ES2190692A1 - Formulacion farmaceutica de amoxicilina y clavulanato de potasio. - Google Patents

Formulacion farmaceutica de amoxicilina y clavulanato de potasio.

Info

Publication number
ES2190692A1
ES2190692A1 ES200000935A ES200000935A ES2190692A1 ES 2190692 A1 ES2190692 A1 ES 2190692A1 ES 200000935 A ES200000935 A ES 200000935A ES 200000935 A ES200000935 A ES 200000935A ES 2190692 A1 ES2190692 A1 ES 2190692A1
Authority
ES
Spain
Prior art keywords
potassium clavulanate
amoxicillin
pharmaceutical formulation
release
amoxycline
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.)
Granted
Application number
ES200000935A
Other languages
English (en)
Other versions
ES2190692B1 (es
Inventor
Kevin Storm
Creighton Conley
John Roush
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.)
Beecham Pharmaceuticals Pte Ltd
Original Assignee
Beecham Pharmaceuticals Pte Ltd
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=27383840&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ES2190692(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Beecham Pharmaceuticals Pte Ltd filed Critical Beecham Pharmaceuticals Pte Ltd
Publication of ES2190692A1 publication Critical patent/ES2190692A1/es
Application granted granted Critical
Publication of ES2190692B1 publication Critical patent/ES2190692B1/es
Anticipated expiration legal-status Critical
Withdrawn - After Issue legal-status Critical Current

Links

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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425—Thiazoles
    • A61K31/429—Thiazoles condensed with heterocyclic ring systems
    • A61K31/43—Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula, e.g. penicillins, penems
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/42—Oxazoles
    • A61K31/424—Oxazoles condensed with heterocyclic ring systems, e.g. clavulanic acid
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • 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
    • A61P31/02—Local antiseptics
    • 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
    • A61P31/04—Antibacterial agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Crystals, And After-Treatments Of Crystals (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Formulación farmacéutica de amoxicilina y clavulanato de potasio. La formulación es de liberación modificada y sus ingredientes activos, la amoxicilina y el clavulanato de potasio, están presentes en una relación de 12:1 a 20:1, formulándose todo el clavulanato de potasio y una primera parte de la amoxicilina con excipientes farmacéuticamente aceptables que permiten la liberación inmediata del clavulanato de potasio y la primera parte de la amoxicilina para formar una fase de liberación inmediata, y formulándose una segunda parte de la amoxicilina con excipientes farmacéuticamente aceptables que permiten la liberación lenta de esta segunda parte para formar una fase de liberación lenta. La formulación se presenta preferiblemente como un comprimido de dos capas y es aplicable al tratamiento de infecciones bacterianas.
ES200000935A 1999-04-13 2000-04-11 Formulacion farmaceutica de amoxicilina y clavulanato de potasio. Withdrawn - After Issue ES2190692B1 (es)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US12907499P 1999-04-13 1999-04-13
US60/129074 1999-04-13
US15072799P 1999-08-25 1999-08-25
US60/150727 1999-08-25
US15981399P 1999-10-15 1999-10-15
US60/159813 1999-10-15

Publications (2)

Publication Number Publication Date
ES2190692A1 true ES2190692A1 (es) 2003-08-01
ES2190692B1 ES2190692B1 (es) 2004-11-16

Family

ID=27383840

Family Applications (2)

Application Number Title Priority Date Filing Date
ES00303033T Expired - Lifetime ES2202004T3 (es) 1999-04-13 2000-04-11 Novedoso procedimiento de tratamiento usando un fuerte regimen de dosificacion de amoxicilina y clavulanato potasico.
ES200000935A Withdrawn - After Issue ES2190692B1 (es) 1999-04-13 2000-04-11 Formulacion farmaceutica de amoxicilina y clavulanato de potasio.

Family Applications Before (1)

Application Number Title Priority Date Filing Date
ES00303033T Expired - Lifetime ES2202004T3 (es) 1999-04-13 2000-04-11 Novedoso procedimiento de tratamiento usando un fuerte regimen de dosificacion de amoxicilina y clavulanato potasico.

