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CO2017010510A2 - Tableta de ribociclib - Google Patents

Tableta de ribociclib

Info

Publication number
CO2017010510A2
CO2017010510A2 CONC2017/0010510A CO2017010510A CO2017010510A2 CO 2017010510 A2 CO2017010510 A2 CO 2017010510A2 CO 2017010510 A CO2017010510 A CO 2017010510A CO 2017010510 A2 CO2017010510 A2 CO 2017010510A2
Authority
CO
Colombia
Prior art keywords
ribociclib
tablet
coating
present disclosure
coated
Prior art date
Application number
CONC2017/0010510A
Other languages
English (en)
Inventor
Bindhumadhavan Gururajan
Arnaud Grandeury
Rui Costa
Original Assignee
Novartis Ag
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
Family has litigation
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=CO2017010510(A2) "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
Publication of CO2017010510A2 publication Critical patent/CO2017010510A2/es

Links

Classifications

    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • 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
    • A61K31/496Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • 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
    • A61K9/2022Organic 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
    • 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
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/2072Pills, 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
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • 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)

Abstract

La presente descripción esta dirigida al comprimido oral de ribociclib incluyendo su(s) sal(es). Una forma de realización de la presente descripción se dirige al comprimido de ribociclib con alta carga de fármaco con un perfil de liberación inmediata. Una realización de la presente descripción se refiere a un comprimido de ribociclib recubierto. Otra realización de la presente descripción se refiere a un comprimido de ribociclib recubierto donde el revestimiento es una avanzada barrera contra la humedad (por ejemplo, el recubrimiento Opadry® amb II donde el recubrimiento se basa en PVA).
CONC2017/0010510A 2015-04-16 2017-10-13 Tableta de ribociclib CO2017010510A2 (es)

Applications Claiming Priority (2)

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

Publications (1)

Publication Number Publication Date
CO2017010510A2 true CO2017010510A2 (es) 2018-03-20

Family

ID=55806565

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2017/0010510A CO2017010510A2 (es) 2015-04-16 2017-10-13 Tableta de ribociclib

Country Status (29)

Country Link
US (3) US10799506B2 (es)
EP (2) EP4197530A1 (es)
JP (1) JP2018514523A (es)
KR (1) KR20170137101A (es)
CN (2) CN107530292B (es)
AR (1) AR104257A1 (es)
AU (5) AU2016248017A1 (es)
BR (1) BR112017021283A2 (es)
CA (1) CA2982425C (es)
CL (1) CL2017002593A1 (es)
CO (1) CO2017010510A2 (es)
DK (1) DK3283058T3 (es)
EA (1) EA201792290A1 (es)
EC (1) ECSP17075052A (es)
ES (1) ES2938261T3 (es)
FI (1) FI3283058T3 (es)
HR (1) HRP20230053T1 (es)
HU (1) HUE061213T2 (es)
IL (1) IL254818A0 (es)
MX (1) MX2017013350A (es)
PE (1) PE20180035A1 (es)
PH (1) PH12017501820A1 (es)
PL (1) PL3283058T3 (es)
PT (1) PT3283058T (es)
SG (1) SG11201708084PA (es)
SI (1) SI3283058T1 (es)
TN (1) TN2017000422A1 (es)
TW (1) TW201642864A (es)
WO (1) WO2016166703A1 (es)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FI3283058T3 (fi) * 2015-04-16 2023-03-01 Novartis Ag Ribosiklibitabletti
CA3048036A1 (en) 2018-07-02 2020-01-02 Apotex Inc Novel crystalline form of ribociclib succinate
WO2021124104A1 (en) 2019-12-16 2021-06-24 Lunella Biotech, Inc. Selective cdk4/6 inhibitor cancer therapeutics
IL293940A (en) 2019-12-16 2022-08-01 Lunella Biotech Inc Selective cancer drugs cdk4/6 inhibitors
WO2022029798A1 (en) * 2020-08-03 2022-02-10 Natco Pharma Limited Pharmaceutical compositions comprising ribociclib
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
TWI848533B (zh) 2022-01-25 2024-07-11 瑞士商諾華公司 瑞博西尼藥物組成物
TW202416991A (zh) 2022-08-31 2024-05-01 美商亞文納營運公司 雌激素受體降解劑之給藥方案
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

