ECSP17075052A - Tableta de Ribociclib - Google Patents

Tableta de Ribociclib

Info

Publication number
ECSP17075052A
ECSP17075052A ECIEPI201775052A ECPI201775052A ECSP17075052A EC SP17075052 A ECSP17075052 A EC SP17075052A EC IEPI201775052 A ECIEPI201775052 A EC IEPI201775052A EC PI201775052 A ECPI201775052 A EC PI201775052A EC SP17075052 A ECSP17075052 A EC SP17075052A
Authority
EC
Ecuador
Prior art keywords
ribociclib
tablet
coating
present disclosure
coated
Prior art date
Application number
ECIEPI201775052A
Other languages
English (en)
Inventor
Grandeury Arnaud
Gururajan Bindhumadhavan
Costa Rui
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=ECSP17075052(A) "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 ECSP17075052A publication Critical patent/ECSP17075052A/es

Links

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
    • A61K31/495—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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (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).
ECIEPI201775052A 2015-04-16 2017-11-10 Tableta de Ribociclib ECSP17075052A (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201562148240P 2015-04-16 2015-04-16

Publications (1)

Publication Number Publication Date
ECSP17075052A true ECSP17075052A (es) 2018-02-28

Family

ID=55806565

Family Applications (1)

Application Number Title Priority Date Filing Date
ECIEPI201775052A ECSP17075052A (es) 2015-04-16 2017-11-10 Tableta de Ribociclib

Country Status (31)

Country Link
US (6) US10799506B2 (es)
EP (3) EP3283058B1 (es)
JP (1) JP2018514523A (es)
KR (2) KR102750931B1 (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 (2) DK4197530T3 (es)
EA (1) EA201792290A1 (es)
EC (1) ECSP17075052A (es)
ES (2) ES2938261T3 (es)
FI (2) FI4197530T3 (es)
HR (2) HRP20230053T1 (es)
HU (1) HUE061213T2 (es)
IL (2) IL254818B1 (es)
LT (1) LT4197530T (es)
MX (1) MX2017013350A (es)
PE (1) PE20180035A1 (es)
PH (1) PH12017501820A1 (es)
PL (2) PL4197530T3 (es)
PT (2) PT4197530T (es)
RS (1) RS67697B1 (es)
SG (1) SG11201708084PA (es)
SI (2) SI4197530T1 (es)
TN (1) TN2017000422A1 (es)
TW (1) TW201642864A (es)
WO (1) WO2016166703A1 (es)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4772247A2 (en) 2013-08-14 2026-07-08 Novartis AG Combination therapy comprising ribociclib and fulvestrant for the treatment of cancer
SI4197530T1 (sl) * 2015-04-16 2026-03-31 Novartis Ag Tableta ribocikliba
CA3048036A1 (en) 2018-07-02 2020-01-02 Apotex Inc Crystalline form of ribociclib succinate
WO2021041348A1 (en) 2019-08-26 2021-03-04 Arvinas Operations, Inc. Methods of treating breast cancer with tetrahydronaphthalene derivatives as estrogen receptor degraders
IL293940B2 (en) 2019-12-16 2026-05-01 Lunella Biotech Inc Selective cancer drugs CDK4/6 inhibitors
EP4077325B1 (en) 2019-12-16 2026-03-11 Lunella Biotech, Inc. Selective cdk4/6 inhibitor cancer therapeutics
WO2022029798A1 (en) * 2020-08-03 2022-02-10 Natco Pharma Limited Pharmaceutical compositions comprising ribociclib
MX2022015336A (es) * 2020-09-29 2023-01-11 Laboratorios Silanes S A De C V Combinaciones farmaceuticas de estatinas y fibratos para el tratamiento y prevencion de hiperlipidemias y enfermedades cardiovasculares.
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
TWI908143B (zh) 2022-01-25 2025-12-11 瑞士商諾華公司 瑞博西尼藥物組成物用於治療癌症之用途
WO2024049926A1 (en) 2022-08-31 2024-03-07 Arvinas Operations, Inc. Dosage regimens of estrogen receptor degraders
EP4626890A1 (en) 2022-12-01 2025-10-08 KRKA, d.d., Novo mesto Ribociclib salts and formulations thereof
JP2026513185A (ja) 2023-03-27 2026-04-23 ノバルティス アーゲー アロマターゼ阻害薬との組み合わせでのリボシクリブによる早期乳癌の治療方法
US20250319032A1 (en) 2024-04-15 2025-10-16 Novartis Ag Pharmaceutical compositions of ribociclib
WO2026128391A1 (en) 2024-12-09 2026-06-18 Arvinas Operations, Inc. Combinations of vepdegestrant and cdk4/6 inhibitors for treating esr1-mutant breast cancer

Family Cites Families (17)

