FI118754B - Farmaceutiskt hjälpämne med förbättrad sammanpressbarhet - Google Patents
Farmaceutiskt hjälpämne med förbättrad sammanpressbarhet Download PDFInfo
- Publication number
- FI118754B FI118754B FI963497A FI963497A FI118754B FI 118754 B FI118754 B FI 118754B FI 963497 A FI963497 A FI 963497A FI 963497 A FI963497 A FI 963497A FI 118754 B FI118754 B FI 118754B
- Authority
- FI
- Finland
- Prior art keywords
- microcrystalline cellulose
- silica
- excipient
- solid dosage
- weight
- Prior art date
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Classifications
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- 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
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- 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
- A61K9/2009—Inorganic compounds
-
- 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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- 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
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
- A61K9/2036—Silicones; Polysiloxanes
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- 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
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S977/00—Nanotechnology
- Y10S977/70—Nanostructure
- Y10S977/724—Devices having flexible or movable element
- Y10S977/727—Devices having flexible or movable element formed from biological material
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S977/00—Nanotechnology
- Y10S977/70—Nanostructure
- Y10S977/773—Nanoparticle, i.e. structure having three dimensions of 100 nm or less
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S977/00—Nanotechnology
- Y10S977/70—Nanostructure
- Y10S977/773—Nanoparticle, i.e. structure having three dimensions of 100 nm or less
- Y10S977/775—Nanosized powder or flake, e.g. nanosized catalyst
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S977/00—Nanotechnology
- Y10S977/70—Nanostructure
- Y10S977/788—Of specified organic or carbon-based composition
- Y10S977/797—Lipid particle
- Y10S977/798—Lipid particle having internalized material
- Y10S977/799—Containing biological material
- Y10S977/801—Drug
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S977/00—Nanotechnology
- Y10S977/84—Manufacture, treatment, or detection of nanostructure
- Y10S977/89—Deposition of materials, e.g. coating, cvd, or ald
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S977/00—Nanotechnology
- Y10S977/84—Manufacture, treatment, or detection of nanostructure
- Y10S977/895—Manufacture, treatment, or detection of nanostructure having step or means utilizing chemical property
- Y10S977/896—Chemical synthesis, e.g. chemical bonding or breaking
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S977/00—Nanotechnology
- Y10S977/902—Specified use of nanostructure
- Y10S977/904—Specified use of nanostructure for medical, immunological, body treatment, or diagnosis
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S977/00—Nanotechnology
- Y10S977/902—Specified use of nanostructure
- Y10S977/904—Specified use of nanostructure for medical, immunological, body treatment, or diagnosis
- Y10S977/906—Drug delivery
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S977/00—Nanotechnology
- Y10S977/902—Specified use of nanostructure
- Y10S977/904—Specified use of nanostructure for medical, immunological, body treatment, or diagnosis
- Y10S977/915—Therapeutic or pharmaceutical composition
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/29—Coated or structually defined flake, particle, cell, strand, strand portion, rod, filament, macroscopic fiber or mass thereof
- Y10T428/2982—Particulate matter [e.g., sphere, flake, etc.]
Claims (14)
1. Fyllnadsäirmessammansättning, som innefattar ingen terapeutiskt aktiv ämnesdel, kännetecknad därav, att den innefattar ett partikelformigt aggregat av 5 mikrokristallin cellulosa och frän 0,1-20 vikt-% processerad kiseldioxid som behandlats tillsammans med denna, varvid den mikrokristallina cellulosan och kiseldioxiden är i närä anslutning till varandra, och kiseldioxiden är integrerad i den mikrokristallina cellulosan eller har delvis belagt den mikrokristallina cellulosan, varvid nämnda kiseldioxiddel av nämnda aggregat är härledd frän en kiseldioxid med 10 en genomsnittlig primär partikelstorlek pä 1 nm-100 mikrometer.
2. Fyllnadsämnessammansättning, som innefattar ingen terapeutiskt aktiv ämnesdel, kännetecknad därav, att den innefattar ett partikelformigt fyllnadsämne av mikrokristallin cellulosa som integrerats med 0,1-20 vikt-% kiseldioxid av nämnda 15 mikrokristallina cellulosa, kiseldioxiden har processerats tillsammans med den mikrokristallina cellulosan och den belägger delvis den mikrokristallina cellulosan, och kiseldioxiddelen av nämnda fyllnadsämne är härledd frän en kiseldioxid med en yta pä 10 m2/g-500 m2/g.
