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WO2025073047A1 - Composition pharmaceutique psychédélique et kit - Google Patents

Composition pharmaceutique psychédélique et kit Download PDF

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Publication number
WO2025073047A1
WO2025073047A1 PCT/CA2024/051310 CA2024051310W WO2025073047A1 WO 2025073047 A1 WO2025073047 A1 WO 2025073047A1 CA 2024051310 W CA2024051310 W CA 2024051310W WO 2025073047 A1 WO2025073047 A1 WO 2025073047A1
Authority
WO
WIPO (PCT)
Prior art keywords
pharmaceutical composition
psilocybin
psychedelic
agent
components
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/CA2024/051310
Other languages
English (en)
Inventor
Austin Lee MILLER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bluestem Api Inc
Original Assignee
Bluestem Api Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bluestem Api Inc filed Critical Bluestem Api Inc
Publication of WO2025073047A1 publication Critical patent/WO2025073047A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/66—Phosphorus compounds
    • A61K31/675—Phosphorus compounds having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07F—ACYCLIC, CARBOCYCLIC OR HETEROCYCLIC COMPOUNDS CONTAINING ELEMENTS OTHER THAN CARBON, HYDROGEN, HALOGEN, OXYGEN, NITROGEN, SULFUR, SELENIUM OR TELLURIUM
    • C07F9/00—Compounds containing elements of Groups 5 or 15 of the Periodic Table
    • C07F9/02—Phosphorus compounds
    • C07F9/547—Heterocyclic compounds, e.g. containing phosphorus as a ring hetero atom
    • C07F9/553—Heterocyclic compounds, e.g. containing phosphorus as a ring hetero atom having one nitrogen atom as the only ring hetero atom
    • C07F9/572—Five-membered rings

