HUE035877T2 - Pharmaceutical preparations containing Refametinib - Google Patents

Pharmaceutical preparations containing Refametinib Download PDF

Info

Publication number
HUE035877T2
HUE035877T2 HUE14766156A HUE14766156A HUE035877T2 HU E035877 T2 HUE035877 T2 HU E035877T2 HU E14766156 A HUE14766156 A HU E14766156A HU E14766156 A HUE14766156 A HU E14766156A HU E035877 T2 HUE035877 T2 HU E035877T2
Authority
HU
Hungary
Prior art keywords
weight
coating
stability
refametinib
sodium
Prior art date
Application number
HUE14766156A
Other languages
English (en)
Hungarian (hu)
Inventor
Anke Stroyer
Susanne Skrabs
Michael Formell
Gabriele Winter
Rosemarie Kissenbeck
Original Assignee
Bayer Pharma 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
Priority claimed from EP13184229.6A external-priority patent/EP2848246A1/en
Application filed by Bayer Pharma AG filed Critical Bayer Pharma AG
Publication of HUE035877T2 publication Critical patent/HUE035877T2/en

Links

Classifications

    • 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
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/18Sulfonamides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2813Inorganic compounds
    • 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
    • A61K9/282Organic compounds, e.g. fats
    • 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
    • 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
    • A61K9/2853Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • 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
    • A61K9/2893Tablet coating processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
HUE14766156A 2013-09-13 2014-09-11 Pharmaceutical preparations containing Refametinib HUE035877T2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP13184229.6A EP2848246A1 (en) 2013-09-13 2013-09-13 Pharmaceutical compositions containing refametinib
EP13184539 2013-09-16

Publications (1)

Publication Number Publication Date
HUE035877T2 true HUE035877T2 (en) 2018-05-28

Family

ID=51541077

Family Applications (1)

Application Number Title Priority Date Filing Date
HUE14766156A HUE035877T2 (en) 2013-09-13 2014-09-11 Pharmaceutical preparations containing Refametinib

Country Status (13)

Country Link
US (1) US20160220494A1 (enExample)
EP (1) EP3043778B1 (enExample)
JP (1) JP2016531151A (enExample)
CN (1) CN105658209A (enExample)
CA (1) CA2923990A1 (enExample)
DK (1) DK3043778T3 (enExample)
ES (1) ES2648267T3 (enExample)
HU (1) HUE035877T2 (enExample)
NO (1) NO3043778T3 (enExample)
PL (1) PL3043778T3 (enExample)
TW (1) TW201542245A (enExample)
UY (1) UY35734A (enExample)
WO (1) WO2015036512A1 (enExample)

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10058630B2 (en) 2012-10-22 2018-08-28 Concievalve, Llc Methods for inhibiting stenosis, obstruction, or calcification of a stented heart valve or bioprosthesis
JP6433085B2 (ja) 2013-04-09 2018-12-05 ボストン バイオメディカル, インコーポレイテッド がんの処置に使用するための2−アセチルナフト[2,3−b]フラン−4,9−ジオン
DK3105226T3 (da) 2014-02-13 2019-10-14 Incyte Corp Cyclopropylaminer som lsd1-inhibitorer
PT3105218T (pt) 2014-02-13 2019-12-05 Incyte Corp Ciclopropilaminas como inibidores de lsd1
WO2016007722A1 (en) 2014-07-10 2016-01-14 Incyte Corporation Triazolopyridines and triazolopyrazines as lsd1 inhibitors
EP3626720A1 (en) 2015-04-03 2020-03-25 Incyte Corporation Heterocyclic compounds as lsd1 inhibitors
KR102710120B1 (ko) 2015-08-12 2024-09-27 인사이트 홀딩스 코포레이션 Lsd1 저해제의 염
EP3359157A4 (en) 2015-10-06 2019-05-15 The Wistar Institute Of Anatomy And Biology METHOD AND COMPOSITIONS FOR THE TREATMENT OF METASTASIVE AND REFRACTORY CANCER DISEASES AND TUMORS
CN107224438B (zh) * 2016-03-25 2021-04-06 江苏豪森药业集团有限公司 富马酸沃诺拉赞药物组合物
US10939164B2 (en) * 2016-05-10 2021-03-02 Rovi Guides, Inc. Method and system for transferring an interactive feature to another device
KR101796684B1 (ko) * 2016-05-19 2017-11-10 건국대학교 산학협력단 케라틴 8 인산화 억제제를 포함하는 황반변성 예방 또는 치료용 약학 조성물 및 황반변성 치료제의 스크리닝 방법
US11299469B2 (en) 2016-11-29 2022-04-12 Sumitomo Dainippon Pharma Oncology, Inc. Naphthofuran derivatives, preparation, and methods of use thereof
CA3058162A1 (en) * 2017-03-30 2018-10-04 Boston Biomedical, Inc. Compositions for treating and/or preventing cancer
WO2018213424A1 (en) 2017-05-17 2018-11-22 Boston Biomedical, Inc. Methods for treating cancer
JP7166754B2 (ja) * 2017-11-22 2022-11-08 沢井製薬株式会社 ダサチニブ無水物含有製剤
US10968200B2 (en) 2018-08-31 2021-04-06 Incyte Corporation Salts of an LSD1 inhibitor and processes for preparing the same
CN115487186B (zh) * 2022-09-29 2024-04-16 北京朗瑞邦科技有限公司 一种具有mTOR抑制活性的药物制剂及其制备方法

