Cannabinoid-containing compositions

Abstract

Provided is a method for treating a condition selected from the group consisting of pain, sleep disorder, cancer, Alzheimer's disease, neurodegenerative diseases, ulcer, hypertension, opioid- related adverse effects, inflammation, asthma, glaucoma, neurodevelopment diseases and combinations thereof in a subject in need thereof, the method comprising administering to the subject: a) a first active pharmaceutical ingredient (API) comprising at least one cannabinoid other than CBD and THC; and b) a second API, which is different from the first API.

Description

CANNABINOID-CONTAINING COMPOSITIONSCross-Reference to Related Applications

[0001] The present application gains priority from U.S Provisional Patent Application Serial No. 63 / 614,638 filed July 16, 2024, which is incorporated by reference as if fully set- forth herein.Field of the Invention

[0002] The present invention relates to the field of pharmaceutical compositions, and more specifically to compositions comprising at least one cannabinoid other than THC or CBD, and at least one additional active pharmaceutical ingredient for use in treating a condition selected from the group consisting of pain, a sleep disorder, cancer, Alzheimer’s disease, a neurodegenerative disease, ulcer, hypertension, an opioids-related adverse effect, inflammation, asthma, glaucoma, a neurodevelopment disease and combinations thereof in a subject in need thereof.Background

[0003] The therapeutic effects of cannabis have been known for thousands of years. The main active components are named cannabinoids. So far, more than 100 cannabinoids have been discovered. Cannabis plants contain multiple cannabinoids, sometimes dozens of them. The most known cannabinoids are tetrahydrocannabinol (THC) and cannabidiol (CBD). Others include cannabigerol (CBG), cannabichromene (CBC) tetrahydrocannabivarin (THCV) Cannabidivarin (CBDV) and cannabinol (CBN). Cannabinoids are found in various parts of the cannabis plant.

[0004] Use of cannabinoids in therapy has mainly been focused on THC and CBD, alone or in combination. For example, Sativex®, an oromucosal spray used for treatment of symptoms of multiple sclerosis, comprises a combination of THC and CBD at a ratio of about 1: 1.

[0005] Cannabinoids other than THC and CBD, also referred to as minor cannabinoids, are cannabinoids which are found in small concentrations in cannabis plants. The therapeutic potential of the minor cannabinoids has not been fully explored. \Summary of the invention

[0006] According to an aspect of some embodiments of the present invention, there is provided a method for treating a condition selected from the group consisting of pain, sleep disorder, cancer, Alzheimer’s disease, neurodegenerative diseases, ulcer, hypertension, opioid-related adverse effects, inflammation, asthma, glaucoma, neurodevelopment diseases and combinations thereof in a subject in need thereof, the method comprising administering to the subject: a) a first active pharmaceutical ingredient (API) comprising at least one cannabinoid other than CBD and THC; and b) a second API, which is different from the first API.Detailed Description of the invention

[0007] The present invention provides a method for treating a condition selected from the group consisting of pain, sleep disorder, cancer, Alzheimer’s disease, neurodegenerative diseases, ulcer, hypertension, opioid-related adverse effects, inflammation, asthma, glaucoma, neurodevelopment diseases and combinations thereof in a subject in need thereof, the method comprising administering to the subject: a) a first active pharmaceutical ingredient (API) comprising at least one cannabinoid other than CBD and THC; and b) a second API, which is different from the first API.

[0008] The present inventors have surprisingly found that use of cannabinoids other than CBD and THC (“minor cannabinoids”) in combination with an additional active pharmaceutical ingredient is surprisingly effective in the treatment of pain, sleep disorders, cancer, Alzheimer’s disease, neurodegenerative diseases, ulcer, hypertension, opioids-related adverse effects, inflammation, asthma, glaucoma and neurodevelopment diseases.

[0009] According to some embodiments, the use of the cannabinoid other than THC or CBD results in a reduced requirement for the second API, which may therefore be administered at a lower daily dose than would be required to provide the same therapeutic effect in the absence of the cannabinoid other than THC or CBD.

