JP2009544706A - 高用量の経口的に溶解可能／分解可能な凍結乾燥剤形 - Google Patents

高用量の経口的に溶解可能／分解可能な凍結乾燥剤形 Download PDF

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Publication number
JP2009544706A
JP2009544706A JP2009521804A JP2009521804A JP2009544706A JP 2009544706 A JP2009544706 A JP 2009544706A JP 2009521804 A JP2009521804 A JP 2009521804A JP 2009521804 A JP2009521804 A JP 2009521804A JP 2009544706 A JP2009544706 A JP 2009544706A
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JP
Japan
Prior art keywords
dosage form
protective
active ingredient
binder
granule
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.)
Pending
Application number
JP2009521804A
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English (en)
Japanese (ja)
Other versions
JP2009544706A5 (enExample
Inventor
ハメド、イーハブ
カンカリ、ラジェンドラ、ケー．
モー、デレック
グエン、タム
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.)
Cephalon France SAS
Original Assignee
Cephalon France SAS
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 EP06291198A external-priority patent/EP1891938A1/en
Priority claimed from EP06291458A external-priority patent/EP1905429A1/en
Application filed by Cephalon France SAS filed Critical Cephalon France SAS
Publication of JP2009544706A publication Critical patent/JP2009544706A/ja
Publication of JP2009544706A5 publication Critical patent/JP2009544706A5/ja
Pending legal-status Critical Current

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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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • 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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425—Thiazoles
    • A61K31/426—1,3-Thiazoles
    • 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/1635—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
    • A61K9/14—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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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
    • 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
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • 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
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
JP2009521804A 2006-07-24 2007-07-24 高用量の経口的に溶解可能／分解可能な凍結乾燥剤形 Pending JP2009544706A (ja)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP06291198A EP1891938A1 (en) 2006-07-24 2006-07-24 High dose orally dissolvable/disintegrable lyophilized dosage form
EP06291458A EP1905429A1 (en) 2006-09-18 2006-09-18 Orally dissolvable/disintegrable lyophilized dosage forms containing protected particles
US11/880,531 US20080031949A1 (en) 2006-07-24 2007-07-23 High dose orally dissolvable/disintegrable lyophilized dosage form
PCT/US2007/016638 WO2008013808A2 (en) 2006-07-24 2007-07-24 High dose orally dissolvable/disintegrable lyophilized dosage form

Publications (2)

Publication Number Publication Date
JP2009544706A true JP2009544706A (ja) 2009-12-17
JP2009544706A5 JP2009544706A5 (enExample) 2011-08-04

Family

ID=39029455

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2009521804A Pending JP2009544706A (ja) 2006-07-24 2007-07-24 高用量の経口的に溶解可能／分解可能な凍結乾燥剤形
JP2009521810A Pending JP2009544707A (ja) 2006-07-24 2007-07-24 保護粒子を含有した経口的に溶解可能／分解可能な凍結乾燥剤形

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2009521810A Pending JP2009544707A (ja) 2006-07-24 2007-07-24 保護粒子を含有した経口的に溶解可能／分解可能な凍結乾燥剤形

Country Status (6)

Country Link
US (2) US20080031947A1 (enExample)
EP (2) EP2068824A2 (enExample)
JP (2) JP2009544706A (enExample)
CA (2) CA2658512A1 (enExample)
MX (2) MX2009000861A (enExample)
WO (2) WO2008013833A2 (enExample)

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US20080031947A1 (en) * 2006-07-24 2008-02-07 Cima Labs Inc. Orally dissolvable/disintegrable lyophilized dosage forms containing protected
EP2328558A2 (en) * 2008-08-08 2011-06-08 McNeil-PPC, Inc. Use of sucralose as a granulating agent
EP2359812A1 (en) * 2010-01-18 2011-08-24 Cephalon France Oral lyophilised compositions
EP2525783A1 (en) * 2010-01-18 2012-11-28 Cephalon France Improved oral lysophilisates containing pvp/va
EP2645943A1 (en) 2010-12-02 2013-10-09 Agile Endosurgery, Inc. Surgical tool
US9730885B2 (en) 2012-07-12 2017-08-15 Mallinckrodt Llc Extended release, abuse deterrent pharmaceutical compositions
US11058642B2 (en) * 2013-04-22 2021-07-13 Tower Laboratories Ltd Tablets with improved friability
US9650338B1 (en) 2016-07-29 2017-05-16 VDM Biochemicals, Inc. Opioid antagonist compounds and methods of making and using
WO2018191794A1 (en) 2017-04-20 2018-10-25 Zeenar Enterprises Pty Ltd Liquid crystalline dosage form for administering a statin
AU2018255718A1 (en) 2017-04-20 2019-12-05 Zeenar Enterprises Pty Ltd Fast disintegrating tablet
CN111432804A (zh) * 2017-11-27 2020-07-17 帝斯曼知识产权资产管理有限公司 冻干的多微粒固体剂型
CA3157405A1 (en) 2019-11-18 2021-05-27 Donald D. EVANS II Lyophilized cake in straight-walled vial

Citations (4)

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JP2003055197A (ja) * 2001-06-07 2003-02-26 Tanabe Seiyaku Co Ltd 機能性粒子含有口腔内速崩壊性製剤
JP2003522465A (ja) * 2000-02-04 2003-07-22 ハリス コーポレイション 偏波ダイバーシティを使用する線形信号分離
JP2003533465A (ja) * 2000-05-18 2003-11-11 エラン ファーマ インターナショナル，リミティド 迅速崩壊固体経口投与形態
WO2006013447A1 (en) * 2004-07-29 2006-02-09 Cephalon France Modafinil oral lyophilizate

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Patent Citations (4)

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Publication number Priority date Publication date Assignee Title
JP2003522465A (ja) * 2000-02-04 2003-07-22 ハリス コーポレイション 偏波ダイバーシティを使用する線形信号分離
JP2003533465A (ja) * 2000-05-18 2003-11-11 エラン ファーマ インターナショナル，リミティド 迅速崩壊固体経口投与形態
JP2003055197A (ja) * 2001-06-07 2003-02-26 Tanabe Seiyaku Co Ltd 機能性粒子含有口腔内速崩壊性製剤
WO2006013447A1 (en) * 2004-07-29 2006-02-09 Cephalon France Modafinil oral lyophilizate

Also Published As

Publication number Publication date
CA2658109A1 (en) 2008-01-31
EP2068824A2 (en) 2009-06-17
EP2068826A2 (en) 2009-06-17
CA2658512A1 (en) 2008-01-31
US20080031947A1 (en) 2008-02-07
MX2009000849A (es) 2009-06-30
WO2008013833A2 (en) 2008-01-31
WO2008013808A2 (en) 2008-01-31
WO2008013833A3 (en) 2008-07-17
WO2008013808A3 (en) 2008-05-15
MX2009000861A (es) 2009-06-19
JP2009544707A (ja) 2009-12-17
US20080031949A1 (en) 2008-02-07

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