BRPI0822398B8 - forma sólida cristalina e composição farmacêutica que a compreende - Google Patents

forma sólida cristalina e composição farmacêutica que a compreende Download PDF

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Publication number
BRPI0822398B8
BRPI0822398B8 BRPI0822398A BRPI0822398A BRPI0822398B8 BR PI0822398 B8 BRPI0822398 B8 BR PI0822398B8 BR PI0822398 A BRPI0822398 A BR PI0822398A BR PI0822398 A BRPI0822398 A BR PI0822398A BR PI0822398 B8 BRPI0822398 B8 BR PI0822398B8
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BR
Brazil
Prior art keywords
pharmaceutical composition
solid form
crystalline solid
crystalline
pharmaceutical
Prior art date
Application number
BRPI0822398A
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English (en)
Inventor
Ge Chuansheng
W Muller George
Man Hon-Wah
Xu Jean
H Schafer Peter
Original Assignee
Celgene Corp
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Application filed by Celgene Corp filed Critical Celgene Corp
Publication of BRPI0822398A2 publication Critical patent/BRPI0822398A2/pt
Publication of BRPI0822398B1 publication Critical patent/BRPI0822398B1/pt
Publication of BRPI0822398B8 publication Critical patent/BRPI0822398B8/pt

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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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/4035—Isoindoles, e.g. phthalimide
    • 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
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/08—Drugs for disorders of the urinary system of the prostate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/10—Drugs for disorders of the urinary system of the bladder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/04—Antipruritics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
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    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P27/00—Drugs for disorders of the senses
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    • 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
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A61P31/08—Antibacterial agents for leprosy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/18—Antivirals for RNA viruses for HIV
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/08—Antiallergic agents
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Immunology (AREA)
  • Neurology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (AREA)
  • Oncology (AREA)
  • Dermatology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Pulmonology (AREA)
  • Communicable Diseases (AREA)
  • Epidemiology (AREA)
  • Urology & Nephrology (AREA)
  • Virology (AREA)
  • Pain & Pain Management (AREA)
  • Hematology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Psychology (AREA)
  • Psychiatry (AREA)
  • Transplantation (AREA)
  • Molecular Biology (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • AIDS & HIV (AREA)
BRPI0822398A 2008-03-27 2008-03-27 forma sólida cristalina e composição farmacêutica que a compreende BRPI0822398B8 (pt)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2008/004021 WO2009120167A1 (en) 2008-03-27 2008-03-27 Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, compositions thereof, and uses thereof

Publications (3)

Publication Number Publication Date
BRPI0822398A2 BRPI0822398A2 (pt) 2014-11-18
BRPI0822398B1 BRPI0822398B1 (pt) 2018-01-16
BRPI0822398B8 true BRPI0822398B8 (pt) 2018-05-29

Family

ID=40043076

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0822398A BRPI0822398B8 (pt) 2008-03-27 2008-03-27 forma sólida cristalina e composição farmacêutica que a compreende

Country Status (21)

Country Link
EP (2) EP2695616A1 (pt)
JP (1) JP5474043B2 (pt)
KR (3) KR20100132045A (pt)
CN (1) CN102046167A (pt)
AU (1) AU2008353468B2 (pt)
BR (1) BRPI0822398B8 (pt)
CA (1) CA2718601A1 (pt)
CY (1) CY1115361T1 (pt)
DK (1) DK2276483T3 (pt)
ES (1) ES2476252T3 (pt)
HR (1) HRP20140609T1 (pt)
IL (3) IL208216A0 (pt)
MX (2) MX359839B (pt)
NO (1) NO2015017I1 (pt)
NZ (1) NZ588104A (pt)
PL (1) PL2276483T3 (pt)
PT (1) PT2276483E (pt)
RU (1) RU2471782C2 (pt)
SI (1) SI2276483T1 (pt)
WO (1) WO2009120167A1 (pt)
ZA (1) ZA201006663B (pt)

