JP2006507277A - 24時間有効な持続放出トラマドール製剤 - Google Patents

24時間有効な持続放出トラマドール製剤 Download PDF

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Publication number
JP2006507277A
JP2006507277A JP2004545655A JP2004545655A JP2006507277A JP 2006507277 A JP2006507277 A JP 2006507277A JP 2004545655 A JP2004545655 A JP 2004545655A JP 2004545655 A JP2004545655 A JP 2004545655A JP 2006507277 A JP2006507277 A JP 2006507277A
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Japan
Prior art keywords
hours
composition
tramadol
administration
plasma concentration
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Pending
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JP2004545655A
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English (en)
Japanese (ja)
Inventor
レナエルツ ビンセント
ローレ オウアジ‐ンジキ パトリシア
ベーコン ジョナサン
オウゼルールー ラシッド
ジェルヴェ ソニア
ラモウニ ミロード
スミス デーモン
Original Assignee
ラボファーマ インコーポレイテッド
ラボファーマ ヨーロッパ リミテッド
ラボファーマ(バルバドス)リミテッド
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=32179487&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=JP2006507277(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by ラボファーマ インコーポレイテッド, ラボファーマ ヨーロッパ リミテッド, ラボファーマ(バルバドス)リミテッド filed Critical ラボファーマ インコーポレイテッド
Publication of JP2006507277A publication Critical patent/JP2006507277A/ja
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/2853Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
JP2004545655A 2002-10-25 2003-10-27 24時間有効な持続放出トラマドール製剤 Pending JP2006507277A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US28102602A 2002-10-25 2002-10-25
US51037803P 2003-10-10 2003-10-10
PCT/CA2003/001638 WO2004037222A2 (en) 2002-10-25 2003-10-27 Sustained-release tramadol formulations with 24-hour efficacy

Publications (1)

Publication Number Publication Date
JP2006507277A true JP2006507277A (ja) 2006-03-02

Family

ID=32179487

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2004545655A Pending JP2006507277A (ja) 2002-10-25 2003-10-27 24時間有効な持続放出トラマドール製剤

Country Status (11)

Country Link
JP (1) JP2006507277A (pt)
KR (1) KR20050083816A (pt)
AR (1) AR045972A1 (pt)
AU (1) AU2003275855B2 (pt)
CA (1) CA2503155A1 (pt)
IL (1) IL168114A (pt)
NO (1) NO20052479D0 (pt)
PT (1) PT1594460E (pt)
RU (1) RU2328275C2 (pt)
UA (1) UA84277C2 (pt)
WO (1) WO2004037222A2 (pt)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009534429A (ja) * 2006-04-26 2009-09-24 アルファファーム ピーティーワイ リミテッド コーティングされていない分離したユニットおよび延長放出マトリクスを含む制御放出配合物
JP2019519488A (ja) * 2016-05-05 2019-07-11 アクエスティブ セラピューティクス インコーポレイテッド 透過性増強された医薬組成物

Families Citing this family (35)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7776314B2 (en) 2002-06-17 2010-08-17 Grunenthal Gmbh Abuse-proofed dosage system
US8487002B2 (en) 2002-10-25 2013-07-16 Paladin Labs Inc. Controlled-release compositions
TWI319713B (en) 2002-10-25 2010-01-21 Sustained-release tramadol formulations with 24-hour efficacy
US7413749B2 (en) 2003-03-11 2008-08-19 Purdue Pharma L.P. Titration dosing regimen for controlled release tramadol
EP1905435A3 (en) * 2003-03-11 2008-05-14 Euro-Celtique S.A. Titration dosing regimen for controlled release tramadol
US20070048228A1 (en) 2003-08-06 2007-03-01 Elisabeth Arkenau-Maric Abuse-proofed dosage form
DE10361596A1 (de) 2003-12-24 2005-09-29 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
DE102005005446A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Bruchfeste Darreichungsformen mit retardierter Freisetzung
DE10336400A1 (de) 2003-08-06 2005-03-24 Grünenthal GmbH Gegen Missbrauch gesicherte Darreichungsform
BRPI0511137A (pt) * 2004-05-14 2007-11-27 Janssen Pharmaceutica Nv compostos opióides de carboxamido
DE102004032049A1 (de) 2004-07-01 2006-01-19 Grünenthal GmbH Gegen Missbrauch gesicherte, orale Darreichungsform
DE102005005449A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
KR101655455B1 (ko) * 2005-09-09 2016-09-07 안젤리니 라보팜 엘엘씨 일일 1회 투여를 위한 트라조돈 조성물
AU2009207796B2 (en) 2008-01-25 2014-03-27 Grunenthal Gmbh Pharmaceutical dosage form
ES2599031T3 (es) 2008-05-09 2017-01-31 Grünenthal GmbH Proceso para la preparación de una formulación de polvo intermedia y una forma de dosificación solida final utilizando un paso de congelación por pulverización
NZ589742A (en) 2008-05-27 2012-06-29 Univ Melbourne Methods of treating mammals with eustachian tube dysfunctions with betahistine
UA102706C2 (ru) * 2008-10-27 2013-08-12 Алза Корпорейшн Лекарственная форма ацетаминофена и комплекса трамадола с замедленным действием для перорального приема
PT2456424E (pt) 2009-07-22 2013-09-30 Gruenenthal Gmbh Forma de dosagem resistente à adulteração e estabilizada contra a oxidação
NZ596667A (en) 2009-07-22 2013-09-27 Gruenenthal Chemie Hot-melt extruded controlled release dosage form
WO2011095314A2 (en) 2010-02-03 2011-08-11 Grünenthal GmbH Preparation of a powdery pharmaceutical composition by means of an extruder
CA2808541C (en) 2010-09-02 2019-01-08 Gruenenthal Gmbh Tamper resistant dosage form comprising an anionic polymer
MX2013002377A (es) 2010-09-02 2013-04-29 Gruenenthal Gmbh Forma de dosificacion resistente a manipulacion que comprende una sal inorganica.
MX348054B (es) 2011-07-29 2017-05-25 Gruenenthal Gmbh Tableta a prueba de alteracion que proporciona liberacion inmediata del farmaco.
AR087360A1 (es) 2011-07-29 2014-03-19 Gruenenthal Gmbh Tableta a prueba de manipulacion que proporciona liberacion de farmaco inmediato
AU2013225106B2 (en) 2012-02-28 2017-11-02 Grunenthal Gmbh Tamper-resistant dosage form comprising pharmacologically active compound and anionic polymer
RS57913B1 (sr) 2012-04-18 2019-01-31 Gruenenthal Gmbh Farmaceutske dozne forme otporne na neovlašćenu upotrebu i naglo oslobađanje celokupne doze
US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
JP6466417B2 (ja) 2013-05-29 2019-02-06 グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング 二峰性放出プロファイルを有する改変防止(tamper−resistant)剤形
JP6445537B2 (ja) 2013-05-29 2018-12-26 グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング 1個または複数の粒子を含有する改変防止(tamper−resistant)剤形
JP6449871B2 (ja) 2013-07-12 2019-01-09 グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング エチレン−酢酸ビニルポリマーを含有する改変防止剤形
BR112016010482B1 (pt) 2013-11-26 2022-11-16 Grünenthal GmbH Preparação de uma composição farmacêutica em pó por meio de criomoagem
WO2015173195A1 (en) 2014-05-12 2015-11-19 Grünenthal GmbH Tamper resistant immediate release capsule formulation comprising tapentadol
JP2017516789A (ja) 2014-05-26 2017-06-22 グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング エタノール過量放出に対して防護されている多粒子
EA035434B1 (ru) 2015-04-24 2020-06-15 Грюненталь Гмбх Защищенная от применения не по назначению лекарственная форма с немедленным высвобождением и устойчивостью к экстракции растворителями
US10842750B2 (en) 2015-09-10 2020-11-24 Grünenthal GmbH Protecting oral overdose with abuse deterrent immediate release formulations

