ATE212224T1 - Verfahren zur herstellung einer arzneizusammensetzung mit verzögerter wirkstoffabgabe - Google Patents

Verfahren zur herstellung einer arzneizusammensetzung mit verzögerter wirkstoffabgabe

Info

Publication number
ATE212224T1
ATE212224T1 AT94308493T AT94308493T ATE212224T1 AT E212224 T1 ATE212224 T1 AT E212224T1 AT 94308493 T AT94308493 T AT 94308493T AT 94308493 T AT94308493 T AT 94308493T AT E212224 T1 ATE212224 T1 AT E212224T1
Authority
AT
Austria
Prior art keywords
producing
delayed release
medicinal composition
carrier
mixture
Prior art date
Application number
AT94308493T
Other languages
English (en)
Inventor
Ronald Brown Miller
Stewart Thomas Leslie
Sandra Therese Antoi Malkowska
Derek Allan Prater
Trevor John Knott
Joanne Heafield
Deborah Challis
Original Assignee
Euro Celtique Sa
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
Priority claimed from GB9324045A external-priority patent/GB2284760B/en
Priority claimed from GB9403922A external-priority patent/GB2288117A/en
Priority claimed from GB9404544A external-priority patent/GB9404544D0/en
Priority claimed from GB9404928A external-priority patent/GB2287880A/en
Priority claimed from EP94303128A external-priority patent/EP0624366B1/de
Priority claimed from EP94304144A external-priority patent/EP0636370B2/de
Priority claimed from GB9411842A external-priority patent/GB9411842D0/en
Application filed by Euro Celtique Sa filed Critical Euro Celtique Sa
Application granted granted Critical
Publication of ATE212224T1 publication Critical patent/ATE212224T1/de

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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • A61K31/435—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
    • 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
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • 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
    • 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
    • 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
    • A61K9/2095—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
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
AT94308493T 1993-11-23 1994-11-17 Verfahren zur herstellung einer arzneizusammensetzung mit verzögerter wirkstoffabgabe ATE212224T1 (de)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
GB9324045A GB2284760B (en) 1993-11-23 1993-11-23 A method of preparing pharmaceutical compositions by melt pelletisation
GB9403922A GB2288117A (en) 1994-03-01 1994-03-01 Sustained release morphine
GB9404544A GB9404544D0 (en) 1994-03-09 1994-03-09 Controlled release formulation
GB9404928A GB2287880A (en) 1994-03-14 1994-03-14 Production of sustained release compositions
EP94303128A EP0624366B1 (de) 1993-05-10 1994-04-29 Tramadol enthaltendes Arzneimittel mit verzögerter Wirkstoffabgabe
EP94304144A EP0636370B2 (de) 1993-07-01 1994-06-09 Morphinenthaltende Arzneizusammensetzungen mit verzögerter Wirkstoffabgabe
GB9411842A GB9411842D0 (en) 1994-06-14 1994-06-14 Pharmaceutical preparation

Publications (1)

Publication Number Publication Date
ATE212224T1 true ATE212224T1 (de) 2002-02-15

Family

ID=27562143

Family Applications (1)

Application Number Title Priority Date Filing Date
AT94308493T ATE212224T1 (de) 1993-11-23 1994-11-17 Verfahren zur herstellung einer arzneizusammensetzung mit verzögerter wirkstoffabgabe

Country Status (17)

Country Link
EP (1) EP0654263B1 (de)
JP (2) JP3411114B2 (de)
CN (1) CN1121213C (de)
AT (1) ATE212224T1 (de)
AU (1) AU682223C (de)
BG (1) BG62429B1 (de)
CZ (1) CZ289650B6 (de)
DE (1) DE69429710T2 (de)
DK (1) DK0654263T3 (de)
ES (1) ES2168290T3 (de)
FI (1) FI113335B (de)
HU (1) HU217205B (de)
IL (1) IL111709A (de)
NO (1) NO314124B1 (de)
NZ (1) NZ264953A (de)
PT (1) PT654263E (de)
SK (1) SK280496B6 (de)