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US6962940B2 (en) 2002-03-20 2005-11-08 Celgene Corporation (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione: methods of using and compositions thereof
EP2695616A1 (en) 2008-03-27 2014-02-12 Celgene Corporation Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, compositions thereof, and uses thereof
CN107964016B (zh) 2009-05-14 2021-10-01 天津合美医药科技有限公司 噻吩衍生物
US20140004182A1 (en) * 2009-11-19 2014-01-02 Jerome B. Zeldis Methods for the treatment of sarcoidosis
WO2011159750A1 (en) * 2010-06-15 2011-12-22 Celgene Corporation Biomarkers for the treatment of psoriasis
US20140018404A1 (en) * 2010-12-16 2014-01-16 Celgene Corporation Controlled release oral dosage forms of poorly soluble drugs and uses thereof
US9532977B2 (en) 2010-12-16 2017-01-03 Celgene Corporation Controlled release oral dosage forms of poorly soluble drugs and uses thereof
US9387195B2 (en) 2011-03-07 2016-07-12 Celgene Corporation Methods for treating diseases using isoindoline compounds
EP2730278A1 (en) * 2012-11-08 2014-05-14 Ratiopharm GmbH Composition melt
WO2014074846A1 (en) * 2012-11-09 2014-05-15 Celgene Corporation Methods for the treatment of bone loss
JP2014114308A (ja) * 2014-01-31 2014-06-26 Celgene Corp （＋）−２−［１−（３−エトキシ−４−メトキシフェニル）−２−メチルスルホニルエチル］−４−アセチルアミノイソインドリン−１，３−ジオンを含む固形物形態、その組成物およびその使用
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MX2016014384A (es) 2014-06-23 2017-01-20 Celgene Corp Apremilast para el tratamiento de una enfermedad del higado o una anormalidad en la funcion del higado.
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CN104496886A (zh) * 2014-12-11 2015-04-08 杭州新博思生物医药有限公司 一种高纯度阿普斯特b晶型的制备方法
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CN107635962A (zh) * 2015-03-19 2018-01-26 印度商西伯拉有限公司 用于制备阿普斯特的改进工艺
WO2016169533A1 (en) 2015-04-24 2016-10-27 Zentiva, K.S. A solid form of apremilast and a process for preparing the same
CN104892486B (zh) * 2015-06-25 2017-12-08 济南纽华医药科技有限公司 阿普斯特的晶型b+及其制备方法
US10544097B2 (en) 2015-08-27 2020-01-28 Msn Laboratories Private Limited Solid state forms of N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide and process for preparation thereof
US9765026B2 (en) * 2015-08-28 2017-09-19 Scinopharm Taiwan, Ltd. Forms of apremilast and the process of making the same
CN105218428A (zh) * 2015-10-20 2016-01-06 南京美嘉宁逸医药研究开发有限公司 一种高手性纯度的阿普斯特的制备方法
WO2017076987A1 (en) * 2015-11-03 2017-05-11 Ratiopharm Gmbh Composition comprising apremilast in amorphous form
CN105330587A (zh) * 2015-11-27 2016-02-17 东华大学 一种3-乙酰胺基邻苯二甲酰亚胺的制备方法
CZ20165A3 (cs) 2016-01-06 2017-07-19 Zentiva, K.S. Způsoby přípravy amorfního apremilastu
US10774042B2 (en) * 2016-05-12 2020-09-15 Zaklady Farmaceutyczne Polpharma Sa Crystalline forms of apremilast
EP3471698A1 (en) 2016-06-15 2019-04-24 Torrent Pharmaceuticals Limited Topical compositions of apremilast
CN106008315A (zh) * 2016-06-16 2016-10-12 珠海联邦制药股份有限公司 一种阿普斯特晶型s及其制备方法
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CN107686461A (zh) * 2016-08-04 2018-02-13 广东东阳光药业有限公司 阿普斯特的溶剂化物及其制备方法和用途
CN110049968A (zh) * 2016-11-09 2019-07-23 广东东阳光药业有限公司 阿普斯特共晶及其制备方法
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MX2010010454A (es) 2010-12-20
EP2276483A1 (en) 2011-01-26
IL227991A0 (en) 2013-09-30
NZ588104A (en) 2012-11-30
JP2011515463A (ja) 2011-05-19
RU2010143907A (ru) 2012-05-10
HRP20140609T1 (hr) 2014-08-15
BRPI0822398B1 (pt) 2018-01-16
DK2276483T3 (da) 2014-06-10
NO2015017I1 (no) 2015-07-27
EP2695616A1 (en) 2014-02-12
KR20150038547A (ko) 2015-04-08
PT2276483E (pt) 2014-07-25
CY1115361T1 (el) 2017-01-04
PL2276483T3 (pl) 2014-09-30
SI2276483T1 (sl) 2014-08-29
JP5474043B2 (ja) 2014-04-16
MX359839B (es) 2018-10-12
IL247411A0 (en) 2016-11-30
AU2008353468A1 (en) 2009-10-01
AU2008353468B2 (en) 2015-08-06
ZA201006663B (en) 2012-02-29
CA2718601A1 (en) 2009-10-01
IL208216A0 (en) 2010-12-30
ES2476252T3 (es) 2014-07-14
EP2276483B1 (en) 2014-05-07
KR20100132045A (ko) 2010-12-16
KR20140142323A (ko) 2014-12-11
BRPI0822398A2 (pt) 2014-11-18
RU2471782C2 (ru) 2013-01-10
CN102046167A (zh) 2011-05-04
WO2009120167A1 (en) 2009-10-01

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