CN107530292B - 瑞博西尼片剂 - Google Patents

瑞博西尼片剂 Download PDF

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Publication number
CN107530292B
CN107530292B CN201680022122.8A CN201680022122A CN107530292B CN 107530292 B CN107530292 B CN 107530292B CN 201680022122 A CN201680022122 A CN 201680022122A CN 107530292 B CN107530292 B CN 107530292B
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China
Prior art keywords
tablet
ribociclib
crospovidone
iii
silicon dioxide
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CN201680022122.8A
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English (en)
Chinese (zh)
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CN107530292A (zh
Inventor
B·古鲁拉杨
A·格兰德瑞
R·柯斯塔
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Novartis AG
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Novartis AG
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Application filed by Novartis AG filed Critical Novartis AG
Priority to CN202211237232.XA priority Critical patent/CN115554257A/zh
Publication of CN107530292A publication Critical patent/CN107530292A/zh
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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
    • 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
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • 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
    • A61K9/2022—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
    • A61K9/20—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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CN201680022122.8A 2015-04-16 2016-04-14 瑞博西尼片剂 Active CN107530292B (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202211237232.XA CN115554257A (zh) 2015-04-16 2016-04-14 瑞博西尼片剂

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562148240P 2015-04-16 2015-04-16
US62/148,240 2015-04-16
PCT/IB2016/052136 WO2016166703A1 (en) 2015-04-16 2016-04-14 Ribociclib tablet

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CN202211237232.XA Division CN115554257A (zh) 2015-04-16 2016-04-14 瑞博西尼片剂

Publications (2)

Publication Number Publication Date
CN107530292A CN107530292A (zh) 2018-01-02
CN107530292B true CN107530292B (zh) 2022-11-01

Family

ID=55806565

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Application Number Title Priority Date Filing Date
CN201680022122.8A Active CN107530292B (zh) 2015-04-16 2016-04-14 瑞博西尼片剂
CN202211237232.XA Pending CN115554257A (zh) 2015-04-16 2016-04-14 瑞博西尼片剂

Family Applications After (1)

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US (6) US10799506B2 (cg-RX-API-DMAC7.html)
EP (3) EP3283058B1 (cg-RX-API-DMAC7.html)
JP (1) JP2018514523A (cg-RX-API-DMAC7.html)
KR (2) KR20250009572A (cg-RX-API-DMAC7.html)
CN (2) CN107530292B (cg-RX-API-DMAC7.html)
AR (1) AR104257A1 (cg-RX-API-DMAC7.html)
AU (5) AU2016248017A1 (cg-RX-API-DMAC7.html)
BR (1) BR112017021283A2 (cg-RX-API-DMAC7.html)
CA (1) CA2982425C (cg-RX-API-DMAC7.html)
CL (1) CL2017002593A1 (cg-RX-API-DMAC7.html)
CO (1) CO2017010510A2 (cg-RX-API-DMAC7.html)
DK (1) DK3283058T3 (cg-RX-API-DMAC7.html)
EA (1) EA201792290A1 (cg-RX-API-DMAC7.html)
EC (1) ECSP17075052A (cg-RX-API-DMAC7.html)
ES (1) ES2938261T3 (cg-RX-API-DMAC7.html)
FI (1) FI3283058T3 (cg-RX-API-DMAC7.html)
HR (1) HRP20230053T1 (cg-RX-API-DMAC7.html)
HU (1) HUE061213T2 (cg-RX-API-DMAC7.html)
IL (1) IL254818A0 (cg-RX-API-DMAC7.html)
MX (1) MX2017013350A (cg-RX-API-DMAC7.html)
PE (1) PE20180035A1 (cg-RX-API-DMAC7.html)
PH (1) PH12017501820A1 (cg-RX-API-DMAC7.html)
PL (1) PL3283058T3 (cg-RX-API-DMAC7.html)
PT (1) PT3283058T (cg-RX-API-DMAC7.html)
SG (1) SG11201708084PA (cg-RX-API-DMAC7.html)
SI (1) SI3283058T1 (cg-RX-API-DMAC7.html)
TN (1) TN2017000422A1 (cg-RX-API-DMAC7.html)
TW (1) TW201642864A (cg-RX-API-DMAC7.html)
WO (1) WO2016166703A1 (cg-RX-API-DMAC7.html)