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DE19729487A1 (de) * 1997-07-10 1999-01-14 Dresden Arzneimittel Verfahren zur Herstellung von Wirkstoff-Zubereitungen mit kontrollierter Freisetzung aus einer Matrix
RS49982B (sr) 1997-09-17 2008-09-29 Euro-Celtique S.A., Sinergistička analgetička kombinacija analgetičkog opijata i inhibitora ciklooksigenaze-2
US6375957B1 (en) 1997-12-22 2002-04-23 Euro-Celtique, S.A. Opioid agonist/opioid antagonist/acetaminophen combinations
SI1685839T1 (sl) 1997-12-22 2013-08-30 Euro-Celtique S.A. Farmacevtska oralna dozirna oblika, ki vsebuje kombinacijo opioidnega agonista in opioidnega antagonista
DE19901687B4 (de) * 1999-01-18 2006-06-01 Grünenthal GmbH Opioide Analgetika mit kontrollierter Wirkstofffreisetzung
DE19901683B4 (de) * 1999-01-18 2005-07-21 Grünenthal GmbH Analgetikum mit kontrollierter Wirkstofffreisetzung
DE19923551A1 (de) * 1999-05-21 2000-11-30 Lohmann Therapie Syst Lts Pharmazeutisches Präparat mit dem Wirkstoff Diamorphin und seine Verwendung in einem Verfahren zur Behandlung der Opiatsucht
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WO2002092060A1 (en) 2001-05-11 2002-11-21 Endo Pharmaceuticals, Inc. Abuse-resistant controlled-release opioid dosage form
ES2546010T3 (es) 2002-04-05 2015-09-17 Euro-Celtique S.A. Preparación farmacéutica que contiene oxicodona y naloxona
US7776314B2 (en) 2002-06-17 2010-08-17 Grunenthal Gmbh Abuse-proofed dosage system
TWI319713B (en) 2002-10-25 2010-01-21 Sustained-release tramadol formulations with 24-hour efficacy
US8487002B2 (en) 2002-10-25 2013-07-16 Paladin Labs Inc. Controlled-release compositions
DE10300325A1 (de) 2003-01-09 2004-07-22 Hexal Ag Granulat mit öliger Substanz, Herstellungsverfahren und Tablette
DE10361596A1 (de) 2003-12-24 2005-09-29 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
DE102004032051A1 (de) 2004-07-01 2006-01-19 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten, festen Darreichungsform
US20070048228A1 (en) 2003-08-06 2007-03-01 Elisabeth Arkenau-Maric Abuse-proofed dosage form
DE102005005446A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Bruchfeste Darreichungsformen mit retardierter Freisetzung
US8075872B2 (en) 2003-08-06 2011-12-13 Gruenenthal Gmbh Abuse-proofed dosage form
DE10336400A1 (de) 2003-08-06 2005-03-24 Grünenthal GmbH Gegen Missbrauch gesicherte Darreichungsform
EP1604666A1 (de) 2004-06-08 2005-12-14 Euro-Celtique S.A. Opioide zur Behandlung der chronischen obstruktiven Lungenkrankheit
DE102004032049A1 (de) 2004-07-01 2006-01-19 Grünenthal GmbH Gegen Missbrauch gesicherte, orale Darreichungsform
AR050615A1 (es) 2004-08-27 2006-11-08 Novartis Ag Composiciones farmaceuticas para la administracion oral
GB2418854B (en) 2004-08-31 2009-12-23 Euro Celtique Sa Multiparticulates
DE102005005449A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
EP1702558A1 (de) 2005-02-28 2006-09-20 Euro-Celtique S.A. Verfahren und Vorrichtung zur Darmtätigkeitserfassung
PL1931346T3 (pl) 2005-09-09 2013-01-31 Angelini Labopharm Llc Kompozycja trazodonu do podawania raz na dobę
WO2007105016A1 (en) * 2006-03-16 2007-09-20 Euro-Celtique S.A. Pharmaceutical spheroids
SA07280459B1 (ar) 2006-08-25 2011-07-20 بيورديو فارما إل. بي. أشكال جرعة صيدلانية للتناول عن طريق الفم مقاومة للعبث تشتمل على مسكن شبه أفيوني
DE102007011485A1 (de) 2007-03-07 2008-09-11 Grünenthal GmbH Darreichungsform mit erschwertem Missbrauch
JP5774853B2 (ja) 2008-01-25 2015-09-09 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 医薬投薬形
WO2009135680A1 (en) 2008-05-09 2009-11-12 Grünenthal GmbH Process for the preparation of an intermediate powder formulation and a final solid dosage form under usage of a spray congealing step
KR20110133602A (ko) 2009-03-10 2011-12-13 유로-셀티큐 에스.에이. 옥시코돈 및 날록손을 포함하는 즉시 방출 제약 조성물
DE102009019268A1 (de) * 2009-04-28 2010-11-11 Lts Lohmann Therapie-Systeme Ag Arzneimittel mit poröser Matrix
CA2765971C (en) 2009-07-22 2017-08-22 Gruenenthal Gmbh Hot-melt extruded controlled release dosage form
AU2010275755B2 (en) 2009-07-22 2014-04-24 Grünenthal GmbH Oxidation-stabilized tamper-resistant dosage form
EP2611426B1 (de) 2010-09-02 2014-06-25 Grünenthal GmbH Manipulationssichere darreichungsform mit einem anorganischen salz
PL2611425T3 (pl) 2010-09-02 2014-09-30 Gruenenthal Gmbh Odporna na ingerencję postać dawki zawierająca polimer anionowy
PT2736495T (pt) 2011-07-29 2017-11-30 Gruenenthal Gmbh Comprimido resistente à adulteração proporcionando libertação imediata de fármaco
HUE034710T2 (hu) 2011-07-29 2018-02-28 Gruenenthal Gmbh Visszaéléssel szemben ellenálló, azonnali hatóanyagfelszabadulást biztosító tabletta
WO2013127831A1 (en) 2012-02-28 2013-09-06 Grünenthal GmbH Tamper-resistant dosage form comprising pharmacologically active compound and anionic polymer
MX362357B (es) 2012-04-18 2019-01-14 Gruenenthal Gmbh Forma de dosificacion farmaceutica resistente a la adulteracion y resistente a la liberacion inmediata de la dosis.
US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
EP3003279A1 (de) 2013-05-29 2016-04-13 Grünenthal GmbH Manipulationssichere darreichungsform mit einem oder mehreren partikeln
EP3003283A1 (de) 2013-05-29 2016-04-13 Grünenthal GmbH Manipulationssichere darreichungsform mit bimodalem freisetzungsprofil
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
MX2016000810A (es) 2013-07-23 2016-08-05 Euro Celtique Sa Combinacion de oxicodona y naloxona para su uso en el tratamiento de dolor en pacientes que sufren de dolor y una enfermedad que resulta la disbiosis intestinal y/o aumento del riesgo de la translocacion bacteriana intestinal.
WO2015078891A1 (en) 2013-11-26 2015-06-04 Farmaceutici Formenti S.P.A. Preparation of a powdery pharmaceutical composition by means of cryo-milling
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Also Published As

