WO2005074925A1 - Compositions substantially free of galactomannan containing piperacillin and tazobactam - Google Patents

Compositions substantially free of galactomannan containing piperacillin and tazobactam Download PDF

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Publication number
WO2005074925A1
WO2005074925A1 PCT/US2005/003048 US2005003048W WO2005074925A1 WO 2005074925 A1 WO2005074925 A1 WO 2005074925A1 US 2005003048 W US2005003048 W US 2005003048W WO 2005074925 A1 WO2005074925 A1 WO 2005074925A1
Authority
WO
WIPO (PCT)
Prior art keywords
piperacillin
pharmaceutical composition
tazobactam
galactomannan
composition according
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.)
Ceased
Application number
PCT/US2005/003048
Other languages
English (en)
French (fr)
Other versions
WO2005074925A8 (en
Inventor
Mark Edward Ruppen
Yu-Fen Wang
Sam Mattackal George
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
Priority to EP05712478A priority Critical patent/EP1711178A1/en
Priority to CA002553038A priority patent/CA2553038A1/en
Priority to JP2006551554A priority patent/JP2007519747A/ja
Publication of WO2005074925A1 publication Critical patent/WO2005074925A1/en
Publication of WO2005074925A8 publication Critical patent/WO2005074925A8/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425—Thiazoles
    • A61K31/429—Thiazoles condensed with heterocyclic ring systems
    • A61K31/43—Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula, e.g. penicillins, penems
    • A61K31/431—Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula, e.g. penicillins, penems containing further heterocyclic rings, e.g. ticarcillin, azlocillin, oxacillin
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/407—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with other heterocyclic ring systems, e.g. ketorolac, physostigmine
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425—Thiazoles
    • A61K31/429—Thiazoles condensed with heterocyclic ring systems
    • A61K31/43—Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula, e.g. penicillins, penems
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • 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
    • 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
    • A61P31/10—Antimycotics

Definitions

  • Sample preparation Reconstitute in water for injection (WFI)USP grade (United States Pharmacopeia) or any other appropriate diluents and make dilutions at desired concentrations. The dilution of the sample may be changed based on the results of the proceeding experiments.
  • WFI water for injection
  • USP grade United States Pharmacopeia
  • Injector Any manual injector or auto-injector capable of reproducible injections and maintaining a sample tray temperature of 5 9 C.
  • Membrane Filter Pore size 0.45 ⁇ m, Nylon-66 membrane filters.
  • Column Temperature Controller - Capable of maintaining a column temperature of 30 e C.
  • Rt retention time, minutes 2. Report the identity as positive if:

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
PCT/US2005/003048 2004-01-30 2005-01-27 Compositions substantially free of galactomannan containing piperacillin and tazobactam Ceased WO2005074925A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP05712478A EP1711178A1 (en) 2004-01-30 2005-01-27 Compositions substantially free of galactomannan containing piperacillin and tazobactam
CA002553038A CA2553038A1 (en) 2004-01-30 2005-01-27 Compositions substantially free of galactomannan containing piperacillin and tazobactam
JP2006551554A JP2007519747A (ja) 2004-01-30 2005-01-27 ピペラシリンおよびタゾバクタムを含みガラクトマンナンを実質的には含まない組成物

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US54091004P 2004-01-30 2004-01-30
US60/540,910 2004-01-30

Publications (2)

Publication Number Publication Date
WO2005074925A1 true WO2005074925A1 (en) 2005-08-18
WO2005074925A8 WO2005074925A8 (en) 2005-12-08

Family

ID=34837439

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2005/003048 Ceased WO2005074925A1 (en) 2004-01-30 2005-01-27 Compositions substantially free of galactomannan containing piperacillin and tazobactam

Country Status (7)

Country Link
US (1) US20050171077A1 (https=)
EP (1) EP1711178A1 (https=)
JP (1) JP2007519747A (https=)
KR (1) KR20060127931A (https=)
CN (1) CN1913890A (https=)
CA (1) CA2553038A1 (https=)
WO (1) WO2005074925A1 (https=)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1787641A1 (de) * 2005-11-22 2007-05-23 Helm AG Tazobactam-Piperacillin-Lyophilisat
US8476425B1 (en) 2012-09-27 2013-07-02 Cubist Pharmaceuticals, Inc. Tazobactam arginine compositions
US8906898B1 (en) 2013-09-27 2014-12-09 Calixa Therapeutics, Inc. Solid forms of ceftolozane
US8968753B2 (en) 2013-03-15 2015-03-03 Calixa Therapeutics, Inc. Ceftolozane-tazobactam pharmaceutical compositions
US9044485B2 (en) 2013-03-15 2015-06-02 Calixa Therapeutics, Inc. Ceftolozane antibiotic compositions
US9872906B2 (en) 2013-03-15 2018-01-23 Merck Sharp & Dohme Corp. Ceftolozane antibiotic compositions
US10376496B2 (en) 2013-09-09 2019-08-13 Merck, Sharp & Dohme Corp. Treating infections with ceftolozane/tazobactam in subjects having impaired renal function

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PL1959933T3 (pl) * 2005-12-05 2011-04-29 Sandoz Ag Sposób wytwarzania liofilizowanej soli sodowej piperacyliny w kombinacji z solą sodową tazobaktamu o ulepszonej trwałości po odtworzeniu
ITMI20070568A1 (it) * 2007-03-22 2008-09-23 Acs Dobfar Spa Comosizione farmaceutica sterile iniettabile avente piperacillina sodica e tazobactam sodico come principi attivi
WO2013036783A2 (en) 2011-09-09 2013-03-14 Cubist Pharmaceuticals, Inc. Methods for treating intrapulmonary infections
US8809314B1 (en) 2012-09-07 2014-08-19 Cubist Pharmacueticals, Inc. Cephalosporin compound
CN103006676B (zh) * 2012-12-27 2015-02-25 石药集团中诺药业（石家庄）有限公司 新型哌拉西林他唑巴坦组合物
CN113209030B (zh) * 2021-04-27 2023-04-25 海南通用康力制药有限公司 哌拉西林钠他唑巴坦钠无菌粉针剂的制备方法

