CA2433366C - Base libre d'amlodipine - Google Patents

Base libre d'amlodipine Download PDF

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Publication number
CA2433366C
CA2433366C CA002433366A CA2433366A CA2433366C CA 2433366 C CA2433366 C CA 2433366C CA 002433366 A CA002433366 A CA 002433366A CA 2433366 A CA2433366 A CA 2433366A CA 2433366 C CA2433366 C CA 2433366C
Authority
CA
Canada
Prior art keywords
free base
amlodipine
amlodipine free
process according
solution
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.)
Expired - Fee Related
Application number
CA002433366A
Other languages
English (en)
Other versions
CA2433366A1 (fr
Inventor
Theodorus Hendricus Antonius Peters
Franciscus Bernardus Gemma Benneker
Jacobus Maria Lemmens
Rolf Keltjens
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.)
Pfizer Ltd
Original Assignee
Pfizer 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=26946752&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2433366(C) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Pfizer Ltd filed Critical Pfizer Ltd
Publication of CA2433366A1 publication Critical patent/CA2433366A1/fr
Application granted granted Critical
Publication of CA2433366C publication Critical patent/CA2433366C/fr
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D209/00—Heterocyclic compounds containing five-membered rings, condensed with other rings, with one nitrogen atom as the only ring hetero atom
    • C07D209/02—Heterocyclic compounds containing five-membered rings, condensed with other rings, with one nitrogen atom as the only ring hetero atom condensed with one carbocyclic ring
    • C07D209/44—Iso-indoles; Hydrogenated iso-indoles
    • C07D209/48—Iso-indoles; Hydrogenated iso-indoles with oxygen atoms in positions 1 and 3, e.g. phthalimide
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D211/00—Heterocyclic compounds containing hydrogenated pyridine rings, not condensed with other rings
    • C07D211/04—Heterocyclic compounds containing hydrogenated pyridine rings, not condensed with other rings with only hydrogen or carbon atoms directly attached to the ring nitrogen atom
    • C07D211/80—Heterocyclic 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
    • C07D211/84—Heterocyclic 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
    • C07D211/90—Carbon atoms having three bonds to hetero atoms with at the most one bond to halogen
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D401/00—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom
    • C07D401/02—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings
    • C07D401/12—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings linked by a chain containing hetero atoms as chain links
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Inorganic Chemistry (AREA)
  • Hospice & Palliative Care (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Hydrogenated Pyridines (AREA)
  • Medicinal Preparation (AREA)
  • Inks, Pencil-Leads, Or Crayons (AREA)

Abstract

L'invention permet de créer des formulations de base libre d'amlodipine, sous forme de doses orales et notamment de comprimés, en évitant à ces comprimés une trop grande adhésivité ou l'apparition de résidus de poinçonnage trop importants. La base libre d'amlodipine peut être sous une forme I cristalline ou sous une nouvelle forme II. L'invention concerne en outre des procédés de fabrication et d'utilisation de la base libre d'amlodipine.
CA002433366A 2000-12-29 2001-12-31 Base libre d'amlodipine Expired - Fee Related CA2433366C (fr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US25861300P 2000-12-29 2000-12-29
US60/258,613 2000-12-29
US80935101A 2001-03-16 2001-03-16
US09/809,351 2001-03-16
PCT/NL2001/000947 WO2002053135A1 (fr) 2000-12-29 2001-12-31 Base libre d'amlodipine

Publications (2)

Publication Number Publication Date
CA2433366A1 CA2433366A1 (fr) 2002-07-11
CA2433366C true CA2433366C (fr) 2006-01-24

Family

ID=26946752

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002433366A Expired - Fee Related CA2433366C (fr) 2000-12-29 2001-12-31 Base libre d'amlodipine

Country Status (9)

