CN115996713A - 治疗性固体剂型 - Google Patents

治疗性固体剂型 Download PDF

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Publication number
CN115996713A
CN115996713A CN202180046533.1A CN202180046533A CN115996713A CN 115996713 A CN115996713 A CN 115996713A CN 202180046533 A CN202180046533 A CN 202180046533A CN 115996713 A CN115996713 A CN 115996713A
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CN
China
Prior art keywords
solid dosage
dosage form
dimethyltryptamine
alpha
dimethylprimary
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
CN202180046533.1A
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English (en)
Chinese (zh)
Inventor
P·兰德斯
T·本威
Z·乔尔
M·雷泽尔
E·詹姆斯
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.)
Smar Pharmaceutical Co ltd
Original Assignee
Smar Pharmaceutical Co 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 GB2008303.6A external-priority patent/GB2585978B/en
Priority claimed from US17/108,679 external-priority patent/US20220168274A1/en
Priority claimed from GBGB2018950.2A external-priority patent/GB202018950D0/en
Priority claimed from GBGB2018955.1A external-priority patent/GB202018955D0/en
Priority claimed from US17/108,938 external-priority patent/US20220169606A1/en
Priority claimed from US17/208,583 external-priority patent/US11773062B2/en
Priority claimed from GB2103981.3A external-priority patent/GB2605144A/en
Application filed by Smar Pharmaceutical Co ltd filed Critical Smar Pharmaceutical Co ltd
Publication of CN115996713A publication Critical patent/CN115996713A/zh
Pending legal-status Critical Current

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D209/00—Heterocyclic compounds containing five-membered rings, condensed with other rings, with one nitrogen atom as the only ring hetero atom
    • C07D209/02—Heterocyclic compounds containing five-membered rings, condensed with other rings, with one nitrogen atom as the only ring hetero atom condensed with one carbocyclic ring
    • C07D209/04—Indoles; Hydrogenated indoles
    • C07D209/10—Indoles; Hydrogenated indoles with substituted hydrocarbon radicals attached to carbon atoms of the hetero ring
    • C07D209/14—Radicals substituted by nitrogen atoms, not forming part of a nitro radical
    • C07D209/16—Tryptamines
    • 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
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • 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
    • 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
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • 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
    • A61P25/22—Anxiolytics
    • 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
    • A61P25/24—Antidepressants
    • 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
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B59/00—Introduction of isotopes of elements into organic compounds ; Labelled organic compounds per se
    • C07B59/002—Heterocyclic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • 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
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/485—Inorganic compounds
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00—Indexing scheme relating to specific properties of organic compounds
    • C07B2200/05—Isotopically modified compounds, e.g. labelled

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurosurgery (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Psychiatry (AREA)
  • Addiction (AREA)
  • Pain & Pain Management (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
CN202180046533.1A 2020-06-02 2021-05-13 治疗性固体剂型 Pending CN115996713A (zh)

Applications Claiming Priority (21)

Application Number Priority Date Filing Date Title
GB2008303.6A GB2585978B (en) 2019-06-03 2020-06-02 Therapeutic compositions
US16/890,664 US11771681B2 (en) 2019-06-03 2020-06-02 Therapeutic compounds
EPPCT/EP2020/065244 2020-06-02
GB2008303.6 2020-06-02
US16/890,664 2020-06-02
PCT/EP2020/065244 WO2020245133A1 (en) 2019-06-03 2020-06-02 Therapeutic compositions comprising deuterated or partially deuterated n,n-dimethyltryptamine compounds
GB2018955.1 2020-12-01
GB2018950.2 2020-12-01
US17/108,938 2020-12-01
US17/108,679 US20220168274A1 (en) 2020-12-01 2020-12-01 Parenteral Formulation
GBGB2018950.2A GB202018950D0 (en) 2020-12-01 2020-12-01 Parenteral formulation
US17/108,679 2020-12-01
GBGB2018955.1A GB202018955D0 (en) 2020-12-01 2020-12-01 Compositions and compounds for bioanalysis
US17/108,938 US20220169606A1 (en) 2020-12-01 2020-12-01 Compositions and compounds for bioanalysis
US17/208,583 US11773062B2 (en) 2021-03-22 2021-03-22 Deuterated compounds
US17/208,583 2021-03-22
GB2103981.3A GB2605144A (en) 2021-03-22 2021-03-22 Deuterated compounds
GB2103981.3 2021-03-22
EPPCT/EP2021/060750 2021-04-23
PCT/EP2021/060750 WO2021116503A2 (en) 2020-06-02 2021-04-23 Deuterated compounds
PCT/EP2021/062794 WO2021244831A1 (en) 2020-06-02 2021-05-13 Therapeutic solid dosage forms

Publications (1)

Publication Number Publication Date
CN115996713A true CN115996713A (zh) 2023-04-21

Family

ID=76329655

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202180046533.1A Pending CN115996713A (zh) 2020-06-02 2021-05-13 治疗性固体剂型

Country Status (8)

Country Link
EP (3) EP3902541B1 (enExample)
JP (1) JP7579888B2 (enExample)
CN (1) CN115996713A (enExample)
AU (1) AU2021284861A1 (enExample)
CA (1) CA3118556A1 (enExample)
GB (1) GB2595776B (enExample)
IL (1) IL298542B2 (enExample)
WO (2) WO2021116503A2 (enExample)