Country Status (44)

Country Link
EP (4) EP1269996A1 (es)
JP (2) JP4880125B2 (es)
KR (1) KR100634937B1 (es)
CN (1) CN100382782C (es)
AP (1) AP1806A (es)
AR (1) AR031068A1 (es)
AT (2) ATE242629T1 (es)
AU (1) AU767177B2 (es)
BE (2) BE1013309A5 (es)
BG (1) BG65006B1 (es)
BR (1) BRPI0009719B8 (es)
CA (1) CA2366304C (es)
CO (1) CO5170471A1 (es)
CZ (1) CZ298801B6 (es)
DE (3) DE10017883A1 (es)
DK (3) DK200000133U3 (es)
DZ (1) DZ3150A1 (es)
EA (1) EA004310B1 (es)
ES (2) ES2202004T3 (es)
FI (2) FI20000863A7 (es)
FR (1) FR2792198A1 (es)
GB (1) GB2351661B (es)
GR (1) GR1003560B (es)
HU (1) HU229097B1 (es)
IE (1) IE20000271A1 (es)
IL (2) IL145580A0 (es)
IT (1) ITMI20000788A1 (es)
MA (1) MA25352A1 (es)
MX (1) MXPA01010377A (es)
MY (1) MY119953A (es)
NL (2) NL1014914C1 (es)
NO (1) NO329694B1 (es)
NZ (1) NZ514575A (es)
OA (1) OA11926A (es)
PE (1) PE20010053A1 (es)
PL (1) PL197448B1 (es)
PT (2) PT1044680E (es)
RO (1) RO120817B1 (es)
SE (1) SE0001330L (es)
SI (2) SI1044680T1 (es)
SK (1) SK285140B6 (es)
TR (1) TR200102963T2 (es)
TW (1) TWI235067B (es)
WO (1) WO2000061116A2 (es)

Families Citing this family (35)

