FI118252B - Förfarande för framställning av formulation som frigörs kontrollerat - Google Patents
Förfarande för framställning av formulation som frigörs kontrollerat Download PDFInfo
- Publication number
- FI118252B FI118252B FI20031891A FI20031891A FI118252B FI 118252 B FI118252 B FI 118252B FI 20031891 A FI20031891 A FI 20031891A FI 20031891 A FI20031891 A FI 20031891A FI 118252 B FI118252 B FI 118252B
- Authority
- FI
- Finland
- Prior art keywords
- oxycodone
- controlled release
- formulation
- weight
- salt
- Prior art date
Links
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Classifications
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- 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
- A61K31/47—Quinolines; Isoquinolines
- A61K31/485—Morphinan derivatives, e.g. morphine, codeine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- A—HUMAN NECESSITIES
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- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
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- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
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- 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
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
- A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
-
- 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
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5015—Organic compounds, e.g. fats, sugars
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/04—Centrally acting analgesics, e.g. opioids
Claims (20)
1. Förfarande för framställning av en formulering med kontrollerad frigöring, kännetecknat avatt formuleringen omfattar ett oxikodonsalt, 5 som ingär i en matris med kontrollerad frigöring sä att (a) granuler, som omfattar minst ett akrylharts och ett oxikodonsalt, bildas genom vätgranulering med vatten, (b) minst en alifatisk Ci2-36-alkohol blandas med granulerna som in-nehäller akrylharts, 10 varvid nämnda formulering omfattar 10-160 mg oxikodonhydroklo- rid, och nämnda alifatiska alkohol är stearylalkohol och formuleringen omfattar 20 vikt-% (beräknat pä hela formuleringen) stearylalkohol.
2. Förfarande enligt patentkrav 1, kännetecknat av att den under vätgranuleringssteget tillförda mängden vatten är 1,5-5 ganger och särskilt 15 1,75-3,5 ganger oxikodonets torrvikt.
3. Förfarande enligt patentkrav 1 eller 2, kännetecknat avatt akrylhartset är poly(met)akrylat med 5 % trimetylammoniummetakrylatklorid.
4. Förfarande enligt nagot av de föregäende patentkraven, kännetecknat av att formuleringen är kapabel att frigöra oxikodon med en frigö- 20 ringshastighet som är väsentligen oberoende av pH vid ett pH-värde 1,6 och pH-värde 7,2. t
5. Förfarande enligt nagot av de föregäende patentkraven, kanne- II* ·*.·* ·* tecknat av att man framställer en oxikodonformulering med kontrollerad fri- :Y: göring, vilken oxikodonformulering omfattar 10 mg, 20 mg, 40 mg, 80 mg eller ·:··: 25 160 mg oxikodonhydroklorid. • v.
6. Förfarande enligt nagot av de föregäende patentkraven, kä n n e- • * .··*. tecknat av att man framställer en 10 mg oxikodonformulering med kontrolle rad frigöring, vilken formulering omfattar 10 mg oxikodonhydroklorid.
;·, 7. Förfarande enligt nagot av de föregäende patentkraven, k ä n n e - • · · 30 tecknat av att man framställer en 20 mg oxikodonformulering med kontrolle-rad frigöring, vilken formulering omfattar 20 mg oxikodonhydroklorid.
• · • *·· 8. Förfarande enligt nagot av de föregäende patentkraven, kä n n e- t e c k n a t av att man framställer en 40 mg oxikodonformulering med kontrolle- :v. rad frigöring, vilken formulering omfattar 40 mg oxikodonhydroklorid. • · 35
9. Förfarande enligt nagot av de föregäende patentkraven, kä n ne- * * *** tecknat av att man framställer en 80 mg oxikodonformulering med kontrolle- 37 1 1 8252 \ rad frigöring, vilken formulering omfattar 80 mg oxikodonhydroklorid.
