WO2018090022A3 – September 6, 2019 – CANNABINOID FORMULATIONS AND METHOD OF MAKING THE SAME

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Inventors :

CROWLEY, Kenton L. - 40970 Alton Court, Temecula, California 92591

Owner :

FARM TO FARMA, INC.

Application Number :

WOUS17061584

Document Number :

WO2018090022A3

Priority Date :

November 14, 2016

Filing Date :

November 14, 2017

Date of Grant/ Publication :

September 6, 2019

Class :

A61K31 / 7068; A61K38 / 48; A61K31 / 352

Abstract

A composition comprising cannabis extract and melatonin is provided, along with formulations for delivering the composition to a subject. The composition can include a base ingredient such as polyethylene glycol, gelatin, tapioca and/or pectin; natural sweeteners; and oils of peppermint, lavender, ginger, citrus, mango, etc. The formulation can include tablets, capsules, lozenges, troches, suppositories, tinctures, a transdermal patch, a vaporizer, a metered dose inhaler, etc. The formulation avoids harmful preservatives (e.g., BHT, BHA), heavy metals and stabilizers while addressing sub-therapeutic dosing and optimizing the synergistic qualities of the ratios of the individual cannabinoids (both acidic and neutral forms), terpenes and flavonoids.

Claim(s)

1. A formulation comprising a cannabis extract and melatonin.;
2. The formulation of claim 1, wherein the melatonin is present at a concentration of 0.05% to 1.6% by weight.;
3. The formulation of claim 1, further comprising a base selected from polyethylene glycol, gelatin, agar, tapioca, and pectin.;
4. The formulation of claim 4, wherein said polyethylene glycol has an average molecular weight of 1450 +/- 300.;
5. The formulation of claim 1, further comprising one or more of the following: gum acacia, citric acid, stevia extract powder, Luo Han Gou, Monoammonium Glycyrrhizinate and Ammonium Glycyrrhizinate.;
6. The formulation of claim 1 further comprising one or more organic oils.;
7. The formulation of claim 6, wherein said one or more oils are selected from peppermint, sweet orange, ginger, tangerine, lavender and/or mango.;
8. The formulation of claim 1, further comprising menthol and/or cream de mint.;
9. The formulation of claim 1, wherein the cannabis extract comprises CBD and THC, wherein the ratio of CBD to THC is in a range of 24000: 1 to 1 :24000.;
10. The formulation of claim 1 wherein said cannabis extracts comprise one or more of the following: (i) Delta-9 Tetrahydrocannabinol in the decarboxylated form; (ii) Tetrahydrocannabinolic acid in the natural, non-decarboxylated form; (iii) Cannabidiol with a Delta-9 THC content less than or equal to 0.3 mg/g; and Cannabidiol (CBD) in combination with Delta-9 Tetrahydrocannabinol in a 2% to 6% ratio of decarboxylated and non-decarboxylated forms and (iv) Delta-8 Tetrahydrocannabinol.;
11. The formulation of claim 1, wherein the cannabis extract comprises CBD at a concentration of 99%-99.9%.;
12. The formulation of claim 1, wherein the cannabis extract comprises one or more of cannabinoids, terpenes and flavonoids.;
13. The formulation of claims 1 to 12, wherein the formulation is provided in a tablet, capsule, lozenge, troche, suppository, tincture, transdermal patch, per inhalation from a vaporizer or metered dose inhaler.;
14. A method of treating a subject having a disorder, the method comprising administering a therapeutically effective amount of the formulation of claims 1 to 13 to the subject.;
15. The method of claim 14, wherein the disorder is selected from inflammation (chronic or acute), inflammatory bowel disease (IBS) with/without constipation or diarrhea, Crohn’s disease (CD), irritable bowel syndrome (IBS), ulcerative colitis (UC), nausea, vomiting, anorexia, cachexia, all forms of pain (i.e. acute, chronic, neuropathic, and pain associated with or accompanying migraine headaches), gastrointestinal tract distress (i.e. heartburn, indigestion, stomachache, etc.), migraine headaches, chronic cluster headaches, seizures, postmenstrual syndrome (PMS), Cancer, neurodegenerative diseases including Lou Gehrig’s disease, Huntington’s disease, Alzheimer’s dementia, Parkinson’s disease and Parkinsonian-type symptoms; spinal-cord injuries, HIV/ AIDS, agitation, sleep disorders such as insomnia, seasonal affective disorder (SAD), and jet lag; depression, muscle spasms, spasticity from multiple sclerosis, glaucoma, Autism Spectrum Disorder (ASD), Attention Deficit Hyperactivity Disorder (ADHD), Post-Traumatic Stress Disorder (PTSD), and anxiety disorders.;
16. A method for making or manufacturing a composition or formulation, the method comprising: (i) preparing a cannabis extract, and (ii) adding melatonin to the extract in an amount sufficient to treat a sleep disorder in a subject.;
17. The method of claim 16, further comprising mixing the composition or formulation with a base selected from polyethylene glycol, gelatin, pectin, agar, tapioca, fatty acid and wax.;
18. The method of claim 17, further comprising adding one or more of the following: gum acacia, citric acid, stevia extract powder, Luo Han Gou, Monoammonium Glycyrrhizinate and Ammonium Glycyrrhizinate, honey or extract thereof.;
19. The method of claim 18, further comprising adding one or more organic oils selected from peppermint, sweet orange, ginger, lavender, tangerine and/or mango.;
20. The method of claim 19, further comprising adding menthol and/or cream de mint.;
claim 21: 21. The method of claim 16, wherein the sleep disorder is insomnia, seasonal affective disorder (SAD), or jet lag.

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