PL2571863T3 - Sole nilotynibu i ich postacie krystaliczne - Google Patents

Sole nilotynibu i ich postacie krystaliczne

Info

Publication number
PL2571863T3
PL2571863T3 PL11728501T PL11728501T PL2571863T3 PL 2571863 T3 PL2571863 T3 PL 2571863T3 PL 11728501 T PL11728501 T PL 11728501T PL 11728501 T PL11728501 T PL 11728501T PL 2571863 T3 PL2571863 T3 PL 2571863T3
Authority
PL
Poland
Prior art keywords
crystalline forms
nilotinib salts
nilotinib
salts
crystalline
Prior art date
Application number
PL11728501T
Other languages
English (en)
Inventor
Maytal Piran
Jacob Rendell
Original Assignee
Teva Pharma
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
Application filed by Teva Pharma filed Critical Teva Pharma
Publication of PL2571863T3 publication Critical patent/PL2571863T3/pl

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Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D401/00Heterocyclic 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
    • C07D401/14Heterocyclic 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 three or more hetero rings
    • 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
    • A61K31/506Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • 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
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C229/00Compounds containing amino and carboxyl groups bound to the same carbon skeleton
    • C07C229/02Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton
    • C07C229/04Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton being acyclic and saturated
    • C07C229/24Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton being acyclic and saturated having more than one carboxyl group bound to the carbon skeleton, e.g. aspartic acid
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C309/00Sulfonic acids; Halides, esters, or anhydrides thereof
    • C07C309/01Sulfonic acids
    • C07C309/25Sulfonic acids having sulfo groups bound to carbon atoms of rings other than six-membered aromatic rings of a carbon skeleton
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C309/00Sulfonic acids; Halides, esters, or anhydrides thereof
    • C07C309/01Sulfonic acids
    • C07C309/28Sulfonic acids having sulfo groups bound to carbon atoms of six-membered aromatic rings of a carbon skeleton
    • C07C309/29Sulfonic acids having sulfo groups bound to carbon atoms of six-membered aromatic rings of a carbon skeleton of non-condensed six-membered aromatic rings
    • C07C309/30Sulfonic acids having sulfo groups bound to carbon atoms of six-membered aromatic rings of a carbon skeleton of non-condensed six-membered aromatic rings of six-membered aromatic rings substituted by alkyl groups
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C53/00Saturated compounds having only one carboxyl group bound to an acyclic carbon atom or hydrogen
    • C07C53/126Acids containing more than four carbon atoms
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C55/00Saturated compounds having more than one carboxyl group bound to acyclic carbon atoms
    • C07C55/02Dicarboxylic acids
    • C07C55/06Oxalic acid
    • C07C55/07Salts thereof
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C55/00Saturated compounds having more than one carboxyl group bound to acyclic carbon atoms
    • C07C55/02Dicarboxylic acids
    • C07C55/08Malonic acid
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C55/00Saturated compounds having more than one carboxyl group bound to acyclic carbon atoms
    • C07C55/02Dicarboxylic acids
    • C07C55/12Glutaric acid
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C55/00Saturated compounds having more than one carboxyl group bound to acyclic carbon atoms
    • C07C55/02Dicarboxylic acids
    • C07C55/14Adipic acid
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C55/00Saturated compounds having more than one carboxyl group bound to acyclic carbon atoms
    • C07C55/22Tricarboxylic acids
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C57/00Unsaturated compounds having carboxyl groups bound to acyclic carbon atoms
    • C07C57/02Unsaturated compounds having carboxyl groups bound to acyclic carbon atoms with only carbon-to-carbon double bonds as unsaturation
    • C07C57/13Dicarboxylic acids
    • C07C57/15Fumaric acid
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C59/00Compounds having carboxyl groups bound to acyclic carbon atoms and containing any of the groups OH, O—metal, —CHO, keto, ether, groups, groups, or groups
    • C07C59/40Unsaturated compounds
    • C07C59/42Unsaturated compounds containing hydroxy or O-metal groups
    • C07C59/48Unsaturated compounds containing hydroxy or O-metal groups containing six-membered aromatic rings
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C62/00Compounds having carboxyl groups bound to carbon atoms of rings other than six—membered aromatic rings and containing any of the groups OH, O—metal, —CHO, keto, ether, groups, groups, or groups
    • C07C62/02Saturated compounds containing hydroxy or O-metal groups
    • 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
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/41641,3-Diazoles
    • A61K31/41781,3-Diazoles not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07BGENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13Crystalline forms, e.g. polymorphs
PL11728501T 2010-06-21 2011-06-21 Sole nilotynibu i ich postacie krystaliczne PL2571863T3 (pl)