10. Förfarande enligt nagot av de föregäende patentkraven, kän- I n e t e c k n a t av att man framställer en 160 mg oxikodonformulering med kon-trollerad frigöring, vilken formulering omfattar 160 mg oxikodonhydroklorid. 5
11. Förfarande enligt nagot av patentkraven 5-10, kännetecknat av att man framställer en oxikodonformulering med kontrollerad frigöring, som omfattar (a) 8 vikt-% oxikodonhydroklorid (b) 55,4 vikt-% laktos (spraytorkat) 10 (c) 4 vikt-% povidon (d) 8 vikt-% EudragitR RS 30D (torrämne) (e) 1,6 vikt-% TriacetinR (f) 20 vikt-% stearylalkohol (g) 2 vikt-% talk 15 (h) 1 vikt-% magnesiumstearat.
12. Förfarande enligt patentkrav 11, kännetecknat avatt man framställer en oxikodonformulering med kontrollerad frigöring, som omfattar (a) 10 mg oxikodonhydroklorid (b) 69,25 mg laktos (spraytorkat) 20 (c) 5,0 mg povidon (d) 10,0 mg EudragitR RS 30D (torrämne) :··: (c) 2,0 mg TriacetinR (f) 25,0 mg stearylalkohol (g) 2,5 mg talk • · ....: 25 (h) 1,25 mg magnesiumstearat.
13. Förfarande enligt patentkrav 11 eller 12, kännetecknat av • · att man framställer en oxikodonformulering med kontrollerad frigöring, som är *** en 10 mg oxikodonhydrokloridtabeltt med kontrollerad frigöring.
,. 14. Förfarande enligt nagot av patentkraven 5-10, kännetecknat 30 av att man framställer en oxikodonformulering med kontrollerad frigöring, som ? omfattar • · • · • · · • · · • · • « * * * • · # • · · • · ... • · ···' • · • » • · · 118252 I (a) 20 mg oxikodonhydroklorid (b) 59,25 mg laktos (spraytorkat) 1 (c) 5 mg povidon (d) 10 mg EudragitR RS 30D (torrämne) 5 (e) 2 mgTriacetinR (f) 25 mg stearylalkohol (g) 2,5 mg talk (h) 1,25 mg magnesiumstearat.
15. Förfarande enligt nägot av patentkraven 5-14, k ä n n e t e c k n a t 10 av att man framställer en oxikodonformulering med kontrollerad frigöring och med en in vitro-upplösningshastighet som uppmätt med USP Paddle-metoden med en hastighet av 100 rpm vid användning av 900 ml vattenhaltig buffert (pH 1,6-7,2) vid 37 °C är 12,5-42,5 % (av vikten) frigjort oxikodon efter 1 tim-me, 25-55 % (av vikten) frigjort oxikodon efter 2 timmar, 45-75 % (av vikten) 15 frigjort oxikodon efter 4 timmar och 55-85 % (av vikten) frigjort oxikodon efter 6 timmar.
16. Förfarande enligt nagot av patentkraven 5-15, kännetecknat av att man framställer en oxikodonformulering med kontrollerad frigöring och med en in vitro-upplösningshastighet som uppmätt med USP Paddle-metoden 20 med en hastighet av 100 rpm vid användning av 900 ml vattenhaltig buffert (pH 1,6-7,2) vid 37 °C är 17,5-38 % (av vikten) frigjort oxikodon efter 1 timme, *:**: 30-50 % (av vikten) frigjort oxikodon efter 2 timmar, 50-70 % (av vikten) frigjort :T: oxikodon efter 4 timmar och 60-80 % (av vikten) frigjort oxikodon efter 6 tim- mar. • · · t · ....: 25
17. Förfarande enligt nagot av patentkraven 5-16, kännetecknat av att man framställer en oxikodonformulering med kontrollerad frigöring och • » med en in vitro-upplösningshastighet som uppmätt med USP Paddle-metoden • · *** med en hastighet av 100 rpm vid användning av 900 ml vattenhaltig buffert „ (pH 1,6-7,2) vid 37 °C är 17,5-32,5 % (av vikten) frigjort oxikodon efter 1 tim- • · 30 me’ 35-45 % (av vikten) frigjort oxikodon efter 2 timmar, 55-65 % (av vikten) frigjort oxikodon efter 4 timmar och 65-75 % (av vikten) frigjort oxikodon efter 6 timmar. t .**·.
