WO2008057267A3 - Co-processed microcrystalline cellulose and sugar alcohol as an excipient for tablet formulations - Google Patents

Co-processed microcrystalline cellulose and sugar alcohol as an excipient for tablet formulations Download PDF

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Publication number
WO2008057267A3
WO2008057267A3 PCT/US2007/022685 US2007022685W WO2008057267A3 WO 2008057267 A3 WO2008057267 A3 WO 2008057267A3 US 2007022685 W US2007022685 W US 2007022685W WO 2008057267 A3 WO2008057267 A3 WO 2008057267A3
Authority
WO
WIPO (PCT)
Prior art keywords
sugar alcohol
microcrystalline cellulose
excipient
tablet formulations
processed microcrystalline
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/US2007/022685
Other languages
French (fr)
Other versions
WO2008057267A2 (en
Inventor
Jian-Xin Li
Brian Carlin
Thomas Ruszkay
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.)
FMC Corp
Original Assignee
FMC Corp
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 FMC Corp filed Critical FMC Corp
Priority to JP2009534667A priority Critical patent/JP5410290B2/en
Priority to CN200780039612.XA priority patent/CN101528201B/en
Priority to DE602007011792T priority patent/DE602007011792D1/en
Priority to EP07852968A priority patent/EP2076250B1/en
Priority to AT07852968T priority patent/ATE493972T1/en
Publication of WO2008057267A2 publication Critical patent/WO2008057267A2/en
Publication of WO2008057267A3 publication Critical patent/WO2008057267A3/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
    • A61K9/14—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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • 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
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

A particulate co-processed composition comprising microcrystalline cellulose and at least one sugar alcohol is disclosed. A preferred sugar alcohol is mannitol. The composition has an improved compactability profile, lubricant sensitivity, and ejection profile compared to microcrystalline cellulose and the at least one sugar alcohol, either alone or in combination as a simple dry blend, in the preparation of solid dosage formulations, such as tablets. Tablets comprising the particulate co-processed composition, an active, and, optionally, one or more other excipients, and method for their preparation, are also disclosed.
PCT/US2007/022685 2006-10-27 2007-10-26 Co-processed microcrystalline cellulose and sugar alcohol as an excipient for tablet formulations Ceased WO2008057267A2 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
JP2009534667A JP5410290B2 (en) 2006-10-27 2007-10-26 CO-PROCESSED COMPOSITION AND PROCESS FOR PRODUCING THE SAME, TABLETABLE TABLET COMPOSITION
CN200780039612.XA CN101528201B (en) 2006-10-27 2007-10-26 As microcrystalline Cellulose and the sugar alcohol of the coprocessing of tablet formulations excipient
DE602007011792T DE602007011792D1 (en) 2006-10-27 2007-10-26 COMMONLY PREPARED MICROCRYSTALLINE CELLULOSE AND SUGAR ALCOHOL AS AN AUXILIARY FOR TABLET FORMULATIONS
EP07852968A EP2076250B1 (en) 2006-10-27 2007-10-26 Co-processed microcrystalline cellulose and sugar alcohol as an excipient for tablet formulations
AT07852968T ATE493972T1 (en) 2006-10-27 2007-10-26 JOINTLY PROCESSED MICROCRYSTALLINE CELLULOSE AND SUGAR ALCOHOL AS AN EXCIPIENT FOR TABLET FORMULATIONS

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US85510606P 2006-10-27 2006-10-27
US85506606P 2006-10-27 2006-10-27
US60/855,106 2006-10-27
US60/855,066 2006-10-27
US92816607P 2007-05-08 2007-05-08
US60/928,166 2007-05-08

Publications (2)

Publication Number Publication Date
WO2008057267A2 WO2008057267A2 (en) 2008-05-15
WO2008057267A3 true WO2008057267A3 (en) 2008-07-24

Family

ID=39317157

Family Applications (2)

Application Number Title Priority Date Filing Date
PCT/US2007/022684 Ceased WO2008057266A2 (en) 2006-10-27 2007-10-26 Dry granulation binders, products, and use thereof
PCT/US2007/022685 Ceased WO2008057267A2 (en) 2006-10-27 2007-10-26 Co-processed microcrystalline cellulose and sugar alcohol as an excipient for tablet formulations

Family Applications Before (1)

Application Number Title Priority Date Filing Date
PCT/US2007/022684 Ceased WO2008057266A2 (en) 2006-10-27 2007-10-26 Dry granulation binders, products, and use thereof

Country Status (7)

Country Link
US (3) US7998505B2 (en)
EP (2) EP2076250B1 (en)
JP (2) JP2010507676A (en)
AT (1) ATE493972T1 (en)
DE (1) DE602007011792D1 (en)
TW (2) TW200826976A (en)
WO (2) WO2008057266A2 (en)

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