of ginger is also used in certain traditional medicines to aid in the reduction of inflammation. [0128] Cinnamon

[0129] Cinnamon oil is believed to have anti-bacterial and anti-fungal properties, possibly due to its o-methoxycinnamaldehyde content. It is believed to be effective in fighting multi-drug resistant bacteria in particular.

[0130] Clove

[0131] Clove bud oil is believed to have analgesic, antiseptic, antispasmodic, anti-neuralgic, carminative, anti-infectious, disinfectant, insecticidal, stimulant, stomachic, uterine, and tonic properties. It has been shown to be effective against planktonic cells and biofilms of

Staphylococcus aureus and is therefore useful in the topical treatment of acne.

[0132] Cardamom [0133] Cardamom oil is an oil extracted from the aromatic pod of cardamom, a seed from the

Zingiberaceae Elettaria and Zingiberaceae Amomum plants. It is believed to be useful in treating muscular spasm (cramps and pulls in muscle fibers) and respiratory spasms (whoopinc cough or pertussis, asthma, etc.). The rich glutinous extract comprises a number of essential volatile oils like pinene, methyl eugenol, sabinene, geraniol, linalyl acetate, myrcene, nerol, phellandrene, citronellol, linalool, limonene, a-terpineol acetate, 1, 8-cineole, terpinene, a- terpineol, p-cymene, terpinen-4-oil, terpinolene, and trans-nerolidol. It has numerous benefits for our health, skin and hair. [0134] Bergamot

[0135] Bergamot oil is believed to increase hormone secretions, and lessen the sensitivity of nerves that create pain. It is used to reduce symptoms of sprains, muscle aches and headaches, and to relieve tension.

[0135] Fennel

[0136] Fennel oil is believed to have anti-fungal properties, and can be used to treat yeast and fungal infections.

[0137] Lactobacillus

[0138] Leucidal Liquid SF (Active Micro Technologies, NC) is a commercially available Lactobacillus ferment, marketed as a natural preservative. It is derived from radishes fermented with Leuconostoc kimchi, a lactic acid bacteria that has been traditionally used to make kimchi.

[0139] Fermented Coconut Fruit [0140] AMTicide ® Coconut (Active Micro Technologies, NC) is a commercially available moisturizer and conditioner for hair and skin care applications, with anti-fungus activity. It is developed by fermenting coconut fruit with Lactobacillus.

[0141] Lysolecithin

[0142] ECOGEL® (Lucas Meyer Cosmetics, a division of International Flavors & Fragrances Inc, NY) is a commercially available gelling-emulsifying agent made from lysolecithin, sclerotium gum, xanthan gum and pullulan. [0143] Suppositories

[0144] Suppositories are a known, effective dosage form for the administration of medicinal ingredients. They are a solid dosage form of drug, inserted into the rectum, vagina, or urethra. Suppositories are formulated such that they dissolve or melt at body temperature, and accordingly, once inserted, they provide local or, by diffusion into the tissue or bloodstream, systemic, effects. [0145] Typically, a suppository utilizes as a base an ingredient which has a melting point above

20 and below 38 degrees Celcius. Cacao butter, polyethylene glycol, glycerinated gelatin are often used as a base ingredient, as are hydrogel formulations. The active ingredients are typically blended into the base. [0146] Brief Description of the Drawings

[0147] Figure 1 is a schematic process diagram of the process for making cannabis root oil (a purified, oil soluble fraction of cannabis root) as hereindescribed. [0148] Summary of the Invention

[0149] According to a certain aspect of the invention is provided a method for manufacturing a root oil from cannabis, comprising: obtaining a root from a cannabis plant; cleaning the root; drying the root; chopping the root; heating the chopped, dry root in an aqueous solvent; adding a lipid solvent to form a heterogeneous solution of macerated root in aqueous and lipid solvent; heating the heterogeneous solution; separating the lipid portion; and filtering the lipid portion to obtain a cannabis root oil. [0150] In certain embodiments, the method further comprises wet milling and/or sonicating the chopped, dry root in aqueous solvent prior to addition of the lipid solvent. [0151] According to a certain aspect of the present invention is provided a method for manufacturing a cannabis root emulsion, comprising: manufacturing the root oil utilizing the method according to claim 1 ; and ultrasonically emulsifying the root oil with water and surfactant. [0152] In certain embodiments, the cannabis is cannabis sativa.

[0153] In certain embodiments, the chopped pieces are between 100 microns and 8 cm in size.

[0154] In certain embodiments, the aqueous solvent is purified water.

[0155] In certain embodiments, the lipid solvent comprises vegetable oil, for example, a mixture of fractionated coconut oil and refined castor oil, such as about 50% fractionated coconut oil and about 50% refined castor oil, by volume. [0156] In certain embodiments, the ratio of aqueous solvent to lipid solvent in the heterogeneous solution is about 6:8 (vol/vol).

[0157] In certain embodiments, the ratio of dry chopped form to lipid solvent in the

heterogeneous solution is about 1 : 16 (wt/vol).

[0158] In certain embodiments, the filtration is through a filter with a pore size of 25 microns. [0159] According to a further aspect of the present invention is a cannabis root oil, for example, a cannabis root oil manufactured by the hereindisclosed method.

[0160] According to a further aspect of the present invention is a method of treatment selected from the group consisting of anti-inflammatory, pain relief, burn treatment, blister prevention, bruise reduction, skin rash reduction, and acne treatment, comprising administering an effective amount of cannabis root oil.

[0161] According to a further aspect of the present invention is a composition for reducing inflammation, pain relief, burn treatment, blister prevention, bruise reduction, skin rash reduction, or acne treatment, comprising an effective amount of the cannabis root oil in a pharmaceutically effective carrier. The pharmaceutically effective carrier may, for example, be pharmaceutically effective for topical administration, inhaled administration, oral administration, or vaginal administration.

[0162] According to a further aspect of the present invention is provided an anti-microbial, anti biotic, anti-fungal, anti-neuralgic, anti-pruritic, anti-rheumatic, anti-sclerotic, anti-septic, emollient, hemostatic, resolvent, and/or styptic composition, comprising an effective amount of cannabis root oil. The carrier may be for topical, inhaled, oral or vaginal administration.

[0163] According to one aspect of the present invention is described a pharmaceutical preparation for topical administration, comprising: delta-9-tetrahydrocannabinol and a cannabis root oil. [0164] In certain embodiments, the pharmaceutical preparation is in the form of a cream, an ointment or a lotion. [0165] In certain embodiments, the cannabis root oil is prepared by: obtaining a root from a cannabis plant; cleaning the root; drying the root; chopping the root; heating chopped, dry root in aqueous solvent; adding a lipid solvent to form a heterogeneous solution of macerated root in aqueous and lipid solvent; heating the heterogeneous solution; decanting the lipid portion; and filtering the lipid portion to obtain a cannabis root oil.

[0166] In certain embodiments, the delta-9-tetrahydrocannabinol is obtained from a THC resin.

[0167] In certain embodiments, the pharmaceutical preparation further comprises aloe vera gel.

[0168] In certain embodiments, the pharmaceutical preparation further comprises lavender essential oil.

[0169] In certain embodiments, the pharmaceutical preparation further comprises turmeric essential oil.

[0170] In certain embodiments, the pharmaceutical preparation further comprises coriander essential oil. [0171] In certain embodiments, the pharmaceutical preparation comprises cannabis root oil, aloe vera gel, lavender essential oil, cannabis THC resin, turmeric essential oil, coriander essential oil, calendula officinalis extract, rosehip seed extract, and sea buckthorn berry extract.

[0172] In certain embodiments, the cannabis root oil and the THC resin are present in a weight ratio of 20: 1.

[0173] In certain embodiments, the cannabis root oil and the aloe vera gel are present in a weight ratio of 1 :3. [0174] According to a certain embodiment, the pharmaceutical preparation comprises, by weight, about 200 parts cannabis root oil, about 600 parts aloe vera gel, about 20 parts lavender essential oil, about 10 parts cannabis THC resin, about 2 parts turmeric essential oil, and about 2 parts coriander essential oil.

[0175] According to a further aspect of the present invention is provided a method of treatment of an ailment selected from the group consisting of inflammation, skin rash, acne, and skin irritation, comprising administering, topically, an effective amount of the pharmaceutical preparation as hereinde scribed.

[0176] In certain embodiments, the inflammation or skin irritation is associated with radiation recall.

[0177] In certain embodiments, the inflammation or skin irritation is a side-effect of

chemotherapy.

[0178] In certain embodiments, the inflammation or skin irritation is associated with skin cancer. [0179] According to one aspect of the present invention is provided a pharmaceutical preparation for topical administration, comprising: delta-9-tetrahydrocannabinol; cannabidiol; and a cannabis root oil or emulsion.

[0180] In certain embodiments, the pharmaceutical preparation is in the form of a cream, an ointment or a lotion.

[0181] In certain embodiments, the cannabis root oil is prepared by: obtaining a root from a cannabis plant; cleaning the root; drying the root; chopping the root; heating chopped, dry root in aqueous solvent; adding a lipid solvent to form a heterogeneous solution of macerated root in aqueous and lipid solvent; heating the heterogeneous solution; decanting the lipid portion; and filtering the lipid portion to obtain a cannabis root oil. [0182] In certain embodiments, the delta-9-tetrahydrocannabinol is obtained from a THC resin.

[0183] In certain embodiments, the cannabidiol is obtained from a THC resin.

[0184] In certain embodiments, the pharmaceutical preparation further comprises aloe vera gel.

[0185] In certain embodiments, the pharmaceutical preparation further comprises lavender essential oil.

[0186] In certain embodiments, the pharmaceutical preparation further comprises menthol.

[0187] In certain embodiments, the pharmaceutical preparation further comprises rosemary essential oil.

[0188] In certain embodiments, the pharmaceutical preparation further comprises arnica Montana essential oil.

[0189] According to one aspect of the present invention, the pharmaceutical preparation comprises cannabis root oil, cannabis THC resin, cannabis CBD resin, aloe vera gel, menthol, lavender essential oil, rosemary essential oil, and arnica Montana essential oil.

