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WO2004022032A3 - Pharmaceutical dosage form comprising a sulfite compound - Google Patents

Pharmaceutical dosage form comprising a sulfite compound Download PDF

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Publication number
WO2004022032A3
WO2004022032A3 PCT/US2003/024044 US0324044W WO2004022032A3 WO 2004022032 A3 WO2004022032 A3 WO 2004022032A3 US 0324044 W US0324044 W US 0324044W WO 2004022032 A3 WO2004022032 A3 WO 2004022032A3
Authority
WO
WIPO (PCT)
Prior art keywords
dosage form
pharmaceutical dosage
sulfite compound
fill material
gelatin capsule
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
Application number
PCT/US2003/024044
Other languages
French (fr)
Other versions
WO2004022032A2 (en
Inventor
Ping Gao
Juliane M Bauer
Gary Ewing
David Sperry
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Pharmacia LLC
Original Assignee
Pharmacia LLC
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Pharmacia LLC filed Critical Pharmacia LLC
Priority to JP2004534259A priority Critical patent/JP2006500389A/en
Priority to BR0313064-9A priority patent/BR0313064A/en
Priority to AU2003257102A priority patent/AU2003257102A1/en
Priority to CA002493974A priority patent/CA2493974A1/en
Priority to EP03794452A priority patent/EP1526847A2/en
Priority to MXPA05001272A priority patent/MXPA05001272A/en
Publication of WO2004022032A2 publication Critical patent/WO2004022032A2/en
Publication of WO2004022032A3 publication Critical patent/WO2004022032A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/485—Inorganic compounds
    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/63—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide
    • A61K31/635—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide having a heterocyclic ring, e.g. sulfadiazine
    • 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
    • A61K9/4816—Wall or shell material
    • A61K9/4825—Proteins, e.g. gelatin
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
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    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
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    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
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    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P25/00—Drugs for disorders of the nervous system
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    • A61P25/32—Alcohol-abuse
    • 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
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/18—Antivirals for RNA viruses for HIV
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P33/00—Antiparasitic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/14—Drugs for disorders of the endocrine system of the thyroid hormones, e.g. T3, T4
    • 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
    • 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
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurology (AREA)
  • Dermatology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Epidemiology (AREA)
  • Endocrinology (AREA)
  • Diabetes (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Pulmonology (AREA)
  • Pain & Pain Management (AREA)
  • Virology (AREA)
  • Psychiatry (AREA)
  • Reproductive Health (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Rheumatology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Addiction (AREA)
  • Hematology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Hospice & Palliative Care (AREA)
  • Obesity (AREA)

Abstract

The present invention provides a pharmaceutical dosage form comprising a fill material sealed in a gelatin capsule; the fill material comprises (a) a selective COX-2 inhibitory drug of low water solubility, and (b) a sulfite compound in an amount sufficient to inhibit cross-linking of gelatin in said gelatin capsule upon storage of the dosage form in a closed container maintained at 40°C and 75% relative humidity for a period of 6 months.
PCT/US2003/024044 2002-07-31 2003-07-31 Pharmaceutical dosage form comprising a sulfite compound Ceased WO2004022032A2 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
JP2004534259A JP2006500389A (en) 2002-07-31 2003-07-31 Pharmaceutical dosage forms containing sulfite compounds
BR0313064-9A BR0313064A (en) 2002-07-31 2003-07-31 Pharmaceutical dosage form comprising a sulfite compound
AU2003257102A AU2003257102A1 (en) 2002-07-31 2003-07-31 Pharmaceutical dosage form comprising a sulfite compound
CA002493974A CA2493974A1 (en) 2002-07-31 2003-07-31 Pharmaceutical dosage form comprising a sulfite compound
EP03794452A EP1526847A2 (en) 2002-07-31 2003-07-31 Pharmaceutical dosage form comprising a sulfite compound
MXPA05001272A MXPA05001272A (en) 2002-07-31 2003-07-31 Pharmaceutical dosage form comprising a sulfite compound.

