DK0654263T3 - Fremgangsmåde til fremstilling af et præparat med langvarig frigivelse - Google Patents

Fremgangsmåde til fremstilling af et præparat med langvarig frigivelse

Info

Publication number
DK0654263T3
DK0654263T3 DK94308493T DK94308493T DK0654263T3 DK 0654263 T3 DK0654263 T3 DK 0654263T3 DK 94308493 T DK94308493 T DK 94308493T DK 94308493 T DK94308493 T DK 94308493T DK 0654263 T3 DK0654263 T3 DK 0654263T3
Authority
DK
Denmark
Prior art keywords
preparation
sustained release
carrier
mixture
agglomerates
Prior art date
Application number
DK94308493T
Other languages
Danish (da)
English (en)
Inventor
Stewart Thomas Leslie
Derek Allan Prater
Sandra Therese Antoi Malkowska
Trevor John Knott
Ronald Brown Miller
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/en
Priority claimed from EP94304144A external-priority patent/EP0636370B2/en
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 DK0654263T3 publication Critical patent/DK0654263T3/da

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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Emergency Medicine (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Pain & Pain Management (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)
  • Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
  • Manufacturing Of Micro-Capsules (AREA)
DK94308493T 1993-11-23 1994-11-17 Fremgangsmåde til fremstilling af et præparat med langvarig frigivelse DK0654263T3 (da)

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 (en) 1993-05-10 1994-04-29 Controlled release formulation containing tramadol
EP94304144A EP0636370B2 (en) 1993-07-01 1994-06-09 Sustained release compositions containing morphine
GB9411842A GB9411842D0 (en) 1994-06-14 1994-06-14 Pharmaceutical preparation

Publications (1)

Publication Number Publication Date
DK0654263T3 true DK0654263T3 (da) 2002-04-29

Family

ID=27562143

Family Applications (1)

Application Number Title Priority Date Filing Date
DK94308493T DK0654263T3 (da) 1993-11-23 1994-11-17 Fremgangsmåde til fremstilling af et præparat med langvarig frigivelse

Country Status (17)