Country Link
EP (1) EP1345901A2 (fr)
AU (1) AU2001294354A1 (fr)
BR (1) BR0116558A (fr)
CA (1) CA2433366C (fr)
CZ (1) CZ20031779A3 (fr)
DE (2) DE20116723U1 (fr)
ES (1) ES2277960T3 (fr)
MX (1) MXPA03005888A (fr)
WO (2) WO2002053535A2 (fr)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BE1014450A6 (nl) * 2000-12-29 2003-10-07 Bioorg Bv Werkwijze voor het maken van amlodipine, derivaten daarvan en voorlopers daarvoor.
GB2371862B (en) 2000-12-29 2004-07-14 Bioorg Bv Reference standards for determining the purity or stability of amlodipine maleate and processes therefor
US6828339B2 (en) * 2001-11-21 2004-12-07 Synthon Bv Amlodipine salt forms and processes for preparing them
NL1019882C2 (nl) * 2002-02-01 2003-08-04 Synthon Licensing Amlodipine vrije base.
ES2211317B1 (es) * 2002-11-18 2005-10-16 Finaf 92, S.A. Compuestos intermedios para la obtencion de principios activos antihipertensivos y procedimientos correspondientes.
BRPI0407038A (pt) * 2003-01-27 2006-01-17 Hanmi Pharm Ind Co Ltd Camsilato de amlodipina amorfo estável, processo para a preparação do mesmo e composição para administração oral deste
WO2004075825A2 (fr) * 2003-02-28 2004-09-10 Ranbaxy Laboratories Limited Formes posologiques d'amlodipine et leurs procedes de preparation
CH697952B1 (de) * 2003-07-25 2009-03-31 Siegfried Generics Int Ag Verfahren zur Reinigung der freien Amlodipinbase.
WO2005023769A1 (fr) * 2003-09-04 2005-03-17 Cipla Limited Procede pour l'elaboration de sels d'amlodipine
KR100604034B1 (ko) * 2003-10-08 2006-07-24 주식회사유한양행 암로디핀 유리염기를 함유한 구강 속붕해정 및 그의 조성물
WO2007131759A1 (fr) * 2006-05-15 2007-11-22 Lek Pharmaceuticals D.D. Procédé de préparation de benzènesulfonate d'amlodipine
EP1975167A1 (fr) 2007-03-30 2008-10-01 Esteve Quimica, S.A. Solvate d'acétone de phtaloyl amlodipine
WO2011117876A1 (fr) 2010-03-26 2011-09-29 Fdc Limited Procédé amélioré pour la préparation de base libre d'amlodipine et des sels d'addition d'acide de celle-ci

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK161312C (da) * 1982-03-11 1991-12-09 Pfizer Analogifremgangsmaade til fremstilling af 2-aminoalkoxymethyl-4-phenyl-6-methyl-1,4-dihydropyridin-3,5-dicarboxylsyreestere eller syreadditionssalte deraf samt phthalimidoderivater til anvendelse som udgangsmateriale ved fremgangsmaaden
PL140069B1 (en) 1982-12-21 1987-03-31 Pfizer Method of obtaining new derivatives of dihydropiridine
DE3544211A1 (de) * 1985-12-13 1987-06-19 Bayer Ag Neue, fluorhaltige 1,4-dihydropyridine, verfahren zu ihrer herstellung sowie ihre verwendung als arzneimittel
DE4305454A1 (de) * 1993-02-23 1994-08-25 Bayer Ag Klotzverfahren mit einer Phthalocyaninmischung
GB9317773D0 (en) * 1993-08-26 1993-10-13 Pfizer Ltd Therapeutic compound
GB0008332D0 (en) * 2000-04-04 2000-05-24 Pfizer Ltd Treament
GB0020842D0 (en) * 2000-08-23 2000-10-11 Pfizer Ltd Therapeutic compositions

Also Published As

Publication number Publication date
MXPA03005888A (es) 2005-04-19
AU2001294354A1 (en) 2002-07-16
CA2433366A1 (fr) 2002-07-11
ES2277960T3 (es) 2007-08-01
WO2002053535A3 (fr) 2003-01-23
WO2002053135A1 (fr) 2002-07-11
EP1345901A2 (fr) 2003-09-24
WO2002053535A2 (fr) 2002-07-11
AU2001294354A8 (fr) 2005-10-06
DE60125981T2 (de) 2007-10-18
DE20116723U1 (de) 2002-01-17
CZ20031779A3 (cs) 2004-10-13
BR0116558A (pt) 2003-10-28
DE60125981D1 (de) 2007-02-22

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Effective date: 20191231