CN1358086A - 含有酮替芬的眼用组合物 - Google Patents
含有酮替芬的眼用组合物 Download PDFInfo
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- CN1358086A CN1358086A CN00809538A CN00809538A CN1358086A CN 1358086 A CN1358086 A CN 1358086A CN 00809538 A CN00809538 A CN 00809538A CN 00809538 A CN00809538 A CN 00809538A CN 1358086 A CN1358086 A CN 1358086A
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- ketotifen
- glycerol
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- 239000000203 mixture Substances 0.000 title claims abstract description 38
- ZCVMWBYGMWKGHF-UHFFFAOYSA-N Ketotifene Chemical compound C1CN(C)CCC1=C1C2=CC=CC=C2CC(=O)C2=C1C=CS2 ZCVMWBYGMWKGHF-UHFFFAOYSA-N 0.000 claims abstract description 9
- 229960004958 ketotifen Drugs 0.000 claims abstract description 7
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 32
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 24
- 229960003630 ketotifen fumarate Drugs 0.000 claims description 13
- YNQQEYBLVYAWNX-WLHGVMLRSA-N ketotifen fumarate Chemical compound OC(=O)\C=C\C(O)=O.C1CN(C)CCC1=C1C2=CC=CC=C2CC(=O)C2=C1C=CS2 YNQQEYBLVYAWNX-WLHGVMLRSA-N 0.000 claims description 13
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 11
- 230000002421 anti-septic effect Effects 0.000 claims description 7
- 229960000686 benzalkonium chloride Drugs 0.000 claims description 7
- CADWTSSKOVRVJC-UHFFFAOYSA-N benzyl(dimethyl)azanium;chloride Chemical compound [Cl-].C[NH+](C)CC1=CC=CC=C1 CADWTSSKOVRVJC-UHFFFAOYSA-N 0.000 claims description 7
- 239000003795 chemical substances by application Substances 0.000 claims description 6
- 239000002253 acid Substances 0.000 claims description 5
- 239000008215 water for injection Substances 0.000 claims description 5
- 150000003839 salts Chemical class 0.000 claims description 4
- 239000003513 alkali Substances 0.000 claims description 3
- 230000002378 acidificating effect Effects 0.000 claims description 2
- 239000013543 active substance Substances 0.000 abstract description 4
- 235000011187 glycerol Nutrition 0.000 description 6
- 239000000470 constituent Substances 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 230000003203 everyday effect Effects 0.000 description 2
- 239000003889 eye drop Substances 0.000 description 2
- 230000002265 prevention Effects 0.000 description 2
- 230000001954 sterilising effect Effects 0.000 description 2
- 238000004659 sterilization and disinfection Methods 0.000 description 2
- 206010002198 Anaphylactic reaction Diseases 0.000 description 1
- 206010008190 Cerebrovascular accident Diseases 0.000 description 1
- 206010010741 Conjunctivitis Diseases 0.000 description 1
- 206010010744 Conjunctivitis allergic Diseases 0.000 description 1
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 description 1