[0190] In certain embodiments, the cannabis root oil and the THC are present in a weight ratio of about 50: 1. [0191] In certain embodiments, the cannabis root oil and the CBD are present in a weight ratio of about 50: 1.

[0192] In certain embodiments, the CBD and the THC are present in a weight ratio of about 1 : 1.

[0193] In certain embodiments, the cannabis root oil and the aloe vera gel are present in a weight ratio of about 1 : 18.

[0194] In certain embodiments, the pharmaceutical preparation comprises, by weight, about 50 parts cannabis root oil, about 900 parts aloe vera gel, about 1 part cannabis CBD resin, about 1 part cannabis cannabidiol resin, about 35 parts of menthol crystals, about 10 parts lavender essential oil, about 5 parts rosemary essential oil, and about 5 parts of arnica Montana essential oil. [0195] In certain embodiments, the cannabis root oil and the THC are present in a weight ratio of about 10: 1.

[0196] In certain embodiments, the cannabis root oil and the CBD are present in a weight ratio of about 10: 1.

[0197] In certain embodiments, the CBD and the THC are present in a weight ratio of about 1 : 1.

[0198] In certain embodiments, the cannabis root oil and the aloe vera gel are present in a weight ratio of about 1 : 18.

[0199] In certain embodiments, the pharmaceutical preparation comprises, by weight, about 50 parts cannabis root oil, about 900 parts aloe vera gel, about 5 part cannabis CBD resin, about 5 part cannabis cannabidiol resin, about 35 parts of menthol crystals, about 10 parts lavender essential oil, about 5 parts rosemary essential oil, and about 50 parts of arnica Montana essential oil.

[0200] According to a further aspect of the present invention is provided a method of treatment of pain, comprising administering, topically, an effective amount of the pharmaceutical preparation as hereinde scribed.

[0201] In certain embodiments, the pain is associated with multiple sclerosis. [0202] In certain embodiments, the pain is associated with fibromyalgia.

[0203] According to one aspect of the present invention is provided a suppository formulation comprising cannabis root oil. The suppository formulation may also contain THC and/or CBD. [0204] According to a further aspect of the present invention is provided a suppository formulation comprising THC and/or CBD.

[0205] In certain embodiments, the suppository formulation further comprises any one or more of lavender oil, clary sage oil, geranium oil, and chamomile oil.

[0206] In certain embodiments, the suppository formulation comprises cannabis root oil, THC, CBD, lavender oil, clary sage oil, geranium oil, and chamomile oil.

[0207] In certain embodiments, the suppository formulation further comprises cacao butter.

[0208] In certain embodiments, the suppository formulation comprises a base of cacao butter, and, per lOOg of base, about 1 ml cannabis root oil, about 200 mg of 1 : 1 THC/CBD resin, about 2.5 ml lavender oil, about 0.25 ml of clary sage oil, about 0.25 ml of geranium oil, about 0.25 ml of chamomile oil.

[0209] According to a further aspect of the present invention, is provided a suppository formulation as hereindescribed, for treatment of pain and other effects of dysmenorrhea.

[0210] According to a further aspect of the present invention is provided a method of treating the effects of dysmenorrhea, comprising applying an effective amount of the suppository. [0211] In certain embodiments, the dysmenorrhea is associated with uterine fibrosis.

[0212] In certain embodiments, the dysmenorrhea is associated with endometriosis.

[0213] In certain embodiments, the effects treated are selected from the group consisting of pain and cramping.

[0214] In certain embodiments, the suppository formulation further comprises any one or more of lavender oil, frankincense essential oil, cypress essential oil, clary sage essential oil, and basil essential oil.

[0215] In certain embodiments, the suppository formulation comprises cannabis root oil, THC, CBD, lavender oil, frankincense essential oil, cypress essential oil, clary sage essential oil, and basil essential oil. [0216] In certain embodiments, the suppository formulation further comprises cacao butter.

[0217] In certain embodiments, the suppository formulation comprises a base of cacao butter, and, per lOOg of base, about 1 ml cannabis root oil, between 200 mg and 10 g of 1 : 1 THC/CBD resin, about 1 ml lavender oil, about 1 ml of frankincense essential oil, about 0.5 ml of cypress essential oil, about 0.2 ml of clary sage oil, and about 0.15 ml of basil essential oil.

[0218] In certain embodiments, the suppository formulation comprises a base of cacao butter, and, per lOOg of base, about 1 ml cannabis root oil, about 2 g of 1 : 1 THC/CBD resin, about 1 ml lavender oil, about 1 ml of frankincense essential oil, about 0.5 ml of cypress essential oil, about 0.2 ml of clary sage oil, and about 0.15 ml of basil essential oil.

[0219] In certain embodiments, the suppository formulation comprises a base of cacao butter, and, per lOOg of base, about 1 ml cannabis root oil, about 5 g of 1 : 1 THC/CBD resin, about 1 ml lavender oil, about 1 ml of frankincense essential oil, about 0.5 ml of cypress essential oil, about 0.2 ml of clary sage oil, and about 0.15 ml of basil essential oil.

[0220] In certain embodiments, the suppository formulation comprises a base of cacao butter, and, per lOOg of base, about 1 ml cannabis root oil, about 10 g of 1 : 1 THC/CBD resin, about 1 ml lavender oil, about 1 ml of frankincense essential oil, about 0.5 ml of cypress essential oil, about 0.2 ml of clary sage oil, and about 0.15 ml of basil essential oil.

[0221] According to a further aspect of the present invention, is provided a suppository formulation as hereindescribed, for treatment for cancer, either to be used alone, or in combination, preferably synergistic combination, with conventional cancer treatments.

[0222] According to a further aspect of the present invention, is provided a suppository formulation as hereindescribed, for use to alleviate certain side effects of conventional cancer drugs, for example, to alleviate pain, to reduce nausea, to prevent vomiting, and/or to decrease appetite suppression.

[0223] According to a further aspect of the present invention is provided a method of treating cancer, comprising administering an effective amount of the suppository, either alone or in combination, preferably synergistic combination, with conventional cancer treatments. In certain embodiments, the cancer is stomach cancer, non-Hodgkin lymphoma, prostate cancer, or kidney cancer. [0224] According to a further aspect of the present invention is provided a method of treating the side effects of conventional chemotherapy or radiation therapy, comprising administering an effective amount of the suppository as hereindescribed. In certain embodiments, the side effects are pain, nausea, vomiting, and/or loss of appetite. [0225] In certain embodiments, the suppository formulation further comprises any one or more of lavender oil, tea tree oil, clary sage oil, geranium oil, basil essential oil, thyme essential oil, Manuka essential oil, and helichrysum essential oil.

[0226] In certain embodiments, the suppository formulation comprises cannabis root oil, THC, CBD, lavender oil, tea tree oil, clary sage oil, geranium oil, basil essential oil, thyme essential oil, Manuka essential oil, and helichrysum essential oil.

[0227] In certain embodiments, the suppository formulation comprises a base of cacao butter, and, per lOOg of base, about 1 ml cannabis root oil, about 200 mg of 1 : 1 THC/CBD resin, about 1.25 ml lavender oil, about 1.25 ml of tea tree essential oil, about 0.5 ml of geranium oil, about

0.25 ml of clary sage oil, about 0.25 ml of basil essential oil, about 0.25 ml of thyme essential oil, about 0.25 ml of Manuka essential oil, and about 0.15 ml of helichrysum essential oil.

[0228] According to a further aspect of the present invention, is provided a suppository formulation as hereindescribed, for treatment of vaginal yeast infection, bacterial vaginosis and/or vaginitis. [0229] According to a further aspect of the present invention is provided a method of treating vaginal yeast infection, bacterial vaginosis and/or vaginitis, comprising administering the suppository. [0230] According to a further aspect of the present invention is provided a suppository formulation comprising THC and/or CBD.

[0231] In certain embodiments, the suppository formulation further comprises any one or more of lavender oil, vitex berry essential oil, clary sage oil, geranium oil, basil essential oil, and chamomile oil.

[0232] In certain embodiments, the suppository formulation comprises cannabis root oil, THC, CBD, lavender oil, vitex berry essential oil, clary sage oil, geranium oil, basil essential oil, and chamomile oil.

[0233] In certain embodiments, the suppository formulation further comprises cacao butter.

[0234] In certain embodiments, the suppository formulation comprises a base of cacao butter, and, per lOOg of base, about 1 ml cannabis root oil, about 200 mg of 1 : 1 THC/CBD resin, about 1.25 ml lavender oil, about 1.25 ml of vitex berry essential oil, about 0.25 ml of clary sage oil, about 0.25 ml of geranium oil, about 0.25 ml of chamomile oil, and about 0.15 ml of basil essential oil.

[0235] According to a further aspect of the present invention, is provided a suppository formulation as hereindescribed, for treatment of pre-menopausal and menopausal symptoms such as hot flashes, shivering, sweating and reddening of the skin, mood changes, vaginal dryness, and trouble sleeping. [0236] According to a further aspect of the present invention is provided a method of treating the pre-menopausal and menopausal symptoms such as hot flashes, shivering, sweating and reddening of the skin, mood changes, vaginal dryness, and trouble sleeping, comprising applying an effective amount of the suppository.

[0237] According to one aspect of the present invention is provided a skin moisturizer composition comprising cannabis root oil.

[0238] According to another aspect of the present invention is provided a skin moisturizer composition comprising cannabidiol.

[0239] According to another aspect of the present invention is provided a skin moisturizer composition comprising cannabis root oil and cannabidiol. [0240] In certain embodiments, the skin moisturizer composition comprises 1 to 20% (wt) cannabis root oil, for example, 4 to 16.5% (wt) cannabis root oil, or about 4% (wt) cannabis root oil, or about 4.5% (wt) cannabis root oil, or about 16.5% (wt) cannabis root oil.

[0241] In certain embodiments, the skin moisturizer composition comprises about 0.003% cannabidiol.