[0010] According to some embodiments, wherein the second API comprises THC and / or CBD, the ratio of a daily dose of cannabinoid other than THC or CBD : daily dose of total THCand CBD which is greater than the respective concentration ratio of the cannabinoids found in the plant in nature.

[0011] The cannabinoid other than TCH or CBD may achieve the therapeutic effect via a mechanism other than that of the second API, such that each of the agents provides a different function in contributing to the overall therapeutic effect.

[0012] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

[0013] As used herein, the term "treating" includes ameliorating, mitigating, and reducing the instances of a disease or condition, or the symptoms of a disease or condition.

[0014] As used herein, the term "administering" includes any mode of administration, such as oral, subcutaneous, sublingual, transmucosal, parenteral, intravenous, intra-arterial, buccal, topical, vaginal, rectal, ophthalmic, otic, nasal, inhaled, intramuscular, intraosseous, intrathecal, and transdermal, or combinations thereof. "Administering" can also include providing a different compound that when ingested or delivered as above will necessarily transform into the compound that is desired to be administered, this type of “different compound” is often being referred to as a “Prodrug”. "Administering" can also include prescribing or filling a prescription for a dosage form comprising a particular compound. "Administering" can also include providing directions to carry out a method involving a particular compound or a dosage form comprising the compound or compounds.

[0015] As used herein, the term "therapeutically effective amount" means the amount of an active substance that, when administered to a subject for treating a disease, disorder, or other undesirable medical condition, is sufficient to have a beneficial effect with respect to that disease, disorder, or condition. The therapeutically effective amount will vary depending on the chemical identity and formulation form of the active substance, the disease or condition and its severity, and the age, weight, and other relevant characteristics of the patient to be treated. Determining the therapeutically effective amount of a given active substance is within the ordinary skill of the art and typically requires no more than routine experimentation.

[0016] The terminology used in the description of the invention herein is for describing particular embodiments only and is not intended to be limiting of the invention. As used in the description of the invention and the appended claims, the singular forms “a,” “an,” and“the” are intended to include the plural forms as well, unless the context clearly indicates otherwise.

[0017] Unless otherwise indicated, all numbers expressing quantities, reaction conditions, and so forth used in the specification and claims are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the following specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the present invention. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should be construed in light of the number of significant digits and ordinary rounding approaches. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. Every numerical range given throughout this specification will include every narrower numerical range that falls within such broader numerical range, as if such narrower numerical ranges were all expressly written herein.

[0018] As used herein, when a numerical value is preceded by the term "about", the term "about" is intended to indicate + / -10% of that value.

[0019] As used herein, the terms “comprising”, “including”, "having" and grammatical variants thereof are to be taken as specifying the stated features, integers, steps or components but do not preclude the addition of one or more additional features, integers, steps, components or groups thereof. These terms encompass the terms "consisting of' and "consisting essentially of'. As used herein, the terms “water content” and “moisture content” are used interchangeably.

[0020] Unless indicated otherwise, percent is weight percent and ratio is weight / weight ratio.

[0021] The particulars shown herein are by way of example and for purposes of illustrative discussion of the various embodiments of the present invention only and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show details of the invention in more detail than is necessary for a fundamentalunderstanding of the invention, the description making apparent to those skilled in the art how the several forms of the invention may be embodied in practice.

[0022] The present invention will now be described by reference to more detailed embodiments. This invention may, however, be embodied in different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.

[0023] Additional advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.

[0024] According to an aspect of some embodiments of the present invention, there is provided a method for treating a condition selected from the group consisting of pain, sleep disorder, cancer, Alzheimer’s disease, neurodegenerative diseases, ulcer, hypertension, opioid-related adverse effects, inflammation, asthma, glaucoma, neurodevelopment diseases and combinations thereof in a subject in need thereof, the method comprising administering to the subject: a) a first active pharmaceutical ingredient (API) comprising at least one cannabinoid other than CBD and THC; and b) a second API, which is different from the first API.