- 208000003251 Pruritus Diseases 0.000 description 1
- 208000006011 Stroke Diseases 0.000 description 1
- 208000002205 allergic conjunctivitis Diseases 0.000 description 1
- 230000036783 anaphylactic response Effects 0.000 description 1
- 208000003455 anaphylaxis Diseases 0.000 description 1
- 208000024998 atopic conjunctivitis Diseases 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000010894 electron beam technology Methods 0.000 description 1
- BEGBSFPALGFMJI-UHFFFAOYSA-N ethene;sodium Chemical group [Na].C=C BEGBSFPALGFMJI-UHFFFAOYSA-N 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 238000005457 optimization Methods 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 230000001932 seasonal effect Effects 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 230000001225 therapeutic effect Effects 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
- A61K31/33—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
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/4436—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a heterocyclic ring having sulfur as a ring hetero atom
-
- 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
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
- A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
- A61K31/4535—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a heterocyclic ring having sulfur as a ring hetero atom, e.g. pizotifen
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0048—Eye, e.g. artificial tears
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
- A61P27/14—Decongestants or antiallergics
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- Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Ophthalmology & Optometry (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
本发明涉及含有酮替芬作为药物活性剂的眼用组合物。
Description
本发明涉及含有酮替芬作为药物活性剂的眼用组合物。
含有酮替芬富马酸盐的眼用组合物是已知的，并且已在市场上销售。与已知的组合物相比，本发明组合物的优越性在于它具有实质上低剂量的药物活性剂。其结果是所述组合物将高功效与较好的耐受性结合起来。正如此处所公开的，该组合物进一步惊人的优点可见于下列事实，即所述组合物能被灭菌，而活性药剂或组合物的其它成分无显著分解现象。
本发明组合物含有浓度为0.01-0.04％的酮替芬的盐，一定量的非离子型张力剂以使组合物的总张力具有范围为210-290毫渗透分子的克分子渗压浓度，任选的防腐剂，使pH达到弱酸性的酸或碱以及水。
在酮替芬的盐类中优选的是酮替芬富马酸盐。酮替芬盐的浓度优选的是0.03-0.04％，更优选的是0.025％。非离子型张力剂优选甘油。非离子型张力剂优选以一定量存在，以使组合物的总张力具有范围为230-260毫渗透分子的克分子渗压浓度，更优选的是235-255毫渗透分子的克分子渗压浓度。如果使用甘油，其浓度范围优选是1.5-2.5％。防腐剂存在于多剂量单位中，通常在单剂量单位时不存在。如果有防腐剂存在，优选的防腐剂是苯扎氯铵。典型的防腐剂用量为0.005-0.02％，更优选的为0.01％。为了调节pH，小量使用酸或碱，例如0.05-0.1％，优选用少量的1N氢氧化钠，例如0.075％这样的溶液。为了稳定性和可忍受度的最优化，将组合物的pH调节到弱酸性，所述的弱酸性pH的含意可理解为优选pH 4.4-5.8，更优选的是pH 5-5.5，最优选的是pH 5.3。组合物中存在的水典型地是注射用水。
本发明优选的组合物含有浓度为0.03-0.04％的酮替芬富马酸盐、浓度为2-2.5％的甘油、任选含量为0.005-0.02％的苯扎氯铵、氢氧化钠以及水。更优选的组合物含有浓度为0.025％的酮替芬富马酸盐、浓度为2.125％的甘油、含量为0.01％的苯扎氯铵、氢氧化钠和水。