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GB9407386D0 (en) 1994-04-14 1994-06-08 Smithkline Beecham Plc Pharmaceutical formulation
GB9408117D0 (en) * 1994-04-23 1994-06-15 Smithkline Beecham Corp Pharmaceutical formulations
AR004510A1 (es) * 1995-09-07 1998-12-16 Smithkline Beecham Plc Composiciones que comprenden amoxicilina y clavulanato, procedimientos para su preparacion y el uso de las composiciones para la fabricacion de unmedicamento
SE9802973D0 (sv) 1998-09-03 1998-09-03 Astra Ab Immediate release tablet
US6294199B1 (en) 1999-04-13 2001-09-25 Beecham Pharmaceuticals (Pte) Limited Method of treating a bacterial infection comprising administering amoxycillin
US6878386B1 (en) 1999-04-13 2005-04-12 Beecham Pharmaceuticals (Pte) Limited Method of treating a bacterial infection comprising amoxycillin and potassium clavulanate
US7250176B1 (en) 1999-04-13 2007-07-31 Beecham Pharmaceuticals (Pte) Limited Method of treating a bacterial infection
US6565882B2 (en) 2000-02-24 2003-05-20 Advancis Pharmaceutical Corp Antibiotic composition with inhibitor
US6544555B2 (en) 2000-02-24 2003-04-08 Advancis Pharmaceutical Corp. Antibiotic product, use and formulation thereof
US6756057B2 (en) 2000-10-12 2004-06-29 Beecham Pharmaceuticals (Pte) Limited Amoxicillin and potassium clavulanate dosage form
WO2002030392A2 (en) * 2000-10-12 2002-04-18 Beecham Pharmaceuticals (Pte) Limited Formulation containing amoxicillin
US6541014B2 (en) 2000-10-13 2003-04-01 Advancis Pharmaceutical Corp. Antiviral product, use and formulation thereof
US20020068078A1 (en) 2000-10-13 2002-06-06 Rudnic Edward M. Antifungal product, use and formulation thereof
US20030035839A1 (en) * 2001-05-15 2003-02-20 Peirce Management, Llc Pharmaceutical composition for both intraoral and oral administration
JP2005515966A (ja) 2001-07-06 2005-06-02 エンドー ファーマシューティカルズ， インコーポレイティド 鎮痛薬としての使用のための６−ヒドロキシ−オキシモルホンの経口投与
GB0117618D0 (en) * 2001-07-19 2001-09-12 Phoqus Ltd Pharmaceutical dosage form
US6863901B2 (en) 2001-11-30 2005-03-08 Collegium Pharmaceutical, Inc. Pharmaceutical composition for compressed annular tablet with molded triturate tablet for both intraoral and oral administration
US6827946B2 (en) 2001-12-05 2004-12-07 Collegium Pharmaceutical, Inc. Compositions containing both sedative and non-sedative antihistamines
EP1492511B3 (fr) 2002-04-09 2012-05-02 Flamel Technologies Formulation pharmaceutique orale sous forme de suspension aqueuse de microcapsules permettant la liberation modifiee de principe(s) actif(s)
JP2005528383A (ja) * 2002-04-10 2005-09-22 ミラー，フレッド，エイチ． 多重相・複数コンパートメントカプセルシステム
US20050042289A1 (en) * 2003-04-29 2005-02-24 Yamanouchi Pharma Technologies, Inc. Tablets and methods for modified release of hydrophylic and other active agents
US8062672B2 (en) 2003-08-12 2011-11-22 Shionogi Inc. Antibiotic product, use and formulation thereof
EP1541129A1 (en) * 2003-12-12 2005-06-15 Cimex AG Pharmaceutical effervescent formulation comprising amoxycillin and clavulanic acid
WO2005079752A2 (en) * 2004-02-11 2005-09-01 Rubicon Research Private Limited Controlled release pharmaceutical compositions with improved bioavailability
WO2005099672A1 (en) * 2004-04-13 2005-10-27 Ranbaxy Laboratories Limited A modified release pharmaceutical formulation comprising amoxicillin and clavulanate
EP1880716A1 (en) * 2006-07-19 2008-01-23 Sandoz AG Kit of parts comprising an acid labile and an acid resistant pharmaceutically active ingredient
CN101578096A (zh) * 2006-10-10 2009-11-11 潘威斯脱药物公司 稳健的缓释制剂
TR200909787A2 (tr) 2009-12-25 2011-07-21 Bi̇lgi̇ç Mahmut Üçüncü kuşak bir sefalosporin ve klavulanik asit içeren farmasötik formülasyonlar.
TR201000686A1 (tr) 2010-01-29 2011-08-22 B�Lg�� Mahmut Bakteriyel enfeksiyonların tedavisinde suda çözünebilir sefdinir ve klavulanik asit formülasyonları.@
TR201000687A1 (tr) 2010-01-29 2011-08-22 Bi̇lgi̇ç Mahmut Aktif madde olarak sefiksim ve klavulanik asit içeren efervesan formülasyonlar
TR201000688A2 (tr) 2010-01-29 2011-08-22 B�Lg�� Mahmut Aktif madde olarak sefaklor ve klavulanik asit içeren efervesan formülasyonlar.
US11154495B2 (en) * 2015-04-07 2021-10-26 Church & Dwight Co., Inc. Multicomponent gummy compositions with soft core
CN109394718B (zh) * 2018-11-15 2021-04-27 石药集团中诺药业（石家庄）有限公司 一种阿莫西林分散片及其制备方法
CN110051637A (zh) * 2019-05-21 2019-07-26 葵花药业集团北京药物研究院有限公司 阿莫西林克拉维酸钾制剂及其制备方法
US20250312324A1 (en) * 2022-04-29 2025-10-09 Overseas Pharmaceuticals, Ltd. Prolonged-release oral solid formulation of pirfenidone

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WO1995020946A1 (en) * 1994-02-04 1995-08-10 Smithkline Beecham Plc Bilayered amoxycillin tablets
WO1995028148A1 (en) * 1994-04-14 1995-10-26 Smithkline Beecham Plc Pharmaceutical formulation
WO1996004908A1 (en) * 1994-08-17 1996-02-22 Smithkline Beecham Plc Pharmaceutical formulation containing amoxycillin and potassium clavulanate

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IT1255522B (it) * 1992-09-24 1995-11-09 Ubaldo Conte Compressa per impiego terapeutico atta a cedere una o piu' sostanze attive con differenti velocita'
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WO1995020946A1 (en) * 1994-02-04 1995-08-10 Smithkline Beecham Plc Bilayered amoxycillin tablets
WO1995028148A1 (en) * 1994-04-14 1995-10-26 Smithkline Beecham Plc Pharmaceutical formulation
WO1996004908A1 (en) * 1994-08-17 1996-02-22 Smithkline Beecham Plc Pharmaceutical formulation containing amoxycillin and potassium clavulanate

