KR102650321B1 - 액체 타시멜테온 제형 및 이의 사용 방법 - Google Patents

액체 타시멜테온 제형 및 이의 사용 방법 Download PDF

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Publication number
KR102650321B1
KR102650321B1 KR1020227022807A KR20227022807A KR102650321B1 KR 102650321 B1 KR102650321 B1 KR 102650321B1 KR 1020227022807 A KR1020227022807 A KR 1020227022807A KR 20227022807 A KR20227022807 A KR 20227022807A KR 102650321 B1 KR102650321 B1 KR 102650321B1
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South Korea
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tasimelteon
pharmaceutical composition
liquid formulation
patient
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Korean (ko)
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KR20220113983A (ko
Inventor
디팩 파드케
미하엘 폴리머로풀로스
Original Assignee
반다 파마슈티칼즈, 인코퍼레이티드.
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Application filed by 반다 파마슈티칼즈, 인코퍼레이티드. filed Critical 반다 파마슈티칼즈, 인코퍼레이티드.
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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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
    • A61K31/343—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
    • 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
    • A61K47/26—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
    • A61K47/32—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
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K9/08—Solutions

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Steroid Compounds (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
KR1020227022807A 2019-12-13 2020-12-11 액체 타시멜테온 제형 및 이의 사용 방법 Active KR102650321B1 (ko)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US201962947774P 2019-12-13 2019-12-13
US62/947,774 2019-12-13
US202062972902P 2020-02-11 2020-02-11
US62/972,902 2020-02-11
US202063119488P 2020-11-30 2020-11-30
US63/119,488 2020-11-30
PCT/US2020/064555 WO2021119456A1 (en) 2019-12-13 2020-12-11 Liquid tasimelteon formulations and methods of use thereof

Publications (2)

Publication Number Publication Date
KR20220113983A KR20220113983A (ko) 2022-08-17
KR102650321B1 true KR102650321B1 (ko) 2024-03-21

Family

ID=73856392

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020227022807A Active KR102650321B1 (ko) 2019-12-13 2020-12-11 액체 타시멜테온 제형 및 이의 사용 방법

Country Status (14)

Country Link
US (5) US11202770B2 (enExample)
EP (1) EP4072542A1 (enExample)
JP (3) JP7503632B2 (enExample)
KR (1) KR102650321B1 (enExample)
CN (1) CN114727978A (enExample)
AU (3) AU2020400065B2 (enExample)
CA (1) CA3161975A1 (enExample)
CL (1) CL2022001546A1 (enExample)
CO (1) CO2022009691A2 (enExample)
IL (2) IL292492A (enExample)
MX (2) MX2022006577A (enExample)
NZ (1) NZ811397A (enExample)
WO (1) WO2021119456A1 (enExample)
ZA (1) ZA202207188B (enExample)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101587394B1 (ko) * 2006-05-22 2016-01-21 반다 파마슈티칼즈, 인코퍼레이티드. 멜라토닌 효능제 치료
CN106604726A (zh) * 2014-09-02 2017-04-26 万达制药公司 用于治疗史密斯‑马吉利综合征的他司美琼
NZ811397A (en) * 2019-12-13 2025-11-28 Vanda Pharmaceuticals Inc Liquid tasimelteon formulations and methods of use thereof
AU2022345260A1 (en) 2021-09-14 2024-04-04 Vanda Pharmaceuticals Inc. Treatment of sleep disturbances in autism spectrum disorder patients
WO2024258786A1 (en) 2023-06-12 2024-12-19 Vanda Pharmaceuticals Inc. Tasimelteon for use in the treatment of delayed sleep-wake phase disorder

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120136050A1 (en) 2009-07-16 2012-05-31 Vanda Pharmaceuticals Inc. Use of a melatonin agonist for the treatment of sleep disorders including primary insomnia
WO2016036619A1 (en) 2014-09-02 2016-03-10 Vanda Pharmaceuticals Inc. Tasimelteon for treating smith-magenis syndrome