无论是作为防腐的多剂量单位或是作为未防腐的单一剂量单位，本发明眼用组合物均可用作滴眼剂。所述的滴眼剂具有高的治疗价值，因为它们可以用于由于过敏性结膜炎引起的眼睛瘙痒的治疗和暂时性预防，并且它们可以用于季节性过敏性结膜炎的征兆和症状的治疗或预防。
尽管采取低浓度的药物活性成分酮替芬富马酸盐，推荐的剂量仍低于已知的酮替芬富马酸盐制剂。因此，有利地应每日使用两次本发明组合物、每次一滴，这和现有技术组合物每日4次、每次1-2滴的使用情况形成对照。本发明组合物能以总的非常低水平的药物活性成分、特别是酮替芬富马酸盐应用的事实是本发明内容惊人的发现之一。进一步的发现是稳定剂例如乙二胺四乙酸钠也许可被省略。
所述眼用组合物能通过混合有关成分并包装所得的混合物来制备，两者均为本领域专业人员已知。组合物的灭菌和初级包装可以通过例如γ线照射、环氧乙烷处理、电子束、高压灭菌或蒸气灭菌等方法实现。
实施例1：多剂量单位
酮替芬富马酸盐 0.25mg(0.025％)
苯扎氯铵 0.10mg(0.010％)
甘油100％ 21.25mg(2.125％)
氢氧化钠1N 大约0.75mg(～0.075％)
注射用水 加至1.0ml
实施例2：单剂量单位
酮替芬富马酸盐 0.25mg(0.025％)
甘油100％ 21.25mg(2.125％)
氢氧化钠1N 大约0.75mg(～0.075％)
注射用水 加至1.0ml
Claims (10)
1.眼用组合物，其含有浓度为0.01-0.04％酮替芬的盐、一定量的非离子型张力剂以使组合物的总张力具有范围为210-290毫渗透分子的克分子渗压浓度、任选防腐剂、使pH达到弱酸性的酸或碱以及水。
2.权利要求1所述的组合物，其中酮替芬的盐是酮替芬富马酸盐。
3.权利要求1所述的组合物，其中酮替芬盐的浓度是0.03-0.04％，优选0.025％。
4.权利要求1所述的组合物，其中非离子型张力剂是甘油。
5.权利要求1所述的组合物，其中非离子型张力剂是含量为1.5-2.5％的甘油。
6.权利要求1所述的组合物，其中的防腐剂是苯扎氯铵。
7.权利要求1所述的组合物，其中不含防腐剂。
8.权利要求1所述的组合物，其含有浓度为0.03-0.04％的酮替芬富马酸盐、浓度为2-2.5％的甘油、任选含量为0.005-0.02％的苯扎氯铵、氢氧化钠和水。
9.权利要求1的组合物，其含有：
酮替芬富马酸盐 0.25mg(0.025％)，
苯扎氯铵 0.10mg(0.010％)，
甘油100％ 21.25mg(2.125％)，
氢氧化钠1N 大约0.75mg(～0.075％)，
注射用水 加至1.0ml。
10.权利要求1的组合物，其含有酮替芬富马酸盐 0.25mg(0.025％)，甘油100％ 21.25mg(2.125％)，氢氧化钠1N 大约0.75mg(～0.075％)，注射用水 加至1.0ml。
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP99114508 | 1999-07-23 | ||
| EP99114508.7 | 1999-07-23 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1358086A true CN1358086A (zh) | 2002-07-10 |
Family
ID=8238654
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN00809538A Pending CN1358086A (zh) | 1999-07-23 | 2000-07-21 | 含有酮替芬的眼用组合物 |
Country Status (20)
| Country | Link |
|---|---|
| US (2) | US6777429B1 (zh) |
| EP (1) | EP1198223A2 (zh) |
| JP (1) | JP2003505419A (zh) |
| KR (1) | KR20020012261A (zh) |
| CN (1) | CN1358086A (zh) |
| BR (2) | BR0012696A (zh) |
| CA (1) | CA2377024A1 (zh) |
| CZ (1) | CZ300614B6 (zh) |
| EE (1) | EE05439B1 (zh) |
| HK (1) | HK1046631A1 (zh) |
| HU (1) | HU230738B1 (zh) |
| IL (1) | IL146973A0 (zh) |
| MX (1) | MXPA02000849A (zh) |
| NO (1) | NO331228B1 (zh) |
| NZ (1) | NZ516108A (zh) |
| PL (1) | PL202496B1 (zh) |
| RU (1) | RU2248789C2 (zh) |
| UA (1) | UA74788C2 (zh) |
| WO (1) | WO2001007049A2 (zh) |
| ZA (1) | ZA200200425B (zh) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111450051A (zh) * | 2020-04-21 | 2020-07-28 | 武汉贝参药业股份有限公司 | 一种富马酸酮替芬口服溶液的制备方法 |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2002345015A1 (en) * | 2001-06-08 | 2002-12-23 | Novartis Pharma Gmbh | Ophthalmic once-a-day composition |
| AR034371A1 (es) * | 2001-06-08 | 2004-02-18 | Novartis Ag | Composiciones farmaceuticas |
| AR034372A1 (es) * | 2001-06-08 | 2004-02-18 | Novartis Ag | Composiciones farmaceuticas |
| CN1738610A (zh) * | 2003-01-22 | 2006-02-22 | 日绊株式会社 | 眼疾治疗用经皮吸收型制剂、其使用及眼疾治疗药向眼局部组织的转移方法 |
