CN114681462A - 包含btk抑制剂的配制品/组合物 - Google Patents

包含btk抑制剂的配制品/组合物 Download PDF

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Publication number
CN114681462A
CN114681462A CN202210154359.9A CN202210154359A CN114681462A CN 114681462 A CN114681462 A CN 114681462A CN 202210154359 A CN202210154359 A CN 202210154359A CN 114681462 A CN114681462 A CN 114681462A
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China
Prior art keywords
pharmaceutical composition
tablet formulation
ibrutinib
lymphoma
load solid
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Pending
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CN202210154359.9A
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English (en)
Chinese (zh)
Inventor
M.K.古普塔
P.R.寇卡尼
B.克里施南奈尔
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Janssen Pharmaceutica NV
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Janssen Pharmaceutica NV
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Publication of CN114681462A publication Critical patent/CN114681462A/zh
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52Purines, e.g. adenine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/04Antipruritics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/04Anorexiants; Antiobesity agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Rheumatology (AREA)
  • Immunology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Hematology (AREA)
  • Inorganic Chemistry (AREA)
  • Oncology (AREA)
  • Pain & Pain Management (AREA)
  • Obesity (AREA)
  • Diabetes (AREA)
  • Child & Adolescent Psychology (AREA)
  • Dermatology (AREA)
  • Transplantation (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)
CN202210154359.9A 2016-01-19 2017-01-18 包含btk抑制剂的配制品/组合物 Pending CN114681462A (zh)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
IN201621001987 2016-01-19
IN201621001987 2016-01-19
CN201780006739.5A CN108472258B (zh) 2016-01-19 2017-01-18 包含btk抑制剂的配制品/组合物
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
CN201780006739.5A Division CN108472258B (zh) 2016-01-19 2017-01-18 包含btk抑制剂的配制品/组合物

Publications (1)

Publication Number Publication Date
CN114681462A true CN114681462A (zh) 2022-07-01

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CN202210154359.9A Pending CN114681462A (zh) 2016-01-19 2017-01-18 包含btk抑制剂的配制品/组合物
CN201780006739.5A Active CN108472258B (zh) 2016-01-19 2017-01-18 包含btk抑制剂的配制品/组合物

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US (3) US20190290650A1 (https=)
EP (2) EP3405178B1 (https=)
JP (3) JP7336195B2 (https=)
KR (2) KR20250025518A (https=)
CN (2) CN114681462A (https=)
AR (1) AR107392A1 (https=)
AU (1) AU2017208473B2 (https=)
BR (1) BR112018014540B1 (https=)
DK (1) DK3405178T3 (https=)
EA (1) EA201891664A1 (https=)
ES (1) ES3041841T3 (https=)
FI (1) FI3405178T3 (https=)
HK (2) HK1259433A1 (https=)
HR (1) HRP20251152T1 (https=)
LT (1) LT3405178T (https=)
MA (1) MA43650B1 (https=)
MX (2) MX2018008772A (https=)
PL (1) PL3405178T3 (https=)
PT (1) PT3405178T (https=)
RS (1) RS67236B1 (https=)
SI (1) SI3405178T1 (https=)
SM (1) SMT202500360T1 (https=)
TW (1) TWI794153B (https=)
WO (1) WO2017125424A1 (https=)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JO3754B1 (ar) 2012-06-04 2021-01-31 Pharmacyclics Llc أشكال كريستالين لمثبط أنزيم كيناز تيروسين بروتون
IL315294A (en) 2015-03-03 2024-10-01 Pharmacyclics Llc Pharmaceutical formulations of bruton's tyrosine kinase inhibitor
KR20250025518A (ko) * 2016-01-19 2025-02-21 얀센 파마슈티카 엔브이 Btk 저해제를 포함하는 제형/조성물
EP3523280B1 (en) 2016-10-06 2026-03-11 Janssen Pharmaceutica NV Processes and intermediates for preparing a btk inhibitor
WO2018119142A1 (en) 2016-12-21 2018-06-28 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
EA202190045A1 (ru) 2018-06-15 2021-03-17 Янссен Фармацевтика Нв Составы/композиции, содержащие ибрутиниб
US10688050B1 (en) * 2018-12-21 2020-06-23 Synthon B.V. Pharmaceutical composition comprising ibrutinib
CA3154908A1 (en) * 2019-10-21 2021-04-29 Sreenivas S. Bhat Pharmaceutical compositions comprising (s)-2-(2,6-dioxopiperidin-3-yl)-4-((2-fluoro-4-((3-morpholinoazetidin-1-yl)methyl)benzyl)amino)isoindoline-1,3-dione and methods of using the sam
US12414950B1 (en) * 2024-05-21 2025-09-16 Telios Pharma Inc. Methods of treating indolent systemic mastocytosis

