WO2008118331A3 - Tablet formulations containing 8-[{1-(3,5-bis-(trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diaza-spiro[4.5]decan-2-one salts and tablets made therefrom - Google Patents

Tablet formulations containing 8-[{1-(3,5-bis-(trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diaza-spiro[4.5]decan-2-one salts and tablets made therefrom Download PDF

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Publication number
WO2008118331A3
WO2008118331A3 PCT/US2008/003653 US2008003653W WO2008118331A3 WO 2008118331 A3 WO2008118331 A3 WO 2008118331A3 US 2008003653 W US2008003653 W US 2008003653W WO 2008118331 A3 WO2008118331 A3 WO 2008118331A3
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WO
WIPO (PCT)
Prior art keywords
phenyl
decan
trifluoromethyl
ethoxy
bis
Prior art date
Application number
PCT/US2008/003653
Other languages
French (fr)
Other versions
WO2008118331A2 (en
Inventor
Zhihui Qiu
Wing-Kee Philip Cho
Na Zhao
Victor Ming-She Wong
Original Assignee
Schering Corp
Zhihui Qiu
Wing-Kee Philip Cho
Na Zhao
Victor Ming-She Wong
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=39541515&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2008118331(A3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Schering Corp, Zhihui Qiu, Wing-Kee Philip Cho, Na Zhao, Victor Ming-She Wong filed Critical Schering Corp
Priority to US12/531,966 priority Critical patent/US8361500B2/en
Priority to EP08742155A priority patent/EP2136793B1/en
Priority to ES08742155T priority patent/ES2406934T3/en
Priority to MX2009010210A priority patent/MX2009010210A/en
Priority to CA2681465A priority patent/CA2681465C/en
Priority to JP2009554571A priority patent/JP5442459B2/en
Publication of WO2008118331A2 publication Critical patent/WO2008118331A2/en
Publication of WO2008118331A3 publication Critical patent/WO2008118331A3/en
Priority to US13/734,432 priority patent/US20130122088A1/en
Priority to US14/540,635 priority patent/US20150283121A1/en

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    • 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
    • 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
    • A61K31/438—The ring being spiro-condensed with carbocyclic or heterocyclic ring systems
    • 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
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/2004—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
    • A61K9/20—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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

Abstract

Pharmaceutical formulations containing a salt of (5S,8S)-8-[{(1R)-1-(3,5-Bis-(trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diazaspiro[4.5]decan-2-one, represented by Formula I, which are suitable for forming into a tablet dosage form, as well as tablet dosage forms are disclosed. Disclosed also are methods of treatment utilizing such dosage forms.
PCT/US2008/003653 2007-03-22 2008-03-20 Tablet formulations containing 8-[{1-(3,5-bis-(trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diaza-spiro[4.5]decan-2-one salts and tablets made therefrom WO2008118331A2 (en)

Priority Applications (8)

Application Number Priority Date Filing Date Title
US12/531,966 US8361500B2 (en) 2007-03-22 2008-03-20 Tablet formulations containing 8-[{1-(3,5-Bis-(trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diaza-spiro[4.5]decan-2-one salts and tablets made therefrom
EP08742155A EP2136793B1 (en) 2007-03-22 2008-03-20 Tablet formulations containing 8-[{1-(3,5-bis-(trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diaza-spiro[4.5]decan-2-one salts and tablets made therefrom
ES08742155T ES2406934T3 (en) 2007-03-22 2008-03-20 Formulations of tablets containing salts of 8 - [{1- (3,5-bis- (trifluoromethyl) phenyl) -ethoxy} -methyl] -8-phenyl-1,7-diaza-spiro [4.5] decan-2- ona and tablets prepared with them
MX2009010210A MX2009010210A (en) 2007-03-22 2008-03-20 Tablet formulations containing 8-[{1-(3,5-bis-(trifluoromethyl)ph enyl)-ethoxy}-methyl]-8-phenyl-1,7-diaza-spiro[4.5]decan-2-one salts and tablets made therefrom.
CA2681465A CA2681465C (en) 2007-03-22 2008-03-20 Tablet formulations containing 8-[{1-(3,5-bis-(trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diaza-spiro[4.5]decan-2-one salts and tablets made therefrom
JP2009554571A JP5442459B2 (en) 2007-03-22 2008-03-20 Salt of 8-[{1- (3,5-bis- (trifluoromethyl) phenyl) -ethoxy} -methyl] -8-phenyl-1,7-diaza-spiro [4.5] decan-2-one Tablet formulations containing and tablets made therefrom
US13/734,432 US20130122088A1 (en) 2007-03-22 2013-01-04 Tablet formulations containing 8-[-methyl]-8-phenyl-1,7-diaza-spiro[4.5]decan-2-one salts and tablets made therefrom
US14/540,635 US20150283121A1 (en) 2007-03-22 2014-11-13 Tablet formulations containing 8-[-methyl]-8-phenyl-1,7-diaza-spiro[4.5]decan-2-one salts and tablets made therefrom

