SG11202000098RA - Polymorphic forms of dasatinib - Google Patents

Polymorphic forms of dasatinib

Info

Publication number
SG11202000098RA
SG11202000098RA SG11202000098RA SG11202000098RA SG11202000098RA SG 11202000098R A SG11202000098R A SG 11202000098RA SG 11202000098R A SG11202000098R A SG 11202000098RA SG 11202000098R A SG11202000098R A SG 11202000098RA SG 11202000098R A SG11202000098R A SG 11202000098RA
Authority
SG
Singapore
Prior art keywords
dasatinib
international
present
butanediol
preparation
Prior art date
Application number
SG11202000098RA
Inventor
Ramakrishna Bhat
Jithendrababu Raghunadhachetty
Mariappan Kaliappan
Venkata Palle
Vijaybhaskar Regalla
Original Assignee
Biocon Ltd
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 Biocon Ltd filed Critical Biocon Ltd
Publication of SG11202000098RA publication Critical patent/SG11202000098RA/en

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D417/00Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and sulfur atoms as the only ring hetero atoms, not provided for by group C07D415/00
    • C07D417/14Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and sulfur atoms as the only ring hetero atoms, not provided for by group C07D415/00 containing three or more hetero rings
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D417/00Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and sulfur atoms as the only ring hetero atoms, not provided for by group C07D415/00
    • C07D417/02Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and sulfur atoms as the only ring hetero atoms, not provided for by group C07D415/00 containing two hetero rings
    • C07D417/12Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and sulfur atoms as the only ring hetero atoms, not provided for by group C07D415/00 containing two hetero rings linked by a chain containing hetero atoms as chain links
    • 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
    • A61P35/02Antineoplastic agents specific for leukemia
    • 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

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Oncology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Epidemiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Plural Heterocyclic Compounds (AREA)

Abstract

21heta - Scale Figure 3 (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) oviolo Ina oimIE (19) World Intellectual Property Organization International Bureau (10) International Publication Number WO 2019/008555 Al (43) International Publication Date 10 January 2019 (10.01.2019) WIPO I PCT Uttara Kannada 581327 (IN). RAGHUNADHACHET- TY, Jithendrababu; No .7-138/D/10, Aragonda, Tha- vanam Palli Mandal, Andhra Pradesh, Chittoor District 517129 (IN). KALIAPPAN, Mariappan; Sri Sangili Matha Stores, Keelakuyilkudi Villakku, Theni Main Road, Nagamalai, Tamilnadu, Madurai 625019 (IN). PALLE, Venkata, Raghavendracharyulu; 194/A, Mythri Nagar, Madinaguda, Miyapur, Telangana, Hyderabad 500049 (IN). REGALLA, VijayBhaskar, Reddy; H.No: 1-102-1, Cha- trai (mandal & Post), Burugugudem Road, Andhra Pradesh, Krishna District 521214 (IN). (74) Agent: MAJUMDAR, Subhatosh et al.; S. Majumdar & Co., 5, Harish Mukherjee Road, West Bengal, Kolkata 700 025 (IN). (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, (51) International Patent Classification: CO7D 417/12 (2006.01) (21) International Application Number: PCT/IB2018/055022 07 July 2018 (07.07.2018) English English (22) International Filing Date: (25) Filing Language: (26) Publication Language: (30) Priority Data: 201741024067 07 July 2017 (07.07.2017) IN 201741029965 24 August 2017 (24.08.2017) IN 201841001249 11 January 2018 (11.01.2018) IN 201841007613 28 February 2018 (28.02.2018) IN (71) Applicant: BIOCON LIMITED [IN/IN]; 20th KM, Hosur Road, Electronic City, Karnataka, Bangalore 560 100 (IN). (72) Inventors: BHAT, Ramakrishna, Parameshwar; Kadekodi, Po: Dhareshwar, Ta: Kumta, Karnataka, Dist: (54) Title: POLYMORPHIC FORMS OF DASATINIB 15<x.2' n.f)f) 11 C 9000 anon r•-• .• W O 20 19/008555 Al (57) : The present invention provides for the dasatinib- thymine co-crystal and dasatinib-adenine co-crystal. The present invention further provides dasatinib-butanediol solvate. The present invention further provides for crystalline dasatinib-(f) — 1, 2-Butane diol, crystalline dasatinib (R)-1, 2-Butanediol, crystalline dasatinib (S)-1, 2-Butanediol and crystalline dasatinib (±)-2, 3-Butanediol and processes for preparation thereof. The present invention also provides for a process for preparation of amorphous dasatinib using dasatinib- butanediol solvate. The present invention further provides for the preparation of anhydrous dasatinib. The present invention also provides for a process for preparation of dasatinib monohydrate from anhydrous dasatinib [Continued on next page] WO 2019/008555 Al MIDEDIMOMOIDEIROMOIDOVIIMHEMMODEVOIMIE KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). Declarations under Rule 4.17: as to applicant's entitlement to apply for and be granted a patent (Rule 4.17(ii)) as to the applicant's entitlement to claim the priority of the earlier application (Rule 4.17(iii)) Published: — with international search report (Art. 21(3))
SG11202000098RA 2017-07-07 2018-07-07 Polymorphic forms of dasatinib SG11202000098RA (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
IN201741024067 2017-07-07
IN201741029965 2017-08-24
IN201841001249 2018-01-11
IN201841007613 2018-02-28
PCT/IB2018/055022 WO2019008555A1 (en) 2017-07-07 2018-07-07 Polymorphic forms of dasatinib