[0025] According to some embodiments, the neurodegenerative disease is selected from the group consisting of Parkinson’s Disease, dementia, Amyotrophic Lateral Sclerosis (ALS) and Huntingdon’s Disease (HD).

[0026] According to some embodiments, the neurodevelopment disease is selected from the group consisting of Autism Spectrum Disorder (ASD), Attention Deficit / Hyperactivity Disorder (ADHD), intellectual disability, Tourette’s Syndrome and Cerebral Palsy.

[0027] According to some embodiments, the cannabinoid other than THC or CBD is selected from the group consisting of Cannabinol (CBN), Cannabicyclol (CBL), Cannabielsoin (CBE), Cannabitriol (CBT), cannabigerolic acid (CBGA), cannabigerol (CBG), cannabichromenic acid (CBCA), cannabichromene (CBC), tetrahydrocannabivarinic acid (THCVA), tetrahydrocannabivarin (THCV), cannabidivarinic acid (CBDVA),cannabidivarin (CBDV), cannabigerovarin (CBGV), hexahydrocannabinol (HHC), 2- arachidonoylglycerol (2-AG), anandamide, palmitoylethanolamide (PEA), oleoyl ethanol ami de (OEA) and combinations thereof.

[0028] As used herein, the terms “THC” and “CBD” are intended to include both the decarboxylated forms (THC and CBD) as well as the acid forms (THCA and CBDA, respectively).

[0029] According to some embodiments, the second API is a cannabinoid. According to some such embodiments, the cannabinoid of the second API is selected from the group consisting of THC, CBD, CBGA, CBG, CBCA, CBC, THCVA, THCV, CBDVA, CBDV, CBGV, HHC, 2-AG, anandamide, PEA, OEA and combinations thereof.

[0030] According to some embodiments wherein the second API is a cannabinoid, the cannabinoid of the first API is different from the cannabinoid of the second API.

[0031] According to some embodiments, at least one of the first API and second API is a cannabinoid isolate. According so some embodiments, the first API is a cannabinoid isolate. According so some embodiments, the second API is a cannabinoid isolate. According so some embodiments, each of the first API and the second API is a cannabinoid isolate. According to some embodiments, the cannabinoid isolate is isolated from a botanical source.

[0032] According to some embodiments, at least one of the first API and second API is a synthetic cannabinoid. According so some embodiments, the first API is a synthetic cannabinoid. According so some embodiments, the second API is a synthetic cannabinoid. According so some embodiments, each of the first API and the second API is a synthetic cannabinoid. According to some embodiments, the synthetic cannabinoid is synthesized by a method selected from the group consisting of chemical synthesis and biological synthesis, or a combination thereof.

[0033] According to some embodiments, the second API is selected from the group consisting of THC, CBN, CBD, CBG, an opioid, a steroid, a bronchodilator, an appetite enhancer, a focus enhancer, a memory enhancer, an anti-inflammatory agent, an anxiolytic agent, an anti-spastic agent, an anti-depressant, a smooth muscle relaxant, a sleep enhancer, a sedative, a hypnotic agent, an anti-emetic agent, an antibiotic, an antimicrobial agent, a neuroleptic agent, an antipsychotic agent, a proton pump inhibitor, a vasodilator and combinations thereof.

[0034] According to some embodiments, the second API is administered at a daily dose of no greater than about 90% (such as about 90%, about 85%, about 80%, about 75%, about 70%, about 65%, about 60%, about 55%, about 50% or less than about 50%) of the daily dose required to achieve a same effect in treatment of the condition in the subject in the absence of the first API.

