AR088250A1 - Forma de dosificacion farmaceutica oral resistente a alteracion comprendiendo agonista opioide y antagonista opioide - Google Patents
Forma de dosificacion farmaceutica oral resistente a alteracion comprendiendo agonista opioide y antagonista opioideInfo
- Publication number
- AR088250A1 AR088250A1 ARP120103721A ARP120103721A AR088250A1 AR 088250 A1 AR088250 A1 AR 088250A1 AR P120103721 A ARP120103721 A AR P120103721A AR P120103721 A ARP120103721 A AR P120103721A AR 088250 A1 AR088250 A1 AR 088250A1
- Authority
- AR
- Argentina
- Prior art keywords
- opioid
- dosage form
- pharmaceutical dosage
- opioid antagonist
- opioid agonist
- 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
- A61K9/2004—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
- 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
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Emergency Medicine (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Neurosurgery (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pain & Pain Management (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
La presente se refiere a una forma de dosificación farmacéutica para administración oral que tiene una resistencia a rompimiento de al menos 300 N y que comprende un agonista opioide, un antagonista opioide, y un óxido de polialquileno que tiene un peso molecular promedio de al menos 200,000 g/mol, en donde de acuerdo con Ph. Eur. el perfil de liberación in vitro del agonista opioide esencialmente corresponde al perfil de liberación in vitro del antagonista opioide, y en donde el agonista opioide y el antagonista opioide se mezclan íntimamente entre sí y se mezclan de manera homogénea en el óxido de polialquileno. Reivindicación 12: La forma de dosificación farmacéutica de acuerdo a cualquiera de las reivindicaciones precedentes, en donde el agonista opioide es oxicodona o una sal fisiológicamente aceptable de la misma. Reivindicación 13: La forma de dosificación farmacéutica de acuerdo a cualquiera de las reivindicaciones precedentes, en donde el antagonista opioide se selecciona del grupo que consiste de naltrexona, naloxona, nalmefeno, ciclazacina, levalorfano, sales farmacéuticamente aceptables de los mismos y mezclas de los mismos.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP11008131 | 2011-10-06 | ||
EP11009090 | 2011-11-16 | ||
EP12001297 | 2012-02-28 |
Publications (1)
Publication Number | Publication Date |
---|---|
AR088250A1 true AR088250A1 (es) | 2014-05-21 |
Family
ID=47018994
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
ARP120103721A AR088250A1 (es) | 2011-10-06 | 2012-10-05 | Forma de dosificacion farmaceutica oral resistente a alteracion comprendiendo agonista opioide y antagonista opioide |
Country Status (18)
Country | Link |
---|---|
US (1) | US20130090349A1 (es) |
EP (1) | EP2763664A2 (es) |
JP (1) | JP2014528437A (es) |
KR (1) | KR20140075704A (es) |
CN (1) | CN103998025A (es) |
AR (1) | AR088250A1 (es) |
AU (1) | AU2012320496C1 (es) |
BR (1) | BR112014008120A2 (es) |
CA (1) | CA2850853A1 (es) |
CL (1) | CL2014000361A1 (es) |
CO (1) | CO6950467A2 (es) |
EA (1) | EA029508B1 (es) |
EC (1) | ECSP14013269A (es) |
HK (1) | HK1200741A1 (es) |
IL (1) | IL230819A0 (es) |
MX (1) | MX2014003973A (es) |
PE (1) | PE20141171A1 (es) |
WO (1) | WO2013050539A2 (es) |
Families Citing this family (56)
Publication number | Priority date | Publication date | Assignee | Title |
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US20040253310A1 (en) | 2001-09-21 | 2004-12-16 | Gina Fischer | Morphine polymer release system |
EP2957281A1 (en) | 2001-09-21 | 2015-12-23 | Egalet Ltd. | Polymer release system |
US7776314B2 (en) | 2002-06-17 | 2010-08-17 | Grunenthal Gmbh | Abuse-proofed dosage system |