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
CR5278A (es) * 1995-03-24 1996-07-04 Lilly Co Eli Formulacion oral de 2-metil-tieno-benzodiacepina
US6448323B1 (en) * 1999-07-09 2002-09-10 Bpsi Holdings, Inc. Film coatings and film coating compositions based on polyvinyl alcohol
SE0201110D0 (sv) * 2002-04-12 2002-04-12 Astrazeneca Ab New film coating
PA8576201A1 (es) * 2002-07-10 2004-05-26 Pfizer Prod Inc Composicion farmaceutica que tiene una distribucion y potencia uniforme de farmaco
JP2004051506A (ja) * 2002-07-17 2004-02-19 Nichiko Pharmaceutical Co Ltd 経時的な変色を抑制した医薬組成物
JP2004300138A (ja) * 2003-03-18 2004-10-28 Takeda Chem Ind Ltd 安定化された経口固形製剤
CA2694646C (en) * 2007-07-30 2017-09-05 Ardea Biosciences, Inc. Combinations of mek inhibitors and raf kinase inhibitors and uses thereof
BRPI0911297A2 (pt) * 2008-04-14 2019-09-24 Ardea Biosciences Inc composição e métodos para preparo e uso das mesmas
DE102008059206A1 (de) * 2008-11-27 2010-06-10 Bayer Schering Pharma Aktiengesellschaft Pharmazeutische Darreichungsform enthaltend Nifedipin oder Nisoldipin und einen Angiotensin-II Antagonisten und/oder ein Diuretikum
MX2011009498A (es) * 2009-03-11 2011-10-14 Ardea Biosciences Inc Combinaciones farmaceuticas que comprenden rdea119/bay 869766 para el tratamiento de canceres especificos.
JP2011162531A (ja) * 2010-02-10 2011-08-25 Takada Seiyaku Kk フェキソフェナジン含有フイルムコーテイング経口製剤
JP5700367B2 (ja) * 2010-05-06 2015-04-15 高田製薬株式会社 パロキセチン含有フイルムコ−テイング経口製剤
WO2012120364A2 (en) * 2011-03-09 2012-09-13 Ideal Cures Pvt. Ltd. Novel immediate release film coating compositions
UY35006A (es) * 2012-09-06 2014-03-31 Bayer Healthcare Llc Composición farmacéutica recubierta que contiene regorafenib

Also Published As

Publication number Publication date
PL3043778T3 (pl) 2018-04-30
TW201542245A (zh) 2015-11-16
UY35734A (es) 2015-04-30
JP2016531151A (ja) 2016-10-06
DK3043778T3 (da) 2017-11-27
NO3043778T3 (enExample) 2018-02-03
WO2015036512A1 (en) 2015-03-19
CN105658209A (zh) 2016-06-08
EP3043778B1 (en) 2017-09-06
EP3043778A1 (en) 2016-07-20
ES2648267T3 (es) 2017-12-29
US20160220494A1 (en) 2016-08-04
CA2923990A1 (en) 2015-03-19

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