AR055336A1 - Proeso de elaboracion para la produccion de tigeciclina como un polvo reconstituible, polvo de tigeciclina liofilizado y producto hecho mediante el proceso - Google Patents

Proeso de elaboracion para la produccion de tigeciclina como un polvo reconstituible, polvo de tigeciclina liofilizado y producto hecho mediante el proceso

Info

Publication number
AR055336A1
AR055336A1 ARP060102533A ARP060102533A AR055336A1 AR 055336 A1 AR055336 A1 AR 055336A1 AR P060102533 A ARP060102533 A AR P060102533A AR P060102533 A ARP060102533 A AR P060102533A AR 055336 A1 AR055336 A1 AR 055336A1
Authority
AR
Argentina
Prior art keywords
powder
tigecycline
tigecicline
solution
production
Prior art date
Application number
ARP060102533A
Other languages
English (en)
Inventor
Gurmukh Chanana
Dominique Ventura
Richard Saunders
Mahdi B Fawzi
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 AR055336A1 publication Critical patent/AR055336A1/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

Abstract

El proceso de elaboracion para la preparacion de tigeciclina adecuado para la infusion intravenosa controla la formacion de epímero y la degradacion por oxidacion durante la produccion en masa de la presentacion en polvo liofilizado. La tigeciclina es protegida mediante rociado con un medio gaseoso inerte como nitrogeno, controlando conjuntamente el nivel de oxígeno y la temperatura de la solucion acuosa en masa, de manera que la tigeciclina es elaborada con degradantes totales menores de 0,9%. Reivindicacion 1: Un proceso de elaboracion para la produccion de tigeciclina como un polvo reconstituible que tiene menos de 0,9% de degradantes totales, caracterizado por comprender las etapas: a) reducir y mantener el nivel de oxígeno en agua WFI a menos de o igual a 0,5 ppm aunque manteniendo la temperatura a 2° a 8°C; b) formar una solucion de tigeciclina en dicha agua de etapa a una concentracion de 10 a 50 mg/ml aunque manteniendo dicha temperatura y nivel de oxígeno; c) llenar los frascos con dicha solucion de la etapa (b); d) liofilizar dicha solucion de la etapa (c) formando 25 mg a 150 mg de polvo reconstituible en un frasco; y e) sellar dicho frasco bajo nitrogeno.
ARP060102533A 2005-06-16 2006-06-15 Proeso de elaboracion para la produccion de tigeciclina como un polvo reconstituible, polvo de tigeciclina liofilizado y producto hecho mediante el proceso AR055336A1 (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
AR055336A1 true AR055336A1 (es) 2007-08-22

Family

ID=37111782

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP060102533A AR055336A1 (es) 2005-06-16 2006-06-15 Proeso de elaboracion para la produccion de tigeciclina como un polvo reconstituible, polvo de tigeciclina liofilizado y producto hecho mediante el proceso

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
WO2007120913A2 (en) * 2006-04-17 2007-10-25 Teva Pharmaceutical Industries Ltd. Isolation of tetracycline derivatives
US8198470B2 (en) * 2006-04-24 2012-06-12 Teva Pharmaceutical Industries Ltd. Crystalline form II of tigecycline and processes for preparation thereof
EP2426104A1 (en) * 2006-04-24 2012-03-07 Teva Pharmaceutical Industries Ltd. Tigecycline crystalline form and process for preparation thereof
EP2236491A3 (en) * 2006-11-29 2010-11-03 Teva Pharmaceutical Industries, Ltd. Crystalline form of tigecycline and processes for preparation thereof
MX2008009727A (es) * 2006-11-30 2009-01-09 Teva Pharma Procesos para la preparacion de 9-haloacetamidominociclinas.
EP2114865A1 (en) * 2007-03-01 2009-11-11 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
PT104350A (pt) * 2009-01-23 2010-07-23 Hovione Farmaci Ncia S A Processo de isolamento de tigeciclina
US20120059190A1 (en) 2009-03-12 2012-03-08 Wyeth Llc Novel 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