3. Fast dosformsammansättning av en sammanpressad blandning, kännetecknad därav, att blandningen innefattar frän 1 % tili 99 vikt-% av ett fyllnadsämne enligt patentkrav 1 eller 2, samt frän 99 % till 1 % av en terapeutiskt aktiv ämnesdel.
·· • ♦ • · [... 4. Sammansättning enligt patentkraven 1-3, kännetecknad därav, att nämnda • · · * . 25 kiseldioxidandel i aggregatet är härledd frän kolloidal kiseldioxid. a·· ·*·· • a · aa·
: ·’ 5. Sammansättning enligt patentkraven 1-3, kännetecknad därav, att kiseldioxid är a · * # *.i.* innesluten i en mängd pä 0,5-10 vikt-%, räknat pä vikten av den mikrokristallina ··· V · cellulosan. 30 ]*·,.
6. Sammansättning enligt patentkraven 1-3, kännetecknad därav, att fyllnadsämnespartiklama vidare innefattar ett ämne frän följande grupp: metalloxider ··· \ som inte innehäller kisel, stärkelser, stärkelsederivat, ytaktiva ämnen, a·· polyalkenoxider, cellulosor, cellulosaetrar, cellulosaestrar och blandningar av dessa. 35 j\;
7. Sammansättning enligt patentkraven 1 eller 2, kännetecknad därav, att den är • a »***. vätgranulerad med den aktiva ämnesdelen. ·♦· 43 1 1 8754
8. Vattenhaltigt slam för framställning av ett farmaceutiskt fyllnadsämne, kännetecknat därav att det vattenhaltiga slammet innefattar en blandning av mikrokristallin cellulosa i form av en vät kaka och frän 0,1-20 % kiseldioxid räknat pä vikten av den mikrokristallina cellulosan, varvid nämnda kiseldioxiddel har en 5 genomsnittlig primär partikelstorlek pä 1 nm-100 mikrometer och innehället av fasta ämnen i nämnda vattenhaltiga slam är frän 0,5-25 vikt-%.
9. Fast dosform enligt patentkrav 3, kännetecknad därav, att den har tillverkats med ett förfarande som innefattar följande steg: 10 (a) man bildar ett vattenhaltigt slam som innehäller en blandning av mikrokristallin cellulosa i form av en vät kaka och kiseldioxid som har en partikelstorlek pä 1 nm -100 pm, varvid mängden kiseldioxid är 0,1-20 % relativt vikten mikrokristallin cellulosa; 15 (b) man torkar nämnda slam för att erhälla ett fyllnadsämne som innefattar ett flertal agglomeratiserade partiklar av denna mikrokristallina cellulosa i närä anslutning tili nämnda kiseldioxid; 20 (c) man blandar en aktiv ämnesdel med detta fyllnadsämne i förhällandet 1:99-99:1; och ··, (d) man innesluter blandningen som erhällits i steg (c) i ett flertal fasta enhetsdoser. t ·· ··· • · i • · · • . 25
10. Fast dosform enligt patentkrav 9, kännetecknad därav, att i detta förfarande den "·· aktiva ämnesdelen och fyllnadsämnet vätgranuleras och därefter sammanpressas tili Ϊ ·1 tabletter. • · · » · i ··* ·«« V i
11. Fast dosform enligt patentkrav 3, kännetecknad därav, att dissolutionsprofilen 30 av den fasta dosformen är en dissolutionsprofil med en förlängd frigörelse. ** • t • ta • .***.