[0242] In certain embodiments, the skin moisturizer composition further comprises any one or more of: Simmondsia chinensis (jojoba) seed oil; Persea gratissima (Avocado) oil; Prunus armeniaca (apricot) kernel oil; Citrus grandis (Grapefruit) seed extract; Cetyl-stearyl alcohol (emulsifying wax); Stearic acid; Curcuma longa (Tumeric) root oil; Juniperus communis

(juniper) berry oil; Rosa damascene (rose) flower oil; Jasminium sambac (Jasmine) flower oil; Santalum spicatum (Sandalwood) wood oil; Copaifera spp (copaiba) oil; Punica Granatum (Pomegranate) seed oil; Zingiber Officinale (Ginger) root oil; Lavandula Angustifoila

(Lavender) flower oil; Cinamomum Zeylanicum (cinnamon) bark oil; Syzygium Aromaticum (clove) bud oil; Elettaria Cardamomom (Cardamom) seed oil; Prunus amygdalus (sweet almond) oil; Goat milk powder; Ocimum basilicum (basil) oil; Citrus bergamia (Bergamot) peel oil; Foeniculum (Fennel) seed oil; and Boswellia Serrata (Frankincense) oil. [0243] In certain embodiments, the skin moisturizer composition is in the form of an

emulsification comprising an aqueous component and a lipid soluble component. The aqueous component may comprise water, honey, Chamaemelum Nobile (Chamomile) water, and/or rose damascene (Rose) water. [0244] In certain embodiments is provided a skin moisturizer composition comprising: Cannabis root oil; Cannabidiol oil; Simmondsia chinensis (jojoba) seed oil; Persea gratissima (Avocado) oil; Prunus armeniaca (apricot) kernel oil; Rose damascene (Rose) water; Honey; Citrus grandis (Grapefruit) seed extract; Cetyl-stearyl alcohol (emulsifying wax); Stearic acid; Curcuma longa (Tumeric) root oil; Juniperus communis (juniper) berry oil; Rosa damascene (rose) flower oil; Jasminium sambac (Jasmine) flower oil; Santalum spicatum (Sandalwood) wood oil; and Copaifera spp (copaiba) oil.

[0245] In certain embodiments is provided a skin moisturizer composition comprising, by weight: 4.5% Cannabis root oil; 0.003% Cannabidiol oil; 13% Simmondsia chinensis (jojoba) seed oil; 8% Persea gratissima (Avocado) oil; 8% Prunus armeniaca (apricot) kernel oil; 56% Rose damascene (Rose) water; 0.6% Honey; 0.3% Citrus grandis (Grapefruit) seed extract; 4.75% Cetyl-stearyl alcohol (emulsifying wax); 4.75% Stearic acid; 0.014% Curcuma longa (Tumeric) root oil; 0.014% Juniperus communis (juniper) berry oil; 0.014% Rosa damascene (rose) flower oil; 0.014% Jasminium sambac (Jasmine) flower oil; 0.014% Santalum spicatum (Sandalwood) wood oil; and 0.027% Copaifera spp (copaiba) oil.

[0246] In certain embodiments is provided a skin moisturizer composition comprising:

Cannabis root oil; Cannabidiol oil; Simmondsia chinensis (jojoba) seed oil; Persea gratissima (Avocado) oil; Honey; Citrus grandis (Grapefruit) seed extract; Cetyl-stearyl alcohol (emulsifying wax); Stearic acid; Rosa damascene (rose) flower oil; Copaifera spp (copaiba) oil; Punica Granatum (Pomegranate) seed oil; Chamaemelum Nobile (Chamomile) water; Zingiber Officinale (Ginger) root oil; Lavandula Angustifoila (Lavender) flower oil; Cinamomum Zeylanicum (cinnamon) bark oil; Syzygium Aromaticum (clove) bud oil; and Elettaria

Cardamomom (Cardamom) seed oil.

[0247] In certain embodiments is provided a skin moisturizer composition comprising, by weight: 4% Cannabis root oil; 0.003% Cannabidiol oil; 13% Simmondsia chinensis (jojoba) seed oil; 10% Persea gratissima (Avocado) oil; 0.6% Honey; 0.3% Citrus grandis (Grapefruit) seed extract; 4.75% Cetyl-stearyl alcohol (emulsifying wax); 4.75% Stearic acid; 0.014% Rosa damascene (rose) flower oil; 0.016% Copaifera spp (copaiba) oil; 6.5% Punica Granatum (Pomegranate) seed oil; 55.997% Chamaemelum Nobile (Chamomile) water; 0.014% Zingiber Officinale (Ginger) root oil; 0.014% Lavandula Angustifoila (Lavender) flower oil; 0.014% Cinamomum Zeylanicum (cinnamon) bark oil; 0.014% Syzygium Aromaticum (clove) bud oil; and 0.014% Elettaria Cardamomom (Cardamom) seed oil.

[0248] In certain embodiments is provided a skin moisturizer composition comprising:

Cannabis root oil; Cannabidiol oil; Simmondsia chinensis (jojoba) seed oil; Prunus amygdalus (sweet almond) oil; Honey; Citrus grandis (Grapefruit) seed extract; Cetyl-stearyl alcohol (emulsifying wax); Stearic acid; Copaifera spp (copaiba) oil; Water; Lavandula Angustifoila (Lavender) flower oil; Syzygium Aromaticum (clove) bud oil; Goat milk powder; Ocimum basilicum (basil) oil; Citrus bergamia (Bergamot) peel oil; Foeniculum (Fennel) seed oil; and Boswellia Serrata (Frankincense) oil. [0249] In certain embodiments is provided a skin moisturizer composition comprising: 16.5%

Cannabis root oil; 0.003% Cannabidiol oil; 10% Simmondsia chinensis (jojoba) seed oil; 6.5% Prunus amygdalus (sweet almond) oil; 0.6% Honey; 0.3% Citrus grandis (Grapefruit) seed extract; 4.75% Cetyl-stearyl alcohol (emulsifying wax); 4.75% Stearic acid; 0.02% Copaifera spp (copaiba) oil; 55.893% Water; 0.014% Lavandula Angustifoila (Lavender) flower oil;

0.014% Syzygium Aromaticum (clove) bud oil; 0.6% Goat milk powder; 0.014% Ocimum basilicum (basil) oil; 0.014% Citrus bergamia (Bergamot) peel oil; 0.014% Foeniculum (Fennel) seed oil; and 0.014% Boswellia Serrata (Frankincense) oil.

[0250] According to a further embodiment of the present invention is provided a method of moisturizing dry skin, comprising applying an effective amount of the skin moisturizer composition as hereindescribed. [0251] According to a certain aspect of the present invention is provided a pharmaceutical preparation for topical administration as a female sexual lubricant, comprising ashwagandha oil, THC, and/or cannabis root oil.

[0252] In certain embodiments, the pharmaceutical preparation further comprises avocado oil, menthol, and/or black pepper oil.

[0253] In certain embodiments, the pharmaceutical preparation is for topical administration as a female sexual lubricant and comprises hemp root oil, avocado oil, ashwaganda oil, THC, menthol crystals and black pepper oil.

[0254] In certain embodiments, the pharmaceutical composition comprises, by weight, about 20% hemp root oil, about 60% avocado oil, about 20% ashwaganda oil, about 0.2% THC, about 1% menthol, and about 0.8% black pepper oil. [0255] In certain embodiments, the pharmaceutical composition comprises, by weight, 19.65% cannabis sativa hemp root oil, 58.73% avocado oil, 19.65% ashwaganda oil, 0.2% THC, 0.98% menthol crystals, and 0.79% black pepper oil. [0256] In certain embodiments, the cannabis root oil is prepared by the hereindescribed method.

[0257] In certain embodiments, the delta-9-tetrahydrocannabinol is obtained from a THC resin. [0258] According to a certain aspect of the present invention is provided a female sexual lubricant comprising the pharmaceutical composition or preparation as hereindescribed.

[0259] According to a certain aspect of the present invention is provided a method of enhancing a sexual experience of a human female, comprising topical, transdermal and/or transmucosal administration of the female sexual lubricant as hereindescribed.

[0260] In certain embodiments, the female suffers from female sexual dysfunction, such as FSAD. [0261] According to one aspect of the present invention is provided a skin anti-aging serum comprising a unique combination of cannabidiol (CBD) and hyaluronic acid (HA). In certain embodiments, the skin anti-aging serum also comprises hemp root oil or emulsion, for example, a hemp root oil or emulsion made as hereindescribed. [0262] In certain embodiments, the skin anti-aging serum composition also comprises any one or more of lavender essential oil, copaiba essential oil, frankincense essential oil, carrot seed essential oil, geranium essential oil, and sea buckthorn berry essential oil.

[0263] In certain embodiments, the skin anti-aging serum composition comprises CBD, HA, lavender essential oil, copaiba essential oil, frankincense essential oil, carrot seed essential oil, geranium essential oil, and sea buckthorn berry essential oil. [0264] In certain embodiments, the skin anti-aging serum composition also comprises a gelling agent, an emulsifying agent, additional moisturizing ingredients, and/or a preservative.

[0265] In certain embodiments, the gelling agent or emulsifying agent is ECOGEL.

[0266] In certain embodiments, the additional moisturizing ingredient is AMTicide® Coconut.

[0267] In certain embodiments, the preservative is Leucidal® Liquid SF. [0268] In certain embodiments, the skin anti-aging serum comprises about 1 wt% HA and about

0.3 wt% of CBD, in an aqueous solution or emulsion.

[0269] In certain embodiments, the skin anti-aging serum comprises about 1% lavender oil, about 1% copaiba oil, about .4% frankincense oil, about .25% carrot seed oil, about 0.3% geranium oil, about .25% sea buckthorn berry oil, about .3% CBD, in an aqueous solution or emulsion.

[0270] In certain embodiments, the skin anti-aging serum comprises .93% HA, 0.93% lavender oil, 0.93% copaiba oil, .37% frankincense oil, .23% carrot seed oil, 0.27% geranium oil, .23% sea buckthorn berry oil, .3% CBD, in an aqueous solution or emulsion.

[0271] In certain embodiments, and as presently measured and used, the CBD is in crystalline or isolate form. In other embodiments, a CBD oil is used, with the weight concentration of the CBD oil in the skin anti-aging serum adjusted according to the concentration of the CBD oil.

[0272] In certain embodiments, the skin anti-aging serum comprises about 2wt% Ecogel, for example, 1.9% Ecogel. [0273] In certain embodiments, the skin anti-aging serum comprises about 2wt% AMTicide, for example, 1.9% AMTicide.

