AU2011335415B2 - Once daily formulation of lacosamide - Google Patents
Once daily formulation of lacosamide Download PDFInfo
- Publication number
- AU2011335415B2 AU2011335415B2 AU2011335415A AU2011335415A AU2011335415B2 AU 2011335415 B2 AU2011335415 B2 AU 2011335415B2 AU 2011335415 A AU2011335415 A AU 2011335415A AU 2011335415 A AU2011335415 A AU 2011335415A AU 2011335415 B2 AU2011335415 B2 AU 2011335415B2
- Authority
- AU
- Australia
- Prior art keywords
- lacosamide
- formulation
- amount
- release
- matrix
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Ceased
Links
Classifications
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- 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
-
- 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
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
- A61K9/2846—Poly(meth)acrylates
-
- 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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
-
- 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
- A61K9/1635—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
- A61K9/14—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
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4891—Coated capsules; Multilayered drug free capsule shells
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5026—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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
- A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
-
- 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
-
- 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
- A61P25/08—Antiepileptics; Anticonvulsants
-
- 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
- A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
-
- 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
- A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
Applications Claiming Priority (17)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US41915310P | 2010-12-02 | 2010-12-02 | |
US41915810P | 2010-12-02 | 2010-12-02 | |
EP10193561A EP2468261A1 (en) | 2010-12-02 | 2010-12-02 | Formulation of lacosamide |
EP10193559.1 | 2010-12-02 | ||
EP10193561.7 | 2010-12-02 | ||
EP10193559 | 2010-12-02 | ||
US61/419,153 | 2010-12-02 | ||
US61/419,158 | 2010-12-02 | ||
US201161444439P | 2011-02-18 | 2011-02-18 | |
US201161444447P | 2011-02-18 | 2011-02-18 | |
US61/444,447 | 2011-02-18 | ||
US61/444,439 | 2011-02-18 | ||
US201161485361P | 2011-05-12 | 2011-05-12 | |
US201161485354P | 2011-05-12 | 2011-05-12 | |
US61/485,354 | 2011-05-12 | ||
US61/485,361 | 2011-05-12 | ||
PCT/EP2011/006027 WO2012072256A2 (en) | 2010-12-02 | 2011-12-01 | Once daily formulation of lacosamide |
Publications (2)
Publication Number | Publication Date |
---|---|
AU2011335415A1 AU2011335415A1 (en) | 2013-06-20 |
AU2011335415B2 true AU2011335415B2 (en) | 2016-05-19 |
Family
ID=46172318
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
AU2011335415A Ceased AU2011335415B2 (en) | 2010-12-02 | 2011-12-01 | Once daily formulation of lacosamide |
Country Status (14)
Country | Link |
---|---|
US (4) | US20130251813A1 (pt-pt) |
EP (3) | EP3766485A1 (pt-pt) |
JP (2) | JP6027539B2 (pt-pt) |
KR (1) | KR101980386B1 (pt-pt) |
CN (1) | CN103561727B (pt-pt) |
AU (1) | AU2011335415B2 (pt-pt) |
BR (1) | BR112013013525A2 (pt-pt) |
CA (1) | CA2817654A1 (pt-pt) |
EA (1) | EA029180B1 (pt-pt) |
IL (1) | IL226231B (pt-pt) |
MX (1) | MX2013005974A (pt-pt) |
NZ (1) | NZ610701A (pt-pt) |
WO (2) | WO2012072256A2 (pt-pt) |
ZA (1) | ZA201303289B (pt-pt) |
Families Citing this family (27)
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EP1642889A1 (en) * | 2004-10-02 | 2006-04-05 | Schwarz Pharma Ag | Improved synthesis scheme for lacosamide |
EP1873527A1 (en) * | 2006-06-30 | 2008-01-02 | Schwarz Pharma Ag | Method for identifying CRMP modulators |
EA019757B1 (ru) | 2006-06-15 | 2014-06-30 | ЮСиБи ФАРМА ГМБХ | Фармацевтическая композиция с синергетическим противосудорожным эффектом |
CN101466390B (zh) * | 2006-06-15 | 2014-03-12 | 优时比制药有限公司 | 用于治疗难治性癫痫持续状态的肽类化合物 |
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EP2468261A1 (en) | 2010-12-02 | 2012-06-27 | UCB Pharma GmbH | Formulation of lacosamide |
CN102805733B (zh) * | 2011-06-01 | 2016-03-09 | 日东电工株式会社 | 颗粒制剂及其制造方法 |
US8779355B2 (en) | 2011-12-28 | 2014-07-15 | Quest Diagnostics Investments, Inc. | Methods for detecting lacosamide by mass spectrometry |
KR101732731B1 (ko) | 2013-04-02 | 2017-05-08 | 주식회사 바이오파마티스 | 라코사마이드(lacosamide) 또는 이의 약학적으로 허용 가능한 염의 용출 패턴 조절이 용이한 약학 조성물 |
WO2014180895A1 (en) * | 2013-05-08 | 2014-11-13 | Sanovel Ilac Sanayi Ve Ticaret A.S. | Pharmaceutical formulations of lacosamide |