Applications Claiming Priority (16)

Application Number Priority Date Filing Date Title
US35677110P 2010-06-21 2010-06-21
US35946910P 2010-06-29 2010-06-29
US36006410P 2010-06-30 2010-06-30
US36169110P 2010-07-06 2010-07-06
US36551010P 2010-07-19 2010-07-19
US37501310P 2010-08-18 2010-08-18
US37621310P 2010-08-23 2010-08-23
US38042810P 2010-09-07 2010-09-07
US38213610P 2010-09-13 2010-09-13
US38442810P 2010-09-20 2010-09-20
US39226610P 2010-10-12 2010-10-12
US40530110P 2010-10-21 2010-10-21
US41020210P 2010-11-04 2010-11-04
US201161434561P 2011-01-20 2011-01-20
EP11728501.5A EP2571863B1 (en) 2010-06-21 2011-06-21 Nilotinib salts and crystalline forms thereof
PCT/US2011/041242 WO2011163222A1 (en) 2010-06-21 2011-06-21 Nilotinib salts and crystalline forms thereof

Publications (1)

Publication Number Publication Date
PL2571863T3 true PL2571863T3 (pl) 2016-03-31

Family

ID=44310310

Family Applications (1)

Application Number Title Priority Date Filing Date
PL11728501T PL2571863T3 (pl) 2010-06-21 2011-06-21 Sole nilotynibu i ich postacie krystaliczne

Country Status (10)

Country Link
US (2) US8937082B2 (pl)
EP (2) EP2571863B1 (pl)
JP (1) JP5894153B2 (pl)
KR (1) KR20130042498A (pl)
CA (1) CA2803559A1 (pl)
ES (1) ES2555263T3 (pl)
HK (1) HK1218913A1 (pl)
HR (1) HRP20151324T1 (pl)
PL (1) PL2571863T3 (pl)
WO (1) WO2011163222A1 (pl)