Definitions

  • Psilocybin is one example of such a compound.
  • Psilocybin-containing mushrooms often collectively referred to as "magic mushrooms" are a group of fungi known for their psychoactive properties.
  • Psilocybin, and its metabolite psilocin is the major psychoactive agent in these mushrooms, the effects of which include altered states of consciousness, visual hallucinations, and changes in perception and cognition.
  • Apprehension to engage in psychedelic-assisted therapy may also relate to the experience of ingesting the psychedelic compounds, which may include aversion to the taste, smell, or appearance of the product. Again, such aversion may dissuade potential users and, for those that do engage in psychedelic-assisted therapy, may detract from the positive effects of psychedelic compounds.
  • psychedelic compounds include muscimol, muscarine, and ibotenic acid, which can be found in Amanita muscaria mushrooms; ibogaine, which can be found in the root bark of the Tabernanthe iboga: 5-MeO-DMT, which can be found in Dictyonema huorani’ lysergic acid and ergotamine, which can be found in ergot; mescaline, which can be found in certain cacti (such as the Mexican Peyote cactus (Lophohora williamsii) and the San Pedro cactus); collybolide which can be found in Rhodocollybia maculata mushroom; salvinorin A.
  • ibogaine which can be found in the root bark of the Tabernanthe iboga: 5-MeO-DMT, which can be found in Dictyonema huorani’ lysergic acid and ergotamine, which
  • psychedelic compounds such as that derived from Salvia divinorunr, myristicin, elemicin, eugenol, and safrole, such as that derived from nutmeg; hyoscyamine, atropine, atropamine, belaplomine, and scopolamine, such as that derived from Atropa belladonna’ bufotenine, dermorphin, and other such psychedelic compounds derived from certain toads and frogs (such as the Colorado River toad); and psychedelic compounds found in certain fish, including sea chubs (from the genus Kyphosus), Siganus spinus, Mulloidichthys flavolineatus, and Sarpa salpa.
  • the present pharmaceutical composition comprises any pharmacologically suitable dosage of a psychedelic compound.
  • a suitable dosage of psilocybin may be from about 1 mg to about 1500 mg, and preferably from about 1 mg to about 50 mg.
  • a suitable dosage of mescaline may be 300-500 mg
  • of LSD may be 20-80 pg
  • amanita muscaria may be 10-500 mg.
  • the pharmaceutical composition may further comprise alkaloids that have been extracted, separated, and/or purified from plants, fungi, and animals. While not wishing to be bound by any particular theory or mode of action, alkaloids may produce an entourage effect with the one or more psychedelic compounds, which may include euphoria, elimination of anxiety, increased bioavailability of the one or more psychedelic compounds, and increased overall potency of the one or more psychedelic compounds and/or effects of same.
  • Alkaloids may include but are not limited to baeocystin, aeruginacyn, norbaeocystin, norpsilocin, and beta-carbolines.
  • the alkaloids such as those listed above, may be extracted, separated, and/or purified from psilocybin-containing mushrooms. In other embodiments, the alkaloids may be extracted from plant or animals sources or may be synthetic.
  • the pharmaceutical composition may further comprise material from one or more non-psilocybin-containing mushroom, such as Lion’s Mane (Hericium erinaceus), Reishi (Ganoderma lucidurri), Caterpillar fungus (Cordyceps), and Chaga mushroom (Inonotus obliquus).
  • the material may comprise one of or a combination of biomass, which may be powered, grounded, or otherwise processed, oil, crystal, or other matter.
  • the pharmaceutical composition may further comprise one or more antiemetics.
  • Suitable antiemetics contemplated for use herein include any known pharmaceutically- acceptable substance or combination thereof that can reduce nausea, including but not limited to botanicals and vitamins.
  • botanicals include Akintunde Vati (Ayurvedic formulation), Alma (Emblica officinalis), Bao He Wan/Balanex Extract (TCM formulation), Bahera (Terminalia bellirica), Black Cohosh (Actaea racemosa), Broom Snakeweed (Gutierrezia sarothrae), Cardamom (seed) (Elettaria cardamomum), Chamomile (Matricaria chamomilla), Chokecherry (Prunus virginiana), Cinnamon (Cinnamomum verum), Cloves (Syzygium aromaticum), Cumin (Cuminum cyminum), Dhania (Coriandrum sativum), Fennel (Foeniculum vulgare), Fever
  • the pharmaceutical composition may further comprise one or more agent to reduce gastro-intestinal distress.
  • Suitable agents contemplated for use herein include any known pharmaceutically-acceptable substance or combination thereof that can reduce gastrointestinal distress.
  • the agent may be derived from a botanical source, such as Aloe Vera (Aloe barbadensis miller), Apple Cider Vinegar (Acetic acid bacteria), Basil (Ocimum basilicum), Caraway (Carum carvi), Chamomile (Matricaria chamomilla), Cinnamon (Cinnamomum verum), Citrus Peel (Citrus spp.), Cloves (Syzygium aromaticum), Dandelion (Taraxacum officinale), Devil’s Claw (Harpagophytum procumbens), Fennel (Foeniculum vulgare), Figs (Ficus carica), Garlic (Allium sativum), Ginger (Zingiber officinale), Hawthorn Berry (Crataegu
  • the anxiolytic agent may be derived from a non-botanical source, such as Bifidobacterium Longum, GABA (gamma-aminobutyric acid), Lactobacillus Rhamnosus, L- Theanine (L-y-glutamylethylamide), Melatonin (N-acetyl-5-methoxytryptamine), Omega-3 (eicosapentaenoic acid, docosahexaenoic acid), and 5-HTP (5-hydroxytryptophan).
  • a non-botanical source such as Bifidobacterium Longum, GABA (gamma-aminobutyric acid), Lactobacillus Rhamnosus, L- Theanine (L-y-glutamylethylamide), Melatonin (N-acetyl-5-methoxytryptamine), Omega-3 (eicosapentaenoic acid, docosahexaenoic acid), and 5-HT
  • the anxiolytic agent may be a psychobiotic, such as Lactobacillus rhamnosus, Bifidobacterium longum, Lactobacillus plantarum, Lactobacillus helveticus, Lactobacillus reuteri, Lactobacillus casei, Lactobacillus fermentum, Bifidobacterium breve, and Galacto-oligosaccharide.
  • the anxiolytic agent may be synthetic.
  • the anxiolytic agent may be in the form of a powder, extract, oil, crystal, or other suitable form.
  • the pharmaceutical composition may further comprise one or more agents to alleviate tachycardia.
  • Suitable agents contemplated for use herein include any known pharmaceutically-acceptable substance or combination thereof that can reduce an increased heart rate.
