KR20250025518A - Btk 저해제를 포함하는 제형/조성물 - Google Patents

Btk 저해제를 포함하는 제형/조성물 Download PDF

Info

Publication number
KR20250025518A
KR20250025518A KR1020257004789A KR20257004789A KR20250025518A KR 20250025518 A KR20250025518 A KR 20250025518A KR 1020257004789 A KR1020257004789 A KR 1020257004789A KR 20257004789 A KR20257004789 A KR 20257004789A KR 20250025518 A KR20250025518 A KR 20250025518A
Authority
KR
South Korea
Prior art keywords
compound
lymphoma
cell
subject
disclosed
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.)
Pending
Application number
KR1020257004789A
Other languages
English (en)
Korean (ko)
Inventor
마니쉬 쿠마르 굽타
파리크시트 라메슈라오 쿨카르니
나이르 비누라즈 크리슈난
Original Assignee
얀센 파마슈티카 엔브이
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 얀센 파마슈티카 엔브이 filed Critical 얀센 파마슈티카 엔브이
Publication of KR20250025518A publication Critical patent/KR20250025518A/ko
Pending legal-status Critical Current

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
    • A61K9/2004—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
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52—Purines, e.g. adenine
    • 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
    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/04—Antipruritics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Rheumatology (AREA)
  • Immunology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Inorganic Chemistry (AREA)
  • Oncology (AREA)
  • Pain & Pain Management (AREA)
  • Diabetes (AREA)
  • Obesity (AREA)
  • Child & Adolescent Psychology (AREA)
  • Transplantation (AREA)
  • Dermatology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
KR1020257004789A 2016-01-19 2017-01-18 Btk 저해제를 포함하는 제형/조성물 Pending KR20250025518A (ko)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
IN201621001987 2016-01-19
IN201621001987 2016-01-19
KR1020187023229A KR20180102150A (ko) 2016-01-19 2017-01-18 Btk 저해제를 포함하는 제형/조성물
PCT/EP2017/050964 WO2017125424A1 (en) 2016-01-19 2017-01-18 Formulations/compositions comprising a btk inhibitor

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
KR1020187023229A Division KR20180102150A (ko) 2016-01-19 2017-01-18 Btk 저해제를 포함하는 제형/조성물

Publications (1)

Publication Number Publication Date
KR20250025518A true KR20250025518A (ko) 2025-02-21

Family

ID=57851068

Family Applications (2)

Application Number Title Priority Date Filing Date
KR1020257004789A Pending KR20250025518A (ko) 2016-01-19 2017-01-18 Btk 저해제를 포함하는 제형/조성물
KR1020187023229A Pending KR20180102150A (ko) 2016-01-19 2017-01-18 Btk 저해제를 포함하는 제형/조성물

Family Applications After (1)

Application Number Title Priority Date Filing Date
KR1020187023229A Pending KR20180102150A (ko) 2016-01-19 2017-01-18 Btk 저해제를 포함하는 제형/조성물

Country Status (24)

