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)
Spanish (es)
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

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/65Tetracyclines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C231/00Preparation of carboxylic acid amides
    • C07C231/12Preparation of carboxylic acid amides by reactions not involving the formation of carboxamide groups
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C231/00Preparation of carboxylic acid amides
    • C07C231/22Separation; Purification; Stabilisation; Use of additives
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07CACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C2603/00Systems containing at least three condensed rings
    • C07C2603/02Ortho- or ortho- and peri-condensed systems
    • C07C2603/40Ortho- or ortho- and peri-condensed systems containing four condensed rings
    • C07C2603/42Ortho- or ortho- and peri-condensed systems containing four condensed rings containing only six-membered rings
    • C07C2603/44Naphthacenes; Hydrogenated naphthacenes
    • C07C2603/461,4,4a,5,5a,6,11,12a- Octahydronaphthacenes, e.g. tetracyclines

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (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)
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 (enExample)
EP (1) EP1898884A2 (enExample)
JP (3) JP2008543871A (enExample)
KR (1) KR20080024201A (enExample)
CN (1) CN101198315A (enExample)
AR (1) AR055336A1 (enExample)
AU (1) AU2006261636A1 (enExample)
BR (1) BRPI0612228A2 (enExample)
CA (1) CA2610909A1 (enExample)
CR (1) CR9594A (enExample)
EC (1) ECSP078005A (enExample)
GT (1) GT200600259A (enExample)
IL (1) IL187979A0 (enExample)
MX (1) MX2007015960A (enExample)
NO (1) NO20076264L (enExample)
PA (1) PA8680201A1 (enExample)
PE (1) PE20070072A1 (enExample)
RU (1) RU2007145595A (enExample)
SV (1) SV2007002575A (enExample)
TW (1) TW200716203A (enExample)
WO (1) WO2006138641A2 (enExample)
ZA (1) ZA200710906B (enExample)

Families Citing this family (20)

* 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
DE202007019460U1 (de) * 2006-04-24 2012-10-24 Teva Pharmaceutical Industries Ltd. Kristalline Tigecyclin-Formen
US8198470B2 (en) * 2006-04-24 2012-06-12 Teva Pharmaceutical Industries Ltd. Crystalline form II of tigecycline and processes for preparation thereof
WO2008066935A2 (en) * 2006-11-29 2008-06-05 Teva Pharmaceutical Industries Ltd. Crystalline forms of tigecycline and processes for preparation thereof
WO2008066908A1 (en) * 2006-11-30 2008-06-05 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
JP2012520305A (ja) 2009-03-12 2012-09-06 ワイス・エルエルシー テトラサイクリンのニトロ化
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 (enExample) 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
WO2019147755A1 (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
EP1531828A4 (en) * 2002-05-23 2005-11-02 Activbiotics Inc METHODS OF TREATING BACTERIAL INFECTIONS AND ASSOCIATED DISEASES
ATE415973T1 (de) * 2004-10-28 2008-12-15 Wyeth Corp Gemeinsame gabe von tigecyclin und digoxin
KR20130122988A (ko) * 2005-03-14 2013-11-11 와이어쓰 엘엘씨 티게사이클린 조성물 및 이의 제조방법
AR057034A1 (es) 2005-05-27 2007-11-14 Wyeth Corp Metodos para purificar tigeciclina

Also Published As

Publication number Publication date
SV2007002575A (es) 2007-01-03
ECSP078005A (es) 2008-01-23
CN101198315A (zh) 2008-06-11
NO20076264L (no) 2008-03-10
US7705168B2 (en) 2010-04-27
MX2007015960A (es) 2008-03-06
CR9594A (es) 2008-03-07
US20070026080A1 (en) 2007-02-01
WO2006138641A2 (en) 2006-12-28
EP1898884A2 (en) 2008-03-19
BRPI0612228A2 (pt) 2011-03-29
GT200600259A (es) 2007-05-08
PA8680201A1 (es) 2007-01-17
KR20080024201A (ko) 2008-03-17
IL187979A0 (en) 2008-03-20
ZA200710906B (en) 2009-03-25
AR055336A1 (es) 2007-08-22
AU2006261636A1 (en) 2006-12-28
TW200716203A (en) 2007-05-01
RU2007145595A (ru) 2009-07-27
JP2008543871A (ja) 2008-12-04
WO2006138641A3 (en) 2007-05-18
JP2009191083A (ja) 2009-08-27
JP2010024252A (ja) 2010-02-04
CA2610909A1 (en) 2006-12-28

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