AU2015305696B2 - High dosage strength tablets of rucaparib - Google Patents

High dosage strength tablets of rucaparib Download PDF

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Publication number
AU2015305696B2
AU2015305696B2 AU2015305696A AU2015305696A AU2015305696B2 AU 2015305696 B2 AU2015305696 B2 AU 2015305696B2 AU 2015305696 A AU2015305696 A AU 2015305696A AU 2015305696 A AU2015305696 A AU 2015305696A AU 2015305696 B2 AU2015305696 B2 AU 2015305696B2
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AU
Australia
Prior art keywords
tablet
rucaparib
tablet according
camsylate
active pharmaceutical
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.)
Active
Application number
AU2015305696A
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English (en)
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AU2015305696A1 (en
Inventor
Jeffrey Etter
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
pharma& Schweiz GmbH
Original Assignee
pharma& Schweiz GmbH
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 pharma& Schweiz GmbH filed Critical pharma& Schweiz GmbH
Publication of AU2015305696A1 publication Critical patent/AU2015305696A1/en
Application granted granted Critical
Publication of AU2015305696B2 publication Critical patent/AU2015305696B2/en
Priority to AU2019272064A priority Critical patent/AU2019272064B2/en
Assigned to PHARMA& SCHWEIZ GMBH reassignment PHARMA& SCHWEIZ GMBH Request for Assignment Assignors: CLOVIS ONCOLOGY, INC.
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • 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
    • A61K9/205—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
    • 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
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
AU2015305696A 2014-08-22 2015-08-17 High dosage strength tablets of rucaparib Active AU2015305696B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2019272064A AU2019272064B2 (en) 2014-08-22 2019-11-29 High dosage strength tablets of rucaparib

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201462040849P 2014-08-22 2014-08-22
US62/040,849 2014-08-22
US201562101739P 2015-01-09 2015-01-09
US62/101,739 2015-01-09
PCT/US2015/045522 WO2016028689A1 (en) 2014-08-22 2015-08-17 High dosage strength tablets of rucaparib

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2019272064A Division AU2019272064B2 (en) 2014-08-22 2019-11-29 High dosage strength tablets of rucaparib

Publications (2)

Publication Number Publication Date
AU2015305696A1 AU2015305696A1 (en) 2017-02-02
AU2015305696B2 true AU2015305696B2 (en) 2019-08-29

Family

ID=55347324

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2015305696A Active AU2015305696B2 (en) 2014-08-22 2015-08-17 High dosage strength tablets of rucaparib
AU2019272064A Active AU2019272064B2 (en) 2014-08-22 2019-11-29 High dosage strength tablets of rucaparib

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2019272064A Active AU2019272064B2 (en) 2014-08-22 2019-11-29 High dosage strength tablets of rucaparib

Country Status (24)

Country Link
US (3) US9987285B2 (enExample)
EP (1) EP3182975B1 (enExample)
JP (3) JP6574477B2 (enExample)
KR (2) KR20170043597A (enExample)
CN (2) CN106794185A (enExample)
AU (2) AU2015305696B2 (enExample)
BR (1) BR112017000865A2 (enExample)
CA (1) CA2955495C (enExample)
DK (1) DK3182975T3 (enExample)
ES (1) ES3048688T3 (enExample)
FI (1) FI3182975T3 (enExample)
HR (1) HRP20251484T1 (enExample)
IL (1) IL249946B (enExample)
LT (1) LT3182975T (enExample)
MX (1) MX367260B (enExample)
NZ (1) NZ728392A (enExample)
PL (1) PL3182975T3 (enExample)
PT (1) PT3182975T (enExample)
RS (1) RS67356B1 (enExample)
RU (1) RU2705156C2 (enExample)
SG (1) SG11201700265VA (enExample)
SI (1) SI3182975T1 (enExample)
SM (1) SMT202600141T1 (enExample)
WO (1) WO2016028689A1 (enExample)