Country Link
US (3) US20190290650A1 (cg-RX-API-DMAC10.html)
EP (2) EP4663247A3 (cg-RX-API-DMAC10.html)
JP (3) JP7336195B2 (cg-RX-API-DMAC10.html)
KR (2) KR20250025518A (cg-RX-API-DMAC10.html)
CN (2) CN108472258B (cg-RX-API-DMAC10.html)
AR (1) AR107392A1 (cg-RX-API-DMAC10.html)
AU (1) AU2017208473B2 (cg-RX-API-DMAC10.html)
BR (1) BR112018014540B1 (cg-RX-API-DMAC10.html)
DK (1) DK3405178T3 (cg-RX-API-DMAC10.html)
EA (1) EA201891664A1 (cg-RX-API-DMAC10.html)
ES (1) ES3041841T3 (cg-RX-API-DMAC10.html)
FI (1) FI3405178T3 (cg-RX-API-DMAC10.html)
HK (2) HK1259433A1 (cg-RX-API-DMAC10.html)
HR (1) HRP20251152T1 (cg-RX-API-DMAC10.html)
LT (1) LT3405178T (cg-RX-API-DMAC10.html)
MA (1) MA43650B1 (cg-RX-API-DMAC10.html)
MX (2) MX2018008772A (cg-RX-API-DMAC10.html)
PL (1) PL3405178T3 (cg-RX-API-DMAC10.html)
PT (1) PT3405178T (cg-RX-API-DMAC10.html)
RS (1) RS67236B1 (cg-RX-API-DMAC10.html)
SI (1) SI3405178T1 (cg-RX-API-DMAC10.html)
SM (1) SMT202500360T1 (cg-RX-API-DMAC10.html)
TW (1) TWI794153B (cg-RX-API-DMAC10.html)
WO (1) WO2017125424A1 (cg-RX-API-DMAC10.html)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MA37711A1 (fr) 2012-06-04 2017-05-31 Pharmacyclics Inc Formes cristallines d'un inhibiteur de tyrosine kinase de bruton
IL315294A (en) * 2015-03-03 2024-10-01 Pharmacyclics Llc Pharmaceutical formulations of proton tyrosine kinase inhibitor
DK3405178T3 (da) * 2016-01-19 2025-09-22 Janssen Pharmaceutica Nv Formuleringer/sammensætninger, der omfatter en btk-inhibitor
CN109790121B (zh) 2016-10-06 2024-01-05 詹森药业有限公司 用于制备btk抑制剂的方法和中间体
EP3824906A1 (en) 2016-12-21 2021-05-26 Amgen Inc. Anti-tnf alpha antibody formulations
US11576917B2 (en) 2018-01-20 2023-02-14 Natco Pharma Limited Pharmaceutical compositions comprising Ibrutinib
EP3575300A1 (en) 2018-05-31 2019-12-04 Apotex Inc. Novel crystalline forms of ibrutinib
KR102844084B1 (ko) 2018-06-15 2025-08-07 얀센 파마슈티카 엔브이 이브루티닙을 포함하는 제형/조성물
US10688050B1 (en) * 2018-12-21 2020-06-23 Synthon B.V. Pharmaceutical composition comprising ibrutinib
CN114885602A (zh) * 2019-10-21 2022-08-09 新基公司 包含(s)-2-(2,6-二氧代哌啶-3-基)-4-((2-氟-4-((3-吗啉代氮杂环丁烷-1-基)甲基)苄基)氨基)异吲哚啉-1,3-二酮的药物组合物及其使用方法
US12414950B1 (en) * 2024-05-21 2025-09-16 Telios Pharma Inc. Methods of treating indolent systemic mastocytosis

Family Cites Families (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4327725A (en) 1980-11-25 1982-05-04 Alza Corporation Osmotic device with hydrogel driving member
US4624848A (en) 1984-05-10 1986-11-25 Ciba-Geigy Corporation Active agent containing hydrogel devices wherein the active agent concentration profile contains a sigmoidal concentration gradient for improved constant release, their manufacture and use
US4968509A (en) 1987-07-27 1990-11-06 Mcneilab, Inc. Oral sustained release acetaminophen formulation and process
IL92966A (en) 1989-01-12 1995-07-31 Pfizer Dispensing devices powered by hydrogel
ES2111065T5 (es) 1991-04-16 2005-06-16 Nippon Shinyaku Company, Limited Procedimiento para producir una dispersion solida.
CZ282760B6 (cs) 1991-11-22 1997-09-17 Procter And Gamble Pharmaceuticals, Inc. Risedronátové prostředky se zpožděným uvolňováním
US5461140A (en) 1992-04-30 1995-10-24 Pharmaceutical Delivery Systems Bioerodible polymers for solid controlled release pharmaceutical compositions
US5323907A (en) 1992-06-23 1994-06-28 Multi-Comp, Inc. Child resistant package assembly for dispensing pharmaceutical medications
WO1994008568A1 (fr) 1992-10-16 1994-04-28 Nippon Shinyaku Co., Ltd. Procede pour fabriquer des matrices de cire
US5686105A (en) 1993-10-19 1997-11-11 The Procter & Gamble Company Pharmaceutical dosage form with multiple enteric polymer coatings for colonic delivery
US6326469B1 (en) 1994-04-22 2001-12-04 Sugen, Inc. Megakaryocytic protein tyrosine kinases
KR19990014865A (ko) 1995-05-17 1999-02-25 피터 이. 브래이브맨 소장에서의 소화 및 흡수를 증진시키기 위한, 지방산을 함유한조성물들
US6395300B1 (en) 1999-05-27 2002-05-28 Acusphere, Inc. Porous drug matrices and methods of manufacture thereof
US6465014B1 (en) 2001-03-21 2002-10-15 Isp Investments Inc. pH-dependent sustained release, drug-delivery composition
US7711492B2 (en) 2003-09-03 2010-05-04 The United States Of America As Represented By The Department Of Health And Human Services Methods for diagnosing lymphoma types
EP2529621B1 (en) 2006-09-22 2016-10-05 Pharmacyclics LLC Inhibitors of bruton's tyrosine kinase
US20140303191A1 (en) * 2011-10-19 2014-10-09 Pharmacyclics, Inc. Use of inhibitors of bruton's tyrosine kinase (btk)
MA37711A1 (fr) 2012-06-04 2017-05-31 Pharmacyclics Inc Formes cristallines d'un inhibiteur de tyrosine kinase de bruton
WO2014004707A1 (en) 2012-06-29 2014-01-03 Principia Biopharma Inc. Formulations comprising ibrutinib
AU2014244518A1 (en) * 2013-03-14 2015-09-17 Pharmacyclics Llc Combinations of Bruton's tyrosine kinase inhibitors and CYP3A4 inhibitors
WO2015071432A1 (en) * 2013-11-14 2015-05-21 Sandoz Ag Pharmaceutical compositions of ibrutinib
CN104523695A (zh) * 2014-11-12 2015-04-22 广东东阳光药业有限公司 一种治疗过度增生性疾病的药物组合物
DK3405178T3 (da) 2016-01-19 2025-09-22 Janssen Pharmaceutica Nv Formuleringer/sammensætninger, der omfatter en btk-inhibitor
FI3405177T3 (fi) * 2016-01-19 2026-06-03 Janssen Pharmaceutica Nv Btk:n estäjää käsittäviä formulaatioita/koostumuksia