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4534977A (en) * 1981-03-26 1985-08-13 American Cyanamid Company Composition of matter comprising a low bulk density lyophilized preparation of Sodium Piperacillin
WO2004098643A1 (en) * 2003-04-14 2004-11-18 Wyeth Holdings Corporation Compositions containing piperacillin and tazobactam useful for injection

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4477452A (en) * 1981-03-26 1984-10-16 American Cyanamid Company Composition of matter comprising a lyophilized preparation of a penicillin derivative
US4562073A (en) * 1982-12-24 1985-12-31 Taiho Pharmaceutical Company Limited Penicillin derivatives
AUPQ137699A0 (en) * 1999-07-02 1999-07-22 University Of New England, The Control of acidosis
US6900184B2 (en) * 2003-04-14 2005-05-31 Wyeth Holdings Corporation Compositions containing pipercillin and tazobactam useful for injection

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4534977A (en) * 1981-03-26 1985-08-13 American Cyanamid Company Composition of matter comprising a low bulk density lyophilized preparation of Sodium Piperacillin
WO2004098643A1 (en) * 2003-04-14 2004-11-18 Wyeth Holdings Corporation Compositions containing piperacillin and tazobactam useful for injection

Non-Patent Citations (5)

* Cited by examiner, † Cited by third party
Title
ANSORG R ET AL: "Detection of Aspergillus galactomannan antigen in foods and antibiotics", MYCOSES, vol. 40, no. 9-10, December 1997 (1997-12-01), pages 353 - 357, XP009049796, ISSN: 0933-7407 *
CULVER S M ET AL: "Piperacillin/tazobactam (ZOSYN)", INFECTIOUS DISEASE IN OBSTETRICS AND GYNECOLOGY 1996 UNITED STATES, vol. 4, no. 5, 1996, pages 258 - 262, XP009049732, ISSN: 1064-7449 *
SULAHIAN ANNIE ET AL: "False positive test for aspergillus antigenemia related to concomitant administration of piperacillin and tazobactam.", THE NEW ENGLAND JOURNAL OF MEDICINE. 11 DEC 2003, vol. 349, no. 24, 11 December 2003 (2003-12-11), pages 2366 - 2367, XP009049737, ISSN: 1533-4406 *
WALSH THOMAS J ET AL: "Detection of galactomannan antigenemia in patients receiving piperacillin-tazobactam and correlations between in vitro, in vivo, and clinical properties of the drug-antigen interaction.", JOURNAL OF CLINICAL MICROBIOLOGY. OCT 2004, vol. 42, no. 10, October 2004 (2004-10-01), pages 4744 - 4748, XP002333423, ISSN: 0095-1137 *
WU D H ET AL: "Platelia Aspergillus assay and potential cross-reaction [6] (multiple letters)", CLINICAL INFECTIOUS DISEASES 01 NOV 2004 UNITED STATES, vol. 39, no. 9, 1 November 2004 (2004-11-01), pages 1402 - 1403, XP009049708, ISSN: 1058-4838 *

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1787641A1 (de) * 2005-11-22 2007-05-23 Helm AG Tazobactam-Piperacillin-Lyophilisat
US8476425B1 (en) 2012-09-27 2013-07-02 Cubist Pharmaceuticals, Inc. Tazobactam arginine compositions
US8968753B2 (en) 2013-03-15 2015-03-03 Calixa Therapeutics, Inc. Ceftolozane-tazobactam pharmaceutical compositions
US9044485B2 (en) 2013-03-15 2015-06-02 Calixa Therapeutics, Inc. Ceftolozane antibiotic compositions
US9320740B2 (en) 2013-03-15 2016-04-26 Merck Sharp & Dohme Corp. Ceftolozane-tazobactam pharmaceutical compositions
US9872906B2 (en) 2013-03-15 2018-01-23 Merck Sharp & Dohme Corp. Ceftolozane antibiotic compositions
US9925196B2 (en) 2013-03-15 2018-03-27 Merck Sharp & Dohme Corp. Ceftolozane-tazobactam pharmaceutical compositions
US10420841B2 (en) 2013-03-15 2019-09-24 Merck, Sharp & Dohme Corp. Ceftolozane antibiotic compositions
US11278622B2 (en) 2013-03-15 2022-03-22 Merck Sharp & Dohme Corp. Ceftolozane antibiotic compositions
US10376496B2 (en) 2013-09-09 2019-08-13 Merck, Sharp & Dohme Corp. Treating infections with ceftolozane/tazobactam in subjects having impaired renal function
US10933053B2 (en) 2013-09-09 2021-03-02 Merck Sharp & Dohme Corp. Treating infections with ceftolozane/tazobactam in subjects having impaired renal function
US8906898B1 (en) 2013-09-27 2014-12-09 Calixa Therapeutics, Inc. Solid forms of ceftolozane

Also Published As

Publication number Publication date
WO2005074925A8 (en) 2005-12-08
KR20060127931A (ko) 2006-12-13
JP2007519747A (ja) 2007-07-19
US20050171077A1 (en) 2005-08-04
EP1711178A1 (en) 2006-10-18
CA2553038A1 (en) 2005-08-18
CN1913890A (zh) 2007-02-14

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