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US12168004B2 (en) 2014-02-05 2024-12-17 Merck Sharp & Dohme Llc Treatment of migraine
US10117836B2 (en) 2014-02-05 2018-11-06 Merck Sharp & Dohme Corp. Tablet formulation for CGRP active compounds
KR20170043597A (ko) * 2014-08-22 2017-04-21 클로비스 온콜로지 인코포레이티드 루카파립의 고 용량 강도 정제
CN106008530B (zh) * 2016-07-24 2018-06-26 石家庄久正生物科技有限公司 一种抗卵巢癌药物Rucaparib关键中间体的制备方法
CN108201534A (zh) * 2016-12-16 2018-06-26 苏州苏融生物医药有限公司 一种瑞卡帕布口服缓控释药物组合物及其用途
EP3573990B1 (en) 2017-01-24 2024-07-10 Assia Chemical Industries Ltd. Solid state forms of rucaparib and of rucaparib salts
AU2018246214B2 (en) 2017-03-27 2021-07-08 Merck Sharp & Dohme Llc Niraparib compositions
CN111278433A (zh) * 2017-09-26 2020-06-12 特沙诺有限公司 尼拉帕尼制剂
WO2019130229A1 (en) 2017-12-28 2019-07-04 Mylan Laboratories Ltd Methods and intermediates for preparing rucaparib
AU2019205325A1 (en) 2018-01-05 2020-08-13 Cybrexa 1, Inc. Compounds, compositions, and methods for treatment of diseases involving acidic or hypoxic diseased tissues
US12383545B1 (en) 2018-06-08 2025-08-12 Allergan Pharmaceuticals International Limited Treatment of migraine
CN109111454A (zh) * 2018-08-01 2019-01-01 宁波金未生物科技有限公司 一种瑞卡帕布s-樟脑磺酸盐
CN108853030B (zh) * 2018-09-26 2021-10-01 上海朝晖药业有限公司 一种治疗恶性肿瘤的药物制剂及其制备方法
WO2020113500A1 (zh) * 2018-12-06 2020-06-11 上海诚妙医药科技有限公司 芦卡帕利樟脑磺酸盐的新晶型和制备方法及其用途
MX2022000449A (es) 2019-07-10 2022-04-25 Cybrexa 2 Inc Conjugados peptídicos de citotoxinas como terapéuticos.
BR112022000297A2 (pt) 2019-07-10 2022-03-15 Cybrexa 3 Inc Conjugados de peptídeos de agentes de alvo de microtúbulos como terapêuticos
KR20220035925A (ko) 2019-07-22 2022-03-22 리페어 세라퓨틱스 인크. Atr 키나제 억제제로서의 치환된 2-모르폴리노피리딘 유도체
ES3014370T3 (en) 2020-04-28 2025-04-22 Rhizen Pharmaceuticals Ag Novel compounds useful as poly(adp-ribose) polymerase (parp) inhibitors
ES3051838T3 (en) 2020-07-14 2025-12-30 Assia Chem Ind Ltd Solid state forms of rucaparib salts
MX2023001071A (es) 2020-07-29 2023-05-12 Allergan Pharmaceuticals Int Ltd Tratamiento de la migraña.
WO2022090938A1 (en) 2020-10-31 2022-05-05 Rhizen Pharmaceuticals Ag Phthalazinone derivatives useful as parp inhibitors
CA3206184A1 (en) 2020-12-22 2022-06-30 Allergan Pharmaceuticals International Limited Treatment of migraine
WO2022215034A1 (en) 2021-04-08 2022-10-13 Rhizen Pharmaceuticals Ag Inhibitors of poly(adp-ribose) polymerase
JP2024533756A (ja) 2021-09-27 2024-09-12 アラガン ファーマスーティカルズ インターナショナル リミテッド アトゲパントを含む片頭痛の併用療法
CN118215467A (zh) * 2021-11-10 2024-06-18 克里蒂泰克公司 鲁卡帕尼颗粒及其用途
WO2023137060A1 (en) 2022-01-11 2023-07-20 Assia Chemical Industries Ltd. Solid state forms of rucaparib tosylate

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US20120302550A1 (en) * 2010-02-12 2012-11-29 Pfizer Inc. Salts and polymorphs of 8-fluoro-2--1,3,4,5-tetrahydro-6h-azepino[5,4,3-cd]indol-6-one

