WO2015092624A1 - Mono-oxalate de nilotinib et sa forme cristalline - Google Patents

Mono-oxalate de nilotinib et sa forme cristalline Download PDF

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Publication number
WO2015092624A1
WO2015092624A1 PCT/IB2014/066771 IB2014066771W WO2015092624A1 WO 2015092624 A1 WO2015092624 A1 WO 2015092624A1 IB 2014066771 W IB2014066771 W IB 2014066771W WO 2015092624 A1 WO2015092624 A1 WO 2015092624A1
Authority
WO
WIPO (PCT)
Prior art keywords
nilotinib
oxalate
mono
nilotinib mono
xrpd pattern
Prior art date
Application number
PCT/IB2014/066771
Other languages
English (en)
Inventor
Satish Manohar Bhoge
Anand Prakash Tiwari
Kaptan Singh
Mohan Prasad
Original Assignee
Ranbaxy Laboratories Limited
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 Ranbaxy Laboratories Limited filed Critical Ranbaxy Laboratories Limited
Publication of WO2015092624A1 publication Critical patent/WO2015092624A1/fr

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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
    • C07D401/14—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 three or more hetero rings
    • 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

Definitions

  • a fifth aspect of the present invention provides a method for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase and for the treatment of chronic phase and accelerated phase Ph+ CML in adult patients resistant or intolerant to prior therapy that included imatinib which comprises administering to a patient in need thereof a therapeutically effective amount of nilotinib mono-oxalate and a pharmaceutically acceptable carrier.
  • Ph+ CML Philadelphia chromosome positive chronic myeloid leukemia
  • Figure 1 depicts the XRPD pattern of nilotinib mono-oxalate prepared as per
  • Figure 2 depicts the TGA thermogram of nilotinib mono-oxalate prepared as per Example 1.
  • the FTIR spectrum of the samples was determined by a PerkinElmer ® system; SCAN: 16 scans; Resolution: 4.0 cm "1 ; potassium bromide pellet method.
  • the compound prepared according to Example 1 had the following x-ray diffraction values associated with the x-ray diffraction pattern of Figure 1.

Abstract

La présente invention concerne le mono-oxalate de nilotinib, une forme cristalline du mono-oxalate de nilotinib, un procédé pour sa préparation et une composition pharmaceutique de celui-ci.
PCT/IB2014/066771 2013-12-16 2014-12-10 Mono-oxalate de nilotinib et sa forme cristalline WO2015092624A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN3660DE2013 2013-12-16
IN3660/DEL/2013 2013-12-16

Publications (1)

Publication Number Publication Date
WO2015092624A1 true WO2015092624A1 (fr) 2015-06-25

Family

ID=52146560

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2014/066771 WO2015092624A1 (fr) 2013-12-16 2014-12-10 Mono-oxalate de nilotinib et sa forme cristalline

Country Status (1)

Country Link
WO (1) WO2015092624A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021161347A1 (fr) 2020-02-15 2021-08-19 Cipla Limited Nouveaux sels de nilotinib et formes polymorphes de celui-ci
CN113292537A (zh) * 2018-06-15 2021-08-24 汉达癌症医药责任有限公司 激酶抑制剂的盐类及其组合物

Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006135641A2 (fr) 2005-06-09 2006-12-21 Novartis Ag Procede de synthese de composes organiques
US7169791B2 (en) 2002-07-05 2007-01-30 Novartis Ag Inhibitors of tyrosine kinases
WO2007015871A1 (fr) 2005-07-20 2007-02-08 Novartis Ag Sels de 4-methyl-n-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide
WO2007015870A2 (fr) 2005-07-20 2007-02-08 Novartis Ag Formes cristallines de 4-methyl-n-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide
WO2010009402A2 (fr) 2008-07-17 2010-01-21 Teva Pharmaceutical Industries Ltd. Intermédiaires de nilotinib, et leur préparation
WO2010054056A2 (fr) 2008-11-05 2010-05-14 Teva Pharmaceutical Industries Ltd. Formes cristallines du chlorhydrate de nilotinib
WO2011033307A1 (fr) 2009-09-17 2011-03-24 Generics [Uk] Limited Sel de dichlorhydrate de nilotinib
WO2011086541A1 (fr) 2010-01-15 2011-07-21 Generics [Uk] Limited Nouveau polymorphe de monochlorhydrate de nilotinib monohydraté
WO2011163222A1 (fr) 2010-06-21 2011-12-29 Teva Pharmaceutical Industries Ltd. Sels de nilotinib et formes cristallines de ceux-ci
WO2012055351A1 (fr) 2010-10-27 2012-05-03 浙江九洲药业股份有限公司 Structure cristalline d'hydrochlorure de nilotinib et son procédé de préparation
WO2012070062A2 (fr) 2010-11-26 2012-05-31 Hetero Research Foundation Nouveau polymorphe de chlorhydrate de nilotinib
US20130210847A1 (en) 2012-02-15 2013-08-15 Natco Pharma Limited Process for the preparation of nilotinib

Patent Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7169791B2 (en) 2002-07-05 2007-01-30 Novartis Ag Inhibitors of tyrosine kinases
WO2006135641A2 (fr) 2005-06-09 2006-12-21 Novartis Ag Procede de synthese de composes organiques
WO2007015871A1 (fr) 2005-07-20 2007-02-08 Novartis Ag Sels de 4-methyl-n-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide
WO2007015870A2 (fr) 2005-07-20 2007-02-08 Novartis Ag Formes cristallines de 4-methyl-n-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide
WO2010009402A2 (fr) 2008-07-17 2010-01-21 Teva Pharmaceutical Industries Ltd. Intermédiaires de nilotinib, et leur préparation
WO2010054056A2 (fr) 2008-11-05 2010-05-14 Teva Pharmaceutical Industries Ltd. Formes cristallines du chlorhydrate de nilotinib
WO2011033307A1 (fr) 2009-09-17 2011-03-24 Generics [Uk] Limited Sel de dichlorhydrate de nilotinib
WO2011086541A1 (fr) 2010-01-15 2011-07-21 Generics [Uk] Limited Nouveau polymorphe de monochlorhydrate de nilotinib monohydraté
WO2011163222A1 (fr) 2010-06-21 2011-12-29 Teva Pharmaceutical Industries Ltd. Sels de nilotinib et formes cristallines de ceux-ci
WO2012055351A1 (fr) 2010-10-27 2012-05-03 浙江九洲药业股份有限公司 Structure cristalline d'hydrochlorure de nilotinib et son procédé de préparation
WO2012070062A2 (fr) 2010-11-26 2012-05-31 Hetero Research Foundation Nouveau polymorphe de chlorhydrate de nilotinib
US20130210847A1 (en) 2012-02-15 2013-08-15 Natco Pharma Limited Process for the preparation of nilotinib

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113292537A (zh) * 2018-06-15 2021-08-24 汉达癌症医药责任有限公司 激酶抑制剂的盐类及其组合物
CN113292537B (zh) * 2018-06-15 2024-04-05 汉达癌症医药责任有限公司 激酶抑制剂的盐类及其组合物
WO2021161347A1 (fr) 2020-02-15 2021-08-19 Cipla Limited Nouveaux sels de nilotinib et formes polymorphes de celui-ci

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