JP7457000B2 - 新規方法 - Google Patents

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Publication number
JP7457000B2
JP7457000B2 JP2021510845A JP2021510845A JP7457000B2 JP 7457000 B2 JP7457000 B2 JP 7457000B2 JP 2021510845 A JP2021510845 A JP 2021510845A JP 2021510845 A JP2021510845 A JP 2021510845A JP 7457000 B2 JP7457000 B2 JP 7457000B2
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JP
Japan
Prior art keywords
capsule
lumateperone
capsules
weight
monotosylate
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JP2021510845A
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English (en)
Japanese (ja)
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JP2021535151A (ja
JP2021535151A5 (https=
JPWO2020047408A5 (https=
Inventor
ポン・リ
ロバート・デイビス
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Intra Cellular Therapies Inc
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Intra Cellular Therapies Inc
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Publication of JP2021535151A publication Critical patent/JP2021535151A/ja
Publication of JP2021535151A5 publication Critical patent/JP2021535151A5/ja
Publication of JPWO2020047408A5 publication Critical patent/JPWO2020047408A5/ja
Priority to JP2024039652A priority Critical patent/JP2024073559A/ja
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Classifications

    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • 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
    • A61K9/4816—Wall or shell material
    • A61K9/4825—Proteins, e.g. gelatin
    • 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
    • A61K9/4858—Organic 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
    • 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
    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells
    • 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
    • A61P25/28—Drugs 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Psychiatry (AREA)
  • Inorganic Chemistry (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Hospice & Palliative Care (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
JP2021510845A 2018-08-31 2019-08-30 新規方法 Active JP7457000B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2024039652A JP2024073559A (ja) 2018-08-31 2024-03-14 新規方法

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201862725948P 2018-08-31 2018-08-31
US62/725,948 2018-08-31
US201862779923P 2018-12-14 2018-12-14
US62/779,923 2018-12-14
PCT/US2019/049062 WO2020047408A1 (en) 2018-08-31 2019-08-30 Novel methods

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2024039652A Division JP2024073559A (ja) 2018-08-31 2024-03-14 新規方法

Publications (4)

Publication Number Publication Date
JP2021535151A JP2021535151A (ja) 2021-12-16
JP2021535151A5 JP2021535151A5 (https=) 2022-09-06
JPWO2020047408A5 JPWO2020047408A5 (https=) 2022-09-06
JP7457000B2 true JP7457000B2 (ja) 2024-03-27

Family

ID=69639696

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2021510845A Active JP7457000B2 (ja) 2018-08-31 2019-08-30 新規方法
JP2024039652A Pending JP2024073559A (ja) 2018-08-31 2024-03-14 新規方法

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2024039652A Pending JP2024073559A (ja) 2018-08-31 2024-03-14 新規方法

Country Status (11)

Country Link
US (8) US10695345B2 (https=)
EP (1) EP3843739A4 (https=)
JP (2) JP7457000B2 (https=)
KR (1) KR20210052472A (https=)
CN (2) CN118873536A (https=)
AU (2) AU2019331490B2 (https=)
BR (1) BR112021003838A2 (https=)
CA (1) CA3108558A1 (https=)
IL (1) IL280913A (https=)
MX (2) MX2021002321A (https=)
WO (1) WO2020047408A1 (https=)

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CN105168219B (zh) * 2008-05-27 2018-11-20 细胞内治疗公司 用于睡眠障碍和其他疾病的方法和组合物
WO2013155504A1 (en) 2012-04-14 2013-10-17 Intra-Cellular Therapies, Inc. Novel methods
CN108883111B (zh) 2016-01-26 2021-10-08 细胞内治疗公司 有机化合物
EP4001281A1 (en) 2016-08-09 2022-05-25 Teva Pharmaceuticals International GmbH Solid state forms of lumateperone ditosylate salt and preparation thereof
US11331316B2 (en) 2016-10-12 2022-05-17 Intra-Cellular Therapies, Inc. Amorphous solid dispersions
IL268970B2 (en) 2017-03-24 2023-12-01 Intra Cellular Therapies Inc Oral transmucosal formulations of substituted heterocycle fused gamma carbolines
CN111107847A (zh) 2017-09-26 2020-05-05 细胞内治疗公司 新的盐和晶体
WO2019178484A1 (en) 2018-03-16 2019-09-19 Intra-Cellular Therapies, Inc. Novel methods
AU2019240226B2 (en) 2018-03-23 2024-11-28 Intra-Cellular Therapies, Inc. Organic compounds
CA3106447A1 (en) * 2018-06-11 2019-12-19 Intra-Cellular Therapies, Inc. Substituted heterocycle fused gamma-carbolines synthesis
CN112584837A (zh) * 2018-08-31 2021-03-30 细胞内治疗公司 新方法
CA3108558A1 (en) 2018-08-31 2020-03-05 Intra-Cellular Therapies, Inc. Novel methods
IL283963B2 (en) 2018-12-17 2025-01-01 Intra Cellular Therapies Inc Synthesis of condensed gamma-carbolines and converted heterocycles
WO2020132605A1 (en) 2018-12-21 2020-06-25 Intra-Cellular Therapies, Inc. Organic compounds
EP4034119A4 (en) 2019-09-25 2023-10-18 Intra-Cellular Therapies, Inc. NOVEL METHODS
EP4072554A4 (en) 2019-12-11 2023-12-20 Intra-Cellular Therapies, Inc. ORGANIC CONNECTION
EP4076461B1 (en) * 2019-12-19 2026-01-28 Intra-Cellular Therapies, Inc. Lumateperone for use in schizophrenia treatment
WO2021182538A1 (ja) * 2020-03-10 2021-09-16 学校法人近畿大学 カリオフィレンを含有する剤、組成物及び各種用途
US12102636B2 (en) 2021-02-11 2024-10-01 Medtronic, Inc. Administration of antipsychotics
US12414948B2 (en) 2022-05-18 2025-09-16 Intra-Cellular Therapies, Inc. Methods
CN115554237B (zh) * 2022-12-08 2023-09-12 山东则正医药技术有限公司 一种卢美哌隆原位凝胶长效注射剂及其制备方法和用途
EP4678165A1 (en) * 2023-03-03 2026-01-14 Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. Long-acting and sustained-release preparation composition of lumateperone and preparation method therefor
WO2024220385A1 (en) * 2023-04-19 2024-10-24 University Of Florida Research Foundation, Incorporated Prodrug atheliapyrrolidine compound and methods of use
WO2025240804A1 (en) 2024-05-16 2025-11-20 Intra-Cellular Therapies, Inc. Novel compositions, devices and methods
CN118557536B (zh) * 2024-07-30 2024-11-15 山东则正医药技术有限公司 一种卢美哌隆口崩片组合物及其制备方法和应用

Citations (3)

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Publication number Priority date Publication date Assignee Title
JP2016539144A (ja) 2013-12-03 2016-12-15 イントラ−セルラー・セラピーズ・インコーポレイテッドＩｎｔｒａ−Ｃｅｌｌｕｌａｒ Ｔｈｅｒａｐｉｅｓ， Ｉｎｃ． 新規方法
WO2018031535A1 (en) 2016-08-09 2018-02-15 Assia Chemical Industries Ltd. Solid state forms of lumateperone ditosylate salt
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