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WO2011137877A3 - A pharmaceutical composition containing solifenacin and a method of its manufacture - Google Patents

A pharmaceutical composition containing solifenacin and a method of its manufacture Download PDF

Info

Publication number
WO2011137877A3
WO2011137877A3 PCT/CZ2011/000039 CZ2011000039W WO2011137877A3 WO 2011137877 A3 WO2011137877 A3 WO 2011137877A3 CZ 2011000039 W CZ2011000039 W CZ 2011000039W WO 2011137877 A3 WO2011137877 A3 WO 2011137877A3
Authority
WO
WIPO (PCT)
Prior art keywords
solifenacin
coated
binder
packed
active ingredient
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.)
Ceased
Application number
PCT/CZ2011/000039
Other languages
French (fr)
Other versions
WO2011137877A2 (en
Inventor
Martin Svoboda
Jakub Hert
Hana Brusova
Tomas Pilarcik
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.)
Zentiva KS
Original Assignee
Zentiva KS
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 CZ20100357A external-priority patent/CZ2010357A3/en
Priority claimed from SK173-2010A external-priority patent/SK1732010A3/en
Application filed by Zentiva KS filed Critical Zentiva KS
Priority to EA201291189A priority Critical patent/EA201291189A1/en
Publication of WO2011137877A2 publication Critical patent/WO2011137877A2/en
Publication of WO2011137877A3 publication Critical patent/WO2011137877A3/en
Anticipated expiration legal-status Critical
Ceased 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
    • A61K9/2022—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
    • 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
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/472—Non-condensed isoquinolines, e.g. papaverine
    • A61K31/4725—Non-condensed isoquinolines, e.g. papaverine containing further heterocyclic rings
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Landscapes

  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)

Abstract

The present solution relates to a coated tablet, comprising the active ingredient solifenacin succinate and the binder hydroxypropyl methyl cellulose, wherein the tablet comprises solifenacin I in the range of 3 to 10% wt. of the solifenacin base and methocel as the binder in the range of 0.5 to 5% wt., related to the core weight, wherein after 3-month stability tests at the 75% relative humidity and 40 °C an increase of the content of the N-oxide impurity of formula II is lower than 0.1% of the HPLC integrated area. Another solutions consist in a pharmaceutical preparation comprising the coated tablet packed in a blister package and a manufacturing method of the coated tablets, wherein a powder mixture containing the active ingredient and the binder is granulated by addition of water, whereafter the granulate is tabletted, the resulting tablets are coated and packed.
PCT/CZ2011/000039 2010-05-07 2011-04-21 A pharmaceutical composition containing solifenacin and a method of its manufacture Ceased WO2011137877A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EA201291189A EA201291189A1 (en) 2010-05-07 2011-04-21 PHARMACEUTICAL COMPOSITION CONTAINING SOLIPHENACIN, AND METHOD FOR ITS OBTAINING

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CZ20100357A CZ2010357A3 (en) 2010-05-07 2010-05-07 Pharmaceutical composition containing solifenacin and process for preparing thereof
CZPV2010-357 2010-05-07
SK173-2010A SK1732010A3 (en) 2010-12-30 2010-12-30 Pharmaceutical composition containing solifenacin and method of manufacture thereof
SKPP00173-2010 2010-12-30

Publications (2)

Publication Number Publication Date
WO2011137877A2 WO2011137877A2 (en) 2011-11-10
WO2011137877A3 true WO2011137877A3 (en) 2012-05-18

Family

ID=44904161

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CZ2011/000039 Ceased WO2011137877A2 (en) 2010-05-07 2011-04-21 A pharmaceutical composition containing solifenacin and a method of its manufacture

Country Status (2)

Country Link
EA (1) EA201291189A1 (en)
WO (1) WO2011137877A2 (en)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015170237A1 (en) * 2014-05-05 2015-11-12 Torrent Pharmaceuticals Limited Stable solifenacin composition
CN104133011A (en) * 2014-07-01 2014-11-05 北京万全德众医药生物技术有限公司 Method for separating and analyzing solifenacin succinate intermediate and correlated substances
JP7098925B2 (en) * 2016-12-21 2022-07-12 ニプロ株式会社 Methods for improving the stability of solid formulations and amorphous bodies

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008128028A2 (en) * 2007-04-11 2008-10-23 Dr. Reddy's Laboratories Ltd. Solifenacin compositions
WO2009012987A1 (en) * 2007-07-24 2009-01-29 Ratiopharm Gmbh Pharmaceutical composition comprising solifenacin or a pharmaceutically acceptable salt thereof
WO2010097243A2 (en) * 2009-02-27 2010-09-02 Krka, D. D., Novo Mesto Process for forming solid oral dosage forms of solifenacin and its pharmaceutically acceptable salts

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PL2156824T3 (en) 2004-03-25 2013-03-29 Astellas Pharma Inc Composition of solifenacin or salt thereof for use in solid formulation
EP1832288B1 (en) 2004-12-27 2012-06-20 Astellas Pharma Inc. Stable granular pharmaceutical composition of solifenacin or its salt

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008128028A2 (en) * 2007-04-11 2008-10-23 Dr. Reddy's Laboratories Ltd. Solifenacin compositions
WO2009012987A1 (en) * 2007-07-24 2009-01-29 Ratiopharm Gmbh Pharmaceutical composition comprising solifenacin or a pharmaceutically acceptable salt thereof
WO2010097243A2 (en) * 2009-02-27 2010-09-02 Krka, D. D., Novo Mesto Process for forming solid oral dosage forms of solifenacin and its pharmaceutically acceptable salts

Also Published As

Publication number Publication date
EA201291189A1 (en) 2013-05-30
WO2011137877A2 (en) 2011-11-10

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