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GB201907871D0 (en) 2019-06-03 2019-07-17 Small Pharma Ltd Therapeutic compositions
KR20220082092A (ko) 2019-11-07 2022-06-16 스몰 파마 엘티디 화합물
KR20220137081A (ko) 2020-02-04 2022-10-11 마인드셋 파마 인크. Cns 장애의 치료를 위한 세로토닌성 사이키델릭 작용제로서의 실로신 유도체
BR112022015379A2 (pt) 2020-02-04 2022-09-27 Mindset Pharma Inc Derivados de 3-pirrolidino-indol como agentes psicodélicos serotonérgicos para o tratamento de distúrbios do snc
WO2021226416A1 (en) 2020-05-08 2021-11-11 Psilera Inc. Novel compositions of matter and pharmaceutical compositions
US12240813B2 (en) 2020-05-19 2025-03-04 Cybin Irl Limited Deuterated tryptamine derivatives and methods of use
US12042564B2 (en) 2020-06-02 2024-07-23 Cybin Uk Ltd Therapeutic solid dosage forms
US11773062B2 (en) 2021-03-22 2023-10-03 Small Pharma Ltd Deuterated compounds
EP4188492A4 (en) * 2020-07-29 2024-08-07 Gregory Ellis DELIVERY SYSTEM FOR AYAHUSCA-LIKE SUBSTANCES
AU2021328671A1 (en) 2020-08-18 2023-02-16 Cybin Irl Limited Phenethylamine derivatives, compositions, and methods of use
US11406619B2 (en) 2020-08-28 2022-08-09 Small Pharma Ltd Injectable formulations
EP4031529B1 (en) * 2020-12-01 2023-09-27 Small Pharma Ltd Deuterated or partially deuterated n,n-dimethyltryptamine compounds
US11660289B2 (en) 2020-12-01 2023-05-30 Small Pharma Ltd. Deuterated or partially deuterated N,N-dimethyltryptamine compounds
US12521370B2 (en) 2020-12-01 2026-01-13 Cybin Uk Ltd Inhalable formulations
WO2022117640A1 (en) 2020-12-01 2022-06-09 Small Pharma Ltd Inhalable formulations
EP4255422A4 (en) 2020-12-03 2024-12-18 Mydecine Innovations Group Inc. NEW PSILOCIN ANALOGUE COMPOSITIONS AND METHODS OF THEIR SYNTHESIS
CA3218110A1 (en) 2021-05-25 2022-12-01 Majed Fawaz New n,n-dimethyltryptamine salts and crystalline salt forms
AU2022287974A1 (en) 2021-06-09 2024-01-04 Atai Therapeutics, Inc. Novel prodrugs and conjugates of dimethyltryptamine
US11697638B2 (en) 2021-09-08 2023-07-11 Small Pharma Ltd 5-methoxy-N,N-dimethyltryptamine crystalline forms
EP4159201A1 (en) 2021-09-30 2023-04-05 Biomind Labs Inc Encapsulated microparticles and nanoparticles of dimethyltriptamines
EP4433049A1 (en) 2021-11-18 2024-09-25 Cybin UK Ltd Injectable and inhalable formulations
US12318477B2 (en) 2021-11-18 2025-06-03 Cybin Uk Ltd Injectable and inhalable formulations
WO2023129956A2 (en) * 2021-12-30 2023-07-06 ATAI Life Sciences AG Dimethyltryptamine analogues as nitric oxide delivery drugs
EP4463440A1 (en) * 2022-01-14 2024-11-20 Cybin IRL Limited Tryptamine compositions and methods
WO2023168023A1 (en) 2022-03-04 2023-09-07 Reset Pharmaceuticals, Inc. Co-crystals or salts comprising psilocin
AU2023242469A1 (en) * 2022-03-31 2024-09-05 Cybin Irl Limited Combination of nitrous oxide and 5-ht2a receptor agonists
AU2023269880A1 (en) 2022-05-10 2024-01-18 Mydecine Innovations Group Inc. Novel psilocin prodrug compounds and methods of synthesizing the same
WO2024108195A1 (en) 2022-11-17 2024-05-23 Remedi, Inc. Combinations of monoamine oxidase inhibitors and serotonin receptor agonists and their therapeutic use

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KR20220082092A (ko) * 2019-11-07 2022-06-16 스몰 파마 엘티디 화합물

Patent Citations (1)

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WO2019081764A1 (en) * 2017-10-26 2019-05-02 Consejo Superior De Investigaciones Científicas (Csic) ASSOCIATION PRODUCT FOR THE TREATMENT OF NEUROLOGICAL AND / OR PSYCHIATRIC DISORDERS

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JOHN M. BEATONN等: "A Comparison of the Behavioral Effects of Proteo- and Deutero-N, N-Dimethyltryptamine", PHARMACOLOGY BIOCHEMISTRY & BEHAVIOR, vol. 16, pages 811 - 814, XP023806754, DOI: 10.1016/0091-3057(82)90240-4 *
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EP3902541B1 (en) 2022-09-14
WO2021116503A8 (en) 2021-08-12
JP7579888B2 (ja) 2024-11-08
EP4494703A2 (en) 2025-01-22
EP4149460B1 (en) 2024-11-27
EP4149460C0 (en) 2024-11-27
GB202106881D0 (en) 2021-06-30
WO2021116503A3 (en) 2023-09-28
CA3118556A1 (en) 2021-12-02
WO2021244831A1 (en) 2021-12-09
JP2023527575A (ja) 2023-06-29
WO2021116503A2 (en) 2021-06-17
IL298542B2 (en) 2025-02-01
EP4494703A3 (en) 2025-04-02
IL298542B1 (en) 2024-10-01
GB2595776B (en) 2023-05-24
AU2021284861A1 (en) 2023-01-05
GB2595776A (en) 2021-12-08
IL298542A (en) 2023-01-01
EP4149460A1 (en) 2023-03-22
EP3902541A2 (en) 2021-11-03
EP4149460B8 (en) 2025-01-08

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