CY1112109T1 - Σκευασμα αργατροβανης περιεχον ενα οξυ ως διαλυτοποιητη - Google Patents

Σκευασμα αργατροβανης περιεχον ενα οξυ ως διαλυτοποιητη

Info

Publication number
CY1112109T1
CY1112109T1 CY20111100825T CY111100825T CY1112109T1 CY 1112109 T1 CY1112109 T1 CY 1112109T1 CY 20111100825 T CY20111100825 T CY 20111100825T CY 111100825 T CY111100825 T CY 111100825T CY 1112109 T1 CY1112109 T1 CY 1112109T1
Authority
CY
Cyprus
Prior art keywords
acid
argatrovan
solvent
package containing
argatroban
Prior art date
Application number
CY20111100825T
Other languages
English (en)
Inventor
George Owoo
Richard A Burgos
Original Assignee
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 International Inc. filed Critical Baxter International Inc.
Publication of CY1112109T1 publication Critical patent/CY1112109T1/el

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical 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
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47Quinolines; Isoquinolines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/4709Non-condensed quinolines and containing further heterocyclic rings
    • 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
    • A61K31/575Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Dermatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Hematology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Diabetes (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Εδώ περιγράφεται μια υδατική, σταθερή, στείρα φαρμακευτική σύνθεση του αναστολέα της θρομβίνης αργατροβάνη εντός ενός διαλύματος που περιέχει ένα οξύ προς διαλυτοποίηση της αργατροβάνης, ουσιαστικώς ελεύθερη από άνυδρη αλκοόλη, καθώς και μια μέθοδος για την παραγωγή της.
CY20111100825T 2005-09-01 2011-08-30 Σκευασμα αργατροβανης περιεχον ενα οξυ ως διαλυτοποιητη CY1112109T1 (el)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US71340305P 2005-09-01 2005-09-01
EP06802424A EP1948133B1 (en) 2005-09-01 2006-08-28 Argatroban formulation comprising an acid as solubilizer

Publications (1)

Publication Number Publication Date
CY1112109T1 true CY1112109T1 (el) 2015-11-04

Family

ID=37809398

Family Applications (1)

Application Number Title Priority Date Filing Date
CY20111100825T CY1112109T1 (el) 2005-09-01 2011-08-30 Σκευασμα αργατροβανης περιεχον ενα οξυ ως διαλυτοποιητη

Country Status (23)

Country Link
US (3) US7642271B2 (el)
EP (1) EP1948133B1 (el)
JP (1) JP5189980B2 (el)
KR (3) KR101753949B1 (el)
CN (2) CN101257890B (el)
AT (1) ATE514416T1 (el)
AU (1) AU2006285097B2 (el)
BR (1) BRPI0616127B8 (el)
CA (1) CA2617920C (el)
CY (1) CY1112109T1 (el)
DK (1) DK1948133T3 (el)
ES (1) ES2368758T3 (el)
HK (2) HK1123193A1 (el)
IL (2) IL189290A (el)
IN (1) IN2015DN03947A (el)
MX (1) MX2008002177A (el)
NZ (1) NZ565821A (el)
PL (1) PL1948133T3 (el)
PT (1) PT1948133E (el)
RU (1) RU2416393C2 (el)
SI (1) SI1948133T1 (el)
WO (1) WO2007027565A2 (el)
ZA (1) ZA200802667B (el)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1948133B1 (en) * 2005-09-01 2011-06-29 BAXTER INTERNATIONAL INC. (a Delaware corporation) Argatroban formulation comprising an acid as solubilizer
US7589106B2 (en) 2006-09-27 2009-09-15 Eagle Pharmaceuticals, Inc. Alcohol free formulation of argatroban
US7687516B2 (en) * 2006-09-27 2010-03-30 Eagle Pharmaceuticals, Inc. Alcohol free formulation of argatroban
US20100076019A1 (en) * 2006-10-11 2010-03-25 Eagle Pharmaceuticals, Inc. Alcohol free formulation of argatroban
US20090221637A1 (en) * 2008-02-29 2009-09-03 Baxter International Inc. Solid-state salt argatroban formulations and methods for producing and using the same
US7915290B2 (en) 2008-02-29 2011-03-29 Baxter International Inc. Argatroban formulations and methods for making and using same
CN101598725B (zh) * 2009-06-23 2012-07-18 南通大学附属医院 阿加曲班在血细胞和生化常规分析中的应用
ES2753981T3 (es) 2010-10-21 2020-04-15 Rtu Pharmaceuticals Llc Formulaciones de ketorolaco listas para uso
CN102119922A (zh) * 2011-03-03 2011-07-13 天津市炜杰科技有限公司 以酸作为增溶剂的21(s)阿加曲班静脉注射液
CN102120026A (zh) * 2011-03-03 2011-07-13 天津市炜杰科技有限公司 以醇作为增溶剂的21(s)阿加曲班静脉注射液
CN102228677A (zh) * 2011-06-17 2011-11-02 天津市炜杰科技有限公司 以酸作为增溶剂的21(r)阿加曲班静脉注射液
TWI632921B (zh) * 2011-10-19 2018-08-21 大塚製藥股份有限公司 口服溶液
EP3383494A4 (en) * 2015-12-04 2019-08-07 The Regents of The University of California Histone deacetylase INHIBITORS
CN107773533A (zh) * 2016-08-26 2018-03-09 四川科瑞德制药股份有限公司 一种新型凝血酶抑制剂及其制备方法