* 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
EP0771339B1 (en) * 1994-07-12 2003-10-15 BPSI Holdings, Inc. Dry moisture barrier film coating composition, method of coating substrates using the same and pharmaceutical tablets coated therewith
US6448323B1 (en) * 1999-07-09 2002-09-10 Bpsi Holdings, Inc. Film coatings and film coating compositions based on polyvinyl alcohol
AU2009284098B2 (en) 2008-08-22 2012-03-29 Astex Therapeutics Ltd. Pyrrolopyrimidine compounds as CDK inhibitors
US8784781B2 (en) * 2009-09-24 2014-07-22 Mcneil-Ppc, Inc. Manufacture of chewing gum product with radiofrequency
CU20090172A7 (es) * 2009-10-09 2011-10-05 Ct De Investigación Y Desarrollo De Medicamentos Sistemas tricíclicos y tetracíclicos con actividad sobre el sistema nervioso central y vascular
AR083797A1 (es) * 2010-11-10 2013-03-20 Novartis Ag Succinato de dimetil-amida del acido 7-ciclopentil-2-(5-piperazin-1-il-piridin-2-il-amino)-7h-pirrolo-[2,3-d]pirimidin-6-carboxilico, proceso para prepararla, intermediarios de dicha sintesis y proceso de preparacion de los mismos
KR101888713B1 (ko) * 2011-02-11 2018-08-14 위스타 레보레이토리스 리미티드 페노티아진 디아미늄 염 및 이의 용도
EP3733170A1 (en) * 2012-07-13 2020-11-04 Oncternal Therapeutics, Inc. A method of treating androgen receptor (ar) -positive breast cancers with selective androgen receptor modulator (sarms)
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
US9913844B2 (en) * 2013-03-21 2018-03-13 Novartis Ag Combination therapy
EP2810644A1 (en) * 2013-06-06 2014-12-10 Ferrer Internacional, S.A. Oral formulation for the treatment of cardiovascular diseases
SI4197530T1 (sl) * 2015-04-16 2026-03-31 Novartis Ag Tableta ribocikliba
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
BR112017021283A2 (en) 2018-06-26
US12064434B2 (en) 2024-08-20
CN107530292B (zh) 2022-11-01
WO2016166703A1 (en) 2016-10-20
FI4197530T3 (fi) 2026-02-03
PH12017501820A1 (en) 2018-04-23
CA2982425C (en) 2023-10-31
US20230104792A1 (en) 2023-04-06
US20250127785A1 (en) 2025-04-24
US20200390771A1 (en) 2020-12-17
CN115554257A (zh) 2023-01-03
EA201792290A1 (ru) 2018-02-28
AR104257A1 (es) 2017-07-05
EP4620458A2 (en) 2025-09-24
AU2022215155A1 (en) 2022-09-01
PT3283058T (pt) 2023-02-03
AU2022215155B2 (en) 2024-08-01
SI4197530T1 (sl) 2026-03-31
AU2019201929B2 (en) 2020-07-09
AU2016248017A1 (en) 2017-10-19
PT4197530T (pt) 2026-02-05
JP2018514523A (ja) 2018-06-07
IL254818A0 (en) 2017-12-31
SG11201708084PA (en) 2017-10-30
TN2017000422A1 (en) 2019-01-16
PL4197530T3 (pl) 2026-03-23
AU2020250190A1 (en) 2020-11-05
EP4620458A3 (en) 2025-10-22
PE20180035A1 (es) 2018-01-09
KR102750931B1 (ko) 2025-01-09
MX2017013350A (es) 2018-01-25
KR20170137101A (ko) 2017-12-12
DK3283058T3 (da) 2023-02-13
TW201642864A (zh) 2016-12-16
CA2982425A1 (en) 2016-10-20
IL327430A (en) 2026-05-01
IL254818B1 (en) 2026-05-01
CN107530292A (zh) 2018-01-02
ES2938261T3 (es) 2023-04-05
HRP20230053T1 (hr) 2023-03-03
ES3062263T3 (en) 2026-04-09
CO2017010510A2 (es) 2018-03-20
US12419894B2 (en) 2025-09-23
US20180071292A1 (en) 2018-03-15
PL3283058T3 (pl) 2023-03-20
SI3283058T1 (sl) 2023-03-31
LT4197530T (lt) 2026-02-25
EP4197530B1 (en) 2025-11-12
EP3283058A1 (en) 2018-02-21
US20250134893A1 (en) 2025-05-01
HUE061213T2 (hu) 2023-05-28
HRP20260123T1 (hr) 2026-03-13
EP4197530A1 (en) 2023-06-21
AU2024227794A1 (en) 2024-11-21
RS67697B1 (sr) 2026-02-27
FI3283058T3 (fi) 2023-03-01
US20250090531A1 (en) 2025-03-20
CL2017002593A1 (es) 2018-05-18
AU2019201929A1 (en) 2019-04-11
US10799506B2 (en) 2020-10-13
DK4197530T3 (da) 2026-02-09
KR20250009572A (ko) 2025-01-17
EP3283058B1 (en) 2022-11-16

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