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WO2008128028A3 - Solifenacin compositions - Google Patents

Solifenacin compositions Download PDF

Info

Publication number
WO2008128028A3
WO2008128028A3 PCT/US2008/060010 US2008060010W WO2008128028A3 WO 2008128028 A3 WO2008128028 A3 WO 2008128028A3 US 2008060010 W US2008060010 W US 2008060010W WO 2008128028 A3 WO2008128028 A3 WO 2008128028A3
Authority
WO
WIPO (PCT)
Prior art keywords
solifenacin
compositions
formulations
salt
preparing
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/US2008/060010
Other languages
French (fr)
Other versions
WO2008128028A2 (en
Inventor
Pramod Kharwade
Movva Snehalatha
Atul Vishvanath Patil
Narayanan Badri Vishwanathan
Indu Bhushan
Venkata Nookaraju Sreedharala
Harshal Prabhakar Bhagwatwar
Surya Narayana Devarakonda
Ravi Kumar Komareddy
Azeezulla Baig Mohammed
Arjun Kumar Tummala
Jaydeepkumar Dahyabhai Lilakar
Srirami Reddy Kikkuru
Swarupa Dudipala
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.)
Dr Reddys Laboratories Ltd
Dr Reddys Laboratories Inc
Original Assignee
Dr Reddys Laboratories Ltd
Dr Reddys Laboratories Inc
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 Dr Reddys Laboratories Ltd, Dr Reddys Laboratories Inc filed Critical Dr Reddys Laboratories Ltd
Priority to EP08745592A priority Critical patent/EP2146693A2/en
Priority to US12/595,290 priority patent/US20100137358A1/en
Publication of WO2008128028A2 publication Critical patent/WO2008128028A2/en
Publication of WO2008128028A3 publication Critical patent/WO2008128028A3/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
    • 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
    • A61K31/439—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 the ring forming part of a bridged ring system, e.g. quinuclidine
    • 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
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—Inorganic compounds
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/4858—Organic compounds
    • 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
    • A61P13/10—Drugs for disorders of the urinary system of the bladder

Landscapes

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

Abstract

Compositions and/or formulations comprising solifenacin or a salt thereof and processes for preparing the same. Certain compositions and formulations contain a stable amorphous form of solifenacin succinate.
PCT/US2008/060010 1996-11-05 2008-04-11 Solifenacin compositions Ceased WO2008128028A2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP08745592A EP2146693A2 (en) 2007-04-11 2008-04-11 Solifenacin compositions
US12/595,290 US20100137358A1 (en) 1996-11-05 2008-04-11 Solifenacin compositions

Applications Claiming Priority (12)

Application Number Priority Date Filing Date Title
IN769CH2007 2007-04-11
IN769/CHE/2007 2007-04-11
IN1084CH2007 2007-05-23
IN1084/CHE/2007 2007-05-23
US95723507P 2007-08-22 2007-08-22
US60/957,235 2007-08-22
IN2237CH2007 2007-10-04
IN2237/CHE/2007 2007-10-04
US2586308P 2008-02-04 2008-02-04
US61/025,863 2008-02-04
US3037408P 2008-02-21 2008-02-21
US61/030,374 2008-02-21

Publications (2)

Publication Number Publication Date
WO2008128028A2 WO2008128028A2 (en) 2008-10-23
WO2008128028A3 true WO2008128028A3 (en) 2009-02-12

Family

ID=39535358

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2008/060010 Ceased WO2008128028A2 (en) 1996-11-05 2008-04-11 Solifenacin compositions

Country Status (2)

Country Link
EP (1) EP2146693A2 (en)
WO (1) WO2008128028A2 (en)

