[go: up one dir, main page]

WO2010003078A3 - Processus de granulation par fusion - Google Patents

Processus de granulation par fusion Download PDF

Info

Publication number
WO2010003078A3
WO2010003078A3 PCT/US2009/049548 US2009049548W WO2010003078A3 WO 2010003078 A3 WO2010003078 A3 WO 2010003078A3 US 2009049548 W US2009049548 W US 2009049548W WO 2010003078 A3 WO2010003078 A3 WO 2010003078A3
Authority
WO
WIPO (PCT)
Prior art keywords
granulation process
melt granulation
quinoline compound
extruder
contain
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.)
Ceased
Application number
PCT/US2009/049548
Other languages
English (en)
Other versions
WO2010003078A2 (fr
Inventor
Zhihui Qiu
Shoufeng Li
Daniel Eliot Benjamin
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Novartis AG
Original Assignee
Novartis AG
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
Application filed by Novartis AG filed Critical Novartis AG
Priority to CN200980125276XA priority Critical patent/CN102076329B/zh
Priority to BRPI0913843A priority patent/BRPI0913843A2/pt
Priority to CA2729596A priority patent/CA2729596A1/fr
Priority to EP09774527A priority patent/EP2309987B1/fr
Priority to MX2010014566A priority patent/MX2010014566A/es
Priority to US13/000,044 priority patent/US20110092515A1/en
Priority to ES09774527T priority patent/ES2393949T3/es
Priority to RU2011103651/15A priority patent/RU2491918C2/ru
Priority to JP2011516879A priority patent/JP2011526928A/ja
Priority to PL09774527T priority patent/PL2309987T3/pl
Priority to AU2009266833A priority patent/AU2009266833B2/en
Publication of WO2010003078A2 publication Critical patent/WO2010003078A2/fr
Publication of WO2010003078A3 publication Critical patent/WO2010003078A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • A61K9/1682—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
    • 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
    • A61K31/4709—Non-condensed quinolines and containing further heterocyclic rings
    • 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
    • A61K9/20—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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L’invention concerne un processus de préparation de formes pharmaceutiques solides contenant un composé de quinoléine. Le processus, par exemple, fournit l’utilisation inventive d’une extrudeuse, en particulier d’une extrudeuse à double vis, pour granuler par fusion le composé de quinoléine avec un excipient de granulation.
PCT/US2009/049548 2008-07-03 2009-07-02 Processus de granulation par fusion Ceased WO2010003078A2 (fr)

Priority Applications (11)

Application Number Priority Date Filing Date Title
CN200980125276XA CN102076329B (zh) 2008-07-03 2009-07-02 熔融制粒法
BRPI0913843A BRPI0913843A2 (pt) 2008-07-03 2009-07-02 processo de granulação por fusão
CA2729596A CA2729596A1 (fr) 2008-07-03 2009-07-02 Processus de granulation par fusion
EP09774527A EP2309987B1 (fr) 2008-07-03 2009-07-02 Processus de granulation par fusion
MX2010014566A MX2010014566A (es) 2008-07-03 2009-07-02 Proceso de granulacion de fundido.
US13/000,044 US20110092515A1 (en) 2008-07-03 2009-07-02 Melt granulation process
ES09774527T ES2393949T3 (es) 2008-07-03 2009-07-02 Proceso de granulación en estado fundido
RU2011103651/15A RU2491918C2 (ru) 2008-07-03 2009-07-02 Способ грануляции из расплава
JP2011516879A JP2011526928A (ja) 2008-07-03 2009-07-02 溶融造粒方法
PL09774527T PL2309987T3 (pl) 2008-07-03 2009-07-02 Granulacja metodą stapiania
AU2009266833A AU2009266833B2 (en) 2008-07-03 2009-07-02 Melt granulation process

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US13385108P 2008-07-03 2008-07-03
US61/133,851 2008-07-03

Publications (2)

Publication Number Publication Date
WO2010003078A2 WO2010003078A2 (fr) 2010-01-07
WO2010003078A3 true WO2010003078A3 (fr) 2010-05-27