12. Fast dosform enligt patentkrav 11, kännetecknad därav, att den vidare innefattar • ta ·. en beläggning av en hydrofob polymer. • aa ··«· • e1 • e
13. Fast dosform enligt patentkrav 11, kännetecknad därav, att den fasta dosform ;1·.· innefattar tillräckligt av beläggningen av den hydrofoba polymeren, för att • a .**·. ästadkomma förlängd frigörelse av den terapeutiskt aktiva ämnesdelen under en ···1 förutbestämd tidsperiod. ^ 118754
14. Fast dosform enligt patentkrav 3, kännetecknad därav, att den vidare innefattar en beläggning av ett enteriskt beläggningsmaterial. 5 • ft • · • ν· • ·· « · I • « I • * • ft · ft··· *· · • · · • · • ft • · · • · 9 ··· ··· ft ft ft ft ft ft ft ftft • ft • ·· ft ··· • ft ft ft • •ft ft ft ft ft ft ft • ft·· ··· ft ft ft ft • ft· ft ft ft ft ft ft • ·· ft ft 1 ft· • ft • ft ft··
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US37057695 | 1995-01-09 | ||
US08/370,576 US5585115A (en) | 1995-01-09 | 1995-01-09 | Pharmaceutical excipient having improved compressability |
PCT/US1996/000660 WO1996021429A1 (en) | 1995-01-09 | 1996-01-05 | Pharmaceutical excipient having improved compressibility |
US9600660 | 1996-01-05 |
Publications (3)
Publication Number | Publication Date |
---|---|
FI963497A0 FI963497A0 (sv) | 1996-09-06 |
FI963497A FI963497A (sv) | 1996-11-06 |
FI118754B true FI118754B (sv) | 2008-03-14 |
Family
ID=23460251
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
FI963497A FI118754B (sv) | 1995-01-09 | 1996-09-06 | Farmaceutiskt hjälpämne med förbättrad sammanpressbarhet |
Country Status (19)
Country | Link |
---|---|
US (10) | US5585115A (sv) |
EP (2) | EP0752848B1 (sv) |
JP (1) | JP3300364B2 (sv) |
KR (1) | KR100332337B1 (sv) |
AT (3) | ATE445391T1 (sv) |
AU (1) | AU698667B2 (sv) |
BR (1) | BR9605329B1 (sv) |
CA (1) | CA2183881C (sv) |
DE (3) | DE69638015D1 (sv) |
DK (1) | DK0752848T3 (sv) |
ES (1) | ES2199281T3 (sv) |
FI (1) | FI118754B (sv) |
HU (1) | HUP9602360A3 (sv) |
IL (1) | IL116675A (sv) |
MX (1) | MX9603745A (sv) |
NO (1) | NO320533B1 (sv) |
PT (1) | PT752848E (sv) |
TW (1) | TW372874B (sv) |
WO (1) | WO1996021429A1 (sv) |
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US5585115A (en) * | 1995-01-09 | 1996-12-17 | Edward H. Mendell Co., Inc. | Pharmaceutical excipient having improved compressability |
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1996
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- 1996-01-05 BR BRPI9605329-1A patent/BR9605329B1/pt active IP Right Grant
- 1996-01-05 PT PT96903539T patent/PT752848E/pt unknown
- 1996-01-05 MX MX9603745A patent/MX9603745A/es unknown
- 1996-01-05 DE DE69638015T patent/DE69638015D1/de not_active Expired - Lifetime
- 1996-01-05 HU HU9602360A patent/HUP9602360A3/hu unknown
- 1996-01-05 KR KR1019960704934A patent/KR100332337B1/ko not_active IP Right Cessation
- 1996-01-05 ES ES96903539T patent/ES2199281T3/es not_active Expired - Lifetime
- 1996-01-05 DK DK96903539T patent/DK0752848T3/da active
- 1996-01-05 AT AT96907007T patent/ATE445391T1/de not_active IP Right Cessation
- 1996-01-05 EP EP96903539A patent/EP0752848B1/en not_active Expired - Lifetime
- 1996-01-05 JP JP52187596A patent/JP3300364B2/ja not_active Expired - Fee Related
- 1996-01-05 AT AT96903539T patent/ATE239450T1/de not_active IP Right Cessation
- 1996-01-05 AT AT02079378T patent/ATE441403T1/de not_active IP Right Cessation
- 1996-01-05 WO PCT/US1996/000660 patent/WO1996021429A1/en active IP Right Grant
- 1996-01-05 EP EP02079378A patent/EP1287823B1/en not_active Expired - Lifetime
- 1996-01-05 DE DE69627934T patent/DE69627934T2/de not_active Expired - Lifetime
- 1996-01-05 DE DE69638054T patent/DE69638054D1/de not_active Expired - Lifetime
- 1996-01-05 CA CA002183881A patent/CA2183881C/en not_active Expired - Lifetime
- 1996-01-05 AU AU47598/96A patent/AU698667B2/en not_active Ceased
- 1996-01-06 TW TW085100141A patent/TW372874B/zh not_active IP Right Cessation
- 1996-09-06 FI FI963497A patent/FI118754B/sv not_active IP Right Cessation
- 1996-09-06 NO NO19963732A patent/NO320533B1/no not_active IP Right Cessation
- 1996-09-30 US US08/724,613 patent/US5725884A/en not_active Expired - Fee Related
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1997
- 1997-12-17 US US08/992,073 patent/US6103219A/en not_active Expired - Lifetime
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1999
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2001
- 2001-01-04 US US09/754,760 patent/US6358533B2/en not_active Expired - Lifetime
- 2001-10-16 US US09/981,319 patent/US6521261B2/en not_active Expired - Fee Related
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2003
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2004
- 2004-05-20 US US10/850,059 patent/US20050013861A1/en not_active Abandoned
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