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

Info

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
Authority
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
Other languages
English (en)
Other versions
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
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material 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)
  • 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)
  • 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 (cg-RX-API-DMAC10.html)
EP (1) EP4135669A1 (cg-RX-API-DMAC10.html)
JP (2) JP7787824B2 (cg-RX-API-DMAC10.html)
KR (1) KR20230002656A (cg-RX-API-DMAC10.html)
CN (1) CN115484937A (cg-RX-API-DMAC10.html)
AU (2) AU2021257662B2 (cg-RX-API-DMAC10.html)
CA (1) CA3180184A1 (cg-RX-API-DMAC10.html)
IL (1) IL297240A (cg-RX-API-DMAC10.html)
MX (1) MX2022012898A (cg-RX-API-DMAC10.html)
PH (1) PH12022552454A1 (cg-RX-API-DMAC10.html)
TW (1) TWI923583B (cg-RX-API-DMAC10.html)
UY (1) UY39171A (cg-RX-API-DMAC10.html)
WO (1) WO2021209893A1 (cg-RX-API-DMAC10.html)

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
EP4349835A4 (en) * 2021-06-01 2025-06-25 Hangzhou Solipharma Co., Ltd. Hydrated crystal form of lazertinib methanesulfonate, process for its preparation and use thereof
WO2023138492A1 (zh) * 2022-01-19 2023-07-27 南京明德新药研发有限公司 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)
IL326946A (en) 2023-09-05 2026-05-01 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 (25)

* 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
DE602007011792D1 (de) * 2006-10-27 2011-02-17 Fmc Corp Gemeinsam aufbereitete mikrokristalline cellulose und zuckeralkohol als hilfsstoff für tablettenformulierungen
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
ES2900353T3 (es) 2010-04-07 2022-03-16 Vertex Pharma Composiciones farmacéuticas de ácido 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-il)ciclopropanocarboxamido)-3-metilpiriidin-2-il)benzoico y administración de las mismas
KR102373193B1 (ko) 2012-11-21 2022-03-10 얀센 바이오테크 인코포레이티드 이중특이성 EGFR/c-Met 항체
US20160151380A1 (en) * 2013-07-12 2016-06-02 The Regents Of The University Of California Therapies for diseases caused by arthropod-borne parasites
MY179355A (en) 2013-12-12 2020-11-05 Almirall Sa Pharmaceutical compositions comprising dimethyl fumarate
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
IL261998B2 (en) * 2016-04-07 2023-03-01 Chemocentryx Inc Reducing your burden by giving ccr1 antagonists in combination with pd-1 inhibitors or pd-l1 inhibitors
UA126970C2 (uk) * 2017-01-20 2023-03-01 Екселіксіс, Інк. Комбінації кабозантинібу і атезолізумабу для лікування раку
JP2020510027A (ja) * 2017-03-08 2020-04-02 アリアド ファーマシューティカルズ，インコーポレーテッド ５−クロロ−ｎ４−［２−（ジメチルホスホリル）フェニル］−ｎ２−｛２−メトキシ−４−［４−（４−メチルピペラジン−１−イル）ピペリジン−１−イル］フェニル｝ピリミジン−２，４−ジアミンを含む医薬製剤
DK3658547T3 (da) 2017-07-28 2023-10-16 Yuhan Corp Fremgangsmåde til fremstilling af n-(5-(4-(4-formyl-3-phenyl-1h-pyrazol-1-yl)pyrimidin-2-ylamino)-4-methoxy-2-morpholinophenyl)acrylamid
RS63497B1 (sr) 2017-07-28 2022-09-30 Yuhan Corp Intermedijeri korisni za sintezu derivata aminopirimidina, proces za pripremu istih i proces za pripremu derivata aminopirimidina korišćenjem istih
ES2962961T3 (es) 2017-07-28 2024-03-22 Yuhan Corp Procedimiento de preparación de n-(5-((4-(4-(dimetilamino)metil)-3-fenil-1h-pirazol-1-il)pirimidin-2-il)amino)-4-metoxi-2-morfolinofenil)acrilamida haciendo reaccionar la amina correspondiente con un cloruro de 3-halo-propionilo
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
US12350734B2 (en) 2018-07-20 2025-07-08 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
CA3136632A1 (en) 2019-04-11 2020-10-15 Goldfinch Bio, Inc. Spray-dried formulation of a pyridazinone trpc5 inhibitor
CN113784704A (zh) 2019-04-17 2021-12-10 诺狄更斯公司 快速崩解大麻素片剂
US11850248B2 (en) 2019-05-14 2023-12-26 Yuhan Corporation Therapies with 3rd generation EGFR tyrosine kinase inhibitors
MX2022001159A (es) 2019-07-31 2022-02-22 Hoffmann La Roche Nueva formulacion farmaceutica.
TW202228689A (zh) * 2020-10-09 2022-08-01 美商賽若凡斯生物製藥研發智財有限責任公司 泛ｊａｋ抑制劑的調配物