Family

ID=41328880

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2009/049548 Ceased WO2010003078A2 (fr) 2008-07-03 2009-07-02 Processus de granulation par fusion

Country Status (14)

Country Link
US (1) US20110092515A1 (fr)
EP (1) EP2309987B1 (fr)
JP (1) JP2011526928A (fr)
KR (1) KR20110031485A (fr)
CN (1) CN102076329B (fr)
AU (1) AU2009266833B2 (fr)
BR (1) BRPI0913843A2 (fr)
CA (1) CA2729596A1 (fr)
ES (1) ES2393949T3 (fr)
MX (1) MX2010014566A (fr)
PL (1) PL2309987T3 (fr)
PT (1) PT2309987E (fr)
RU (1) RU2491918C2 (fr)
WO (1) WO2010003078A2 (fr)

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
DE102005005446A1 (de) * 2005-02-04 2006-08-10 Grünenthal GmbH Bruchfeste Darreichungsformen mit retardierter Freisetzung
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
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
EP2249811A1 (fr) 2008-01-25 2010-11-17 Grünenthal GmbH Forme posologique pharmaceutique
KR101690094B1 (ko) 2008-05-09 2016-12-27 그뤼넨탈 게엠베하 분무 응결 단계의 사용하에 중간 분말 제형 및 최종 고체 제형을 제조하는 방법
SI2456424T1 (sl) * 2009-07-22 2013-10-30 Gruenenthal Gmbh Oksidacijsko stabilizirana odmerna oblika, varna pred zlorabo
AR077493A1 (es) 2009-07-22 2011-08-31 Gruenenthal Gmbh Composicion farmaceutica extruida en caliente con liberacion controlada. procedimiento de preparacion
EP2531176B1 (fr) * 2010-02-03 2016-09-07 Grünenthal GmbH Préparation de composition pharmaceutique en poudre au moyen d'une extrudeuse
MX2013002377A (es) 2010-09-02 2013-04-29 Gruenenthal Gmbh Forma de dosificacion resistente a manipulacion que comprende una sal inorganica.
PL2611425T3 (pl) 2010-09-02 2014-09-30 Gruenenthal Gmbh Odporna na ingerencję postać dawki zawierająca polimer anionowy
EP2736497B1 (fr) 2011-07-29 2017-08-23 Grünenthal GmbH Comprimé multiparticulaire inviolable fournissant une libération immédiate de médicament
JP2014524925A (ja) 2011-07-29 2014-09-25 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 即時薬剤放出を提供するタンパーレジスタント錠剤
MX356421B (es) 2012-02-28 2018-05-29 Gruenenthal Gmbh Forma de dosificacion resistente a la manipulacion indebida que comprende un compuesto farmacologicamente activo y un polimero anionico.
AR090695A1 (es) 2012-04-18 2014-12-03 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
GB2502080A (en) * 2012-05-15 2013-11-20 Univ Bradford Preparation of metastable polymorphs of active pharmaceutical ingredients
US9395468B2 (en) 2012-08-27 2016-07-19 Ocular Dynamics, Llc Contact lens with a hydrophilic layer
US9956709B2 (en) * 2013-05-27 2018-05-01 Steerlife India Private Limited Hot melt fragmentation extruder and process
MX371432B (es) 2013-05-29 2020-01-30 Gruenenthal Gmbh Forma de dosificacion resistente al uso indebido que contiene una o mas particulas.
US9737490B2 (en) 2013-05-29 2017-08-22 Grünenthal GmbH Tamper resistant dosage form with bimodal release profile
EA032465B1 (ru) 2013-07-12 2019-05-31 Грюненталь Гмбх Защищенная от применения не по назначению пероральная фармацевтическая лекарственная форма, содержащая этиленвинилацетатный полимер, и способ ее изготовления
AU2014348502B2 (en) 2013-11-15 2019-08-15 Tangible Science, Inc. Contact lens with a hydrophilic layer
BR112016010482B1 (pt) 2013-11-26 2022-11-16 Grünenthal GmbH Preparação de uma composição farmacêutica em pó por meio de criomoagem
MX2016014738A (es) 2014-05-12 2017-03-06 Gruenenthal Gmbh Formulacion en capsula de liberacion inmediata resistente a alteraciones que comprende tapentadol.
MX2016015417A (es) 2014-05-26 2017-02-22 Gruenenthal Gmbh Multiparticulas protegidas contra vertido de dosis etanolico.
AU2015360637B2 (en) 2014-12-09 2019-08-22 Tangible Science, Inc. Medical device coating with a biocompatible layer
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
WO2017042325A1 (fr) 2015-09-10 2017-03-16 Grünenthal GmbH Protection contre un surdosage par voie orale à l'aide de formulations à libération immédiate dissuasives d'abus
US10342886B2 (en) 2016-01-26 2019-07-09 S.C. Johnson & Son, Inc. Extruded wax melt and method of producing same
US10010638B2 (en) 2016-06-14 2018-07-03 S. C. Johnson & Son, Inc. Wax melt with filler
KR102530612B1 (ko) * 2020-08-21 2023-05-09 한국휴텍스제약 주식회사 자가과립화 기법을 이용한 딜티아젬 서방정 조성물의 제조방법

