DE69535445D1 - Schmelzextrudierte oral verabreichbare Opioidformulierungen - Google Patents
Schmelzextrudierte oral verabreichbare OpioidformulierungenInfo
- Publication number
- DE69535445D1 DE69535445D1 DE69535445T DE69535445T DE69535445D1 DE 69535445 D1 DE69535445 D1 DE 69535445D1 DE 69535445 T DE69535445 T DE 69535445T DE 69535445 T DE69535445 T DE 69535445T DE 69535445 D1 DE69535445 D1 DE 69535445D1
- Authority
- DE
- Germany
- Prior art keywords
- melt extruded
- opioid formulations
- oral opioid
- extruded oral
- matrix
- 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.)
- Expired - Lifetime
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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
-
- 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
-
- 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
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
-
- 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
- A61K9/2077—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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- 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
-
- 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]
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29B—PREPARATION OR PRETREATMENT OF THE MATERIAL TO BE SHAPED; MAKING GRANULES OR PREFORMS; RECOVERY OF PLASTICS OR OTHER CONSTITUENTS OF WASTE MATERIAL CONTAINING PLASTICS
- B29B9/00—Making granules
- B29B9/02—Making granules by dividing preformed material
- B29B9/06—Making granules by dividing preformed material in the form of filamentary material, e.g. combined with extrusion
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US334209 | 1994-11-04 | ||
US08/334,209 US5965161A (en) | 1994-11-04 | 1994-11-04 | Extruded multi-particulates |
Publications (2)
Publication Number | Publication Date |
---|---|
DE69535445D1 true DE69535445D1 (de) | 2007-05-10 |
DE69535445T2 DE69535445T2 (de) | 2008-01-24 |
Family
ID=23306123
Family Applications (5)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DE69535426T Expired - Lifetime DE69535426T2 (de) | 1994-11-04 | 1995-11-03 | Schmelzextrudierte oral verabreichbare Opioidformulierungen |
DE69535767T Expired - Lifetime DE69535767D1 (de) | 1994-11-04 | 1995-11-03 | Schmelzextrudierte oral verabreichbare Hydromorphoneformulierungen |
DE69532415T Expired - Lifetime DE69532415T3 (de) | 1994-11-04 | 1995-11-03 | Schmelzextrudierte oral verabreichbare opioidformulierungen |
DE69535445T Expired - Lifetime DE69535445T2 (de) | 1994-11-04 | 1995-11-03 | Schmelzextrudierte oral verabreichbare Opioidformulierungen |
DE69536035T Expired - Lifetime DE69536035D1 (de) | 1994-11-04 | 1995-11-03 | Schmelzextrudierte oral verabreichbare Opioidformulierungen |
Family Applications Before (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DE69535426T Expired - Lifetime DE69535426T2 (de) | 1994-11-04 | 1995-11-03 | Schmelzextrudierte oral verabreichbare Opioidformulierungen |
DE69535767T Expired - Lifetime DE69535767D1 (de) | 1994-11-04 | 1995-11-03 | Schmelzextrudierte oral verabreichbare Hydromorphoneformulierungen |
DE69532415T Expired - Lifetime DE69532415T3 (de) | 1994-11-04 | 1995-11-03 | Schmelzextrudierte oral verabreichbare opioidformulierungen |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DE69536035T Expired - Lifetime DE69536035D1 (de) | 1994-11-04 | 1995-11-03 | Schmelzextrudierte oral verabreichbare Opioidformulierungen |
Country Status (17)
Country | Link |
---|---|
US (11) | US5965161A (de) |
EP (7) | EP1348429B1 (de) |
JP (1) | JP3186064B2 (de) |
KR (1) | KR100232945B1 (de) |
AT (5) | ATE356616T1 (de) |
AU (1) | AU705894B2 (de) |
CA (1) | CA2204180C (de) |
DE (5) | DE69535426T2 (de) |
DK (5) | DK1741426T3 (de) |
ES (5) | ES2282757T3 (de) |
HK (3) | HK1069110A1 (de) |
HU (1) | HUT77626A (de) |
IL (5) | IL142413A (de) |
PT (5) | PT1449530E (de) |
TW (1) | TW425288B (de) |
WO (1) | WO1996014058A1 (de) |