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HUE061213T2 (hu) * 2015-04-16 2023-05-28 Novartis Ag Ribociklib tabletta
CA3048036A1 (en) 2018-07-02 2020-01-02 Apotex Inc Novel crystalline form of ribociclib succinate
MX2022002415A (es) 2019-08-26 2022-03-22 Arvinas Operations Inc Metodos de tratamiento del cancer de mama con derivados de tetrahidronaftaleno como degradadores del receptor de estrogenos.
CA3164619A1 (en) 2019-12-16 2021-06-24 Lunella Biotech, Inc. Selective cdk4/6 inhibitor cancer therapeutics
JP7681599B2 (ja) 2019-12-16 2025-05-22 ルネラ・バイオテック・インコーポレーテッド 選択的ｃｄｋ４／６阻害剤のがん治療薬
WO2022029798A1 (en) * 2020-08-03 2022-02-10 Natco Pharma Limited Pharmaceutical compositions comprising ribociclib
KR20230079187A (ko) * 2020-09-29 2023-06-05 라보라토리오스 실레인즈, 에스.에이. 드 씨.브이. 고지혈증 및 심혈관 질환의 치료 및 예방을 위한 스타틴 및 피브레이트의 약학적 병용
WO2022162122A1 (en) 2021-01-29 2022-08-04 Biotx.Ai Gmbh Genetically verified netosis inhibitor for use in the treatment of a sars-cov2 infection
EP4370126A4 (en) 2021-07-16 2025-05-28 Dana-Farber Cancer Institute, Inc. Small molecule cyclin dependent kinase 4/6 (cdk4/6) and ikzf2 (helios) degraders and methods of use thereof
TWI848533B (zh) 2022-01-25 2024-07-11 瑞士商諾華公司 瑞博西尼藥物組成物
CA3266061A1 (en) 2022-08-31 2024-03-07 Arvinas Operations, Inc. DOSING REGIMEN BASED ON ESTROGEN RECEPTOR DEGRADING AGENTS
WO2024115680A1 (en) 2022-12-01 2024-06-06 Krka, D.D., Novo Mesto Ribociclib salts and formulations thereof
WO2024201299A1 (en) 2023-03-27 2024-10-03 Novartis Ag Method of treating early breast cancer with ribociclib in combination with an aromatase inhibitor
US20250319032A1 (en) 2024-04-15 2025-10-16 Novartis Ag Pharmaceutical compositions of ribociclib

Citations (5)

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CN1157002A (zh) * 1994-07-12 1997-08-13 伯温德药品服务公司 隔潮膜涂层组合物及其生产方法以及涂层制品
CN1360612A (zh) * 1999-07-09 2002-07-24 伯温德药品服务公司 基于聚乙烯醇的涂膜和涂膜组合物
WO2012064805A1 (en) * 2010-11-10 2012-05-18 Novartis Ag Salt(s) of 7-cyclopentyl-2 -(5-piperazin-1-yl-pyridin-2-ylamino)-7h-pyrrolo[2,3-d]pyrimidine-6-carboxylic acid dimethylamide and processes of making thereof
EP2742940A1 (en) * 2012-12-13 2014-06-18 IP Gesellschaft für Management mbH Salts of aza-bicyclo-di-aryl ethers for adminstration once daily, twice daily or thrice daily
WO2014097125A1 (en) * 2012-12-20 2014-06-26 Novartis Ag Pharmaceutical combination comprising binimetinib