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20010036476A1 (en) * 1994-11-04 2001-11-01 Euro-Celtique S.A. Melt-extruded orally administrable opioid formulations
WO2007064719A2 (fr) * 2005-11-29 2007-06-07 Novartis Ag Formulations de quinolinones

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19504832A1 (de) * 1995-02-14 1996-08-22 Basf Ag Feste Wirkstoff-Zubereitungen
HN1998000115A (es) * 1997-08-21 1999-06-02 Warner Lambert Co Formas de dosificación farmacéuticas sólidas
RU2377988C2 (ru) * 2004-02-20 2010-01-10 Новартис Вэксинес Энд Дайэгностикс, Инк. Модуляция воспалительных и метастатических процессов
CN101166517B (zh) * 2005-05-10 2012-01-04 诺瓦提斯公司 制备含有可压性差的治疗性化合物的组合物的挤压方法
WO2006122021A1 (fr) * 2005-05-10 2006-11-16 Novartis Ag Procede d'extrusion permettant de fabriquer des compositions renfermant des composes therapeutiques peu compressibles
KR101368519B1 (ko) * 2005-05-23 2014-02-27 노파르티스 아게 결정형 및 기타 형태의 4-아미노-5-플루오로-3-［6-(4-메틸피페라진-1-일)-1ｈ-벤즈이미다졸-2-일］-1ｈ-퀴놀린-2-온 락트산염
CN101316593B (zh) * 2005-11-29 2012-05-02 诺瓦提斯公司 喹啉酮类的制剂

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20010036476A1 (en) * 1994-11-04 2001-11-01 Euro-Celtique S.A. Melt-extruded orally administrable opioid formulations
WO2007064719A2 (fr) * 2005-11-29 2007-06-07 Novartis Ag Formulations de quinolinones

Also Published As

Publication number Publication date
CN102076329A (zh) 2011-05-25
RU2011103651A (ru) 2012-08-10
CA2729596A1 (fr) 2010-01-07
PL2309987T3 (pl) 2013-01-31
WO2010003078A2 (fr) 2010-01-07
AU2009266833B2 (en) 2013-01-31
BRPI0913843A2 (pt) 2015-10-20
CN102076329B (zh) 2013-03-06
KR20110031485A (ko) 2011-03-28
PT2309987E (pt) 2012-12-13
RU2491918C2 (ru) 2013-09-10
MX2010014566A (es) 2011-02-15
US20110092515A1 (en) 2011-04-21
JP2011526928A (ja) 2011-10-20
EP2309987A2 (fr) 2011-04-20
ES2393949T3 (es) 2013-01-02
EP2309987B1 (fr) 2012-08-29
AU2009266833A1 (en) 2010-01-07