Family Cites Families (15)

* 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
CZ297271B6 (cs) * 1994-07-12 2006-10-11 Bpsi Holdings, Inc. Suchá povlaková hmota pro výrobu filmu zabranujícímu prístupu vlhkosti, zpusob a tvorba povlaku
US6448323B1 (en) * 1999-07-09 2002-09-10 Bpsi Holdings, Inc. Film coatings and film coating compositions based on polyvinyl alcohol
RS53574B1 (en) 2008-08-22 2015-02-27 Novartis Ag PYROLOPYRIMIDINE COMPOUNDS AS CDK INHIBITORS
US20120115878A1 (en) 2010-11-10 2012-05-10 John Vincent Calienni 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
BR112013020539A2 (pt) * 2011-02-11 2017-09-26 Wista Lab Ltd sais de diamínio fenotiazina e seu uso
RU2648959C2 (ru) * 2012-07-13 2018-03-28 Джи Ти Икс, ИНК. Способ лечения андроген-рецептора(ar)-положительных форм рака молочной железы с использованием селективных модуляторов андрогенных рецепторов(sarm)
EP2742940B1 (en) 2012-12-13 2017-07-26 IP Gesellschaft für Management mbH Fumarate salt of (R)-3-(6-(4-methylphenyl)-pyridin-3-yloxy)-l-aza-bicyclo-[2.2.2]octane for adminstration once daily, twice daily or thrice daily
EP2934515B1 (en) * 2012-12-20 2018-04-04 Novartis AG A pharmaceutical combination comprising binimetinib
WO2014147573A2 (en) * 2013-03-21 2014-09-25 Novartis Ag Combination therapy
EP2810644A1 (en) * 2013-06-06 2014-12-10 Ferrer Internacional, S.A. Oral formulation for the treatment of cardiovascular diseases
FI3283058T3 (fi) 2015-04-16 2023-03-01 Novartis Ag Ribosiklibitabletti
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

Also Published As

Publication number Publication date
PE20180035A1 (es) 2018-01-09
EP3283058B1 (en) 2022-11-16
ECSP17075052A (es) 2018-02-28
US10799506B2 (en) 2020-10-13
US20180071292A1 (en) 2018-03-15
EP3283058A1 (en) 2018-02-21
PH12017501820A1 (en) 2018-04-23
AU2016248017A1 (en) 2017-10-19
US12064434B2 (en) 2024-08-20
AU2022215155B2 (en) 2024-08-01
TW201642864A (zh) 2016-12-16
CN107530292B (zh) 2022-11-01
ES2938261T3 (es) 2023-04-05
US20200390771A1 (en) 2020-12-17
JP2018514523A (ja) 2018-06-07
AU2019201929A1 (en) 2019-04-11
CL2017002593A1 (es) 2018-05-18
EA201792290A1 (ru) 2018-02-28
AU2022215155A1 (en) 2022-09-01
IL254818A0 (en) 2017-12-31
CA2982425A1 (en) 2016-10-20
HUE061213T2 (hu) 2023-05-28
DK3283058T3 (da) 2023-02-13
SG11201708084PA (en) 2017-10-30
CA2982425C (en) 2023-10-31
BR112017021283A2 (pt) 2018-06-26
PL3283058T3 (pl) 2023-03-20
AU2019201929B2 (en) 2020-07-09
HRP20230053T1 (hr) 2023-03-03
EP4197530A1 (en) 2023-06-21
WO2016166703A1 (en) 2016-10-20
KR20170137101A (ko) 2017-12-12
SI3283058T1 (sl) 2023-03-31
TN2017000422A1 (en) 2019-01-16
AU2020250190A1 (en) 2020-11-05
CN107530292A (zh) 2018-01-02
PT3283058T (pt) 2023-02-03
AR104257A1 (es) 2017-07-05
US20230104792A1 (en) 2023-04-06
CN115554257A (zh) 2023-01-03
MX2017013350A (es) 2018-01-25
AU2024227794A1 (en) 2024-11-21
FI3283058T3 (fi) 2023-03-01

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