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AR130877A1 - N-N-DIMETHYLTRYPTAMINE (DMT) AND DMT-ANALOGUE COMPOSITIONS, METHODS OF MANUFACTURING AND METHODS OF USING THESE - Google Patents

N-N-DIMETHYLTRYPTAMINE (DMT) AND DMT-ANALOGUE COMPOSITIONS, METHODS OF MANUFACTURING AND METHODS OF USING THESE

Info

Publication number
AR130877A1
AR130877A1 ARP230102864A ARP230102864A AR130877A1 AR 130877 A1 AR130877 A1 AR 130877A1 AR P230102864 A ARP230102864 A AR P230102864A AR P230102864 A ARP230102864 A AR P230102864A AR 130877 A1 AR130877 A1 AR 130877A1
Authority
AR
Argentina
Prior art keywords
dmt
composition
dimethyltryptamine
amorphous
polymeric carrier
Prior art date
Application number
ARP230102864A
Other languages
Spanish (es)
Original Assignee
Atai Therapeutics 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
Priority claimed from US17/974,443 external-priority patent/US20230136824A1/en
Application filed by Atai Therapeutics Inc filed Critical Atai Therapeutics Inc
Publication of AR130877A1 publication Critical patent/AR130877A1/en

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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K9/141—Intimate 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
    • A61K9/146—Intimate 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Se describen composiciones farmacéuticas que incluyen una N-N-dimetiltriptamina amorfa (DMT) o una sal o profármaco farmacéuticamente aceptable de esta, y un portador polimérico. Estas composiciones son adecuadas para la administración bucal o sublingual a un paciente. Se describen métodos para tratar trastornos, que incluyen trastornos neurológicos, mediante la administración de estas composiciones. Reivindicación 1: Una composición que comprende una cantidad farmacéuticamente efectiva de una N,N-dimetiltriptamina (DMT) amorfa incorporada dentro de una matriz portadora polimérica. Reivindicación 2: La composición de la reivindicación 1, en donde la DMT se caracteriza por un difractograma de rayos X en polvo libre de cualquier pico discernible. Reivindicación 3: La composición de la reivindicación 1, en donde la DMT se caracteriza por un espectro de calorimetría diferencial de barrido (DSC) que carece de una endotermia de fusión aguda de DMT cristalina y/o que carece de una indicación de cambio de fase. Reivindicación 4: La composición de la reivindicación 1, en donde la matriz portadora polimérica es un polímero mucoadhesivo. Reivindicación 5: La composición de la reivindicación 1, en donde la DMT es una base libre de DMT. Reivindicación 10: La composición de la reivindicación 1, en donde la matriz portadora polimérica comprende un derivado de celulosa, un ácido poliacrílico, un poliacrilato, un óxido de polietileno, polivinilpirrolidona, poli(vinilpirrolidona-co-vinil acetato), hidroxietilceluloda, hidroxipropilcelulosa, hidroxipropilmetilcelulosa, alcohol polivinílico, éster de alginato de propilenglicol, tragacanto, alginato, una goma, un almidón soluble, gelatina, lectina, pectina, o quitosano, o una mezcla de estos. Reivindicación 26: Una composición, que comprende: aproximadamente 0,5% a aproximadamente 60% en peso de una N-N-dimetiltriptamina amorfa o una sal o profármaco farmacéuticamente aceptable de esta; aproximadamente 15% a aproximadamente 80% en peso de una matriz polimérica mucoadhesiva; y aproximadamente 0,1% a aproximadamente 30% en peso de un potenciador de la permeación. Reivindicación 46: La composición de la reivindicación 1, en donde la DMT permanece en un estado amorfo después del envejecimiento a 25ºC y 60% de humedad relativa durante 6 meses.Pharmaceutical compositions are disclosed that include an amorphous N,N-dimethyltryptamine (DMT) or a pharmaceutically acceptable salt or prodrug thereof, and a polymeric carrier. These compositions are suitable for buccal or sublingual administration to a patient. Methods of treating disorders, including neurological disorders, by administering these compositions are disclosed. Claim 1: A composition comprising a pharmaceutically effective amount of an amorphous N,N-dimethyltryptamine (DMT) incorporated within a polymeric carrier matrix. Claim 2: The composition of claim 1, wherein the DMT is characterized by an X-ray powder diffractogram free of any discernible peaks. Claim 3: The composition of claim 1, wherein the DMT is characterized by a differential scanning calorimetry (DSC) spectrum that lacks a sharp melting endotherm of crystalline DMT and/or that lacks an indication of phase change. Claim 4: The composition of claim 1, wherein the polymeric carrier matrix is a mucoadhesive polymer. Claim 5: The composition of claim 1, wherein the DMT is a DMT free base. Claim 10: The composition of claim 1, wherein the polymeric carrier matrix comprises a cellulose derivative, a polyacrylic acid, a polyacrylate, a polyethylene oxide, polyvinylpyrrolidone, poly(vinylpyrrolidone-co-vinyl acetate), hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, polyvinyl alcohol, propylene glycol alginate ester, tragacanth, alginate, a gum, a soluble starch, gelatin, lectin, pectin, or chitosan, or a mixture thereof. Claim 26: A composition, comprising: about 0.5% to about 60% by weight of an amorphous N-N-dimethyltryptamine or a pharmaceutically acceptable salt or prodrug thereof; about 15% to about 80% by weight of a mucoadhesive polymeric matrix; and about 0.1% to about 30% by weight of a permeation enhancer. Claim 46: The composition of claim 1, wherein the DMT remains in an amorphous state after aging at 25° C. and 60% relative humidity for 6 months.