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

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GB9514842D0 (en) * 1995-07-20 1995-09-20 Smithkline Beecham Plc Novel formulation
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GB9519363D0 (en) * 1995-09-22 1995-11-22 Euro Celtique Sa Pharmaceutical formulation
GB9713549D0 (en) * 1996-10-18 1997-09-03 Euro Celtique Sa Pharmaceutical combination formulation
BE1010803A3 (fr) * 1996-12-16 1999-02-02 Therabel Research Sa Comprimes pharmaceutiques a liberation prolongee a base de tramadol et leur preparation.
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
SI1041987T1 (sl) 1997-12-22 2006-10-31 Euro Celtique Sa Farmacevtska oralna dozirna oblika, ki obsega kombinacijo opioidnega agonista in naltreksona
US6375957B1 (en) 1997-12-22 2002-04-23 Euro-Celtique, S.A. Opioid agonist/opioid antagonist/acetaminophen combinations
DE19901683B4 (de) * 1999-01-18 2005-07-21 Grünenthal GmbH Analgetikum mit kontrollierter Wirkstofffreisetzung
DE19901687B4 (de) * 1999-01-18 2006-06-01 Grünenthal GmbH Opioide Analgetika 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
SK285128B6 (sk) 1999-12-28 2006-07-07 Zentiva, A. S. Liečivý prípravok s riadeným uvoľňovaním obsahujúci tramadol hydrochlorid a spôsob jeho prípravy
AU2002305559B2 (en) 2001-05-11 2008-04-03 Mundipharma Pty Limited Abuse-resistant controlled-release opioid dosage form
KR100717591B1 (ko) 2002-04-05 2007-05-15 유로-셀띠끄 소시에떼 아노님 활성 화합물의 지속적, 불변적 및 독립적 방출용 매트릭스
US7776314B2 (en) 2002-06-17 2010-08-17 Grunenthal Gmbh Abuse-proofed dosage system
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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
US20070048228A1 (en) 2003-08-06 2007-03-01 Elisabeth Arkenau-Maric Abuse-proofed dosage form
DE10336400A1 (de) 2003-08-06 2005-03-24 Grünenthal GmbH Gegen Missbrauch gesicherte Darreichungsform
DE102005005446A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Bruchfeste Darreichungsformen mit retardierter Freisetzung
DE102004032051A1 (de) 2004-07-01 2006-01-19 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten, festen Darreichungsform
US8075872B2 (en) 2003-08-06 2011-12-13 Gruenenthal Gmbh Abuse-proofed dosage form
EP1604666A1 (en) 2004-06-08 2005-12-14 Euro-Celtique S.A. Opioids for the treatment of the Chronic Obstructive Pulmonary Disease (COPD)
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 (en) 2005-02-28 2006-09-20 Euro-Celtique S.A. Method and device for the assessment of bowel function
EP1940467B1 (en) 2005-09-09 2016-11-02 Paladin Labs Inc. Sustained drug release composition
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
NZ586792A (en) 2008-01-25 2012-09-28 Gruenenthal Chemie Tamper resistant controlled release pharmaceutical tablets form having convex and concave surfaces
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
NZ595663A (en) 2009-03-10 2013-11-29 Euro Celtique Sa Immediate release pharmaceutical compositions comprising oxycodone and naloxone
DE102009019268A1 (de) * 2009-04-28 2010-11-11 Lts Lohmann Therapie-Systeme Ag Arzneimittel mit poröser Matrix
PL2456427T3 (pl) 2009-07-22 2015-07-31 Gruenenthal Gmbh Wytłaczana na gorąco postać dawki o kontrolowanym uwalnianiu
CN102573806B (zh) 2009-07-22 2015-02-25 格吕伦塔尔有限公司 用于对氧化敏感的阿片类物质的抗破坏剂型
AU2011297892B2 (en) 2010-09-02 2014-05-29 Grunenthal Gmbh Tamper resistant dosage form comprising an anionic polymer
WO2012028319A1 (en) 2010-09-02 2012-03-08 Grünenthal GmbH Tamper resistant dosage form comprising inorganic salt
NO2736497T3 (cs) 2011-07-29 2018-01-20
AR087360A1 (es) 2011-07-29 2014-03-19 Gruenenthal Gmbh Tableta a prueba de manipulacion que proporciona liberacion de farmaco inmediato
EP2819656A1 (en) 2012-02-28 2015-01-07 Grünenthal GmbH Tamper-resistant dosage form comprising pharmacologically active compound and anionic polymer
WO2013156453A1 (en) 2012-04-18 2013-10-24 Grünenthal GmbH Tamper resistant and dose-dumping resistant pharmaceutical dosage form
US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
BR112015026549A2 (pt) 2013-05-29 2017-07-25 Gruenenthal Gmbh forma de dosagem à prova de violação contendo uma ou mais partículas
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
EP3019157A1 (en) 2013-07-12 2016-05-18 Grünenthal GmbH Tamper-resistant dosage form containing ethylene-vinyl acetate polymer
KR20160034352A (ko) 2013-07-23 2016-03-29 유로-셀티큐 에스.에이. 장내 세균총이상을 초래하고/하거나 장내 박테리아 전위에 대한 위험을 증가시키는 질환과 통증으로 인해 고통받고 있는 환자에서 통증을 치료하는데 사용하기 위한 옥시코돈과 날록손의 조합물
EP3073994A1 (en) 2013-11-26 2016-10-05 Grünenthal GmbH Preparation of a powdery pharmaceutical composition by means of cryo-milling
CN106572980A (zh) 2014-05-12 2017-04-19 格吕伦塔尔有限公司 包含他喷他多的防篡改即释胶囊制剂
WO2015181059A1 (en) 2014-05-26 2015-12-03 Grünenthal GmbH Multiparticles safeguarded against ethanolic dose-dumping
EP3285745A1 (en) 2015-04-24 2018-02-28 Grünenthal GmbH Tamper-resistant dosage form with immediate release and resistance against solvent extraction
US10842750B2 (en) 2015-09-10 2020-11-24 Grünenthal GmbH Protecting oral overdose with abuse deterrent immediate release formulations
CA3085348A1 (en) 2017-12-20 2019-06-27 Purdue Pharma L.P. Abuse deterrent morphine sulfate dosage forms
CN115248141A (zh) * 2021-04-28 2022-10-28 北京泰德制药股份有限公司 一种制备缓释药物组合物检测样品的方法

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SE9003296L (sv) * 1990-10-16 1992-04-17 Kabi Pharmacia Ab Foerfarande foer att formulera laekemedel
SE9200858L (sv) * 1992-03-20 1993-09-21 Kabi Pharmacia Ab Metod för framställning av pellets med fördröjd frisättning
CN1230154C (zh) * 1993-07-01 2005-12-07 欧洲凯尔特公司 缓释组合物及制备药用组合物的方法

Also Published As

Publication number Publication date
AU7901594A (en) 1995-06-01
NO314124B1 (no) 2003-02-03
DE69429710D1 (de) 2002-03-14
ATE212224T1 (de) 2002-02-15
NO944473L (no) 1995-05-24
CN1116521A (zh) 1996-02-14
EP0654263A1 (en) 1995-05-24
AU682223B2 (en) 1997-09-25
IL111709A (en) 2002-12-01
BG99198A (en) 1995-08-28
DE69429710T2 (de) 2002-08-08
CN1121213C (zh) 2003-09-17
CZ289650B6 (cs) 2002-03-13
JP2003113075A (ja) 2003-04-18
HU217205B (hu) 1999-12-28
NZ264953A (en) 1996-11-26
HUT74910A (en) 1997-03-28
HU9403353D0 (en) 1995-02-28
JPH07196475A (ja) 1995-08-01
SK280496B6 (sk) 2000-03-13
JP3411114B2 (ja) 2003-05-26
BG62429B1 (bg) 1999-11-30
FI113335B (fi) 2004-04-15
SK140694A3 (en) 1995-07-11
IL111709A0 (en) 1995-01-24
CZ286694A3 (en) 1995-06-14
FI945476A0 (fi) 1994-11-22
PT654263E (pt) 2002-06-28
EP0654263B1 (en) 2002-01-23
FI945476L (fi) 1995-05-24
ES2168290T3 (es) 2002-06-16
NO944473D0 (no) 1994-11-22
AU682223C (en) 2005-03-24

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