CN101674806B - 一种固体口服剂型 - Google Patents

一种固体口服剂型 Download PDF

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Publication number
CN101674806B
CN101674806B CN2008800144640A CN200880014464A CN101674806B CN 101674806 B CN101674806 B CN 101674806B CN 2008800144640 A CN2008800144640 A CN 2008800144640A CN 200880014464 A CN200880014464 A CN 200880014464A CN 101674806 B CN101674806 B CN 101674806B
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CN
China
Prior art keywords
dosage form
solid oral
oral dosage
treatment
benzazepine
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 - Fee Related
Application number
CN2008800144640A
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English (en)
Chinese (zh)
Other versions
CN101674806A (zh
Inventor
艾伦·J·克拉克
戴维·G·卡林福德
李宇
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Glaxo Group Ltd
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Glaxo Group Ltd
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Publication of CN101674806A publication Critical patent/CN101674806A/zh
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Expired - Fee Related 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
    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • 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
    • A61K9/08—Solutions
    • 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
    • A61K9/20—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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K9/2806—Coating materials
    • A61K9/282—Organic compounds, e.g. 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • 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
    • 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
    • A61P25/06—Antimigraine agents
    • 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
    • A61P25/08—Antiepileptics; Anticonvulsants
    • 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
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson drugs
    • 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
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • 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
    • A61P25/20—Hypnotics; Sedatives
    • 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
    • A61P25/22—Anxiolytics
    • 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
    • A61P25/24—Antidepressants
    • 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
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • 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]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Pain & Pain Management (AREA)
  • Psychiatry (AREA)
  • Zoology (AREA)
  • Biophysics (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Molecular Biology (AREA)
  • Rheumatology (AREA)
  • Psychology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hospice & Palliative Care (AREA)
  • Immunology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Cardiology (AREA)
  • Anesthesiology (AREA)
  • Diabetes (AREA)
  • Child & Adolescent Psychology (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Medicinal Preparation (AREA)
CN2008800144640A 2007-03-01 2008-02-28 一种固体口服剂型 Expired - Fee Related CN101674806B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US89226707P 2007-03-01 2007-03-01
US60/892,267 2007-03-01
PCT/EP2008/052430 WO2008104590A2 (en) 2007-03-01 2008-02-28 Novel dosage form

Publications (2)

Publication Number Publication Date
CN101674806A CN101674806A (zh) 2010-03-17
CN101674806B true CN101674806B (zh) 2013-03-13

Family

ID=39248198

Family Applications (1)

Application Number Title Priority Date Filing Date
CN2008800144640A Expired - Fee Related CN101674806B (zh) 2007-03-01 2008-02-28 一种固体口服剂型

Country Status (29)

Country Link
US (1) US20110014283A1 (enExample)
EP (1) EP2131818B1 (enExample)
JP (2) JP5743177B2 (enExample)
KR (1) KR101504371B1 (enExample)
CN (1) CN101674806B (enExample)
AR (1) AR065529A1 (enExample)
AU (1) AU2008220795B2 (enExample)
BR (1) BRPI0807882A2 (enExample)
CA (1) CA2679529A1 (enExample)
CL (1) CL2008000596A1 (enExample)
CO (1) CO6220900A2 (enExample)
CR (1) CR11013A (enExample)
DK (1) DK2131818T3 (enExample)
DO (1) DOP2009000207A (enExample)
EA (1) EA019865B1 (enExample)
ES (1) ES2463468T3 (enExample)
HR (1) HRP20140390T1 (enExample)
IL (1) IL200619A (enExample)
MA (1) MA31198B1 (enExample)
MX (1) MX2009009362A (enExample)
NZ (1) NZ579374A (enExample)
PE (1) PE20090114A1 (enExample)
PL (1) PL2131818T3 (enExample)
PT (1) PT2131818E (enExample)
SI (1) SI2131818T1 (enExample)
TW (1) TWI424856B (enExample)
UA (1) UA102515C2 (enExample)
WO (1) WO2008104590A2 (enExample)
ZA (1) ZA200905866B (enExample)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9108948B2 (en) 2006-06-23 2015-08-18 Abbvie Inc. Cyclopropyl amine derivatives
US8829041B2 (en) 2006-06-23 2014-09-09 Abbvie Inc. Cyclopropyl amine derivatives
WO2010023170A1 (en) * 2008-08-29 2010-03-04 Glaxo Group Limited Dosage form comprising 1-isopropyl-4-{[4-(tetrahydro-2H-pyran- 4-yloxy)phenyl]carbonyl}hexahydro-1H-1,4-diazepine or a salt thereof
US9186353B2 (en) * 2009-04-27 2015-11-17 Abbvie Inc. Treatment of osteoarthritis pain
WO2011051423A1 (en) 2009-11-02 2011-05-05 Glaxo Group Limited Treatment or prophylaxis of dementia, neurodegenerative disorders, schizophrenia, adhd, somnolence or epilepsy
WO2012037258A1 (en) 2010-09-16 2012-03-22 Abbott Laboratories Processes for preparing 1,2-substituted cyclopropyl derivatives
US20130244943A1 (en) 2011-09-06 2013-09-19 Allergan, Inc. Hyaluronic acid-collagen matrices for dermal filling and volumizing applications
WO2016100184A1 (en) 2014-12-16 2016-06-23 Forum Pharmaceuticals, Inc. Geminal substituted quinuclidine amide compounds as agonists of alpha-7 nicotinic acetylcholine receptors
JP2018516973A (ja) 2015-06-10 2018-06-28 フォーラム・ファーマシューティカルズ・インコーポレイテッドＦｏｒｕｍ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ Ｉｎｃ． α７−ニコチン性アセチルコリン受容体のアゴニストとしてのアミノベンゾイソオキサゾール化合物
EP3334740A4 (en) 2015-08-12 2019-02-06 Axovant Sciences GmbH GEMINAL SUBSTITUTED AMINOBENZISOXAZOLE COMPOUNDS AS AGONISTS OF ALPHA 7-NICOTINIC ACETYLCHOLINE RECEPTORS

