SI3433285T1 - Izboljšan postopek za pripravo sugamadeksa - Google Patents

Izboljšan postopek za pripravo sugamadeksa

Info

Publication number
SI3433285T1
SI3433285T1 SI201730346T SI201730346T SI3433285T1 SI 3433285 T1 SI3433285 T1 SI 3433285T1 SI 201730346 T SI201730346 T SI 201730346T SI 201730346 T SI201730346 T SI 201730346T SI 3433285 T1 SI3433285 T1 SI 3433285T1
Authority
SI
Slovenia
Prior art keywords
sugammadex
preparation
improved process
improved
Prior art date
Application number
SI201730346T
Other languages
English (en)
Inventor
Walter Cabri
Antonio Ricci
Jacopo Zanon
Saswata Lahiri
Govind Singh
Shivaji Haribhau Shelke
Tapanjyoti Biswal
Nitin Kumar
Madan Singh
Original Assignee
Fresenius Kabi Ipsum S.R.L.
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 Fresenius Kabi Ipsum S.R.L. filed Critical Fresenius Kabi Ipsum S.R.L.
Publication of SI3433285T1 publication Critical patent/SI3433285T1/sl

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08BPOLYSACCHARIDES; DERIVATIVES THEREOF
    • C08B37/00Preparation of polysaccharides not provided for in groups C08B1/00 - C08B35/00; Derivatives thereof
    • C08B37/0006Homoglycans, i.e. polysaccharides having a main chain consisting of one single sugar, e.g. colominic acid
    • C08B37/0009Homoglycans, i.e. polysaccharides having a main chain consisting of one single sugar, e.g. colominic acid alpha-D-Glucans, e.g. polydextrose, alternan, glycogen; (alpha-1,4)(alpha-1,6)-D-Glucans; (alpha-1,3)(alpha-1,4)-D-Glucans, e.g. isolichenan or nigeran; (alpha-1,4)-D-Glucans; (alpha-1,3)-D-Glucans, e.g. pseudonigeran; Derivatives thereof
    • C08B37/0012Cyclodextrin [CD], e.g. cycle with 6 units (alpha), with 7 units (beta) and with 8 units (gamma), large-ring cyclodextrin or cycloamylose with 9 units or more; Derivatives thereof
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C319/00Preparation of thiols, sulfides, hydropolysulfides or polysulfides
    • C07C319/02Preparation of thiols, sulfides, hydropolysulfides or polysulfides of thiols
    • C07C319/12Preparation of thiols, sulfides, hydropolysulfides or polysulfides of thiols by reactions not involving the formation of mercapto groups
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C323/00Thiols, sulfides, hydropolysulfides or polysulfides substituted by halogen, oxygen or nitrogen atoms, or by sulfur atoms not being part of thio groups
    • C07C323/50Thiols, sulfides, hydropolysulfides or polysulfides substituted by halogen, oxygen or nitrogen atoms, or by sulfur atoms not being part of thio groups containing thio groups and carboxyl groups bound to the same carbon skeleton
    • C07C323/51Thiols, sulfides, hydropolysulfides or polysulfides substituted by halogen, oxygen or nitrogen atoms, or by sulfur atoms not being part of thio groups containing thio groups and carboxyl groups bound to the same carbon skeleton having the sulfur atoms of the thio groups bound to acyclic carbon atoms of the carbon skeleton
    • C07C323/52Thiols, sulfides, hydropolysulfides or polysulfides substituted by halogen, oxygen or nitrogen atoms, or by sulfur atoms not being part of thio groups containing thio groups and carboxyl groups bound to the same carbon skeleton having the sulfur atoms of the thio groups bound to acyclic carbon atoms of the carbon skeleton the carbon skeleton being acyclic and saturated
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08BPOLYSACCHARIDES; DERIVATIVES THEREOF
    • C08B37/00Preparation of polysaccharides not provided for in groups C08B1/00 - C08B35/00; Derivatives thereof
    • C08B37/0003General processes for their isolation or fractionation, e.g. purification or extraction from biomass

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Materials Engineering (AREA)
  • Molecular Biology (AREA)
  • Medicinal Chemistry (AREA)
  • Polymers & Plastics (AREA)
  • General Health & Medical Sciences (AREA)
  • Sustainable Development (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Polysaccharides And Polysaccharide Derivatives (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
SI201730346T 2016-03-22 2017-03-20 Izboljšan postopek za pripravo sugamadeksa SI3433285T1 (sl)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN201611009993 2016-03-22
EP17720572.1A EP3433285B1 (en) 2016-03-22 2017-03-20 An improved process for the preparation of sugammadex
PCT/IB2017/051594 WO2017163165A1 (en) 2016-03-22 2017-03-20 An improved process for the preparation of sugammadex

Publications (1)

Publication Number Publication Date
SI3433285T1 true SI3433285T1 (sl) 2020-10-30

Family

ID=58645335

Family Applications (1)

Application Number Title Priority Date Filing Date
SI201730346T SI3433285T1 (sl) 2016-03-22 2017-03-20 Izboljšan postopek za pripravo sugamadeksa

Country Status (9)

Country Link
US (1) US10577433B2 (sl)
EP (2) EP3733717A3 (sl)
JP (1) JP6829304B2 (sl)
KR (1) KR20180127428A (sl)
CN (1) CN108779186B (sl)
AU (1) AU2017236669B2 (sl)
ES (1) ES2810980T3 (sl)
SI (1) SI3433285T1 (sl)
WO (1) WO2017163165A1 (sl)

