BR112014011504A2 - forma de dosagem farmacêutica oral inviolável compreendendo ingrediente farmacologicamente ativo, antagonista opioide e/ou agente aversivo, óxido de polialquileno e polímero aniônico - Google Patents
forma de dosagem farmacêutica oral inviolável compreendendo ingrediente farmacologicamente ativo, antagonista opioide e/ou agente aversivo, óxido de polialquileno e polímero aniônicoInfo
- Publication number
- BR112014011504A2 BR112014011504A2 BR112014011504A BR112014011504A BR112014011504A2 BR 112014011504 A2 BR112014011504 A2 BR 112014011504A2 BR 112014011504 A BR112014011504 A BR 112014011504A BR 112014011504 A BR112014011504 A BR 112014011504A BR 112014011504 A2 BR112014011504 A2 BR 112014011504A2
- Authority
- BR
- Brazil
- Prior art keywords
- active ingredient
- dosage form
- pharmaceutical dosage
- pharmacologically active
- polyalkylene oxide
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, 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
- A61K9/20—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
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- 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
Abstract
resumo patente de invenção: "forma de dosagem farmacêutica oral inviolável compreendendo ingrediente farmacologicamente ativo, antagonista opioide e/ou agente aversivo, óxido de polialquileno e polímero aniônico". a presente invenção refere-se a uma forma de dosagem farmacêutica para administração oral tendo uma resistência à ruptura de pelo menos 300 n e compreendendo (i) um ingrediente farmacologicamente ativo; (ii) um antagonista opioide e/ou um agente aversivo; (iii) um óxido de polialquileno tendo um peso molecular médio de pelo menos 200.000 g/mol; e (a) compreendendo (iv) um polímero aniônico; e/ou (b) tendo uma estabilidade em armazenamento a 40°c de pelo menos 3 meses.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP11009129 | 2011-11-17 | ||
EP12001295 | 2012-02-28 | ||
PCT/EP2012/072678 WO2013072395A1 (en) | 2011-11-17 | 2012-11-15 | Tamper-resistant oral pharmaceutical dosage form comprising a pharmacologically active ingredient, an opioid antagonist and/or aversive agent, polyalkylene oxide and anionic polymer |
Publications (1)
Publication Number | Publication Date |
---|---|
BR112014011504A2 true BR112014011504A2 (pt) | 2017-05-09 |
Family
ID=47191746
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
BR112014011504A BR112014011504A2 (pt) | 2011-11-17 | 2012-11-15 | forma de dosagem farmacêutica oral inviolável compreendendo ingrediente farmacologicamente ativo, antagonista opioide e/ou agente aversivo, óxido de polialquileno e polímero aniônico |
Country Status (17)
Country | Link |
---|---|
US (1) | US20130129826A1 (pt) |
EP (1) | EP2780000B1 (pt) |
JP (1) | JP6085307B2 (pt) |
KR (1) | KR20140096062A (pt) |
CN (1) | CN104066426A (pt) |
AR (1) | AR088875A1 (pt) |
AU (1) | AU2012338872B2 (pt) |
BR (1) | BR112014011504A2 (pt) |
CA (1) | CA2855718A1 (pt) |
CL (1) | CL2014000904A1 (pt) |
CO (1) | CO7210299A2 (pt) |
EA (1) | EA201400590A1 (pt) |
HK (1) | HK1200742A1 (pt) |
IL (1) | IL232054A0 (pt) |
MX (1) | MX349725B (pt) |
PE (1) | PE20141671A1 (pt) |
WO (1) | WO2013072395A1 (pt) |
Families Citing this family (52)
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WO2003024429A1 (en) | 2001-09-21 | 2003-03-27 | Egalet A/S | Polymer release system |
EP1429744A1 (en) | 2001-09-21 | 2004-06-23 | Egalet A/S | Morphine polymer release system |
US7776314B2 (en) | 2002-06-17 | 2010-08-17 | Grunenthal Gmbh | Abuse-proofed dosage system |
