ZA200407998B - Immediate release pharmaceutical granule compositions and a continuous process for making them - Google Patents
Immediate release pharmaceutical granule compositions and a continuous process for making them Download PDFInfo
- Publication number
- ZA200407998B ZA200407998B ZA200407998A ZA200407998A ZA200407998B ZA 200407998 B ZA200407998 B ZA 200407998B ZA 200407998 A ZA200407998 A ZA 200407998A ZA 200407998 A ZA200407998 A ZA 200407998A ZA 200407998 B ZA200407998 B ZA 200407998B
- Authority
- ZA
- South Africa
- Prior art keywords
- immediate release
- release pharmaceutical
- drug
- excipient
- granule composition
- Prior art date
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- 239000012729 immediate-release (IR) formulation Substances 0.000 title claims description 38
- 239000008193 pharmaceutical granule composition Substances 0.000 title claims description 31
- 238000010924 continuous production Methods 0.000 title claims description 7
- 239000000203 mixture Substances 0.000 claims description 74
- 229940079593 drug Drugs 0.000 claims description 70
- 239000003814 drug Substances 0.000 claims description 70
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 37
- 239000007787 solid Substances 0.000 claims description 31
- AYIRNRDRBQJXIF-NXEZZACHSA-N (-)-Florfenicol Chemical compound CS(=O)(=O)C1=CC=C([C@@H](O)[C@@H](CF)NC(=O)C(Cl)Cl)C=C1 AYIRNRDRBQJXIF-NXEZZACHSA-N 0.000 claims description 19
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 15
- 229960003760 florfenicol Drugs 0.000 claims description 15
- 239000008187 granular material Substances 0.000 claims description 15
- 229920001223 polyethylene glycol Polymers 0.000 claims description 14
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 13
- -1 glidants Substances 0.000 claims description 13
- 239000002202 Polyethylene glycol Substances 0.000 claims description 11
- 150000001875 compounds Chemical class 0.000 claims description 11
- 238000000034 method Methods 0.000 claims description 11
- 241001465754 Metazoa Species 0.000 claims description 10
- 239000008202 granule composition Substances 0.000 claims description 10
- 230000008569 process Effects 0.000 claims description 10
- 229920002774 Maltodextrin Polymers 0.000 claims description 9
- 229960000074 biopharmaceutical Drugs 0.000 claims description 9
- 238000004519 manufacturing process Methods 0.000 claims description 9
- 125000005456 glyceride group Chemical group 0.000 claims description 8
- 239000007788 liquid Substances 0.000 claims description 8
- 239000005913 Maltodextrin Substances 0.000 claims description 7
- 239000000945 filler Substances 0.000 claims description 7
- 229940035034 maltodextrin Drugs 0.000 claims description 7
- 238000002156 mixing Methods 0.000 claims description 6
- 239000004094 surface-active agent Substances 0.000 claims description 6
- IEDVJHCEMCRBQM-UHFFFAOYSA-N trimethoprim Chemical compound COC1=C(OC)C(OC)=CC(CC=2C(=NC(N)=NC=2)N)=C1 IEDVJHCEMCRBQM-UHFFFAOYSA-N 0.000 claims description 6
- 229960001082 trimethoprim Drugs 0.000 claims description 5
- 239000004375 Dextrin Substances 0.000 claims description 4
- 229920001353 Dextrin Polymers 0.000 claims description 4
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- 239000000416 hydrocolloid Substances 0.000 claims description 4
- 239000000463 material Substances 0.000 claims description 4
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- DKYWVDODHFEZIM-UHFFFAOYSA-N ketoprofen Chemical compound OC(=O)C(C)C1=CC=CC(C(=O)C=2C=CC=CC=2)=C1 DKYWVDODHFEZIM-UHFFFAOYSA-N 0.000 claims description 2
- 229960000991 ketoprofen Drugs 0.000 claims description 2
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- JZUFKLXOESDKRF-UHFFFAOYSA-N Chlorothiazide Chemical compound C1=C(Cl)C(S(=O)(=O)N)=CC2=C1NCNS2(=O)=O JZUFKLXOESDKRF-UHFFFAOYSA-N 0.000 description 10
- 239000002253 acid Substances 0.000 description 8
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- 239000011734 sodium Substances 0.000 description 5
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- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 4
