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)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (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. |
EP09808796.8A EP2334287A4 (fr) | 2008-08-20 | 2009-08-20 | Extrusion à chaud de multiparticules à libération modifiée |
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. |
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 |
RU2011110100/15A RU2483713C2 (ru) | 2008-08-20 | 2009-08-20 | Экструзия горячего расплава множественных частиц модифицированного высвобождения |
CN2009801413687A CN102271661A (zh) | 2008-08-20 | 2009-08-20 | 缓释多颗粒的热熔挤出 |
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 (50)
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US7776314B2 (en) | 2002-06-17 | 2010-08-17 | Grunenthal Gmbh | Abuse-proofed dosage system |
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 |
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 |
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 |
US8383152B2 (en) | 2008-01-25 | 2013-02-26 | Gruenenthal Gmbh | Pharmaceutical dosage form |
HUE030803T2 (en) | 2008-05-09 | 2017-06-28 | Gruenenthal Gmbh | Process for the preparation of an intermediate powder formulation and a final solid dosage form using a spraying step \ t |
RU2483713C2 (ru) | 2008-08-20 | 2013-06-10 | Борд Оф Риджентс, Зе Юниверсити Оф Техас Систем | Экструзия горячего расплава множественных частиц модифицированного высвобождения |
AR077420A1 (es) | 2009-07-22 | 2011-08-24 | Gruenenthal Gmbh | Forma de dosificacion resistente a la manipulacion para opiaceos sensibles a la oxidacion |
EP2456427B1 (fr) | 2009-07-22 | 2015-03-04 | Grünenthal GmbH | Formule de dosage pharmaceutique extrudée thermofusible à libération prolongée |
ES2486791T3 (es) | 2010-09-02 | 2014-08-19 | Grünenthal GmbH | Forma de dosificación resistente a la manipulación que comprende una sal inorgánica |
JP5933553B2 (ja) | 2010-09-02 | 2016-06-15 | 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 | アニオン性ポリマーを含む不正使用抵抗性剤形 |
DE102011015370A1 (de) * | 2011-03-29 | 2012-10-04 | Emodys Gmbh | Matrix für eine orale Darreichungsform, Verfahren zu deren Herstellung sowie Verwendung derselben |
RS56527B1 (sr) | 2011-07-29 | 2018-02-28 | Gruenenthal Gmbh | Tableta za trenutno oslobađanje leka rezistentna na zloupotrebu |
LT2736495T (lt) | 2011-07-29 | 2017-11-10 | Grünenthal GmbH | Sugadinimui atspari tabletė, pasižyminti greitu vaisto atpalaidavimu |
US9884042B2 (en) | 2011-09-14 | 2018-02-06 | Celgene Corporation | 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 |
CA2864949A1 (fr) | 2012-02-28 | 2013-09-06 | Grunenthal Gmbh | Forme pharmaceutique inviolable comprenant un compose pharmacologiquement actif et un polymere anionique |
EP2838512B1 (fr) | 2012-04-18 | 2018-08-22 | Grünenthal GmbH | Forme pharmaceutique inviolable et résistante au basculement de dose |
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 |
JP6466417B2 (ja) | 2013-05-29 | 2019-02-06 | 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 | 二峰性放出プロファイルを有する改変防止(tamper−resistant)剤形 |
MX371432B (es) | 2013-05-29 | 2020-01-30 | Gruenenthal Gmbh | Forma de dosificacion resistente al uso indebido que contiene una o mas particulas. |
GB201312245D0 (en) * | 2013-07-08 | 2013-08-21 | Gorman Eddie O | An extrusion process |
MX368846B (es) | 2013-07-12 | 2019-10-18 | Gruenenthal Gmbh | Forma de dosificación resistente a la alteración que contiene polímero de acetato de etilen-vinilo. |
WO2015071394A1 (fr) * | 2013-11-15 | 2015-05-21 | Dsm Ip Assets B.V. | Formulation de composés modérément solubles obtenue par extrusion à chaud |
EP3073994A1 (fr) | 2013-11-26 | 2016-10-05 | Grünenthal GmbH | Préparation de composition pharmaceutique en poudre par cryo-broyage |
