PL402028A1 - Method for preparing polymorph B form of Prasugrel hydrochloride in pharmaceutical grade - Google Patents

Method for preparing polymorph B form of Prasugrel hydrochloride in pharmaceutical grade

Info

Publication number
PL402028A1
PL402028A1 PL402028A PL40202812A PL402028A1 PL 402028 A1 PL402028 A1 PL 402028A1 PL 402028 A PL402028 A PL 402028A PL 40202812 A PL40202812 A PL 40202812A PL 402028 A1 PL402028 A1 PL 402028A1
Authority
PL
Poland
Prior art keywords
prasugrel
aliphatic
prasugrel hydrochloride
pharmaceutical grade
volume
Prior art date
Application number
PL402028A
Other languages
Polish (pl)
Inventor
Marcin Cybulski
Wioleta Maruszak
Adam Formela
Kinga Trzcińska
Anna Witkowska
Magdalena Bodziachowska-Panfil
Original Assignee
Instytut Farmaceutyczny
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 Instytut Farmaceutyczny filed Critical Instytut Farmaceutyczny
Priority to PL402028A priority Critical patent/PL402028A1/en
Priority to PCT/PL2013/000164 priority patent/WO2014092589A1/en
Publication of PL402028A1 publication Critical patent/PL402028A1/en

Links

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
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Diabetes (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)

Abstract

Sposób wytwarzania postaci krystalicznej B chlorowodorku prasugrelu o czystości farmaceutycznej polega na tym, że reakcję addycji zasady prasugrelu z chlorowodorem prowadzi się w rozpuszczalniku organicznym wybranym z grupy ketonów, estrów alifatycznych lub eterów alifatycznych bądź cyklicznych, z dodatkiem alkoholu metylowego w ilości 0,1-10% objętościowo w stosunku do objętości użytego wyjściowego rozpuszczalnika i zarodków krystalicznych postaci polimorficznej B chlorowodorku prasugrelu, oraz ewentualnie przeciwrozpuszczalnika wybranego z grupy eterów alifatycznych bądź cyklicznych. Prasugrel, ester 5-[2-cyklopropylo-1-(2-fluorofenylo)-2-oksetylo]-4,5,6,7,- tetrahydrotieno[3,2-c]pirydyn-2-ylowego kwasu octowego, jest związek o działaniu przeciwplytkowym.The method of producing crystalline form B of prasugrel hydrochloride in pharmaceutical purity is that the addition reaction of Prasugrel base with hydrogen chloride is carried out in an organic solvent selected from the group of ketones, aliphatic esters or aliphatic or cyclic ethers, with the addition of 0.1-10 methyl alcohol % by volume in relation to the volume of the starting solvent and crystalline nuclei used, form Prasugrel hydrochloride polymorph B, and optionally an anti-solvent selected from the group of aliphatic or cyclic ethers. Prasugrel, 5- [2-cyclopropyl-1- (2-fluorophenyl) -2-oxetyl] -4,5,6,7, - tetrahydrothieno [3,2-c] pyridin-2-yl acetic acid, is a compound antiplatelet effect.

PL402028A 2012-12-12 2012-12-12 Method for preparing polymorph B form of Prasugrel hydrochloride in pharmaceutical grade PL402028A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
PL402028A PL402028A1 (en) 2012-12-12 2012-12-12 Method for preparing polymorph B form of Prasugrel hydrochloride in pharmaceutical grade
PCT/PL2013/000164 WO2014092589A1 (en) 2012-12-12 2013-12-12 Process for preparation of prasugrel hydrochloride polymorphic form b of pharmaceutical purity

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PL402028A PL402028A1 (en) 2012-12-12 2012-12-12 Method for preparing polymorph B form of Prasugrel hydrochloride in pharmaceutical grade

Publications (1)

Publication Number Publication Date
PL402028A1 true PL402028A1 (en) 2014-06-23

Family

ID=49958649

Family Applications (1)

Application Number Title Priority Date Filing Date
PL402028A PL402028A1 (en) 2012-12-12 2012-12-12 Method for preparing polymorph B form of Prasugrel hydrochloride in pharmaceutical grade

Country Status (2)

Country Link
PL (1) PL402028A1 (en)
WO (1) WO2014092589A1 (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105669696B (en) * 2014-11-21 2019-03-26 四川海思科制药有限公司 A kind of prasugrel hydrochloride compound
CN112898359A (en) * 2019-12-03 2021-06-04 晨光生物科技集团股份有限公司 Preparation method of low-solubility residual crystal

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HU230762B1 (en) 2000-07-06 2018-03-28 Daiichi Sankyo Company, Limited Maleate addition salts of hydropyridine derivates
TWI392681B (en) 2006-04-06 2013-04-11 Daiichi Sankyo Co Ltd Prasugrel with high purity and a method for preparing its acid addition salt
DE602007003024D1 (en) 2006-06-27 2009-12-10 Sandoz Ag NEW PROCESS FOR SALT PRODUCTION
US20100261908A1 (en) 2007-11-09 2010-10-14 Dr. Reddy's Laboratories Ltd. Processes for the preparation of prasugrel , and its salts and polymorphs
WO2010070677A2 (en) 2008-12-15 2010-06-24 Glenmark Generics Limited A process for the preparation of prasugrel and its pharmaceutically acceptable salts thereof
CZ2009828A3 (en) 2009-12-09 2011-06-22 Zentiva, K.S. Process for preparing 5-[2-cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate hydrochloride (prasugrelu hydrochloride in polymorphous B form
EP2528924A1 (en) 2010-03-23 2012-12-05 Alembic Pharmaceuticals Limited A process for the preparation of prasugrel hcl salt
EP2601200A4 (en) * 2010-08-06 2014-01-08 Reddys Lab Ltd Dr Preparation of prasugrel hydrochloride

Also Published As

Publication number Publication date
WO2014092589A1 (en) 2014-06-19

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