[0035] According to some embodiments, the total administered cannabinoid dose is from about 1 mg to about 100 mg per day (such as about 1 mg, about 5 mg, about 10 mg, about 15 mg, about 20 mg, about 25 mg, about 30 mg, about 35 mg, about 40 mg, about 50 mg, about 55 mg, about 60 mg, about 65 mg, about 70 mg, about 75 mg, about 80 mg, about 85 mg, about 90 mg, about 95 mg or about 100 mg per day).

[0036] According to some embodiments, the method further comprises administering at least one terpene, in addition to the first API and the second API.

[0037] According to some embodiments, the ratio between the first API and the second API is less than 1 : 1. According to some such embodiments, the ratio between the first API and the second API is in the range of from 1 : 1.1 to 1 :30, such as 1 : 1.1, 1 : 1.5, 1 :2, 1 :3, 1 :4, 1 :5, 1 : 10, 1 : 15, 1 :20, l :25or 1 :30.

[0038] According to some embodiments, the ratio between the first API and the second API is greater than 1 : 1. According to some such embodiments, the ratio between the first API and the second API is from 1 :0.1 to 1 :0.9, such as 1 :0.1, 1 :0.2, 1 :0.3, 1:0.4, 1 :0.5, 1 :0.6, 1 :0.7, 1 :0.8 or 1 :0.9.

[0039] According to some embodiments, the ratio between the second API and the first API equals 1.

[0040] According to some embodiments, the second API comprises at least one terpene.

[0041] According to some embodiments, a ratio between a total amount of terpenes administered to a total amount of cannabinoids administered is greater than 0.05: 1.

[0042] According to some such embodiments, the total amount of non-cannabinoid, nonterpene content administered is less than 5%wt of the total amount of material administered.

[0043] According to some embodiments, the first API and the second API are administered in a single composition.

[0044] According to some such embodiments, the non-cannabinoid, non-terpene content of cannabis plant material in the composition is less than 5%wt of the total composition.

[0045] According to some embodiments, the single composition is administered by a delivery route selected from the group consisting of oral (including sublingual and buccal), subcutaneous, transmucosal, parenteral, intravenous, intra-arterial, topical, vaginal, rectal, ophthalmic, otic, nasal, inhaled, intramuscular, intraosseous, intrathecal and transdermal administration or combinations thereof.

[0046] According to some embodiments, the first API and the second API are administered separately, in a first and a second composition, respectively. According to some such embodiments, the first and the second composition are administered independently, sequentially, simultaneously or concomitantly, or any combination thereof. According to some such embodiments, the first and second composition are administered separately within no more than 30 minutes of each other, such as within 30 minutes, within 25 minutes, within 20 minutes, within 15 minutes, within 10 minutes, within 5 minutes, within 1 minute of each other.

[0047] According to some such embodiments, the non-cannabinoid, non-terpene content of cannabis plant material in each of the first and the second composition is less than 5%wt of the total respective composition.

[0048] According to some such embodiments, each of the first composition and the second composition is administered by a delivery route selected from the group consisting of oral (including sublingual and buccal), subcutaneous, transmucosal, parenteral, intravenous, intraarterial, topical, vaginal, rectal, ophthalmic, otic, nasal, inhaled, intramuscular, intraosseous, intrathecal and transdermal administration or combinations thereof.

[0049] According to a preferred embodiment, at least one of the first API and the second API is administered by oral administration.

[0050] According to some embodiments, wherein the condition comprises pain, the second API is selected from the group consisting of THC, CBD, CBG, an analgesic, an opioid, an anti-inflammatory agent, an anxiolytic agent, an anti-spastic agent, an anti-depressant, a smooth muscle relaxant, a sleep enhancer, a sedative, a hypnotic agent, and combinations thereof.

[0051] According to some embodiments, wherein the pain is due to Parkinson’ s disease, the second API is selected from the group consisting of THC, CBD, CBG, an analgesic, an opioid, an anti-spastic agent, an anti-depressant and combinations thereof.