  • the agent may be derived from a botanical source, such as Hawthorn (Crataegus monogyna Jacq.), Motherwort (Leonurus cardiaca), Linden (Tiliae flos), Lemon balm (Melissa officinalis), Passion Flower (Passiflora incarnata), Valerian (Valeriana officinalis), Lavender (Lavandula spp.), Chamomile (Matricaria chamomilla), Ginkgo biloba, and Cayenne (Capsicum annuum).
  • the agent may be derived from a botanical source, such as ginger/Zingiber officinale Roscoe (gingerols, shogaols, paradols), Volkameria inermis (flavone Acacetin), Huperzia serrata (Huperzine A), Uncaria rhynchophylla (Rhynchophylline), panax notoginseng (ginsenosides, Dencichine), Sophora flavescens Ait (Oxymatrine), Salvia miltiorrhiza Bunge (Magnesium lithospermate B), Polygala tenuifolia (senegenin), Glycyrrhiza glabra/licorice (Isoliquiritigenin), Gastrodia elata Blume (Gastrodin), A.
  • a botanical source such as ginger/Zingiber officinale Roscoe (gingerols, shogaols, paradols), Volk
  • agents may be derived from vitamins and minerals such as vitamin C, magnesium, vitamin D, omega-3 fatty acids, taurine, zinc, CoQ10. Such agents may be in the form of a powder, extract, oil, crystal, or other suitable form. Other agents may include memantine or riluzole.
  • the pharmaceutical composition may further comprise one or more stabilizers, preservatives, fillers, and/or carriers, which include any known pharmaceutically-acceptable substance or combination thereof.
  • the present pharmaceutical composition and kit can be used in psychedelic-assisted therapy.
  • the present pharmaceutical composition and kit can be used to treat mental and physical health disorders including but not limited to major depressive disorder, treatment resistant depression, depression, anxiety, generalized anxiety disorder, body dysmorphia, pain, chronic pain, cluster headaches, migraines, trauma, PTSD, end of life grief (those dying and those close to them), ADHD, OCD, substance use disorders, colour blindness, and traumatic brain injury.
  • major depressive disorder treatment resistant depression, depression, anxiety, generalized anxiety disorder, body dysmorphia, pain, chronic pain, cluster headaches, migraines, trauma, PTSD, end of life grief (those dying and those close to them), ADHD, OCD, substance use disorders, colour blindness, and traumatic brain injury.
  • the pharmaceutical composition and one or more of the other substances described herein may be contained in a form suitable for sustained, delayed, or timed release, such as in nested or twinned capsules, which may be comprised of gelatin, mycelium-derived chitin, or any other known pharmaceutically-acceptable substance or combination thereof.
  • the pharmaceutical composition may be contained in a solid oral dosage form comprising one or more particles, each comprising one or more of an immediate release layer, a sustained release layer, and a delayed release layer, configured for one or more of the immediate release of one or more substances, the sustained release of one or more substances, and the delayed release of one or more substances.
  • Nanophytomedicine delivery methods may include nanoparticles, including but not limited to solid lipid nanoparticles, polymeric nanoparticles, poly(lactic-co-glycolic) nanospheres, polylactic acid nanospheres, graphene nanoparticles, solid drug nanoparticles, magnetic nanoparticles, metal and/or other inorganic nanoparticles, sillica nanoparticles, and mesoporous sillica nanoparticles, nanospheres, nanosuspension, nanostructured lipid carriers, liquid crystal systems, microemulsions, selfmicroemulsifying drug delivery systems, liposomes, colloidal nano-liposomes, niosomes, vesosomes, phytosomes, polymersomes, polymeric micelles, phospholipid micelles, nanogels, hydrophobically modified glycol chitosan, dendrimers, carbon nanotubes, drug nanocrystals, and quantum dots.
  • nanoparticles including but not limited to solid lipid nanoparticles,
  • the kit may include an agent to alter the flavour, aroma, or colour of the present psychedelic pharmaceutical composition, which users can add to the present psychedelic pharmaceutical composition to reduce the user’s aversions to the composition and which may assist in creating a positive experience for the user.
  • Suitable agents contemplated for use herein include any known pharmaceutically-acceptable substance or combination thereof that can produce a desired flavour, aroma, or colour, including but not limited to the flavouring agents, aromatic agents, and colouring agents described herein.
  • the kit may contain agents or compositions of agents that may be ingested independently to enhance or potentiate the effects of the present psychedelic pharmaceutical composition (i.e., a user may elect to potentiate their dose of psychedelic compound or not).
  • Suitable agents to enhance or potentiate the effects of the previously- ingested psychedelic compound(s) contemplated for use herein include any known pharmaceutically-acceptable substance or combination thereof that can enhance the effects of one or more psychedelic compounds, including but not limited to the potentiating agents described herein.
  • the kit may include devices and instructions related to light therapy.
  • Light therapy may assist in enhancing the psychedelic experience and reduce the side effects associated with use of psychedelics. While not wishing to be bound by any particular theory or mode of action, light therapy may act to increase blood flow, reduce inflammation, and/or contribute to mitochondrial repair, which may impact the psychedelic experience.
  • the kit may include Red Light Therapy and/or Blue Light Therapy delivery mechanisms including but not limited to masks, hoods, shrouds, caps, and lamps.
  • the kit may include certain light blocking devices, such as goggles, masks, or glasses tinted to block green light.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La présente invention concerne une composition pharmaceutique qui combine des composés psychédéliques, tels que la psilocybine, avec un ou plusieurs autres composants, tels que des champignons ou des extraits végétaux ou animaux et des isolats, des adaptogènes, des produits phytochimiques, des algues, des vitamines, des minéraux, des acides aminés, des psychobiotiques, ou d'autres matériaux de ce type pour améliorer l'expérience de l'utilisateur par comparaison avec des psychédéliques classiques. L'invention concerne également un kit pour moduler les effets de composés psychédéliques. On pense que la présente formulation a une application dans une thérapie assistée par psychédéliques.
PCT/CA2024/051310 2023-10-03 2024-10-03 Composition pharmaceutique psychédélique et kit Pending WO2025073047A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363542110P 2023-10-03 2023-10-03
US63/542,110 2023-10-03

