CA2883767C - Coated pharmaceutical composition containing regorafenib - Google Patents

Coated pharmaceutical composition containing regorafenib Download PDF

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Publication number
CA2883767C
CA2883767C CA2883767A CA2883767A CA2883767C CA 2883767 C CA2883767 C CA 2883767C CA 2883767 A CA2883767 A CA 2883767A CA 2883767 A CA2883767 A CA 2883767A CA 2883767 C CA2883767 C CA 2883767C
Authority
CA
Canada
Prior art keywords
regorafenib
composition
polyvinyl alcohol
coating
pharmaceutical composition
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
CA2883767A
Other languages
English (en)
French (fr)
Other versions
CA2883767A1 (en
Inventor
Susanne Skrabs
Adrian Funke
Mayk Kresse
Ulrich Oberdieck
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.)
Bayer Healthcare LLC
Original Assignee
Bayer Healthcare LLC
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=46963450&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2883767(C) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Bayer Healthcare LLC filed Critical Bayer Healthcare LLC
Publication of CA2883767A1 publication Critical patent/CA2883767A1/en
Application granted granted Critical
Publication of CA2883767C publication Critical patent/CA2883767C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2893—Tablet coating processes
    • 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
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system

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)
  • Hematology (AREA)
  • Oncology (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
CA2883767A 2012-09-06 2013-09-05 Coated pharmaceutical composition containing regorafenib Active CA2883767C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP12183331.3 2012-09-06
EP12183331 2012-09-06
PCT/US2013/058257 WO2014039677A1 (en) 2012-09-06 2013-09-05 Coated pharmaceutical composition containing regorafenib

Publications (2)

Publication Number Publication Date
CA2883767A1 CA2883767A1 (en) 2014-03-13
CA2883767C true CA2883767C (en) 2018-11-13

Family

ID=46963450

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2883767A Active CA2883767C (en) 2012-09-06 2013-09-05 Coated pharmaceutical composition containing regorafenib

Country Status (43)

Country Link
US (1) US20140065212A1 (enExample)
EP (2) EP2892507B1 (enExample)
JP (1) JP6445436B2 (enExample)
KR (1) KR102162036B1 (enExample)
CN (5) CN116392484A (enExample)
AP (1) AP2015008292A0 (enExample)
AR (1) AR092439A1 (enExample)
AU (1) AU2013312531B2 (enExample)
BR (1) BR112015004936B1 (enExample)
CA (1) CA2883767C (enExample)
CL (1) CL2015000544A1 (enExample)
CO (1) CO7310528A2 (enExample)
CR (1) CR20150114A (enExample)
CU (1) CU24244B1 (enExample)
CY (1) CY1118839T1 (enExample)
DK (1) DK2892507T3 (enExample)
EA (1) EA027685B1 (enExample)
ES (1) ES2623205T3 (enExample)
GT (1) GT201500053A (enExample)
HK (1) HK1214170A1 (enExample)
HR (1) HRP20170620T1 (enExample)
HU (1) HUE032758T2 (enExample)
IL (1) IL237350B (enExample)
IN (1) IN2015DN01673A (enExample)
JO (1) JO3479B1 (enExample)
LT (1) LT2892507T (enExample)
MA (1) MA37888B1 (enExample)
MX (1) MX359922B (enExample)
MY (1) MY176135A (enExample)
NZ (1) NZ705578A (enExample)
PE (1) PE20151005A1 (enExample)
PH (1) PH12015500460A1 (enExample)
PL (1) PL2892507T3 (enExample)
PT (1) PT2892507T (enExample)
RS (1) RS56019B1 (enExample)
SA (1) SA515360113B1 (enExample)
SG (1) SG11201501683WA (enExample)
SI (1) SI2892507T1 (enExample)
TW (1) TWI640329B (enExample)
UA (1) UA115994C2 (enExample)
UY (1) UY35006A (enExample)
WO (1) WO2014039677A1 (enExample)
ZA (1) ZA201501394B (enExample)