[0052] According to some embodiments, wherein the pain is due to arthritis, the second API is selected from the group consisting of THC, CBD, CBG, an analgesic, an opioid, an anti- spastic agent, an anti-inflammatory agent, a steroid and combinations thereof

[0053] According to some embodiments, wherein the condition comprises inflammation, the second API is selected from the group consisting of THC, CBD, CBG, an analgesic, an opioid, an anti-inflammatory agent, a steroid and combinations thereof.

[0054] According to some embodiments, wherein the condition comprises hypertension, the second API is selected from the group consisting of THC, CBD, CBG, a vasodilator and combinations thereof.

[0055] According to some embodiments, wherein the condition comprises a sleep disorder and / or insomnia, the second API is selected from the group consisting of THC, CBD, CBG, CBN, an anxiolytic, a sleep enhancer, a sedative, a hypnotic drugand combinations thereof.

[0056] According to some embodiments, wherein the condition comprises Alzheimer’s disease, the second API is selected from the group consisting of THC, CBD, CBG, an anxiolytic, an appetite enhancer, a sleep enhancer, a sedative, a hypnotic drug, an antidepressant and combinations thereof.

[0057] According to some embodiments, wherein the condition comprises cancer, the second API is selected from the group consisting of THC, CBD, CBG, an analgesic, an anxiolytic, an appetite enhancer, an antiemetic drug, an antibiotic and combinations thereof.

[0058] According to some embodiments, wherein the condition comprises an ulcer, the second API is selected from the group consisting of THC, CBD, CBG, a proton pump inhibitor, an anti-inflammatory agent, an antibiotic and combinations thereof.

[0059] According to some embodiments, wherein the condition comprises asthma, the second API is selected from the group consisting of THC, a steroid, a bronchodilator, and combinations thereof.

[0060] According to some embodiments, wherein the condition comprises glaucoma, the second API comprises THC.

[0061] According to some embodiments, wherein the condition comprises a neurodegenerative disease, the second API is selected from the group consisting of THC, CBD, CBG, an anti-inflammatory agent, an anxiolytic, an antidepressant, a neuroleptic agent and combinations thereof.

[0062] According to some embodiments, wherein the condition comprises a neurodevelopment disease, the second API is selected from the group consisting of THC, CBD, CBG, an anti-inflammatory agent, an anxiolytic, an antidepressant, a neuroleptic agent and combinations thereof.ExamplesExample 1: treating an elderly man with Alzheimer disease.

[0063] A man aged 83 diagnosed with Alzheimer disease is treated by administering sublingual cannabis oil, containing 5% CBG and 10% CBD. Administration involves 5 drops per dose, 3 times per day, providing a daily dose of 24mg CBG and 48mg CBD.Example 2: treating an elderly man with Parkinson disease.

[0064] A man aged 65 diagnosed with Parkinson disease is treated by administering oral cannabis capsule, containing 15mg CBC and 15mg CBG. Administration involves 1 capsule per dose, twice a day, providing a daily dose of 30mg CBC and 30mg CBG.Example 3: treating an elderly women with sleep disorders.

[0065] A woman aged 75 with symptoms of sleep disorder is treated by administering 1 ml of oral cannabis solution, containing 10 mg CBN and 2.5 mg linalool, and an anxiolytic solution. The two compositions are taken one hour before bedtime.Example 4: treating a women with arthritis.

[0066] A woman aged 52 diagnosed with arthritis is treated by administering an oral tablet, containing 25mg CBC and 5mg beta-caryophyllene and an oral steroid tablet. Each of the CBC and steroid tablets is administrated once a day, in the morning.Example 5: treating a man with ulcer.

[0067] A man aged 47 suffering from diabetic foot ulcer is treated by administering a topical cream containing 2.5% THCV and 2.5% anti -microbial agent (silver-based agents, such as silver sulfadiazine). The cream is applied on the foot ulcer 3 times a day.Example 6: treating a child with asthma.

