JP2011520889A - 安定な医薬製剤 - Google Patents

安定な医薬製剤 Download PDF

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Publication number
JP2011520889A
JP2011520889A JP2011509571A JP2011509571A JP2011520889A JP 2011520889 A JP2011520889 A JP 2011520889A JP 2011509571 A JP2011509571 A JP 2011509571A JP 2011509571 A JP2011509571 A JP 2011509571A JP 2011520889 A JP2011520889 A JP 2011520889A
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JP
Japan
Prior art keywords
pharmaceutical
solution
aqueous
combinations
additive
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.)
Pending
Application number
JP2011509571A
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English (en)
Japanese (ja)
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JP2011520889A5 (cg-RX-API-DMAC10.html
Inventor
ジェイムス イー. キップ,
ジョセフ シー. ティー. ウォン,
ラクシュミー ネア,
レーガン ミラー,
バーレット イー. ラビナウ,
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.)
Baxter Healthcare SA
Baxter International Inc
Original Assignee
Baxter Healthcare SA
Baxter International Inc
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 Baxter Healthcare SA, Baxter International Inc filed Critical Baxter Healthcare SA
Publication of JP2011520889A publication Critical patent/JP2011520889A/ja
Publication of JP2011520889A5 publication Critical patent/JP2011520889A5/ja
Pending legal-status Critical Current

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    • 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
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2011509571A 2008-05-15 2009-05-08 安定な医薬製剤 Pending JP2011520889A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US5330108P 2008-05-15 2008-05-15
US61/053,301 2008-05-15
PCT/US2009/043295 WO2009140162A1 (en) 2008-05-15 2009-05-08 Stable pharmaceutical formulations

Publications (2)

Publication Number Publication Date
JP2011520889A true JP2011520889A (ja) 2011-07-21
JP2011520889A5 JP2011520889A5 (cg-RX-API-DMAC10.html) 2013-04-04

Family

ID=40941781

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2011509571A Pending JP2011520889A (ja) 2008-05-15 2009-05-08 安定な医薬製剤

Country Status (8)

Country Link
US (2) US8183233B2 (cg-RX-API-DMAC10.html)
EP (1) EP2288338A1 (cg-RX-API-DMAC10.html)
JP (1) JP2011520889A (cg-RX-API-DMAC10.html)
CN (1) CN102026621A (cg-RX-API-DMAC10.html)
CA (1) CA2722602A1 (cg-RX-API-DMAC10.html)
MX (1) MX2010012451A (cg-RX-API-DMAC10.html)
TW (1) TW201008594A (cg-RX-API-DMAC10.html)
WO (1) WO2009140162A1 (cg-RX-API-DMAC10.html)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017528436A (ja) * 2014-08-20 2017-09-28 デウン ファーマシューティカル カンパニー リミテッド エルタペネム含有凍結乾燥製剤の製造方法

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2007234612B2 (en) 2006-12-14 2013-06-27 Johnson & Johnson Regenerative Therapeutics, Llc Protein stabilization formulations
US7678764B2 (en) 2007-06-29 2010-03-16 Johnson & Johnson Regenerative Therapeutics, Llc Protein formulations for use at elevated temperatures
CN101801405A (zh) 2007-08-07 2010-08-11 先进科技及再生医学有限责任公司 包含于酸性水溶液中的gdf-5的蛋白质配方
JP5599778B2 (ja) 2008-04-14 2014-10-01 デピュイ・シンセス・プロダクツ・エルエルシー 液体緩衝gdf−5製剤
CN102614492B (zh) * 2011-01-31 2013-12-11 上海天伟生物制药有限公司 一种含有棘白菌素类抗真菌剂米卡芬净的液体药用组合物
CN102614491B (zh) * 2011-01-31 2014-04-16 上海天伟生物制药有限公司 一种含有棘白菌素类抗真菌剂米卡芬净的药用组合物及其制备方法和用途
WO2013078554A1 (en) * 2011-12-02 2013-06-06 University Health Network Compositions of tigecycline and uses thereof
US9636407B2 (en) 2012-11-20 2017-05-02 Fresenius Kabi Usa, Llc Caspofungin acetate formulations
CN103330933B (zh) * 2013-04-26 2015-08-05 江苏豪森药业股份有限公司 含有米卡芬净或其盐的药物组合物
WO2015105720A1 (en) * 2014-01-07 2015-07-16 Hospira Inc. Stabilised carbapenem compositions
WO2015180681A1 (zh) * 2014-05-29 2015-12-03 上海天伟生物制药有限公司 一种环肽类化合物的组合物及其制备方法和用途
EP3058958B1 (en) * 2015-02-23 2018-09-19 Selectchemie AG Anidulafungin composition
US10905113B2 (en) 2015-11-12 2021-02-02 Regents Of The University Of Minnesota Compositions and method for storing liquid biospecimens
PT3554474T (pt) 2016-12-16 2024-02-12 Baxter Healthcare Sa Composições de micafungina
US11968975B2 (en) * 2019-04-30 2024-04-30 Regents Of The University Of Minnesota Compositions and methods for storing liquid biospecimens
WO2023205165A1 (en) * 2022-04-22 2023-10-26 Brii Biosciences Offshore Limited A polymyxin composition and methods for producing the same
CN117088974B (zh) * 2023-08-14 2024-02-13 武汉健昊生物科技有限公司 一种抗体保存液
WO2026089981A1 (en) * 2024-10-23 2026-04-30 Merck Sharp & Dohme Llc Pharmaceutical composition comprising a monobactam and a solubilizer

