AU2003288604A1 - Controlled release pharmaceutical compositions of tamsulosin - Google Patents
Controlled release pharmaceutical compositions of tamsulosin Download PDFInfo
- Publication number
- AU2003288604A1 AU2003288604A1 AU2003288604A AU2003288604A AU2003288604A1 AU 2003288604 A1 AU2003288604 A1 AU 2003288604A1 AU 2003288604 A AU2003288604 A AU 2003288604A AU 2003288604 A AU2003288604 A AU 2003288604A AU 2003288604 A1 AU2003288604 A1 AU 2003288604A1
- Authority
- AU
- Australia
- Prior art keywords
- composition
- tamsulosin
- cellulose
- mixtures
- enteric
- 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.)
- Abandoned
Links
- DRHKJLXJIQTDTD-OAHLLOKOSA-N Tamsulosine Chemical compound CCOC1=CC=CC=C1OCCN[C@H](C)CC1=CC=C(OC)C(S(N)(=O)=O)=C1 DRHKJLXJIQTDTD-OAHLLOKOSA-N 0.000 title claims description 63
- 229960002613 tamsulosin Drugs 0.000 title claims description 63
- 239000008194 pharmaceutical composition Substances 0.000 title claims description 24
- 238000013270 controlled release Methods 0.000 title claims description 21
- 239000000203 mixture Substances 0.000 claims description 96
- 238000000034 method Methods 0.000 claims description 74
- 230000008569 process Effects 0.000 claims description 62
- 229920000642 polymer Polymers 0.000 claims description 55
- 150000003839 salts Chemical class 0.000 claims description 41
- 239000003795 chemical substances by application Substances 0.000 claims description 36
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 30
- 229920001577 copolymer Polymers 0.000 claims description 28
- 239000002702 enteric coating Substances 0.000 claims description 28
- 238000009505 enteric coating Methods 0.000 claims description 28
- 239000001993 wax Substances 0.000 claims description 23
- 239000002775 capsule Substances 0.000 claims description 20
- 235000014113 dietary fatty acids Nutrition 0.000 claims description 20
- 239000000194 fatty acid Substances 0.000 claims description 20
- 229930195729 fatty acid Natural products 0.000 claims description 20
- 150000004665 fatty acids Chemical class 0.000 claims description 20
- 229910052751 metal Inorganic materials 0.000 claims description 20
- 239000002184 metal Substances 0.000 claims description 20
- CERQOIWHTDAKMF-UHFFFAOYSA-N Methacrylic acid Chemical compound CC(=C)C(O)=O CERQOIWHTDAKMF-UHFFFAOYSA-N 0.000 claims description 19
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical group CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 claims description 18
- 238000000576 coating method Methods 0.000 claims description 15
- 235000019359 magnesium stearate Nutrition 0.000 claims description 15
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 15
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 14
- 150000004668 long chain fatty acids Chemical class 0.000 claims description 14
- XNGIFLGASWRNHJ-UHFFFAOYSA-L phthalate(2-) Chemical compound [O-]C(=O)C1=CC=CC=C1C([O-])=O XNGIFLGASWRNHJ-UHFFFAOYSA-L 0.000 claims description 14
- 239000004014 plasticizer Substances 0.000 claims description 14
- 229920003176 water-insoluble polymer Polymers 0.000 claims description 14
- 229920003169 water-soluble polymer Polymers 0.000 claims description 14
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 13
- 229920000623 Cellulose acetate phthalate Polymers 0.000 claims description 12
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- PNJWIWWMYCMZRO-UHFFFAOYSA-N pent‐4‐en‐2‐one Natural products CC(=O)CC=C PNJWIWWMYCMZRO-UHFFFAOYSA-N 0.000 claims description 11
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- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical group CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 10
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims description 10
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- 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 claims description 8
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 claims description 8
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- SMZOUWXMTYCWNB-UHFFFAOYSA-N 2-(2-methoxy-5-methylphenyl)ethanamine Chemical compound COC1=CC=C(C)C=C1CCN SMZOUWXMTYCWNB-UHFFFAOYSA-N 0.000 claims description 7
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- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims description 7
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- MUZDXNQOSGWMJJ-UHFFFAOYSA-N 2-methylprop-2-enoic acid;prop-2-enoic acid Chemical compound OC(=O)C=C.CC(=C)C(O)=O MUZDXNQOSGWMJJ-UHFFFAOYSA-N 0.000 claims description 6
