WO2010022193A3 - Extrusion à chaud de multiparticules à libération modifiée - Google Patents
Extrusion à chaud de multiparticules à libération modifiée Download PDFInfo
- Publication number
- WO2010022193A3 WO2010022193A3 PCT/US2009/054374 US2009054374W WO2010022193A3 WO 2010022193 A3 WO2010022193 A3 WO 2010022193A3 US 2009054374 W US2009054374 W US 2009054374W WO 2010022193 A3 WO2010022193 A3 WO 2010022193A3
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- particulates
- modified release
- release multi
- hot
- melt extrusion
- Prior art date
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
- A61K9/20—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
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
- A61K31/52—Purines, e.g. adenine
- A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
-
- 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
- A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, 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
- A61K9/14—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
- A61K9/20—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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/08—Bronchodilators
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/03—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
- B29C48/05—Filamentary, e.g. strands
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
-
- 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
- B29K2105/0005—Condition, form or state of moulded material or of the material to be shaped containing compounding ingredients
- B29K2105/0035—Medical or pharmaceutical agents
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Mechanical Engineering (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Pulmonology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Priority Applications (7)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
BRPI0917358A BRPI0917358A2 (pt) | 2008-08-20 | 2009-08-20 | formulação farmacêutica de liberação controlada e método. |
CN2009801413687A CN102271661A (zh) | 2008-08-20 | 2009-08-20 | 缓释多颗粒的热熔挤出 |
EP09808796.8A EP2334287A4 (fr) | 2008-08-20 | 2009-08-20 | Extrusion à chaud de multiparticules à libération modifiée |
JP2011523974A JP2012501967A (ja) | 2008-08-20 | 2009-08-20 | 調節放出型多粒子のホットメルト押出成形 |
CA2734646A CA2734646C (fr) | 2008-08-20 | 2009-08-20 | Extrusion a chaud de multiparticules a liberation modifiee |
MX2011001864A MX2011001864A (es) | 2008-08-20 | 2009-08-20 | Extrusion de fusion en caliente de multiples particulas de liberacion modificada. |
RU2011110100/15A RU2483713C2 (ru) | 2008-08-20 | 2009-08-20 | Экструзия горячего расплава множественных частиц модифицированного высвобождения |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US9043908P | 2008-08-20 | 2008-08-20 | |
US61/090,439 | 2008-08-20 | ||
US10702708P | 2008-10-21 | 2008-10-21 | |
US61/107,027 | 2008-10-21 |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2010022193A2 WO2010022193A2 (fr) | 2010-02-25 |
WO2010022193A3 true WO2010022193A3 (fr) | 2010-05-27 |
Family
ID=41696597
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2009/054374 WO2010022193A2 (fr) | 2008-08-20 | 2009-08-20 | Extrusion à chaud de multiparticules à libération modifiée |
Country Status (9)
Country | Link |
---|---|
US (2) | US9192578B2 (fr) |
EP (1) | EP2334287A4 (fr) |
JP (2) | JP2012501967A (fr) |
CN (1) | CN102271661A (fr) |
BR (1) | BRPI0917358A2 (fr) |
CA (1) | CA2734646C (fr) |
MX (1) | MX2011001864A (fr) |