[0274] In certain embodiments, the anti-aging serum comprises about 2wt% Leucidal liquid SF, for example, 1.9% Leucidal liquid SF.

[0275] In certain embodiments, the aqueous solution or emulsion is a water-based emulsion.

[0276] According to a further embodiment of the present invention is provided a method of treating skin to prevent signs of aging, comprising applying an effective amount of the skin anti aging serum composition as hereinde scribed.

[0277] In certain embodiments, the skin anti-aging serum further comprises by weight about 1% lavender oil, about 1% copaiba oil, about .4% frankincense oil, about .25% carrot seed oil, about 0.3% geranium oil, and about .25% sea buckthorn berry oil.

[0278] In certain embodiments, the skin anti-aging serum further comprises by weight 0.93% HA, 0.93% lavender oil, 0.93% copaiba oil, .37% frankincense oil, .23% carrot seed oil, 0.27% geranium oil, .23% sea buckthorn berry oil.

[0279] In certain embodiments, the skin anti-aging serum further comprises about 2wt%

ECOGEL, for example, l.9wt% ECOGEL, about 2wt% AMTicide coconut, for example, l.9wt% AMTicide coconut, about 2wt% Leucidal liquid SF, for example, l.9wt% Leucidal liquid SF and/or wherein the aqueous emulsion or solution is a water-based emulsion.

[0280] In certain embodiments, the skin anti-aging serum composition further comprises lactobacillus ferment, lactobacillus, coconut fruit extract, hyaluronic acid, lavender oil, copaiba resin oil, Franckinsence gum oil, Geranium flower oil, Carrot seed oil, Sea buckthorn oil, Cannabis seed oil, Cannabis root oil, and optionally one or more of lysolecithin, sclerotium gum, xanthan gum, and pullulan.

[0281] In certain embodiments, the skin anti-aging serum composition comprises, by weight, 91.220% water, 2% lactobacillus ferment, 2% lactobacillus, coconut fruit extract, 1 hyaluronic acid, 1% lavender oil, 1% balsam copaiba resin oil, 0.5% mixture of lysolecithin, sclerotium gum, xanthan gum and pullulan, 0.4% Frankincense gum oil, 0.3% Geranium flower oil, .25% carrot seed oil, 0.25% sea buckthorn oil, 0.04% hemp seed oil, and 0.04% Hemp root oil. [0282] Detailed Description

[0283] Example 1 : Manufacture of a Cannabis Root Oil Extract and Nano Emulsion of Same

[0284] Disclosed herein is a unique cannabis root oil with medicinal properties, a method of manufacturing the cannabis root oil from cannabis root, for example, Cannabis sativa root, and formulations containing said cannabis root oil.

[0285] The cannabis root oil produced by this method can be used advantageously in therapeutic products, for a variety of purposes, and a variety of administration methods, as detailed and exemplified further below.

[0286] The cannabis root oil is made as follows.

[0287] The root structure of one or more cannabis plants is obtained and/or separated from the rest of the plant. Preferably, the entire cannabis root is used. A cannabis root is defined as the portion of the plant that would ordinarily reside underground in a naturally growing, healthy plant, or underwater in a hydroponically-grown plant. [0288] The cannabis root is thoroughly cleaned, to remove soil, pesticide, fertilizer, or other impurities, by dry shaking, mechanical manipulation, and cold or room temperature water spray. In certain embodiments, for example, if the root is obtained straight out of the ground, a high pressure room temperature or cold water washer can be used to wash away most of the dirt and impurities. In certain other embodiments, the cannabis root may be obtained from the grower/manufacturer in a dry, washed form.

[0289] In certain embodiments, the cannabis root may be washed and sterilized in a vegetable washing machine, such as a modified Sormac GWM 2500, wherein the root is intensely washed in the machine’s wash tank in a solution of 1.5% H ₂ 0 ₂ in water, and then mixed and transported along the length of the wash tank as a result of the turbulent water flow. The root is then over- flumed out of the wash tank, onto a vibratory de- watering screen where it is sprayed off with fresh water, then gently transported forward, draining the excess water. Remaining water and moisture is then removed, using an air knife dryer at the end of the wash and drainage cycle, which uses forced air to dry the root.

[0290] In certain embodiments, the cannabis root is then thoroughly dried, preferably at room temperature and pressure, but alternatively, if a more rapid drying is desired, a dehydrator utilizing air circulation, vacuum and/or heat can be used. A heat of up to 60 degrees Celsius may be used without affecting the desired chemical properties of the extract, with even higher heat potentially possible. Preferably, the cannabis root is dried to a moisture content of less than 5%.

[0291] After drying, the cannabis root is roughly chopped, to pieces with widely varying size up to about 8 cm. Preferably, the root is cut to about l.5mm, which may be done in a commercial food processor such as the Hobart FP400i, which offers a continuous use hopper feeding system for high volume production. [0292] In certain embodiments, the dried cannabis root is then wet milled and/or (preferably) sonicated into a slurry mixture in water. For example, an Ultrasonic UP400St, with a Sonotrode S24d7 with a 7mm tip, or a Sonotrode S24d22 with a 22mm tip, can be utilized for simultaneous wet milling and sonication (sonic cavitation). For commercial applications, the Ultrasonic can be replaced with a Digital Ultrasonic Device UlPlOOOhd (Hielscher), utilizing for example a Sonotrode BS2d22 (22 mm tip) or a Sonotrode BS2d34 (34mm tip). In one embodiment, 250 g of dessicated hemp root is combined with 500 ml of distilled water, and the cells in the hemp root are disrupted with the ultrasound for a period of about 5 minutes. The use of sonication and the resultant cell disruption has been found to increase the quantity of recoverable desirable active compounds recovered from the root.

[0293] Water is added to the dry, chopped material in a ratio of about 6 litres of water for about 500 grams of dry cannabis chopped root, and the mixture is then heated to 100C for 6 hours, preferably without agitation. A lipid solvent, for example, a vegetable oil, is added; preferably an oil blend of fractionated coconut oil and refined castor oil (preferably about 50/50 by volume), in an amount of about 4 litres of each for about 500 grams of dry cannabis root powder. The solution is then heated again to about 100 Celsius for about 48 hours, with stirring about every hour. During this stage, the oil-soluble elements of the hemp root are solubilized into the oil.

[0294] In (preferred) embodiments where sonication is utilized, the sonication slurry is heated in a kettle and simmered for about an hour, left to cool and settle, and the water hemp root mixture is decanted. A lipid solvent, for example, a vegetable oil, is added to the remaining water, preferably an oil blend of fractionated coconut oil and refined castor oil (preferably about 50/50 by volume), in an amount of about 2 litres of each for about 500 ml of the sonication slurry.

The solution is then heated again to about 100 Celsius for about 48 hours, with stirring about every hour. During this stage, the oil-soluble elements of the hemp root are solubilized into the oil. [0295] The oil/water mixture is cooled and the oil portion is decanted, optionally further dried, and filtered through 25 microns to produce the cannabis root oil product. [0296] In certain embodiments, the cannabis root oil product is nanoized with the addition of a surfactant, to produce a water in oil emulsion, utilizing an ultrasonic process to produce an emulsion measurable in the 20 - 40 nanometer range.

[0297] The cannabis root oil produced by this method has unique and desirable pharmaceutical properties, and can be combined with other ingredients for additional benefits, and with known pharmaceutically acceptable additives, carriers, fillers and excipients for oral, inhaled, subcutaneous, intravenous, intramuscular, vaginal, rectal, or topical administration. In particular, the cannabis root oil produced by this method can be used advantageously in a topical therapeutic, for pain, anti-inflammation, as well as relief of arthritis, endometriosis, menstrual cramping, and rheumatism.

[0298] The cannabis root oil and/or emulsion product exhibits advantageous therapeutic properties, which may include anti-inflammatory, pain relieving, burn treating, blister prevention, bruise reducing, skin rash reducing and anti-acne properties. It also exhibits further advantageous properties, including anti-microbial, anti-biotic, anti-fungal, anti-neuralgic, anti pruritic, anti-rheumatic, anti-sclerotic, anti-septic, emollient, hemostatic, resolvent, and styptic properties.

[0299] The cannabis root oil and/or emulsion can be ingested, either alone or in an edible formulation, inhaled, for example in a vaporized form, or used as a topical cream, ointment, balm, gel, or spray. Alternatively, the cannabis root oil can be injected in a suitable carrier, either intravenously, subcutaneously or intramuscularly; the cannabis root oil may be

administered using known skin patch technologies, rectally for example in a suppository, intravaginally, or through other high permeability areas such as the nasal cavity, the inside of the cheek, or sublingually.

[0300] Example 2 - Method and Formulation for Treating Skin Inflammation

[0301] The cannabis root oil and/or emulsion as described in Example 1 is particularly useful as an ingredient in a topical formulation for the treatment of skin inflammation, particularly, inflammation, irritation and rash associated with radiation recall, from skin cancer, and/or from chemotherapy. The formulation contains the oil soluble fraction of cannabis root, as well as THC. It is believed topical, oil soluble fractions of cannabis root have never previously been used medicinally. It is also believed that the combination of an oil soluble fraction of cannabis root, with THC, provides advantageous effects, and possibly additive and/or synergistic effects.

[0302] The cannabis root oil is combined with a THC active, for example, marinol, but more preferably, a cannabis THC resin, and blended or mixed into a topical formulation. In certain preferred embodiments, aloe vera gel is used as a carrier/base for the formulation, because of its known cancer inhibiting and skin nourishing qualities, which can act in combination with the cannabis root oil and THC active ingredients. Optionally, other active ingredients, such as ingredients known to have anti-inflammatory or irritation soothing effects, or cancer fighting properties, can also be added. Such ingredients may include lavender essential oil, turmeric essential oil, coriander essential oil, extract of calendula officinalis, extract of rosehip seed, and extract of sea buckthorn berry.

[0303] According to one example of a topical cream of the present invention, 100 grams of cannabis root oil prepared as described above is mixed into 300 grams of aloe vera gel, to obtain an oil/gel emulsion. 5 grams of cannabis THC resin is added, along with one gram of turmeric essential oil, one gram of coriander essential oil, 10 grams of lavender essential oil, and 2.5 grams of C02 Combination extract, an extract of calendula officinalis, rosehip seed and sea buckthorn berry available from Rae Dunphy Aromatics Ltd (Canada) (www.raedunphy.ca).