EP2878296A1 (en) | 2013-11-29 | 2015-06-03 | UCB Pharma GmbH | Pharmaceutical composition comprising lacosamide and levetiracetam |
WO2015079010A2 (en) * | 2013-11-29 | 2015-06-04 | Ucb Pharma Gmbh | Pharmaceutical composition comprising lacosamide and levetiracetam |
US20150328246A1 (en) * | 2014-05-16 | 2015-11-19 | Vivus, Inc. | Orally administratable formulations for the controlled release of a pharmacologically active agent |
WO2016131947A1 (en) | 2015-02-20 | 2016-08-25 | Ucb Biopharma Sprl | Combination treatment |
JO3543B1 (ar) * | 2015-09-28 | 2020-07-05 | Applied Pharma Res | تراكيب حمض أميني إصدار معدل تعطى عن طريق الفم |
US10973783B2 (en) * | 2015-12-30 | 2021-04-13 | Adamas Pharmaceuticals, Inc. | Methods and compositions for the treatment of seizure-related disorders |
WO2018062955A1 (ko) * | 2016-09-29 | 2018-04-05 | 에스케이케미칼(주) | 라코사미드 서방성 제제 |
CN106551900A (zh) * | 2016-12-05 | 2017-04-05 | 北京万全德众医药生物技术有限公司 | 一种拉科酰胺口服溶液及其制备工艺 |
KR20190104531A (ko) | 2016-12-09 | 2019-09-10 | 알렉스자 파마스티칼즈, 인크. | 간질 치료 방법 |
KR102083241B1 (ko) | 2018-02-14 | 2020-03-02 | 환인제약 주식회사 | 라코사미드를 함유하는 약제학적 서방성 조성물 |
CN110833528A (zh) * | 2018-08-17 | 2020-02-25 | 北京万全德众医药生物技术有限公司 | 一种拉科酰胺脂质体冻干粉针剂及其制备方法 |
CN109010301B (zh) * | 2018-09-05 | 2021-01-26 | 上海上药第一生化药业有限公司 | 一种拉考沙胺晶型ii片剂及其制备方法和应用 |
EP3981390A4 (en) | 2019-06-06 | 2023-01-25 | Shanghai Aucta Pharmaceuticals Co., Ltd. | LACOSAMIDE PHARMACEUTICAL COMPOSITION AND PHARMACEUTICAL PREPARATION THEREOF |
CN112022804A (zh) * | 2020-09-28 | 2020-12-04 | 健民药业集团股份有限公司 | 一种拉考沙胺口服溶液及制备方法 |
JP2024510761A (ja) * | 2021-03-17 | 2024-03-11 | 上海雲晟研新生物科技有限公司 | ラコサミド医薬組成物、その製造方法及び応用 |
WO2024054987A1 (en) * | 2022-09-08 | 2024-03-14 | The Children's Hospital Of Philadlphia | Gpcr latrophilin-3 as biomarker for detecting increased risk for mild brain injury and methods of use thereof for diagnosis and treatment of the same |
CN115581676A (zh) * | 2022-09-30 | 2023-01-10 | 澳美制药(苏州)有限公司 | 拉考沙胺片剂及其制备工艺 |
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2011
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- 2011-12-01 WO PCT/EP2011/006027 patent/WO2012072256A2/en active Application Filing
- 2011-12-01 EP EP20188230.5A patent/EP3766485A1/en not_active Withdrawn
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- 2011-12-01 US US13/990,863 patent/US20130251813A1/en not_active Abandoned
- 2011-12-01 EP EP11817472.1A patent/EP2646001A2/en not_active Withdrawn
- 2011-12-01 NZ NZ610701A patent/NZ610701A/en not_active IP Right Cessation
- 2011-12-01 BR BR112013013525A patent/BR112013013525A2/pt not_active Application Discontinuation
- 2011-12-01 CN CN201180057820.9A patent/CN103561727B/zh not_active Expired - Fee Related
- 2011-12-01 EP EP11791442.4A patent/EP2645997B1/en active Active
- 2011-12-01 AU AU2011335415A patent/AU2011335415B2/en not_active Ceased
- 2011-12-01 MX MX2013005974A patent/MX2013005974A/es not_active Application Discontinuation
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2012
- 2012-02-01 KR KR1020137017171A patent/KR101980386B1/ko active IP Right Grant
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2013
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2014
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2016
- 2016-10-14 JP JP2016202383A patent/JP6357687B2/ja active Active
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2018
- 2018-07-05 US US16/027,963 patent/US20190008758A1/en not_active Abandoned
- 2018-08-21 US US16/106,655 patent/US20190054009A1/en not_active Abandoned
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Also Published As
Publication number | Publication date |
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CN103561727A (zh) | 2014-02-05 |
NZ610701A (en) | 2015-06-26 |
US20190008758A1 (en) | 2019-01-10 |
BR112013013525A2 (pt) | 2016-10-18 |
JP2013545762A (ja) | 2013-12-26 |
JP6357687B2 (ja) | 2018-07-18 |
EP2645997B1 (en) | 2022-08-10 |
IL226231A0 (en) | 2013-07-31 |
JP6027539B2 (ja) | 2016-11-16 |
EA201390804A1 (ru) | 2013-10-30 |
WO2012084126A3 (en) | 2013-05-02 |
WO2012072256A2 (en) | 2012-06-07 |
US20130251813A1 (en) | 2013-09-26 |
CN103561727B (zh) | 2018-03-27 |
AU2011335415A1 (en) | 2013-06-20 |
JP2017031206A (ja) | 2017-02-09 |
KR20150034579A (ko) | 2015-04-03 |
EP2645997A2 (en) | 2013-10-09 |
KR101980386B1 (ko) | 2019-05-20 |
IL226231B (en) | 2018-01-31 |
EP2646001A2 (en) | 2013-10-09 |
US20150104507A1 (en) | 2015-04-16 |
WO2012084126A2 (en) | 2012-06-28 |
EA029180B1 (ru) | 2018-02-28 |
ZA201303289B (en) | 2014-02-26 |
CA2817654A1 (en) | 2012-06-07 |
MX2013005974A (es) | 2013-07-29 |
EP3766485A1 (en) | 2021-01-20 |
US20190054009A1 (en) | 2019-02-21 |
WO2012072256A3 (en) | 2014-01-23 |
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