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
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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
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Janssen Biotech Inc
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Filing date
Publication date
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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)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nutrition Science (AREA)
  • Physiology (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 (12)

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

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20200043618A (ko) * 2018-10-18 2020-04-28 주식회사유한양행 아미노피리미딘 유도체 또는 이의 염을 포함하는 경구투여용 약학 조성물
WO2022253261A1 (zh) * 2021-06-01 2022-12-08 杭州领业医药科技有限公司 Lazertinib甲磺酸盐的水合物晶型及其制备方法和用途
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)

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Family Cites Families (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6437006B1 (en) * 1999-09-27 2002-08-20 American Cyanamid Company Pharmaceutical carrier formulation
US6399591B1 (en) * 2000-01-19 2002-06-04 Yung-Shin Pharmaceutical Ind. Co., Ltd. Chargeable pharmaceutical tablets
WO2008057266A2 (en) * 2006-10-27 2008-05-15 Fmc Corporation Dry granulation binders, products, and use thereof
EP2198857A1 (en) * 2008-12-19 2010-06-23 Ratiopharm GmbH Oral dispersible tablet
US9278063B2 (en) * 2009-12-11 2016-03-08 Sumitomo Dainippon Pharma Co., Ltd. Press-coated orally-disintegrating tablets
JP2013523833A (ja) * 2010-04-07 2013-06-17 バーテックス ファーマシューティカルズ インコーポレイテッド ３−（６−（１−（２，２−ジフルオロベンゾ［ｄ］［１，３］ジオキソール−５−イル）シクロプロパンカルボキサミド）−３−メチルピリジン−２−イル）安息香酸の医薬組成物およびその投与
CN113201073A (zh) 2012-11-21 2021-08-03 詹森生物科技公司 双特异性EGFR/c-Met抗体
WO2015006753A2 (en) * 2013-07-12 2015-01-15 The Regents Of The University Of California Therapies for diseases caused by arthropod-borne parasites
JP6581088B2 (ja) * 2013-12-12 2019-09-25 アルミラル・ソシエダッド・アノニマＡｌｍｉｒａｌｌ， Ｓ．Ａ． フマル酸ジメチルを含む医薬組成物
GB201402070D0 (en) * 2014-02-07 2014-03-26 Galapagos Nv Pharmaceutical compositions for the treatment of inflammatory disorders
EP3929190B1 (en) 2014-10-13 2024-12-25 Yuhan Corporation Compounds and compositions for modulating egfr mutant kinase activities
CN109310677A (zh) 2016-04-07 2019-02-05 凯莫森特里克斯股份有限公司 通过联合施用ccr1拮抗剂与pd-1抑制剂或pd-l1拮抗剂降低肿瘤负荷
KR20230169458A (ko) * 2017-01-20 2023-12-15 엑셀리시스, 인코포레이티드 암을 치료하기 위한 카보잔티닙 및 아테졸리주맙의 조합
CN110520110A (zh) * 2017-03-08 2019-11-29 阿瑞雅德制药公司 包含5-氯-n4-[2-(二甲基磷酰基)苯基]-n2-{2-甲氧基-4-[4-(4-甲基哌嗪-1-基)哌啶-1-基]苯基}嘧啶-2,4-二胺的药物制剂
FI3658552T3 (fi) 2017-07-28 2023-11-16 Yuhan Corp Menetelmä n-(5-((4-(4-((dimetyyliamino)metyyli)-3-fenyyli-1h-pyratsol-1-yyli)pyrimidin-2-yyli)amino)-4-metoksi-2-morfolinofenyyli)akryyliamidin valmistamiseksi saattamalla vastaava amiini reagoimaan 3-halopropionyylikloridin kanssa
EP3658553B1 (en) 2017-07-28 2022-06-15 Yuhan Corporation Intermediates useful for the synthesis of aminopyrimidine derivatives, process for preparing the same, and process for preparing aminopyrimidine derivatives using the same
ES2959967T3 (es) 2017-07-28 2024-02-29 Yuhan Corp Procedimiento de preparación deN-(5-(4-(4-formil-3-fenil-1h-pirazol-1-il)pirimidin-2-ilamino)-4-metoxi-2-morfolinofenil)acrilamida
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
JP7455807B2 (ja) * 2018-07-20 2024-03-26 アイメリーズ ユーエスエー，インコーポレーテッド 鋳造砂廃棄物からの砂、ベントナイト、及び有機物の回収
KR20200043618A (ko) 2018-10-18 2020-04-28 주식회사유한양행 아미노피리미딘 유도체 또는 이의 염을 포함하는 경구투여용 약학 조성물
CA3136632A1 (en) * 2019-04-11 2020-10-15 Goldfinch Bio, Inc. Spray-dried formulation of a pyridazinone trpc5 inhibitor
FI3920891T3 (fi) * 2019-04-17 2024-03-19 Nordiccan As Nopeasti hajoavat kannabinoiditabletit
US11850248B2 (en) 2019-05-14 2023-12-26 Yuhan Corporation Therapies with 3rd generation EGFR tyrosine kinase inhibitors
AU2020319662B2 (en) * 2019-07-31 2024-02-29 F. Hoffmann-La Roche Ag New pharmaceutical formulation

Patent Citations (1)

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

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