[0304] The mixture provides a smooth emoliant cream which is easy to apply onto skin. As would be understood by a person of skill in the art, with the proper added ingredients, the mixture can also be made into an ointment or (for example) by adding more water soluble ingredients or more aloe vera gel, the mixture can be made into a lotion. The cream provides excellent treatment for inflammation caused by radiation recall, as well as for skin irritation resulting from chemotherapy.

[0305] Example 3 - Method and Formulation for Pain Management

[0306] The cannabis root oil and/or emulsion as described in Example 1 is particularly useful in a topical formulation for pain management, especially useful for the treatment of chronic pain presented with or manifesting in association with inflammation. The formulation is particularly useful for alleviation of pain and/or inflammation related to fibromyalgia and/or multiple sclerosis. The formulation comprises the oil soluble fraction of cannabis root manufactured as described in Claim 1, THC, and CBD. It is believed topical, oil soluble fractions of cannabis root have never been used medicinally. It is also believed that the combination of an oil soluble fraction of cannabis root, when combined with THC and CBD, provides advantageous effects, and possibly additive and/or synergistic effects, especially for the treatment or alleviation of pain with inflammation, for example, the pain associated with fibromyalgia and/or multiple sclerosis.

[0307] The cannabis root oil or emulsion produced as hereindescribed can be used

advantageously in a topical therapeutic, in combination with THC and CBD, for pain.

[0308] The cannabis root oil is combined with a THC active, for example, marinol, but more preferably, a cannabis THC resin, as well as CBD, preferably a CBD resin, and blended or mixed into a topical formulation. In certain preferred embodiments, aloe vera gel is used as a carrier/base for the formulation, because of its known skin nourishing qualities. Optionally, other active ingredients, such as ingredients known to have anti-inflammatory or pain relief effects, can also be added. Such ingredients may include menthol, which provides a soothing, cooling sensation, lavender essential oil (essential oil derived from lavandula angustifolia), which is known to have disinfectant and skin soothing properties, rosemary essential oil

(essential oil derived from Rosmarinus officinalis), which is known for its pain reduction properties, and essential oil derived from arnica Montana, a flower known to have pain reduction properties.

[0309] According to one example of a topical cream of the present invention, 50 parts by weight of cannabis root oil prepared as described above is mixed into about 900 parts of aloe vera gel, to obtain an oil/gel emulsion. About 1 part cannabis THC resin and about 1 part cannabis CBD resin is added. Alternatively, about 2 parts of an approximately 50:50 mixture of THC and CBD, for example, Sativex, can be added. In preferred embodiments, about 35 parts of menthol crystals (L-menthol), about 10 parts of lavender essential oil, about 5 parts of rosemary essential oil, and about 5 parts of arnica montana essential oil are also added.

[0310] The mixture provides a smooth emoliant cream which is easy to apply onto skin. As would be understood by a person of skill in the art, with the proper added ingredients, the mixture can also be made into an ointment or (for example) by adding more water soluble ingredients or more aloe vera gel, the mixture can be made into a lotion. The cream provides excellent treatment for the pain caused by MS. The cream also provides excellent treatment of pain caused by fibromyalgia.

[0311] Example 4 - Method and Formulation for Management of Chronic Intense Pain [0312] The cannabis root oil and/or emulsion as described in Example 1 is particularly useful in a topical formulation for pain management, especially useful for the treatment of chronic pain presented with or manifesting in association with inflammation. The formulation is particularly useful for alleviation of pain and/or inflammation related to fibromyalgia and/or multiple sclerosis. The formulation comprises an oil soluble fraction of cannabis root, THC, and CBD. It is believed topical, oil soluble fractions of cannabis root have never been used medicinally. It is also believed that the combination of an oil soluble fraction of cannabis root, when combined with THC and CBD, provides advantageous effects, and possibly additive and/or synergistic effects, especially for the treatment or alleviation of pain with inflammation, for example, the pain associated with fibromyalgia and/or multiple sclerosis.

[0313] The cannabis root oil produced by this method can be used advantageously in a topical therapeutic, in combination with THC and CBD, for pain. [0314] The cannabis root oil is combined with a THC active, for example, marinol, but more preferably, a cannabis THC resin, as well as CBD, preferably a CBD resin, and blended [mixed] into a topical formulation. In certain preferred embodiments, aloe vera gel is used as a carrier/base for the formulation, because of its known skin nourishing qualities. Optionally, other active ingredients, such as ingredients known to have anti-inflammatory or pain relief effects, can also be added. Such ingredients may include menthol, which provides a soothing, cooling sensation, lavender essential oil (essential oil derived from lavandula angustifolia), which is known to have disinfectant and skin soothing properties, rosemary essential oil

(essential oil derived from Rosmarinus officinalis), which is known for its pain reduction properties, and essential oil derived from arnica Montana, a flower known to have pain reduction properties.

[0315] According to one example of a topical cream of the present invention, 50 parts by weight of cannabis root oil prepared as described above is mixed into about 900 parts of aloe vera gel, to obtain an oil/gel emulsion. About 5 part cannabis THC resin and about 5 part cannabis CBD resin is added. Alternatively, about 10 parts of an approximately 50:50 mixture of THC and CBD, for example, Sativex, can be added. In preferred embodiments, about 35 parts of menthol crystals (L-menthol), about 10 parts of lavender essential oil, about 5 parts of rosemary essential oil, and about 50 parts of arnica montana essential oil are also added.

[0316] The mixture provides a smooth emoliant cream which is easy to apply onto skin. As would be understood by a person of skill in the art, with the proper added ingredients, the mixture can also be made into an ointment or (for example) by adding more water soluble ingredients or more aloe vera gel, the mixture can be made into a lotion. The cream provides excellent treatment for the pain caused by MS. The cream also provides excellent treatment of pain caused by fibromyalgia.

[0317] Example 5 - Method and Formulation for Treatment of Dysmenorrhea

[0318] The cannabis root oil and/or emulsion as described in Example 1 is particularly useful as a remedy for dysmenorrhea, in particular, in treating menstrual pain associated with uterine fibroids, adenomyosis, or endometriosis, when administered in a suppository formulation. It has also been discovered that tetrahydrocannabinol and/or cannabidiol are also useful in alleviating menstrual pain. We have obtained excellent therapeutic effect, which may be additive or even synergistic, when administering combinations of cannabis root oil, tetrahydrocannabinol and cannabidiol.

[0319] Disclosed are a variety of suppositories highly effective for treating menstrual pain, containing such cannabis root oil, either alone, or combined with THC and/or CBD. Other therapeutics may also be used in the formulation. For example, lavender essential oil, clary sage essential oil, geranium essential oil, and/or chamomile essential oil. We have created a combination particularly useful and effective in treating dysmenorrhea, comprising cannabis root oil, CBD, THC, lavender oil, clary sage oil, geranium oil, and chamomile oil.

[0320] Any known base can be used for the suppository; we have found that cacao butter can be effectively used.

[0321] Example 5 A: Suppository formulation utilizing cannabis root oil

[0322] 100 g of cacao butter is melted in a stainless steel pot, to about 102 degrees F. About 1 ml cannabis root oil is added, and the liquid is stirred until the oil appears completely blended.

The composition is poured into about 50 suppository moulds, each containing about 2g of composition; the suppository moulds are sealed and cooled.

[0323] The suppository is administered vaginally and/or rectally to women suffering from dysmenorrhea associated with a wide variety of conditions, including endometriosis and uterine fibroids, and results in a noticeable decrease in pain.

[0324] Example 5B: Suppository formulation utilizing cannabis root oil THC and CBD [0325] 100 g of cacao butter is melted in a stainless steel pot, to about 102 degrees F. About 1 ml cannabis root oil, and about 200 mg of a 2 mg active/gram, 1 : 1 ratio THC/CBD resin is added, and the liquid is stirred until homogeneous. The composition is poured into about 50 suppository moulds, each containing about 2g of composition; the suppository moulds are sealed and cooled.

[0326] The suppository is administered vaginally and/or rectally to women suffering from dysmenorrhea associated with a wide variety of conditions, including endometriosis and uterine fibroids, and results in a noticeable decrease in pain. [0327] Example 5C: Suppository formulation

[0328] 100 g of cacao butter was melted in a stainless steel pot, to about 102 degrees F. About 1 ml cannabis root oil, about 200 mg of a 2mg/g active, 1 : 1 ratio THC/CBD resin, about 2.5 ml lavender oil, and about 0.25 ml of each of clary sage oil, geranium oil, and chamomile oil was added, and the liquid was stirred until homogeneous. The composition was poured into about 50 suppository moulds, each containing about 2g of composition; the suppository moulds were sealed and cooled.

[0329] The suppository was administered vaginally to women suffering from dysmenorrhea associated with a wide variety of conditions, including endometriosis and uterine fibroids, and resulted in a noticeable decrease in pain. [0330] Example 6 - Method and Formulation for Treatment of Cancer

The cannabis root oil and/or emulsion as described in Example 1 may also be highly effective in treating certain forms of cancer, including stomach cancer, non-Hodgkin lymphoma, prostate cancer, and kidney cancer, both on its own, or in synergistic combination with known cancer therapies. The formulations may also be useful in reducing the side effects of conventional cancer therapies, including pain, nausea, vomiting, and/or loss of appetite.

[0331] In particular, it is possible that the cannabis root oil produced by this method can be used advantageously in a suppository, for treating certain forms of cancer, including stomach cancer, non-Hodgkin lymphoma, prostate cancer, and kidney cancer, both on its own, or in synergistic combination with known cancer therapies. The formulations may also be useful in reducing the side effects of conventional cancer therapies, including pain, nausea, vomiting, and/or loss of appetite. [0332] The cannabis root oil product exhibits advantageous therapeutic properties, which may include treating certain forms of cancer, including stomach cancer, non-Hodgkin lymphoma, prostate cancer, and kidney cancer, either on its own, formulated in combination with other ingredients, and/or in synergistic combination with known cancer therapies. The cannabis root oil may also be useful in reducing the side effects of conventional cancer therapies, including pain, nausea, vomiting, and/or loss of appetite. It also exhibits further advantageous properties, including anti-microbial, anti-biotic, anti-fungal, anti-neuralgic, anti-pruritic, anti-rheumatic, anti-sclerotic, anti-septic, emollient, hemostatic, resolvent, and styptic properties. [0333] The cannabis root oil can be ingested, either alone or in an edible formulation, inhaled, for example in a vaporized form, or used as a topical cream, ointment, balm, gel, or spray.