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AR081060A1 (es) 2010-04-15 2012-06-06 Bayer Schering Pharma Ag Procedimiento para preparar 4-{4-[({[4-cloro-3-(trifluorometil)fenil]amino}carbonil)amino]-3-fluorofenoxi}-n-metilpiridin-2-carboxamida
EP3043778B1 (en) * 2013-09-13 2017-09-06 Bayer Pharma Aktiengesellschaft Pharmaceutical compositions containing refametinib
CN104586808B (zh) * 2014-12-27 2017-08-18 北京元延医药科技股份有限公司 抗肿瘤药物组合物
CN105267167A (zh) * 2015-09-11 2016-01-27 江苏嘉逸医药有限公司 一种瑞戈非尼口服固体药物组合物的制备方法
CN105136956A (zh) * 2015-09-11 2015-12-09 江苏嘉逸医药有限公司 一种快速测定瑞戈非尼含量的方法
CN106880615A (zh) * 2015-12-15 2017-06-23 北大方正集团有限公司 一种瑞戈非尼的口服固体制剂及其制备方法
CN106880607A (zh) * 2015-12-15 2017-06-23 北大方正集团有限公司 一种含有瑞戈非尼的口腔崩解片及其制备方法
CN105496975B (zh) * 2015-12-17 2019-01-04 河南润弘制药股份有限公司 一种瑞戈非尼片剂及其制备方法
CN106913527A (zh) * 2015-12-28 2017-07-04 江苏先声药业有限公司 一种瑞戈非尼速释微丸及其制备方法
CN105879049B (zh) * 2016-05-13 2019-03-26 浙江大学 一种瑞戈非尼与β-环糊精的包合物及其制备方法
CN107661296A (zh) * 2016-07-27 2018-02-06 江苏先声药业有限公司 一种瑞戈非尼固体分散体及其制备方法
PT3630112T (pt) * 2017-06-02 2024-04-23 Bayer Healthcare Llc Combinação de regorafenib e nivolumab para tratamento de cancro
CA3103498A1 (en) * 2018-07-06 2020-01-09 Agios Pharmaceuticals, Inc. Ivosidenib forms and pharmaceutical compositions
CN111053751A (zh) * 2018-10-16 2020-04-24 正大天晴药业集团股份有限公司 瑞戈非尼的缓释片剂及其制备方法
TWI799599B (zh) * 2019-06-06 2023-04-21 華納國際生物科技股份有限公司 醫藥或保健品自乳化固體分散組成物
EP3861989A1 (en) * 2020-02-07 2021-08-11 Bayer Aktiengesellschaft Pharmaceutical composition containing regorafenib and a stabilizing agent
CN112587485A (zh) * 2021-01-08 2021-04-02 湖南南新制药股份有限公司 一种药物固体分散体及其制备方法
CN113018274A (zh) * 2021-03-10 2021-06-25 药源生物科技(启东)有限公司 一种含羟丙甲纤维素的药物组合物及其制备方法
TR2023002707A2 (tr) * 2023-03-10 2024-09-23 Abdi Ibrahim Ilac Sanayi Ve Ticaret Anonim Sirketi Regorafenib içeren bir farmasötik bileşim.
WO2025242583A1 (en) 2024-05-24 2025-11-27 Bayer Consumer Care Ag Novel formulation comprising elinzanetant in a solid dispersion