ATE495732T1 (de) | 2003-03-26 | 2011-02-15 | Egalet As | Morphin-system mit kontrollierter freisetzung |
DE10336400A1 (de) | 2003-08-06 | 2005-03-24 | Grünenthal GmbH | Gegen Missbrauch gesicherte Darreichungsform |
US20070048228A1 (en) | 2003-08-06 | 2007-03-01 | Elisabeth Arkenau-Maric | Abuse-proofed dosage form |
DE102005005446A1 (de) | 2005-02-04 | 2006-08-10 | Grünenthal GmbH | Bruchfeste Darreichungsformen mit retardierter Freisetzung |
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 |
DE102005005449A1 (de) | 2005-02-04 | 2006-08-10 | Grünenthal GmbH | Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform |
DE102007011485A1 (de) | 2007-03-07 | 2008-09-11 | Grünenthal GmbH | Darreichungsform mit erschwertem Missbrauch |
WO2008148798A2 (en) | 2007-06-04 | 2008-12-11 | Egalet A/S | Controlled release pharmaceutical compositions for prolonged effect |
KR101616246B1 (ko) | 2008-01-25 | 2016-05-02 | 그뤼넨탈 게엠베하 | 약제학적 투여형 |
MX2010012039A (es) | 2008-05-09 | 2010-11-30 | Gruenenthal Gmbh | Proceso para la preparacion de una formulacion de polvo intermedia y una forma de dosificacion solida final bajo el uso de un paso de congelacion por rocio. |
NZ594207A (en) | 2009-02-06 | 2013-03-28 | Egalet Ltd | Immediate release composition resistant to abuse by intake of alcohol |
NZ597283A (en) | 2009-06-24 | 2013-07-26 | Egalet Ltd | Controlled release formulations |
MX2012000317A (es) | 2009-07-22 | 2012-02-08 | Gruenenthal Gmbh | Forma de dosificacion de liberacion controlada extruida por fusion en caliente. |
RU2015138422A (ru) | 2009-07-22 | 2018-12-25 | Грюненталь Гмбх | Стабильная при окислении, прочная на излом лекарственная форма |
CA2808219C (en) | 2010-09-02 | 2019-05-14 | Gruenenthal Gmbh | Tamper resistant dosage form comprising inorganic salt |
ES2487244T3 (es) | 2010-09-02 | 2014-08-20 | Grünenthal GmbH | Forma de dosificación resistente a la manipulación que comprende un polímero aniónico |
AU2012292418B2 (en) | 2011-07-29 | 2017-02-16 | Grunenthal Gmbh | Tamper-resistant tablet providing immediate drug release |
CA2839123A1 (en) | 2011-07-29 | 2013-02-07 | Grunenthal Gmbh | Tamper-resistant tablet providing immediate drug release |
MX356421B (es) | 2012-02-28 | 2018-05-29 | Gruenenthal Gmbh | Forma de dosificacion resistente a la manipulacion indebida que comprende un compuesto farmacologicamente activo y un polimero anionico. |
CN104394851B (zh) | 2012-04-18 | 2017-12-01 | 格吕伦塔尔有限公司 | 抗篡改和抗剂量‑倾泻药物剂型 |
US10064945B2 (en) | 2012-05-11 | 2018-09-04 | Gruenenthal Gmbh | Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc |
KR20150059167A (ko) | 2012-07-06 | 2015-05-29 | 에갈렛 리미티드 | 제어된 방출을 위한 남용 제지 약학적 조성물 |
WO2014011830A1 (en) * | 2012-07-12 | 2014-01-16 | Mallinckrodt Llc | Extended release, abuse deterrent pharmaceutical compositions |
AR096438A1 (es) | 2013-05-29 | 2015-12-30 | Gruenenthal Gmbh | Forma de dosificación resistente al uso indebido con perfil de liberación bimodal, proceso |
CA2907950A1 (en) | 2013-05-29 | 2014-12-04 | Grunenthal Gmbh | Tamper-resistant dosage form containing one or more particles |
CN103304570A (zh) * | 2013-07-12 | 2013-09-18 | 四川省惠达药业有限公司 | 一种盐酸纳洛酮化合物、其制备方法及其药物组合物 |
BR112016000194A8 (pt) | 2013-07-12 | 2019-12-31 | Gruenenthal Gmbh | forma de dosagem resistente à violação contendo o polímero de acetato de etileno-vinila |
US10195153B2 (en) | 2013-08-12 | 2019-02-05 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded immediate release abuse deterrent pill |
CN105934241B (zh) | 2013-11-26 | 2020-06-05 | 格吕伦塔尔有限公司 | 通过低温研磨制备粉末状药物组合物 |
US10172797B2 (en) | 2013-12-17 | 2019-01-08 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded extended release abuse deterrent pill |
