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CO2024007518A2 - Injectable and inhalable formulations - Google Patents

Injectable and inhalable formulations

Info

Publication number
CO2024007518A2
CO2024007518A2 CONC2024/0007518A CO2024007518A CO2024007518A2 CO 2024007518 A2 CO2024007518 A2 CO 2024007518A2 CO 2024007518 A CO2024007518 A CO 2024007518A CO 2024007518 A2 CO2024007518 A2 CO 2024007518A2
Authority
CO
Colombia
Prior art keywords
dimethyltryptamine
compound
formulations
optionally substituted
aqueous pharmaceutical
Prior art date
Application number
CONC2024/0007518A
Other languages
Spanish (es)
Inventor
Peter Rands
Carol Routledge
Marie Layzell
Ellen James
Zelah Joel
Tiffanie Benway
Meghan Good
Original Assignee
Cybin Uk 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
Priority claimed from TW110143066A external-priority patent/TWI891942B/en
Priority claimed from GBGB2119021.0A external-priority patent/GB202119021D0/en
Application filed by Cybin Uk Ltd filed Critical Cybin Uk Ltd
Publication of CO2024007518A2 publication Critical patent/CO2024007518A2/en

Links

Classifications

    • 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
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40Heterocyclic 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
    • A61K31/403Heterocyclic 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
    • A61K31/404Indoles, e.g. pindolol
    • A61K31/4045Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0078Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug 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
    • A61K9/08Solutions
    • 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
    • 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
    • A61P25/30Drugs for disorders of the nervous system for treating abuse or dependence

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Addiction (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dispersion Chemistry (AREA)
  • Otolaryngology (AREA)
  • Pulmonology (AREA)
  • Dermatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

La presente invención se refiere a formulaciones farmacéuticas acuosas, métodos para su producción y usos de las mismas. Las formulaciones farmacéuticas acuosas comprenden una sal de un compuesto de dimetiltriptamina opcionalmente sustituida y agua, con un pH de 5 a 6.5, preferentemente de aproximadamente 5 a aproximadamente 6, y una concentración del compuesto de dimetiltriptamina opcionalmente sustituida de aproximadamente 10 mg/ml o mayor como el equivalente de base libre. Estas formulaciones pueden comprender una dosis efectiva de un compuesto de dimetiltriptamina opcionalmente sustituida para usarse en terapia psicodélica asistida dentro de un volumen de 5 ml o menos. Estas formulaciones son sorprendentemente adecuadas tanto para inyección intramuscular como para inhalación nebulizada, siendo tanto estables como clínicamente aceptables, y tienen usos potenciales en el tratamiento de trastornos psiquiátricos o neurológicos.The present invention relates to aqueous pharmaceutical formulations, methods for their production and uses thereof. The aqueous pharmaceutical formulations comprise a salt of an optionally substituted dimethyltryptamine compound and water, having a pH of 5 to 6.5, preferably about 5 to about 6, and a concentration of the optionally substituted dimethyltryptamine compound of about 10 mg/ml or greater as the free base equivalent. These formulations may comprise an effective dose of an optionally substituted dimethyltryptamine compound for use in assisted psychedelic therapy within a volume of 5 ml or less. These formulations are surprisingly suitable for both intramuscular injection and nebulized inhalation, being both stable and clinically acceptable, and have potential uses in the treatment of psychiatric or neurological disorders.

CONC2024/0007518A 2021-11-18 2024-06-14 Injectable and inhalable formulations CO2024007518A2 (en)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
TW110143066A TWI891942B (en) 2020-12-01 2021-11-18 Deuterated compounds
PCT/EP2021/082227 WO2022117359A1 (en) 2020-12-01 2021-11-18 Deuterated or partially deuterated n,n-dimethyltryptamine compounds
GBGB2119021.0A GB202119021D0 (en) 2021-11-18 2021-12-24 Injectable and inhalable formulations
US202217574424A 2022-01-12 2022-01-12
EP2022055324 2022-03-02
PCT/EP2022/082486 WO2023089132A1 (en) 2021-11-18 2022-11-18 Injectable and inhalable formulations

Publications (1)

Publication Number Publication Date
CO2024007518A2 true CO2024007518A2 (en) 2024-07-29

Family

ID=84440034

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2024/0007518A CO2024007518A2 (en) 2021-11-18 2024-06-14 Injectable and inhalable formulations

Country Status (11)

Country Link
EP (1) EP4433049A1 (en)
JP (1) JP2024540527A (en)
KR (1) KR20240110836A (en)
AU (1) AU2022393234A1 (en)
CA (1) CA3238583A1 (en)
CL (1) CL2024001452A1 (en)
CO (1) CO2024007518A2 (en)
IL (1) IL312859A (en)
MX (1) MX2024005955A (en)
WO (1) WO2023089132A1 (en)
ZA (1) ZA202403906B (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PH12022553135A1 (en) 2020-05-19 2024-03-04 Cybin Irl Ltd Deuterated tryptamine derivatives and methods of use

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2666149A1 (en) * 2006-10-19 2008-04-24 Auspex Pharmaceuticals, Inc. Substituted indoles
US20220071958A1 (en) * 2019-02-22 2022-03-10 GH Research Ireland Limited 5-methoxy-n,n-dimethyltryptamine (5-meo-dmt) for treating depression
GB201907871D0 (en) 2019-06-03 2019-07-17 Small Pharma Ltd Therapeutic compositions
PT3873883T (en) 2019-11-07 2023-03-24 Small Pharma Ltd SYNTHESIS METHOD
EP3902541B1 (en) 2020-06-02 2022-09-14 Small Pharma Ltd Therapeutic compositions comprising deuterated or partially deuterated n,n-dimethyltryptamine compounds
AU2021334933B2 (en) * 2020-08-28 2023-01-19 Cybin Uk Ltd Injectable formulation
IL303288A (en) * 2020-12-01 2023-07-01 Small Pharma Ltd N,N-Dimethyltryptamine compounds partially or fully deuterated

Also Published As

Publication number Publication date
ZA202403906B (en) 2025-08-27
KR20240110836A (en) 2024-07-16
EP4433049A1 (en) 2024-09-25
WO2023089132A1 (en) 2023-05-25
AU2022393234A1 (en) 2024-06-06
CL2024001452A1 (en) 2024-09-27
MX2024005955A (en) 2024-06-11
CA3238583A1 (en) 2023-05-25
IL312859A (en) 2024-07-01
JP2024540527A (en) 2024-10-31

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