AU2021257662B2 - Pharmaceutical composition for oral administration comprising aminopyrimidine derivative or pharmaceutically acceptable salt, hydrate, or solvate thereof - Google Patents

Pharmaceutical composition for oral administration comprising aminopyrimidine derivative or pharmaceutically acceptable salt, hydrate, or solvate thereof Download PDF

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Publication number
AU2021257662B2
AU2021257662B2 AU2021257662A AU2021257662A AU2021257662B2 AU 2021257662 B2 AU2021257662 B2 AU 2021257662B2 AU 2021257662 A AU2021257662 A AU 2021257662A AU 2021257662 A AU2021257662 A AU 2021257662A AU 2021257662 B2 AU2021257662 B2 AU 2021257662B2
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AU
Australia
Prior art keywords
lazertinib
pharmaceutical composition
tablet
amount
sugar
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.)
Active
Application number
AU2021257662A
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English (en)
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AU2021257662A1 (en
Inventor
Jacqueline MAXIMILIEN
Gopal Rajan
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.)
Janssen Biotech Inc
Original Assignee
Janssen Biotech 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
Application filed by Janssen Biotech Inc filed Critical Janssen Biotech Inc
Publication of AU2021257662A1 publication Critical patent/AU2021257662A1/en
Priority to AU2025203347A priority Critical patent/AU2025203347A1/en
Application granted granted Critical
Publication of AU2021257662B2 publication Critical patent/AU2021257662B2/en
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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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/5377—1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
    • 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
    • A61K9/20—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
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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
    • C07B2200/13—Crystalline forms, e.g. polymorphs

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
AU2021257662A 2020-04-14 2021-04-13 Pharmaceutical composition for oral administration comprising aminopyrimidine derivative or pharmaceutically acceptable salt, hydrate, or solvate thereof Active AU2021257662B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2025203347A AU2025203347A1 (en) 2020-04-14 2025-05-09 Pharmaceutical composition for oral administration comprising aminopyrimidine derivative or pharmaceutically acceptable salt, hydrate, or solvate thereof

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US202063009623P 2020-04-14 2020-04-14
US63/009,623 2020-04-14
US202063014277P 2020-04-23 2020-04-23
US63/014,277 2020-04-23
PCT/IB2021/053035 WO2021209893A1 (en) 2020-04-14 2021-04-13 Pharmaceutical composition for oral administration comprising amin op yrimidine derivative or pharmaceutically acceptable salt, hydrate, or solvate thereof

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2025203347A Division AU2025203347A1 (en) 2020-04-14 2025-05-09 Pharmaceutical composition for oral administration comprising aminopyrimidine derivative or pharmaceutically acceptable salt, hydrate, or solvate thereof

Publications (2)

Publication Number Publication Date
AU2021257662A1 AU2021257662A1 (en) 2022-12-15
AU2021257662B2 true AU2021257662B2 (en) 2025-06-12

Family

ID=75562794

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2021257662A Active AU2021257662B2 (en) 2020-04-14 2021-04-13 Pharmaceutical composition for oral administration comprising aminopyrimidine derivative or pharmaceutically acceptable salt, hydrate, or solvate thereof
AU2025203347A Pending AU2025203347A1 (en) 2020-04-14 2025-05-09 Pharmaceutical composition for oral administration comprising aminopyrimidine derivative or pharmaceutically acceptable salt, hydrate, or solvate thereof

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2025203347A Pending AU2025203347A1 (en) 2020-04-14 2025-05-09 Pharmaceutical composition for oral administration comprising aminopyrimidine derivative or pharmaceutically acceptable salt, hydrate, or solvate thereof

Country Status (13)

Country Link
US (2) US12138351B2 (enExample)
EP (1) EP4135669A1 (enExample)
JP (2) JP7787824B2 (enExample)
KR (1) KR20230002656A (enExample)
CN (1) CN115484937A (enExample)
AU (2) AU2021257662B2 (enExample)
CA (1) CA3180184A1 (enExample)
IL (1) IL297240A (enExample)
MX (1) MX2022012898A (enExample)
PH (1) PH12022552454A1 (enExample)
TW (1) TW202207940A (enExample)
UY (1) UY39171A (enExample)
WO (1) WO2021209893A1 (enExample)

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KR20200043618A (ko) * 2018-10-18 2020-04-28 주식회사유한양행 아미노피리미딘 유도체 또는 이의 염을 포함하는 경구투여용 약학 조성물
US20240270733A1 (en) * 2021-06-01 2024-08-15 Hangzhou Solipharma Co., Ltd. Hydrate form of lazertinib mesylate, preparation method thereof and use thereof
CN118251220A (zh) * 2022-01-19 2024-06-25 江苏奥赛康药业有限公司 一种包含嘧啶基团的三并环类化合物的组合物及其制备方法和应用
CA3228195A1 (en) 2023-05-23 2025-06-30 Janssen Biotech, Inc. Methods for treatment of non-small cell lung cancer (nsclc)
WO2025052273A1 (en) 2023-09-05 2025-03-13 Janssen Biotech, Inc. Methods of treating non-small cell lung cancer
WO2026042017A1 (en) 2024-08-19 2026-02-26 Janssen Biotech, Inc. Amivantamab in combination with lazertinib for the treatment of non-small cell lung cancer (nsclc)

