JP2008543871A - チゲサイクリンのための製造プロセス - Google Patents

チゲサイクリンのための製造プロセス Download PDF

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Publication number
JP2008543871A
JP2008543871A JP2008517178A JP2008517178A JP2008543871A JP 2008543871 A JP2008543871 A JP 2008543871A JP 2008517178 A JP2008517178 A JP 2008517178A JP 2008517178 A JP2008517178 A JP 2008517178A JP 2008543871 A JP2008543871 A JP 2008543871A
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JP
Japan
Prior art keywords
tigecycline
solution
ppm
water
temperature
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
JP2008517178A
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English (en)
Japanese (ja)
Other versions
JP2008543871A5 (cg-RX-API-DMAC10.html
Inventor
グルムク チャナナ,
ドミニク ベンチュラ,
リチャード サンダース,
マーディ ビー. ファウジ,
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Wyeth LLC
Original Assignee
Wyeth LLC
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 Wyeth LLC filed Critical Wyeth LLC
Publication of JP2008543871A publication Critical patent/JP2008543871A/ja
Publication of JP2008543871A5 publication Critical patent/JP2008543871A5/ja
Pending legal-status Critical Current

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    • 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
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • 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
    • A61K31/65—Tetracyclines
    • 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
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C231/00—Preparation of carboxylic acid amides
    • C07C231/12—Preparation of carboxylic acid amides by reactions not involving the formation of carboxamide groups
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C231/00—Preparation of carboxylic acid amides
    • C07C231/22—Separation; Purification; Stabilisation; Use of additives
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C2603/00—Systems containing at least three condensed rings
    • C07C2603/02—Ortho- or ortho- and peri-condensed systems
    • C07C2603/40—Ortho- or ortho- and peri-condensed systems containing four condensed rings
    • C07C2603/42—Ortho- or ortho- and peri-condensed systems containing four condensed rings containing only six-membered rings
    • C07C2603/44—Naphthacenes; Hydrogenated naphthacenes
    • C07C2603/46—1,4,4a,5,5a,6,11,12a- Octahydronaphthacenes, e.g. tetracyclines

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (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)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Dermatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
  • Medicinal Preparation (AREA)
JP2008517178A 2005-06-16 2006-06-16 チゲサイクリンのための製造プロセス Pending JP2008543871A (ja)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US69117305P 2005-06-16 2005-06-16
PCT/US2006/023613 WO2006138641A2 (en) 2005-06-16 2006-06-16 Manufacturing process for tigecycline

Related Child Applications (2)

Application Number Title Priority Date Filing Date
JP2009136753A Division JP2009191083A (ja) 2005-06-16 2009-06-05 チゲサイクリンのための製造プロセス
JP2009254475A Division JP2010024252A (ja) 2005-06-16 2009-11-05 チゲサイクリンのための製造プロセス

Publications (2)

Publication Number Publication Date
JP2008543871A true JP2008543871A (ja) 2008-12-04
JP2008543871A5 JP2008543871A5 (cg-RX-API-DMAC10.html) 2009-07-23

Family

ID=37111782

Family Applications (3)

Application Number Title Priority Date Filing Date
JP2008517178A Pending JP2008543871A (ja) 2005-06-16 2006-06-16 チゲサイクリンのための製造プロセス
JP2009136753A Withdrawn JP2009191083A (ja) 2005-06-16 2009-06-05 チゲサイクリンのための製造プロセス
JP2009254475A Withdrawn JP2010024252A (ja) 2005-06-16 2009-11-05 チゲサイクリンのための製造プロセス

Family Applications After (2)

Application Number Title Priority Date Filing Date
JP2009136753A Withdrawn JP2009191083A (ja) 2005-06-16 2009-06-05 チゲサイクリンのための製造プロセス
JP2009254475A Withdrawn JP2010024252A (ja) 2005-06-16 2009-11-05 チゲサイクリンのための製造プロセス

Country Status (22)

Country Link
US (1) US7705168B2 (cg-RX-API-DMAC10.html)
EP (1) EP1898884A2 (cg-RX-API-DMAC10.html)
JP (3) JP2008543871A (cg-RX-API-DMAC10.html)
KR (1) KR20080024201A (cg-RX-API-DMAC10.html)
CN (1) CN101198315A (cg-RX-API-DMAC10.html)
AR (1) AR055336A1 (cg-RX-API-DMAC10.html)
AU (1) AU2006261636A1 (cg-RX-API-DMAC10.html)
BR (1) BRPI0612228A2 (cg-RX-API-DMAC10.html)
CA (1) CA2610909A1 (cg-RX-API-DMAC10.html)
CR (1) CR9594A (cg-RX-API-DMAC10.html)
EC (1) ECSP078005A (cg-RX-API-DMAC10.html)
GT (1) GT200600259A (cg-RX-API-DMAC10.html)
IL (1) IL187979A0 (cg-RX-API-DMAC10.html)
MX (1) MX2007015960A (cg-RX-API-DMAC10.html)
NO (1) NO20076264L (cg-RX-API-DMAC10.html)
PA (1) PA8680201A1 (cg-RX-API-DMAC10.html)
PE (1) PE20070072A1 (cg-RX-API-DMAC10.html)
RU (1) RU2007145595A (cg-RX-API-DMAC10.html)
SV (1) SV2007002575A (cg-RX-API-DMAC10.html)
TW (1) TW200716203A (cg-RX-API-DMAC10.html)
WO (1) WO2006138641A2 (cg-RX-API-DMAC10.html)
ZA (1) ZA200710906B (cg-RX-API-DMAC10.html)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012515753A (ja) * 2009-01-23 2012-07-12 ホビオネ インテル リミテッド チゲサイクリンの単離方法

