DK2305263T3 - Stabiliserede amorfe former af imatinibmesylat - Google Patents

Stabiliserede amorfe former af imatinibmesylat

Info

Publication number
DK2305263T3
DK2305263T3 DK10178116.9T DK10178116T DK2305263T3 DK 2305263 T3 DK2305263 T3 DK 2305263T3 DK 10178116 T DK10178116 T DK 10178116T DK 2305263 T3 DK2305263 T3 DK 2305263T3
Authority
DK
Denmark
Prior art keywords
imatinib mesylate
amorphous forms
stabilized amorphous
stabilized
imatinib
Prior art date
Application number
DK10178116.9T
Other languages
English (en)
Inventor
Elisabete Goncalves
Oskar Kalb
Michael Mutz
Wolfgang Wirth
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=38229765&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK2305263(T3) "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
Application granted granted Critical
Publication of DK2305263T3 publication Critical patent/DK2305263T3/da

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D401/00—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom
    • C07D401/02—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings
    • C07D401/04—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings directly linked by a ring-member-to-ring-member bond
    • 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
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • 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
    • A61P35/00—Antineoplastic agents
    • A61P35/04—Antineoplastic agents specific for metastasis
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
    • A61K9/4825—Proteins, e.g. gelatin

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oncology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Hematology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
DK10178116.9T 2007-06-07 2007-06-07 Stabiliserede amorfe former af imatinibmesylat DK2305263T3 (da)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP07109816A EP2000139A1 (en) 2007-06-07 2007-06-07 Stabilized amorphous forms of imatinib mesylate

Publications (1)

Publication Number Publication Date
DK2305263T3 true DK2305263T3 (da) 2012-10-22

Family

ID=38229765

Family Applications (1)

Application Number Title Priority Date Filing Date
DK10178116.9T DK2305263T3 (da) 2007-06-07 2007-06-07 Stabiliserede amorfe former af imatinibmesylat

Country Status (26)

Country Link
US (4) US20100178336A1 (da)
EP (2) EP2305263B1 (da)
JP (2) JP5380440B2 (da)
KR (2) KR101454086B1 (da)
CN (2) CN104910134A (da)
AR (1) AR067328A1 (da)
AU (1) AU2008262059B2 (da)
BR (1) BRPI0812442A2 (da)
CA (1) CA2687741A1 (da)
CL (1) CL2008001658A1 (da)
CO (1) CO6241118A2 (da)
CY (1) CY1113178T1 (da)
DK (1) DK2305263T3 (da)
ES (1) ES2391625T3 (da)
IL (2) IL202157A0 (da)
MX (1) MX2009013272A (da)
MY (1) MY148878A (da)
NZ (3) NZ598428A (da)
PL (1) PL2305263T3 (da)
PT (1) PT2305263E (da)
RU (1) RU2489149C2 (da)
SG (1) SG182175A1 (da)
SI (1) SI2305263T1 (da)
UY (1) UY31125A1 (da)
WO (1) WO2008154262A1 (da)
ZA (2) ZA200900796B (da)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2010003200A (es) * 2007-09-25 2010-04-30 Teva Pharma Composiciones de imatibnib estables.
CZ20098A3 (cs) * 2009-01-13 2010-07-21 Zentiva, K.S. Lékové formy inhibitoru tyrosinových kináz
CZ2009570A3 (cs) 2009-08-26 2011-03-09 Zentiva, K. S. Príprava, stabilizace a využití polymorfu imatinib mesylátu pro vývoj lékových forem
WO2012080703A1 (en) * 2010-12-15 2012-06-21 Cipla Limited Pharmaceutical composition comprising imatinib
BR112014012400A2 (pt) 2011-11-24 2017-06-13 Imuneks Farma Ilaç Sanayi Ve Ticaret A S formas de dosagens sólidas de imatinibe reconstituídas logo antes do uso
KR101386697B1 (ko) 2012-06-18 2014-04-18 아주대학교산학협력단 이매티닙 또는 이의 약학적으로 허용되는 염을 유효성분으로 포함하는 혈관 투과성 관련 질환의 치료 또는 예방용 조성물
US9439903B2 (en) 2012-10-25 2016-09-13 Cadila Healthcare Limited Process for the preparation of amorphous imatinib mesylate
CN103784411B (zh) * 2012-11-01 2016-03-23 齐鲁制药(海南)有限公司 一种盐酸厄洛替尼药用组合物及其制备方法
CA2919498C (en) 2013-07-31 2023-07-25 Windward Pharma, Inc. Aerosol nintedanib compounds and uses thereof
WO2015110949A1 (en) 2014-01-22 2015-07-30 Novartis Ag Imatinib as cholesterol decreasing agent
US20210046096A1 (en) * 2018-02-13 2021-02-18 Sandoz Ag Pharmaceutical Composition of Brigatinib
CN109044977A (zh) * 2018-10-26 2018-12-21 武汉工程大学 一种乐伐替尼固体分散体及其制备方法和制剂
WO2021083346A1 (zh) * 2019-11-01 2021-05-06 正大天晴药业集团股份有限公司 包含喹唑啉衍生物或其盐的药物组合物
CN116897045A (zh) * 2021-01-06 2023-10-17 英凯达治疗公司 可吸入伊马替尼制剂
WO2022150483A1 (en) * 2021-01-06 2022-07-14 Incarda Therapeutics, Inc. Inhalable imatinib formulation

Family Cites Families (21)

