JP7787824B2 - アミノピリミジン誘導体若しくはその薬学的に許容される塩、水和物、又は溶媒和物を含む経口投与のための医薬組成物 - Google Patents

アミノピリミジン誘導体若しくはその薬学的に許容される塩、水和物、又は溶媒和物を含む経口投与のための医薬組成物

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JP7787824B2
JP7787824B2 JP2022562451A JP2022562451A JP7787824B2 JP 7787824 B2 JP7787824 B2 JP 7787824B2 JP 2022562451 A JP2022562451 A JP 2022562451A JP 2022562451 A JP2022562451 A JP 2022562451A JP 7787824 B2 JP7787824 B2 JP 7787824B2
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pharmaceutical composition
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lazertinib
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morpholinophenyl
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JP2023522634A (ja
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マクシミリアン，ジャクリーン
ラジャン，ゴパール
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ヤンセン バイオテツク，インコーポレーテツド
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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
    • A61K9/20—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)
JP2022562451A 2020-04-14 2021-04-13 アミノピリミジン誘導体若しくはその薬学的に許容される塩、水和物、又は溶媒和物を含む経口投与のための医薬組成物 Active JP7787824B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2025138920A JP2025179094A (ja) 2020-04-14 2025-08-22 アミノピリミジン誘導体若しくはその薬学的に許容される塩、水和物、又は溶媒和物を含む経口投与のための医薬組成物

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)

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JP2025138920A Division JP2025179094A (ja) 2020-04-14 2025-08-22 アミノピリミジン誘導体若しくはその薬学的に許容される塩、水和物、又は溶媒和物を含む経口投与のための医薬組成物

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JP2023522634A JP2023522634A (ja) 2023-05-31
JP7787824B2 true JP7787824B2 (ja) 2025-12-17

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JP2022562451A Active JP7787824B2 (ja) 2020-04-14 2021-04-13 アミノピリミジン誘導体若しくはその薬学的に許容される塩、水和物、又は溶媒和物を含む経口投与のための医薬組成物
JP2025138920A Pending JP2025179094A (ja) 2020-04-14 2025-08-22 アミノピリミジン誘導体若しくはその薬学的に許容される塩、水和物、又は溶媒和物を含む経口投与のための医薬組成物

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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)
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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
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)

Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001213765A (ja) 2000-01-19 2001-08-07 Yung Shin Pharmaceutical Industry Co Ltd 活性成分を添加できる医薬錠剤
JP2010507677A (ja) 2006-10-27 2010-03-11 エフ エム シー コーポレーション 錠剤処方物の賦形剤としての微結晶セルロースおよび糖アルコールの共処理物
WO2011071139A1 (ja) 2009-12-11 2011-06-16 大日本住友製薬株式会社 有核型の口腔内崩壊錠
JP2018058886A (ja) 2010-04-07 2018-04-12 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Ｖｅｒｔｅｘ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ Ｉｎｃｏｒｐｏｒａｔｅｄ 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
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
JP2019510832A (ja) 2016-04-07 2019-04-18 ケモセントリクス，インコーポレーテッド Ｐｄ−１阻害剤又はｐｄ−ｌ１阻害剤と組み合わせてｃｃｒ１アンタゴニストを投与することによる腫瘍負荷の低減
JP2019218385A (ja) 2013-12-12 2019-12-26 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
WO2020018928A1 (en) 2018-07-20 2020-01-23 Imerys Usa, Inc. Recovering sand, bentonite and organics from foundry sand waste
WO2020211915A1 (en) 2019-04-17 2020-10-22 Nordiccan A/S Fast disintegrating cannabinoid tablets
JP2022504943A (ja) 2018-10-18 2022-01-13 ユハン コーポレーション アミノピリミジン誘導体又はその塩を含む経口投与用医薬組成物
JP2022525797A (ja) 2019-04-11 2022-05-19 ゴールドフィンチ バイオ，インク． ピリダジノンｔｒｐｃ５阻害剤の噴霧乾燥された製剤
JP2022543552A (ja) 2019-07-31 2022-10-13 エフ・ホフマン－ラ・ロシュ・アクチェンゲゼルシャフト 新規医薬製剤

Family Cites Families (13)

* 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
EP2198857A1 (en) * 2008-12-19 2010-06-23 Ratiopharm GmbH Oral dispersible tablet
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
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.
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
US11850248B2 (en) 2019-05-14 2023-12-26 Yuhan Corporation Therapies with 3rd generation EGFR tyrosine kinase inhibitors

Patent Citations (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001213765A (ja) 2000-01-19 2001-08-07 Yung Shin Pharmaceutical Industry Co Ltd 活性成分を添加できる医薬錠剤
JP2010507677A (ja) 2006-10-27 2010-03-11 エフ エム シー コーポレーション 錠剤処方物の賦形剤としての微結晶セルロースおよび糖アルコールの共処理物
JP2010507676A (ja) 2006-10-27 2010-03-11 エフ エム シー コーポレーション 乾式顆粒化結合剤、生成物およびその使用
WO2011071139A1 (ja) 2009-12-11 2011-06-16 大日本住友製薬株式会社 有核型の口腔内崩壊錠
JP2018058886A (ja) 2010-04-07 2018-04-12 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Ｖｅｒｔｅｘ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ Ｉｎｃｏｒｐｏｒａｔｅｄ 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
JP2019218385A (ja) 2013-12-12 2019-12-26 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
JP2019510832A (ja) 2016-04-07 2019-04-18 ケモセントリクス，インコーポレーテッド Ｐｄ−１阻害剤又はｐｄ−ｌ１阻害剤と組み合わせてｃｃｒ１アンタゴニストを投与することによる腫瘍負荷の低減
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
WO2020018928A1 (en) 2018-07-20 2020-01-23 Imerys Usa, Inc. Recovering sand, bentonite and organics from foundry sand waste
JP2022504943A (ja) 2018-10-18 2022-01-13 ユハン コーポレーション アミノピリミジン誘導体又はその塩を含む経口投与用医薬組成物
JP2022525797A (ja) 2019-04-11 2022-05-19 ゴールドフィンチ バイオ，インク． ピリダジノンｔｒｐｃ５阻害剤の噴霧乾燥された製剤
WO2020211915A1 (en) 2019-04-17 2020-10-22 Nordiccan A/S Fast disintegrating cannabinoid tablets
JP2022529037A (ja) 2019-04-17 2022-06-16 ノルディックカン・アー／エス 速崩壊カンナビノイド錠剤
JP2022543552A (ja) 2019-07-31 2022-10-13 エフ・ホフマン－ラ・ロシュ・アクチェンゲゼルシャフト 新規医薬製剤

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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
AU2021257662B2 (en) 2025-06-12
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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