Also Published As

Publication number Publication date
HK1259433A1 (zh) 2019-11-29
JP2019506450A (ja) 2019-03-07
CN108472258A (zh) 2018-08-31
LT3405178T (lt) 2025-11-10
KR20180102150A (ko) 2018-09-14
MA43650A (fr) 2018-11-28
HK1259441A1 (zh) 2019-11-29
AU2017208473B2 (en) 2022-04-21
JP2022105006A (ja) 2022-07-12
PL3405178T3 (pl) 2025-11-12
EA201891664A1 (ru) 2019-02-28
US20230364090A1 (en) 2023-11-16
DK3405178T3 (da) 2025-09-22
JP7565971B2 (ja) 2024-10-11
SMT202500360T1 (it) 2025-11-10
HRP20251152T1 (hr) 2025-12-05
EP4663247A2 (en) 2025-12-17
US20190290650A1 (en) 2019-09-26
WO2017125424A1 (en) 2017-07-27
FI3405178T3 (fi) 2025-09-30
MX2018008772A (es) 2018-11-09
TW201737918A (zh) 2017-11-01
JP2024138243A (ja) 2024-10-08
CN114681462A (zh) 2022-07-01
TWI794153B (zh) 2023-03-01
MX2022006817A (es) 2022-07-11
RS67236B1 (sr) 2025-10-31
PT3405178T (pt) 2025-10-06
AU2017208473A1 (en) 2018-07-12
MA43650B1 (fr) 2025-09-30
EP4663247A3 (en) 2026-03-04
ES3041841T3 (en) 2025-11-14
SI3405178T1 (sl) 2025-11-28
BR112018014540B1 (pt) 2024-02-27
US20210169888A1 (en) 2021-06-10
EP3405178B1 (en) 2025-07-02
CA3008576A1 (en) 2017-07-27
BR112018014540A2 (pt) 2018-12-11
JP7336195B2 (ja) 2023-08-31
CN108472258B (zh) 2024-05-24
EP3405178A1 (en) 2018-11-28
AR107392A1 (es) 2018-04-25

Similar Documents

Publication Publication Date Title
JP7565971B2 (ja) Ｂｔｋ阻害剤を含む製剤／組成物
US20220339157A1 (en) Formulations/Compositions Comprising a BTK Inhibitor
TW202419091A (zh) 布魯東氏(bruton’s)酪胺酸激酶抑制劑之醫藥調配物
KR20250151610A (ko) 브루톤 타이로신 키나아제 저해제의 결정 형태
CA3008338C (en) Formulations/compositions comprising a btk inhibitor
CA3008576C (en) Formulations/compositions comprising a btk inhibitor
HK40076908A (en) Formulations/compositions comprising a btk inhibitor

Legal Events

Date Code Title Description
A107 Divisional application of patent
PA0104 Divisional application for international application

Comment text: Divisional Application for International Patent

Patent event code: PA01041R01D

Patent event date: 20250213

Application number text: 1020187023229

Filing date: 20180810

PG1501 Laying open of application
A201 Request for examination
PA0201 Request for examination

Patent event code: PA02012R01D

Patent event date: 20250311

Comment text: Request for Examination of Application