AU2022277515B2 - Formulations of psilocybin - Google Patents

Formulations of psilocybin

Info

Publication number
AU2022277515B2
AU2022277515B2 AU2022277515A AU2022277515A AU2022277515B2 AU 2022277515 B2 AU2022277515 B2 AU 2022277515B2 AU 2022277515 A AU2022277515 A AU 2022277515A AU 2022277515 A AU2022277515 A AU 2022277515A AU 2022277515 B2 AU2022277515 B2 AU 2022277515B2
Authority
AU
Australia
Prior art keywords
disorder
acid
polymer
compound
formula
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.)
Active
Application number
AU2022277515A
Other languages
English (en)
Other versions
AU2022277515A1 (en
Inventor
Kenneth L. Avery
Alex Nivorozhkin
Michael Palfreyman
Pradip M. Pathare
Mohammed I. SHUKOOR
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.)
Cybin IRL Ltd
Original Assignee
Cybin IRL Ltd
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 Cybin IRL Ltd filed Critical Cybin IRL Ltd
Publication of AU2022277515A1 publication Critical patent/AU2022277515A1/en
Application granted granted Critical
Publication of AU2022277515B2 publication Critical patent/AU2022277515B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/66Phosphorus compounds
    • A61K31/675Phosphorus compounds having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2063Proteins, e.g. gelatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/18Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/22Anxiolytics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/24Antidepressants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/30Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/32Alcohol-abuse
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Addiction (AREA)
  • Physiology (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Hospice & Palliative Care (AREA)
  • Rheumatology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
AU2022277515A 2021-05-17 2022-05-17 Formulations of psilocybin Active AU2022277515B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202163189449P 2021-05-17 2021-05-17
US63/189,449 2021-05-17
PCT/EP2022/063269 WO2022243285A1 (en) 2021-05-17 2022-05-17 Formulations of psilocybin

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2026202771A Division AU2026202771A1 (en) 2021-05-17 2026-04-13 Formulations of psilocybin

Publications (2)

Publication Number Publication Date
AU2022277515A1 AU2022277515A1 (en) 2023-10-19
AU2022277515B2 true AU2022277515B2 (en) 2026-01-15

Family

ID=82019233

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2022277515A Active AU2022277515B2 (en) 2021-05-17 2022-05-17 Formulations of psilocybin

Country Status (7)

Country Link
US (1) US20240261306A1 (https=)
EP (1) EP4340809A1 (https=)
JP (1) JP2024522065A (https=)
KR (1) KR20240009433A (https=)
AU (1) AU2022277515B2 (https=)
CA (1) CA3216799A1 (https=)
WO (1) WO2022243285A1 (https=)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20240074434A1 (en) * 2019-04-12 2024-03-07 Jeffrey Hanson Robbins Composition including effervescent agents, biostimulant, nutrient, and pesticide
AU2021268204A1 (en) 2020-05-08 2022-12-08 Psilera Inc. Novel compositions of matter and pharmaceutical compositions
JP2024545787A (ja) 2021-12-30 2024-12-11 アタイ セラピューティクス, インコーポレイテッド 一酸化窒素送達剤としてのジメチルトリプタミン類似体
WO2023168023A1 (en) 2022-03-04 2023-09-07 Reset Pharmaceuticals, Inc. Co-crystals or salts comprising psilocin
CA3247344A1 (en) * 2022-06-09 2023-12-14 Diamond Therapeutics Inc. AMORPHIC PSILOCYBIN (A-POLYMORPHIC)
US20250360148A1 (en) * 2022-06-22 2025-11-27 Cybin Irl Limited Solid dispersions of psilocybin
WO2024031152A1 (en) * 2022-08-12 2024-02-15 Woke Pharmaceuticals Pty Ltd Process for improving powder flow characteristics of a crystalline compound
EP4615444A1 (en) * 2022-11-07 2025-09-17 Natural Medtech Pty Ltd Tryptamine formulations and uses thereof
EP4720039A2 (en) * 2023-05-24 2026-04-08 Psilera Inc. Formulations containing tryptamine derivatives and uses thereof
WO2025080937A1 (en) * 2023-10-11 2025-04-17 University Of Padova Compositions with psilocybin and psilocin derivatives

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021003467A1 (en) * 2019-07-04 2021-01-07 Sw Holdings, Inc. Metered dosing compositions and methods of use of psychedelic compounds
US20210015738A1 (en) * 2019-07-17 2021-01-21 Concept Matrix Solutions Oral dissolvable film containing psychedelic compound
US11000534B1 (en) * 2020-10-08 2021-05-11 Lennham Pharmaceuticals, Inc. Deuterated derivatives of psilocybin and uses thereof

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5612059A (en) 1988-08-30 1997-03-18 Pfizer Inc. Use of asymmetric membranes in delivery devices
US5798119A (en) 1995-06-13 1998-08-25 S. C. Johnson & Son, Inc. Osmotic-delivery devices having vapor-permeable coatings
US20020017295A1 (en) 2000-07-07 2002-02-14 Weers Jeffry G. Phospholipid-based powders for inhalation
US6777400B2 (en) 2000-08-05 2004-08-17 Smithkline Beecham Corporation Anti-inflammatory androstane derivative compositions
US8585580B2 (en) * 2008-01-23 2013-11-19 Ams Research Corporation Inflatable medical implant system
JP2013103899A (ja) * 2011-11-11 2013-05-30 Fuji Chem Ind Co Ltd 難溶性薬物の新規な固体分散体
GB2571696B (en) 2017-10-09 2020-05-27 Compass Pathways Ltd Large scale method for the preparation of Psilocybin and formulations of Psilocybin so produced
JP7502308B2 (ja) * 2019-01-18 2024-06-18 メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフツング 固体投与形態を製造する方法および固体投与形態
KR20220009954A (ko) * 2019-04-17 2022-01-25 컴퍼스 패쓰파인더 리미티드 신경인지 장애, 만성 통증을 치료하고 염증을 감소시키는 방법
GB201907871D0 (en) * 2019-06-03 2019-07-17 Small Pharma Ltd Therapeutic compositions

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021003467A1 (en) * 2019-07-04 2021-01-07 Sw Holdings, Inc. Metered dosing compositions and methods of use of psychedelic compounds
US20210015738A1 (en) * 2019-07-17 2021-01-21 Concept Matrix Solutions Oral dissolvable film containing psychedelic compound
US11000534B1 (en) * 2020-10-08 2021-05-11 Lennham Pharmaceuticals, Inc. Deuterated derivatives of psilocybin and uses thereof

Also Published As

Publication number Publication date
KR20240009433A (ko) 2024-01-22
JP2024522065A (ja) 2024-06-11
AU2022277515A1 (en) 2023-10-19
EP4340809A1 (en) 2024-03-27
US20240261306A1 (en) 2024-08-08
CA3216799A1 (en) 2022-11-24
WO2022243285A1 (en) 2022-11-24

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