[0068] A child aged 8 diagnosed with asthma is treated by inhaling an aerosol containing 5% CBG and 2% corticosteroids. The drug is inhaled twice a day, in the morning and before bed-time.Example 7: treating an adolescent with ADHD .

[0069] An adolescent aged 14 diagnosed with ADHD is treated by administering an oral solution containing 2% CBDV and 20% CBD. Administration involves 30 drops per dose, 2 times per day, providing a daily dose of 38.4 mg CBDV and 384 mg CBD.Example 8: treating a child diagnosed with autism.

[0070] A child aged 6 diagnosed with autism is treated by administering an oral solution containing 1% THCV and 28% CBD. Administration involves 10 drops per dose, 3 times per day, providing a daily dose of 9.6mg THCV and 268.8mg CBD.Example 9: treating a man with hypertension.

[0071] A man aged 55 diagnosed with hypertension is treated by orally administering capsules containing 5mg THCV, 5mg CBD, and 0.5mg beta-caryophyllene. Administration involves 1 capsule per dose, 3 times per day.Example 10: treating a women with cancer.

[0072] A woman aged 31, diagnosed with breast cancer and suffering from severe nausea due to chemotherapy is treated by inhaling grided cannabis buds containing 2.5% CBC and 20% THC. Administration involves 0.25g of grinded cannabis buds inhaled 4 times a day.Example 11: treating an adolescent diagnosed with Tourette syndrome.

[0073] An adolescent aged 16 diagnosed with Tourette syndrome is treated by administering oral tablets containing 1.5 mg CBN and lOmg CBD. Administration involves 1 tablet per dose, 3 times per day, providing a daily dose of 4.5mg CBN and 30mg CBD.Example 12: treating an elderly man with Amyotrophic Lateral Sclerosis (ALS).

[0074] A man aged 68 diagnosed with Amyotrophic Lateral Sclerosis (ALS) is treated by inhaling aerosol of a CBG solution, containing 12% CBG, and by administering antidepressant drug. The CBG solution is inhaled 3 times a day (in the morning, noon, and evening). The antidepressant drug is administrated once a day, in the morning.

Claims

CLAIMS1. A method for treating a condition selected from the group consisting of pain, sleep disorder, cancer, Alzheimer’s disease, neurodegenerative diseases, ulcer, hypertension, opioid- related adverse effects, inflammation, asthma, glaucoma, neurodevelopment diseases and combinations thereof in a subject in need thereof, the method comprising administering to the subject: a) a first active pharmaceutical ingredient (API) comprising at least one cannabinoid other than CBD and THC; and b) a second API, which is different from said first API.

2. The method of claim 1, wherein said second API is a cannabinoid.

3. The method of claim 1, wherein at least one of said first API and said second API is a cannabinoid isolate.

4. The method of claim 3, wherein said isolate is isolated from a botanical source.

5. The method of claim 1, wherein at least one of said first API and said second API is a synthetic cannabinoid.

6. The method of claim 5, wherein said synthetic cannabinoid is synthesized by a method selected from the group consisting of chemical synthesis and biological synthesis.

7. The method of claim 1, wherein a non-cannabinoid, non-terpene content of cannabis plant material in a composition comprising the first and / or second API is less than 5%wt of the total composition.

8. The method of claim 1, wherein said second API is selected from the group consisting of THC, CBN, CBD, CBG, an opioid, a steroid, a bronchodilator, an appetite enhancer, a focus enhancer, a memory enhancer, an anti-inflammatory agent, an anxiolytic agent, an anti-spastic agent, an anti-depressant, a smooth muscle relaxant, a sleep enhancer, a sedative, a hypnotic agent, an anti-emetic agent, an antibiotic, an antimicrobial agent, a neuroleptic agent, an antipsychotic agent, a proton pump inhibitor, a vasodilator and combinations thereof.

9. The method of claim 1, wherein said second API is administered at a daily dose of less than 90% of the daily dose required to achieve a same effect in treatment of the condition in the subject in the absence of the first API.

