BR112017010445B8 - Processo de produção de cristais de derivado de diazabiciclo-octano e preparação liofilizada estável - Google Patents

Processo de produção de cristais de derivado de diazabiciclo-octano e preparação liofilizada estável

Info

Publication number
BR112017010445B8
BR112017010445B8 BR112017010445A BR112017010445A BR112017010445B8 BR 112017010445 B8 BR112017010445 B8 BR 112017010445B8 BR 112017010445 A BR112017010445 A BR 112017010445A BR 112017010445 A BR112017010445 A BR 112017010445A BR 112017010445 B8 BR112017010445 B8 BR 112017010445B8
Authority
BR
Brazil
Prior art keywords
compound
diazabicyclo
production process
stable lyophilized
crystals
Prior art date
Application number
BR112017010445A
Other languages
English (en)
Other versions
BR112017010445A2 (pt
BR112017010445B1 (pt
Inventor
Kenichi Fushihara
Masato Ichiki
Shusuke Furuyama
Takaya Ogawa
Takuya Yokoyama
Original Assignee
Meiji Seika Pharma Co 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 Meiji Seika Pharma Co Ltd filed Critical Meiji Seika Pharma Co Ltd
Publication of BR112017010445A2 publication Critical patent/BR112017010445A2/pt
Publication of BR112017010445B1 publication Critical patent/BR112017010445B1/pt
Publication of BR112017010445B8 publication Critical patent/BR112017010445B8/pt

Links

Classifications

    • 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
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D471/00—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, at least one ring being a six-membered ring with one nitrogen atom, not provided for by groups C07D451/00 - C07D463/00
    • C07D471/02—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, at least one ring being a six-membered ring with one nitrogen atom, not provided for by groups C07D451/00 - C07D463/00 in which the condensed system contains two hetero rings
    • C07D471/08—Bridged systems
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/439—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom the ring forming part of a bridged ring system, e.g. quinuclidine
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00—Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13—Crystalline forms, e.g. polymorphs

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
  • Medicinal Preparation (AREA)

Abstract

processo de produção de cristais de derivado de diazabiciclo-octano e preparação liofilizada estável. os objetivos da presente invenção são fornecer um processo para produção de cristais do composto (i) facilmente em uma escala industrial e uma composição liofilizada estável do composto (i). foi descoberto que a submissão de uma solução aquosa que contém o composto (i) e um sal inorgânico tal como cloreto de sódio à liofilização produz uma composição liofilizada que possui boa estabilidade de armazenamento em que o composto (i) é cristalino e adicionalmente que os cristais do composto (i) podem ser obtidos a partir da dita solução aquosa sem liofilização.
BR112017010445A 2014-12-05 2015-12-04 Processo de produção de cristais de derivado de diazabiciclo-octano e preparação liofilizada estável BR112017010445B8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2014246425 2014-12-05
JP2014-246425 2014-12-05
PCT/JP2015/084094 WO2016088863A1 (ja) 2014-12-05 2015-12-04 ジアザビシクロオクタン誘導体の結晶及び安定な凍結乾燥製剤の製造法

Publications (3)

Publication Number Publication Date
BR112017010445A2 BR112017010445A2 (pt) 2017-12-26
BR112017010445B1 BR112017010445B1 (pt) 2024-01-30
BR112017010445B8 true BR112017010445B8 (pt) 2024-02-27

Family

ID=56091802

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112017010445A BR112017010445B8 (pt) 2014-12-05 2015-12-04 Processo de produção de cristais de derivado de diazabiciclo-octano e preparação liofilizada estável

Country Status (18)