RU (1) | RU2483713C2 (fr) |
WO (1) | WO2010022193A2 (fr) |
Families Citing this family (51)
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US7776314B2 (en) | 2002-06-17 | 2010-08-17 | Grunenthal Gmbh | Abuse-proofed dosage system |
DE102005005446A1 (de) | 2005-02-04 | 2006-08-10 | Grünenthal GmbH | Bruchfeste Darreichungsformen mit retardierter Freisetzung |
US20070048228A1 (en) | 2003-08-06 | 2007-03-01 | Elisabeth Arkenau-Maric | Abuse-proofed dosage form |
DE10336400A1 (de) | 2003-08-06 | 2005-03-24 | Grünenthal GmbH | Gegen Missbrauch gesicherte Darreichungsform |
DE10361596A1 (de) | 2003-12-24 | 2005-09-29 | Grünenthal GmbH | Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform |
DE102004032049A1 (de) | 2004-07-01 | 2006-01-19 | Grünenthal GmbH | Gegen Missbrauch gesicherte, orale Darreichungsform |
US9061027B2 (en) | 2004-08-27 | 2015-06-23 | Board Of Regents, The University Of Texas System | Enhanced delivery of drug compositions to treat life threatening infections |
DE102005005449A1 (de) | 2005-02-04 | 2006-08-10 | Grünenthal GmbH | Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform |
JP5774853B2 (ja) | 2008-01-25 | 2015-09-09 | グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング | 医薬投薬形 |
EP2273983B1 (fr) | 2008-05-09 | 2016-07-20 | Grünenthal GmbH | Procédé de préparation d'une formulation de poudre intermédiaire et d'une forme galénique solide finale en utilisant une étape de congélation par pulvérisation |
JP2012501967A (ja) | 2008-08-20 | 2012-01-26 | ボード・オブ・リージエンツ,ザ・ユニバーシテイ・オブ・テキサス・システム | 調節放出型多粒子のホットメルト押出成形 |
EP2997965B1 (fr) | 2009-07-22 | 2019-01-02 | Grünenthal GmbH | Formule de dosage inviolable pour opioïdes sensibles à l'oxydation |
CA2765971C (fr) | 2009-07-22 | 2017-08-22 | Gruenenthal Gmbh | Forme galenique extrudee a chaud a liberation controlee |
PE20131102A1 (es) | 2010-09-02 | 2013-10-12 | Gruenenthal Chemie | Forma de dosificacion resistente a manipulacion que comprende una sal inorganica |
AR082862A1 (es) | 2010-09-02 | 2013-01-16 | Gruenenthal Gmbh | Forma de dosificacion resistente a alteracion que comprende un polimero anionico |
DE102011015370A1 (de) * | 2011-03-29 | 2012-10-04 | Emodys Gmbh | Matrix für eine orale Darreichungsform, Verfahren zu deren Herstellung sowie Verwendung derselben |
AR087359A1 (es) | 2011-07-29 | 2014-03-19 | Gruenenthal Gmbh | Tableta a prueba de alteracion que proporciona liberacion inmediata del farmaco |
EA201400172A1 (ru) | 2011-07-29 | 2014-06-30 | Грюненталь Гмбх | Устойчивая к разрушению таблетка, которая обеспечивает немедленное высвобождение лекарственного средства |
AU2012308663B2 (en) * | 2011-09-14 | 2017-06-08 | Amgen (Europe) GmbH | Formulations of cyclopropanecarboxylic acid {2-[(1S)-1-(3-ethoxy-4-methoxy-phenyl)-2-methanesulfonyl-ethyl]-3-oxo-2,3-dihydro-1H-isoindol-4-yl}-amide |
EP2819656A1 (fr) | 2012-02-28 | 2015-01-07 | Grünenthal GmbH | Forme pharmaceutique inviolable comprenant un composé pharmacologiquement actif et un polymère anionique |
AU2013248351B2 (en) | 2012-04-18 | 2018-04-26 | Grunenthal Gmbh | Tamper resistant and dose-dumping resistant pharmaceutical dosage form |
US10064945B2 (en) | 2012-05-11 | 2018-09-04 | Gruenenthal Gmbh | Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc |
WO2014139803A1 (fr) * | 2013-03-15 | 2014-09-18 | AbbVie Deutschland GmbH & Co. KG | Procédé et appareil de mesure d'une formulation plastifiée |
AU2014273227B2 (en) | 2013-05-29 | 2019-08-15 | Grunenthal Gmbh | Tamper-resistant dosage form containing one or more particles |