* Cited by examiner, † Cited by third party
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US4727064A (en) * 1984-04-25 1988-02-23 The United States Of America As Represented By The Department Of Health And Human Services Pharmaceutical preparations containing cyclodextrin derivatives
US5521184A (en) 1992-04-03 1996-05-28 Ciba-Geigy Corporation Pyrimidine derivatives and processes for the preparation thereof
RU2173172C2 (ru) * 1997-05-05 2001-09-10 Сайдекс Инк. Твердые фармацевтические препараты, содержащие физическую смесь сульфоалкилового эфира циклодекстрина и терапевтического агента
CO4940418A1 (es) 1997-07-18 2000-07-24 Novartis Ag Modificacion de cristal de un derivado de n-fenil-2- pirimidinamina, procesos para su fabricacion y su uso
DE60039379D1 (de) * 1999-02-10 2008-08-21 Pfizer Prod Inc Pharmazeutische feste Dispersionen
RU2288921C2 (ru) * 2000-12-19 2006-12-10 Калифорниа Инститьют оф Текнолоджи Композиции, содержащие комплексы включения
AU2002253642B2 (en) * 2001-04-26 2007-05-24 Meiji Seika Kaisha, Ltd. Amorphous cefditoren pivoxil composition and process for producing the same
AR039090A1 (es) * 2002-03-22 2005-02-09 Novartis Ag Combinacion de compuestos organicos
GB2398565A (en) * 2003-02-18 2004-08-25 Cipla Ltd Imatinib preparation and salts
WO2004106326A1 (en) * 2003-06-02 2004-12-09 Hetero Drugs Limited Novel polymorphs of imatinib mesylate
RU2373923C2 (ru) * 2004-06-08 2009-11-27 Вертекс Фармасьютикалз Инкорпорейтед Фармацевтические композиции
US7329495B2 (en) * 2004-06-09 2008-02-12 Board Of Regents, The University Of Texas System Mutations in KIT confer imatinib resistance in gastrointestinal stromal tumors
FR2873693B1 (fr) * 2004-07-29 2006-09-15 Sanofi Synthelabo Derives d'amino-tropane, leur preparation et leur application en therapeutique
JP5128948B2 (ja) * 2004-08-27 2013-01-23 ニッポネックス インコーポレイテッド 癌の治療のための新規な薬剤組成物
MY148074A (en) * 2005-05-10 2013-02-28 Novartis Ag Pharmaceutical compositions comprising imatinib and a release retardant
CA2608952A1 (en) * 2005-05-19 2006-11-23 Dwayne Thomas Friesen Pharmaceutical compostions comprising an amorphous form of a vegf-r inhibitor
CN101232870A (zh) * 2005-06-03 2008-07-30 伊兰制药国际有限公司 纳米微粒甲磺酸伊马替尼制剂
US8067421B2 (en) * 2006-04-27 2011-11-29 Sicor Inc. Polymorphic forms of imatinib mesylate and processes for preparation of novel crystalline forms as well as amorphous and form α
MX2009002336A (es) * 2006-09-01 2009-03-20 Teva Pharma Composiciones de imatinib.
EP2120877A2 (en) * 2007-03-12 2009-11-25 Dr. Reddy's Laboratories Ltd. Imatinib mesylate
US20080234286A1 (en) * 2007-03-20 2008-09-25 Chemagis Ltd. Stable amorphous imatinib mesylate and production process therefor

Also Published As

Publication number Publication date
NZ581176A (en) 2012-10-26
US20140323495A1 (en) 2014-10-30
JP5380440B2 (ja) 2014-01-08
RU2489149C2 (ru) 2013-08-10
KR20100020955A (ko) 2010-02-23
IL202157A0 (en) 2010-06-16
HK1150764A1 (en) 2012-01-13
AU2008262059B2 (en) 2012-04-05
MX2009013272A (es) 2010-01-25
NZ598427A (en) 2013-06-28
PT2305263E (pt) 2012-10-22
CN104910134A (zh) 2015-09-16
KR101267782B1 (ko) 2013-06-04
BRPI0812442A2 (pt) 2013-02-26
MY148878A (en) 2013-06-14
EP2305263A1 (en) 2011-04-06
US20100178336A1 (en) 2010-07-15
US20130225598A1 (en) 2013-08-29
CO6241118A2 (es) 2011-01-20
AU2008262059A1 (en) 2008-12-18
CY1113178T1 (el) 2016-04-13
CL2008001658A1 (es) 2009-02-20
EP2000139A1 (en) 2008-12-10
AR067328A1 (es) 2009-10-07
ZA200907961B (en) 2014-03-26
ES2391625T3 (es) 2012-11-28
JP2010529964A (ja) 2010-09-02
KR20120039717A (ko) 2012-04-25
SG182175A1 (en) 2012-07-30
WO2008154262A1 (en) 2008-12-18
CN101678023A (zh) 2010-03-24
KR101454086B1 (ko) 2014-10-27
JP2013227324A (ja) 2013-11-07
RU2009148985A (ru) 2011-08-20
IL237160A0 (en) 2015-03-31
ZA200900796B (en) 2010-07-28
NZ598428A (en) 2013-06-28
PL2305263T3 (pl) 2012-12-31
US20130022672A1 (en) 2013-01-24
CA2687741A1 (en) 2008-12-18
EP2305263B1 (en) 2012-09-19
UY31125A1 (es) 2009-01-30
SI2305263T1 (sl) 2012-10-30

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