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EP4601655A1 - Système d'administration pour la libération contrôlée d'un composé psychédélique, composition pharmaceutique et utilisations associées - Google Patents

Système d'administration pour la libération contrôlée d'un composé psychédélique, composition pharmaceutique et utilisations associées

Info

Publication number
EP4601655A1
EP4601655A1 EP23790401.6A EP23790401A EP4601655A1 EP 4601655 A1 EP4601655 A1 EP 4601655A1 EP 23790401 A EP23790401 A EP 23790401A EP 4601655 A1 EP4601655 A1 EP 4601655A1
Authority
EP
European Patent Office
Prior art keywords
delivery system
controlled release
psychedelic
release delivery
psilocybe
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
EP23790401.6A
Other languages
German (de)
English (en)
Inventor
Luca Santi
Luigi Mondello
Anna NOTTI
Ilaria CACCIOTTI
Salvatore Cuzzocrea
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.)
Sintalica Srl
Original Assignee
Sintalica Srl
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 Sintalica Srl filed Critical Sintalica Srl
Publication of EP4601655A1 publication Critical patent/EP4601655A1/fr
Pending legal-status Critical Current

Links

Classifications

    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/357—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having two or more oxygen atoms in the same ring, e.g. crown ethers, guanadrel
    • A61K31/36—Compounds containing methylenedioxyphenyl groups, e.g. sesamin
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/4045—Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/48—Ergoline derivatives, e.g. lysergic acid, ergotamine
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • 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
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/07—Basidiomycota, e.g. Cryptococcus
    • A61K36/078—Psilocybe
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • 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
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin

Definitions

  • the present invention relates to a delivery system for the controlled release of psychedelic compounds, preferably derived from psychedelic mushrooms belonging to the Psilocybe genus.
  • psilocybin is a prodrug: in fact, when it is orally administered, while passing through the liver it undergoes dephosphorlyation to psilocin active drug, which can cross the blood-brain barrier and produce its psychoactive effects. In this step, a not quantifiable amount of psilocin is destroyed, thus it is not possible to guarantee a drug precise dosage.
  • psychedelic drugs and entheogens that are derived from and extracted from mushrooms, fungi, plants, botanicals, animals, flora, or synthesized in the laboratory are highly unstable. They can degrade over time after manufacturing and during storage before their use. Degradation appears more problematic for drugs made from natural product drug extraction techniques.
  • psychedelics are characterized by a rapid metabolism and clearance in the body through the action of both monoamine oxidase (MAO) and aldehyde dehydrogenase (ALDH); thus, only a small amount of said psychedelics is able to act on a serotonin receptor.
  • Monoamine oxidases are metabolic enzymes attached to cytosolic side of the outer membrane of mitochondria of neuronal, glial and several cell types. Specifically, they catalyze the oxidative deamination of neuroactive and vasoactive biogenic compounds (including serotonin and tryptamines) and xenobiotic amines into the corresponding aldehyde and ammonia, both in the central nervous system and peripheral tissues.
  • MAOIs monoamine oxidase inhibitors
  • MAOIs monoamine oxidase inhibitors
  • Monoamine oxidase A is predominantly responsible for the metabolism of psilocin (Reniers et al., “Synthesis and evaluation of [3-carboline derivatives as potential monoamine oxidase inhibitors”, Bioorg. Med. Chem. (2011 ) v. 19(1 ), p. 134-44).
  • MAOIs monoamine oxidases inhibitors
  • US20220054402 discloses a delivery system for psychedelic drugs based on nano-dimensional structures able to deliver fast psychedelic drugs through the skin, through the gastrointestinal tract, and to the brain through the olfactory and trigeminal nerves in the nasal cavity.
  • the “psychedelic compounds” are preferably derived from psychedelic psilocybin mushrooms, more preferably derived from psychedelic psilocybin mushrooms belonging to the Psilocybe genus.
  • the psychedelic psilocybin mushrooms include a polyphyletic, informal group of fungi that contain psilocybin, psilocin, or both within their biomass, typically within their fruiting bodies, resulting in their activation of a psychedelic reaction in a subject
  • Preferred psychedelic compounds used in the invention comprise psilocybin and/or psilocin and/or their derivatives, such as baeocystin, norpsilocin, norbaeocystin and/or aeruginascin, and combination thereof. Also comprised in the definition of said psychoactive compounds are the extracts of psychedelic psilocybin mushrooms, preferably belonging to the Psilocybe genus.
  • Psilocybe genus may refer to the following non-limiting examples of suitable mushrooms containing psilocybin-like psychedelic compounds: Psilocybe atlantis, Psilocybe azurenscens, Psilocybe bohemica, Psylocibe baeocystis, Psilocybe cyanescens, Psilocybe cubensis, Psilocybe tampanensis, Psilocybe hoogshagenii Psilocybe mexicana, Psilocybe ovoideocystidiata, Psilocybe semilanceata Psilocybe wasaroa, Psilocybe stuntzii, Psilocybe cyanofibrillosa, Psilocybe zapotacorum, Psilocybe y 11.
  • pharmaceutically acceptable salts or derivatives refers to those salts or derivatives which possess the biological effectiveness and properties of the salified or derivatized compound and which and which do not produce adverse reactions when administered to a mammal, preferably a human.
  • the pharmaceutically acceptable salts may be inorganic or organic salts; examples of pharmaceutically acceptable salts include but are not limited to: carbonate, hydrochloride, hydrobromide, sulphate, hydrogen sulphate, citrate, maleate, fumarate, trifluoroacetate, 2-naphthalenesulphonate, and para-toluenesulphonate. Further information on pharmaceutically acceptable salts can be found in Handbook of pharmaceutical salts, P. Stahl, C. Wermuth, WILEY-VCH, 127-133, (2008), herein incorporated by reference.
  • the pharmaceutically acceptable derivatives include the esters, the ethers and the N-oxides.
  • Psilocybin is the common name of 4-phosphoryloxy-N,N- dimethyltryptamine.
  • Psilocin is the common name of 4-hydroxy-N,N-dimethyltryptamine.
  • Boeocystin is the common name of 4-phosphoryloxy-N- methyltryptamine.
  • “Aeruginascin” is the common name of N,N,N-trimethyl-4- phosphoryloxytryptamine.
  • controlled release can be considered synonymous, and they refer to delivers of a drug, namely psychoactive compounds with a delay after its administration (delayed-release dosage) or for a prolonged period of time (extended-release [ER, XR, XL] dosage) or to a specific target in the body (targeted-release dosage).
  • MAOIs means monoamine oxidases inhibitors. Preferred MAOIs belong to the [3-carboline class of inhibitors.
  • micrometric indicate objects having dimensions of the order of micrometres.
  • micrometric indicate objects having dimensions less than micrometres, namely of the order of hundreds of nanometers.
  • the present invention relates to a delivery system for the controlled release of psychedelic compounds, preferably derived from psychedelic psilocybin mushrooms, more preferably derived from psychedelic psilocybin mushrooms belonging to the Psilocybe genus.
  • the invention also relates to a pharmaceutical composition comprising the controlled release delivery system of the invention.
  • a further object of the invention is the controlled release delivery system of the invention for use in the treatment of fibromyalgia, spinal cord injury- induced chronic neuropathic pain, neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, chronic musculoskeletal pain and/or a TNF-a-induced inflammatory disease.
  • the TNF-a-induced inflammatory disease is selected between rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and/or uveitis.
  • the invention relates to a pharmaceutical composition
  • a pharmaceutical composition comprising the controlled release delivery system of the invention for use in the treatment of fibromyalgia, spinal cord injury-induced chronic neuropathic pain, neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, chronic musculoskeletal pain and/or a TNF-a- induced inflammatory disease.
  • the TNF-a-induced inflammatory disease is selected between rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and/or uveitis.
  • the present invention relates to a delivery system for the controlled release of psychedelic compounds, preferably derived from psychedelic psilocybin mushrooms, more preferably derived from psychedelic psilocybin mushrooms belonging to the Psilocybe genus.
  • the controlled release delivery system of the invention comprises a) polymeric spheres, namely micro- and nano- spheres, comprising at least one psychedelic compound, and b) a polymeric fibrous membrane.
  • the fibrous membrane is made up of micrometric polymeric fibers, or it is made up of submicrometric polymeric fibers.
  • the micrometric or submicrometric polymeric fibers are intertwined and/or aligned to make up the fibrous membrane.
