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PE20070072A1 - Proceso de manufactura para tigeciclina como polvo reconstituible - Google Patents

Proceso de manufactura para tigeciclina como polvo reconstituible

Info

Publication number
PE20070072A1
PE20070072A1 PE2006000670A PE2006000670A PE20070072A1 PE 20070072 A1 PE20070072 A1 PE 20070072A1 PE 2006000670 A PE2006000670 A PE 2006000670A PE 2006000670 A PE2006000670 A PE 2006000670A PE 20070072 A1 PE20070072 A1 PE 20070072A1
Authority
PE
Peru
Prior art keywords
tigecycline
reconstitutable powder
less
manufacturing process
solution
Prior art date
Application number
PE2006000670A
Other languages
English (en)
Inventor
Gurmukh Chanana
Dominic Ventura
Mahdi B Fawzi
Richard Saunder
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 PE20070072A1 publication Critical patent/PE20070072A1/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)
  • 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)
  • Medicinal Preparation (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)

Abstract

REFERIDA A UN PROCESO DE ELABORACION DE TIGECICLINA COMO UN POLVO RECONSTITUIBLE QUE TIENE MENOS DE 0,9% DE DEGRADANTES TOTALES, DONDE DICHO PROCESO COMPRENDE: a) REDUCIR Y MANTENER EL NIVEL DE OXIGENO EN AGUA PARA INYECCION (WFI) A MENOS DE O IGUAL A 0,5 ppm, MANTENIENDO LA TEMPERATURA ENTRE 2ºC Y 8ºC, b) FORMAR UNA SOLUCION DE TIGECICLINA EN DICHA AGUA DEL PASO ANTERIOR A UNA CONCENTRACION DE ENTRE 10 A 50 MG/ML, MANTENIENDO LA TEMPERATURA Y NIVEL DE OXIGENO, c) LLENAR LOS FRASCOS CON LA SOLUCION FORMADA, d) LIOFILIZAR LA SOLUCION DE LA ETAPA C FORMANDO 25 MG A 150 MG DE POLVO RECONSTITUIBLE EN UN FRASCO Y e) SELLAR EL FRASCO BAJO NITROGENO. DICHA PREPARACION DE TIGECICLINA ES PARA INYECCIONES
PE2006000670A 2005-06-16 2006-06-15 Proceso de manufactura para tigeciclina como polvo reconstituible PE20070072A1 (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
PE20070072A1 true PE20070072A1 (es) 2007-02-25

Family

ID=37111782

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2006000670A PE20070072A1 (es) 2005-06-16 2006-06-15 Proceso de manufactura para tigeciclina como polvo reconstituible

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 (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2649221A1 (en) * 2006-04-17 2007-10-25 Evgeny Tsiperman 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
MX2008009520A (es) * 2006-11-29 2009-02-26 Teva Pharma Formas cristalinas de tigeciclina y procesos de preparacion de ellas.
EP2084126A1 (en) * 2006-11-30 2009-08-05 Teva Pharmaceutical Industries Ltd. Processes for preparation of 9-haloacetamidominocyclines
US20080214869A1 (en) * 2007-03-01 2008-09-04 Sergei Fine 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
IN2013MU01127A (es) 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
EP1531828A4 (en) * 2002-05-23 2005-11-02 Activbiotics Inc METHODS OF TREATING BACTERIAL INFECTIONS AND ASSOCIATED DISEASES
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
BRPI0612228A2 (pt) 2011-03-29
ZA200710906B (en) 2009-03-25
SV2007002575A (es) 2007-01-03
CA2610909A1 (en) 2006-12-28
WO2006138641A3 (en) 2007-05-18
JP2009191083A (ja) 2009-08-27
KR20080024201A (ko) 2008-03-17
TW200716203A (en) 2007-05-01
JP2010024252A (ja) 2010-02-04
IL187979A0 (en) 2008-03-20
EP1898884A2 (en) 2008-03-19
GT200600259A (es) 2007-05-08
US20070026080A1 (en) 2007-02-01
MX2007015960A (es) 2008-03-06
CR9594A (es) 2008-03-07
CN101198315A (zh) 2008-06-11
AU2006261636A1 (en) 2006-12-28
NO20076264L (no) 2008-03-10
WO2006138641A2 (en) 2006-12-28
US7705168B2 (en) 2010-04-27
JP2008543871A (ja) 2008-12-04
PA8680201A1 (es) 2007-01-17
AR055336A1 (es) 2007-08-22
RU2007145595A (ru) 2009-07-27
ECSP078005A (es) 2008-01-23

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