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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CN
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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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=55806565&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CN107530292(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
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)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (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

Family Applications (2)

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)

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

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US (6) US10799506B2 (enExample)
EP (3) EP4197530B1 (enExample)
JP (1) JP2018514523A (enExample)
KR (2) KR102750931B1 (enExample)
CN (2) CN107530292B (enExample)
AR (1) AR104257A1 (enExample)
AU (5) AU2016248017A1 (enExample)
BR (1) BR112017021283A2 (enExample)
CA (1) CA2982425C (enExample)
CL (1) CL2017002593A1 (enExample)
CO (1) CO2017010510A2 (enExample)
DK (1) DK3283058T3 (enExample)
EA (1) EA201792290A1 (enExample)
EC (1) ECSP17075052A (enExample)
ES (1) ES2938261T3 (enExample)
FI (1) FI3283058T3 (enExample)
HR (1) HRP20230053T1 (enExample)
HU (1) HUE061213T2 (enExample)
IL (1) IL254818A0 (enExample)
MX (1) MX2017013350A (enExample)
PE (1) PE20180035A1 (enExample)
PH (1) PH12017501820A1 (enExample)
PL (1) PL3283058T3 (enExample)
PT (1) PT3283058T (enExample)
SG (1) SG11201708084PA (enExample)
SI (1) SI3283058T1 (enExample)
TN (1) TN2017000422A1 (enExample)
TW (1) TW201642864A (enExample)
WO (1) WO2016166703A1 (enExample)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102750931B1 (ko) * 2015-04-16 2025-01-09 노파르티스 아게 리보시클립 정제
CA3048036A1 (en) 2018-07-02 2020-01-02 Apotex Inc Novel crystalline form of ribociclib succinate
CN118986983A (zh) 2019-08-26 2024-11-22 阿尔维纳斯运营股份有限公司 用四氢萘衍生物作为雌激素受体降解剂的治疗乳腺癌的方法
EP4077331A4 (en) 2019-12-16 2023-12-27 Lunella Biotech, Inc. SELECTIVE CDK4/6 INHIBITOR CANCER THERAPEUTICS
BR112022011851A2 (pt) 2019-12-16 2022-09-06 Lunella Biotech Inc Terapêutica de câncer inibidor de cdk4/6 seletivo
CA3187241A1 (en) * 2020-08-03 2022-02-10 Krishna Murthy Bhavanasi Pharmaceutical compositions comprising ribociclib
CA3191478A1 (en) * 2020-09-29 2022-04-07 Paola Yazmin Ollervides Rubio Pharmaceutical combinations of statins and fibrates for the treatment and prevention of hyperlipidemias and cardiovascular disease
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
CN117396208A (zh) 2021-07-16 2024-01-12 达纳－法伯癌症研究所公司 细胞周期蛋白依赖性激酶4/6(cdk4/6)和ikzf2(helios)的小分子降解剂及其使用方法
TWI848533B (zh) 2022-01-25 2024-07-11 瑞士商諾華公司 瑞博西尼藥物組成物
CN120112291A (zh) 2022-08-31 2025-06-06 阿尔维纳斯运营股份有限公司 雌激素受体降解剂的给药方案
EP4626890A1 (en) 2022-12-01 2025-10-08 KRKA, d.d., Novo mesto Ribociclib salts and formulations thereof
TW202440113A (zh) 2023-03-27 2024-10-16 瑞士商諾華公司 治療早期乳癌之方法
WO2025219830A1 (en) 2024-04-15 2025-10-23 Novartis Ag Pharmaceutical compositions of ribociclib

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5428812A (en) * 1977-08-09 1979-03-03 Yoshitomi Pharmaceut Ind Ltd Preparation of coated tablet
GB9414045D0 (en) 1994-07-12 1994-08-31 Berwind Pharma Service Moisture barrier film coating composition, method, and coated form
SI2331547T1 (sl) 2008-08-22 2014-11-28 Novartis Ag Pirolopirimidinske spojine kot CDK inhibitorji
US8807979B2 (en) * 2009-09-24 2014-08-19 Mcneil-Ppc, Inc. Machine for the manufacture of dosage forms utilizing radiofrequency energy
SI2673266T1 (sl) * 2011-02-11 2016-11-30 Wista Laboratories Ltd. Fenotiazin diaminijeve soli in njihova uporaba
WO2014011220A2 (en) * 2012-07-13 2014-01-16 Gtx, Inc. A method of treating androgen receptor (ar)-positive breast cancers with selective androgen receptor modulator (sarms)
MY181085A (en) * 2013-03-21 2020-12-17 Novartis Ag Combination therapy
EP2810644A1 (en) * 2013-06-06 2014-12-10 Ferrer Internacional, S.A. Oral formulation for the treatment of cardiovascular diseases
KR102750931B1 (ko) * 2015-04-16 2025-01-09 노파르티스 아게 리보시클립 정제
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

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
"欧巴代在片剂薄膜包衣中的应用";匿名;《中国医药工业杂志》;20131231;第44卷(第2期);第221页最后一段 *

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

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