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- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 description 4
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- ZFXYFBGIUFBOJW-UHFFFAOYSA-N theophylline Chemical compound O=C1N(C)C(=O)N(C)C2=C1NC=N2 ZFXYFBGIUFBOJW-UHFFFAOYSA-N 0.000 description 4
- 239000000230 xanthan gum Substances 0.000 description 4
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- WVDDGKGOMKODPV-UHFFFAOYSA-N Benzyl alcohol Chemical compound OCC1=CC=CC=C1 WVDDGKGOMKODPV-UHFFFAOYSA-N 0.000 description 3
- 229920003171 Poly (ethylene oxide) Polymers 0.000 description 3
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 3
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 description 3
- 150000007513 acids Chemical class 0.000 description 3
- 229940058936 antimalarials diaminopyrimidines Drugs 0.000 description 3
- 239000003795 chemical substances by application Substances 0.000 description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 3
- 238000001125 extrusion Methods 0.000 description 3
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- 238000010438 heat treatment Methods 0.000 description 3
- 239000007791 liquid phase Substances 0.000 description 3
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- WWZKQHOCKIZLMA-UHFFFAOYSA-N octanoic acid Chemical compound CCCCCCCC(O)=O WWZKQHOCKIZLMA-UHFFFAOYSA-N 0.000 description 3
- 239000008177 pharmaceutical agent Substances 0.000 description 3
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 3
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 3
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 3
- 238000002360 preparation method Methods 0.000 description 3
- MISVBCMQSJUHMH-UHFFFAOYSA-N pyrimidine-4,6-diamine Chemical class NC1=CC(N)=NC=N1 MISVBCMQSJUHMH-UHFFFAOYSA-N 0.000 description 3
- 208000023504 respiratory system disease Diseases 0.000 description 3
- 150000003839 salts Chemical class 0.000 description 3
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 3
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- 239000007909 solid dosage form Substances 0.000 description 3
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- 239000002904 solvent Substances 0.000 description 3
- 229960004306 sulfadiazine Drugs 0.000 description 3
- SEEPANYCNGTZFQ-UHFFFAOYSA-N sulfadiazine Chemical compound C1=CC(N)=CC=C1S(=O)(=O)NC1=NC=CC=N1 SEEPANYCNGTZFQ-UHFFFAOYSA-N 0.000 description 3
- 238000009736 wetting Methods 0.000 description 3
- KEEYRKYKLYARHO-UHFFFAOYSA-N 5-[(4,5-dimethoxy-2-methylphenyl)methyl]pyrimidine-2,4-diamine Chemical compound C1=C(OC)C(OC)=CC(C)=C1CC1=CN=C(N)N=C1N KEEYRKYKLYARHO-UHFFFAOYSA-N 0.000 description 2
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 description 2
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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
-
- 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
- A61K9/14—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
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
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ZA200407998B true ZA200407998B (en) | 2006-06-28 |
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ZA200407998A ZA200407998B (en) | 2002-03-06 | 2004-10-05 | Immediate release pharmaceutical granule compositions and a continuous process for making them |
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US (4) | US20050058705A1 (ar) |
EP (1) | EP1480622B1 (ar) |
KR (1) | KR20040091099A (ar) |
CN (1) | CN1638738B (ar) |
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AT (1) | ATE418327T1 (ar) |
AU (1) | AU2003215449B2 (ar) |
BR (1) | BR0308231A (ar) |
CA (1) | CA2477890C (ar) |
DE (1) | DE60325461D1 (ar) |
DK (1) | DK1480622T3 (ar) |
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GB (1) | GB0205253D0 (ar) |
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MY (1) | MY138752A (ar) |
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TW (1) | TWI296198B (ar) |
WO (1) | WO2003074031A1 (ar) |
ZA (1) | ZA200407998B (ar) |
Families Citing this family (41)