| US20070208058A1 (en) * | 2004-10-25 | 2007-09-06 | Bryant Roy W | Stable Pharmaceutical Compositions and Methods of Making and Using Same |
| US20060089384A1 (en) * | 2004-10-25 | 2006-04-27 | Minno George E | Ophthalmic compositions and methods of using the same |
| ATE463244T1 (de) * | 2004-10-25 | 2010-04-15 | Bausch & Lomb | Ophthalmische zusammensetzungen und verfahren zu deren verwendung |
| US20070048389A1 (en) * | 2005-08-26 | 2007-03-01 | Fu-Pao Tsao | Stabilized and preserved ketotifen ophthalmic compositions |
| US20070077302A1 (en) * | 2005-09-30 | 2007-04-05 | Azaam Alli | Methods for stabilizing ophthalmic compositions |
| CA2654510C (en) | 2006-06-16 | 2015-03-17 | Regeneron Pharmaceuticals, Inc. | Vegf antagonist formulations suitable for intravitreal administration |
| US8445437B2 (en) * | 2006-07-27 | 2013-05-21 | The Brigham And Women's Hospital, Inc. | Treatment and prevention of cardiovascular disease using mast cell stabilizers |
| HUE033597T2 (hu) | 2006-09-29 | 2017-12-28 | Johnson & Johnson Vision Care | Eljárás allergia elleni szert tartalmazó szemészeti eszköz oxidációjának megelõzésére |
| US20100166804A1 (en) * | 2007-05-23 | 2010-07-01 | Dennis Penn | Methods |
| EP2205243A4 (en) | 2007-09-28 | 2012-06-13 | Brigham & Womens Hospital | STABILIZERS OF MAST CELLS IN THE TREATMENT OF OBESITY |
| WO2009142772A2 (en) * | 2008-05-23 | 2009-11-26 | Mastcell Pharmaceuticals, Inc. | Methods and treatment for allergies and inflammation associated with gastrointestinal diseases |
| CA2754996A1 (en) * | 2009-03-17 | 2010-09-23 | Aciex Therapeutics, Inc. | Ophthalmic formulations of ketotifen and methods of use |
| RU2549472C1 (ru) * | 2013-12-26 | 2015-04-27 | Илья Александрович Марков | Фармацевтическая композиция в форме капель для профилактики и лечения аллергических заболеваний глаз |
| IL302424A (en) | 2015-12-03 | 2023-06-01 | Regeneron Pharma | Methods for associating genetic variants with clinical outcome in patients suffering from age-related macular degeneration and receiving treatment against tubular endothelial growth factor |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS62277323A (ja) | 1986-02-19 | 1987-12-02 | Sankyo Co Ltd | フマル酸ケトチフエン含有点眼液の製法 |
| JPH07324034A (ja) * | 1994-05-30 | 1995-12-12 | Toa Yakuhin Kk | フマル酸ケトチフェン含有の点眼剤 |
| JPH11189533A (ja) * | 1997-12-25 | 1999-07-13 | Taisho Pharmaceut Co Ltd | 点眼薬 |
| EP0938896A1 (en) | 1998-01-15 | 1999-09-01 | Novartis AG | Autoclavable pharmaceutical compositions containing a chelating agent |
-
2000
- 2000-07-19 US US09/619,349 patent/US6777429B1/en not_active Expired - Lifetime
- 2000-07-21 BR BR0012696-9A patent/BR0012696A/pt not_active Application Discontinuation