ZA (1) | ZA959367B (de) |
Families Citing this family (331)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5266331A (en) * | 1991-11-27 | 1993-11-30 | Euroceltique, S.A. | Controlled release oxycodone compositions |
US5968551A (en) | 1991-12-24 | 1999-10-19 | Purdue Pharma L.P. | Orally administrable opioid formulations having extended duration of effect |
US5958459A (en) * | 1991-12-24 | 1999-09-28 | Purdue Pharma L.P. | Opioid formulations having extended controlled released |
US5478577A (en) * | 1993-11-23 | 1995-12-26 | Euroceltique, S.A. | Method of treating pain by administering 24 hour oral opioid formulations exhibiting rapid rate of initial rise of plasma drug level |
US20080075781A1 (en) * | 1992-11-25 | 2008-03-27 | Purdue Pharma Lp | Controlled release oxycodone compositions |
IL119660A (en) | 1993-05-10 | 2002-09-12 | Euro Celtique Sa | Controlled release formulation comprising tramadol |
US20070275062A1 (en) * | 1993-06-18 | 2007-11-29 | Benjamin Oshlack | Controlled release oxycodone compositions |
US5914131A (en) * | 1994-07-07 | 1999-06-22 | Alza Corporation | Hydromorphone therapy |
GB9422154D0 (en) | 1994-11-03 | 1994-12-21 | Euro Celtique Sa | Pharmaceutical compositions and method of producing the same |
US5965161A (en) † | 1994-11-04 | 1999-10-12 | Euro-Celtique, S.A. | Extruded multi-particulates |
US20020006438A1 (en) * | 1998-09-25 | 2002-01-17 | Benjamin Oshlack | Sustained release hydromorphone formulations exhibiting bimodal characteristics |
DE19531277A1 (de) | 1995-08-25 | 1997-02-27 | Basf Ag | Verwendung von Lipiden als Hilfsmittel bei der Herstellung von festen Arzneiformen nach dem Schmelzextrusionsverfahren |
GB9519363D0 (en) | 1995-09-22 | 1995-11-22 | Euro Celtique Sa | Pharmaceutical formulation |
DE19539360A1 (de) * | 1995-10-23 | 1997-04-24 | Basf Ag | Verfahren zur Herstellung von festen Arzneiformen |
GB9614902D0 (en) * | 1996-07-16 | 1996-09-04 | Rhodes John | Sustained release composition |
JPH1050306A (ja) * | 1996-07-31 | 1998-02-20 | Toyota Autom Loom Works Ltd | 水素吸蔵合金電極の製造方法 |
EP1342548B1 (de) * | 1996-10-28 | 2015-12-23 | General Mills, Inc. | Einbettung und Einkapselung von Teilchen zur kontrollierten Abgabe und eingekapseltes Produkt |
US6190591B1 (en) * | 1996-10-28 | 2001-02-20 | General Mills, Inc. | Embedding and encapsulation of controlled release particles |
BE1010803A3 (fr) * | 1996-12-16 | 1999-02-02 | Therabel Research Sa | Comprimes pharmaceutiques a liberation prolongee a base de tramadol et leur preparation. |
US5968547A (en) | 1997-02-24 | 1999-10-19 | Euro-Celtique, S.A. | Method of providing sustained analgesia with buprenorphine |
PT1009387E (pt) | 1997-07-02 | 2006-08-31 | Euro Celtique Sa | Formulacoes estabilizadas de libertacao controlada de tramadol |
DE19733505A1 (de) * | 1997-08-01 | 1999-02-04 | Knoll Ag | Schnell wirksames Analgeticum |
RS49982B (sr) * | 1997-09-17 | 2008-09-29 | Euro-Celtique S.A., | Sinergistička analgetička kombinacija analgetičkog opijata i inhibitora ciklooksigenaze-2 |
US20030158220A1 (en) * | 1997-11-03 | 2003-08-21 | Foss Joseph F. | Use of methylnaltrexone and related compounds to treat chronic opioid use side effects |
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US6274591B1 (en) * | 1997-11-03 | 2001-08-14 | Joseph F. Foss | Use of methylnaltrexone and related compounds |
RU2241458C2 (ru) | 1997-12-22 | 2004-12-10 | Эро-Селтик, С.А. | Комбинации агонист/антагонист опиоида |
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1994
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1995
- 1995-11-03 ES ES04012331T patent/ES2282757T3/es not_active Expired - Lifetime
- 1995-11-03 HU HU9800457A patent/HUT77626A/hu active IP Right Revival
- 1995-11-03 AT AT04012330T patent/ATE356616T1/de not_active IP Right Cessation
- 1995-11-03 EP EP03015267A patent/EP1348429B1/de not_active Expired - Lifetime
- 1995-11-03 AT AT03015267T patent/ATE452627T1/de not_active IP Right Cessation
