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BRPI0416648A2 - process for the preparation of pharmaceutically acceptable chiral salts of amlodipine - Google Patents

process for the preparation of pharmaceutically acceptable chiral salts of amlodipine

Info

Publication number
BRPI0416648A2
BRPI0416648A2 BRPI0416648-5A BRPI0416648A BRPI0416648A2 BR PI0416648 A2 BRPI0416648 A2 BR PI0416648A2 BR PI0416648 A BRPI0416648 A BR PI0416648A BR PI0416648 A2 BRPI0416648 A2 BR PI0416648A2
Authority
BR
Brazil
Prior art keywords
preparation
pharmaceutically acceptable
amlodipine
amiodipine
chiral salts
Prior art date
Application number
BRPI0416648-5A
Other languages
Portuguese (pt)
Inventor
Rohini Ramesh Joshi
Ramesh Anna Joshi
Nilesh Bapurao Karade
Mukund Keshav Gurjar
Original Assignee
Council Scient Ind Res
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 Council Scient Ind Res filed Critical Council Scient Ind Res
Publication of BRPI0416648A2 publication Critical patent/BRPI0416648A2/en

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D211/00Heterocyclic compounds containing hydrogenated pyridine rings, not condensed with other rings
    • C07D211/04Heterocyclic compounds containing hydrogenated pyridine rings, not condensed with other rings with only hydrogen or carbon atoms directly attached to the ring nitrogen atom
    • C07D211/80Heterocyclic compounds containing hydrogenated pyridine rings, not condensed with other rings with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having two double bonds between ring members or between ring members and non-ring members
    • C07D211/84Heterocyclic compounds containing hydrogenated pyridine rings, not condensed with other rings with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having two double bonds between ring members or between ring members and non-ring members with hetero atoms or with carbon atoms having three bonds to hetero atoms, with at the most one bond to halogen directly attached to ring carbon atoms
    • C07D211/90Carbon atoms having three bonds to hetero atoms with at the most one bond to halogen
    • 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/44221,4-Dihydropyridines, e.g. nifedipine, nicardipine
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07BGENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00Indexing scheme relating to specific properties of organic compounds
    • C07B2200/07Optical isomers

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Hydrogenated Pyridines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

PROCESSO PARA A PREPARAÇçO DE SAIS QUIRAIS FARMACEUTICAMENTE ACEITÁVEIS DE AMLODIPINA. A presente invenção refere-se a um processo para a preparação de sais farmaceuticamente aceitáveis de Amiodipina quiral, mais especificamente S(-) Amiodipina e R(+) Amiodipina sem isolar a base livre quiral na qual o produto tem uma pureza ótica variando entre 95 e 99% é descrito na presente invenção. O processo compreende resolver uma base RS de Arnlodipina usando ácido tartárico L(+) ou D(-) seguido pela reação do sal de tartrato separado com um ácido orgânico para obter o sal correspondente ao ácido usado com um ee variando a partir de 96 - 99%.PROCESS FOR THE PREPARATION OF PHARMACEUTICALLY ACCEPTABLE AMLODIPINE CHALAL SALTS. The present invention relates to a process for the preparation of pharmaceutically acceptable salts of chiral Amiodipine, more specifically S (-) Amiodipine and R (+) Amiodipine without isolating the chiral free base in which the product has an optical purity ranging from 95 ° C. and 99% is described in the present invention. The process comprises resolving an Arnlodipine RS base using L (+) or D (-) tartaric acid followed by reacting the separated tartrate salt with an organic acid to obtain the acid corresponding salt used with an ee ranging from 96 - 99%.

BRPI0416648-5A 2003-11-20 2004-10-19 process for the preparation of pharmaceutically acceptable chiral salts of amlodipine BRPI0416648A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN1440DE2003 2003-11-20
PCT/IN2004/000324 WO2005049571A1 (en) 2003-11-20 2004-10-19 Process for preparation of chiral amlodipine salts

Publications (1)

Publication Number Publication Date
BRPI0416648A2 true BRPI0416648A2 (en) 2009-01-13

Family

ID=34611190

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0416648-5A BRPI0416648A2 (en) 2003-11-20 2004-10-19 process for the preparation of pharmaceutically acceptable chiral salts of amlodipine

Country Status (5)

Country Link
EP (1) EP1687273A1 (en)
KR (1) KR20060086432A (en)
CN (1) CN1882543A (en)
BR (1) BRPI0416648A2 (en)
WO (1) WO2005049571A1 (en)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7858801B2 (en) * 2004-10-20 2010-12-28 Emcure Pharmaceuticals Limited Process for producing enantiomer of amlodipine in high optical purity
KR101235116B1 (en) * 2005-10-17 2013-02-20 에스케이케미칼주식회사 Process for preparation of chiral amlodipine gentisate
KR100843400B1 (en) * 2006-11-14 2008-07-04 씨제이제일제당 (주) Crystalline S-(-)-Amlodipine Maleic Acid Anhydride and Method for Making the Same
CN101468986B (en) * 2007-12-26 2010-12-29 香港南北兄弟国际投资有限公司 Resolution method of dihydropyrimidine racemic compound
KR100979772B1 (en) * 2008-06-12 2010-09-02 에이치 엘 지노믹스(주) Method of Making Optically Pure S-(-)-Amlodipine Benzenesulfonate
KR101313842B1 (en) * 2010-09-15 2013-10-01 대화제약 주식회사 A manufacturing method of esamlodipine besilate and its hydrate
CN102516159B (en) * 2011-12-15 2013-10-09 扬子江药业集团江苏海慈生物药业有限公司 Method for producing S-(-)-amlodipine besylate
CN104592099A (en) * 2014-12-30 2015-05-06 山东鲁抗医药股份有限公司 Refining method for improving optical purity of levoamlodipine besylate
CN111689894B (en) * 2019-03-13 2023-05-02 鲁南制药集团股份有限公司 Levamlodipine besylate crystal form
CN112110850B (en) * 2019-06-20 2023-05-02 鲁南制药集团股份有限公司 Novel crystal form of levamlodipine besylate
CN115850159B (en) * 2022-11-11 2025-03-14 常州瑞明药业有限公司 A kind of preparation method of levamlodipine maleate
CN116332832A (en) * 2023-03-29 2023-06-27 安徽美致诚药业有限公司 Maleic acid levo-amlodipine amorphous crystal form and preparation method thereof

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB9405833D0 (en) * 1994-03-24 1994-05-11 Pfizer Ltd Separation of the enantiomers of amlodipine
MXPA03005885A (en) * 2000-12-29 2005-04-19 Pfizer Ltd Process for making amlodipine maleate.
US6608206B1 (en) * 2002-10-30 2003-08-19 Council Of Scientific & Industrial Research Process for making S(-) Amlodipine salts

Also Published As

Publication number Publication date
KR20060086432A (en) 2006-07-31
CN1882543A (en) 2006-12-20
WO2005049571A1 (en) 2005-06-02
EP1687273A1 (en) 2006-08-09

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Legal Events

Date Code Title Description
B08F Application fees: application dismissed [chapter 8.6 patent gazette]

Free format text: REFERENTE AS 3A, 4A, 5A, 6A E 7A ANUIDADES.

B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]

Free format text: REFERENTE AO DESPACHO 8.6 PUBLICADO NA RPI 2158 DE 15/05/2012.