EP2301526B1 (en) | 2003-03-26 | 2016-03-23 | Egalet Ltd. | Morphine controlled release system |
US20070048228A1 (en) | 2003-08-06 | 2007-03-01 | Elisabeth Arkenau-Maric | Abuse-proofed dosage form |
DE10361596A1 (de) | 2003-12-24 | 2005-09-29 | Grünenthal GmbH | Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform |
DE10336400A1 (de) | 2003-08-06 | 2005-03-24 | Grünenthal GmbH | Gegen Missbrauch gesicherte Darreichungsform |
DE102005005446A1 (de) | 2005-02-04 | 2006-08-10 | Grünenthal GmbH | Bruchfeste Darreichungsformen mit retardierter Freisetzung |
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 |
WO2008148798A2 (en) | 2007-06-04 | 2008-12-11 | Egalet A/S | Controlled release pharmaceutical compositions for prolonged effect |
EP2249811A1 (en) | 2008-01-25 | 2010-11-17 | Grünenthal GmbH | Pharmaceutical dosage form |
EP2273983B1 (en) | 2008-05-09 | 2016-07-20 | Grünenthal GmbH | Process for the preparation of an intermediate powder formulation and a final solid dosage form under usage of a spray congealing step |
WO2010089132A1 (en) | 2009-02-06 | 2010-08-12 | Egalet A/S | Immediate release composition resistant to abuse by intake of alcohol |
NZ597283A (en) | 2009-06-24 | 2013-07-26 | Egalet Ltd | Controlled release formulations |
PL2456427T3 (pl) | 2009-07-22 | 2015-07-31 | Gruenenthal Gmbh | Wytłaczana na gorąco postać dawki o kontrolowanym uwalnianiu |
PL2456424T3 (pl) | 2009-07-22 | 2013-12-31 | Gruenenthal Gmbh | Stabilizowana przed utlenianiem odporna na naruszenie postać dawkowania |
US9901540B2 (en) | 2010-05-10 | 2018-02-27 | Euro-Celtique S.A. | Combination of active loaded granules with additional actives |
CN103002882B (zh) | 2010-05-10 | 2016-03-02 | 欧洲凯尔特公司 | 不含活性剂之颗粒及包含其之片剂的制备 |
MX2013002293A (es) | 2010-09-02 | 2013-05-09 | Gruenenthal Gmbh | Forma de dosificacion resistente a alteracion que comprende un polimero anionico. |
AU2011297901B2 (en) | 2010-09-02 | 2014-07-31 | Grunenthal Gmbh | Tamper resistant dosage form comprising inorganic salt |
US20130028972A1 (en) | 2011-07-29 | 2013-01-31 | Grunenthal Gmbh | Tamper-resistant tablet providing immediate drug release |
PE20141638A1 (es) | 2011-07-29 | 2014-11-22 | Gruenenthal Chemie | Tableta a prueba de manipulacion que proporciona liberacion de farmaco inmediato |
KR20140096062A (ko) * | 2011-11-17 | 2014-08-04 | 그뤼넨탈 게엠베하 | 약리학적 활성 성분, 오피오이드 길항제 및/또는 혐오제, 폴리알킬렌 옥사이드 및 음이온성 중합체를 포함하는 탬퍼-저항성 경구 약제학적 투여형 |
US20130225697A1 (en) | 2012-02-28 | 2013-08-29 | Grunenthal Gmbh | Tamper-resistant dosage form comprising pharmacologically active compound and anionic polymer |
EA201401139A1 (ru) | 2012-04-18 | 2015-03-31 | Грюненталь Гмбх | Устойчивая к разрушению и к сбросу дозы фармацевтическая лекарственная форма |
US10064945B2 (en) | 2012-05-11 | 2018-09-04 | Gruenenthal Gmbh | Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc |
US9549899B2 (en) | 2012-07-06 | 2017-01-24 | Egalet Ltd. | Abuse deterrent pharmaceutical compositions for controlled release |
CA2795324C (en) * | 2012-11-09 | 2015-07-14 | Purdue Pharma | Pharmaceutical compositions comprising hydromorphone and naloxone |
JP6445537B2 (ja) * | 2013-05-29 | 2018-12-26 | 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 | 1個または複数の粒子を含有する改変防止(tamper−resistant)剤形 |
MX2015016254A (es) | 2013-05-29 | 2016-04-20 | Gruenenthal Gmbh | Forma de dosificacion resistente al uso indebido con perfil de liberacion bimodal. |
JP6449871B2 (ja) | 2013-07-12 | 2019-01-09 | 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 | エチレン−酢酸ビニルポリマーを含有する改変防止剤形 |
CA2919892C (en) | 2013-08-12 | 2019-06-18 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded immediate release abuse deterrent pill |
KR102194174B1 (ko) | 2013-11-13 | 2020-12-23 | 유로-셀티큐 에스.에이. | 통증 및 오피오이드 장 기능장애 증후군의 치료를 위한 히드로모르폰 및 날록손 |