US9492444B2 (en) | 2013-12-17 | 2016-11-15 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded extended release abuse deterrent pill |
JP2017501228A (ja) * | 2013-12-23 | 2017-01-12 | パーデュー、ファーマ、リミテッド、パートナーシップ | オピオイド拮抗薬製剤 |
WO2015173195A1 (en) | 2014-05-12 | 2015-11-19 | Grünenthal GmbH | Tamper resistant immediate release capsule formulation comprising tapentadol |
JP2017516789A (ja) | 2014-05-26 | 2017-06-22 | 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 | エタノール過量放出に対して防護されている多粒子 |
ES2809458T3 (es) | 2014-07-17 | 2021-03-04 | Pharmaceutical Manufacturing Res Services Inc | Forma de dosificación llena de líquido, disuasoria del abuso y de liberación inmediata |
WO2016016431A1 (en) * | 2014-08-01 | 2016-02-04 | Krka, D.D., Novo Mesto | Pharmaceutical formulation comprising an opioid agonist and an opioid antagonist prepared by melt granulation using lipid esters |
JP2017531026A (ja) | 2014-10-20 | 2017-10-19 | ファーマシューティカル マニュファクチュアリング リサーチ サービシズ,インコーポレーテッド | 徐放性乱用抑止性液体充填剤形 |
CN107205943A (zh) * | 2014-12-08 | 2017-09-26 | 德威洛克制药有限公司 | 纳洛酮单剂和多层片剂 |
EP3285748A1 (en) | 2015-04-24 | 2018-02-28 | Grünenthal GmbH | Tamper-resistant fixed dose combination providing fast release of two drugs from different particles |
EP3285745A1 (en) | 2015-04-24 | 2018-02-28 | Grünenthal GmbH | Tamper-resistant dosage form with immediate release and resistance against solvent extraction |
US20160310486A1 (en) | 2015-04-24 | 2016-10-27 | Grünenthal GmbH | Tamper-resistant fixed dose combination providing fast release of two drugs from particles and a matrix |
WO2016170094A1 (en) | 2015-04-24 | 2016-10-27 | Grünenthal GmbH | Tamper-resistant fixed dose combination providing fast release of two drugs from particles |
US20180200190A1 (en) * | 2015-07-10 | 2018-07-19 | Sun Pharma Advanced Research Company Ltd. | Multiple pill abuse-resistant immediate release solid dosage form of hydrocodone |
AU2016101552A4 (en) * | 2015-09-03 | 2016-10-13 | Acino Pharma Ag | Reduction of the deallylation of naloxone during the storage of a naloxone-containing retard formulation |
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EP3473246A1 (en) | 2017-10-19 | 2019-04-24 | Capsugel Belgium NV | Immediate release abuse deterrent formulations |
US11708463B2 (en) | 2018-04-06 | 2023-07-25 | Capsugel Belgium Nv | Spray drying process for low aspect ratio particles comprising poly[(methyl methacrylate)-co-(methacrylic acid)] |
CN115337440B (zh) * | 2022-08-22 | 2024-03-29 | 南通大学 | 一种促进伤口复原的纳米敷料及其制备方法 |
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ES2168610T3 (es) | 1996-03-12 | 2002-06-16 | Alza Corp | Composicion y forma galenica que contiene un antagonista opioide. |
EP1387673B1 (en) * | 2001-05-11 | 2010-12-29 | Endo Pharmaceuticals Inc. | Abuse-resistant controlled-release opioid dosage form |
AU2002321879A1 (en) | 2001-08-06 | 2003-03-03 | Thomas Gruber | Pharmaceutical formulation containing dye |
US7141250B2 (en) | 2001-08-06 | 2006-11-28 | Euro-Celtique S.A. | Pharmaceutical formulation containing bittering agent |
DE20308437U1 (de) | 2002-04-05 | 2003-11-13 | Euro Celtique Sa | Matrix zur verzögerten, gleichbleibenden und unabhängigen Freisetzung von Wirkstoffen |
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 |
NZ545202A (en) * | 2003-08-06 | 2010-03-26 | Gruenenthal Chemie | Abuse-proofed dosage form comprising opiods and a high molecular weight polyethylene oxide |
DE10336400A1 (de) | 2003-08-06 | 2005-03-24 | Grünenthal GmbH | Gegen Missbrauch gesicherte Darreichungsform |
