JP7250006B2 - 高投与量バルベナジン製剤ならびにそれに関連する組成物、方法およびキット - Google Patents

高投与量バルベナジン製剤ならびにそれに関連する組成物、方法およびキット Download PDF

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JP7250006B2
JP7250006B2 JP2020516437A JP2020516437A JP7250006B2 JP 7250006 B2 JP7250006 B2 JP 7250006B2 JP 2020516437 A JP2020516437 A JP 2020516437A JP 2020516437 A JP2020516437 A JP 2020516437A JP 7250006 B2 JP7250006 B2 JP 7250006B2
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pharmaceutical composition
solid pharmaceutical
valbenazine
item
disorder
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JP2020534305A5 (enExample
JP2020534305A (ja
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リチャード アレクサンダー ジュニア ムーア，
グレゴリー エー． マクレランド，
クリストファー エフ． オブライエン，
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ニューロクライン バイオサイエンシーズ，インコーポレイテッド
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    • 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
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/4738—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4745—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines
    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • 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
    • A61K9/0012—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
    • A61K9/48—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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
JP2020516437A 2017-09-21 2018-09-18 高投与量バルベナジン製剤ならびにそれに関連する組成物、方法およびキット Active JP7250006B2 (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201762561629P 2017-09-21 2017-09-21
US62/561,629 2017-09-21
US201762564951P 2017-09-28 2017-09-28
US62/564,951 2017-09-28
PCT/US2018/051579 WO2019060322A2 (en) 2017-09-21 2018-09-18 HIGH DOSAGE VALBENAZINE FORMULATION AND COMPOSITIONS, METHODS AND KITS THEREOF

Publications (3)

Publication Number Publication Date
JP2020534305A JP2020534305A (ja) 2020-11-26
JP2020534305A5 JP2020534305A5 (enExample) 2021-11-04
JP7250006B2 true JP7250006B2 (ja) 2023-03-31

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US (3) US20200276184A1 (enExample)
EP (1) EP3684333B1 (enExample)
JP (1) JP7250006B2 (enExample)
CN (1) CN111372567B (enExample)
AU (1) AU2018335259B2 (enExample)
BR (1) BR112020005373A2 (enExample)
CA (1) CA3076000A1 (enExample)
DK (1) DK3684333T3 (enExample)
ES (1) ES3024958T3 (enExample)
FI (1) FI3684333T3 (enExample)
HR (1) HRP20250561T1 (enExample)
HU (1) HUE071873T2 (enExample)
IL (3) IL301770B2 (enExample)
LT (1) LT3684333T (enExample)
MA (1) MA50175B1 (enExample)
MD (1) MD3684333T2 (enExample)
MX (1) MX2020002841A (enExample)
PL (1) PL3684333T3 (enExample)
PT (1) PT3684333T (enExample)
RS (1) RS66714B1 (enExample)
SI (1) SI3684333T1 (enExample)
SM (1) SMT202500305T1 (enExample)
TW (1) TWI875681B (enExample)
WO (1) WO2019060322A2 (enExample)

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LT3875459T (lt) 2015-10-30 2024-02-26 Neurocrine Biosciences, Inc. Valbenazino dihidrochlorido druskos ir jų polimorfai
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JP7090151B2 (ja) 2017-01-27 2022-06-23 ニューロクライン バイオサイエンシーズ，インコーポレイテッド 特定のｖｍａｔ２インヒビターを投与するための方法
MA50175B1 (fr) 2017-09-21 2025-05-30 Neurocrine Biosciences, Inc. Formulation de valbenazine à dosage élevé et compositions, procédés et kits associés
AU2017435893B2 (en) 2017-10-10 2023-06-29 Neurocrine Biosciences, Inc Methods for the administration of certain VMAT2 inhibitors
KR20250070134A (ko) 2017-10-10 2025-05-20 뉴로크린 바이오사이언시즈 인코퍼레이티드 특정 vmat2 억제제의 투여 방법
CA3086611C (en) 2017-12-26 2023-07-25 Crystal Pharmaceutical (Suzhou) Co., Ltd. A crystalline form of valbenazine ditosylate, processes for preparation thereof and use thereof
WO2019241555A1 (en) 2018-06-14 2019-12-19 Neurocrine Biosciences, Inc. Vmat2 inhibitor compounds, compositions, and methods relating thereto
SG11202100303QA (en) 2018-08-15 2021-02-25 Neurocrine Biosciences Inc Methods for the administration of certain vmat2 inhibitors
US10940141B1 (en) * 2019-08-23 2021-03-09 Neurocrine Biosciences, Inc. Methods for the administration of certain VMAT2 inhibitors
CN114423755A (zh) 2019-09-13 2022-04-29 纽罗克里生物科学有限公司 用于合成缬苯那嗪的方法
IL307826A (en) 2021-04-26 2023-12-01 Neurocrine Biosciences Inc Processes for the synthesis of valbanazine
WO2025038959A1 (en) 2023-08-17 2025-02-20 Neurocrine Biosciences, Inc. Methods for the administration of certain vmat2 inhibitors
TW202521119A (zh) 2023-08-17 2025-06-01 美商紐羅克里生物科學有限公司 用於投與特定vmat2抑制劑之方法

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