Country Link
US (2) US10294224B2 (pt)
EP (1) EP3228620B1 (pt)
JP (1) JP6779787B2 (pt)
KR (1) KR102555657B1 (pt)
CN (1) CN107001366B (pt)
AR (1) AR102915A1 (pt)
AU (1) AU2015355970B2 (pt)
BR (1) BR112017010445B8 (pt)
CA (1) CA2969192C (pt)
ES (1) ES2821826T3 (pt)
IL (1) IL252691B (pt)
MX (1) MX2017007191A (pt)
MY (1) MY190283A (pt)
RU (1) RU2732129C2 (pt)
SG (1) SG11201704576SA (pt)
TW (1) TWI691499B (pt)
WO (1) WO2016088863A1 (pt)
ZA (1) ZA201704063B (pt)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX366948B (es) 2012-05-30 2019-07-30 Meiji Seika Pharma Co Ltd Nuevo inhibidor de beta-lactamasa y proceso para prepararlo.
JP6617029B2 (ja) 2013-10-08 2019-12-04 Ｍｅｉｊｉ Ｓｅｉｋａファルマ株式会社 ジアザビシクロオクタン誘導体の結晶とその製造法
US10294224B2 (en) 2014-12-05 2019-05-21 Meiji Seika Pharma Co., Ltd. Lyophilized composition of a diazabicyclooctane compound and process of producing the same
CA3076959A1 (en) * 2017-09-27 2019-04-04 Fedora Pharmaceuticals Inc. Crystalline forms of diazabicyclooctane derivatives and production process thereof
TW201920174A (zh) 2017-09-27 2019-06-01 瑞士商羅氏大藥廠股份有限公司 二氮雜雙環辛烷衍生物之醫藥形式及其製法
WO2019064065A1 (en) * 2017-09-27 2019-04-04 F. Hoffmann-La Roche Ag PHARMACEUTICAL FORMS OF DIAZABICYCLOOCTANE DERIVATIVES AND METHOD FOR THE PRODUCTION THEREOF
JP6375463B1 (ja) * 2018-02-28 2018-08-15 日本曹達株式会社 ビス（フルオロスルホニル）アミドアルカリ金属塩粉末の製造方法
CN110314163A (zh) * 2018-03-30 2019-10-11 杭州森泽医药科技有限公司 一种拉氧头孢钠药物组合物及应用
JP2022094481A (ja) * 2020-12-15 2022-06-27 大阪瓦斯株式会社 ヒドロキシアルカン酸結晶の製造方法及びヒドロキシアルカン酸の結晶多形体

Family Cites Families (33)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6019759B2 (ja) 1977-11-24 1985-05-17 イ−ライ・リリ−・アンド・カンパニ− 非経口投予用１１１１５１５２１３９１９９東京都中央区京橋２丁目３番１３号
GB1589317A (en) * 1977-11-24 1981-05-13 Lilly Co Eli Freeze drying cephalothin sodium
JPS6019759A (ja) 1983-07-15 1985-01-31 Nippon Soda Co Ltd ホルムアミドオキシム誘導体その製造方法及び農園芸用殺菌剤
JPS60255723A (ja) 1984-05-31 1985-12-17 Ono Pharmaceut Co Ltd メシル酸ガベキサートの結晶性凍結乾燥製剤及びその製造方法
JPH07117533B2 (ja) 1985-08-28 1995-12-18 株式会社生体科学研究所 トランスフエリンおよびその用途
PL157979B1 (pl) 1989-02-14 1992-07-31 Sprezyna z dwoma stanami równowagi trwalej PL PL
US20030220521A1 (en) 1989-07-27 2003-11-27 G.D. Searle & Co. Renal-selective prodrugs for control of renal sympathetic nerve activity in the treatment of hypertension
TW264475B (pt) 1991-09-20 1995-12-01 Takeda Pharm Industry Co Ltd
AU700545B2 (en) * 1994-05-02 1999-01-07 Shionogi & Co., Ltd. Crystal of pyrrolidylthiocarbapenem derivative, lyophilized preparation containing said crystal, and process for producing the same
JP2843444B2 (ja) 1994-05-02 1999-01-06 塩野義製薬株式会社 ピロリジルチオカルバペネム誘導体の結晶，該結晶を含む凍結乾燥製剤，およびその製造方法
DE19531874C1 (de) 1995-08-30 1996-10-02 Daimler Benz Ag Seitenwandbaugruppe für eine Kraftfahrzeugkarosserie
TWI233805B (en) * 1999-07-01 2005-06-11 Fujisawa Pharmaceutical Co Stabilized pharmaceutical composition in lyophilized form as antifungal agent
FR2812635B1 (fr) 2000-08-01 2002-10-11 Aventis Pharma Sa Nouveaux composes heterocycliques, preparation et utilisation comme medicaments notamment comme anti- bacteriens
FR2825705B1 (fr) 2001-06-08 2005-05-20 Aventis Pharma Sa Nouveaux composes heterocycliques, leur preparation et leur utilisation comme medicaments, notamment comme anti-bacteriens
FR2835186B1 (fr) 2002-01-28 2006-10-20 Aventis Pharma Sa Nouveaux composes heterocycliques, actifs comme inhibiteurs de beta-lactamases
FR2921060B1 (fr) 2007-09-14 2012-06-15 Novexel Nouveau procede de preparation d'une piperidine disubsituee et nouveaux intermediaires
UA101966C2 (en) 2008-01-18 2013-05-27 Мерк Шарп Енд Доме Корп. Beta-lactamase inhibitors
FR2930553B1 (fr) 2008-04-29 2010-05-21 Novexel Composes azabicycliques, leur preparation et leur utilisation comme medicaments, notamment inhibiteurs de beta-lactamases
FR2936798B1 (fr) 2008-10-03 2012-09-28 Novexel Nouveaux composes heterocycliques azotes, leur preparation et leur utilisation comme medicaments antibacteriens.
WO2010126820A2 (en) 2009-04-30 2010-11-04 Merck Sharp & Dohme Corp. Preparation of alkyl esters of n-protected oxo-azacycloalkylcarboxylic acids
FR2951171A1 (fr) 2009-10-09 2011-04-15 Novexel Nouveau sel de sodium d'un compose azabicyclique sous forme enantiomere cristallisee et nouvelles formes polymorphes et pseudopolymorphes ainsi que leur preparation
US8772490B2 (en) 2010-12-22 2014-07-08 Meiji Seika Pharma Co., Ltd. Optically active diazabicyclooctane derivatives and process for preparing the same
CN103328476B (zh) 2010-12-22 2016-12-28 明治制果药业株式会社 光学活性二氮杂环辛烷衍生物及其制备方法
RU2769076C2 (ru) 2011-06-17 2022-03-28 Пфайзер Анти-Инфективз Аб Способ получения гетероциклических соединений, включая транс-7-оксо-6-(сульфокси)-1,6-диазабицикло[3.2.1]октан-2-карбоксамид и его соли
JP5666743B2 (ja) 2011-08-27 2015-02-12 ウォックハート リミテッド １，６−ジアザビシクロ［３，２，１］オクタン−７−オン誘導体および細菌感染の処置におけるそれらの使用
WO2013030735A1 (en) 2011-08-30 2013-03-07 Wockhardt Limited 1,6- diazabicyclo [3,2,1] octan- 7 - one derivatives and their use in the treatment of bacterial infections
AU2012310136B2 (en) 2011-09-13 2016-07-07 Wockhardt Limited Nitrogen containing compounds and their use
US8796257B2 (en) 2011-12-02 2014-08-05 Naeja Pharmaceutical Inc. Bicyclic compounds and their use as antibacterial agents and β-lactamase inhibitors
US9505761B2 (en) 2011-12-02 2016-11-29 Fedora Pharmaceuticals Inc. Bicyclic compounds and their use as antibacterial agents and beta-lactamase inhibitors
MX366948B (es) 2012-05-30 2019-07-30 Meiji Seika Pharma Co Ltd Nuevo inhibidor de beta-lactamasa y proceso para prepararlo.
HUE049027T2 (hu) * 2013-09-24 2020-08-28 Meiji Seika Pharma Co Ltd Diazabiciklooktán-származékok és intermedierek elõállítási eljárása
JP6617029B2 (ja) 2013-10-08 2019-12-04 Ｍｅｉｊｉ Ｓｅｉｋａファルマ株式会社 ジアザビシクロオクタン誘導体の結晶とその製造法
US10294224B2 (en) 2014-12-05 2019-05-21 Meiji Seika Pharma Co., Ltd. Lyophilized composition of a diazabicyclooctane compound and process of producing the same