US10406234B2 (en) | 2014-03-24 | 2019-09-10 | Kashiv Biosciences, Llc | Method of manufacturing fine particles suitable for orally disintegrating pharmaceutical dosage forms |
EP3142646A1 (fr) | 2014-05-12 | 2017-03-22 | Grünenthal GmbH | Formulation pour capsule à libération immédiate résistant aux manipulations illicites comprenant du tapentadol |
AU2015266117A1 (en) | 2014-05-26 | 2016-11-24 | Grunenthal Gmbh | Multiparticles safeguarded against ethanolic dose-dumping |
CA2964068A1 (fr) * | 2014-09-19 | 2016-03-24 | Board Of Regents, The University Of Texas System | Procedes de preparation d'extrudats |
EA035434B1 (ru) | 2015-04-24 | 2020-06-15 | Грюненталь Гмбх | Защищенная от применения не по назначению лекарственная форма с немедленным высвобождением и устойчивостью к экстракции растворителями |
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 |
CN109640947A (zh) | 2016-08-05 | 2019-04-16 | 株式会社新日本科学 | 鼻内药物粉末组合物 |
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 |
PL3449931T3 (pl) * | 2017-08-28 | 2020-06-01 | Ever Neuro Pharma Gmbh | Zastosowanie cerebrolizyny |
ES2938608T3 (es) * | 2017-09-20 | 2023-04-13 | Tillotts Pharma Ag | Método para preparar una forma farmacéutica sólida que comprende anticuerpos mediante granulación en húmedo, extrusión y esferonización |
CN111465390A (zh) | 2017-10-13 | 2020-07-28 | 格吕伦塔尔有限公司 | 调释防滥用剂型 |
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. |
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US6190591B1 (en) | 1996-10-28 | 2001-02-20 | General Mills, Inc. | Embedding and encapsulation of controlled release particles |
DE19710009A1 (de) | 1997-03-12 | 1998-09-24 | Knoll Ag | Mehrphasige wirkstoffhaltige Zubereitungsformen |
US5958873A (en) * | 1997-06-09 | 1999-09-28 | University Of Cincinnati | Oral formulation for treatment of bacteria-induced diseases of the colon |
ATE251449T1 (de) | 1999-06-14 | 2003-10-15 | Cosmo Spa | Geschmacksmaskierte orale pharmazeutische zusammensetzungen mit kontrollierter abgabe |
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KR100540035B1 (ko) * | 2002-02-01 | 2005-12-29 | 주식회사 태평양 | 다단계 경구 약물 방출 제어 시스템 |
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RU2483713C2 (ru) | 2008-08-20 | 2013-06-10 | Борд Оф Риджентс, Зе Юниверсити Оф Техас Систем | Экструзия горячего расплава множественных частиц модифицированного высвобождения |
-
2009
- 2009-08-20 RU RU2011110100/15A patent/RU2483713C2/ru not_active IP Right Cessation
- 2009-08-20 WO PCT/US2009/054374 patent/WO2010022193A2/fr active Application Filing
- 2009-08-20 CA CA2734646A patent/CA2734646C/fr not_active Expired - Fee Related
- 2009-08-20 US US12/544,963 patent/US9192578B2/en not_active Expired - Fee Related
- 2009-08-20 EP EP09808796.8A patent/EP2334287A4/fr not_active Withdrawn
- 2009-08-20 JP JP2011523974A patent/JP2012501967A/ja active Pending
- 2009-08-20 BR BRPI0917358A patent/BRPI0917358A2/pt not_active Application Discontinuation
- 2009-08-20 CN CN2009801413687A patent/CN102271661A/zh active Pending
- 2009-08-20 MX MX2011001864A patent/MX2011001864A/es not_active Application Discontinuation
-
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 |
---|---|
US20100047340A1 (en) | 2010-02-25 |
JP2014196315A (ja) | 2014-10-16 |
CA2734646C (fr) | 2016-06-28 |
US9827202B2 (en) | 2017-11-28 |
BRPI0917358A2 (pt) | 2015-11-17 |
CN102271661A (zh) | 2011-12-07 |
RU2011110100A (ru) | 2012-09-27 |
WO2010022193A2 (fr) | 2010-02-25 |
CA2734646A1 (fr) | 2010-02-25 |
EP2334287A4 (fr) | 2013-12-25 |
EP2334287A2 (fr) | 2011-06-22 |
MX2011001864A (es) | 2011-06-20 |
RU2483713C2 (ru) | 2013-06-10 |
JP2012501967A (ja) | 2012-01-26 |
US20160101057A1 (en) | 2016-04-14 |
US9192578B2 (en) | 2015-11-24 |
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