18. Förfarande enligt nagot av patentkraven 5-17, kännetecknat • · m av att man framställer en oral dosformulering med kontrollerad frigöring, vars in • · · : 35 vitro-upplösningshastighet är väsentligen oberoende av pH vid ett pH-värde '*··** 1,6 och pH-värde 7,2. 39 1 1 8 2 5 2
19. Förfarande enligt nägot av de föregäende patentkraven, kän-netecknat av att man framställer en oral dosform med kontrollerad frigö-ring, vilken dosform är en kapsel.
20. Förfarande enligt nägot av de föregäende patentkraven, kä n-5 netecknat av att man framställer en oral dosform med kontrollerad frigö- ring, vilken dosform är en tablett. * ····« ♦ t • »* * · · • · · « i • * · ·*· • · • > ····· ♦ · • · · • · · • · **· • * • ♦ ··· *· * · • «· *·· • · • · ··· * • * · · *** • · I · f * · • · · • · t ♦ • · * * · • · »·
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US80054991 | 1991-11-27 | ||
US07/800,549 US5266331A (en) | 1991-11-27 | 1991-11-27 | Controlled release oxycodone compositions |
PCT/US1992/010146 WO1993010765A1 (en) | 1991-11-27 | 1992-11-25 | Controlled release oxycodone compositions |
US9210146 | 1992-11-25 |
Publications (2)
Publication Number | Publication Date |
---|---|
FI20031891A FI20031891A (sv) | 2003-12-22 |
FI118252B true FI118252B (sv) | 2007-09-14 |
Family
ID=25178688
Family Applications (5)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
FI933330A FI113152B (sv) | 1991-11-27 | 1993-07-23 | Förfarande för framställning av en kontrollerat avgivande oxikodonsammansättning |
FI20031889A FI116658B (sv) | 1991-11-27 | 2003-12-22 | Förfarande för framställning av formulation som frigörs kontrollerat |
FI20031891A FI118252B (sv) | 1991-11-27 | 2003-12-22 | Förfarande för framställning av formulation som frigörs kontrollerat |
FI20031888A FI118250B (sv) | 1991-11-27 | 2003-12-22 | Förfarande för framställning av oxikodondosform som frigörs kontrollerat |
FI20031890A FI118251B (sv) | 1991-11-27 | 2003-12-22 | Förfarande för framställning av en oxikodonsaltformulering som innehåller cellulosaeter och frigörs kontrollerat |
Family Applications Before (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
FI933330A FI113152B (sv) | 1991-11-27 | 1993-07-23 | Förfarande för framställning av en kontrollerat avgivande oxikodonsammansättning |
FI20031889A FI116658B (sv) | 1991-11-27 | 2003-12-22 | Förfarande för framställning av formulation som frigörs kontrollerat |
Family Applications After (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
FI20031888A FI118250B (sv) | 1991-11-27 | 2003-12-22 | Förfarande för framställning av oxikodondosform som frigörs kontrollerat |
FI20031890A FI118251B (sv) | 1991-11-27 | 2003-12-22 | Förfarande för framställning av en oxikodonsaltformulering som innehåller cellulosaeter och frigörs kontrollerat |
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US (13) | US5266331A (sv) |
EP (15) | EP1258246B1 (sv) |
JP (2) | JP3375960B2 (sv) |
KR (1) | KR100280973B1 (sv) |
CN (2) | CN1245958C (sv) |
AT (9) | ATE261725T1 (sv) |
AU (1) | AU657027B2 (sv) |
BG (1) | BG61753B1 (sv) |
BR (1) | BR9205498A (sv) |
CA (1) | CA2098738C (sv) |
CZ (4) | CZ300183B6 (sv) |
DE (10) | DE69233699T2 (sv) |
DK (10) | DK1810679T3 (sv) |
ES (9) | ES2096781T3 (sv) |
FI (5) | FI113152B (sv) |
GR (1) | GR3022273T3 (sv) |
HK (6) | HK1059210A1 (sv) |
HU (10) | HU227815B1 (sv) |
IL (1) | IL103909A (sv) |
MX (1) | MX9302968A (sv) |
NO (6) | NO307028B3 (sv) |
PH (1) | PH31679A (sv) |
PL (2) | PL172236B1 (sv) |
PT (8) | PT1327446E (sv) |
RO (1) | RO115112B1 (sv) |
