ZA200503711B - An aqueous pharmaceutical formulation comprising the thrombin inhibitor melagatran and use of the formulation in the manufacture for use by nasal administration in treating thromboembolism - Google Patents
An aqueous pharmaceutical formulation comprising the thrombin inhibitor melagatran and use of the formulation in the manufacture for use by nasal administration in treating thromboembolism Download PDFInfo
- Publication number
- ZA200503711B ZA200503711B ZA200503711A ZA200503711A ZA200503711B ZA 200503711 B ZA200503711 B ZA 200503711B ZA 200503711 A ZA200503711 A ZA 200503711A ZA 200503711 A ZA200503711 A ZA 200503711A ZA 200503711 B ZA200503711 B ZA 200503711B
- Authority
- ZA
- South Africa
- Prior art keywords
- melagatran
- thrombin inhibitor
- pharmaceutically
- nasal administration
- formulation
- Prior art date
Links
- DKWNMCUOEDMMIN-PKOBYXMFSA-N melagatran Chemical compound C1=CC(C(=N)N)=CC=C1CNC(=O)[C@H]1N(C(=O)[C@H](NCC(O)=O)C2CCCCC2)CC1 DKWNMCUOEDMMIN-PKOBYXMFSA-N 0.000 title claims description 51
- 229960002137 melagatran Drugs 0.000 title claims description 50
- 239000008194 pharmaceutical composition Substances 0.000 title claims description 25
- 229940122388 Thrombin inhibitor Drugs 0.000 title claims description 24
- 239000000203 mixture Substances 0.000 title claims description 24
- 239000003868 thrombin inhibitor Substances 0.000 title claims description 24
- 101000712605 Theromyzon tessulatum Theromin Proteins 0.000 title claims description 22
- 208000005189 Embolism Diseases 0.000 title claims description 11
- 208000001435 Thromboembolism Diseases 0.000 title claims description 11
- 238000004519 manufacturing process Methods 0.000 title claims description 7
- 238000009472 formulation Methods 0.000 title description 15
- 238000011282 treatment Methods 0.000 claims description 18
- 238000000034 method Methods 0.000 claims description 12
- 239000003814 drug Substances 0.000 claims description 9
- 239000003146 anticoagulant agent Substances 0.000 claims description 8
- 239000000126 substance Substances 0.000 claims description 7
- 230000002785 anti-thrombosis Effects 0.000 claims description 6
- 238000010521 absorption reaction Methods 0.000 description 18
- 206010061218 Inflammation Diseases 0.000 description 12
- 230000004054 inflammatory process Effects 0.000 description 12
- 239000003623 enhancer Substances 0.000 description 10
- 208000007536 Thrombosis Diseases 0.000 description 7
- 108090000190 Thrombin Proteins 0.000 description 6
- 150000001875 compounds Chemical class 0.000 description 6
- 239000003795 chemical substances by application Substances 0.000 description 5
- 239000004615 ingredient Substances 0.000 description 5
- 229960004072 thrombin Drugs 0.000 description 5
- 102000009123 Fibrin Human genes 0.000 description 4
- 108010073385 Fibrin Proteins 0.000 description 4
- BWGVNKXGVNDBDI-UHFFFAOYSA-N Fibrin monomer Chemical compound CNC(=O)CNC(=O)CN BWGVNKXGVNDBDI-UHFFFAOYSA-N 0.000 description 4
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 4
- 230000015271 coagulation Effects 0.000 description 4
- 238000005345 coagulation Methods 0.000 description 4
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- 229950003499 fibrin Drugs 0.000 description 4
- 230000005764 inhibitory process Effects 0.000 description 4
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- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 4
- 208000029523 Interstitial Lung disease Diseases 0.000 description 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- 210000004204 blood vessel Anatomy 0.000 description 3
- 230000002708 enhancing effect Effects 0.000 description 3
- 239000011521 glass Substances 0.000 description 3
- 210000002850 nasal mucosa Anatomy 0.000 description 3
- 210000001519 tissue Anatomy 0.000 description 3
- IADUEWIQBXOCDZ-UHFFFAOYSA-N (2S)-azetidine-2-carboxylic acid Natural products OC(=O)C1CCN1 IADUEWIQBXOCDZ-UHFFFAOYSA-N 0.000 description 2