  • the micrometric fibers commonly lead to the development of bigger voids between the fibers, whereas the submicrometric ones to a tighter structure.
  • the fibrous membrane is made up of micrometric polymeric fibers, wherein the micrometric polymeric fibers comprise the polymeric spheres comprising the at least one psychedelic compound.
  • the at least one psychedelic compound can be a compound of the class of tryptamines, phenethylamines and/or lysergamides, such as psilocybin, psilocin, LSD (lysergic acid diethylamide), DMT (diemethyltryptamine), ibogaine, mescaline, MDMA (3,4-methylenedioxymethamphetamine) and/or salts, derivatives, hydrate, or solvate thereof and/or combination thereof.
  • tryptamines phenethylamines and/or lysergamides
  • psilocybin psilocin
  • LSD lysergic acid diethylamide
  • DMT diemethyltryptamine
  • ibogaine mescaline
  • MDMA 3,4-methylenedioxymethamphetamine
  • the at least one psychedelic compound can be psilocybin, psilocin, baeocystin, norpsilocin, norbaeocystin, aeruginascin and/or salts, derivatives, hydrate, or solvate thereof and/or combination thereof.
  • the at least one psychoactive compound can be an extract of psychedelic psilocybin mushrooms, preferably belonging to the Psilocybe genus.
  • the psychedelic psilocybin mushrooms include a polyphyletic, informal group of fungi that contain psilocybin, psilocin or both within their biomass, typically within their fruiting bodies, resulting in their activation of a psychedelic reaction in a subject.
  • Non limiting examples of suitable psilocybin-containing mushrooms that are in the genus Psilocybe include Psilocybe atlantis, Psilocybe azurenscens, Psilocybe bohemica, Psylocibe baeocystis, Psilocybe cyanescens, Psilocybe cubensis, Psilocybe tampanensis, Psilocybe hoogshagenii Psilocybe mexicana, Psilocybe ovoideocystidiata, Psilocybe semilanceata Psilocybe wasaroa, Psilocybe stuntzii, Psilocybe cyanofibrillosa, Psilocybe zapotacorum, Psilocybe yieuxsis, Psilocybe liniformans, Psilocybe xalapensis
  • the polymeric spheres may also comprise an antioxidant together with the at least one psychedelic compound.
  • Preferred antioxidants are selected from ascorbic acid, tannic acid, carotenoids, melatonin, curcumin, retinol, silver derivatives, zinc derivatives and/or salts, derivatives, hydrate, or solvate thereof and/or combination thereof.
  • the polymeric spheres are produced with hydrophilic polymers.
  • Preferred hydrophilic polymers are poly(vinyl alcohol), zein, polyvinylpyrrolidone, chitosan, agarose and/or alginate.
  • the polymeric spheres can be produced for example by emulsion method or mini spray dryer.
  • the polymer used to produce the micrometric and the submicrometric polymeric fibers of the fibrous membranes is a polyester, such as polylactic acid, polycaprolactone, polyglycolide, poly(lactic-co- glycolic acid) and/or polyhydroxyalkanoates.
  • Polyesters in fact, allow to obtain micrometric polymeric fibers and submicrometric polymeric fibers showing higher mechanical properties with respect to those prepared using natural and hydrophilic polymers.
  • micrometric polymeric fibers or submicrometric polymeric fibers are obtained.
  • chloroform and dichloromethane commonly allow to obtain micrometric fibers
  • tetrahydrofuran, formic acid/acetic acid chloroform/N,N-dimethylformamide submicrometric fibers.
  • micrometric polymeric fibers comprising the spheres comprising at least one psychedelic compound
  • a polymer solution of the selected polymer and of the polymeric spheres is firstly prepared. Then the electrospinning procedure is carried out. In this way, the micrometric polymeric fibers comprising the spheres encapsulating the at least one psychedelic compound are obtained.
  • the micrometric fibers have an average diameter comprised between 0,5 pm and 15 pm, preferably between 1 pm and 3 pm.
  • the submicrometric fibers have an average diameter comprised between 400 nm and 600 nm, preferably between 450 nm and 550 nm and more preferably the average diameter is 500 nm.
  • At least one MAOI may be immobilized on the micrometric or submicrometric polymeric fibers, preferably by physi- or chemi-sorption, in order to further stabilize the at least one psychedelic compound during the controlled release.
  • Preferred MAOIs belong to the [3-carboline class of inhibitors that comprise: harman, harmine, norharmane, harmol, 6-methoxyharmalan, harmalan, harmaline, harmalol, dihydro-[3-carbolines (DH[3C), tetrahydro- [3-carboline (TH[3C), tetrahydroharmine, methyl-tetrahydro-[3-carboline MTH[3C, pinoline, 1 -trichloromethyl-1 ,2,3,4tetrahydro-b-carboline (TaClo), 6-methoxytetrahydroharmalan, ethyl [3-carboline-3-carboxylate ([3CCE
  • Objects of the invention is also a pharmaceutical composition comprising the controlled release delivery system of the invention.
  • the pharmaceutical composition comprising the controlled release delivery system of the invention is a transdermal pharmaceutical composition.
  • a further object of the invention relates to the controlled release delivery system of the invention for use in the treatment of fibromyalgia, spinal cord injury-induced chronic neuropathic pain, neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, chronic musculoskeletal pain and/or a TNF-a-induced inflammatory disease.
  • the TNF-a-induced inflammatory disease is selected between rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and/or uveitis.
  • the invention relates to a pharmaceutical composition comprising the controlled release delivery system of the invention for use in the treatment of fibromyalgia, spinal cord injury-induced chronic neuropathic pain, neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, chronic musculoskeletal pain and/or a TNF-a- induced inflammatory disease.
  • the TNF-a-induced inflammatory disease is selected between rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and/or uveitis.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Engineering & Computer Science (AREA)
  • Mycology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Medical Informatics (AREA)
  • Botany (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Dermatology (AREA)
  • Emergency Medicine (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Un système d'administration à libération contrôlée comprenant : a) des sphères polymères comprenant au moins un composé psychédélique de la classe des tryptamines, des phénéthylamines et/ou des lysergamides, de préférence de la psilocybine, de la psilocine, du LSD, du DMT, de l'ibogaïne, de la mescaline, de la MDMA et/ou des sels, des dérivés, un hydrate ou un solvate de ceux-ci et/ou une combinaison de ceux-ci, et b) une membrane fibreuse polymère. Ledit système d'administration à libération contrôlée est destiné à être utilisé dans le traitement de la fibromyalgie, de la douleur neuropathique chronique induite par une lésion de la moelle épinière, de la douleur neuropathique associée à la neuropathie périphérique diabétique, de la névralgie post-herpétique, de la douleur musculo-squelettique chronique et/ou d'une maladie inflammatoire induite par TNF-α.
EP23790401.6A 2022-10-11 2023-10-11 Système d'administration pour la libération contrôlée d'un composé psychédélique, composition pharmaceutique et utilisations associées Pending EP4601655A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT202200020898 2022-10-11
PCT/IB2023/060211 WO2024079648A1 (fr) 2022-10-11 2023-10-11 Système d'administration pour la libération contrôlée d'un composé psychédélique, composition pharmaceutique et utilisations associées