- 1995-11-03 DE DE69535426T patent/DE69535426T2/de not_active Expired - Lifetime
- 1995-11-03 DE DE69535767T patent/DE69535767D1/de not_active Expired - Lifetime
- 1995-11-03 DK DK06123277T patent/DK1741426T3/da active
- 1995-11-03 ES ES03015267T patent/ES2338641T3/es not_active Expired - Lifetime
- 1995-11-03 PT PT04012330T patent/PT1449530E/pt unknown
- 1995-11-03 DK DK03015267.2T patent/DK1348429T3/da active
- 1995-11-03 PT PT95939928T patent/PT785775E/pt unknown
- 1995-11-03 KR KR1019970702984A patent/KR100232945B1/ko not_active IP Right Cessation
- 1995-11-03 EP EP10177509A patent/EP2283816A1/de not_active Ceased
- 1995-11-03 JP JP51553796A patent/JP3186064B2/ja not_active Expired - Lifetime
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- 1995-11-03 AU AU41570/96A patent/AU705894B2/en not_active Expired
- 1995-11-03 EP EP04012330A patent/EP1449530B1/de not_active Expired - Lifetime
- 1995-11-03 EP EP04012331A patent/EP1449531B1/de not_active Expired - Lifetime
- 1995-11-03 ES ES04012330T patent/ES2282756T3/es not_active Expired - Lifetime
- 1995-11-03 CA CA002204180A patent/CA2204180C/en not_active Expired - Lifetime
- 1995-11-03 PT PT03015267T patent/PT1348429E/pt unknown
- 1995-11-03 DK DK04012330T patent/DK1449530T3/da active
- 1995-11-03 PT PT04012331T patent/PT1449531E/pt unknown
- 1995-11-03 EP EP04022651A patent/EP1488786A1/de not_active Ceased
- 1995-11-03 EP EP06123277A patent/EP1741426B1/de not_active Expired - Lifetime
- 1995-11-03 IL IL11587195A patent/IL115871A/xx not_active IP Right Cessation
- 1995-11-03 PT PT06123277T patent/PT1741426E/pt unknown
- 1995-11-03 DE DE69532415T patent/DE69532415T3/de not_active Expired - Lifetime
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- 1995-11-03 IL IL12941095A patent/IL129410A/xx not_active IP Right Cessation
- 1995-11-03 DK DK04012331T patent/DK1449531T3/da active
- 1995-11-03 DK DK95939928.8T patent/DK0785775T4/da active
- 1995-11-03 AT AT95939928T patent/ATE257375T1/de active
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- 1995-11-03 WO PCT/US1995/014745 patent/WO1996014058A1/en active IP Right Grant
- 1995-11-03 AT AT04012331T patent/ATE357909T1/de not_active IP Right Cessation
- 1995-11-03 DE DE69536035T patent/DE69536035D1/de not_active Expired - Lifetime
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- 1995-11-03 IL IL159766A patent/IL159766A/en not_active IP Right Cessation
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1996
- 1996-02-09 TW TW085101623A patent/TW425288B/zh not_active IP Right Cessation
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1997
- 1997-04-10 US US08/833,948 patent/US5958452A/en not_active Expired - Lifetime
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1999
- 1999-07-22 US US09/358,828 patent/US6335033B2/en not_active Expired - Lifetime
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2001
- 2001-02-06 US US09/777,616 patent/US6743442B2/en not_active Expired - Fee Related
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2002
- 2002-01-02 US US10/038,867 patent/US6706281B2/en not_active Expired - Fee Related
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2003
- 2003-09-16 US US10/664,602 patent/US20050089568A1/en not_active Abandoned
- 2003-10-21 US US10/690,389 patent/US20040081694A1/en not_active Abandoned
- 2003-12-23 US US10/745,950 patent/US7510727B2/en not_active Expired - Fee Related
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2004
- 2004-01-08 IL IL15976604A patent/IL159766A0/xx active IP Right Grant
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- 2004-02-27 HK HK04101468.7A patent/HK1059887A1/xx not_active IP Right Cessation
-
2009
- 2009-02-17 US US12/372,460 patent/US20090148517A1/en not_active Abandoned
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2010
- 2010-03-12 US US12/722,974 patent/US20100172974A1/en not_active Abandoned
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