JP5704789B2 - 耐アルコール性剤形 - Google Patents

耐アルコール性剤形 Download PDF

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Publication number
JP5704789B2
JP5704789B2 JP2007552587A JP2007552587A JP5704789B2 JP 5704789 B2 JP5704789 B2 JP 5704789B2 JP 2007552587 A JP2007552587 A JP 2007552587A JP 2007552587 A JP2007552587 A JP 2007552587A JP 5704789 B2 JP5704789 B2 JP 5704789B2
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JP
Japan
Prior art keywords
opioid
controlled release
use according
matrix formulation
minutes
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.)
Expired - Lifetime
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JP2007552587A
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English (en)
Japanese (ja)
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JP2008528534A (ja
JP2008528534A5 (https=
Inventor
マニオン，リチャード，オー．
マッケナ，ウィリアム，エイチ．
オドネル，エドワード，ピー．
ダナゲル，ヘレン，カスリーン
ヘイズ，ジェフリー，ジェラルド
モハマド，ハッサン
プラター，デレック，アラン
タンバー，ハルジット
ワルデン，マルコム
ホワイトナット，スティーブ
フライシャー，ウルフガング
アーン，ウド
シュピッツレー，クリスチャン
レウナー，クリスチャン
Original Assignee
ユーロ−セルティーク エス．エイ．
ユーロ−セルティーク エス．エイ．
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 PCT/GB2005/050014 external-priority patent/WO2005079760A1/en
Application filed by ユーロ−セルティーク エス．エイ．, ユーロ−セルティーク エス．エイ． filed Critical ユーロ−セルティーク エス．エイ．
Priority claimed from PCT/EP2006/000727 external-priority patent/WO2006079550A2/en
Publication of JP2008528534A publication Critical patent/JP2008528534A/ja
Publication of JP2008528534A5 publication Critical patent/JP2008528534A5/ja
Application granted granted Critical
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Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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    • 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
    • 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
    • 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
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • 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
    • 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
    • A61K9/1605—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
    • A61K9/20—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
    • A61K9/2022—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
    • A61K9/2072—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
    • A61K9/2072—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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/36—Opioid-abuse
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29B—PREPARATION OR PRETREATMENT OF THE MATERIAL TO BE SHAPED; MAKING GRANULES OR PREFORMS; RECOVERY OF PLASTICS OR OTHER CONSTITUENTS OF WASTE MATERIAL CONTAINING PLASTICS
    • B29B9/00—Making granules
    • B29B9/02—Making granules by dividing preformed material
    • B29B9/06—Making granules by dividing preformed material in the form of filamentary material, e.g. combined with extrusion
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2033/00—Use of polymers of unsaturated acids or derivatives thereof as moulding material
    • B29K2033/04—Polymers of esters
    • B29K2033/12—Polymers of methacrylic acid esters, e.g. PMMA, i.e. polymethylmethacrylate
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2105/00—Condition, form or state of moulded material or of the material to be shaped
    • B29K2105/0085—Copolymers

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pain & Pain Management (AREA)
  • Emergency Medicine (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Addiction (AREA)
  • Mechanical Engineering (AREA)
  • Psychiatry (AREA)
  • Rheumatology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)
JP2007552587A 2005-01-28 2006-01-27 耐アルコール性剤形 Expired - Lifetime JP5704789B2 (ja)

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
GBGB0501638.1A GB0501638D0 (en) 2005-01-28 2005-01-28 Particulates
GB0501638.1 2005-01-28
GBPCT/GB2005/050014 2005-02-11
PCT/GB2005/050014 WO2005079760A1 (en) 2004-02-12 2005-02-11 Particulates
US67050605P 2005-04-12 2005-04-12
US60/670,506 2005-04-12
US73033905P 2005-10-26 2005-10-26
US60/730,339 2005-10-26
PCT/EP2006/000727 WO2006079550A2 (en) 2005-01-28 2006-01-27 Alcohol resistant dosage forms