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH051075A (ja) * 1991-06-25 1993-01-08 Lederle Japan Ltd カルバペネム化合物を安定に含有する水溶液
JPH0769887A (ja) * 1993-07-09 1995-03-14 Takeda Chem Ind Ltd ペネム化合物含有固形組成物、その製造法および剤
JPH0920688A (ja) * 1995-07-01 1997-01-21 Hideyo Yamaguchi 抗菌用剤
WO2006078066A1 (ja) * 2005-01-21 2006-07-27 Dainippon Sumitomo Pharma Co., Ltd. 経気道呼吸器感染症治療剤
WO2007142212A1 (ja) * 2006-06-08 2007-12-13 Dainippon Sumitomo Pharma Co., Ltd. 製剤組成物

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2908614A (en) 1954-08-10 1959-10-13 Glaxo Lab Ltd Use of dextran in freeze-drying process
US4457916A (en) * 1982-08-31 1984-07-03 Asahi Kasei Kogyo Kabushiki Kaisha Method for stabilizing Tumor Necrosis Factor and a stable aqueous solution or powder containing the same
EP0150067A3 (en) * 1984-01-23 1986-12-30 Takeda Chemical Industries, Ltd. Stable composition of gamma-interferon
US4727064A (en) * 1984-04-25 1988-02-23 The United States Of America As Represented By The Department Of Health And Human Services Pharmaceutical preparations containing cyclodextrin derivatives
US4883785A (en) * 1984-07-27 1989-11-28 Chow Wing Sun Complex of anti-fungal agent and cyclodextrin and method
DE69029765T2 (de) * 1989-07-24 1997-05-15 Bayer Ag Stabilisierung von hochgereinigten Proteinen
US5472954A (en) * 1992-07-14 1995-12-05 Cyclops H.F. Cyclodextrin complexation
SE9803517D0 (sv) * 1998-10-15 1998-10-15 Astra Ab Pharmaceutical preparation
ATE294571T1 (de) 1999-03-03 2005-05-15 Lilly Co Eli Echinocandin pharmazeutische zusammensetzungen
US7094601B2 (en) 2000-05-16 2006-08-22 The General Hospital Corporation Microinjection of cryoprotectants for preservation of cells
US20030072807A1 (en) 2000-12-22 2003-04-17 Wong Joseph Chung-Tak Solid particulate antifungal compositions for pharmaceutical use
US20030138403A1 (en) 2001-06-29 2003-07-24 Maxygen Aps Interferon formulations
US20030054042A1 (en) * 2001-09-14 2003-03-20 Elaine Liversidge Stabilization of chemical compounds using nanoparticulate formulations
CN101472562A (zh) * 2006-05-12 2009-07-01 陈献 用于静脉刺激性药物的药物组合物
BRPI0716091A2 (pt) * 2006-08-29 2013-09-17 Daiichi Sankyo Co Ltd preparaÇço liofilizada, e, mÉtodo de produÇço da mesma.
BRPI0720125A2 (pt) 2006-12-06 2014-01-28 Wyeth Corp Método para armazenar uma formulação líquida; método para a preparação de uma formulação líquida; composição; e método para inibir a agregação induzida por manitol de uma proteína em uma formulação líquida.
AU2008216090A1 (en) 2007-02-16 2008-08-21 Wyeth Protein formulations containing sorbitol

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH051075A (ja) * 1991-06-25 1993-01-08 Lederle Japan Ltd カルバペネム化合物を安定に含有する水溶液
JPH0769887A (ja) * 1993-07-09 1995-03-14 Takeda Chem Ind Ltd ペネム化合物含有固形組成物、その製造法および剤
JPH0920688A (ja) * 1995-07-01 1997-01-21 Hideyo Yamaguchi 抗菌用剤
WO2006078066A1 (ja) * 2005-01-21 2006-07-27 Dainippon Sumitomo Pharma Co., Ltd. 経気道呼吸器感染症治療剤
WO2007142212A1 (ja) * 2006-06-08 2007-12-13 Dainippon Sumitomo Pharma Co., Ltd. 製剤組成物

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
JPN7013003634; メロペネム点滴静注用バッグ0.5g(NP)添付文書, 2011 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017528436A (ja) * 2014-08-20 2017-09-28 デウン ファーマシューティカル カンパニー リミテッド エルタペネム含有凍結乾燥製剤の製造方法

Also Published As

Publication number Publication date
EP2288338A1 (en) 2011-03-02
CN102026621A (zh) 2011-04-20
US20120207762A1 (en) 2012-08-16
MX2010012451A (es) 2010-12-07
WO2009140162A1 (en) 2009-11-19
US20090286764A1 (en) 2009-11-19
US8183233B2 (en) 2012-05-22
TW201008594A (en) 2010-03-01
CA2722602A1 (en) 2009-11-19

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