JP6480936B2 (ja) | 2013-11-26 | 2019-03-13 | 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 | クライオミリングによる粉末状医薬組成物の調製 |
WO2015086528A1 (de) | 2013-12-11 | 2015-06-18 | Develco Pharma Schweiz Ag | Naloxon-monopräparat und mehrschichttablette |
US10105360B2 (en) | 2013-12-11 | 2018-10-23 | Develco Pharma Schweiz Ag | Method and composition for the treatment of opioid induced constipation |
WO2015095391A1 (en) | 2013-12-17 | 2015-06-25 | 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 |
EP3086789A4 (en) * | 2013-12-23 | 2017-08-02 | Purdue Pharma L.P. | Opioid antagonist formulations |
CA2847781C (en) * | 2014-03-28 | 2019-03-12 | Purdue Pharma | Reducing drug liking in a subject |
WO2015173195A1 (en) | 2014-05-12 | 2015-11-19 | Grünenthal GmbH | Tamper resistant immediate release capsule formulation comprising tapentadol |
EP3148512A1 (en) | 2014-05-26 | 2017-04-05 | Grünenthal GmbH | Multiparticles safeguarded against ethanolic dose-dumping |
US9707184B2 (en) | 2014-07-17 | 2017-07-18 | Pharmaceutical Manufacturing Research Services, Inc. | Immediate release abuse deterrent liquid fill dosage form |
EP3209282A4 (en) | 2014-10-20 | 2018-05-23 | Pharmaceutical Manufacturing Research Services, Inc. | Extended release abuse deterrent liquid fill dosage form |
EP3229785A2 (de) * | 2014-12-08 | 2017-10-18 | Develco Pharma Schweiz AG | Naloxon-monopräparat und mehrschichttablette |
CA2983634A1 (en) | 2015-04-24 | 2016-10-27 | Grunenthal Gmbh | Tamper-resistant fixed dose combination providing fast release of two drugs from particles |
EP3285744A1 (en) | 2015-04-24 | 2018-02-28 | Grünenthal GmbH | Tamper-resistant fixed dose combination providing fast release of two drugs from particles and a matrix |
CA2983640A1 (en) | 2015-04-24 | 2016-10-27 | Grunenthal Gmbh | Tamper-resistant fixed dose combination providing fast release of two drugs from different particles |
WO2016170097A1 (en) | 2015-04-24 | 2016-10-27 | Grünenthal GmbH | Tamper-resistant dosage form with immediate release and resistance against solvent extraction |
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 |
US9943513B1 (en) | 2015-10-07 | 2018-04-17 | Banner Life Sciences Llc | Opioid abuse deterrent dosage forms |
US10335405B1 (en) | 2016-05-04 | 2019-07-02 | Patheon Softgels, Inc. | Non-burst releasing pharmaceutical composition |
EP3290027A1 (en) * | 2016-09-02 | 2018-03-07 | Develco Pharma Schweiz AG | Method and composition for the treatment of opioid induced constipation |
US10335375B2 (en) | 2017-05-30 | 2019-07-02 | Patheon Softgels, Inc. | Anti-overingestion abuse deterrent compositions |
EP3473246A1 (en) | 2017-10-19 | 2019-04-24 | Capsugel Belgium NV | Immediate release abuse deterrent formulations |
Family Cites Families (21)
Publication number | Priority date | Publication date | Assignee | Title |
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DE19710008A1 (de) * | 1997-03-12 | 1998-09-17 | Basf Ag | Feste, mindestens zweiphasige Zubereitungsformen eines Opioid-Analgeticums mit verzögerter Freisetzung |
AU2002316738B2 (en) * | 2001-07-18 | 2009-01-08 | Euro-Celtique S.A. | Pharmaceutical combinations of oxycodone and naloxone |
WO2003015531A2 (en) | 2001-08-06 | 2003-02-27 | Thomas Gruber | Pharmaceutical formulation containing dye |
US7141250B2 (en) | 2001-08-06 | 2006-11-28 | Euro-Celtique S.A. | Pharmaceutical formulation containing bittering agent |
EP1492506B2 (en) * | 2002-04-05 | 2016-06-29 | Euro-Celtique S.A. | Matrix for sustained, invariant and independent release of active compounds |
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 |
PL1658054T3 (pl) * | 2003-08-06 | 2007-11-30 | Gruenenthal Gmbh | Postać aplikacyjna zabezpieczona przed nadużyciem |
DE102005005446A1 (de) | 2005-02-04 | 2006-08-10 | Grünenthal GmbH | Bruchfeste Darreichungsformen mit retardierter Freisetzung |
