ECSP078005A - Proceso de fabricación para tigeciclina - Google Patents

Proceso de fabricación para tigeciclina

Info

Publication number
ECSP078005A
ECSP078005A EC2007008005A ECSP078005A ECSP078005A EC SP078005 A ECSP078005 A EC SP078005A EC 2007008005 A EC2007008005 A EC 2007008005A EC SP078005 A ECSP078005 A EC SP078005A EC SP078005 A ECSP078005 A EC SP078005A
Authority
EC
Ecuador
Prior art keywords
manufacturing process
tigecicline
tigecycline
preparation
intravenous infusion
Prior art date
Application number
EC2007008005A
Other languages
English (en)
Inventor
Mahdi Bakir Fawzi
Richard William Saunders
Gurmukh Chanana
Dominic Ventura
Original Assignee
Wyeth Corp
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 Corp filed Critical Wyeth Corp
Publication of ECSP078005A publication Critical patent/ECSP078005A/es

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
    • 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

Landscapes

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

Abstract

Se describe aquí un proceso de fabricación para la preparación de la tigeciclina adecuada para infusión intravenosa.
EC2007008005A 2005-06-16 2007-12-12 Proceso de fabricación para tigeciclina ECSP078005A (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US69117305P 2005-06-16 2005-06-16

Publications (1)

Publication Number Publication Date
ECSP078005A true ECSP078005A (es) 2008-01-23

Family

ID=37111782

Family Applications (1)

Application Number Title Priority Date Filing Date
EC2007008005A ECSP078005A (es) 2005-06-16 2007-12-12 Proceso de fabricación para tigeciclina

Country Status (22)

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

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101489987A (zh) * 2006-04-17 2009-07-22 特瓦制药工业有限公司 四环素衍生物的分离
US8198470B2 (en) * 2006-04-24 2012-06-12 Teva Pharmaceutical Industries Ltd. Crystalline form II of tigecycline and processes for preparation thereof
ES2622356T3 (es) * 2006-04-24 2017-07-06 Teva Pharmaceutical Industries, Ltd. Formas cristalinas de tigeciclina y procesos para su preparación
EP2086926A2 (en) * 2006-11-29 2009-08-12 Teva Pharmaceutical Industries Ltd. Crystalline forms of tigecycline and processes for preparation thereof
EP2084126A1 (en) * 2006-11-30 2009-08-05 Teva Pharmaceutical Industries Ltd. Processes for preparation of 9-haloacetamidominocyclines
EP2114865A1 (en) * 2007-03-01 2009-11-11 Teva Pharmaceutical Industries Ltd. Processes for purification of tigecycline
US20090099376A1 (en) * 2007-10-16 2009-04-16 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
US20100035845A1 (en) * 2008-08-06 2010-02-11 Wyeth Tigecycline formulations
PT104350A (pt) * 2009-01-23 2010-07-23 Hovione Farmaci Ncia S A Processo de isolamento de tigeciclina
CA2751238A1 (en) 2009-03-12 2010-10-07 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
WO2014167575A2 (en) 2013-03-26 2014-10-16 Astron Research Limited Stable tigecycline composition
IN2013MU01127A (es) 2013-03-26 2015-05-01 Astron Res Ltd
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

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
US20030236265A1 (en) * 2002-05-23 2003-12-25 Sayada Chalom B. Methods of treating bacterial infections and diseases associated therewith
EP1804807B1 (en) * 2004-10-28 2008-12-03 Wyeth a Corporation of the State of Delaware Coadministration of tigecycline and digoxin
JP4972081B2 (ja) * 2005-03-14 2012-07-11 ワイス・エルエルシー チゲサイクリン組成物および調製方法
AR057034A1 (es) 2005-05-27 2007-11-14 Wyeth Corp Metodos para purificar tigeciclina

Also Published As

Publication number Publication date
TW200716203A (en) 2007-05-01
JP2009191083A (ja) 2009-08-27
JP2010024252A (ja) 2010-02-04
GT200600259A (es) 2007-05-08
US20070026080A1 (en) 2007-02-01
WO2006138641A2 (en) 2006-12-28
AR055336A1 (es) 2007-08-22
KR20080024201A (ko) 2008-03-17
BRPI0612228A2 (pt) 2011-03-29
SV2007002575A (es) 2007-01-03
AU2006261636A1 (en) 2006-12-28
US7705168B2 (en) 2010-04-27
MX2007015960A (es) 2008-03-06
WO2006138641A3 (en) 2007-05-18
CR9594A (es) 2008-03-07
NO20076264L (no) 2008-03-10
IL187979A0 (en) 2008-03-20
CA2610909A1 (en) 2006-12-28
ZA200710906B (en) 2009-03-25
PE20070072A1 (es) 2007-02-25
EP1898884A2 (en) 2008-03-19
CN101198315A (zh) 2008-06-11
PA8680201A1 (es) 2007-01-17
JP2008543871A (ja) 2008-12-04
RU2007145595A (ru) 2009-07-27

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