- 206010001052 Acute respiratory distress syndrome Diseases 0.000 description 2
- 206010016654 Fibrosis Diseases 0.000 description 2
- 208000031071 Hamman-Rich Syndrome Diseases 0.000 description 2
- 201000009794 Idiopathic Pulmonary Fibrosis Diseases 0.000 description 2
- 208000013616 Respiratory Distress Syndrome Diseases 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 description 2
- 208000027418 Wounds and injury Diseases 0.000 description 2
- 239000013543 active substance Substances 0.000 description 2
- 201000004073 acute interstitial pneumonia Diseases 0.000 description 2
- 208000011341 adult acute respiratory distress syndrome Diseases 0.000 description 2
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- 239000007864 aqueous solution Substances 0.000 description 2
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- -1 but not limited to Substances 0.000 description 2
- 238000006243 chemical reaction Methods 0.000 description 2
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- 239000003112 inhibitor Substances 0.000 description 2
- 208000014674 injury Diseases 0.000 description 2
- 208000036971 interstitial lung disease 2 Diseases 0.000 description 2
- 230000000670 limiting effect Effects 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 210000003928 nasal cavity Anatomy 0.000 description 2
- 239000007922 nasal spray Substances 0.000 description 2
- 229940097496 nasal spray Drugs 0.000 description 2
- 201000004071 non-specific interstitial pneumonia Diseases 0.000 description 2
- 231100000252 nontoxic Toxicity 0.000 description 2
- 230000003000 nontoxic effect Effects 0.000 description 2
- 230000035699 permeability Effects 0.000 description 2
- 210000002381 plasma Anatomy 0.000 description 2
- 229920000642 polymer Polymers 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
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- 239000000651 prodrug Substances 0.000 description 2
- 229940002612 prodrug Drugs 0.000 description 2
- 238000011321 prophylaxis Methods 0.000 description 2
- 208000005069 pulmonary fibrosis Diseases 0.000 description 2
- 230000004044 response Effects 0.000 description 2
- 206010039073 rheumatoid arthritis Diseases 0.000 description 2
- 150000003839 salts Chemical class 0.000 description 2
- 239000007921 spray Substances 0.000 description 2
- 208000024891 symptom Diseases 0.000 description 2
- 230000009885 systemic effect Effects 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- 230000008719 thickening Effects 0.000 description 2
- WAMWSIDTKSNDCU-ZETCQYMHSA-N (2s)-2-azaniumyl-2-cyclohexylacetate Chemical compound OC(=O)[C@@H](N)C1CCCCC1 WAMWSIDTKSNDCU-ZETCQYMHSA-N 0.000 description 1
- IADUEWIQBXOCDZ-VKHMYHEASA-N (S)-azetidine-2-carboxylic acid Chemical group OC(=O)[C@@H]1CCN1 IADUEWIQBXOCDZ-VKHMYHEASA-N 0.000 description 1
- CHOGNBXWAZDZBM-UHFFFAOYSA-N 4-(aminomethyl)benzenecarboximidamide Chemical group NCC1=CC=C(C(N)=N)C=C1 CHOGNBXWAZDZBM-UHFFFAOYSA-N 0.000 description 1
- 208000035939 Alveolitis allergic Diseases 0.000 description 1
- 208000023275 Autoimmune disease Diseases 0.000 description 1
- 208000035143 Bacterial infection Diseases 0.000 description 1
- 102000008186 Collagen Human genes 0.000 description 1
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- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 description 1
- 206010014513 Embolism arterial Diseases 0.000 description 1
- 206010014522 Embolism venous Diseases 0.000 description 1
- 108010014172 Factor V Proteins 0.000 description 1
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- 108010049003 Fibrinogen Proteins 0.000 description 1
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- 108010094028 Prothrombin Proteins 0.000 description 1
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- 238000004458 analytical method Methods 0.000 description 1