RS (3) | RS50056B (sv) |
RU (1) | RU2122411C1 (sv) |
SK (1) | SK280295B6 (sv) |
WO (1) | WO1993010765A1 (sv) |
YU (1) | YU49495B (sv) |
ZA (1) | ZA929227B (sv) |
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- 1992-11-25 EP EP03006022A patent/EP1327446B2/en not_active Expired - Lifetime
- 1992-11-25 RU RU93051780A patent/RU2122411C1/ru active
- 1992-11-25 ES ES92925406T patent/ES2096781T3/es not_active Expired - Lifetime
- 1992-11-25 DE DE69233699T patent/DE69233699T2/de not_active Expired - Lifetime
- 1992-11-25 AT AT02008249T patent/ATE261725T1/de active
- 1992-11-25 US US08/081,302 patent/US5549912A/en not_active Expired - Lifetime
- 1992-11-25 EP EP03006021A patent/EP1327445B1/en not_active Expired - Lifetime
- 1992-11-25 DK DK07100188.7T patent/DK1810679T3/da active
- 1992-11-25 AT AT07100188T patent/ATE454150T1/de active
- 1992-11-25 EP EP10181156A patent/EP2340833A3/en not_active Withdrawn
- 1992-11-25 HU HU0401532A patent/HU227815B1/hu unknown
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- 1992-11-25 PT PT03006022T patent/PT1327446E/pt unknown
- 1992-11-25 DK DK92925406T patent/DK0576643T5/da active
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- 1992-11-25 ES ES02008249T patent/ES2213720T3/es not_active Expired - Lifetime
- 1992-11-25 EP EP92925406A patent/EP0576643B1/en not_active Expired - Lifetime
- 1992-11-25 EP EP04026291A patent/EP1502592B1/en not_active Expired - Lifetime
- 1992-11-25 DE DE69233327T patent/DE69233327T2/de not_active Expired - Lifetime
- 1992-11-25 DK DK96102992.3T patent/DK0722730T4/da active
- 1992-11-25 PL PL92300145A patent/PL172236B1/pl unknown
- 1992-11-25 AU AU31476/93A patent/AU657027B2/en not_active Expired
- 1992-11-25 CZ CZ19931764A patent/CZ286913B6/cs not_active IP Right Cessation
- 1992-11-25 PL PL92315835A patent/PL173574B1/pl unknown
- 1992-11-25 EP EP07100187A patent/EP1774969A3/en not_active Withdrawn
- 1992-11-25 PT PT04026291T patent/PT1502592E/pt unknown
- 1992-11-25 RO RO93-00878A patent/RO115112B1/ro unknown
- 1992-11-25 HU HU9301517A patent/HU224075B1/hu not_active IP Right Cessation
- 1992-11-25 ES ES04005576T patent/ES2286523T3/es not_active Expired - Lifetime
- 1992-11-25 AT AT92925406T patent/ATE144418T1/de active
- 1992-11-25 WO PCT/US1992/010146 patent/WO1993010765A1/en active IP Right Grant
- 1992-11-25 DE DE69233778T patent/DE69233778D1/de not_active Expired - Lifetime
- 1992-11-25 DK DK03006021T patent/DK1327445T3/da active
- 1992-11-25 ES ES03006020T patent/ES2268189T3/es not_active Expired - Lifetime
- 1992-11-25 PT PT96102992T patent/PT722730E/pt unknown
- 1992-11-25 DK DK04026291T patent/DK1502592T3/da active
- 1992-11-25 EP EP04005576A patent/EP1438959B1/en not_active Expired - Lifetime
- 1992-11-25 EP EP10165398A patent/EP2243484A3/en not_active Withdrawn
- 1992-11-25 HU HU0303097A patent/HU227517B1/hu unknown
- 1992-11-25 HU HU0302920A patent/HU228058B1/hu unknown
- 1992-11-25 DK DK03006022T patent/DK1327446T4/da active
- 1992-11-25 AT AT04005576T patent/ATE360421T1/de active
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- 1992-11-25 AT AT03006021T patent/ATE261726T1/de active
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- 1992-11-25 EP EP07100188A patent/EP1810679B1/en not_active Revoked
- 1992-11-25 DK DK02008249T patent/DK1258246T3/da active
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- 1992-11-25 DE DE69232837.8T patent/DE69232837T3/de not_active Expired - Lifetime
- 1992-11-25 AT AT03006022T patent/ATE261727T1/de active