- 2000-07-21 MX MXPA02000849A patent/MXPA02000849A/es active IP Right Grant
- 2000-07-21 WO PCT/EP2000/007030 patent/WO2001007049A2/en not_active Application Discontinuation
- 2000-07-21 EP EP00953080A patent/EP1198223A2/en not_active Withdrawn
- 2000-07-21 IL IL14697300A patent/IL146973A0/xx unknown
- 2000-07-21 HU HU0202243A patent/HU230738B1/hu unknown
- 2000-07-21 NZ NZ516108A patent/NZ516108A/en not_active IP Right Cessation
- 2000-07-21 RU RU2002103315/15A patent/RU2248789C2/ru active
- 2000-07-21 PL PL352382A patent/PL202496B1/pl unknown
- 2000-07-21 UA UA2002010531A patent/UA74788C2/uk unknown
- 2000-07-21 EE EEP200200040A patent/EE05439B1/xx unknown
- 2000-07-21 JP JP2001511933A patent/JP2003505419A/ja active Pending
- 2000-07-21 CA CA002377024A patent/CA2377024A1/en not_active Abandoned
- 2000-07-21 KR KR1020017015745A patent/KR20020012261A/ko not_active Application Discontinuation
- 2000-07-21 CZ CZ20020243A patent/CZ300614B6/cs not_active IP Right Cessation
- 2000-07-21 CN CN00809538A patent/CN1358086A/zh active Pending
- 2000-07-21 BR BRPI0017528A patent/BRPI0017528B8/pt not_active IP Right Cessation
-
2002
- 2002-01-17 ZA ZA200200425A patent/ZA200200425B/en unknown
- 2002-01-21 NO NO20020319A patent/NO331228B1/no not_active IP Right Cessation
- 2002-04-29 US US10/134,795 patent/US6774137B2/en not_active Expired - Lifetime
- 2002-09-25 HK HK02107011.8A patent/HK1046631A1/zh unknown
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111450051A (zh) * | 2020-04-21 | 2020-07-28 | 武汉贝参药业股份有限公司 | 一种富马酸酮替芬口服溶液的制备方法 |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2001007049A2 (en) | 2001-02-01 |
| US6774137B2 (en) | 2004-08-10 |
| CZ2002243A3 (cs) | 2002-04-17 |
| UA74788C2 (en) | 2006-02-15 |
| CZ300614B6 (cs) | 2009-07-01 |
| KR20020012261A (ko) | 2002-02-15 |
| RU2248789C2 (ru) | 2005-03-27 |
| EE05439B1 (et) | 2011-08-15 |
| US6777429B1 (en) | 2004-08-17 |
| US20020183359A1 (en) | 2002-12-05 |
| HU230738B1 (hu) | 2018-01-29 |
| HUP0202243A2 (hu) | 2002-12-28 |
| NZ516108A (en) | 2004-04-30 |
| WO2001007049A3 (en) | 2001-03-29 |
| PL202496B1 (pl) | 2009-06-30 |
| EE200200040A (et) | 2003-04-15 |
| BRPI0017528B1 (pt) | 2017-06-13 |
| ZA200200425B (en) | 2002-10-30 |
| NO331228B1 (no) | 2011-11-07 |
| CA2377024A1 (en) | 2001-02-01 |
| HUP0202243A3 (en) | 2006-03-28 |
| BR0012696A (pt) | 2002-04-09 |
| IL146973A0 (en) | 2002-08-14 |
| NO20020319L (no) | 2002-01-21 |
| JP2003505419A (ja) | 2003-02-12 |
| NO20020319D0 (no) | 2002-01-21 |
| HK1046631A1 (zh) | 2003-01-24 |
| BRPI0017528B8 (pt) | 2021-05-25 |
| BRPI0017528A2 (pt) | 2010-01-19 |
| PL352382A1 (en) | 2003-08-25 |
| EP1198223A2 (en) | 2002-04-24 |
| MXPA02000849A (es) | 2002-07-30 |
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