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0753361A (ja) * 1993-05-10 1995-02-28 Euro Celtique Sa 放出が調整された調合物、経口投与形態及びその製造方法
JP2000510487A (ja) * 1997-07-02 2000-08-15 ユーロ―セルティーク,エス.エイ. 安定化された徐放性トラマドール製剤
JP2001278813A (ja) * 2000-03-29 2001-10-10 Basf Ag 遅延された作用物質の放出および高い機械的安定性を有する経口投与形、前記投与形の医薬品および該投与形の使用
WO2002002084A1 (en) * 2000-06-29 2002-01-10 Vincent Lenaerts Cross-linked high amylose starch for use in controlled-release pharmaceutical formulations and processes for its manufacture
WO2002066026A2 (de) * 2001-02-21 2002-08-29 Grünenthal GmbH Arzneimittel auf basis von tramadol

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19530575A1 (de) * 1995-08-19 1997-02-20 Gruenenthal Gmbh Schnell zerfallende Arzneiform von Tramadol oder einem Tramadolsalz

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0753361A (ja) * 1993-05-10 1995-02-28 Euro Celtique Sa 放出が調整された調合物、経口投与形態及びその製造方法
JP2000510487A (ja) * 1997-07-02 2000-08-15 ユーロ―セルティーク,エス.エイ. 安定化された徐放性トラマドール製剤
JP2001278813A (ja) * 2000-03-29 2001-10-10 Basf Ag 遅延された作用物質の放出および高い機械的安定性を有する経口投与形、前記投与形の医薬品および該投与形の使用
WO2002002084A1 (en) * 2000-06-29 2002-01-10 Vincent Lenaerts Cross-linked high amylose starch for use in controlled-release pharmaceutical formulations and processes for its manufacture
WO2002066026A2 (de) * 2001-02-21 2002-08-29 Grünenthal GmbH Arzneimittel auf basis von tramadol

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009534429A (ja) * 2006-04-26 2009-09-24 アルファファーム ピーティーワイ リミテッド コーティングされていない分離したユニットおよび延長放出マトリクスを含む制御放出配合物
JP2019519488A (ja) * 2016-05-05 2019-07-11 アクエスティブ セラピューティクス インコーポレイテッド 透過性増強された医薬組成物

Also Published As

Publication number Publication date
RU2328275C2 (ru) 2008-07-10
IL168114A (en) 2011-05-31
NO20052479L (no) 2005-05-23
PT1594460E (pt) 2008-06-27
CA2503155A1 (en) 2004-05-06
NO20052479D0 (no) 2005-05-23
WO2004037222A2 (en) 2004-05-06
UA84277C2 (ru) 2008-10-10
RU2005115855A (ru) 2006-01-20
AU2003275855A1 (en) 2004-05-13
KR20050083816A (ko) 2005-08-26
WO2004037222A3 (en) 2005-09-22
AU2003275855B2 (en) 2009-04-23
AR045972A1 (es) 2005-11-23

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