AU2017208472B2 - Formulations/compositions comprising a BTK inhibitor - Google Patents

Formulations/compositions comprising a BTK inhibitor Download PDF

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Publication number
AU2017208472B2
AU2017208472B2 AU2017208472A AU2017208472A AU2017208472B2 AU 2017208472 B2 AU2017208472 B2 AU 2017208472B2 AU 2017208472 A AU2017208472 A AU 2017208472A AU 2017208472 A AU2017208472 A AU 2017208472A AU 2017208472 B2 AU2017208472 B2 AU 2017208472B2
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AU
Australia
Prior art keywords
tablet formulation
solid tablet
load solid
ibrutinib
crospovidone
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AU2017208472A
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English (en)
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AU2017208472A1 (en
Inventor
Manish Kumar Gupta
Binuraj KRISHNAN NAIR
Parikshit Rameshrao Kulkarni
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Janssen Pharmaceutica NV
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Janssen Pharmaceutica NV
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Publication of AU2017208472A1 publication Critical patent/AU2017208472A1/en
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Publication of AU2017208472B2 publication Critical patent/AU2017208472B2/en
Priority to AU2022275514A priority Critical patent/AU2022275514A1/en
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Anticipated expiration legal-status Critical

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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
    • A61K9/2022—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
    • 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
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • 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
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • 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
    • A61P35/00—Antineoplastic agents
    • A61P35/04—Antineoplastic agents specific for metastasis
    • 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
    • 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
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Rheumatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Immunology (AREA)
  • Inorganic Chemistry (AREA)
  • Oncology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Hematology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Obesity (AREA)
  • Diabetes (AREA)
  • Child & Adolescent Psychology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
AU2017208472A 2016-01-19 2017-01-18 Formulations/compositions comprising a BTK inhibitor Active AU2017208472B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2022275514A AU2022275514A1 (en) 2016-01-19 2022-11-25 Formulations/compositions comprising a BTK inhibitor

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN201621001986 2016-01-19
IN201621001986 2016-01-19
PCT/EP2017/050962 WO2017125423A1 (en) 2016-01-19 2017-01-18 Formulations/compositions comprising a btk inhibitor

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2022275514A Division AU2022275514A1 (en) 2016-01-19 2022-11-25 Formulations/compositions comprising a BTK inhibitor

Publications (2)

Publication Number Publication Date
AU2017208472A1 AU2017208472A1 (en) 2018-07-05
AU2017208472B2 true AU2017208472B2 (en) 2022-09-01

Family

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Family Applications (2)

Application Number Title Priority Date Filing Date
AU2017208472A Active AU2017208472B2 (en) 2016-01-19 2017-01-18 Formulations/compositions comprising a BTK inhibitor
AU2022275514A Abandoned AU2022275514A1 (en) 2016-01-19 2022-11-25 Formulations/compositions comprising a BTK inhibitor

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2022275514A Abandoned AU2022275514A1 (en) 2016-01-19 2022-11-25 Formulations/compositions comprising a BTK inhibitor

Country Status (23)