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2012284017A Division JP2013100306A (ja) 2005-01-28 2012-12-27 耐アルコール性剤形

Publications (3)

Publication Number Publication Date
JP2008528534A JP2008528534A (ja) 2008-07-31
JP2008528534A5 JP2008528534A5 (https=) 2008-10-23
JP5704789B2 true JP5704789B2 (ja) 2015-04-22

Family

ID=34259727

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2007552587A Expired - Lifetime JP5704789B2 (ja) 2005-01-28 2006-01-27 耐アルコール性剤形
JP2012284017A Pending JP2013100306A (ja) 2005-01-28 2012-12-27 耐アルコール性剤形

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2012284017A Pending JP2013100306A (ja) 2005-01-28 2012-12-27 耐アルコール性剤形

Country Status (11)

Country Link
EP (3) EP2319499A1 (https=)
JP (2) JP5704789B2 (https=)
CN (1) CN101132772B (https=)
AP (1) AP2274A (https=)
EA (1) EA015615B1 (https=)
GB (1) GB0501638D0 (https=)
IL (1) IL184858A (https=)
MA (1) MA29368B1 (https=)
NZ (2) NZ590772A (https=)
TN (1) TNSN07293A1 (https=)
ZA (1) ZA200705913B (https=)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090317355A1 (en) * 2006-01-21 2009-12-24 Abbott Gmbh & Co. Kg, Abuse resistant melt extruded formulation having reduced alcohol interaction
US20070212414A1 (en) * 2006-03-08 2007-09-13 Penwest Pharmaceuticals Co. Ethanol-resistant sustained release formulations
WO2010034342A1 (en) * 2008-09-24 2010-04-01 Evonik Röhm Gmbh Ph-dependent controlled release pharmaceutical opioid composition with resistance against the influence of ethanol
CA2755808C (en) * 2009-03-18 2016-01-19 Evonik Operations Gmbh Controlled release pharmaceutical composition with resistance against the influence of ethanol employing a coating comprising neutral vinyl polymers and excipients
EP2408437A1 (en) * 2009-03-18 2012-01-25 Evonik Röhm GmbH Controlled release pharmaceutical composition with resistance against the influence of ethanol employing a coating comprising a polymer mixture and excipients
GB0909680D0 (en) * 2009-06-05 2009-07-22 Euro Celtique Sa Dosage form
PH12012502083A1 (en) * 2010-05-10 2017-07-26 Euro Celtique Sa Manufacturing of active-free granules and tablets comprising the same
US9700508B2 (en) * 2010-05-10 2017-07-11 Euro-Celtique S.A. Pharmaceutical compositions comprising hydromorphone and naloxone
EP2568965A1 (en) * 2010-05-10 2013-03-20 Euro-Celtique S.A. Combination of active loaded granules with additional actives
GB201020895D0 (en) * 2010-12-09 2011-01-26 Euro Celtique Sa Dosage form
ES2628303T3 (es) * 2011-06-01 2017-08-02 Fmc Corporation Formas de dosis sólidas de liberación controlada
WO2013057570A2 (en) * 2011-10-18 2013-04-25 Purdue Pharma L.P. Acrylic polymer formulations
EP2838512B1 (en) * 2012-04-18 2018-08-22 Grünenthal GmbH Tamper resistant and dose-dumping resistant pharmaceutical dosage form
CA2881144A1 (en) * 2012-11-09 2014-05-09 Purdue Pharma Pharmaceutical compositions comprising hydromorphone and naloxone
MX2015010041A (es) 2013-02-05 2015-10-30 Purdue Pharma Lp Formulacion farmaceuticas resistentes a la alteracion.
RU2020117757A (ru) 2017-11-01 2021-11-29 Эджмонт Фармасьютикалс, Ллк Траст Оральные фармацевтические композиции лоразепама, устойчивые к спирту