Alternatively, the cannabis root oil can be injected in a suitable carrier, either intravenously, subcutaneously or intramuscularly; the cannabis root oil may be administered using known skin patch technologies, rectally for example in a suppository, intravaginally, or through other high permeability areas such as the nasal cavity, the inside of the cheek, or sublingually.

[0334] It has been discovered that the cannabis root oil as hereindescribed may be useful for treating certain forms of cancer, including stomach cancer, non-Hodgkin lymphoma, prostate cancer, and kidney cancer, both on its own, or in synergistic combination with known cancer therapies. The cannabis root oil may also be useful in reducing the side effects of conventional cancer therapies, including pain, nausea, vomiting, and/or loss of appetite, when administered in a suppository formulation. It has also been discovered that tetrahydrocannabinol and/or cannabidiol are also useful in these treatments. We believe we will obtain excellent therapeutic effect, which may be additive or even synergistic, when administering combinations of cannabis root oil, tetrahydrocannabinol and cannabidiol.

[0335] Disclosed are a variety of suppositories believed to be highly effective for treating certain forms of cancer, including stomach cancer, non-Hodgkin lymphoma, prostate cancer, and kidney cancer, both on their own, or in synergistic combination with known cancer therapies.

The suppositories may also be useful in reducing the side effects of conventional cancer therapies, including pain, nausea, vomiting, and/or loss of appetite. The suppositories contain cannabis root oil as hereindescribed, either alone, or combined with THC and/or CBD. Other therapeutics may also be used in the formulation. For example, lavender oil, frankincense essential oil, cypress essential oil, clary sage oil, and/or basil essential oil may form part of the suppository formulation.

[0336] We have created a combination particularly useful and effective in such cancer treatment and/or relief of side effects, comprising cannabis root oil, CBD, THC, lavender oil, frankincense essential oil, cypress essential oil, clary sage oil, and basil essential oil.

[0337] Any known base can be used for the suppository; we have found that cacao butter can be effectively used.

[0338] Example 6A: Suppository formulation utilizing cannabis root oil

[0339] 100 g of cacao butter is melted in a stainless steel pot, to about 102 degrees F. About 1 ml cannabis root oil is added, and the liquid is stirred until the oil appears completely blended. The composition is poured into about 50 suppository moulds, each containing about 2g of composition; the suppository moulds are sealed and cooled.

[0340] The suppository is administered vaginally and/or rectally to individuals suffering from cancer, either alone or in combination with conventional cancer therapy, and results in a reduction of tumor growth. The suppository is also administered vaginally and/or rectally to individuals afflicted with side effects resulting from conventional cancer therapy, and reduces the incidences of such side effects. [0341] Example 6B: Suppository formulation utilizing cannabis root oil THC and CBD

[0342] 100 g of cacao butter is melted in a stainless steel pot, to about 102 degrees F. About 1 ml cannabis root oil, and about 2 g of a 2 mg active/gram, 1 : 1 ratio THC/CBD resin is added, and the liquid is stirred until homogeneous. The composition is poured into about 50 suppository moulds, each containing about 2g of composition; the suppository moulds are sealed and cooled.

[0343] The suppository is administered vaginally and/or rectally to individuals suffering from cancer, either alone or in combination with conventional cancer therapy, and results in a reduction of tumor growth. The suppository is also administered vaginally and/or rectally to individuals afflicted with side effects resulting from conventional cancer therapy, and reduces the incidences of such side effects.

[03441 Example 6C: Suppository formulation

[0345] 100 g of cacao butter was melted in a stainless steel pot, to about 102 degrees F. About 1 ml cannabis root oil, about 200 mg of a 2mg/g active, 1 : 1 ratio THC/CBD resin, about 1 ml lavender oil, about 1 ml of frankincense essential oil, about 0.5 ml of cypress essential oil, about 0.2 ml of clary sage oil, and about 0.15 ml of basil essential oil were added, and the liquid was stirred until homogeneous. The composition was poured into about 50 suppository moulds, each containing about 2g of composition; the suppository moulds were sealed and cooled.

[0346] The suppository is administered vaginally and/or rectally to individuals suffering from cancer, either alone or in combination with conventional cancer therapy, and results in a reduction of tumor growth. The suppository is also administered vaginally and/or rectally to individuals afflicted with side effects resulting from conventional cancer therapy, and reduces the incidences of such side effects. [03471 Example 6D: Suppository formulation

[0348] 100 g of cacao butter was melted in a stainless steel pot, to about 102 degrees F. About 1 ml cannabis root oil, about 2 g of a 2mg/g active, 1 : 1 ratio THC/CBD resin, about 1 ml lavender oil, about 1 ml of frankincense essential oil, about 0.5 ml of cypress essential oil, about 0.2 ml of clary sage oil, and about 0.15 ml of basil essential oil were added, and the liquid was stirred until homogeneous. The composition was poured into about 50 suppository moulds, each containing about 2g of composition; the suppository moulds were sealed and cooled. [0349] The suppository is administered vaginally and/or rectally to individuals suffering from cancer, either alone or in combination with conventional cancer therapy, and results in a reduction of tumor growth. The suppository is also administered vaginally and/or rectally to individuals afflicted with side effects resulting from conventional cancer therapy, and reduces the incidences of such side effects.

[03501 Example 6E: Suppository formulation

[0351] 100 g of cacao butter was melted in a stainless steel pot, to about 102 degrees F. About 1 ml cannabis root oil, about 5 g of a 2mg/g active, 1 : 1 ratio THC/CBD resin, about 1 ml lavender oil, about 1 ml of frankincense essential oil, about 0.5 ml of cypress essential oil, about 0.2 ml of clary sage oil, and about 0.15 ml of basil essential oil were added, and the liquid was stirred until homogeneous. The composition was poured into about 50 suppository moulds, each containing about 2g of composition; the suppository moulds were sealed and cooled. [0352] The suppository is administered vaginally and/or rectally to individuals suffering from cancer, either alone or in combination with conventional cancer therapy, and results in a reduction of tumor growth. The suppository is also administered vaginally and/or rectally to individuals afflicted with side effects resulting from conventional cancer therapy, and reduces the incidences of such side effects.

[03531 Example 6F: Suppository formulation

[0354] 100 g of cacao butter was melted in a stainless steel pot, to about 102 degrees F. About 1 ml cannabis root oil, about 10 g of a 2mg/g active, 1 : 1 ratio THC/CBD resin, about 1 ml lavender oil, about 1 ml of frankincense essential oil, about 0.5 ml of cypress essential oil, about 0.2 ml of clary sage oil, and about 0.15 ml of basil essential oil were added, and the liquid was stirred until homogeneous. The composition was poured into about 50 suppository moulds, each containing about 2g of composition; the suppository moulds were sealed and cooled.

[0355] The suppository is administered vaginally and/or rectally to individuals suffering from cancer, either alone or in combination with conventional cancer therapy, and results in a reduction of tumor growth. The suppository is also administered vaginally and/or rectally to individuals afflicted with side effects resulting from conventional cancer therapy, and reduces the incidences of such side effects.

[0356] Example 7 - Method and Formulation for Treatment of Vaginal Yeast Infection.

Bacteriosis and Vaginitis

[0357] The cannabis root oil and/or emulsion as described in Example 1 is particularly useful as a treatment of vaginal yeast infection, bacterial vaginosis and vaginitis. In particular, the cannabis root oil produced by this method can be used advantageously in a suppository, for treatment of vaginal yeast infection, bacterial vaginosis and vaginitis.

[0358] It has been discovered that the cannabis root oil and/or emulsion as hereindescribed is a useful remedy for treatment of vaginal yeast infection, bacterial vaginosis and vaginitis, when administered in a suppository formulation. It has also been discovered that tetrahydrocannabinol and/or cannabidiol are also useful in alleviating these symptoms. We have obtained excellent therapeutic effect, which may be additive or even synergistic, when administering combinations of cannabis root oil, tetrahydrocannabinol and cannabidiol.

[0359] Disclosed are a variety of suppositories highly effective for treatment of vaginal yeast infection, bacterial vaginosis and vaginitis, containing such cannabis root oil, either alone, or combined with THC and/or CBD. Other therapeutics may also be used in the formulation. For example, tea tree essential oil, lavender essential oil, geranium essential oil, clary sage essential oil, basil essential oil, thyme essential oil, Manuka essential oil, and/or helichrysum essential oil. We have created a combination particularly useful and effective in treatment of vaginal yeast infection, bacterial vaginosis and vaginitis, comprising cannabis root oil, CBD, THC, tea tree essential oil, lavender essential oil, geranium essential oil, clary sage essential oil, basil essential oil, thyme essential oil, Manuka essential oil, and helichrysum essential oil.

[0360] Any known base can be used for the suppository; we have found that cacao butter can be effectively used.

[03611 Example 7A: Suppository formulation utilizing cannabis root oil

[0362] 100 g of cacao butter is melted in a stainless steel pot, to about 102 degrees F. About 1 ml cannabis root oil is added, and the liquid is stirred until the oil appears completely blended. The composition is poured into about 50 suppository moulds, each containing about 2g of composition; the suppository moulds are sealed and cooled.

[0363] The suppository is administered vaginally and/or rectally to women suffering from vaginal yeast infection, bacterial vaginosis and/or vaginitis, and results in a noticeable decrease in those ailments. [03641 Example 7B: Suppository formulation utilizing cannabis root oil THC and CBD

[0365] 100 g of cacao butter is melted in a stainless steel pot, to about 102 degrees F. About 1 ml cannabis root oil, and about 200 mg of a 2 mg active/gram, 1 : 1 ratio THC/CBD resin is added, and the liquid is stirred until homogeneous. The composition is poured into about 50 suppository moulds, each containing about 2g of composition; the suppository moulds are sealed and cooled. [0366] The suppository is administered vaginally and/or rectally to women suffering from vaginal yeast infection, bacterial vaginosis and/or vaginitis, and results in a noticeable decrease in those ailments.