Families Citing this family (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3741779A1 (en) 2015-11-25 2020-11-25 Fresenius Kabi iPSUM S.r.l. An improved process for the preparation of sugammadex and its intermediates
ES2812226T5 (es) 2015-11-25 2024-04-29 Fresenius Kabi Ipsum S R L Formas cristalinas de percloro-gamma-ciclodextrinas
ES2915423T3 (es) 2016-06-23 2022-06-22 Synthon Bv Proceso de preparación de sugammadex
US10385142B2 (en) * 2017-01-23 2019-08-20 Scinopharm Taiwan, Ltd. Method for preparing sugammadex sodium
US10336835B2 (en) * 2017-08-23 2019-07-02 Formosa Laboratories, Inc. Polymorphs of sugammadex and process for preparation of sugammadex
WO2019102009A1 (en) 2017-11-27 2019-05-31 Medichem, S.A. Process for the synthesis of a cyclodextrin derivative
CN107892727B (zh) * 2017-11-27 2019-12-24 合肥博思科创医药科技有限公司 一种舒更葡糖钠的纯化方法
US11225565B2 (en) 2018-04-06 2022-01-18 Synthon B.V. Purification of sugammadex
CA3102090C (en) * 2018-06-07 2024-05-21 Merck Sharp & Dohme Corp. Processes for the preparation of sugammadex
CN110655594B (zh) * 2018-06-29 2021-04-30 江苏海悦康医药科技有限公司 一种单羟基舒更葡糖钠的制备方法
WO2020013759A1 (en) * 2018-07-12 2020-01-16 Scinopharm Taiwan Ltd. Method for preparing sugammadex sodium
CN109053933B (zh) * 2018-08-01 2020-10-23 合肥博思科创医药科技有限公司 一种无定型舒更葡糖钠的制备方法
WO2020058987A1 (en) 2018-09-20 2020-03-26 Natco Pharma Limited An improved process for the preparation of sugammadex sodium and its novel polymorphic form
US20220049023A1 (en) * 2018-09-27 2022-02-17 Werthenstein Biopharma Gmbh Novel crystalline forms of sugammadex
CN109824800A (zh) * 2018-12-29 2019-05-31 鼎元(天津)生物医药科技有限公司 一种选择性肌松拮抗药舒更葡萄糖钠的制备方法
CN109593143B (zh) * 2018-12-29 2021-02-09 博瑞生物医药(苏州)股份有限公司 一种舒更葡糖钠制备中间体的纯化方法
EP3753946A1 (en) 2019-06-18 2020-12-23 Fresenius Kabi iPSUM S.r.l. Improved process for the preparation of high purity glucagon
US11324692B2 (en) 2019-07-03 2022-05-10 Galenicum Health S.L.U. Method to prepare pharmaceutical compositions of suggamadex
US20230167203A1 (en) 2020-02-28 2023-06-01 Medichem, S.A. Method for drying sugammadex
CN113456598B (zh) * 2020-03-31 2024-04-02 鲁南制药集团股份有限公司 一种舒更葡糖钠冻干粉针剂及其制备方法
US11097023B1 (en) 2020-07-02 2021-08-24 Par Pharmaceutical, Inc. Pre-filled syringe containing sugammadex
ES2949710T1 (es) 2020-07-03 2023-10-02 Galenicum Health S L U Método para preparar composiciones farmacéuticas
CN112279938A (zh) * 2020-10-26 2021-01-29 江苏阿尔法药业有限公司 一种舒更葡糖钠药物中间体的制备方法
CN115266968A (zh) * 2022-03-30 2022-11-01 上海上药创新医药技术有限公司 一种hplc分离测定舒更葡糖钠中间体及其杂质的方法

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI242015B (en) 1999-11-29 2005-10-21 Akzo Nobel Nv 6-mercapto-cyclodextrin derivatives: reversal agents for drug-induced neuromuscular block
CN101864003B (zh) 2010-06-11 2012-05-02 漆又毛 一种6-脱氧硫醚氨基酸环糊精衍生物的合成方法
US9120876B2 (en) * 2010-08-25 2015-09-01 Ramamohan Rao Davuluri Process for preparation of Sugammadex
US9879096B2 (en) * 2013-02-14 2018-01-30 Neuland Laboratories Limited Process for preparation of sugammadex sodium
CN105273095A (zh) 2014-05-28 2016-01-27 四川海思科制药有限公司 一种舒更葡糖钠及其中间体的制备方法
CN104844732B (zh) * 2015-03-27 2017-05-03 山东滨州智源生物科技有限公司 一种舒更葡糖钠的制备方法
US10494450B2 (en) 2015-05-29 2019-12-03 Lakshmi Prasad ALAPARTHI Processes for preparation of Sugammadex and intermediates thereof
CN106749771A (zh) * 2015-11-23 2017-05-31 成都渊源生物科技有限公司 一种高纯度的舒更葡糖钠制备方法
EP3741779A1 (en) 2015-11-25 2020-11-25 Fresenius Kabi iPSUM S.r.l. An improved process for the preparation of sugammadex and its intermediates
ES2812226T5 (es) 2015-11-25 2024-04-29 Fresenius Kabi Ipsum S R L Formas cristalinas de percloro-gamma-ciclodextrinas

Also Published As

Publication number Publication date
EP3733717A2 (en) 2020-11-04
JP6829304B2 (ja) 2021-02-10
AU2017236669A1 (en) 2018-09-27
US20190284308A1 (en) 2019-09-19
EP3433285A1 (en) 2019-01-30
KR20180127428A (ko) 2018-11-28
AU2017236669B2 (en) 2021-02-18
US10577433B2 (en) 2020-03-03
ES2810980T3 (es) 2021-03-10
EP3733717A3 (en) 2020-12-30
CN108779186A (zh) 2018-11-09
EP3433285B1 (en) 2020-06-03
JP2019510128A (ja) 2019-04-11
WO2017163165A1 (en) 2017-09-28
CN108779186B (zh) 2021-07-13

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