Also Published As

Publication number Publication date
IL252691A0 (en) 2017-08-31
US11117895B2 (en) 2021-09-14
RU2017123112A (ru) 2019-01-09
WO2016088863A1 (ja) 2016-06-09
EP3228620A1 (en) 2017-10-11
RU2732129C2 (ru) 2020-09-11
AU2015355970A1 (en) 2017-06-15
CN107001366A (zh) 2017-08-01
BR112017010445A2 (pt) 2017-12-26
AU2015355970B2 (en) 2020-05-21
NZ732214A (en) 2021-10-29
KR102555657B1 (ko) 2023-07-18
AR102915A1 (es) 2017-04-05
ZA201704063B (en) 2021-10-27
IL252691B (en) 2020-08-31
US10294224B2 (en) 2019-05-21
CN107001366B (zh) 2020-08-28
JPWO2016088863A1 (ja) 2017-09-14
EP3228620B1 (en) 2020-09-02
MX2017007191A (es) 2017-08-28
KR20170094272A (ko) 2017-08-17
CA2969192A1 (en) 2016-06-09
RU2017123112A3 (pt) 2019-06-25
TWI691499B (zh) 2020-04-21
CA2969192C (en) 2023-02-28
EP3228620A4 (en) 2018-05-02
TW201629062A (zh) 2016-08-16
BR112017010445B1 (pt) 2024-01-30
US20190202831A1 (en) 2019-07-04
MY190283A (en) 2022-04-12
US20170327499A1 (en) 2017-11-16
JP6779787B2 (ja) 2020-11-04
SG11201704576SA (en) 2017-07-28
ES2821826T3 (es) 2021-04-27

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B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
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