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE420919B (sv) * 1973-08-13 1981-11-09 Mitsubishi Chem Ind Forfarande for framstellning av n?722-dansyl-l-argininderivat och farmaceutiskt godtagbara syradditionssalter derav
US5214052A (en) * 1987-07-28 1993-05-25 Mitsubishi Kasei Corporation Method for dissolving arginineamides and pharmaceutical compositions containing them
CA2091715A1 (en) 1992-03-18 1993-09-19 Mitsubishi Kasei Corporation Argatroban preparations for ophthalmic use
US5506241A (en) * 1992-03-18 1996-04-09 Mitsubishi Chemical Corporation Argatroban preparations for ophthalmic use
JPH06219948A (ja) * 1993-01-25 1994-08-09 Mitsubishi Kasei Corp 抗トロンビン剤及びその製造方法
JPH06219949A (ja) * 1993-01-25 1994-08-09 Mitsubishi Kasei Corp 抗トロンビン剤及びその製造方法
ATE177635T1 (de) 1993-04-22 1999-04-15 Senju Pharma Co Wässrige arzneizubereitungen enthaltend argatroban und cyclodextrin oder coffein
JPH07228532A (ja) * 1993-04-22 1995-08-29 Senju Pharmaceut Co Ltd 水性液剤、その有効成分の溶解性向上方法および安定化方法
US5849843A (en) * 1993-11-16 1998-12-15 Baxter International Inc. Polymeric compositions for medical packaging and devices
US5998019A (en) * 1993-11-16 1999-12-07 Baxter International Inc. Multi-layered polymer structure for medical products
FR2715566B1 (fr) * 1994-02-03 1996-03-08 Synthelabo Solutions aqueuses concentrées d'argatroban.
US5840733A (en) * 1996-07-01 1998-11-24 Redcell, Canada, Inc. Methods and compositions for producing novel conjugates of thrombin inhibitors and endogenous carriers resulting in anti-thrombins with extended lifetimes
JPH10316569A (ja) * 1997-05-19 1998-12-02 Mitsubishi Chem Corp アルガトロバンの可溶化方法及びそれによるアルガトロバン含有外用水性薬剤
CN100344624C (zh) * 2003-03-20 2007-10-24 三菱制药株式会社 含有精氨酰胺类的医药制剂
WO2005009361A2 (en) 2003-07-17 2005-02-03 Smithkline Beecham Corporation Method of treating hit patients with argatroban
EP1948133B1 (en) * 2005-09-01 2011-06-29 BAXTER INTERNATIONAL INC. (a Delaware corporation) Argatroban formulation comprising an acid as solubilizer

Also Published As

Publication number Publication date
IL189290A (en) 2011-10-31
RU2416393C2 (ru) 2011-04-20
ZA200802667B (en) 2009-01-28
MX2008002177A (es) 2008-04-22
KR20140009599A (ko) 2014-01-22
CN101257890B (zh) 2012-10-31
KR20150108430A (ko) 2015-09-25
IN2015DN03947A (el) 2015-10-02
ATE514416T1 (de) 2011-07-15
EP1948133A2 (en) 2008-07-30
KR20080042155A (ko) 2008-05-14
JP5189980B2 (ja) 2013-04-24
BRPI0616127B8 (pt) 2021-05-25
KR101753949B1 (ko) 2017-07-04
CA2617920A1 (en) 2007-03-08
CN102895179A (zh) 2013-01-30
US20100099705A1 (en) 2010-04-22
PL1948133T3 (pl) 2012-03-30
RU2008112311A (ru) 2009-10-10
NZ565821A (en) 2010-05-28
IL208183A0 (en) 2010-12-30
JP2009507018A (ja) 2009-02-19
AU2006285097B2 (en) 2011-08-18
BRPI0616127B1 (pt) 2020-05-12
WO2007027565A3 (en) 2007-10-04
ES2368758T3 (es) 2011-11-22
SI1948133T1 (sl) 2011-08-31
US20070049617A1 (en) 2007-03-01
WO2007027565A2 (en) 2007-03-08
CN102895179B (zh) 2014-10-22
EP1948133B1 (en) 2011-06-29
AU2006285097A1 (en) 2007-03-08
DK1948133T3 (da) 2011-10-03
HK1123193A1 (en) 2009-06-12
CA2617920C (en) 2014-05-27
US7642271B2 (en) 2010-01-05
IL189290A0 (en) 2008-06-05
BRPI0616127A2 (pt) 2011-06-07
US8034830B2 (en) 2011-10-11
HK1178053A1 (en) 2013-09-06
US20100099706A1 (en) 2010-04-22
PT1948133E (pt) 2011-08-01
US7985757B2 (en) 2011-07-26
CN101257890A (zh) 2008-09-03

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