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005042491A1 (en) * 2003-10-22 2005-05-12 Arena Pharmaceuticals, Inc. Benzazepine derivatives and methods of prophylaxis or treatment of 5ht2c receptor associated diseases
WO2005123723A1 (en) * 2004-06-18 2005-12-29 Glaxo Group Limited 3-cycloalkylbenzazepines as histamine h3 antagonists
WO2006018260A1 (en) * 2004-08-16 2006-02-23 Glaxo Group Limited Tetrahydrobenzazepines as antagonists and/or reverse agonists of the histamine h 3 receptor

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH09504271A (ja) * 1993-09-03 1997-04-28 スミスクライン・ビーチャム・コーポレイション 安定した錠剤処方
AU776299B2 (en) * 1998-12-01 2004-09-02 Dr Reddy's Laboratories, Inc. New pharmaceutical composition and the process for its preparation
US20040037869A1 (en) * 2002-08-16 2004-02-26 Douglas Cleverly Non-animal product containing veterinary formulations
ATE441417T1 (de) * 2002-12-20 2009-09-15 Glaxo Group Ltd Benzoädüazepinderivate für die behandlung von neurologischen krankheiten
CN1805938B (zh) * 2003-06-17 2010-06-16 艾尼纳制药公司 用于治疗5ht2c受体相关疾病的苯并氮杂卓衍生物
CA2531019A1 (en) * 2003-06-30 2005-01-06 Takeda Pharmaceutical Company Limited Preventive/remedy for urinary disturbance
US20060002986A1 (en) * 2004-06-09 2006-01-05 Smithkline Beecham Corporation Pharmaceutical product
JP2006022039A (ja) * 2004-07-08 2006-01-26 Towa Yakuhin Kk 高い安定性を有するシンバスタチン固形製剤

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005042491A1 (en) * 2003-10-22 2005-05-12 Arena Pharmaceuticals, Inc. Benzazepine derivatives and methods of prophylaxis or treatment of 5ht2c receptor associated diseases
WO2005123723A1 (en) * 2004-06-18 2005-12-29 Glaxo Group Limited 3-cycloalkylbenzazepines as histamine h3 antagonists
WO2006018260A1 (en) * 2004-08-16 2006-02-23 Glaxo Group Limited Tetrahydrobenzazepines as antagonists and/or reverse agonists of the histamine h 3 receptor

Also Published As

Publication number Publication date
CA2679529A1 (en) 2008-09-04
UA102515C2 (ru) 2013-07-25
JP5743177B2 (ja) 2015-07-01
KR20090127311A (ko) 2009-12-10
SI2131818T1 (sl) 2014-06-30
MX2009009362A (es) 2009-09-14
AU2008220795B2 (en) 2013-06-06
PT2131818E (pt) 2014-06-05
KR101504371B1 (ko) 2015-03-19
TW200900093A (en) 2009-01-01
HK1137363A1 (en) 2010-07-30
CR11013A (es) 2009-12-15
NZ579374A (en) 2012-01-12
EA200970817A1 (ru) 2010-06-30
AR065529A1 (es) 2009-06-10
JP2015038098A (ja) 2015-02-26
IL200619A0 (en) 2010-05-17
US20110014283A1 (en) 2011-01-20
AU2008220795A1 (en) 2008-09-04
TWI424856B (zh) 2014-02-01
HRP20140390T1 (hr) 2014-06-06
DK2131818T3 (da) 2014-05-26
JP2010520174A (ja) 2010-06-10
ZA200905866B (en) 2010-05-26
CL2008000596A1 (es) 2008-09-05
EP2131818A2 (en) 2009-12-16
CO6220900A2 (es) 2010-11-19
DOP2009000207A (es) 2009-10-31
PL2131818T3 (pl) 2014-08-29
BRPI0807882A2 (pt) 2014-06-17
WO2008104590A2 (en) 2008-09-04
EP2131818B1 (en) 2014-04-09
CN101674806A (zh) 2010-03-17
MA31198B1 (fr) 2010-02-01
PE20090114A1 (es) 2009-04-13
ES2463468T3 (es) 2014-05-28
EA019865B1 (ru) 2014-06-30
IL200619A (en) 2014-09-30
WO2008104590A3 (en) 2009-07-02

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