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GB0205253D0 (en) * | 2002-03-06 | 2002-04-17 | Univ Gent | Immediate release pharmaceutical granule compositions and a continuous process for making them |
US7749533B2 (en) * | 2003-05-07 | 2010-07-06 | Akina, Inc. | Highly plastic granules for making fast melting tablets |
US8377952B2 (en) * | 2003-08-28 | 2013-02-19 | Abbott Laboratories | Solid pharmaceutical dosage formulation |
US8025899B2 (en) | 2003-08-28 | 2011-09-27 | Abbott Laboratories | Solid pharmaceutical dosage form |
US7888412B2 (en) | 2004-03-26 | 2011-02-15 | Board Of Trustees Of The University Of Alabama | Polymer dissolution and blend formation in ionic liquids |
US7550520B2 (en) | 2005-05-31 | 2009-06-23 | The University Of Alabama | Method of preparing high orientation nanoparticle-containing sheets or films using ionic liquids, and the sheets or films produced thereby |
US8883193B2 (en) | 2005-06-29 | 2014-11-11 | The University Of Alabama | Cellulosic biocomposites as molecular scaffolds for nano-architectures |
EP1745775B1 (en) * | 2005-07-19 | 2008-05-28 | Ethypharm | Gastroretentive formulations and manufacturing process thereof. |
GB0612695D0 (en) * | 2006-06-27 | 2006-08-09 | Univ Gent | Process for preparing a solid dosage form |
PL2054040T3 (pl) | 2006-08-16 | 2011-09-30 | Novartis Ag | Sposób wytwarzania stałych dyspersji midostauryny |
WO2008021666A2 (en) * | 2006-08-18 | 2008-02-21 | Morton Grove Pharmaceuticals, Inc. | Stable liquid levetiracetam compositions and methods |
BRPI0720492A2 (pt) * | 2006-12-19 | 2014-02-04 | Schering Plough Ltd | Formulações efervescentes de florfenicol para adição em sistemas de água potável |
KR20100028537A (ko) * | 2007-04-27 | 2010-03-12 | 쉐링-프라우 리미티드 | 사이클로덱스트린을 사용하여 플로르페니콜 및 구조적으로 관련된 항생제의 용해도를 증진시키기 위한 화합물 및 방법 |
EP2257669B1 (en) | 2008-02-19 | 2017-03-22 | The Board Of Trustees Of The University Of Alabama | Ionic liquid systems for the processing of biomass, their components and/or derivatives, and mixtures thereof |
JP5519639B2 (ja) * | 2008-04-28 | 2014-06-11 | フォーマック ファーマシューティカルズ ナムローゼ フェンノートシャップ | 秩序化したメソポーラスシリカ材料 |
FR2935084B1 (fr) * | 2008-08-19 | 2011-05-06 | Pancosma Sa Pour L Ind Des Produits Biochimiques | Additif pour l'alimentation animale et son procede de preparation |
US9278134B2 (en) | 2008-12-29 | 2016-03-08 | The Board Of Trustees Of The University Of Alabama | Dual functioning ionic liquids and salts thereof |
WO2010141470A2 (en) | 2009-06-01 | 2010-12-09 | The Board Of Trustees Of The University Of Alabama | Process for forming films, fibers, and beads from chitinous biomass |
WO2011011322A1 (en) | 2009-07-24 | 2011-01-27 | The Board Of Trustees Of The University Of Alabama | Conductive composites prepared using ionic liquids |
BRPI1002023A2 (pt) * | 2010-03-01 | 2011-10-25 | Nanocore Biotecnologia S A | forma farmacêutica sólida de dissolução rápida para tratamento de infecções bacterianas |
CN101843586B (zh) * | 2010-04-29 | 2012-05-23 | 山东迅达康兽药有限公司 | 一种含有氟苯尼考的可溶于水的微粉及其制备方法 |
CN102178068B (zh) * | 2010-07-06 | 2013-07-31 | 新疆农业大学 | 一种饲料添加剂的使用方法 |
US9394375B2 (en) | 2011-03-25 | 2016-07-19 | Board Of Trustees Of The University Of Alabama | Compositions containing recyclable ionic liquids for use in biomass processing |
RU2013150323A (ru) * | 2011-05-02 | 2015-06-10 | Апталис Фарматек, Инк. | Композиции в форме быстрорастворимых таблеток для вагинального введения |
EP2537518A1 (en) * | 2011-06-24 | 2012-12-26 | Elanco Animal Health Ireland Limited | Fast dissolving azaperone granulate formulation |
WO2014106962A1 (ko) | 2013-01-07 | 2014-07-10 | 삼아제약 주식회사 | 향상된 용해도를 갖는 신규한 속용성 과립제형 |
BR102013020508B1 (pt) * | 2013-08-12 | 2021-01-12 | Ems S/A. | Forma de dosagem que compreende um inibidor de esteroide 5-alfa-redutase e um bloqueador alfa, processo para a preparaçãode uma forma de dosagem e uso da forma de dosagem |
US10100131B2 (en) | 2014-08-27 | 2018-10-16 | The Board Of Trustees Of The University Of Alabama | Chemical pulping of chitinous biomass for chitin |