Publication number Publication date
HUT74910A (en) 1997-03-28
DE69429710T2 (de) 2002-08-08
FI113335B (fi) 2004-04-15
CZ286694A3 (en) 1995-06-14
HU217205B (hu) 1999-12-28
NO314124B1 (no) 2003-02-03
NO944473L (no) 1995-05-24
FI945476A0 (fi) 1994-11-22
DE69429710D1 (de) 2002-03-14
CN1116521A (zh) 1996-02-14
PT654263E (pt) 2002-06-28
EP0654263A1 (de) 1995-05-24
SK140694A3 (en) 1995-07-11
EP0654263B1 (de) 2002-01-23
BG99198A (en) 1995-08-28
BG62429B1 (bg) 1999-11-30
CN1121213C (zh) 2003-09-17
IL111709A (en) 2002-12-01
AU7901594A (en) 1995-06-01
JP2003113075A (ja) 2003-04-18
NZ264953A (en) 1996-11-26
ES2168290T3 (es) 2002-06-16
FI945476A (fi) 1995-05-24
JP3411114B2 (ja) 2003-05-26
SK280496B6 (sk) 2000-03-13
NO944473D0 (no) 1994-11-22
IL111709A0 (en) 1995-01-24
CZ289650B6 (cs) 2002-03-13
JPH07196475A (ja) 1995-08-01
AU682223B2 (en) 1997-09-25
DK0654263T3 (da) 2002-04-29
HU9403353D0 (en) 1995-02-28
AU682223C (en) 2005-03-24

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UEP Publication of translation of european patent specification