- 230000010100 anticoagulation Effects 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
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- 239000002552 dosage form Substances 0.000 description 1
- 231100000673 dose–response relationship Toxicity 0.000 description 1
- 238000001647 drug administration Methods 0.000 description 1
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- 238000006911 enzymatic reaction Methods 0.000 description 1
- 201000001155 extrinsic allergic alveolitis Diseases 0.000 description 1
- 229960000301 factor viii Drugs 0.000 description 1
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- 230000003902 lesion Effects 0.000 description 1
- 210000000265 leukocyte Anatomy 0.000 description 1
- 150000002632 lipids Chemical class 0.000 description 1
- 238000004895 liquid chromatography mass spectrometry Methods 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 230000002503 metabolic effect Effects 0.000 description 1
- 150000007522 mineralic acids Chemical class 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 239000000178 monomer Substances 0.000 description 1
- 230000001338 necrotic effect Effects 0.000 description 1
- 231100000344 non-irritating Toxicity 0.000 description 1
- 150000007524 organic acids Chemical class 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- 238000007911 parenteral administration Methods 0.000 description 1
- 230000001575 pathological effect Effects 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 230000036470 plasma concentration Effects 0.000 description 1
- 230000010118 platelet activation Effects 0.000 description 1
- 230000008092 positive effect Effects 0.000 description 1
- 230000009024 positive feedback mechanism Effects 0.000 description 1
- 231100000683 possible toxicity Toxicity 0.000 description 1
- 230000003389 potentiating effect Effects 0.000 description 1
- 238000001556 precipitation Methods 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 108090000765 processed proteins & peptides Proteins 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 210000003456 pulmonary alveoli Anatomy 0.000 description 1
- 230000002685 pulmonary effect Effects 0.000 description 1
- 230000002441 reversible effect Effects 0.000 description 1
- 206010039083 rhinitis Diseases 0.000 description 1
- 201000000306 sarcoidosis Diseases 0.000 description 1
- 230000037390 scarring Effects 0.000 description 1
- 238000007391 self-medication Methods 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 239000012453 solvate Substances 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 238000010561 standard procedure Methods 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- 230000008961 swelling Effects 0.000 description 1
- 208000011580 syndromic disease Diseases 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 208000004043 venous thromboembolism Diseases 0.000 description 1
- 230000003612 virological effect Effects 0.000 description 1
- 229960001522 ximelagatran Drugs 0.000 description 1
- ZXIBCJHYVWYIKI-PZJWPPBQSA-N ximelagatran Chemical compound C1([C@@H](NCC(=O)OCC)C(=O)N2[C@@H](CC2)C(=O)NCC=2C=CC(=CC=2)C(\N)=N\O)CCCCC1 ZXIBCJHYVWYIKI-PZJWPPBQSA-N 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/55—Protease inhibitors
-
- 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
- A61K9/0043—Nose
-
- 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
- A61K31/13—Amines
- A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
-
- 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
- A61K31/397—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having four-membered rings, e.g. azetidine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/05—Dipeptides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
-
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
-
- 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
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Otolaryngology (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Hematology (AREA)