Also Published As

Publication number Publication date
AU767177B2 (en) 2003-11-06
CO5170471A1 (es) 2002-06-27
PL339591A1 (en) 2000-10-23
WO2000061116A3 (en) 2001-02-01
GB2351661A (en) 2001-01-10
PT1044680E (pt) 2003-10-31
CN1382040A (zh) 2002-11-27
SI1044680T1 (en) 2003-12-31
BRPI0009719B8 (pt) 2021-05-25
NL1014915C2 (nl) 2001-02-12
BR0009719B1 (pt) 2014-09-30
EP1270005A3 (en) 2006-05-17
ITMI20000788A1 (it) 2001-10-11
HUP0001471A2 (en) 2001-03-28
IL145580A0 (en) 2002-11-10
FI20000863L (fi) 2000-10-13
SK5342000A3 (en) 2000-11-07
ES2202004T3 (es) 2004-04-01
HU0001471D0 (en) 2000-06-28
EA200101075A1 (ru) 2002-04-25
KR20020015312A (ko) 2002-02-27
EP1044680B1 (en) 2003-06-11
DE20006626U1 (de) 2000-10-19
AR031068A1 (es) 2003-09-10
ITMI20000788A0 (it) 2000-04-11
FI20000863A7 (fi) 2000-10-13
CZ298801B6 (cs) 2008-02-06
FI4823U1 (fi) 2001-02-16
DE10017883A1 (de) 2000-10-26
EP1044680A1 (en) 2000-10-18
EP1269997A1 (en) 2003-01-02
BG65006B1 (bg) 2006-12-29
NZ514575A (en) 2004-05-28
TWI235067B (en) 2005-07-01
PT102450A (pt) 2001-02-01
FI20000863A0 (fi) 2000-04-11
NO329694B1 (no) 2010-12-06
FR2792198A1 (fr) 2000-10-20
SE0001330L (sv) 2000-10-14
MY119953A (en) 2005-08-30
HUP0001471A3 (en) 2001-10-29
AP2001002284A0 (en) 2001-12-31
AP1806A (en) 2007-12-14
RO120817B1 (ro) 2006-08-30
PE20010053A1 (es) 2001-03-10
JP2011256180A (ja) 2011-12-22
PL197448B1 (pl) 2008-03-31
SK285140B6 (sk) 2006-07-07
AU5702000A (en) 2000-11-14
IE20000271A1 (en) 2001-04-04
DZ3150A1 (fr) 2000-10-19
NL1014915A1 (nl) 2000-10-16
DK1044680T3 (da) 2003-09-29
KR100634937B1 (ko) 2006-10-17
DK200000133U3 (da) 2000-07-28
AT4327U1 (de) 2001-06-25
MA25352A1 (fr) 2001-12-31
ES2190692B1 (es) 2004-11-16
WO2000061116A2 (en) 2000-10-19
MXPA01010377A (es) 2002-10-23
HK1032741A1 (en) 2001-08-03
OA11926A (en) 2006-04-12
SE0001330D0 (sv) 2000-04-11
EP1269996A1 (en) 2003-01-02
HU229097B1 (en) 2013-07-29
NO20001870L (no) 2000-10-16
BE1013309A5 (fr) 2001-11-06
CN100382782C (zh) 2008-04-23
GR1003560B (el) 2001-03-16
FIU20000164U0 (fi) 2000-04-11
SI20304A (sl) 2001-02-28
BR0009719A (pt) 2002-01-08
NO20001870D0 (no) 2000-04-11
PT102450B (pt) 2003-09-30
DE60003255D1 (de) 2003-07-17
DE60003255T2 (de) 2004-05-06
GB2351661B (en) 2001-10-10
ATE242629T1 (de) 2003-06-15
DK200000602A (da) 2000-10-14
CA2366304A1 (en) 2000-10-19
NL1014914C1 (nl) 2000-10-16
JP4880125B2 (ja) 2012-02-22
EP1270005A2 (en) 2003-01-02
CZ20001311A3 (cs) 2000-11-15
BE1012733A6 (fr) 2001-02-06
BG104329A (en) 2001-11-30
CA2366304C (en) 2004-06-29
GB0008923D0 (en) 2000-05-31
IL145580A (en) 2007-05-15
EA004310B1 (ru) 2004-02-26
JP2002541187A (ja) 2002-12-03
TR200102963T2 (tr) 2002-02-21

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