Publications (1)

Publication Number Publication Date
SG11202000098RA true SG11202000098RA (en) 2020-02-27

Family

ID=64949779

Family Applications (1)

Application Number Title Priority Date Filing Date
SG11202000098RA SG11202000098RA (en) 2017-07-07 2018-07-07 Polymorphic forms of dasatinib

Country Status (12)

Country Link
US (1) US11059813B2 (en)
EP (1) EP3649126A4 (en)
JP (1) JP2020526528A (en)
KR (1) KR20200036867A (en)
CN (1) CN111108104A (en)
AU (1) AU2018297710A1 (en)
BR (1) BR112020000302A2 (en)
CA (1) CA3069107A1 (en)
MX (1) MX2020000185A (en)
RU (1) RU2020105723A (en)
SG (1) SG11202000098RA (en)
WO (1) WO2019008555A1 (en)

Family Cites Families (21)

* Cited by examiner, † Cited by third party
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MXPA01010292A (en) 1999-04-15 2002-10-23 Squibb Bristol Myers Co Cyclic protein tyrosine kinase inhibitors.
US7491725B2 (en) 2004-02-06 2009-02-17 Bristol-Myers Squibb Company Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors
TWI338004B (en) * 2004-02-06 2011-03-01 Bristol Myers Squibb Co Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors
EP1937270A1 (en) 2005-09-21 2008-07-02 Brystol-Myers Squibb Company Oral administration of n-(2-chloro-6-methylphenyl)-2-[[6-4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-1,3-thiazole-5-carboxamide and salts thereof
EP2508523B2 (en) * 2007-10-23 2019-04-17 Teva Pharmaceutical Industries Ltd. Polymorphs of dasatinib and process for preparation thereof
WO2010062715A2 (en) 2008-11-03 2010-06-03 Teva Pharmaceutical Industries Ltd. Polymorphs of dasatinib and process for preparation thereof
WO2010067374A2 (en) 2008-12-08 2010-06-17 Hetero Research Foundation Polymorphs of dasatinib
CN102040596A (en) * 2009-10-10 2011-05-04 上海希迪制药有限公司 Dasatinib polymorph and preparation method thereof
CN102030745B (en) 2010-11-26 2012-05-09 江苏先声药物研究有限公司 Dasatinib solvate and preparation method thereof
CN102086195B (en) * 2011-01-28 2013-04-03 南京卡文迪许生物工程技术有限公司 Dasatinib polymorphic substance as well as preparation method and medicinal composition thereof
ES2637829T3 (en) 2012-06-15 2017-10-17 Basf Se Multi-component crystals comprising dasatinib and selected co-crystal forming agents
CZ306598B6 (en) * 2012-12-06 2017-03-22 Zentiva, K.S. A method of preparation and purification of new and known polymorphs and dasatinib solvates
WO2015049645A2 (en) * 2013-10-04 2015-04-09 Alembic Pharmaceuticals Limited An improved process for the preparation of dasatinib
EP3160963A1 (en) * 2014-06-30 2017-05-03 Basf Se Multicomponent crystals of dasatinib with menthol or vanillin
EP3186284B1 (en) 2014-08-28 2022-04-06 BioAtla, Inc. Conditionally active chimeric antigen receptors for modified t-cells
WO2016178148A1 (en) * 2015-05-05 2016-11-10 Glenmark Pharmaceuticals Limited Process for preparation of dapagliflozin
US10301302B2 (en) * 2015-06-29 2019-05-28 Msn Laboratories Private Limited Crystalline forms of N-(2-chloro-6-methy]phenvn-2-[F6-[4-(2-hvdroxvethvl)-L-piperazin-vil-2-methvil-4-pvrimidinvllaminol-5-thiazolecarboxamide and their process thereof
US9845303B2 (en) * 2015-10-19 2017-12-19 Cadila Healthcare Limited Process for the preparation of dapagliflozin
WO2017098391A1 (en) 2015-12-11 2017-06-15 Shilpa Medicare Limited Process for the preparation of dasatinib
WO2017134617A1 (en) * 2016-02-03 2017-08-10 Dr. Reddy's Laboratories Limited Process for the preparation of amorphous dasatinib
US10464933B2 (en) * 2016-02-03 2019-11-05 Dr. Reddy's Laboratories Limited Solid state forms of dasatinib and processes for their preparation

Also Published As

Publication number Publication date
EP3649126A4 (en) 2021-04-07
EP3649126A1 (en) 2020-05-13
BR112020000302A2 (en) 2020-07-14
JP2020526528A (en) 2020-08-31
CN111108104A (en) 2020-05-05
US20200377495A1 (en) 2020-12-03
MX2020000185A (en) 2021-01-29
CA3069107A1 (en) 2019-01-10
RU2020105723A (en) 2021-08-09
AU2018297710A2 (en) 2020-03-05
AU2018297710A1 (en) 2020-02-27
WO2019008555A1 (en) 2019-01-10
KR20200036867A (en) 2020-04-07
US11059813B2 (en) 2021-07-13

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