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- 229920002472 Starch Polymers 0.000 description 5
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- 238000004090 dissolution Methods 0.000 description 5
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- 210000000936 intestine Anatomy 0.000 description 5
- 239000008107 starch Substances 0.000 description 5
- 235000019698 starch Nutrition 0.000 description 5
- ZZIZZTHXZRDOFM-UHFFFAOYSA-N 2-(2-ethoxyphenoxy)ethyl-[1-(4-methoxy-3-sulfamoylphenyl)propan-2-yl]azanium;chloride Chemical compound Cl.CCOC1=CC=CC=C1OCCNC(C)CC1=CC=C(OC)C(S(N)(=O)=O)=C1 ZZIZZTHXZRDOFM-UHFFFAOYSA-N 0.000 description 4
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- 239000013543 active substance Substances 0.000 description 4
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- 239000008213 purified water Substances 0.000 description 4
- 229960003198 tamsulosin hydrochloride Drugs 0.000 description 4
- URAYPUMNDPQOKB-UHFFFAOYSA-N triacetin Chemical compound CC(=O)OCC(OC(C)=O)COC(C)=O URAYPUMNDPQOKB-UHFFFAOYSA-N 0.000 description 4
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 3
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- GDCRSXZBSIRSFR-UHFFFAOYSA-N ethyl prop-2-enoate;2-methylprop-2-enoic acid Chemical compound CC(=C)C(O)=O.CCOC(=O)C=C GDCRSXZBSIRSFR-UHFFFAOYSA-N 0.000 description 3
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- ZZIZZTHXZRDOFM-XFULWGLBSA-N tamsulosin hydrochloride Chemical compound [H+].[Cl-].CCOC1=CC=CC=C1OCCN[C@H](C)CC1=CC=C(OC)C(S(N)(=O)=O)=C1 ZZIZZTHXZRDOFM-XFULWGLBSA-N 0.000 description 3
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- 229920003023 plastic Polymers 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 229920001223 polyethylene glycol Polymers 0.000 description 1
- 229920002223 polystyrene Polymers 0.000 description 1
- 125000002924 primary amino group Chemical group [H]N([H])* 0.000 description 1
- 125000001436 propyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
- 210000002307 prostate Anatomy 0.000 description 1
- 238000009490 roller compaction Methods 0.000 description 1
- 239000004576 sand Substances 0.000 description 1
- 235000012239 silicon dioxide Nutrition 0.000 description 1
- 238000009491 slugging Methods 0.000 description 1
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 1
- 239000002195 soluble material Substances 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 150000005846 sugar alcohols Chemical class 0.000 description 1
- 238000013268 sustained release Methods 0.000 description 1
- 239000012730 sustained-release form Substances 0.000 description 1
- 230000009885 systemic effect Effects 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 230000004584 weight gain Effects 0.000 description 1
- 235000019786 weight gain Nutrition 0.000 description 1
- 238000005550 wet granulation Methods 0.000 description 1
- 239000000811 xylitol Substances 0.000 description 1
- 235000010447 xylitol Nutrition 0.000 description 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
- 229960002675 xylitol Drugs 0.000 description 1
Classifications
-
- 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
- A61K31/18—Sulfonamides
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/08—Drugs for disorders of the urinary system of the prostate
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
-
- 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
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/14—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
-
- 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
- A61K9/5089—Processes
Landscapes
- Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Cardiology (AREA)
- Epidemiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hospice & Palliative Care (AREA)
- Urology & Nephrology (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN1292DE2002 IN192381B (enrdf_load_stackoverflow) | 2002-12-20 | 2002-12-20 | |
| IN1292/DEL/2002 | 2002-12-20 | ||
| PCT/IB2003/006072 WO2004056354A1 (en) | 2002-12-20 | 2003-12-18 | Controlled release pharmaceutical compositions of tamsulosin |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AU2003288604A1 true AU2003288604A1 (en) | 2004-07-14 |
Family
ID=32676755
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2003288604A Abandoned AU2003288604A1 (en) | 2002-12-20 | 2003-12-18 | Controlled release pharmaceutical compositions of tamsulosin |