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2529180T3 (es) * 2002-09-20 2015-02-17 Andrx Labs Llc Formulación multietapa que contiene una biguanida y un derivado de tiazolidinodiona
CN1265793C (zh) * 2002-11-18 2006-07-26 杭州容立医药科技有限公司 左西替利嗪伪麻黄碱复方口服制剂及制备方法
PL1663978T3 (pl) * 2003-07-23 2008-04-30 Bayer Healthcare Llc Fluoropodstawiony omega-karboksyarylodifenylomocznik do leczenia i profilaktyki chorób i stanów
MY191349A (en) * 2004-08-27 2022-06-17 Bayer Pharmaceuticals Corp New pharmaceutical compositions for the treatment of hyper-proliferative disorders
JP2009519266A (ja) * 2005-12-15 2009-05-14 バイエル・ヘルスケア・アクチェンゲゼルシャフト 炎症性の皮膚、眼および/または耳疾患を処置するためのジアリールウレア類
AR062927A1 (es) * 2006-10-11 2008-12-17 Bayer Healthcare Ag 4- [4-( [ [ 4- cloro-3-( trifluorometil) fenil) carbamoil] amino] -3- fluorofenoxi) -n- metilpiridin-2- carboxamida monohidratada
WO2008044111A1 (en) * 2006-10-13 2008-04-17 Pfizer Products Inc. Pharmaceutical formulation tablet
AU2007333302A1 (en) * 2006-12-07 2008-06-19 Eli Lilly And Company An article comprising prasugrel
JP5351490B2 (ja) * 2007-10-25 2013-11-27 バイエル薬品株式会社 ニフェジピン含有有核錠剤およびその製法
AR081060A1 (es) * 2010-04-15 2012-06-06 Bayer Schering Pharma Ag Procedimiento para preparar 4-{4-[({[4-cloro-3-(trifluorometil)fenil]amino}carbonil)amino]-3-fluorofenoxi}-n-metilpiridin-2-carboxamida
ES2643693T3 (es) * 2011-05-20 2017-11-23 Astrazeneca Uk Limited Composición farmacéutica de rosuvastatina cálcica

Also Published As

Publication number Publication date
DK2892507T3 (en) 2017-05-01
IN2015DN01673A (enExample) 2015-07-03
EP2892507A1 (en) 2015-07-15
WO2014039677A1 (en) 2014-03-13
PH12015500460B1 (en) 2015-04-20
PH12015500460A1 (en) 2015-04-20
CR20150114A (es) 2015-05-11
KR20150048872A (ko) 2015-05-07
AR092439A1 (es) 2015-04-22
TW201414510A (zh) 2014-04-16
SA515360113B1 (ar) 2016-08-10
SI2892507T1 (sl) 2017-08-31
MX359922B (es) 2018-10-16
TWI640329B (zh) 2018-11-11
HK1214170A1 (zh) 2016-07-22
CA2883767A1 (en) 2014-03-13
CO7310528A2 (es) 2015-06-30
NZ705578A (en) 2017-10-27
AP2015008292A0 (en) 2015-02-28
SG11201501683WA (en) 2015-04-29
IL237350B (en) 2020-11-30
CU20150020A7 (es) 2015-05-28
HUE032758T2 (en) 2017-10-30
CN116392485A (zh) 2023-07-07
JP2015527395A (ja) 2015-09-17
ZA201501394B (en) 2016-07-27
PE20151005A1 (es) 2015-06-27
RS56019B1 (sr) 2017-09-29
EP2892507B1 (en) 2017-02-01
CY1118839T1 (el) 2018-01-10
MA37888B1 (fr) 2019-08-30
UA115994C2 (uk) 2018-01-25
JP6445436B2 (ja) 2018-12-26
JO3479B1 (ar) 2020-07-05
GT201500053A (es) 2015-10-12
BR112015004936B1 (pt) 2022-12-06
MY176135A (en) 2020-07-24
LT2892507T (lt) 2017-06-12
EA027685B1 (ru) 2017-08-31
CL2015000544A1 (es) 2015-08-21
CN116392484A (zh) 2023-07-07
PT2892507T (pt) 2017-05-02
PL2892507T3 (pl) 2017-09-29
HRP20170620T1 (hr) 2017-06-30
KR102162036B1 (ko) 2020-10-07
EA201590520A1 (ru) 2015-10-30
BR112015004936A2 (pt) 2017-07-04
EP3243508A1 (en) 2017-11-15
MA37888A1 (fr) 2018-07-31
ES2623205T3 (es) 2017-07-10
CN111249247A (zh) 2020-06-09
CN104902878A (zh) 2015-09-09
CU24244B1 (es) 2017-02-02
UY35006A (es) 2014-03-31
AU2013312531B2 (en) 2017-10-19
MX2015002815A (es) 2015-05-15
CN116392598A (zh) 2023-07-07
US20140065212A1 (en) 2014-03-06
AU2013312531A1 (en) 2015-03-12
IL237350A0 (en) 2015-04-30

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