Families Citing this family (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2489666A3 (en) * 2007-12-04 2012-12-26 Cadila Healthcare Limited Chemically and chirally pure solifenacin base and its salts
EA023529B1 (en) * 2009-02-27 2016-06-30 КРКА, д.д., НОВО МЕСТО Process for forming solid oral dosage forms of solifenacin and its pharmaceutically acceptable salts for oral administration
JP4816828B2 (en) * 2009-03-30 2011-11-16 アステラス製薬株式会社 Solid pharmaceutical composition containing amorphous solifenacin
EA201291189A1 (en) * 2010-05-07 2013-05-30 Зентива К.С. PHARMACEUTICAL COMPOSITION CONTAINING SOLIPHENACIN, AND METHOD FOR ITS OBTAINING
MX2012013328A (en) * 2010-05-19 2013-02-01 Astellas Pharma Inc Pharmaceutical composition containing solifenacin.
CN101851200A (en) * 2010-06-01 2010-10-06 武汉理工大学 The synthetic method of 1-phenyl-1,2,3,4-tetrahydroisoquinoline
EP2500013B1 (en) 2011-03-15 2019-10-02 Alfred E. Tiefenbacher (GmbH & Co. KG) Pharmaceutical composition comprising solifenacin
EP2778167A1 (en) 2013-03-11 2014-09-17 Abdi Ibrahim Ilac Sanayi Ve Ticaret Anonim Sirketi Stable pharmaceutical composition comprising amorphous solifenacin or its pharmaceutically acceptable salt
CN103159677B (en) * 2013-03-19 2016-03-16 济南圣泉唐和唐生物科技有限公司 The preparation method of IQL
CN103288667A (en) * 2013-03-19 2013-09-11 济南圣泉唐和唐生物科技有限公司 A method for preparing N- (2 - phenylethyl) benzamide
KR20150092385A (en) 2014-02-03 2015-08-13 씨제이헬스케어 주식회사 Stable pharmaceutical composition comprising solifenacin, and method for preparing the same
CN105362245A (en) * 2014-08-30 2016-03-02 山东中泰药业有限公司 Tablet composition with solifenacin and preparation method of tablet composition
JP2016079102A (en) * 2014-10-10 2016-05-16 テバ製薬株式会社 Solifenacin-containing formulation
JP6639024B2 (en) * 2016-04-08 2020-02-05 大原薬品工業株式会社 Amorphous solifenacin-containing formulation with improved chemical stability
JP6446511B2 (en) * 2016-09-02 2018-12-26 大原薬品工業株式会社 Solid preparation containing amorphous solifenacin and antioxidant
JP6805699B2 (en) * 2016-10-04 2020-12-23 ニプロ株式会社 Pharmaceutical compositions, methods for producing pharmaceutical compositions, and methods for improving the stability of amorphous materials.
JP7102200B2 (en) * 2017-04-14 2022-07-19 東和薬品株式会社 Solid pharmaceutical composition containing solifenacin succinate
EP3697392B1 (en) * 2017-10-17 2023-11-15 Synthon B.V. Tablets comprising tamsulosin and solifenacin
UY38137A (en) * 2018-03-08 2019-07-31 Intas Third Party Sales 2005 S L A SOLID PHARMACEUTICAL SOLID ORAL DOSAGE FORM
KR101977890B1 (en) * 2018-05-08 2019-05-13 씨제이헬스케어 주식회사 Stable pharmaceutical composition comprising solifenacin, and method for preparing the same
JP7198021B2 (en) * 2018-09-21 2022-12-28 沢井製薬株式会社 Preparations containing solifenacin succinate
CN113440492B (en) * 2020-03-27 2024-10-15 广东东阳光药业股份有限公司 Composition of muscarinic receptor antagonist and preparation method thereof
WO2022117594A1 (en) * 2020-12-01 2022-06-09 Adamed Pharma S.A. Orally-administered preparation containing solifenacin and tamsulosin

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0801067A1 (en) * 1994-12-28 1997-10-15 Yamanouchi Pharmaceutical Co. Ltd. Novel quinuclidine derivatives and medicinal composition thereof
US20050181031A1 (en) * 2004-02-18 2005-08-18 Katsumi Saito Solifenacin transdermal preparation and method for enhancing transdermal permeation thereof
CA2591761A1 (en) * 2004-12-27 2006-07-06 Astellas Pharma Inc. Stable particulate pharmaceutical composition of solifenacin or salt thereof
CA2599158A1 (en) * 2005-02-25 2006-08-31 Astellas Pharma Inc. Pharmaceutical agent comprising solifenacin
EP1714965A1 (en) * 2004-02-09 2006-10-25 Astellas Pharma Inc. Composition containing solifenacin succinate
DE102005041860A1 (en) * 2005-09-02 2007-03-08 Schering Ag Nano-particle embedded- and charged-complex, useful for the production of a pharmaceutical composition, comprises two complex partners, where the complex partner is an embedded anionic and a cationic active substance

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0801067A1 (en) * 1994-12-28 1997-10-15 Yamanouchi Pharmaceutical Co. Ltd. Novel quinuclidine derivatives and medicinal composition thereof
EP1714965A1 (en) * 2004-02-09 2006-10-25 Astellas Pharma Inc. Composition containing solifenacin succinate
US20050181031A1 (en) * 2004-02-18 2005-08-18 Katsumi Saito Solifenacin transdermal preparation and method for enhancing transdermal permeation thereof
CA2591761A1 (en) * 2004-12-27 2006-07-06 Astellas Pharma Inc. Stable particulate pharmaceutical composition of solifenacin or salt thereof
CA2599158A1 (en) * 2005-02-25 2006-08-31 Astellas Pharma Inc. Pharmaceutical agent comprising solifenacin
DE102005041860A1 (en) * 2005-09-02 2007-03-08 Schering Ag Nano-particle embedded- and charged-complex, useful for the production of a pharmaceutical composition, comprises two complex partners, where the complex partner is an embedded anionic and a cationic active substance

Also Published As

Publication number Publication date
EP2146693A2 (en) 2010-01-27
WO2008128028A2 (en) 2008-10-23

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