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140303191A1 (en) * 2011-10-19 2014-10-09 Pharmacyclics, Inc. Use of inhibitors of bruton's tyrosine kinase (btk)
WO2015071432A1 (en) * 2013-11-14 2015-05-21 Sandoz Ag Pharmaceutical compositions of ibrutinib
CN104736178A (zh) * 2012-06-04 2015-06-24 药品循环公司 布鲁顿酪氨酸激酶抑制剂的晶形
CN105073115A (zh) * 2013-03-14 2015-11-18 药品循环有限责任公司 布鲁顿氏酪氨酸激酶抑制剂和cyp3a4抑制剂的组合

Family Cites Families (20)

* 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
KR0182801B1 (ko) 1991-04-16 1999-05-01 아만 히데아키 고체 분산체의 제조방법
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
DE69332291T2 (de) 1992-10-16 2003-07-31 Nippon Shinyaku Co., Ltd. Verfahren zur herstellung von wachsmatrizes
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
JPH11505258A (ja) 1995-05-17 1999-05-18 セダーシナイ メディカル センター 小腸における消化および吸収を改善させる脂肪酸を含む組成物
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
EP2157524A3 (en) 2003-09-03 2010-12-08 GOVERNMENT OF THE UNITED STATES OF AMERICA, as represented by THE SECRETARY, DEPARTMENT OF HEALTH AND HUMAN SERVICES Methods for identifying, diagnosing, and predicting survival of lymphomas
BRPI0622054B8 (pt) 2006-09-22 2021-05-25 Oxford Amherst Llc composto e composição farmacêutica
WO2014004707A1 (en) 2012-06-29 2014-01-03 Principia Biopharma Inc. Formulations comprising 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
WO2017125423A1 (en) * 2016-01-19 2017-07-27 Janssen Pharmaceutica Nv Formulations/compositions comprising a btk inhibitor
KR20250025518A (ko) * 2016-01-19 2025-02-21 얀센 파마슈티카 엔브이 Btk 저해제를 포함하는 제형/조성물

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140303191A1 (en) * 2011-10-19 2014-10-09 Pharmacyclics, Inc. Use of inhibitors of bruton's tyrosine kinase (btk)
CN104736178A (zh) * 2012-06-04 2015-06-24 药品循环公司 布鲁顿酪氨酸激酶抑制剂的晶形
CN105073115A (zh) * 2013-03-14 2015-11-18 药品循环有限责任公司 布鲁顿氏酪氨酸激酶抑制剂和cyp3a4抑制剂的组合
WO2015071432A1 (en) * 2013-11-14 2015-05-21 Sandoz Ag Pharmaceutical compositions of ibrutinib

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
刘蜀宝: "《药剂学》", vol. 2007, 31 July 2007, 河南科学技术出版社, pages: 182 *

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MA43650A (fr) 2018-11-28
JP2019506450A (ja) 2019-03-07
US20190290650A1 (en) 2019-09-26
SMT202500360T1 (it) 2025-11-10
ES3041841T3 (en) 2025-11-14
BR112018014540A2 (pt) 2018-12-11
BR112018014540B1 (pt) 2024-02-27
PL3405178T3 (pl) 2025-11-12
KR20180102150A (ko) 2018-09-14
JP2024138243A (ja) 2024-10-08
CN108472258B (zh) 2024-05-24
CN108472258A (zh) 2018-08-31
MX2022006817A (es) 2022-07-11
TWI794153B (zh) 2023-03-01
EP4663247A3 (en) 2026-03-04
TW201737918A (zh) 2017-11-01
LT3405178T (lt) 2025-11-10
EP3405178A1 (en) 2018-11-28
US20230364090A1 (en) 2023-11-16
HRP20251152T1 (hr) 2025-12-05
AU2017208473A1 (en) 2018-07-12
EP3405178B1 (en) 2025-07-02
JP7565971B2 (ja) 2024-10-11
US20210169888A1 (en) 2021-06-10
DK3405178T3 (da) 2025-09-22
HK1259441A1 (zh) 2019-11-29
AU2017208473B2 (en) 2022-04-21
AR107392A1 (es) 2018-04-25
JP2022105006A (ja) 2022-07-12
KR20250025518A (ko) 2025-02-21
JP7336195B2 (ja) 2023-08-31
SI3405178T1 (sl) 2025-11-28
HK1259433A1 (zh) 2019-11-29
PT3405178T (pt) 2025-10-06
FI3405178T3 (fi) 2025-09-30
CA3008576A1 (en) 2017-07-27
WO2017125424A1 (en) 2017-07-27
EP4663247A2 (en) 2025-12-17
MX2018008772A (es) 2018-11-09
EA201891664A1 (ru) 2019-02-28
MA43650B1 (fr) 2025-09-30
RS67236B1 (sr) 2025-10-31

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