Families Citing this family (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2648519A4 (en) * 2010-11-26 2014-04-30 Hetero Research Foundation NEW POLYMORPH OF NILOTINIB HYDROCHLORIDE
AR086913A1 (es) * 2011-06-14 2014-01-29 Novartis Ag 4-metil-3-[[4-(3-piridinil)-2-pirimidinil]-amino]-n-[5-(4-metil-1h-imidazol-1-il)-3-(trifluoro-metil)-fenil]-benzamida amorfa, forma de dosificacion que la contiene y metodo para prepararlas
ES2564969T3 (es) * 2012-02-09 2016-03-30 Natco Pharma Limited Proceso para la preparación de clorhidrato de nilotinib
US9061028B2 (en) 2012-02-15 2015-06-23 Natco Pharma Limited Process for the preparation of Nilotinib
AU2013332205B2 (en) * 2012-10-15 2017-08-31 Apotex Inc. Solid forms of Nilotinib hydrochloride
US9567317B2 (en) 2012-10-19 2017-02-14 Basf Se Multicomponent crystalline system comprising nilotinib and selected co-crystal formers
EA201592032A1 (ru) 2013-04-24 2016-04-29 Др. Реддис Лабораторис Лимитед Полиморфные формы гидрохлорида нилотиниба
WO2015092624A1 (en) 2013-12-16 2015-06-25 Ranbaxy Laboratories Limited Nilotinib mono-oxalate and its crystalline form
EP3177610A4 (en) 2014-08-08 2018-01-10 Dr. Reddy's Laboratories Ltd. Process for the preparation of polymorphic forms of nilotinib
US10016423B2 (en) 2014-10-16 2018-07-10 Apotex Inc. Solid forms of nilotinib hydrochloride
CN106478603B (zh) * 2015-08-25 2021-01-01 江苏豪森药业集团有限公司 尼洛替尼盐酸盐的新晶型及其制备方法和医药用途
SI3408264T1 (sl) 2016-01-26 2020-07-31 Farma Grs, D.O.O. Nilotinibijev dinitrat (V) in njegove kristalne oblike
EP3430004B1 (en) * 2016-03-14 2020-07-15 Pliva Hrvatska D.O.O. Solid state forms of nilotinib salts
CA3041134A1 (en) * 2016-10-28 2018-05-03 Apotex Inc. Novel salts of nilotinib and crystalline forms thereof
EP3404025B1 (en) * 2017-05-16 2019-12-04 F.I.S.- Fabbrica Italiana Sintetici S.p.A. Process for the preparation of pure nilotinib and its salt
CZ2017821A3 (cs) 2017-12-20 2019-07-03 Zentiva, K.S. Léková forma obsahující krystalický nilotinib
EP3806858A4 (en) 2018-06-15 2022-03-09 Handa Pharmaceuticals, Inc. SALTS OF KINASE INHIBITORS AND ASSOCIATED COMPOSITIONS
EP3877379A4 (en) * 2018-11-05 2022-08-31 Laurus Labs Limited CRYSTALLINE FORM OF NILOTINIB HYDROCHLORIDE, METHOD FOR PREPARING IT AND PHARMACEUTICAL COMPOSITION CONTAINING IT
US10874671B2 (en) 2019-02-18 2020-12-29 Slayback Pharma Llc Pharmaceutical compositions of nilotinib
EP4103560A1 (en) 2020-02-15 2022-12-21 Cipla Limited Novel salts of nilotinib and polymorphic forms thereof
WO2023285981A1 (en) * 2021-07-15 2023-01-19 Torrent Pharmaceuticals Limited Stable pharmaceutical liquid composition of nilotinib

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0215676D0 (en) * 2002-07-05 2002-08-14 Novartis Ag Organic compounds
GT200600315A (es) 2005-07-20 2007-03-19 Formas cristalinas de 4-metilo-n-[3-(4-metilo-imidazol-1-ilo)-5-trifluorometilo-fenilo]-3-(4-pyridina-3-ilo-pirimidina-2-iloamino)-benzamida
GT200600316A (es) * 2005-07-20 2007-04-02 Sales de 4-metilo-n-(3-(4-metilo-imidazol-1-ilo)-5-trifluorometilo-fenilo)-3-(4-piridina-3-ilo-pirimidina-2-iloamino)- benzamida.
HU227474B1 (en) 2005-12-20 2011-07-28 Richter Gedeon Nyrt Process for industrial scale production of high purity donepezil hydrochloride polymorph i.
PL2262793T3 (pl) 2008-11-05 2013-01-31 Teva Pharma Formy krystaliczne nilotynibu HCL
WO2011033307A1 (en) 2009-09-17 2011-03-24 Generics [Uk] Limited Nilotinib dihydrochloride salt

Also Published As

Publication number Publication date
KR20130042498A (ko) 2013-04-26
US20130158059A1 (en) 2013-06-20
EP2966072A3 (en) 2016-02-24
US20150099885A1 (en) 2015-04-09
EP2571863A1 (en) 2013-03-27
ES2555263T3 (es) 2015-12-30
CA2803559A1 (en) 2011-12-29
HRP20151324T1 (hr) 2016-01-29
JP5894153B2 (ja) 2016-03-23
HK1218913A1 (zh) 2017-03-17
US8937082B2 (en) 2015-01-20
JP2013529639A (ja) 2013-07-22
WO2011163222A1 (en) 2011-12-29
EP2966072A2 (en) 2016-01-13
EP2571863B1 (en) 2015-09-23
US9090598B2 (en) 2015-07-28

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