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100499106B1 (ko) * 1996-12-10 2005-07-01 브리스톨-마이어즈 스퀴브 컴페니 벤조디옥솔, 벤조퓨란, 디히드로벤조퓨란, 및 벤조디옥산 멜라토닌 작용제
US20050137247A1 (en) * 2003-12-22 2005-06-23 The Brigham And Women's Hospital, Inc. Methods and compositions for treatment of hypertension
KR101587394B1 (ko) 2006-05-22 2016-01-21 반다 파마슈티칼즈, 인코퍼레이티드. 멜라토닌 효능제 치료
US20080260837A1 (en) * 2007-04-20 2008-10-23 Qpharma, L.L.C. Physically stable aqueous suspensions of active pharmaceuticals
WO2011112167A1 (en) * 2009-03-13 2011-09-15 Reset Therapeutics, Inc. Compositions and methods for diabetes treatment
IL330095A (en) 2012-01-26 2026-08-01 Vanda Pharmaceuticals Inc Tesimalta for use in the treatment of asynchronous circadian rhythm of cortisol
CN102675268A (zh) 2012-05-18 2012-09-19 济南志合医药科技有限公司 制备（1r，2r）-2-（2,3-二氢苯并呋喃-4-基）环丙甲胺的方法
IL266159B2 (en) 2012-12-18 2024-07-01 Vanda Pharmaceuticals Inc Treatment of circadian rhythm disorders
US10376487B2 (en) 2013-11-12 2019-08-13 Vanda Pharmaceuticals Inc. Method of treatment
JP6921534B2 (ja) 2014-02-12 2021-08-18 バンダ・ファーマシューティカルズ・インコーポレイテッドＶａｎｄａ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ Ｉｎｃ． 高純度医薬品等級タシメルテオン
CN106542973B (zh) * 2015-09-16 2019-06-25 南京华威医药科技集团有限公司 他司美琼中间体及其制备方法
WO2017059877A1 (en) 2015-10-07 2017-04-13 Rontis Hellas S.A. Pharmaceutical composition containing agomelatine and process for the preparation thereof
US9944616B2 (en) * 2016-06-08 2018-04-17 Apotex Inc. Processes for the preparation of Tasimelteon and intermediates thereof
NZ811397A (en) * 2019-12-13 2025-11-28 Vanda Pharmaceuticals Inc Liquid tasimelteon formulations and methods of use thereof

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120136050A1 (en) 2009-07-16 2012-05-31 Vanda Pharmaceuticals Inc. Use of a melatonin agonist for the treatment of sleep disorders including primary insomnia
WO2016036619A1 (en) 2014-09-02 2016-03-10 Vanda Pharmaceuticals Inc. Tasimelteon for treating smith-magenis syndrome

Also Published As

Publication number Publication date
US12447141B2 (en) 2025-10-21
JP2024084859A (ja) 2024-06-25
US20260007633A1 (en) 2026-01-08
US11759446B2 (en) 2023-09-19
JP7503632B2 (ja) 2024-06-20
US11202770B2 (en) 2021-12-21
MX2026003536A (es) 2026-05-04
US20210177799A1 (en) 2021-06-17
CL2022001546A1 (es) 2023-02-24
MX2022006577A (es) 2022-07-04
NZ811397A (en) 2025-11-28
US20250090492A1 (en) 2025-03-20
AU2026202446A1 (en) 2026-04-23
CN114727978A (zh) 2022-07-08
JP2026117039A (ja) 2026-07-14
JP7875899B2 (ja) 2026-06-18
AU2025205489B2 (en) 2026-01-29
CO2022009691A2 (es) 2022-07-29
US12440470B2 (en) 2025-10-14
WO2021119456A1 (en) 2021-06-17
AU2025205489A1 (en) 2025-08-14
AU2020400065B2 (en) 2025-08-14
EP4072542A1 (en) 2022-10-19
JP2023506225A (ja) 2023-02-15
US20210212980A1 (en) 2021-07-15
AU2020400065A1 (en) 2022-06-30
IL292492A (en) 2022-06-01
NZ811345A (en) 2025-07-25
KR20220113983A (ko) 2022-08-17
ZA202207188B (en) 2022-08-31
US20230372285A1 (en) 2023-11-23
IL317244A (en) 2025-01-01
NZ789270A (en) 2024-07-05
CA3161975A1 (en) 2021-06-17

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