BR112018014540B1 - Formulações compreendendo inibidor de btk, seus usos e processo para a preparação dos mesmos - Google Patents

Formulações compreendendo inibidor de btk, seus usos e processo para a preparação dos mesmos Download PDF

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Publication number
BR112018014540B1
BR112018014540B1 BR112018014540-8A BR112018014540A BR112018014540B1 BR 112018014540 B1 BR112018014540 B1 BR 112018014540B1 BR 112018014540 A BR112018014540 A BR 112018014540A BR 112018014540 B1 BR112018014540 B1 BR 112018014540B1
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BR
Brazil
Prior art keywords
lymphoma
tablet formulation
cell
compound
ibrutinib
Prior art date
Application number
BR112018014540-8A
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English (en)
Portuguese (pt)
Other versions
BR112018014540A2 (pt
Inventor
Manish Kumar Gupta
Parikshit Rameshrao Kulkarni
Binuraj Krishnan Nair
Original Assignee
Janssen Pharmaceutica Nv
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Application filed by Janssen Pharmaceutica Nv filed Critical Janssen Pharmaceutica Nv
Publication of BR112018014540A2 publication Critical patent/BR112018014540A2/pt
Publication of BR112018014540B1 publication Critical patent/BR112018014540B1/pt

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    • 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
    • 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
    • A61K9/2022Organic 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • 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)
BR112018014540-8A 2016-01-19 2017-01-18 Formulações compreendendo inibidor de btk, seus usos e processo para a preparação dos mesmos BR112018014540B1 (pt)

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

Publications (2)

Publication Number Publication Date
BR112018014540A2 BR112018014540A2 (pt) 2018-12-11
BR112018014540B1 true BR112018014540B1 (pt) 2024-02-27

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
BR112018014540-8A BR112018014540B1 (pt) 2016-01-19 2017-01-18 Formulações compreendendo inibidor de btk, seus usos e processo para a preparação dos mesmos

Country Status (24)

Country Link
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

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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

Also Published As

Publication number Publication date
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
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
CN114681462A (zh) 2022-07-01
MA43650B1 (fr) 2025-09-30
RS67236B1 (sr) 2025-10-31

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