- 1992-11-25 AT AT96102992T patent/ATE226822T1/de active
- 1992-11-25 BR BR9205498A patent/BR9205498A/pt not_active Application Discontinuation
- 1992-11-25 PT PT03006020T patent/PT1325746E/pt unknown
- 1992-11-25 AT AT03006020T patent/ATE332691T1/de active
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- 1992-11-25 HU HU0400224A patent/HU227514B1/hu unknown
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- 1992-11-25 SK SK922-93A patent/SK280295B6/sk not_active IP Right Cessation
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- 1992-11-25 ES ES96102992T patent/ES2186737T5/es not_active Expired - Lifetime
- 1992-11-25 DK DK04005576T patent/DK1438959T3/da active
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- 1992-11-25 KR KR1019930702201A patent/KR100280973B1/ko not_active IP Right Cessation
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- 1992-11-25 PT PT04005576T patent/PT1438959E/pt unknown
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1993
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- 1993-05-21 YU YU35893A patent/YU49495B/sh unknown
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- 1993-07-20 BG BG97973A patent/BG61753B1/bg unknown
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- 1993-07-23 FI FI933330A patent/FI113152B/sv not_active IP Right Cessation
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1995
- 1995-06-06 US US08/467,584 patent/US5508042A/en not_active Expired - Lifetime
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1997
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1999
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2000
- 2000-12-08 DK DK200000364U patent/DK200000364U3/da active
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2001
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- 2001-08-20 US US09/933,411 patent/US20020018810A1/en not_active Abandoned
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2002
- 2002-06-05 US US10/163,484 patent/US20030099704A1/en not_active Abandoned
- 2002-06-11 JP JP2002169981A patent/JP4016074B2/ja not_active Expired - Lifetime
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2003
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- 2003-04-09 HK HK05100220A patent/HK1068004A1/xx not_active IP Right Cessation
- 2003-11-12 US US10/706,496 patent/US20040105887A1/en not_active Abandoned
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- 2003-12-22 FI FI20031889A patent/FI116658B/sv not_active IP Right Cessation
- 2003-12-22 FI FI20031891A patent/FI118252B/sv not_active IP Right Cessation
- 2003-12-22 FI FI20031888A patent/FI118250B/sv not_active IP Right Cessation
- 2003-12-22 FI FI20031890A patent/FI118251B/sv not_active IP Right Cessation
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2004
- 2004-03-24 US US10/809,766 patent/US20040185098A1/en not_active Abandoned
- 2004-04-22 NO NO20041662A patent/NO323334B1/no unknown
- 2004-04-22 NO NO20041667A patent/NO322378B1/no unknown
- 2004-04-22 NO NO20041939A patent/NO325483B1/no not_active IP Right Cessation
- 2004-08-04 NO NO20043264A patent/NO20043264L/no not_active Application Discontinuation
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2005
- 2005-08-17 US US11/207,144 patent/US20060057210A1/en not_active Abandoned
- 2005-12-16 US US11/303,553 patent/US20060099255A1/en not_active Abandoned
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2006
- 2006-01-12 US US11/332,644 patent/US20060165792A1/en not_active Abandoned
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