Country Status (9)
Families Citing this family (21)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2004066991A1 (ja) * | 2003-01-27 | 2004-08-12 | Yamanouchi Pharmaceutical Co., Ltd. | タムスロシンまたはその塩の腸溶性徐放微粒子およびその製造法 |
| CA2529984C (en) | 2003-06-26 | 2012-09-25 | Isa Odidi | Oral multi-functional pharmaceutical capsule preparations of proton pump inhibitors |
| US8394409B2 (en) | 2004-07-01 | 2013-03-12 | Intellipharmaceutics Corp. | Controlled extended drug release technology |
| DE502004004032D1 (de) * | 2004-07-14 | 2007-07-19 | Siegfried Generics Internat Lt | Granulat zur kontrollierten Freisetzung von Tamsulosin, enthaltend Alginat |
| US10624858B2 (en) | 2004-08-23 | 2020-04-21 | Intellipharmaceutics Corp | Controlled release composition using transition coating, and method of preparing same |
| US10064828B1 (en) | 2005-12-23 | 2018-09-04 | Intellipharmaceutics Corp. | Pulsed extended-pulsed and extended-pulsed pulsed drug delivery systems |
| CA2648280C (en) | 2006-04-03 | 2014-03-11 | Isa Odidi | Controlled release delivery device comprising an organosol coat |
| CA2648278C (en) * | 2006-04-03 | 2019-05-28 | Isa Odidi | Drug delivery composition |
| US10960077B2 (en) | 2006-05-12 | 2021-03-30 | Intellipharmaceutics Corp. | Abuse and alcohol resistant drug composition |
| WO2008089593A1 (fr) * | 2007-01-18 | 2008-07-31 | Standard Chem. & Pharm. Co., Ltd. | Preparation de tamsulosine a liberation prolongee et procede de production associe |
| US8529953B2 (en) * | 2008-07-01 | 2013-09-10 | Sawai Pharmaceutical Co., Ltd. | Process for production of spherical microparticles comprising tamsulosin hydrochloride |
| CN101695478B (zh) * | 2009-10-23 | 2012-01-18 | 江苏大学 | 盐酸坦索罗辛缓释微丸制剂及其制备方法 |
| KR101423237B1 (ko) * | 2010-05-04 | 2014-07-30 | 주식회사 삼양바이오팜 | 탐스로신 또는 이의 약학적으로 허용 가능한 염을 포함하는 방출 제어용 약학 조성물, 및 이를 포함하는 경구용 제제 |
| CN103315962A (zh) * | 2013-02-01 | 2013-09-25 | 北京科信必成医药科技发展有限公司 | 一种坦索罗辛缓释微丸制剂及其制备方法 |
| CN103142492A (zh) * | 2013-02-01 | 2013-06-12 | 北京科信必成医药科技发展有限公司 | 一种缓释微丸制剂及其制备方法 |
| CN103919735B (zh) * | 2014-05-04 | 2018-04-17 | 翰宇药业（武汉）有限公司 | 一种盐酸坦索罗辛缓释微丸及其制备方法 |
| EP2949319A1 (en) | 2014-05-26 | 2015-12-02 | Galenicum Health S.L. | Pharmaceutical compositions comprising an active agent |
| JP2019514958A (ja) * | 2016-05-04 | 2019-06-06 | アスペン パーク ファーマシューティカルズ，インコーポレイティド | 遅延放出型経口用タムスロシン塩酸塩 |
| EP3473244A1 (en) | 2017-10-20 | 2019-04-24 | Veru Inc. | Controlled release oral tamsulosin hydrochloride |
| EP3473245A1 (en) | 2017-10-20 | 2019-04-24 | Veru Inc. | Controlled release oral tamsulosin hydrochloride |
| KR20200078146A (ko) * | 2018-12-21 | 2020-07-01 | 한미약품 주식회사 | 내산성이 우수한 탐수로신 염산염 함유 제약 조성물 및 이의 제조방법 |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5158777A (en) * | 1990-02-16 | 1992-10-27 | E. R. Squibb & Sons, Inc. | Captopril formulation providing increased duration of activity |
| US6248363B1 (en) * | 1999-11-23 | 2001-06-19 | Lipocine, Inc. | Solid carriers for improved delivery of active ingredients in pharmaceutical compositions |
| EP1064938A1 (en) * | 1999-06-28 | 2001-01-03 | Sanofi-Synthelabo | Pharmaceutical dosage forms for controlled release producing at least a timed pulse |
| DE60210315T2 (de) * | 2001-11-07 | 2006-11-02 | Synthon B.V. | Tamsulosin tabletten |
-
2002
- 2002-12-20 IN IN1292DE2002 patent/IN192381B/en unknown
-
2003
- 2003-12-18 JP JP2004561893A patent/JP2006512358A/ja not_active Withdrawn
- 2003-12-18 EP EP03780445A patent/EP1596849A1/en not_active Withdrawn
- 2003-12-18 WO PCT/IB2003/006072 patent/WO2004056354A1/en not_active Application Discontinuation
- 2003-12-18 CN CNA2003801094133A patent/CN1744889A/zh active Pending
- 2003-12-18 AU AU2003288604A patent/AU2003288604A1/en not_active Abandoned
- 2003-12-18 CA CA002511208A patent/CA2511208A1/en not_active Abandoned
- 2003-12-18 RU RU2005121999/15A patent/RU2005121999A/ru not_active Application Discontinuation
- 2003-12-18 BR BR0317567-7A patent/BR0317567A/pt not_active Application Discontinuation
Also Published As
| Publication number | Publication date |
|---|---|
| CA2511208A1 (en) | 2004-07-08 |
| BR0317567A (pt) | 2005-11-22 |
| IN192381B (enrdf_load_stackoverflow) | 2004-04-10 |
| EP1596849A1 (en) | 2005-11-23 |
| JP2006512358A (ja) | 2006-04-13 |
| RU2005121999A (ru) | 2006-01-20 |
| WO2004056354A1 (en) | 2004-07-08 |
| CN1744889A (zh) | 2006-03-08 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MK1 | Application lapsed section 142(2)(a) - no request for examination in relevant period |