Family Cites Families (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB8626098D0 (en) * 1986-10-31 1986-12-03 Euro Celtique Sa Controlled release hydromorphone composition
US5266331A (en) 1991-11-27 1993-11-30 Euroceltique, S.A. Controlled release oxycodone compositions
US5656295A (en) 1991-11-27 1997-08-12 Euro-Celtique, S.A. Controlled release oxycodone compositions
US5968551A (en) 1991-12-24 1999-10-19 Purdue Pharma L.P. Orally administrable opioid formulations having extended duration of effect
NZ260408A (en) * 1993-05-10 1996-05-28 Euro Celtique Sa Controlled release preparation comprising tramadol
US5965161A (en) 1994-11-04 1999-10-12 Euro-Celtique, S.A. Extruded multi-particulates
DE19710008A1 (de) * 1997-03-12 1998-09-17 Basf Ag Feste, mindestens zweiphasige Zubereitungsformen eines Opioid-Analgeticums mit verzögerter Freisetzung
PT1009387E (pt) * 1997-07-02 2006-08-31 Euro Celtique Sa Formulacoes estabilizadas de libertacao controlada de tramadol
DE19901085C2 (de) * 1999-01-14 2003-12-18 Lohmann Therapie Syst Lts Transdermales therapeutisches System mit einer selbstklebenden Matrix, enthaltend organische Säure-Additionssalze von Alkaloiden des Morphin- bzw. Morphinantyps
US20030118641A1 (en) 2000-07-27 2003-06-26 Roxane Laboratories, Inc. Abuse-resistant sustained-release opioid formulation
HU229705B1 (en) 2000-02-08 2014-05-28 Euro Celtique Sa Tamper-resistant oral opioid agonist formulations
GB0026137D0 (en) * 2000-10-25 2000-12-13 Euro Celtique Sa Transdermal dosage form
WO2003004009A1 (en) * 2001-07-02 2003-01-16 Geneva Pharmaceuticals, Inc. Pharmaceutical composition
WO2003013476A1 (en) * 2001-08-06 2003-02-20 Euro-Celtique S.A. Compositions and methods to prevent abuse of opioids
CA2456322A1 (en) * 2001-08-06 2003-02-20 Euro-Celtique, S.A. Compositions and methods to prevent abuse of opioids
EP1492505B1 (en) * 2002-04-05 2015-06-03 Euro-Celtique S.A. Pharmaceutical preparation containing oxycodone and naloxone
US7399488B2 (en) 2002-07-05 2008-07-15 Collegium Pharmaceutical, Inc. Abuse-deterrent pharmaceutical compositions of opiods and other drugs
EP1551402A4 (en) * 2002-09-23 2009-05-27 Verion Inc PHARMACEUTICAL COMPOSITIONS NOT INDUCING ABUSE
ATE482695T1 (de) * 2002-12-13 2010-10-15 Durect Corp Orale darreichungsform mit flüssigen hochviskosen trägersystemen
US20060153915A1 (en) * 2003-01-23 2006-07-13 Amorepacific Corporation Sustained-release preparations and method for producing the same
TWI357815B (en) * 2003-06-27 2012-02-11 Euro Celtique Sa Multiparticulates
TWI350762B (en) * 2004-02-12 2011-10-21 Euro Celtique Sa Particulates

Also Published As

Publication number Publication date
JP2008528534A (ja) 2008-07-31
NZ590772A (en) 2012-05-25
EP2319499A1 (en) 2011-05-11
IL184858A0 (en) 2007-12-03
CN101132772A (zh) 2008-02-27
NZ560669A (en) 2012-09-28
GB0501638D0 (en) 2005-03-02
MA29368B1 (fr) 2008-04-01
EP2289491A1 (en) 2011-03-02
TNSN07293A1 (fr) 2008-12-31
IL184858A (en) 2016-03-31
CN101132772B (zh) 2012-05-09
EP3228308A1 (en) 2017-10-11
ZA200705913B (en) 2008-08-27
AP2274A (en) 2011-08-19
EA200701595A1 (ru) 2008-02-28
AP2007004099A0 (en) 2007-08-31
JP2013100306A (ja) 2013-05-23
EA015615B1 (ru) 2011-10-31

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