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WO2018194356A1 (en) * 2017-04-21 2018-10-25 Yuhan Corporation Salt of an aminopyridine derivative compound, a crystalline form thereof, and a process for preparing the same

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WO2008057267A2 (en) * 2006-10-27 2008-05-15 Fmc Corporation Co-processed microcrystalline cellulose and sugar alcohol as an excipient for tablet formulations
EP2198857A1 (en) * 2008-12-19 2010-06-23 Ratiopharm GmbH Oral dispersible tablet
ES2713330T3 (es) 2009-12-11 2019-05-21 Sumitomo Dainippon Pharma Co Ltd Comprimido recubierto en seco que se desintegra oralmente
BR112012026255A2 (pt) 2010-04-07 2017-03-14 Vertex Pharma composições farmacêuticas de ácido 3-(6-(1-(2-,2-difluorbenzo[d][1,3]dioxol-5-il)ciclopropanocarboxamido)-3-metilpiridin-2-il)benzóico e administração das mesmas
AU2013347962B2 (en) 2012-11-21 2018-10-25 Janssen Biotech, Inc. Bispecific EGFR/c-Met antibodies
WO2015006752A1 (en) * 2013-07-12 2015-01-15 The Regents Of The University Of California Combination therapies for malaria
UA120428C2 (uk) 2013-12-12 2019-12-10 Алміралл, С.А. Фармацевтичні композиції, які містять диметилфумарат
GB201402070D0 (en) * 2014-02-07 2014-03-26 Galapagos Nv Pharmaceutical compositions for the treatment of inflammatory disorders
MX2017003181A (es) 2014-10-13 2017-07-20 Yuhan Corp Compuestos y composiciones para modular actividades de quinasa de mutante de receptor del factor de crecimiento epidermico.
TWI808938B (zh) 2016-04-07 2023-07-21 美商卡默森屈有限公司 藉由投予ccr1拮抗劑與pd-1抑制劑或pd-l1抑制劑之組合減少腫瘤負荷
MX389966B (es) * 2017-01-20 2025-03-20 Exelixis Inc Combinaciones de cabozantinib y atezolizumab para tratar cancer.
EP3592338A1 (en) * 2017-03-08 2020-01-15 ARIAD Pharmaceuticals, Inc. Pharmaceutical formulations comprising 5-chloro-n4
MX393995B (es) 2017-07-28 2025-03-24 Yuhan Corp Proceso mejorado para preparar derivados de aminopirimidina
DK3658553T3 (da) 2017-07-28 2022-07-25 Yuhan Corp Mellemprodukter som er anvendelige til syntesen af aminopyrimidinderivater, fremgangsmåde til fremstilling deraf og fremgangsmåde til fremstilling af aminopyrimidinderivater under anvendelse deraf
CN111295381A (zh) 2017-07-28 2020-06-16 株式会社柳韩洋行 可用于合成抗蛋白激酶的选择性抑制剂的中间体及其制备方法
CN110580014B (zh) * 2018-06-11 2021-03-30 北京京东尚科信息技术有限公司 用于控制自动导引运输车的方法、装置和系统
WO2020018928A1 (en) 2018-07-20 2020-01-23 Imerys Usa, Inc. Recovering sand, bentonite and organics from foundry sand waste
KR20200043618A (ko) 2018-10-18 2020-04-28 주식회사유한양행 아미노피리미딘 유도체 또는 이의 염을 포함하는 경구투여용 약학 조성물
SG11202110585SA (en) 2019-04-11 2021-10-28 Goldfinch Bio Inc Spray-dried formulation of a pyridazinone trpc5 inhibitor
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Patent Citations (1)

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WO2018194356A1 (en) * 2017-04-21 2018-10-25 Yuhan Corporation Salt of an aminopyridine derivative compound, a crystalline form thereof, and a process for preparing the same

Also Published As

Publication number Publication date
WO2021209893A1 (en) 2021-10-21
PH12022552454A1 (en) 2024-02-05
IL297240A (en) 2022-12-01
US20250177311A1 (en) 2025-06-05
CA3180184A1 (en) 2021-10-21
AU2021257662A1 (en) 2022-12-15
EP4135669A1 (en) 2023-02-22
US12138351B2 (en) 2024-11-12
JP7787824B2 (ja) 2025-12-17
CN115484937A (zh) 2022-12-16
WO2021209893A8 (en) 2022-10-13
KR20230002656A (ko) 2023-01-05
AU2025203347A1 (en) 2025-05-29
MX2022012898A (es) 2023-01-24
TW202207940A (zh) 2022-03-01
JP2023522634A (ja) 2023-05-31
US20210322323A1 (en) 2021-10-21
UY39171A (es) 2021-10-29
BR112022020609A2 (pt) 2022-11-29
JP2025179094A (ja) 2025-12-09

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