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2007713A2 (en) * 2006-04-17 2008-12-31 Teva Pharmaceutical Industries Ltd Isolation of tetracycline derivatives
PT2016045E (pt) * 2006-04-24 2015-02-05 Teva Pharma Forma cristalina de tigeciclina e processos para a sua preparação
US8198470B2 (en) * 2006-04-24 2012-06-12 Teva Pharmaceutical Industries Ltd. Crystalline form II of tigecycline and processes for preparation thereof
EP2086926A2 (en) * 2006-11-29 2009-08-12 Teva Pharmaceutical Industries Ltd. Crystalline forms of tigecycline and processes for preparation thereof
MX2008009727A (es) * 2006-11-30 2009-01-09 Teva Pharma Procesos para la preparacion de 9-haloacetamidominociclinas.
WO2008106234A1 (en) * 2007-03-01 2008-09-04 Teva Pharmaceutical Industries Ltd. Processes for purification of tigecycline
WO2009052152A2 (en) * 2007-10-16 2009-04-23 Wyeth Tigecycline and methods of preparing intermediates
US9107929B2 (en) 2008-05-01 2015-08-18 Ranbaxy Laboratories Limited Stable parenteral formulations of tigecycline
ITMI20080807A1 (it) 2008-05-05 2009-11-06 Antibioticos Spa Procedimento per la preparazione di tigeciclina in forma amorfa
WO2010017273A2 (en) * 2008-08-06 2010-02-11 Wyeth Tigecycline formulations
EP2406213A1 (en) 2009-03-12 2012-01-18 Wyeth LLC Nitration of tetracyclines
CN103417498B (zh) * 2012-05-18 2017-09-12 山东新时代药业有限公司 一种替加环素冻干粉针剂的制备方法
IN2013MU01127A (cg-RX-API-DMAC10.html) 2013-03-26 2015-05-01 Astron Res Ltd
WO2014167575A2 (en) 2013-03-26 2014-10-16 Astron Research Limited Stable tigecycline composition
CN103202814A (zh) * 2013-04-23 2013-07-17 成都百裕科技制药有限公司 一种注射用替加环素的制备方法
CN105924367B (zh) * 2016-04-18 2017-12-29 镇江高海生物药业有限公司 多西环素一水物的有关物质及其分析检测方法
US20190233153A1 (en) * 2018-01-26 2019-08-01 AL Pharma, Inc. Manufacturing and packaging of a sterile drug product
CN108653216B (zh) * 2018-05-28 2020-12-18 福安药业集团湖北人民制药有限公司 注射用替加环素
WO2021063468A1 (en) 2019-10-02 2021-04-08 Anfarm Hellas S.A. Stable parenteral pharmaceutical composition containing tigecycline and process for the preparation thereof
CN116531322A (zh) * 2023-06-27 2023-08-04 遂成药业股份有限公司 一种高稳定性呋塞米注射液及其制备方法和应用

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3026248A (en) * 1959-09-11 1962-03-20 Pfizer & Co C Thioglycerol and formaldehyde sulfoxylate stabilized tetracycline antibiotics in polyhydric alcohol solvents
US5494903A (en) * 1991-10-04 1996-02-27 American Cyanamid Company 7-substituted-9-substituted amino-6-demethyl-6-deoxytetracyclines
US5284963A (en) * 1992-08-13 1994-02-08 American Cyanamid Company Method of producing 7-(substituted)-9-[(substituted glycyl)-amidol]-6-demethyl-6-deoxytetra-cyclines
US6660267B1 (en) * 1992-12-21 2003-12-09 Promega Corporation Prevention and treatment of sepsis
US5675030A (en) * 1994-11-16 1997-10-07 American Cyanamid Company Method for selective extracting a 7-(hydrogen or substituted amino)-9- (substituted glycyl) amido!-6-demethyl-6-deoxytetracycline compound
AU2003265241A1 (en) * 2002-05-23 2003-12-12 Activbiotics, Inc. Methods of treating bacterial infections and diseases associated therewith
CN101039679A (zh) * 2004-10-28 2007-09-19 惠氏公司 替加环素和地高辛的共投与
EP1858488B2 (en) * 2005-03-14 2022-07-20 Wyeth LLC Tigecycline compositions and methods of preparation
AR057034A1 (es) 2005-05-27 2007-11-14 Wyeth Corp Metodos para purificar tigeciclina

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012515753A (ja) * 2009-01-23 2012-07-12 ホビオネ インテル リミテッド チゲサイクリンの単離方法
JP2015166347A (ja) * 2009-01-23 2015-09-24 ホビオネ インテル リミテッド チゲサイクリンの単離方法

Also Published As

Publication number Publication date
AR055336A1 (es) 2007-08-22
EP1898884A2 (en) 2008-03-19
JP2009191083A (ja) 2009-08-27
WO2006138641A3 (en) 2007-05-18
GT200600259A (es) 2007-05-08
SV2007002575A (es) 2007-01-03
CR9594A (es) 2008-03-07
AU2006261636A1 (en) 2006-12-28
RU2007145595A (ru) 2009-07-27
CN101198315A (zh) 2008-06-11
KR20080024201A (ko) 2008-03-17
BRPI0612228A2 (pt) 2011-03-29
WO2006138641A2 (en) 2006-12-28
CA2610909A1 (en) 2006-12-28
JP2010024252A (ja) 2010-02-04
US7705168B2 (en) 2010-04-27
MX2007015960A (es) 2008-03-06
TW200716203A (en) 2007-05-01
ZA200710906B (en) 2009-03-25
NO20076264L (no) 2008-03-10
PE20070072A1 (es) 2007-02-25
IL187979A0 (en) 2008-03-20
PA8680201A1 (es) 2007-01-17
ECSP078005A (es) 2008-01-23
US20070026080A1 (en) 2007-02-01

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