Country Link
US (2) US20190282577A1 (cg-RX-API-DMAC10.html)
EP (1) EP3405177B1 (cg-RX-API-DMAC10.html)
JP (3) JP7109365B2 (cg-RX-API-DMAC10.html)
KR (2) KR102974264B1 (cg-RX-API-DMAC10.html)
CN (2) CN108472259A (cg-RX-API-DMAC10.html)
AR (1) AR107391A1 (cg-RX-API-DMAC10.html)
AU (2) AU2017208472B2 (cg-RX-API-DMAC10.html)
BR (1) BR112018014590A2 (cg-RX-API-DMAC10.html)
DK (1) DK3405177T3 (cg-RX-API-DMAC10.html)
EA (1) EA201891440A1 (cg-RX-API-DMAC10.html)
ES (1) ES3071000T3 (cg-RX-API-DMAC10.html)
FI (1) FI3405177T3 (cg-RX-API-DMAC10.html)
HK (2) HK1259440A1 (cg-RX-API-DMAC10.html)
HR (1) HRP20260680T1 (cg-RX-API-DMAC10.html)
LT (1) LT3405177T (cg-RX-API-DMAC10.html)
MA (1) MA43649B1 (cg-RX-API-DMAC10.html)
MX (3) MX2018008771A (cg-RX-API-DMAC10.html)
PL (1) PL3405177T3 (cg-RX-API-DMAC10.html)
PT (1) PT3405177T (cg-RX-API-DMAC10.html)
RS (1) RS68165B1 (cg-RX-API-DMAC10.html)
SM (1) SMT202600226T1 (cg-RX-API-DMAC10.html)
TW (1) TWI803454B (cg-RX-API-DMAC10.html)
WO (1) WO2017125423A1 (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
TWI794171B (zh) 2016-05-11 2023-03-01 美商滬亞生物國際有限公司 Ｈｄａｃ抑制劑與ｐｄ-ｌ１抑制劑之組合治療
TWI808055B (zh) 2016-05-11 2023-07-11 美商滬亞生物國際有限公司 Hdac 抑制劑與 pd-1 抑制劑之組合治療
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
CN111278433A (zh) 2017-09-26 2020-06-12 特沙诺有限公司 尼拉帕尼制剂
US11576917B2 (en) 2018-01-20 2023-02-14 Natco Pharma Limited Pharmaceutical compositions comprising 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
CN117064862B (zh) * 2023-04-10 2025-12-19 山东新时代药业有限公司 一种伊布替尼肠溶片及其制备方法

Citations (3)

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US20140336203A1 (en) * 2012-06-04 2014-11-13 Pharmacyclics, Inc. Crystalline forms of a bruton's tyrosine kinase inhibitor
WO2016141068A1 (en) * 2015-03-03 2016-09-09 Pharmacyclics Llc Pharmaceutical formulations of bruton's tyrosine kinase inhibtor

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US20140336203A1 (en) * 2012-06-04 2014-11-13 Pharmacyclics, Inc. Crystalline forms of a bruton's tyrosine kinase inhibitor
WO2014004707A1 (en) * 2012-06-29 2014-01-03 Principia Biopharma Inc. Formulations comprising ibrutinib
WO2016141068A1 (en) * 2015-03-03 2016-09-09 Pharmacyclics Llc Pharmaceutical formulations of bruton's tyrosine kinase inhibtor

Also Published As

Publication number Publication date
HK1259434A1 (zh) 2019-11-29
BR112018014590A2 (en) 2018-12-11
MX2022006768A (es) 2022-06-17
JP2019506387A (ja) 2019-03-07
LT3405177T (lt) 2026-06-25
MA43649B1 (fr) 2026-05-26
JP2022105009A (ja) 2022-07-12
RS68165B1 (sr) 2026-06-30
US20190282577A1 (en) 2019-09-19
CN108472259A (zh) 2018-08-31
AR107391A1 (es) 2018-04-25
HRP20260680T1 (hr) 2026-07-17
AU2017208472A1 (en) 2018-07-05
EP3405177B1 (en) 2026-03-11
WO2017125423A1 (en) 2017-07-27
TW201731513A (zh) 2017-09-16
DK3405177T3 (da) 2026-05-26
KR20260093426A (ko) 2026-06-19
AU2022275514A1 (en) 2023-01-05
KR20180101521A (ko) 2018-09-12
ES3071000T3 (en) 2026-06-18
JP2024023184A (ja) 2024-02-21
FI3405177T3 (fi) 2026-06-03
MX2024009894A (es) 2024-09-10
CA3008338A1 (en) 2017-07-27
EP3405177A1 (en) 2018-11-28
TWI803454B (zh) 2023-06-01
US20220339157A1 (en) 2022-10-27
CN122097373A (zh) 2026-05-29
KR102974264B1 (ko) 2026-06-05
EA201891440A1 (ru) 2018-12-28
HK1259440A1 (zh) 2019-11-29
JP7887878B2 (ja) 2026-07-10
PL3405177T3 (pl) 2026-06-29
MA43649A (fr) 2018-11-28
PT3405177T (pt) 2026-06-12
JP7109365B2 (ja) 2022-07-29
SMT202600226T1 (it) 2026-07-16
MX2018008771A (es) 2018-11-09

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