EA200900294A1 - Кристаллический толтеродина тартрат и фармацевтическая композиция, содержащая его - Google Patents

Кристаллический толтеродина тартрат и фармацевтическая композиция, содержащая его

Info

Publication number
EA200900294A1
EA200900294A1 EA200900294A EA200900294A EA200900294A1 EA 200900294 A1 EA200900294 A1 EA 200900294A1 EA 200900294 A EA200900294 A EA 200900294A EA 200900294 A EA200900294 A EA 200900294A EA 200900294 A1 EA200900294 A1 EA 200900294A1
Authority
EA
Eurasian Patent Office
Prior art keywords
tolterodine
pharmaceutical composition
composition containing
less
tartrat
Prior art date
Application number
EA200900294A
Other languages
English (en)
Other versions
EA016325B1 (ru
Inventor
Мартин Свобода
Йосеф Ямпилек
Мартина Кациркова
Вацлав Томасек
Микулас Легоцкий
Людмила Гейтманкова
Вацлав Восатка
Original Assignee
Зентива, К.С.
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
Priority claimed from CZ20060506A external-priority patent/CZ298448B6/cs
Priority claimed from CZ20070160A external-priority patent/CZ302585B6/cs
Application filed by Зентива, К.С. filed Critical Зентива, К.С.
Publication of EA200900294A1 publication Critical patent/EA200900294A1/ru
Publication of EA016325B1 publication Critical patent/EA016325B1/ru

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C215/00—Compounds containing amino and hydroxy groups bound to the same carbon skeleton
    • C07C215/46—Compounds containing amino and hydroxy groups bound to the same carbon skeleton having hydroxy groups bound to carbon atoms of at least one six-membered aromatic ring and amino groups bound to acyclic carbon atoms or to carbon atoms of rings other than six-membered aromatic rings of the same carbon skeleton
    • C07C215/48—Compounds containing amino and hydroxy groups bound to the same carbon skeleton having hydroxy groups bound to carbon atoms of at least one six-membered aromatic ring and amino groups bound to acyclic carbon atoms or to carbon atoms of rings other than six-membered aromatic rings of the same carbon skeleton with amino groups linked to the six-membered aromatic ring, or to the condensed ring system containing that ring, by carbon chains not further substituted by hydroxy groups
    • C07C215/54—Compounds containing amino and hydroxy groups bound to the same carbon skeleton having hydroxy groups bound to carbon atoms of at least one six-membered aromatic ring and amino groups bound to acyclic carbon atoms or to carbon atoms of rings other than six-membered aromatic rings of the same carbon skeleton with amino groups linked to the six-membered aromatic ring, or to the condensed ring system containing that ring, by carbon chains not further substituted by hydroxy groups linked by carbon chains having at least three carbon atoms between the amino groups and the six-membered aromatic ring or the condensed ring system containing that ring
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/06—Anti-spasmodics
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C213/00—Preparation of compounds containing amino and hydroxy, amino and etherified hydroxy or amino and esterified hydroxy groups bound to the same carbon skeleton
    • C07C213/10—Separation; Purification; Stabilisation; Use of additives

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Urology & Nephrology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Кристаллическая соль 2-[(1R)-3-[бис(1-метилэтил)амино]-1-фенилпропил]-4-метилфенола с (2R,3R)-2,3-дигидроксибутандиовой кислотой, известная под названием R-толтеродина тартрат, в которой: а) по меньшей мере 90% всех присутствующих кристаллов имеют размер менее 30 мкм, б) по меньшей мере 40% кристаллического вещества менее 250 мкм, в) максимальный размер кристаллов не превышает 800 мкм, г) соль содержит менее 0,1 мас.% нежелательного энантиомера S-толтеродина тартрата, д) аналитический тест на сульфатную золу (Европейская Фармакопея) дает значение ниже, чем 0,1%. Способ ее получения включает по меньшей мере одну кристаллизацию из воды. Фармацевтическая композиция, содержащая толтеродин или его фармацевтически приемлемые соли, дополнительно содержит наполнитель, разрыхлитель и смазывающий агент, где указанная композиция свободна от ионов щелочно-земельных металлов.
EA200900294A 2006-08-09 2007-08-09 Способ получения кристаллического (r)-толтеродина тартрата EA016325B1 (ru)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CZ20060506A CZ298448B6 (cs) 2006-08-09 2006-08-09 Farmaceutická kompozice s obsahem tolterodinu
CZ20070160A CZ302585B6 (cs) 2007-02-26 2007-02-26 Krystalická sul 2-[(1R)-3-[bis(1-methylethyl)amino]-1-fenylpropyl]-4-methylfenolu s kyselinou (2R,3R)-2,3-dihydroxybutandiovou
PCT/CZ2007/000078 WO2008017278A2 (en) 2006-08-09 2007-08-09 Crystalline tolterodine tartarate and a pharmaceutical composition containing the same

Publications (2)

Publication Number Publication Date
EA200900294A1 true EA200900294A1 (ru) 2009-08-28
EA016325B1 EA016325B1 (ru) 2012-04-30

Family

ID=38951261

Family Applications (1)

Application Number Title Priority Date Filing Date
EA200900294A EA016325B1 (ru) 2006-08-09 2007-08-09 Способ получения кристаллического (r)-толтеродина тартрата

Country Status (4)

Country Link
US (1) US20100189786A1 (ru)
EP (1) EP2054372A2 (ru)
EA (1) EA016325B1 (ru)
WO (1) WO2008017278A2 (ru)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8871275B2 (en) 2007-08-08 2014-10-28 Inventia Healthcare Private Limited Extended release compositions comprising tolterodine
ITMI20082055A1 (it) * 2008-11-19 2009-02-18 Dipharma Francis Srl Procedimento per la preparazione di (r)-tolterodina base libera
ITMI20110410A1 (it) * 2011-03-15 2012-09-16 Cambrex Profarmaco Milano Srl Procedimento per la preparazione di (r)-tolterodina l-tartrato di forma cristallina definita

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE8800207D0 (sv) * 1988-01-22 1988-01-22 Kabivitrum Ab Nya aminer, deras anvendning och framstellning
US20030152624A1 (en) * 2001-12-20 2003-08-14 Aldrich Dale S. Controlled release dosage form having improved drug release properties

Also Published As

Publication number Publication date
EA016325B1 (ru) 2012-04-30
WO2008017278B1 (en) 2008-08-28
EP2054372A2 (en) 2009-05-06
US20100189786A1 (en) 2010-07-29
WO2008017278A2 (en) 2008-02-14
WO2008017278A3 (en) 2008-07-10

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Legal Events

Date Code Title Description
MM4A Lapse of a eurasian patent due to non-payment of renewal fees within the time limit in the following designated state(s)

Designated state(s): AM AZ KG MD TJ TM