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GB9414045D0 (en) 1994-07-12 1994-08-31 Berwind Pharma Service Moisture barrier film coating composition, method, and coated form
EP2331547B1 (en) 2008-08-22 2014-07-30 Novartis AG Pyrrolopyrimidine compounds as cdk inhibitors
US8871263B2 (en) * 2009-09-24 2014-10-28 Mcneil-Ppc, Inc. Manufacture of tablet in a die utilizing radiofrequency energy and meltable binder
JP5898701B2 (ja) * 2011-02-11 2016-04-13 ウィスタ ラボラトリーズ リミテッド フェノチアジンジアミニウム塩およびそれらの使用
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HUE061213T2 (hu) * 2015-04-16 2023-05-28 Novartis Ag Ribociklib tabletta
CN109953966A (zh) * 2017-12-26 2019-07-02 天津耀辰实业发展有限公司 一种含有瑞博西尼的药物组合物及其制备方法
JP7347388B2 (ja) 2020-09-25 2023-09-20 信越化学工業株式会社 紫外線硬化型有機変性シリコーン組成物および硬化物

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CN1157002A (zh) * 1994-07-12 1997-08-13 伯温德药品服务公司 隔潮膜涂层组合物及其生产方法以及涂层制品
CN1360612A (zh) * 1999-07-09 2002-07-24 伯温德药品服务公司 基于聚乙烯醇的涂膜和涂膜组合物
WO2012064805A1 (en) * 2010-11-10 2012-05-18 Novartis Ag Salt(s) of 7-cyclopentyl-2 -(5-piperazin-1-yl-pyridin-2-ylamino)-7h-pyrrolo[2,3-d]pyrimidine-6-carboxylic acid dimethylamide and processes of making thereof
EP2742940A1 (en) * 2012-12-13 2014-06-18 IP Gesellschaft für Management mbH Salts of aza-bicyclo-di-aryl ethers for adminstration once daily, twice daily or thrice daily
WO2014097125A1 (en) * 2012-12-20 2014-06-26 Novartis Ag Pharmaceutical combination comprising binimetinib

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Also Published As

Publication number Publication date
CL2017002593A1 (es) 2018-05-18
WO2016166703A1 (en) 2016-10-20
US12064434B2 (en) 2024-08-20
US20250090531A1 (en) 2025-03-20
JP2018514523A (ja) 2018-06-07
EP3283058A1 (en) 2018-02-21
AU2022215155A1 (en) 2022-09-01
AU2016248017A1 (en) 2017-10-19
AU2020250190A1 (en) 2020-11-05
US20250134893A1 (en) 2025-05-01
EP4620458A3 (en) 2025-10-22
DK3283058T3 (da) 2023-02-13
MX2017013350A (es) 2018-01-25
EP4197530B1 (en) 2025-11-12
SI3283058T1 (sl) 2023-03-31
ES2938261T3 (es) 2023-04-05
AU2019201929A1 (en) 2019-04-11
AU2019201929B2 (en) 2020-07-09
CA2982425A1 (en) 2016-10-20
HUE061213T2 (hu) 2023-05-28
KR20170137101A (ko) 2017-12-12
US10799506B2 (en) 2020-10-13
PL3283058T3 (pl) 2023-03-20
US20200390771A1 (en) 2020-12-17
AU2024227794A1 (en) 2024-11-21
PE20180035A1 (es) 2018-01-09
ECSP17075052A (es) 2018-02-28
CN115554257A (zh) 2023-01-03
EP3283058B1 (en) 2022-11-16
EP4197530A1 (en) 2023-06-21
KR102750931B1 (ko) 2025-01-09
TW201642864A (zh) 2016-12-16
HRP20230053T1 (hr) 2023-03-03
CN107530292A (zh) 2018-01-02
IL254818A0 (en) 2017-12-31
CA2982425C (en) 2023-10-31
PH12017501820A1 (en) 2018-04-23
TN2017000422A1 (en) 2019-01-16
US12419894B2 (en) 2025-09-23
US20180071292A1 (en) 2018-03-15
EP4620458A2 (en) 2025-09-24
AR104257A1 (es) 2017-07-05
EA201792290A1 (ru) 2018-02-28
BR112017021283A2 (pt) 2018-06-26
AU2022215155B2 (en) 2024-08-01
PT3283058T (pt) 2023-02-03
FI3283058T3 (fi) 2023-03-01
US20250127785A1 (en) 2025-04-24
CO2017010510A2 (es) 2018-03-20
SG11201708084PA (en) 2017-10-30
US20230104792A1 (en) 2023-04-06
KR20250009572A (ko) 2025-01-17

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