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JP2006522088A (ja) 2003-03-31 2006-09-28 ファイザー・インク ポリ(adp−リボース)ポリメラーゼの三環系阻害剤の塩
MXPA06000993A (es) 2003-07-25 2006-08-31 Cancer Rec Tech Ltd Inhbidores triciclicos de parp.
JP2008513435A (ja) 2004-09-22 2008-05-01 ファイザー・インク ポリ(adp−リボース)ポリメラーゼ阻害剤を含む治療用組成物
CA2580833C (en) 2004-09-22 2010-12-21 Pfizer, Inc. Method of preparing poly(adp-ribose) polymerases inhibitors
CA2581025C (en) 2004-09-22 2011-06-07 Pfizer Inc. Polymorphic and amorphous forms of the phosphate salt of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6h-azepino[5,4,3-cd]indol-6-one
US20110136883A1 (en) * 2008-04-09 2011-06-09 Lek Pharmaceuticals D.D. Granulation of active pharmaceutical ingredients
CN104582795B (zh) 2012-04-05 2018-04-20 沃泰克斯药物股份有限公司 可用作atr激酶抑制剂的化合物及其组合疗法
KR20170043597A (ko) 2014-08-22 2017-04-21 클로비스 온콜로지 인코포레이티드 루카파립의 고 용량 강도 정제

Patent Citations (1)

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US20120302550A1 (en) * 2010-02-12 2012-11-29 Pfizer Inc. Salts and polymorphs of 8-fluoro-2--1,3,4,5-tetrahydro-6h-azepino[5,4,3-cd]indol-6-one

Non-Patent Citations (1)

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Also Published As

Publication number Publication date
SG11201700265VA (en) 2017-02-27
US20160051561A1 (en) 2016-02-25
AU2019272064A1 (en) 2019-12-19
NZ728392A (en) 2023-06-30
PT3182975T (pt) 2025-10-28
RU2017109139A3 (enExample) 2019-03-06
SMT202600141T1 (it) 2026-05-12
BR112017000865A2 (pt) 2017-12-05
EP3182975A1 (en) 2017-06-28
JP6574477B2 (ja) 2019-09-11
CA2955495A1 (en) 2016-02-25
FI3182975T3 (fi) 2025-11-13
KR20170043597A (ko) 2017-04-21
CN113209033A (zh) 2021-08-06
DK3182975T3 (da) 2025-10-20
US10130636B2 (en) 2018-11-20
EP3182975A4 (en) 2018-04-18
SI3182975T1 (sl) 2025-12-31
IL249946A0 (en) 2017-03-30
JP6797980B2 (ja) 2020-12-09
AU2015305696A1 (en) 2017-02-02
US20190099430A1 (en) 2019-04-04
US20180200260A1 (en) 2018-07-19
HRP20251484T1 (hr) 2026-01-02
JP2021038242A (ja) 2021-03-11
EP3182975B1 (en) 2025-10-01
LT3182975T (lt) 2025-11-25
AU2019272064B2 (en) 2021-11-18
IL249946B (en) 2020-05-31
JP2017525712A (ja) 2017-09-07
MX2017001540A (es) 2017-05-11
RS67356B1 (sr) 2025-11-28
JP7127101B2 (ja) 2022-08-29
CN106794185A (zh) 2017-05-31
MX367260B (es) 2019-08-12
JP2020002149A (ja) 2020-01-09
RU2017109139A (ru) 2018-09-24
US9987285B2 (en) 2018-06-05
KR102803917B1 (ko) 2025-05-07
RU2705156C2 (ru) 2019-11-05
CA2955495C (en) 2023-09-19
KR20230097211A (ko) 2023-06-30
ES3048688T3 (en) 2025-12-11
PL3182975T3 (pl) 2026-02-23
WO2016028689A1 (en) 2016-02-25

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PC Assignment registered

Owner name: PHARMA& SCHWEIZ GMBH

Free format text: FORMER OWNER(S): CLOVIS ONCOLOGY, INC.