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
TW202207940A (zh) 2022-03-01
JP2025179094A (ja) 2025-12-09
JP2023522634A (ja) 2023-05-31
UY39171A (es) 2021-10-29
BR112022020609A2 (pt) 2022-11-29
WO2021209893A1 (en) 2021-10-21
IL297240A (en) 2022-12-01
EP4135669A1 (en) 2023-02-22
TWI923583B (zh) 2026-05-01
CN115484937A (zh) 2022-12-16
US20250177311A1 (en) 2025-06-05
CA3180184A1 (en) 2021-10-21
MX2022012898A (es) 2023-01-24
US12138351B2 (en) 2024-11-12
KR20230002656A (ko) 2023-01-05
PH12022552454A1 (en) 2024-02-05
AU2025203347A1 (en) 2025-05-29
US20210322323A1 (en) 2021-10-21
WO2021209893A8 (en) 2022-10-13
AU2021257662A1 (en) 2022-12-15
JP7787824B2 (ja) 2025-12-17

Similar Documents

Publication Publication Date Title
US12138351B2 (en) Pharmaceutical composition for oral administration comprising aminopyrimidine derivative or pharmaceutically acceptable salt, hydrate, or solvate thereof
EP3102213B1 (en) Pharmaceutical compositions for the treatment of inflammatory disorders
AU2024216519B2 (en) Pharmaceutical composition for oral administration comprising aminopyrimidine derivative or its salt
EP2623100B1 (en) Preparation for improving solubility of poorly soluble drug
EP2450057A1 (en) Novel forms of CDDO methyl ester
JP7809780B2 (ja) 粒状組成物、粒状組成物の製造方法、および粒状組成物の溶出性改善方法
US20230026232A1 (en) Ahr inhibitors and uses thereof
EP2435052B1 (en) Solid oral dosage forms of lamivudine with isomalt
TW202432128A (zh) （Ｒ）－１－（１－丙烯醯基哌啶－３－基）－４－胺基－３－（４－苯氧基苯基）－１Ｈ－咪唑並［４，５－ｃ］吡啶－２（３Ｈ）－酮之藥品調配物
US20140093563A1 (en) Febuxostat compositions
EA048109B1 (ru) Фармацевтическая композиция для перорального введения, содержащая производное аминопиримидина или его фармацевтически приемлемую соль, гидрат или сольват
BR112022020609B1 (pt) Composição e formulação farmacêutica para administração oral que compreende derivado de aminopirimidina ou sal, hidrato ou solvato farmaceuticamente aceitável do mesmo e seus usos
HK40085907A (en) Pharmaceutical composition for oral administration comprising aminopyrimidine derivative or pharmaceutically acceptable salt, hydrate, or solvate thereof
KR20110025926A (ko) 텔카게판트 칼륨의 고체 투여 제형
US20250000839A1 (en) Pharmaceutical composition comprising enavogliflozin
KR20040016988A (ko) Ｌｔｂ4 길항제를 함유하는 약제학적 제형
EP2881116A1 (en) Febuxostat composition
HK40058521A (en) Pharmaceutical composition for oral administration comprising aminopyrimidine derivative or its salt
KR20240024419A (ko) 피리미딘-4-카복사마이드 화합물의 결정형 및 이를 포함하는 경구용 약학 제제
EA052328B1 (ru) Фармацевтическая композиция, содержащая энавоглифлозин
HK40037156A (en) Granular composition, method for producing granular composition, and method for improving elution property of granular composition
ZA200309710B (en) Pharmaceutical formulation containing an LTB4 antagonist.
NZ717137A (en) Solid dosage forms of (s)-ethyl 2-amino-3-(4-(2-amino-6-((r)-1-(4-chloro-2-(3-methyl-1h-pyrazol-1-yl)phenyl)-2,2,2-trifluoroethoxy)pyrimidin-4-yl)phenyl)propanoate

Legal Events

Date Code Title Description
FGA Letters patent sealed or granted (standard patent)