WO2005102286A1 (de) | 2004-04-22 | 2005-11-03 | Grünenthal GmbH | Verfahren zur herstellung einer gegen missbrauch gesicherten, festen darreinchungsform |
PL1765298T3 (pl) | 2004-07-01 | 2013-01-31 | Gruenenthal Gmbh | Sposób wytwarzania stałej postaci dawkowania, która jest zabezpieczona przez nadużywaniem, wykorzystujący wytłaczarkę z przekładnią planetarną |
FI1765303T4 (fi) * | 2004-07-01 | 2023-01-31 | Väärinkäytöltä suojattu oraalinen tabletti | |
CA2572352A1 (en) | 2004-07-01 | 2006-01-12 | Gruenenthal Gmbh | Oral dosage form safeguarded against abuse containing (1r,2r)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol |
EP1771152B1 (en) * | 2004-07-27 | 2008-05-28 | Unilever Plc | Hair care compositions |
DE102005005449A1 (de) | 2005-02-04 | 2006-08-10 | Grünenthal GmbH | Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform |
US20060194759A1 (en) * | 2005-02-25 | 2006-08-31 | Eidelson Stewart G | Topical compositions and methods for treating pain and inflammation |
CA2637755A1 (en) * | 2006-01-21 | 2007-07-26 | Abbott Gmbh & Co. Kg | Dosage form and method for the delivery of drugs of abuse |
DE102007011485A1 (de) | 2007-03-07 | 2008-09-11 | Grünenthal GmbH | Darreichungsform mit erschwertem Missbrauch |
RU2551781C2 (ru) | 2008-07-31 | 2015-05-27 | Англо Нетерлендс Грейн Бв | Устойчивые к гербицидам растения подсолнечника |
GB0909680D0 (en) * | 2009-06-05 | 2009-07-22 | Euro Celtique Sa | Dosage form |
PL2456424T3 (pl) * | 2009-07-22 | 2013-12-31 | Gruenenthal Gmbh | Stabilizowana przed utlenianiem odporna na naruszenie postać dawkowania |
-
2012
- 2012-10-05 WO PCT/EP2012/069735 patent/WO2013050539A2/en active Application Filing
- 2012-10-05 AU AU2012320496A patent/AU2012320496C1/en not_active Ceased
- 2012-10-05 JP JP2014533921A patent/JP2014528437A/ja active Pending
- 2012-10-05 AR ARP120103721A patent/AR088250A1/es unknown
- 2012-10-05 MX MX2014003973A patent/MX2014003973A/es unknown
- 2012-10-05 BR BR112014008120A patent/BR112014008120A2/pt not_active IP Right Cessation
- 2012-10-05 CN CN201280049146.4A patent/CN103998025A/zh active Pending
- 2012-10-05 US US13/645,595 patent/US20130090349A1/en not_active Abandoned
- 2012-10-05 KR KR1020147009106A patent/KR20140075704A/ko not_active Application Discontinuation
- 2012-10-05 EP EP12772756.8A patent/EP2763664A2/en not_active Withdrawn
- 2012-10-05 PE PE2014000279A patent/PE20141171A1/es not_active Application Discontinuation
- 2012-10-05 CA CA2850853A patent/CA2850853A1/en not_active Abandoned
- 2012-10-05 EA EA201400413A patent/EA029508B1/ru not_active IP Right Cessation
-
2014
- 2014-02-05 IL IL230819A patent/IL230819A0/en unknown
- 2014-02-12 CO CO14029690A patent/CO6950467A2/es not_active Application Discontinuation
- 2014-02-13 CL CL2014000361A patent/CL2014000361A1/es unknown
- 2014-03-25 EC ECSP14013269 patent/ECSP14013269A/es unknown
-
2015
- 2015-02-11 HK HK15101501.3A patent/HK1200741A1/xx unknown
Also Published As
Publication number | Publication date |
---|---|
US20130090349A1 (en) | 2013-04-11 |
JP2014528437A (ja) | 2014-10-27 |
AU2012320496A1 (en) | 2014-02-13 |
AU2012320496C1 (en) | 2017-09-28 |
BR112014008120A2 (pt) | 2017-04-11 |
CL2014000361A1 (es) | 2014-06-20 |
WO2013050539A3 (en) | 2013-05-30 |
KR20140075704A (ko) | 2014-06-19 |
CN103998025A (zh) | 2014-08-20 |
EP2763664A2 (en) | 2014-08-13 |
HK1200741A1 (en) | 2015-08-14 |
CA2850853A1 (en) | 2013-04-11 |
ECSP14013269A (es) | 2014-12-30 |
IL230819A0 (en) | 2014-03-31 |
MX2014003973A (es) | 2014-05-07 |
PE20141171A1 (es) | 2014-09-21 |
AU2012320496B2 (en) | 2017-05-18 |
WO2013050539A2 (en) | 2013-04-11 |
EA029508B1 (ru) | 2018-04-30 |
EA201400413A1 (ru) | 2014-11-28 |
NZ620252A (en) | 2015-09-25 |
CO6950467A2 (es) | 2014-05-20 |
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