- Diabetes (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| SE0203349A SE0203349D0 (sv) | 2002-11-12 | 2002-11-12 | New use |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ZA200503711B true ZA200503711B (en) | 2006-11-29 |
Family
ID=20289548
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ZA200503711A ZA200503711B (en) | 2002-11-12 | 2005-05-09 | An aqueous pharmaceutical formulation comprising the thrombin inhibitor melagatran and use of the formulation in the manufacture for use by nasal administration in treating thromboembolism |
Country Status (13)
| Country | Link |
|---|---|
| US (1) | US20060014699A1 (ko) |
| EP (1) | EP1581255A1 (ko) |
| JP (1) | JP2006507323A (ko) |
| KR (1) | KR20050074598A (ko) |
| CN (1) | CN1711104A (ko) |
| AU (1) | AU2003276801A1 (ko) |
| BR (1) | BR0316123A (ko) |
| CA (1) | CA2504480A1 (ko) |
| MX (1) | MXPA05005118A (ko) |
| NO (1) | NO20052313L (ko) |
| SE (1) | SE0203349D0 (ko) |
| WO (1) | WO2004043486A1 (ko) |
| ZA (1) | ZA200503711B (ko) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2005065185A2 (en) * | 2003-12-24 | 2005-07-21 | Collegium Pharmaceuticals, Inc. | Temperature-stable formulations, and methods of development thereof |
| US7345093B2 (en) * | 2004-04-27 | 2008-03-18 | Formatech, Inc. | Methods of enhancing solubility of compounds |
| EP2480208A1 (en) | 2009-09-23 | 2012-08-01 | Indu Javeri | Methods for the preparation of liposomes |
| US20110070294A1 (en) * | 2009-09-23 | 2011-03-24 | Javeri Indu | Methods for the Administration of Drugs Using Liposomes |
| US10143652B2 (en) | 2009-09-23 | 2018-12-04 | Curirx Inc. | Methods for the preparation of liposomes |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6984627B1 (en) * | 1993-06-03 | 2006-01-10 | Astrazeneca Ab | Peptide derivatives |
| SE9404196D0 (sv) * | 1994-12-02 | 1994-12-02 | Astra Ab | New antithrombotic formulation |
| SE9602145D0 (sv) * | 1996-05-31 | 1996-05-31 | Astra Ab | New improved formulation for treatment of thromboembolism |
| SE9900070D0 (sv) * | 1999-01-13 | 1999-01-13 | Astra Ab | New use |
| AR023510A1 (es) * | 1999-04-21 | 2002-09-04 | Astrazeneca Ab | Un equipo de partes, formulacion farmaceutica y uso de un inhibidor de trombina. |
| GB0014134D0 (en) * | 2000-06-10 | 2000-08-02 | Astrazeneca Ab | Combination therapy |
-
2002
- 2002-11-12 SE SE0203349A patent/SE0203349D0/xx unknown
-
2003
- 2003-11-11 BR BR0316123-4A patent/BR0316123A/pt not_active IP Right Cessation
- 2003-11-11 MX MXPA05005118A patent/MXPA05005118A/es unknown
- 2003-11-11 EP EP03811169A patent/EP1581255A1/en not_active Withdrawn
- 2003-11-11 US US10/533,869 patent/US20060014699A1/en not_active Abandoned
- 2003-11-11 JP JP2004551332A patent/JP2006507323A/ja active Pending
- 2003-11-11 CN CNA2003801030983A patent/CN1711104A/zh active Pending
- 2003-11-11 AU AU2003276801A patent/AU2003276801A1/en not_active Abandoned
- 2003-11-11 KR KR1020057008436A patent/KR20050074598A/ko not_active Application Discontinuation
- 2003-11-11 WO PCT/SE2003/001738 patent/WO2004043486A1/en not_active Application Discontinuation
- 2003-11-11 CA CA002504480A patent/CA2504480A1/en not_active Abandoned
-
2005
- 2005-05-09 ZA ZA200503711A patent/ZA200503711B/en unknown
- 2005-05-11 NO NO20052313A patent/NO20052313L/no not_active Application Discontinuation
Also Published As
| Publication number | Publication date |
|---|---|
| CA2504480A1 (en) | 2004-05-27 |
| SE0203349D0 (sv) | 2002-11-12 |
| AU2003276801A1 (en) | 2004-06-03 |
| CN1711104A (zh) | 2005-12-21 |
| NO20052313L (no) | 2005-06-06 |
| WO2004043486A1 (en) | 2004-05-27 |
| KR20050074598A (ko) | 2005-07-18 |
| MXPA05005118A (es) | 2005-07-01 |
| WO2004043486A8 (en) | 2005-03-17 |
| JP2006507323A (ja) | 2006-03-02 |
| US20060014699A1 (en) | 2006-01-19 |
| BR0316123A (pt) | 2005-09-27 |
| EP1581255A1 (en) | 2005-10-05 |
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