Publications (1)

Publication Number Publication Date
EP4601655A1 true EP4601655A1 (fr) 2025-08-20

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP23790401.6A Pending EP4601655A1 (fr) 2022-10-11 2023-10-11 Système d'administration pour la libération contrôlée d'un composé psychédélique, composition pharmaceutique et utilisations associées

Country Status (2)

Country Link
EP (1) EP4601655A1 (fr)
WO (1) WO2024079648A1 (fr)

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114040767A (zh) * 2019-01-30 2022-02-11 钻石治疗公司 用于治疗心理、认知、行为和/或情绪障碍的包含5ht受体激动剂的方法和组合物
CN113993523A (zh) * 2019-04-17 2022-01-28 指南针探路者有限公司 用赛洛西宾治疗抑郁症和其他各种病症
WO2021003467A1 (fr) * 2019-07-04 2021-01-07 Sw Holdings, Inc. Compositions de dosage et procédés d'utilisation de composés psychédéliques
IL299191A (en) * 2020-06-19 2023-02-01 Cannovex Bv Formulation comprising cannabinoids
US20220054402A1 (en) 2020-11-05 2022-02-24 Richard C Kaufman Compositions and methods for extracting, stabilizing, and manufacturing stable dosage forms of psilocin, psychedelic drugs, entheogens, and medicinal mushrooms as nano-dimensional drug delivery structures

Also Published As

Publication number Publication date
WO2024079648A1 (fr) 2024-04-18

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