JP5064209B2 (ja) | 2004-04-22 | 2012-10-31 | グリューネンタール・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング | 乱用防止固体剤形を製造する方法 |
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AU2005259478B2 (en) | 2004-07-01 | 2010-07-15 | Gruenenthal Gmbh | Oral dosage form safeguarded against abuse containing (1R, 2R)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol |
PL1765303T5 (pl) | 2004-07-01 | 2023-05-22 | Grünenthal GmbH | Tabletka doustna zabezpieczona przed nadużywaniem |
DE102005005449A1 (de) | 2005-02-04 | 2006-08-10 | Grünenthal GmbH | Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform |
US10960077B2 (en) * | 2006-05-12 | 2021-03-30 | Intellipharmaceutics Corp. | Abuse and alcohol resistant drug composition |
SA07280459B1 (ar) | 2006-08-25 | 2011-07-20 | بيورديو فارما إل. بي. | أشكال جرعة صيدلانية للتناول عن طريق الفم مقاومة للعبث تشتمل على مسكن شبه أفيوني |
DE102007011485A1 (de) | 2007-03-07 | 2008-09-11 | Grünenthal GmbH | Darreichungsform mit erschwertem Missbrauch |
JP5667575B2 (ja) * | 2008-12-16 | 2015-02-12 | パラディン ラブス インコーポレーテッド | 誤用を防止する放出制御製剤 |
GB0909680D0 (en) * | 2009-06-05 | 2009-07-22 | Euro Celtique Sa | Dosage form |
ES2487244T3 (es) * | 2010-09-02 | 2014-08-20 | Grünenthal GmbH | Forma de dosificación resistente a la manipulación que comprende un polímero aniónico |
WO2012112952A1 (en) * | 2011-02-17 | 2012-08-23 | QRxPharma Ltd. | Technology for preventing abuse of solid dosage forms |
CN103998025A (zh) * | 2011-10-06 | 2014-08-20 | 格吕伦塔尔有限公司 | 包含阿片样物质激动剂和阿片样物质拮抗剂的防篡改口服药物剂型 |
-
2012
- 2012-11-15 JP JP2014541653A patent/JP6085307B2/ja not_active Expired - Fee Related
- 2012-11-15 BR BR112014011504A patent/BR112014011504A2/pt not_active IP Right Cessation
- 2012-11-15 EA EA201400590A patent/EA201400590A1/ru unknown
- 2012-11-15 MX MX2014005820A patent/MX349725B/es active IP Right Grant
- 2012-11-15 CA CA2855718A patent/CA2855718A1/en not_active Abandoned
- 2012-11-15 KR KR1020147013076A patent/KR20140096062A/ko not_active Application Discontinuation
- 2012-11-15 AR ARP120104298A patent/AR088875A1/es unknown
- 2012-11-15 EP EP12787711.6A patent/EP2780000B1/en not_active Not-in-force
- 2012-11-15 AU AU2012338872A patent/AU2012338872B2/en not_active Ceased
- 2012-11-15 CN CN201280056414.5A patent/CN104066426A/zh active Pending
- 2012-11-15 PE PE2014000627A patent/PE20141671A1/es not_active Application Discontinuation
- 2012-11-15 US US13/677,446 patent/US20130129826A1/en not_active Abandoned
- 2012-11-15 WO PCT/EP2012/072678 patent/WO2013072395A1/en active Application Filing
-
2014
- 2014-04-09 CO CO14077088A patent/CO7210299A2/es unknown
- 2014-04-10 IL IL232054A patent/IL232054A0/en unknown
- 2014-04-10 CL CL2014000904A patent/CL2014000904A1/es unknown
-
2015
- 2015-02-11 HK HK15101505.9A patent/HK1200742A1/xx unknown
Also Published As
Publication number | Publication date |
---|---|
JP6085307B2 (ja) | 2017-02-22 |
WO2013072395A1 (en) | 2013-05-23 |
CN104066426A (zh) | 2014-09-24 |
AU2012338872B2 (en) | 2017-06-22 |
CO7210299A2 (es) | 2015-03-09 |
KR20140096062A (ko) | 2014-08-04 |
AR088875A1 (es) | 2014-07-16 |
IL232054A0 (en) | 2014-05-28 |
MX2014005820A (es) | 2014-06-04 |
EA201400590A1 (ru) | 2014-11-28 |
EP2780000B1 (en) | 2019-04-03 |
MX349725B (es) | 2017-08-10 |
EP2780000A1 (en) | 2014-09-24 |
NZ623291A (en) | 2016-01-29 |
PE20141671A1 (es) | 2014-11-22 |
AU2012338872A1 (en) | 2014-04-17 |
US20130129826A1 (en) | 2013-05-23 |
HK1200742A1 (en) | 2015-08-14 |
CA2855718A1 (en) | 2013-05-23 |
CL2014000904A1 (es) | 2014-08-18 |
JP2014533668A (ja) | 2014-12-15 |
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