[03671 Example 7C: Suppository formulation

[0368] 100 g of cacao butter was melted in a stainless steel pot, to about 102 degrees F. About 1 ml cannabis root oil, about 200 mg of a 2mg/g active, 1 : 1 ratio THC/CBD resin, about 1.25 ml lavender oil, about 1.25 ml of tea tree essential oil, about 0.5 ml of geranium oil, about 0.25 ml of clary sage oil, about 0.25 ml of basil essential oil, about 0.25 ml of thyme essential oil, about 0.25 ml of Manuka essential oil, and about 0.15 ml of helichrysum essential oil was added, and the liquid was stirred until homogeneous. The composition was poured into about 50

suppository moulds, each containing about 2g of composition; the suppository moulds were sealed and cooled. [0369] The suppository was administered vaginally to women suffering from vaginal yeast infection, bacterial vaginosis and/or vaginitis, and resulted in a noticeable decrease in at least one or more of those ailments. [0370] Example 8 - Method and Formulation for the Treatment of Effects of Menopause

[0371] The cannabis root oil and/or emulsion as described in Example 1 is particularly effective when used in a formulation for treatment of pre-menopausal and menopausal symptoms such as hot flashes, shivering, sweating and reddening of the skin, mood changes, vaginal dryness, and trouble sleeping. In particular, the cannabis root oil produced by this method can be used advantageously in a suppository, for treatment of pre-menopausal and menopausal symptoms such as hot flashes, shivering, sweating and reddening of the skin, mood changes, vaginal dryness, and trouble sleeping.

[0372] It has been discovered that the cannabis root oil as hereindescribed is a useful remedy for treatment of pre-menopausal and menopausal symptoms such as hot flashes, shivering, sweating and reddening of the skin, mood changes, vaginal dryness, and trouble sleeping, when administered in a suppository formulation. It has also been discovered that tetrahydrocannabinol and/or cannabidiol are also useful in alleviating these symptoms. We have obtained excellent therapeutic effect, which may be additive or even synergistic, when administering combinations of cannabis root oil/emulsion, tetrahydrocannabinol and cannabidiol.

[0373] Disclosed are a variety of suppositories highly effective for treatment of pre-menopausal and menopausal symptoms such as hot flashes, shivering, sweating and reddening of the skin, mood changes, vaginal dryness, and trouble sleeping, containing such cannabis root oil, either alone, or combined with THC and/or CBD. Other therapeutics may also be used in the formulation. For example, vitex berry essential oil, lavender essential oil, clary sage essential oil, geranium essential oil, basil essential oil and/or chamomile essential oil. We have created a combination particularly useful and effective in treatment of pre-menopausal and menopausal symptoms such as hot flashes, shivering, sweating and reddening of the skin, mood changes, vaginal dryness, and trouble sleeping, comprising cannabis root oil, CBD, THC, vitex berry essential oil, lavender oil, clary sage oil, basil oil, geranium oil, and chamomile oil. [0374] Any known base can be used for the suppository; we have found that cacao butter can be effectively used.

[0375] Example 8A: Suppository formulation utilizing cannabis root oil

[0376] 100 g of cacao butter is melted in a stainless steel pot, to about 102 degrees F. About 1 ml cannabis root oil is added, and the liquid is stirred until the oil appears completely blended. The composition is poured into about 50 suppository moulds, each containing about 2g of composition; the suppository moulds are sealed and cooled.

[0377] The suppository is administered vaginally and/or rectally to women suffering from pre- menopausal and menopausal symptoms such as hot flashes, shivering, sweating and reddening of the skin, mood changes, vaginal dryness, and trouble sleeping, and results in a noticeable decrease in those symptoms.

[0378] Example 8B: Suppository formulation utilizing cannabis root oil THC and CBD

[0379] 100 g of cacao butter is melted in a stainless steel pot, to about 102 degrees F. About 1 ml cannabis root oil, and about 200 mg of a 2 mg active/gram, 1 : 1 ratio THC/CBD resin is added, and the liquid is stirred until homogeneous. The composition is poured into about 50 suppository moulds, each containing about 2g of composition; the suppository moulds are sealed and cooled.

[0380] The suppository is administered vaginally and/or rectally to women suffering from pre- menopausal and menopausal symptoms such as hot flashes, shivering, sweating and reddening of the skin, mood changes, vaginal dryness, and trouble sleeping, and results in a noticeable decrease in those symptoms. [03811 Example 8C: Suppository formulation

[0382] 100 g of cacao butter was melted in a stainless steel pot, to about 102 degrees F. About 1 ml cannabis root oil, about 200 mg of a 2mg/g active, 1 : 1 ratio THC/CBD resin, about 1.25 ml lavender oil, about 1.25 ml vitex berry essential oil, about 0.25 ml of each of clary sage oil, geranium oil, and chamomile oil, and about 0.15 ml of basil essential oil was added, and the liquid was stirred until homogeneous. The composition was poured into about 50 suppository moulds, each containing about 2g of composition; the suppository moulds were sealed and cooled.

[0383] The suppository was administered vaginally to women suffering from pre-menopausal and menopausal symptoms such as hot flashes, shivering, sweating and reddening of the skin, mood changes, vaginal dryness, and trouble sleeping, and resulted in a noticeable decrease in at least one or more of those symptoms.

[0384] Example 9 - Skin Moisturizer Formulations

[0385] The cannabis root oil and/or emulsion as described in Example 1 is highly effective as skin moisturizers when used in topical formulations, containing such cannabis root oil.

Unexpectedly, cannabis root oil has been found to have excellent skin moisturizing properties. Also unexpectedly, CBD oil has been found to have excellent skin moisturizing properties. We have found that a combination of cannabis root oil and CBD oil to be particularly effective as a skin moisturizer. In particular, one or more of CBD oil and cannabis root oil with other oils have resulted in formulations highly effective as skin moisturizers. For example, one or more of CBD oil and cannabis root oil may be combined with one or more of jojoba seed oil, avocado oil, apricot kernel oil, rose water, honey, grapefruit seed extract, cetyl stearyl alcohol, stearic acid, turmeric root oil, juniper berry oil, jasmine flower oil, sandalwood oil, copaiba oil, pomegranate seed oil, chamomile water, stearic acid, ginger root oil, cinnamon bark oil, clove bud oil, cardamom seed oil, lavender flower oil, rose flower oil, sweet almond oil, goat milk powder, basil oil, bergamot peel oil, fennel seed oil, frankincense oil, and lavender flower oil.

[0386] Example 9A: Balance moisturizer

[0387] A skin moisturizer was made by blending and emulsifying the following ingredients in the following wt. proportions:

[0388] The skin moisturizer was found to have excellent hydrating effect, that provided a superior benefit and would last all day. The skin moisturizer composition was found to work especially well for sensitive skin types. The moisturizer composition was tested against a known, commercially available, highly rated skin moisturizer, by applying the known moisturizer on half the face of an individual, and applying similar amounts of the moisturizer of the present invention on the other half. The moisturizer of the present invention provided immediate difference in skin texture when applied, and the skin felt more robust and elastic, and appeared more lustrous and youthful. The skin felt thicker to the touch, yet softer at the same time. The skin looked“uplifted”, and these qualities remained throughout the day. These differences were noticeable and improved both against the non-treated faces, as well as the face treated with known moisturizer.

[0389] Example 9B: Vitalize moisturizer [0390] A skin moisturizer was made by blending and emulsifying the following ingredients in the following wt. proportions:

[0391] The skin moisturizer was found to have excellent hydrating effect, that provided a superior benefit and would last all day. The skin moisturizer composition was found to work especially well for dry skin types. The moisturizer composition was tested against a known, commercially available, highly rated skin moisturizer, by applying the known moisturizer on half the face of an individual, and applying similar amounts of the moisturizer of the present invention on the other half. The moisturizer of the present invention provided immediate difference in skin texture when applied, and the skin felt more robust and elastic, and appeared more lustrous and youthful. The skin felt thicker to the touch, yet softer at the same time. The skin looked“uplifted”, and these qualities remained throughout the day. These differences were noticeable and improved both against the non-treated faces, as well as the face treated with known moisturizer.

[0392] Example 9C: Align moisturizer

[0393] A skin moisturizer was made by blending and emulsifying the following ingredients in the following wt. proportions:

[0394] The skin moisturizer was found to have excellent hydrating effect, that provided a superior benefit and would last all day. The skin moisturizer composition was found to work especially well for oily skin types. The moisturizer composition was tested against a known, commercially available, highly rated skin moisturizer, by applying the known moisturizer on half the face of an individual, and applying similar amounts of the moisturizer of the present invention on the other half. The moisturizer of the present invention provided immediate difference in skin texture when applied, and the skin felt more robust and elastic, and appeared more lustrous and youthful. The skin felt thicker to the touch, yet softer at the same time. The skin looked“uplifted”, and these qualities remained throughout the day. These differences were noticeable and improved both against the non-treated faces, as well as the face treated with known moisturizer. [0395] Example 9D: Testimonials

[0396] Users of the skin moisturizers of the present invention provided the following

testimonials:

• The serum and vitalize moisturizer feel like a fountain of youth on my face when used together - 1 am truly amazed at how it works literally as soon as they are applied!

• I wanted to reach out and let you know that your moisturizer is amazing! I held off on using it however I ran out of my usual moisturizer and this was a game changer for my skin.

• l am very prone to hormonal breakouts and this past month and a half I have not

experienced breakouts, my skin is a lot brighter and so much softer.

• I get stopped on the street by people who don't even know me asking what products I use.

My skin looks hydrated, healthy and alive.

• This product is unreal! My Mom and I both are using it and we love it. It smells gorgeous and it hydrates my dry skin in the prairies. No negative reactions to my sensitive skin. I love it.

• I suffer from inflammation daily. This line has completely helped my skin to calm the inflammation. I will continue to purchase it.