10. The method of claim 1, wherein a total administered cannabinoid dose is from about 1 mg to about 100 mg.

11. The method of claim 1, wherein each of said first API and said second API is administered by a delivery route selected from the group consisting of oral, subcutaneous, transmucosal, parenteral, intravenous, intra-arterial, topical, vaginal, rectal, ophthalmic, otic, nasal, inhaled, intramuscular, intraosseous, intrathecal and transdermal administration or combinations thereof.

12. The method of claim 11, wherein at least one of said first API and said second API is administered by oral administration.

13. The method of claim 1, further comprising administering at least one terpene.

14. The method of claim 1, wherein said second API comprises at least one terpene.

15. The method of claim 13 or claim 14, wherein a ratio between a total amount of terpenes administered to a total amount of cannabinoids administered is greater than 0.05: 1.

16. The method of claim 1, wherein said first API and said second API are administered in a single composition.

17. The method of claim 1, wherein said first API and said second API are administered in separate compositions.

18. The method of claim 1, wherein when said condition comprises pain, said second API is selected from the group consisting of THC, CBD, CBG, an analgesic, an opioid, an antiinflammatory agent, an anxiolytic agent, an anti-spastic agent, an anti-depressant, a smooth muscle relaxant, a sleep enhancer, a sedative, a hypnotic agent, and combinations thereof.

19. The method of claim 18, wherein when said pain is due to Parkinson’s disease, said second API is selected from the group consisting of THC, CBD, CBG, an analgesic, an opioid, an anti-spastic agent, an anti-depressant and combinations thereof.

20. The method of claim 18, wherein when said pain is due to arthritis, said second API is selected from the group consisting of THC, CBD, CBG, an analgesic, an opioid, an anti-spastic agent, an anti-inflammatory agent, a steroid, and combinations thereof21. The method of claim 1, wherein when said condition comprises inflammation, said second API is selected from the group consisting of THC, CBD, CBG, an analgesic, an opioid, an anti-inflammatory agent, a steroid and combinations thereof.

22. The method of claim 1, wherein when said condition comprises hypertension, said second API is selected from the group consisting of THC, CBD, CBG, a vasodilator and combinations thereof.

23. The method of claim 1, wherein when said condition comprises a sleep disorder and / or insomnia, said second API is selected from the group consisting of THC, CBD, CBG, CBN, an anxiolytic, a sleep enhancer, a sedative, a hypnotic drug and combinations thereof.

24. The method of claim 1, wherein when said condition comprises Alzheimer’s disease, said second API is selected from the group consisting of THC, CBD, CBG, an anxiolytic, an appetite enhancer, a sleep enhancer, a sedative, a hypnotic drug, an anti-depressant and combinations thereof.

25. The method of claim 1, wherein when said condition comprises cancer, said second API is selected from the group consisting of THC, CBD, CBG, an analgesic, an anxiolytic, an appetite enhancer, an antiemetic drug, an antibiotic and combinations thereof.

26. The method of claim 1, wherein when said condition comprises an ulcer, said second API is selected from the group consisting of THC, CBD, CBG, a proton pump inhibitor, an anti-inflammatory agent, an antibiotic and combinations thereof.

27. The method of claim 1, wherein when said condition comprises asthma, said second API is selected from the group consisting of THC, a steroid, a bronchodilator, and combinations thereof.

28. The method of claim 1, wherein when said condition comprises glaucoma, said second API comprises THC.

29. The method of claim 1, wherein when said condition comprises a neurodegenerative disease, said second API is selected from the group consisting of THC, CBD, CBG, an antiinflammatory agent, an anxiolytic, an antidepressant, a neuroleptic agent and combinations thereof.

30. The method of claim 1, wherein when said condition comprises a neurodegenerative disease, the second API is selected from the group consisting of THC, CBD, CBG, an antiinflammatory agent, an anxiolytic, an antidepressant, a neuroleptic agent and combinations thereof.