CN108472258B - 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
CN108472258B
CN108472258B CN201780006739.5A CN201780006739A CN108472258B CN 108472258 B CN108472258 B CN 108472258B CN 201780006739 A CN201780006739 A CN 201780006739A CN 108472258 B CN108472258 B CN 108472258B
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amount
compound
tablet formulation
ibrutinib
crospovidone
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Chinese (zh)
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CN108472258A (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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    • 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

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

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202210154359.9A CN114681462A (zh) 2016-01-19 2017-01-18 包含btk抑制剂的配制品/组合物

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN201621001987 2016-01-19
IN201621001987 2016-01-19
PCT/EP2017/050964 WO2017125424A1 (en) 2016-01-19 2017-01-18 Formulations/compositions comprising a btk inhibitor

Related Child Applications (1)

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

Publications (2)

Publication Number Publication Date
CN108472258A CN108472258A (zh) 2018-08-31
CN108472258B true CN108472258B (zh) 2024-05-24

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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

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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)
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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)
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TW (1) TWI794153B (cg-RX-API-DMAC10.html)
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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

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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
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

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WO2014004707A1 (en) * 2012-06-29 2014-01-03 Principia Biopharma Inc. Formulations comprising ibrutinib
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

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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
KR20250025518A (ko) 2025-02-21
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
EP3405178A1 (en) 2018-11-28
AR107392A1 (es) 2018-04-25

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