• The moisturizing face cream really helps hydrate my skin. Not greasy.

• I suffer from psoriasis. These products have totally saved my hands and feet.

• My skin is SO sensitive. This line totally calms my skin and makes it feel so good. I'm no longer as red in the face. Use it twice a day. My new favourite line. • I never use product normally but my girlfriend had these products and she had me try them. I'm hooked.

• I found the products to be surprisingly hydrating with just a small amount.

• I live in Saskatchewan where it is very dry. I have been receiving numerous comments from my staff at the bank telling me how great my skin feels. It is due to these products!

• This has been so amazing for my dry skin in the winter time! ! ! I've been applying the moisturizer right after washing my face in the morning (and under my make up), and I've also been utilizing it at night time after washing my make up off. I love the fact that it has such a soothing smell; it doesn't leave any oily residue behind, and it doesn't seem to affect my make up application/wear either (which is a total plus).

• I don't have sensitive skin by any means, but I'm usually pretty hesitant when it comes to trying out new serums. I've been using this at night time only, and I've noticed a significant difference in the appearance of my skin - it's brighter, and there's a lot less discoloration. It's also made my skin a lot softer, and it's removed the dry patches/ spots that I had gotten from the drying winter months. I've also gotten my mom to test it, who has much oily skin than me, and she's had good results as well.

[0397] Example 10 - Method and Formulation for use as a Female Sexual Lubricant

[0398] Disclosed is a topical formulation for use as a female sexual lubricant. The topical formulation is useful in healthy individuals as an aid or enhancer of the sexual experience. It promotes lubrication, provides a desirable“tingling” sensation, and encourages and/or enhances orgasm. In addition, it is useful in individuals suffering from sexual dysfunction, providing the same benefits. Informal studies have shown that the topical formulation has allowed or facilitated certain women suffering from sexual dysfunction to experience orgasm for the first time. [0399] The topical formulation contains THC, for example in the form of a THC resin, and/or ashwagandha oil, and/or cannabis root oil. Without being limited by theory, it is believed that the THC provides a desirable“tingling” sensation in the sexual lubricant, the cannabis root oil has promoted vascularization and relaxation, and the ashwagandha oil enhances the sexual experience and promotes excitement and/or orgasm, by relaxing muscle and skin, and by stimulating natural vaginal lubrication. The topical formulation has also been found to promote lubrication; it is believed that all three active ingredients may contribute to this, as well as some of the other ingredients in the formulation. It is believed that the three active ingredients, or any two of the three active ingredients, may act synergistically or additively to greatly enhance the sexual experience in both healthy women and women suffering from sexual dysfunction.

[0400] In certain embodiments, the pharmaceutical formulation is in the form of a cream, an ointment, or a lotion. Preferably, the pharmaceutical formulation is in the form of an oil. [0401] The topical formulation is prepared in the form of an oil. The topical formulation comprises ashwaganda oil, cannabis root oil, and/or THC.

[0402] In certain embodiments, the topical formulation comprises ashwaganda oil and THC. In other embodiments, the topical formulation comprises ashwaganda oil and cannabis root oil. In a preferred embodiment, the topical formulation comprises ashwaganda oil, cannabis root oil, and THC.

[0403] It is believed that the hemp root oil provides anti-bacterial, anti-microbial, and pain relieving qualities. It may also act as a relaxant, which can act to aid in the sexual experience.

[0404] It has been found that the addition of the THC, preferably in the form of a THC resin, amplified the sexual experience. Interestingly, users of the topical formulation reported a pleasurable“tingling” sensation when the topical formulation contained THC. [0405] The ashwagandha oil was found to enhance the sexual experience and promotes excitement and/or orgasm, by relaxing muscle and skin, and by stimulating natural vaginal lubrication.

[0406] The three active ingredients can be placed in a carrier/diluent, which may be any pharmaceutically acceptable oil. Preferably, avocado oil can be used as a carrier and diluant; we have found that the specific viscosity of the avocado oil to be especially suitable for use as a sexual lubricant. Avocado oil was also particularly advantageous due to its skin nourishing properties. Preferably, a“natural” oil is utilized, i.e. an oil extracted from a fruit or vegetable source, or a grain or plant.

[0407] Other, optional ingredients may be added, as follows. [0408] Menthol crystals, can be added to the formulation to enhance stimulation, and provide a unique sensation.

[0409] Black pepper oil can be added to the formulation, for its energizing and warming (stimulating) properties, as well as for its anti-oxidant and antimicrobial qualities.

[0410] A topical formulation was prepared comprising (by weight) about 20% hemp root oil, about 60% avocado oil (Persea gratissima), and about 20% ashwaganda oil. About 0.2% by weight of THC, about 1% by weight of menthol crystals, and about 0.8% by weight of black pepper oil was added.

[0411] The topical formulation was provided to women pre-coitus, and was applied liberally, intervaginally. The topical formulation was found to enhance and improve the sexual experience. In many cases, orgasm was induced, notably, in some cases, in individuals who had never previously experienced the sensation.

[0412] Example 11 : Method and Formulation for Use as an Anti- Aging Serum

[0413] Disclosed are a variety of topical formulations highly effective as anti-aging serum. A combination of CBD and HA has been found to have unexpectedly high effectiveness at reducing the signs of aging, including wrinkles, loss of firmness, and diminished appearance of plumpness, suppleness, and elasticity. The formulations are effective in smoothing skin, increasing suppleness and elasticity, and giving skin a more youthful and desirable appearance.

It is believed that the combination of CBD and HA provide results that are better than either ingredient alone, and may provide additive or even synergistic results. [0414] CBD and HA can be combined with other ingredients to form formulations with even greater effect. For example, it has been found that CBD and HA may be combined with one or more of a lactobacillus and coconut fruit extract such as AMTicide® Coconut, lavender essential oil, copaiba essential oil, frankincense essential oil, carrot seed essential oil, geranium essential oil, and sea buckthorn berry essential oil. CBD and/or HA can also be combined with the hemp root oil or emulsion as hereinde scribed for excellent results.

[0415] The formulations may also contain an gel or emulsifying agent, or both; for example, the formulations may contain ECOGEL™, a gelling-emulsifying agent that increases the viscosity and stability of formulations. As well, the formulations may contain preservative agents, such as for example, Leucidal® Liquid SF.

[0416] Example 11 A: Anti-aging Serum

[0417] An anti-aging serum was made by blending and emulsifying the following ingredients in the following wt. proportions:

[0418] The anti-aging serum was found to have excellent and unexpectedly high effectiveness at reducing the signs of aging, including wrinkles, loss of firmness, and diminished appearance of plumpness, suppleness, and elasticity. The formulations were effective in smoothing skin, increasing suppleness and elasticity, and giving skin a more youthful and desirable appearance. The anti-aging serum composition was tested against a known, commercially available, highly rated anti-aging serum, by applying the known anti-aging serum on half the face of an individual, and applying similar amounts of the anti-aging serum of the present invention on the other half. The anti-aging serum of the present invention provided immediate difference in skin texture when applied, and the skin felt more robust and elastic, and appeared more lustrous and youthful. The skin felt thicker to the touch, yet softer at the same time. The skin looked“uplifted”, and these qualities remained throughout the day. These differences were noticeable and improved both against the non-treated faces, as well as the face treated with known anti-aging serum. [0419] Example 11B: Anti-aging serum

[0420] An anti-aging serum can be made by blending and emulsifying the following ingredients in the following wt. proportions:

[0421] The anti-aging serum has excellent and unexpectedly high effectiveness at reducing the signs of aging, including wrinkles, loss of firmness, and diminished appearance of plumpness, suppleness, and elasticity. The formulation is effective in smoothing skin, increasing suppleness and elasticity, and giving skin a more youthful and desirable appearance. The anti-aging serum composition can be tested against a known, commercially available, highly rated anti-aging serum, by applying the known anti-aging serum on half the face of an individual, and applying similar amounts of the anti-aging serum of the present invention on the other half. The anti aging serum of the present invention can provide immediate difference in skin texture when applied, with the skin feeling more robust and elastic, and more lustrous and youthful. The skin will feel thicker to the touch, yet softer at the same time. The skin looks“uplifted”, and these qualities remain throughout the day. These differences are noticeable and improved both against the non-treated faces, as well as the face treated with known anti-aging serum. [0422] Example 11C: Anti- Aging Serum

[0423] An anti-aging serum can be made by blending and emulsifying the following ingredients in the following wt. proportions: Ingredient - INCI name Formula %

Aqua 91.220 Lactobacillus Ferment 2.000

Lactobacillus, Cocos Nucifera (Coconut) Fruit Extract 2.000

Hyaluronic Acid 1.000

Lavandula Angustifolia (Lavender) Oil 1.000

Copaifera Officinalis (Balsam Copaiba) Resin Oil 1.000

Lysolecithin, Sclerotium Gum, Xanthan Gum, Pullulan 0.500

Boswellia Carterii (Frankincense) Gum Oil 0.400

Pelargonium Graveolens (Geranium) Flower Oil 0.300

Daucus Carota Sativa (Carrot) Seed Oil 0.250

Hippophae Rhamnoides (Sea Buckthorn) Oil 0.250

Cannabis Sativa (Hemp) Seed Oil 0.040

Hemp Root Oil 0.040

[0424] The anti-aging serum has an off-white slightly viscous serum form, and a pH of 4.5-5.5.

It has excellent and unexpectedly high effectiveness at reducing the signs of aging, including wrinkles, loss of firmness, and diminished appearance of plumpness, suppleness, and elasticity. The formulation is effective in smoothing skin, increasing suppleness and elasticity, and giving skin a more youthful and desirable appearance. The anti-aging serum composition can be tested against a known, commercially available, highly rated anti-aging serum, by applying the known anti-aging serum on half the face of an individual, and applying similar amounts of the anti-aging serum of the present invention on the other half. The anti-aging serum of the present invention can provide immediate difference in skin texture when applied, with the skin feeling more robust and elastic, and more lustrous and youthful. The skin will feel thicker to the touch, yet softer at the same time. The skin looks“uplifted”, and these qualities remain throughout the day. These differences are noticeable and improved both against the non-treated faces, as well as the face treated with known anti-aging serum.