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
EP1804807B1 (en) * 2004-10-28 2008-12-03 Wyeth a Corporation of the State of Delaware Coadministration of tigecycline and digoxin
PE20061107A1 (es) * 2005-03-14 2006-12-08 Wyeth Corp Composiciones de tigeciclina y metodos para su preparacion
AR057034A1 (es) 2005-05-27 2007-11-14 Wyeth Corp Metodos para purificar tigeciclina

Also Published As

Publication number Publication date
PA8680201A1 (es) 2007-01-17
RU2007145595A (ru) 2009-07-27
GT200600259A (es) 2007-05-08
JP2009191083A (ja) 2009-08-27
US20070026080A1 (en) 2007-02-01
MX2007015960A (es) 2008-03-06
ECSP078005A (es) 2008-01-23
JP2008543871A (ja) 2008-12-04
CR9594A (es) 2008-03-07
NO20076264L (no) 2008-03-10
TW200716203A (en) 2007-05-01
IL187979A0 (en) 2008-03-20
ZA200710906B (en) 2009-03-25
SV2007002575A (es) 2007-01-03
JP2010024252A (ja) 2010-02-04
KR20080024201A (ko) 2008-03-17
CN101198315A (zh) 2008-06-11
CA2610909A1 (en) 2006-12-28
WO2006138641A2 (en) 2006-12-28
AU2006261636A1 (en) 2006-12-28
PE20070072A1 (es) 2007-02-25
EP1898884A2 (en) 2008-03-19
BRPI0612228A2 (pt) 2011-03-29
US7705168B2 (en) 2010-04-27
WO2006138641A3 (en) 2007-05-18

Similar Documents

Publication Publication Date Title
AR055336A1 (es) Proeso de elaboracion para la produccion de tigeciclina como un polvo reconstituible, polvo de tigeciclina liofilizado y producto hecho mediante el proceso
JP2008543871A5 (es)
US20040054012A1 (en) Method for obtaining aqueous formulations of oxidation-sensitive active principles
US20170189943A1 (en) Antibacterial water
DE60309731D1 (de) Injizierbare pharmazeutische suspension in einer phiole mit zwei kammern
WO2007079287A3 (en) Storage-stable aqueous solutions of chlorine dioxide and methods for preparing and using them
RU2011140749A (ru) Устройство для интраназального введения
PE20090838A1 (es) Pontenciacion de quimioterapia de cancer
JP6244608B2 (ja) 水素含有エアゾールおよび該水素含有エアゾールの保管方法
CN105979949B (zh) 不含抗氧化剂的药物组合物及其制备方法
RU2016147362A (ru) Препараты жидкого концетрата циклофосфамида
US20150190509A1 (en) Resiniferatoxin solution
EP2920106B1 (en) A method for filling bottles
HRP20130695T1 (hr) Adiponektin za lijeäśenje pluä†ne bolesti
EA201171440A1 (ru) Способ ароматизации размещаемого в упаковке пищевого продукта
WO2009081283A2 (en) Aqueous formulations of acetaminophen for injection
AR124867A1 (es) Un medicamento en una bolsa de goteo intravenoso plegable lista para usar herméticamente sellada, método para hacer dicho medicamento y medicamento elaborado mediante dicho método
ES2267421T1 (es) Procedimiento para la preparacion de acido (6rs)-n(5)-formil-5,6,7,8-tetrahidrofolico cristalino.
ES2445871T3 (es) Procedimiento para el almacenamiento y para el transporte de diésteres cíclicos
JP2015124215A (ja) 注射液製剤及びその製造方法
JP6150703B2 (ja) ピタバスタチンカルシウム塩の分解抑制方法
AU2006203741B2 (en) Method for obtaining aqueous formulations with active principles susceptible to oxidation and the aqueous solutions thus obtained
HRP20090595T1 (hr) Nova stabilna hiperbarična kompozicija koja sadrži prilokain hcl, primjena navedene nove kompozicije za intratekalnu anesteziju i postupak za proizvodnju navedene kompozicije
WO2019244965A1 (ja) ペメトレキセドナトリウム注射用溶液製剤、並びにその製造方法
RU2017146440A (ru) Способ получения лекарственного средства на основе олигопептида аллоферона-1, имеющего противовирусную и иммуномодулирующую направленность и лекарственное средство увеличенного срока хранения, полученное с его помощью

Legal Events

Date Code Title Description
FB Suspension of granting procedure