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US91950107P 2007-03-22 2007-03-22
US60/919,501 2007-03-22

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US12/531,966 A-371-Of-International US8361500B2 (en) 2007-03-22 2008-03-20 Tablet formulations containing 8-[{1-(3,5-Bis-(trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diaza-spiro[4.5]decan-2-one salts and tablets made therefrom
US13/734,432 Continuation US20130122088A1 (en) 2007-03-22 2013-01-04 Tablet formulations containing 8-[-methyl]-8-phenyl-1,7-diaza-spiro[4.5]decan-2-one salts and tablets made therefrom

Publications (2)

Publication Number Publication Date
WO2008118331A2 WO2008118331A2 (en) 2008-10-02
WO2008118331A3 true WO2008118331A3 (en) 2009-04-23

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2008/003653 WO2008118331A2 (en) 2007-03-22 2008-03-20 Tablet formulations containing 8-[{1-(3,5-bis-(trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diaza-spiro[4.5]decan-2-one salts and tablets made therefrom

Country Status (11)

Country Link
US (3) US8361500B2 (en)
EP (1) EP2136793B1 (en)
JP (3) JP5442459B2 (en)
AR (1) AR065802A1 (en)
CA (1) CA2681465C (en)
CL (1) CL2008000819A1 (en)
ES (1) ES2406934T3 (en)
MX (1) MX2009010210A (en)
PE (1) PE20081891A1 (en)
TW (1) TWI350185B (en)
WO (1) WO2008118331A2 (en)

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AR065802A1 (en) * 2007-03-22 2009-07-01 Schering Corp FORMULATIONS OF TABLETS CONTAINING SALTS OF 8- [(1- (3,5- BIS- (TRIFLUOROMETIL) FENIL) -ETOXI) - METHYL) -8- PHENYL -1, 7- DIAZA- SPIRO [4,5] DECAN - 2- ONA AND TABLETS PREPARED FROM THESE
AR066191A1 (en) 2007-03-22 2009-08-05 Schering Corp PROCESS AND INTERMEDIARIES FOR THE SYNTHESIS OF COMPOUNDS 8- [(1- (3,5- BIS- (TRIFLUOROMETIL) PHENYL) - ETOXI) - METAL] - 8 PHENYL - 1,7- DIAZA - ESPIRO (4, 5) DECAN - 2 ONA
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Publication number Publication date
JP2010522173A (en) 2010-07-01
JP2015108023A (en) 2015-06-11
EP2136793B1 (en) 2013-02-20
US20130122088A1 (en) 2013-05-16
TWI350185B (en) 2011-10-11
US8361500B2 (en) 2013-01-29
WO2008118331A2 (en) 2008-10-02
JP5763134B2 (en) 2015-08-12
TW200902087A (en) 2009-01-16
JP6041919B2 (en) 2016-12-14
AR065802A1 (en) 2009-07-01
JP5442459B2 (en) 2014-03-12
ES2406934T3 (en) 2013-06-10
JP2013216694A (en) 2013-10-24
MX2009010210A (en) 2009-10-19
US20100104637A1 (en) 2010-04-29
CA2681465A1 (en) 2008-10-02
US20150283121A1 (en) 2015-10-08
PE20081891A1 (en) 2008-12-27
EP2136793A2 (en) 2009-12-30
CL2008000819A1 (en) 2008-09-26
CA2681465C (en) 2015-12-15

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