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US39980802P 2002-07-31 2002-07-31
US39986202P 2002-07-31 2002-07-31
US39977602P 2002-07-31 2002-07-31
US39986302P 2002-07-31 2002-07-31
US60/399,776 2002-07-31
US60/399,863 2002-07-31
US60/399,808 2002-07-31
US60/399,862 2002-07-31

Publications (2)

Publication Number Publication Date
WO2004022032A2 WO2004022032A2 (en) 2004-03-18
WO2004022032A3 true WO2004022032A3 (en) 2004-08-12

Family

ID=31192378

Family Applications (4)

Application Number Title Priority Date Filing Date
PCT/US2003/024042 Ceased WO2004010972A2 (en) 2002-07-31 2003-07-31 Pellicle-resistant gelatin capsule
PCT/US2003/024044 Ceased WO2004022032A2 (en) 2002-07-31 2003-07-31 Pharmaceutical dosage form comprising a sulfite compound
PCT/US2003/024045 Ceased WO2004010974A2 (en) 2002-07-31 2003-07-31 Gelatin capsule exhibiting reduced cross-linking
PCT/US2003/024043 Ceased WO2004010973A2 (en) 2002-07-31 2003-07-31 Pharmaceutical dosage form capable of maintaining stable dissolution profile upon storage

Family Applications Before (1)

Application Number Title Priority Date Filing Date
PCT/US2003/024042 Ceased WO2004010972A2 (en) 2002-07-31 2003-07-31 Pellicle-resistant gelatin capsule

Family Applications After (2)

Application Number Title Priority Date Filing Date
PCT/US2003/024045 Ceased WO2004010974A2 (en) 2002-07-31 2003-07-31 Gelatin capsule exhibiting reduced cross-linking
PCT/US2003/024043 Ceased WO2004010973A2 (en) 2002-07-31 2003-07-31 Pharmaceutical dosage form capable of maintaining stable dissolution profile upon storage

Country Status (7)

Country Link
EP (4) EP1526845A2 (en)
JP (4) JP2006500389A (en)
AU (4) AU2003257103A1 (en)
BR (4) BR0313064A (en)
CA (4) CA2494358A1 (en)
MX (4) MXPA05001272A (en)
WO (4) WO2004010972A2 (en)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8895059B2 (en) 2002-06-05 2014-11-25 Ivax Pharmaceuticals S.R.O. Reduction of cross-linking gelatin in gelatin capsules
KR101364762B1 (en) 2005-02-17 2014-02-17 신타 파마슈티칼스 코프. Compounds for the treatment of proliferative disorders
US7485323B2 (en) 2005-05-31 2009-02-03 Gelita Ag Process for making a low molecular weight gelatine hydrolysate and gelatine hydrolysate compositions
PT1906938E (en) * 2005-07-26 2011-01-17 Nicox Sa Pharmaceutical formulation of nitrooxyderivatives of nsaids
JP5503939B2 (en) * 2009-10-16 2014-05-28 東洋カプセル株式会社 Azelastine hydrochloride-containing capsule
JP6887456B2 (en) 2018-07-04 2021-06-16 キャプシュゲル・ベルジウム・エヌ・ヴィ A film-forming composition containing a surfactant or a surfactant and a salt as a whitening agent.
US11364478B2 (en) * 2019-05-22 2022-06-21 Mezzimatic, LLC Method of manufacturing throwable paintballs and paintballs made therefrom
AR124178A1 (en) * 2020-12-01 2023-02-22 Lg Chemical Ltd COMPOSITE FORMULATION FOR ORAL ADMINISTRATION COMPRISING 1-(3-CYANO-1-ISOPROPYL-INDOL-5-IL)PYRAZOLE-4-CARBOXYLIC ACID AND A PROCESS FOR ITS PREPARATION
CN113230241A (en) * 2021-06-11 2021-08-10 北京畅盛医药科技有限公司 Application of tris (hydroxymethyl) aminomethane salt in medicine for treating cardiovascular and cerebrovascular diseases