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US10335371B2 (en) | 2015-02-17 | 2019-07-02 | Universiteit Gent | Solid pharmaceutical dosage form suitable for use as drinking water medication |
JP2019510756A (ja) * | 2016-03-04 | 2019-04-18 | エンベラ ニューロセラピューティクス,インコーポレイティド | 常用癖又は物質使用障害を治療するための組成物と方法 |
MX2018010421A (es) | 2016-03-25 | 2019-05-20 | Natural Fiber Welding Inc | Metodos, procesos y aparatos para producir sustratos soldados. |
JP7114484B2 (ja) | 2016-05-03 | 2022-08-08 | ナチュラル ファイバー ウェルディング インコーポレーテッド | 染色及び溶着された基材を製造するための方法、プロセス、及び装置 |
CN108210501B (zh) * | 2016-12-14 | 2019-03-08 | 中国人民解放军军事医学科学院毒物药物研究所 | 一种磺酰脲类药物的注射用药物组合物及其制备方法 |
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US10941258B2 (en) | 2017-03-24 | 2021-03-09 | The Board Of Trustees Of The University Of Alabama | Metal particle-chitin composite materials and methods of making thereof |
CA3111385A1 (en) * | 2018-09-06 | 2020-03-12 | Yissum Research Development Company Of The Hebrew University Of Jerusalem Ltd. | Sustained-release injectable antibiotical formulation |
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-
2002
- 2002-03-06 GB GBGB0205253.8A patent/GB0205253D0/en not_active Ceased
-
2003
- 2003-03-04 TW TW092104481A patent/TWI296198B/zh not_active IP Right Cessation
- 2003-03-05 PT PT03743276T patent/PT1480622E/pt unknown
- 2003-03-05 CN CN038053861A patent/CN1638738B/zh not_active Expired - Fee Related
- 2003-03-05 AR ARP030100736A patent/AR038880A1/es not_active Application Discontinuation
- 2003-03-05 AT AT03743276T patent/ATE418327T1/de active
- 2003-03-05 MX MXPA04008543A patent/MXPA04008543A/es active IP Right Grant
- 2003-03-05 PL PL372579A patent/PL208133B1/pl unknown
- 2003-03-05 EP EP03743276A patent/EP1480622B1/en not_active Expired - Lifetime
- 2003-03-05 KR KR10-2004-7013775A patent/KR20040091099A/ko not_active Application Discontinuation
- 2003-03-05 WO PCT/BE2003/000040 patent/WO2003074031A1/en active IP Right Grant
- 2003-03-05 DK DK03743276T patent/DK1480622T3/da active
- 2003-03-05 DE DE60325461T patent/DE60325461D1/de not_active Expired - Lifetime
- 2003-03-05 ES ES03743276T patent/ES2318147T3/es not_active Expired - Lifetime
- 2003-03-05 BR BR0308231-8A patent/BR0308231A/pt active Search and Examination
- 2003-03-05 MY MYPI20030770A patent/MY138752A/en unknown
- 2003-03-05 AU AU2003215449A patent/AU2003215449B2/en not_active Ceased
- 2003-03-05 CA CA2477890A patent/CA2477890C/en not_active Expired - Fee Related
- 2003-04-21 SA SA3240089A patent/SA03240089B1/ar unknown
-
2004
- 2004-09-03 US US10/933,674 patent/US20050058705A1/en not_active Abandoned
- 2004-10-05 ZA ZA200407998A patent/ZA200407998B/en unknown
-
2005
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2006
- 2006-03-06 US US11/276,577 patent/US20070009592A1/en not_active Abandoned
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2010
- 2010-06-15 US US12/815,715 patent/US8349366B2/en not_active Expired - Fee Related
- 2010-06-15 US US12/815,781 patent/US8337897B2/en not_active Expired - Fee Related
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PL372579A1 (en) | 2005-07-25 |
US8337897B2 (en) | 2012-12-25 |
EP1480622A1 (en) | 2004-12-01 |
DE60325461D1 (de) | 2009-02-05 |
PL208133B1 (pl) | 2011-03-31 |
US20050058705A1 (en) | 2005-03-17 |
DK1480622T3 (da) | 2009-02-16 |
CA2477890C (en) | 2011-05-10 |
AU2003215449A1 (en) | 2003-09-16 |
AR038880A1 (es) | 2005-02-02 |
SA03240089B1 (ar) | 2008-07-12 |
CA2477890A1 (en) | 2003-09-12 |
ATE418327T1 (de) | 2009-01-15 |
MXPA04008543A (es) | 2004-12-06 |
TW200305446A (en) | 2003-11-01 |
HK1078006A1 (en) | 2006-03-03 |
US20110008454A1 (en) | 2011-01-13 |
AU2003215449B2 (en) | 2007-07-26 |
ES2318147T3 (es) | 2009-05-01 |
US20110027377A1 (en) | 2011-02-03 |
US20070009592A1 (en) | 2007-01-11 |
CN1638738B (zh) | 2012-06-06 |
CN1638738A (zh) | 2005-07-13 |
KR20040091099A (ko) | 2004-10-27 |
TWI296198B (en) | 2008-05-01 |
BR0308231A (pt) | 2004-12-28 |
EP1480622B1 (en) | 2008-12-24 |
WO2003074031A1 (en) | 2003-09-12 |
MY138752A (en) | 2009-07-31 |
US8349366B2 (en) | 2013-01-08 |
GB0205253D0 (en) | 2002-04-17 |
PT1480622E (pt) | 2009-03-06 |
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