AR096438A1 (es) | 2013-05-29 | 2015-12-30 | Gruenenthal Gmbh | Forma de dosificación resistente al uso indebido con perfil de liberación bimodal, proceso |
GB201312245D0 (en) * | 2013-07-08 | 2013-08-21 | Gorman Eddie O | An extrusion process |
KR20160031526A (ko) | 2013-07-12 | 2016-03-22 | 그뤼넨탈 게엠베하 | 에틸렌-비닐 아세테이트 중합체를 함유하는 템퍼 내성 투여형 |
KR102388143B1 (ko) | 2013-11-15 | 2022-04-19 | 디에스엠 아이피 어셋츠 비.브이. | 고온-용융 압출에 의한 난용성 화합물의 제형 |
BR112016010482B1 (pt) | 2013-11-26 | 2022-11-16 | Grünenthal GmbH | Preparação de uma composição farmacêutica em pó por meio de criomoagem |
US10406234B2 (en) | 2014-03-24 | 2019-09-10 | Kashiv Biosciences, Llc | Method of manufacturing fine particles suitable for orally disintegrating pharmaceutical dosage forms |
AU2015261060A1 (en) | 2014-05-12 | 2016-11-03 | Grunenthal Gmbh | Tamper resistant immediate release capsule formulation comprising Tapentadol |
MX2016015417A (es) | 2014-05-26 | 2017-02-22 | Gruenenthal Gmbh | Multiparticulas protegidas contra vertido de dosis etanolico. |
WO2016044733A1 (fr) * | 2014-09-19 | 2016-03-24 | Board Of Regents, The University Of Texas System | Procédés de préparation d'extrudats |
WO2016170097A1 (fr) | 2015-04-24 | 2016-10-27 | Grünenthal GmbH | Forme galénique inviolable avec libération immédiate et résistance à l'extraction par solvant. |
JP2018526414A (ja) | 2015-09-10 | 2018-09-13 | グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング | 乱用抑止性の即放性製剤を用いた経口過剰摂取に対する保護 |
US20170296476A1 (en) | 2016-04-15 | 2017-10-19 | Grünenthal GmbH | Modified release abuse deterrent dosage forms |
KR102489453B1 (ko) | 2016-08-05 | 2023-01-16 | 신 니뽄 바이오메디칼 라보라토리즈, 엘티디. | 비강내 제약 분말 조성물 |
CN106176682A (zh) * | 2016-08-30 | 2016-12-07 | 铜陵翔宇商贸有限公司 | 茶碱缓释制胶囊剂及其制备方法 |
WO2018187728A1 (fr) * | 2017-04-07 | 2018-10-11 | Maa Laboratories, Inc. | Procédés d'amélioration de la solubilité et de la biodisponibilité d'agents thérapeutiques |
PL3449931T3 (pl) * | 2017-08-28 | 2020-06-01 | Ever Neuro Pharma Gmbh | Zastosowanie cerebrolizyny |
EP3459527B1 (fr) * | 2017-09-20 | 2022-11-23 | Tillotts Pharma Ag | Procédé de préparation d'une forme posologique solide comprenant des anticorps par granulation par voie humide, extrusion et sphéronisation |
AU2018349031A1 (en) | 2017-10-13 | 2020-03-26 | Grünenthal GmbH | Modified release abuse deterrent dosage forms |
EP3728543A1 (fr) | 2017-12-21 | 2020-10-28 | Danisco US Inc. | Granulés thermofusibles contenant des enzymes, comprenant un déshydratant thermotolérant |
CN108619523B (zh) * | 2018-03-23 | 2020-06-30 | 浙江工业大学 | 一种可用于快速热塑包衣制剂的包衣膜片及其制备方法 |
WO2019209290A1 (fr) * | 2018-04-25 | 2019-10-31 | Hewlett-Packard Development Company, L.P. | Libération sélective de matériau dans une capsule thermiquement dégradable |
US11931441B2 (en) * | 2018-10-10 | 2024-03-19 | The Procter & Gamble Company | Personal care product customized by discrete particles and method of apply thereof |
CN109674656A (zh) * | 2019-01-15 | 2019-04-26 | 苏州璞佩珊科技有限公司 | 一种制备药物制剂的方法 |
JP7287032B2 (ja) | 2019-03-20 | 2023-06-06 | 株式会社リコー | シート、シート積層体、医薬品、シートの製造方法、及びシート積層体の製造方法 |
US20210129406A1 (en) * | 2019-11-04 | 2021-05-06 | Board Of Regents, The University Of Texas System | Drug solvates in thermal processes to make solid dispersions at lower processing temperatures |
CN113080436B (zh) * | 2021-04-08 | 2024-03-01 | 南京纽邦生物科技有限公司 | γ-氨基丁酸干混悬剂及其制备方法 |
