WO2011083955A3 - Method for manufacturing crystalline form (i) of clopidogrel hydrogen sulphate - Google Patents

Method for manufacturing crystalline form (i) of clopidogrel hydrogen sulphate Download PDF

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Publication number
WO2011083955A3
WO2011083955A3 PCT/KR2011/000038 KR2011000038W WO2011083955A3 WO 2011083955 A3 WO2011083955 A3 WO 2011083955A3 KR 2011000038 W KR2011000038 W KR 2011000038W WO 2011083955 A3 WO2011083955 A3 WO 2011083955A3
Authority
WO
WIPO (PCT)
Prior art keywords
crystalline form
clopidogrel hydrogen
hydrogen sulphate
clopidogrel
manufacturing crystalline
Prior art date
Application number
PCT/KR2011/000038
Other languages
French (fr)
Other versions
WO2011083955A2 (en
Inventor
Yoon Seok Oh
Dong Hyuk Shin
Jin Yong Jung
Original Assignee
Dong Wha Pharm. Co., Ltd.
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 Dong Wha Pharm. Co., Ltd. filed Critical Dong Wha Pharm. Co., Ltd.
Publication of WO2011083955A2 publication Critical patent/WO2011083955A2/en
Publication of WO2011083955A3 publication Critical patent/WO2011083955A3/en

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D495/00—Heterocyclic compounds containing in the condensed system at least one hetero ring having sulfur atoms as the only ring hetero atoms
    • C07D495/02—Heterocyclic compounds containing in the condensed system at least one hetero ring having sulfur atoms as the only ring hetero atoms in which the condensed system contains two hetero rings
    • C07D495/04—Ortho-condensed systems
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N43/00—Biocides, pest repellants or attractants, or plant growth regulators containing heterocyclic compounds
    • A01N43/90—Biocides, pest repellants or attractants, or plant growth regulators containing heterocyclic compounds having two or more relevant hetero rings, condensed among themselves or with a common carbocyclic ring system
    • 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
    • A61K31/435—Heterocyclic 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • 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
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D403/00—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group C07D401/00
    • C07D403/14—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group C07D401/00 containing three or more hetero rings
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D495/00—Heterocyclic compounds containing in the condensed system at least one hetero ring having sulfur atoms as the only ring hetero atoms
    • C07D495/02—Heterocyclic compounds containing in the condensed system at least one hetero ring having sulfur atoms as the only ring hetero atoms in which the condensed system contains two hetero rings

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Agronomy & Crop Science (AREA)
  • Environmental Sciences (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Dentistry (AREA)
  • Engineering & Computer Science (AREA)
  • Plant Pathology (AREA)
  • Pest Control & Pesticides (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)

Abstract

The present invention provides a method for manufacturing a crystalline form (I) of clopidogrel hydrogen sulphate(clopidogrel hydrogen sulfate), including reacting a clopidogrel free base with concentrated sulfuric acid in the presence of a mixed solvent containing water in an amount of 4 to 14% by weight based on the weight of the clopidogrel free base and 2-butanol.
PCT/KR2011/000038 2010-01-07 2011-01-05 Method for manufacturing crystalline form (i) of clopidogrel hydrogen sulphate WO2011083955A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020100001379A KR101616928B1 (en) 2010-01-07 2010-01-07 Method for manufacturing crystalline form (I) of Clopidogrel hydrogen sulphate
KR10-2010-0001379 2010-01-07

Publications (2)

Publication Number Publication Date
WO2011083955A2 WO2011083955A2 (en) 2011-07-14
WO2011083955A3 true WO2011083955A3 (en) 2011-12-08

Family

ID=44305929

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2011/000038 WO2011083955A2 (en) 2010-01-07 2011-01-05 Method for manufacturing crystalline form (i) of clopidogrel hydrogen sulphate

Country Status (2)

Country Link
KR (1) KR101616928B1 (en)
WO (1) WO2011083955A2 (en)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104478895B (en) * 2014-12-05 2017-04-12 广东东阳光药业有限公司 Preparation method of clopidogrel sulfate
US9815848B2 (en) * 2014-12-31 2017-11-14 Tianjin University Method for preparing spherical Clopidogrel Hydrogen Sulfate polymorph I
KR101710922B1 (en) 2015-06-03 2017-02-28 경동제약 주식회사 Method for preparing crystalline form I of Clopidogrel hydrogen sulfate

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004081016A1 (en) * 2003-03-12 2004-09-23 Cadila Healthcare Limited Polymorphs and amorphous form of (s) - (+) -clopidogrel bisulfate
WO2005063708A2 (en) * 2003-11-03 2005-07-14 Cadila Healthcare Limited Processes for preparing different forms of (s)-(+)- clopidogrel bisulfate
WO2007094006A1 (en) * 2006-02-13 2007-08-23 Lee Pharma Limited Process for preparation of clopidogrel bisulfate form 1
US20080188663A1 (en) * 2007-01-29 2008-08-07 Ashok Kumar Process for the preparation of crystalline clopidogrel hydrogen sulphate Form I

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7772398B2 (en) 2005-03-11 2010-08-10 Dr. Reddy's Laboratories, Inc. Process for making crystalline form I of clopidogrel hydrogen sulphate
CN102050829A (en) 2009-11-04 2011-05-11 北京华禧联合科技发展有限公司 Crystallizing method for obtaining I crystal form (+)-(S)-clopidogrel bisulfate

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004081016A1 (en) * 2003-03-12 2004-09-23 Cadila Healthcare Limited Polymorphs and amorphous form of (s) - (+) -clopidogrel bisulfate
WO2005063708A2 (en) * 2003-11-03 2005-07-14 Cadila Healthcare Limited Processes for preparing different forms of (s)-(+)- clopidogrel bisulfate
WO2007094006A1 (en) * 2006-02-13 2007-08-23 Lee Pharma Limited Process for preparation of clopidogrel bisulfate form 1
US20080188663A1 (en) * 2007-01-29 2008-08-07 Ashok Kumar Process for the preparation of crystalline clopidogrel hydrogen sulphate Form I

Also Published As

Publication number Publication date
KR20110080931A (en) 2011-07-13
KR101616928B1 (en) 2016-05-02
WO2011083955A2 (en) 2011-07-14

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