Similar Documents

Publication Publication Date Title
WO2010003078A3 (fr) Processus de granulation par fusion
TNSN07415A1 (en) Extrusion process for making compositions with poorly compressible therapeutic compounds
EP2194093B8 (fr) Composition de résine, composition de résine de moulage préparée à l'aide de celle-ci, stratifiés et procédé de fabrication des stratifiés
IL219530A (en) Converted 4-aminocyclohexane compounds, drugs containing these compounds and their use in the preparation of drugs
TN2009000093A1 (en) Pharmaceutical compositions comprising nilotinib or its salt
IL198423A0 (en) Granules, tablets an granulation
WO2008046581A3 (fr) Composés tétrahydropyrrolopyrazine substitués et leur utilisation dans des médicaments
WO2012010401A3 (fr) Mélange plastique
WO2010015657A3 (fr) Nouveaux alcoxypyrazoles
EP2083032A4 (fr) Composition polymérisable, résine réticulable, procédé de production et d'utilisation
IL208540A0 (en) Process for preparing 2-(aminomethylidene)-4,4-difluoro-3-oxobutyric esters
EP2573130A4 (fr) Pastilles de mélange-maître, leur procédé de fabrication et composition de résine de polyamide contenant les pastilles de mélange-maître
EP1997848A4 (fr) Film polymere avec addition de compose norbornene, procede de production de celui-ci et son utilisation
WO2012085927A3 (fr) Compositions de tadalafil
WO2009092702A3 (fr) Carboxylate de ((2s,4r)-4,6-dihydroxytétrahydro-2h-pyran-2-yl)méthyle et son procédé de fabrication
EP2138531A4 (fr) Procédé de production de résine réticulée d'acétal de polyvinyle, et résine réticulée d'acétal de polyvinyle
EP2137126A4 (fr) Procédé à cisaillement élevé pour production de cyclohexanol
ZA201004118B (en) Process for the production of 1,2-propanediol
GB0922333D0 (en) Granulate, process for the production of use thereof
WO2011087765A3 (fr) Procédés de production de compositions pharmaceutiques galéniques solides stabilisées contenant des morphinanes
FR2931154B1 (fr) Copolymere amphiphile a blocs, procede pour sa preparation
SI2473492T1 (sl) Postopek za pripravo(1S,4R)-2-oksa-3-azabiciklo(2.2.1)hept-5-enov
FR2909671B1 (fr) Procede de preparation de composes 1,3,2-oxazaborolidines
HU228212B1 (en) Process for the preparation of 1-(3,4-dimethoxy-phenyl)-5-ethyl-7,8-dimethoxy-4-methyl-5h-2,3-benzodiazepine with high purity
PL385054A1 (pl) Czynny układ uplastyczniający, zwłaszcza wytłaczarki ślimakowej

Legal Events

Date Code Title Description
WWE Wipo information: entry into national phase

Ref document number: 200980125276.X

Country of ref document: CN

121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 09774527

Country of ref document: EP

Kind code of ref document: A2

DPE1 Request for preliminary examination filed after expiration of 19th month from priority date (pct application filed from 20040101)
WWE Wipo information: entry into national phase

Ref document number: 2009266833

Country of ref document: AU

WWE Wipo information: entry into national phase

Ref document number: 13000044

Country of ref document: US

WWE Wipo information: entry into national phase

Ref document number: MX/A/2010/014566

Country of ref document: MX

WWE Wipo information: entry into national phase

Ref document number: 2009774527

Country of ref document: EP

WWE Wipo information: entry into national phase

Ref document number: 9189/DELNP/2010

Country of ref document: IN

ENP Entry into the national phase

Ref document number: 2011516879

Country of ref document: JP

Kind code of ref document: A

ENP Entry into the national phase

Ref document number: 2729596

Country of ref document: CA

NENP Non-entry into the national phase

Ref country code: DE

ENP Entry into the national phase

Ref document number: 2009266833

Country of ref document: AU

Date of ref document: 20090702

Kind code of ref document: A

ENP Entry into the national phase

Ref document number: 20117002593

Country of ref document: KR

Kind code of ref document: A

WWE Wipo information: entry into national phase

Ref document number: 2011103651

Country of ref document: RU

ENP Entry into the national phase

Ref document number: PI0913843

Country of ref document: BR

Kind code of ref document: A2

Effective date: 20101231