CA3224528A1 (fr) * | 2021-06-23 | 2022-12-29 | Bionaut Labs Ltd. | Formulations d'ingredients pharmaceutiques actifs (api) pour une administration locale par l'intermediaire d'un microrobot actif |
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US6488963B1 (en) * | 1996-06-26 | 2002-12-03 | The University Of Texas System | Hot-melt extrudable pharmaceutical formulation |
US20040234602A1 (en) * | 2001-09-21 | 2004-11-25 | Gina Fischer | Polymer release system |
US20070298103A1 (en) * | 2004-02-12 | 2007-12-27 | Euro-Celtique S.A. | Particulates |
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NL194389C (nl) * | 1984-06-14 | 2002-03-04 | Novartis Ag | Werkwijze voor het bereiden van een vaste dispersie van een farmaceutisch actief middel dat een lage oplosbaarheid in water heeft, in een vaste matrix van een in water oplosbaar polyalkyleenglycol als drager. |
DE4138513A1 (de) * | 1991-11-23 | 1993-05-27 | Basf Ag | Feste pharmazeutische retardform |
US5965161A (en) * | 1994-11-04 | 1999-10-12 | Euro-Celtique, S.A. | Extruded multi-particulates |
WO1998018610A1 (fr) | 1996-10-28 | 1998-05-07 | Lengerich Bernhard H Van | Inclusion et encapsulation de particules a liberation controlee |
DE19710009A1 (de) | 1997-03-12 | 1998-09-24 | Knoll Ag | Mehrphasige wirkstoffhaltige Zubereitungsformen |
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EP1639997A1 (fr) * | 2002-04-05 | 2006-03-29 | Euro-Celtique S.A. | Matrices pour libération modifiée des agents actives |
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JP2012501967A (ja) | 2008-08-20 | 2012-01-26 | ボード・オブ・リージエンツ,ザ・ユニバーシテイ・オブ・テキサス・システム | 調節放出型多粒子のホットメルト押出成形 |
-
2009
- 2009-08-20 JP JP2011523974A patent/JP2012501967A/ja active Pending
- 2009-08-20 MX MX2011001864A patent/MX2011001864A/es not_active Application Discontinuation
- 2009-08-20 RU RU2011110100/15A patent/RU2483713C2/ru not_active IP Right Cessation
- 2009-08-20 CA CA2734646A patent/CA2734646C/fr not_active Expired - Fee Related
- 2009-08-20 WO PCT/US2009/054374 patent/WO2010022193A2/fr active Application Filing
- 2009-08-20 EP EP09808796.8A patent/EP2334287A4/fr not_active Withdrawn
- 2009-08-20 US US12/544,963 patent/US9192578B2/en not_active Expired - Fee Related
- 2009-08-20 BR BRPI0917358A patent/BRPI0917358A2/pt not_active Application Discontinuation
- 2009-08-20 CN CN2009801413687A patent/CN102271661A/zh active Pending
-
2014
- 2014-06-04 JP JP2014115891A patent/JP2014196315A/ja active Pending
-
2015
- 2015-10-01 US US14/873,176 patent/US9827202B2/en active Active
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6488963B1 (en) * | 1996-06-26 | 2002-12-03 | The University Of Texas System | Hot-melt extrudable pharmaceutical formulation |
US20040234602A1 (en) * | 2001-09-21 | 2004-11-25 | Gina Fischer | Polymer release system |
US20070298103A1 (en) * | 2004-02-12 | 2007-12-27 | Euro-Celtique S.A. | Particulates |
Also Published As
Publication number | Publication date |
---|---|
CA2734646A1 (fr) | 2010-02-25 |
WO2010022193A2 (fr) | 2010-02-25 |
MX2011001864A (es) | 2011-06-20 |
EP2334287A4 (fr) | 2013-12-25 |
US9192578B2 (en) | 2015-11-24 |
JP2012501967A (ja) | 2012-01-26 |
JP2014196315A (ja) | 2014-10-16 |
US20160101057A1 (en) | 2016-04-14 |
BRPI0917358A2 (pt) | 2015-11-17 |
US9827202B2 (en) | 2017-11-28 |
US20100047340A1 (en) | 2010-02-25 |
RU2483713C2 (ru) | 2013-06-10 |
CN102271661A (zh) | 2011-12-07 |
CA2734646C (fr) | 2016-06-28 |
RU2011110100A (ru) | 2012-09-27 |
EP2334287A2 (fr) | 2011-06-22 |
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