ARP230102864A 2022-10-26 2023-10-26 N-N-DIMETHYLTRYPTAMINE (DMT) AND DMT-ANALOGUE COMPOSITIONS, METHODS OF MANUFACTURING AND METHODS OF USING THESE AR130877A1 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US17/974,443 US20230136824A1 (en) 2021-04-26 2022-10-26 N-n-dimethyltryptamine (dmt) and dmt analog compositions, methods of making, and methods of use thereof

Publications (1)

Publication Number Publication Date
AR130877A1 true AR130877A1 (en) 2025-01-29

Family

ID=90832092

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP230102864A AR130877A1 (en) 2022-10-26 2023-10-26 N-N-DIMETHYLTRYPTAMINE (DMT) AND DMT-ANALOGUE COMPOSITIONS, METHODS OF MANUFACTURING AND METHODS OF USING THESE

Country Status (6)

Country Link
EP (1) EP4608395A2 (en)
AR (1) AR130877A1 (en)
AU (1) AU2023367107A1 (en)
CA (1) CA3267555A1 (en)
TW (1) TW202423415A (en)
WO (1) WO2024092106A2 (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL297861A (en) 2020-05-08 2023-01-01 Psilera Inc New compositions of pharmaceutical substances and preparations
MX2023013928A (en) 2021-05-25 2023-12-08 Atai Therapeutics Inc NEW SALTS AND CRYSTALLINE FORMS OF N,N-DIMETHYLTRYPTAMINE SALTS.

Family Cites Families (6)

* 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
IL297861A (en) * 2020-05-08 2023-01-01 Psilera Inc New compositions of pharmaceutical substances and preparations
EP4595962A3 (en) * 2020-06-12 2025-10-22 Beckley Psytech Limited Pharmaceutical composition
EP4214192A4 (en) * 2020-09-20 2024-09-25 Tactogen Inc. TRYPTAMINE COMPOSITIONS BENEFICIAL FOR MENTAL DISORDERS OR MENTAL IMPROVEMENT
BR112023022195A2 (en) * 2021-04-26 2024-01-16 Atai Therapeutics Inc NEW N,N-DIMETHYLTRYPTAMINE COMPOSITIONS AND METHODS

Also Published As

Publication number Publication date
CA3267555A1 (en) 2024-05-02
AU2023367107A1 (en) 2025-03-27
WO2024092106A2 (en) 2024-05-02
TW202423415A (en) 2024-06-16
EP4608395A2 (en) 2025-09-03
WO2024092106A3 (en) 2024-06-06

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