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2204401A1 (en) * 1972-11-01 1974-05-24 Meiji Seika Co
US4590183A (en) * 1985-04-22 1986-05-20 Sterling Drug Inc. Gastric cytoprotection with sodium thiosulfate in oral administration of aspirin
EP0672414A2 (en) * 1994-03-15 1995-09-20 Senju Pharmaceutical Co., Ltd. Method for stabilizing pranoprofen and stable liquid preparation of pranoprofen
EP0695544A1 (en) * 1994-08-05 1996-02-07 Shionogi & Co., Ltd. Hard gelatin capsules resistant to denaturation and the production thereof

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4349529A (en) * 1980-04-14 1982-09-14 E. R. Squibb & Sons, Inc. Diagnostic and therapeutic capsules and method of producing
FR2617047B1 (en) * 1987-06-23 1991-05-10 Sanofi Sa TANNING RESISTANT GELATIN COMPOSITION, CAPSULES BASED ON THIS COMPOSITION AND THEIR PHARMACEUTICAL APPLICATION, IN PARTICULAR TO FENOFIBRATE
JP2790659B2 (en) * 1989-06-30 1998-08-27 帝国臓器製薬株式会社 Gelatin capsule
IT1269583B (en) * 1994-04-26 1997-04-08 Bayer Italia Spa PHARMACEUTICAL PREPARATIONS BASED ON A SOLUTION OF KETOPROFENE IN SOFT GELATINE CAPSULES AND METHOD FOR THEIR PRODUCTION
US5620704A (en) * 1994-11-07 1997-04-15 Warner-Lambert Company Process for stabilizing gelatin products
US7115565B2 (en) * 2001-01-18 2006-10-03 Pharmacia & Upjohn Company Chemotherapeutic microemulsion compositions of paclitaxel with improved oral bioavailability

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2204401A1 (en) * 1972-11-01 1974-05-24 Meiji Seika Co
US4590183A (en) * 1985-04-22 1986-05-20 Sterling Drug Inc. Gastric cytoprotection with sodium thiosulfate in oral administration of aspirin
EP0672414A2 (en) * 1994-03-15 1995-09-20 Senju Pharmaceutical Co., Ltd. Method for stabilizing pranoprofen and stable liquid preparation of pranoprofen
EP0695544A1 (en) * 1994-08-05 1996-02-07 Shionogi & Co., Ltd. Hard gelatin capsules resistant to denaturation and the production thereof

Also Published As

Publication number Publication date
AU2003257981A8 (en) 2004-02-16
AU2003257982A8 (en) 2004-02-16
AU2003257981A1 (en) 2004-02-16
BR0313149A (en) 2005-06-28
JP2005538994A (en) 2005-12-22
BR0313150A (en) 2005-06-28
CA2494358A1 (en) 2004-02-05
WO2004010974A3 (en) 2004-08-05
EP1526847A2 (en) 2005-05-04
AU2003257102A8 (en) 2004-03-29
EP1526846A2 (en) 2005-05-04
WO2004010974A2 (en) 2004-02-05
CA2494069A1 (en) 2004-02-05
MXPA05000862A (en) 2005-04-19
AU2003257103A8 (en) 2004-02-16
MXPA05001166A (en) 2005-05-16
JP2006500389A (en) 2006-01-05
EP1526844A2 (en) 2005-05-04
MXPA05001272A (en) 2005-04-28
JP2005538102A (en) 2005-12-15
WO2004010973A2 (en) 2004-02-05
BR0312875A (en) 2005-06-28
AU2003257982A1 (en) 2004-02-16
WO2004010972A2 (en) 2004-02-05
AU2003257102A1 (en) 2004-03-29
MXPA05001167A (en) 2005-05-16
JP2005538993A (en) 2005-12-22
CA2493980A1 (en) 2004-02-05
AU2003257103A1 (en) 2004-02-16
EP1526845A2 (en) 2005-05-04
CA2493974A1 (en) 2004-03-18
WO2004022032A2 (en) 2004-03-18
BR0313064A (en) 2005-06-28
WO2004010972A3 (en) 2004-07-29
WO2004010973A3 (en) 2004-08-05

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