Publications (1)

Publication Number Publication Date
WO2025073047A1 true WO2025073047A1 (fr) 2025-04-10

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PCT/CA2024/051310 Pending WO2025073047A1 (fr) 2023-10-03 2024-10-03 Composition pharmaceutique psychédélique et kit

Country Status (1)

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WO (1) WO2025073047A1 (fr)

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP3592723B2 (ja) * 1991-02-19 2004-11-24 帝國製薬株式会社 非崩壊・持続性カプセル製剤
US20190142851A1 (en) * 2017-11-16 2019-05-16 CaaMTech, LLC Compositions comprising a psilocybin derivative and a cannabinoid
US20210069170A1 (en) * 2016-07-23 2021-03-11 Paul Edward Stamets Tryptamine compositions for enhancing neurite outgrowth
WO2022018709A1 (fr) * 2020-07-21 2022-01-27 Ai Pharmaceuticals Jamaica Limited Compositions et méthodes de traitement de psychoses et de troubles psychotiques
WO2022072808A1 (fr) * 2020-10-01 2022-04-07 Mydecine Innovations Group Inc. Nouvelles compositions psychédéliques, systèmes d'administration et leurs utilisations thrapeutiques
WO2022212789A1 (fr) * 2021-03-31 2022-10-06 Mycrodose Therapeutics Inc. Système transdermique, formulation et méthode d'administration thérapeutique d'un agent psychédélique
WO2023183618A1 (fr) * 2022-03-25 2023-09-28 Ojai Energetics Pbc Compositions psychédéliques et leurs procédés de formation

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP3592723B2 (ja) * 1991-02-19 2004-11-24 帝國製薬株式会社 非崩壊・持続性カプセル製剤
US20210069170A1 (en) * 2016-07-23 2021-03-11 Paul Edward Stamets Tryptamine compositions for enhancing neurite outgrowth
US20190142851A1 (en) * 2017-11-16 2019-05-16 CaaMTech, LLC Compositions comprising a psilocybin derivative and a cannabinoid
WO2022018709A1 (fr) * 2020-07-21 2022-01-27 Ai Pharmaceuticals Jamaica Limited Compositions et méthodes de traitement de psychoses et de troubles psychotiques
WO2022072808A1 (fr) * 2020-10-01 2022-04-07 Mydecine Innovations Group Inc. Nouvelles compositions psychédéliques, systèmes d'administration et leurs utilisations thrapeutiques
WO2022212789A1 (fr) * 2021-03-31 2022-10-06 Mycrodose Therapeutics Inc. Système transdermique, formulation et méthode d'administration thérapeutique d'un agent psychédélique
WO2023183618A1 (fr) * 2022-03-25 2023-09-28 Ojai Energetics Pbc Compositions psychédéliques et leurs procédés de formation

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
CARBONE, FEDERICO ET AL.: "Apomorphine for Parkinson's Disease: Efficacy and Safety of Current and New Formulations", CNS DRUGS, vol. 33, 31 August 2019 (2019-08-31), pages 905 - 918, XP055978018, DOI: 10.1007%2Fs40263-019-00661-z *
GIACOSA A, MORAZZONI P, BOMBARDELLI E, RIVA A, BIANCHI PORRO G, RONDANELLI MARIANGELA, : "Can nausea and vomiting be treated with ginger extract?", EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES, vol. 19, 1 April 2015 (2015-04-01), pages 1291 - 1296, XP093303641 *
LAZAREVIC, VESNA ET AL.: "Ketamine decreases neuronally released glutamate via retrograde stimulation of presynaptic adenosine A1 receptors", MOLECULAR PSYCHIATRY, vol. 26, 11 August 2021 (2021-08-11), pages 7425 - 7435, XP037701661, DOI: 10.1038/s41380-021-01246- 3 *
TRIBL, G. G. ET AL.: "Apomorphine in idiopathic restless legs syndrome: an exploratory study", JOURNAL OF NEUROLOGY, NEUROSURGERY AND PSYCHIATRY, BMJ PUBLISHING GROUP LTD, LONDON, vol. 76, no. 2, 14 January 2005 (2005-01-14), London, pages 181 - 185, XP009562630, ISSN: 0022-3050, DOI: 10.1136/jnnp.2003.034843 *

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